BECKMAN COULTER

CHEMISTRY ANALYZER

AU480
USER GUIDE
© 2009 Beckman Coulter Biomedical K.K.. All Rights Reserved.
Beckman Coulter AU480 User Guide.
This User Guide as well as the system described in it may be used or copied only in accordance with
the terms of copyright. The content of this User Guide is intended for instructional use only and is
subject to change without notice.
No part of this publication may be reproduced, stored in a retrieval system, or transmitted, in any form
or by any means, electronic, mechanical or otherwise, without the prior written permission of Beckman
Coulter Biomedical K.K..
Please remember that existing artwork or images from this guide that you may want to include in your
project may be protected under copyright law.
The unauthorized incorporation of such material into your new work could be a violation of the rights of
the copyright owner. Please be sure to obtain any permission required from the copyright owner.
Any references to any company names or peoples names in sample templates and windows are for
demonstration purposes only and are not intended to refer to any actual organization or names of
persons.

Beckman Coulter Biomedical Limited.

Lismeehan, O’Callaghan’s EC REP
Mills, Co. Clare,
Ireland

Beckman Coulter Biomedical Limited. is the EC authorized representative of:

Beckman Coulter Biomedical K.K.

TOC Ariake West Tower,
3-5-7, Ariake,
Koutou-ku, Tokyo, 135-0063,
Japan

Beckman Coulter Mishima K.K.

454-32 Higashino,
Nagaizumi-cho,
Sunto-gun, Shizuoka, 411-0931,
Japan

Lumi-Phos ® 530 is a registered trademark of Lumigen, Inc., Southfield, Michigan, USA.

Windows ® is either a registered trademark or trademark of Microsoft Corporation in the United States
and/or other countries.
Adobe Acrobat® Reader ® is either a registered trademark or trademark of Adobe Systems
Incorporated in the United States and/or other countries.

Manufacturer Authorized Representative in the European

EC REP Community
Return to Main Table of Contents

Document Change Notification

Document Software Date AU480 User Guide change description

Revision Version
Number
1 1.0 2009/10/25 New manual

DCN-1
AU480 User Guide
Version 1.0
 Contents

Document Change Notification ...................................................................................Behind Cover Page

Introduction 1-1
1.1 Beckman Coulter Guarantee..................................................................................... 1-2
1.2 Using this Guide......................................................................................................... 1-2
1.2.1 Assumptions............................................................................................ 1-2
1.2.2 Where to Start . ....................................................................................... 1-3
1.2.3 System Installation . ................................................................................ 1-3
1.2.4 Users New to Automated Analyzers ....................................................... 1-3
1.2.5 System Administrators ............................................................................ 1-3
1.3 Using the Online Help . ............................................................................................. 1-4
1.4 Printing this User Guide ........................................................................................... 1-6
1.5 Typographical Conventions Used in this Guide .................................................... 1-7
1.5.1 Tips, Cautions and Warnings .................................................................. 1-7
1.5.2 Software Paths........................................................................................ 1-7
1.5.3 Software Buttons .................................................................................... 1-8
1.5.4 Window Illustrations ................................................................................ 1-8
1.5.5 Notation of Units ..................................................................................... 1-8

Precautions, Installation and Specifications 2-1

2.1 Safe Use of the System............................................................................................. 2-2
2.1.1 Observing Warning Labels ..................................................................... 2-3
2.1.2 Preventing Fire and Damage . ................................................................ 2-4
2.1.3 Preventing Electric Shocks...................................................................... 2-4
2.1.4 Preventing Damage to Other Equipment and Facilities . ........................ 2-4
2.1.5 Preventing Personal and Serious Injury ................................................. 2-5
2.1.6 Preventing Infection ................................................................................ 2-6
2.1.7 Handling the Keyboard, Monitor and Mouse .......................................... 2-6
2.1.8 Precautions for Operating the System . .................................................. 2-6
2.1.9 Ensuring Optimal Analytical Performance .............................................. 2-7
2.1.10 Performing Important Checks at Analysis . ............................................. 2-7
2.1.11 Handling Reagents, Wash Solutions, Calibrators and QC Samples ...... 2-8
2.1.12 Handling Samples . ................................................................................. 2-9
2.1.13 Managing Liquid Waste .......................................................................... 2-10
2.1.14 Managing Solid Waste ............................................................................ 2-10
2.1.15 Preventing Water Leaks ......................................................................... 2-10
2.1.16 Electromagnetic Wave and Noise Precautions . ..................................... 2-10
2.1.17 Replacing Parts and Routine Maintenance ............................................ 2-11
2.1.18 Setting Analysis Parameters . ................................................................. 2-11
2.1.19 Precautions for using the analyzer independently .................................. 2-11
2.1.20 Cleaning contaminants from the covers ................................................. 2-11
2.1.21 Other Precautions ................................................................................... 2-11
2.1.22 System Waste . ....................................................................................... 2-11
2.2 Installation Environment Precautions .................................................................... 2-12
2.2.1 Installation Environment ......................................................................... 2-12
2.2.2 System Specifications.............................................................................. 2-17
2.2.3 Installation Space Requirements ............................................................ 2-24
2.2.4 System Connections ............................................................................... 2-25


AU480 User Guide System Outline
Version 1.0
 2.3 System Labels and Displays . .................................................................................. 2-27
2.4 Trade Marks ............................................................................................................... 2-30

System Outline 3-1

3.1 How the AU480 Analyzes Samples .......................................................................... 3-3
3.1.1 Reagent Blank ........................................................................................ 3-3
3.1.2 End Point Assay . .................................................................................... 3-4
3.1.3 Rate Assay . ............................................................................................ 3-6
3.1.4 Fixed Point Assay ................................................................................... 3-6
3.1.5 Quality Control......................................................................................... 3-7
3.1.6 Summary of Calibration Types................................................................. 3-10
3.1.7 Principle of the ISE Measuring Method................................................... 3-10-4
3.2 Key Sub-Processes .................................................................................................. 3-11
3.2.1 Computer Automation ............................................................................. 3-11
3.2.2 Sample Identification .............................................................................. 3-12
3.2.3 Sample Transfer ..................................................................................... 3-13
3.2.4 Reagent Transfer .................................................................................... 3-13
3.2.5 Reaction Fluid Mixing ............................................................................. 3-13
3.2.6 Reaction Fluid Incubation and Washing ................................................. 3-13
3.2.7 Measurement by Photometry . ................................................................ 3-13
3.3 Understanding and Handling Reagents, Calibrators and Controls . .................... 3-14
3.3.1 Reagents ................................................................................................ 3-14
3.3.2 Sample diluent ........................................................................................ 3-14
3.3.3 Calibrator ................................................................................................ 3-14
3.3.4 QC control sample .................................................................................. 3-14
3.4 Understanding the System Hardware...................................................................... 3-15
3.4.1 System Switches and Buttons................................................................. 3-17
3.4.2 Rack Feeder Unit..................................................................................... 3-18
3.4.3 Hand Scanner (Optional) ........................................................................ 3-19
3.4.4 Sample Cups and Tubes ........................................................................ 3-19
3.4.5 Racks ...................................................................................................... 3-20
3.4.6 Sample Transfer Unit............................................................................... 3-21
3.4.7 Reagent Transfer Unit.............................................................................. 3-22
3.4.8 Mixing Unit............................................................................................... 3-22
3.4.9 Incubation Bath Unit................................................................................ 3-23
3.4.10 Photometry Unit....................................................................................... 3-23
3.4.11 Wash Nozzle Unit.................................................................................... 3-24
3.4.12 Reagent Refrigeration Unit...................................................................... 3-25
3.4.13 STAT Table Unit....................................................................................... 3-26
3.4.14 Syringe Unit............................................................................................. 3-28
3.4.15 Wash Solution Roller Pump Unit.............................................................. 3-28
3.4.16 Tank Storage............................................................................................ 3-29
3.4.17 Breakers and Fuses................................................................................. 3-30
3.4.18 ISE Unit (optional).................................................................................... 3-30
3.5 Understanding the Computer Software .................................................................. 3-32
3.5.1 Graphical User Interface (GUI)................................................................ 3-32
3.5.2 Main button bar . ..................................................................................... 3-33
3.5.3 Processing Time ..................................................................................... 3-33
3.5.4 Measure Modes ...................................................................................... 3-34
3.5.5 Touch Screen and Keyboard .................................................................. 3-35

Configuring Tests 4-1

4.1 Setting Analysis Mode .............................................................................................. 4-2
4.1.1 Set the common conditions for analysis.................................................. 4-2
4.1.2 Set the Rack Number Limit ..................................................................... 4-5
4.1.3 Parameter Setting for STAT Table Analysis ............................................ 4-6
4.2 Setting the System Time .......................................................................................... 4-8
4.3 Entering Online Settings........................................................................................... 4-9
4.3.1 Editing Online Conditions ....................................................................... 4-9
4.3.2 Setting the Online Protocol...................................................................... 4-12
4.3.3 Editing Online Data Format..................................................................... 4-13
4.3.4 Editing an Online Item Number . ............................................................. 4-14


System Outline AU480 User Guide
Version 1.0
 4.4 Entry of Test Items .................................................................................................... 4-15
4.4.1 Test Name Setting .................................................................................. 4-15
4.4.2 Creating a New Profile ............................................................................ 4-20
4.4.3 Adding the New Test to a Group ............................................................. 4-25
4.5 Setting Specific Test Parameters ............................................................................ 4-28
4.5.1 Set General Tests ................................................................................... 4-29
4.5.2 LIH Test Setting ...................................................................................... 4-32
4.5.3 ISE (option) Test Setting ......................................................................... 4-34
4.5.4 Set Calculated Test Items........................................................................ 4-35
4.5.5 Set the Range.......................................................................................... 4-37
4.6 Programming Repeat Tests . .................................................................................... 4-39
4.6.1 Repeat run Parameter Setting ................................................................ 4-40
4.6.2 Setting Specific Test Repeat-run Parameters ......................................... 4-42
4.7 Set Calibration Analysis ........................................................................................... 4-44
4.7.1 Calibrator Registration ............................................................................ 4-45
4.7.2 Set the Specific Calibration Parameters ................................................. 4-48
4.7.3 Set Calibration Using the STAT Table ..................................................... 4-53
4.8 Configuring QC Analysis . ........................................................................................ 4-57
4.8.1 Requesting QC Analysis ......................................................................... 4-58
4.8.2 Set the Specific Quality Control Parameters .......................................... 4-59
4.8.3 Set Quality Control Using the STAT Table .............................................. 4-64
4.9 Setting the Tests to be Checked .............................................................................. 4-67
4.10 Preventing Contamination ....................................................................................... 4-69
4.10.1 Preventing Contamination Between Items . ............................................ 4-70
4.10.2 Preventing Contamination Between Sample Types . .............................. 4-72
4.10.3 Setting the Contamination Prevention Conditions by Analysis Items ..... 4-73
4.11 Setting up Data Lists ................................................................................................ 4-74
4.11.1 Set the Basic Condition for Print . ........................................................... 4-74
4.12 Setting the test requisition format............................................................................ 4-78
4.12.1 Setting the test requisition format............................................................ 4-78

Preparing for Analysis 5-1

5.1 Starting the System .................................................................................................. 5-2
5.1.1 Switching on the System ........................................................................ 5-2
5.1.2 Logging into the System ......................................................................... 5-3
5.1.3 Updating Index......................................................................................... 5-4
5.2 Performing System Preparation .............................................................................. 5-6
5.2.1 Confirm the Analyzer Status and the Reagent . ...................................... 5-6
5.2.2 Check the Printer (Optional) and Paper . ................................................ 5-7
5.2.3 Performing Daily Maintenance . .............................................................. 5-8
5.2.4 Preparing for ISE (Optional) ................................................................... 5-9
5.3 Preparing the Reagent............................................................................................... 5-15
5.4 Preparing Samples for Analysis .............................................................................. 5-19
5.4.1 Attaching Barcode Labels to Sample Racks . ......................................... 5-19
5.4.2 Sample Barcode Specifications .............................................................. 5-20
5.4.3 Sample Cup Preparation ........................................................................ 5-23
5.4.4 Applying Barcode Labels to Sample Cups ............................................. 5-25
5.4.5 Sample Preparation ................................................................................ 5-26
5.4.6 Placing the Sample Cups/Tubes in the Rack ......................................... 5-27
5.4.7 Placing Racks on the Feeder................................................................... 5-32
5.5 Calibrating Tests ....................................................................................................... 5-34
5.6 Performing Quality Control (QC) ............................................................................. 5-38
5.7 Sample Requisitions: Entering Data and Choosing Tests .................................... 5-42
5.7.1 Group Setting . ........................................................................................ 5-43
5.7.2 Entering Manual Requisitions ................................................................. 5-45
5.7.3 Entering Batch Requisitions . .................................................................. 5-46
5.7.4 Downloading Requisitions from a Host Computer .................................. 5-48
5.7.5 Entering Requisitions for Emergency Samples ...................................... 5-49
5.7.6 Delete Requisition.................................................................................... 5-49


AU480 User Guide System Outline
Version 1.0
 Performing Analysis 6-1
6.1 Starting Analysis ....................................................................................................... 6-2
6.2 Monitoring Analysis................................................................................................... 6-3
6.3 Disable a Test ............................................................................................................ 6-9
6.4 Check Results ........................................................................................................... 6-11
6.4.1 Check the Test Results ........................................................................... 6-11
6.4.2 Displaying Reaction Monitor ................................................................... 6-11
6.4.3 Check the Calibration and Reagent Blank . ............................................ 6-15
6.4.4 Check for Error Flags and Alarms . ......................................................... 6-22
6.4.5 Check QC ............................................................................................... 6-23
6.5 Processing Emergency Samples ............................................................................ 6-29
6.5.1 Performing STAT Table Analysis ............................................................. 6-31
6.5.2 Simple STAT Mode ................................................................................. 6-36
6.5.3 Using a Red Rack.................................................................................... 6-37
6.6 Printing Results . ....................................................................................................... 6-39
6.7 Performing a Repeat Run ......................................................................................... 6-42
6.7.1 Preparing to Run a Standard (Manual) Repeat Test . ............................. 6-43
6.7.2 Performing a Repeat Test on the STAT Table ......................................... 6-45
6.7.3 Performing Repeat Test Using an Orange Rack . ................................... 6-45
6.7.4 Check the Repeat-Test Result Data ....................................................... 6-46
6.8 Transferring Data to Another PC.............................................................................. 6-48
6.9 Pausing Analysis Operation .................................................................................... 6-49
6.10 Rack Supply Stop ..................................................................................................... 6-50
6.11 System Shutdown...................................................................................................... 6-51
6.12 Performing an Emergency Stop............................................................................... 6-52
6.13 Editing Quality Control Data .................................................................................... 6-53
6.14 Editing Analysis Data ............................................................................................... 6-56
6.14.1 Rewriting Patient Sample Data . ............................................................. 6-57
6.14.2 Correcting Patient Sample Data ............................................................. 6-59
6.14.3 Recalculating Analysis Data Using a Changed Calibration Curve . ........ 6-62
6.14.4 Transferring the Edited Data Online ....................................................... 6-63
6.15 Confirming the ISE (optional) Status ...................................................................... 6-64
6.16 Managing Reagent Condition................................................................................... 6-67
6.16.1 Check Reagent Condition........................................................................ 6-67
6.16.2 Editing and Managing Reagent Condition............................................... 6-69
6.16.3 Set the reagent volumes required for daily analysis................................ 6-75

Additional Tasks 7-1

7.1 Using the Automatic Startup Function ................................................................... 7-2
7.2 Setting a User Login ................................................................................................. 7-4
7.2.1 Setting a User Name and Password . ..................................................... 7-4
7.2.2 Delete Users............................................................................................ 7-6
7.2.3 Setting Menu Access Level . ................................................................... 7-7
7.2.4 Security Settings ..................................................................................... 7-8
7.3 Creating a User Menu ............................................................................................... 7-10
7.4 Calculating Statistics . .............................................................................................. 7-12
7.4.1 Viewing Data Statistics ........................................................................... 7-12
7.4.2 Creating a Correlation Chart . ................................................................. 7-16
7.5 Calibration Verification.............................................................................................. 7-19
7.5.1 Entering Material Parameters ................................................................. 7-19
7.5.2 Displaying the Verification Chart . ........................................................... 7-20
7.6 Using Comment Master............................................................................................. 7-22
7.7 Data Management ..................................................................................................... 7-24
7.7.1 External Data Management .................................................................... 7-25
7.7.2 Management of Condition File . .............................................................. 7-27
7.7.3 Offline Conditions ................................................................................... 7-29
7.8 Print the Set Contents .............................................................................................. 7-31


System Outline AU480 User Guide
Version 1.0
 7.9 Confirmation the Reagent Consumption ................................................................ 7-32
7.9.1 Confirm the Reagent Consumption................................................................ 7-32

Maintenance 8-1
8.1 Using the Routine Maintenance Schedule . ............................................................ 8-3
8.2 Maintenance Log........................................................................................................ 8-4
8.2.1 Adding a Maintenance Task..................................................................... 8-4
8.2.2 Updating the Maintenance Register........................................................ 8-6
8.2.3 Viewing Maintenance History................................................................... 8-7
8.3 Daily Maintenance...................................................................................................... 8-8
8.3.1 Inspect the Syringes for Leaks and Proper Installation........................... 8-8
8.3.2 Inspect the Wash Solution Roller Pump Unit for Leaks .......................... 8-11
8.3.3 Inspect and Replenish the Concentrated Wash Solution ....................... 8-13
8.3.4 Inspect, Clean and Prime the Sample, Reagent Probes,
and Mix Bars............................................................................................ 8-15
8.3.5 Inspect the Printer (option) and Paper..................................................... 8-18
8.4 Weekly Maintenance.................................................................................................. 8-19
8.4.1 Manual cleaning the Sample Probe and Mix bars................................... 8-20
8.4.2 Perform a W2 (Automatic Washing of each Probe,
Mix bar and Cuvettes, etc.)...................................................................... 8-24
8.4.3 Perform a Photocal.................................................................................. 8-27
8.4.4 Clean the Sample Pre-diluent Bottle........................................................ 8-30
8.5 Monthly Maintenance................................................................................................. 8-31
8.5.1 Clean the Sample Probe and Reagent Probe Wash Stations................. 8-32
8.5.2 Clean the Mix Bar Wash Station.............................................................. 8-35
8.5.3 Clean the Wash Nozzle Unit and Check the Tube Mounting Joints......... 8-37
8.5.4 Clean the Deionized Water Filter and the Sample Probe Filter............... 8-42
8.5.5 Clean the Sample Probe Filter................................................................. 8-45
8.6 Maintenance Every Three Months............................................................................ 8-48
8.6.1 Clean the Air Filters................................................................................. 8-49
8.6.2 Replace the Deionized Water Filter......................................................... 8-50
8.6.3 Replace the Sample Probe Filter and O-Ring......................................... 8-52
8.6.4 Clean the Deionized Water Tank............................................................. 8-54
8.6.5 Replace the Wash Solution Roller Tube.................................................. 8-57
8.7 Maintenance Performed Every Six Months............................................................. 8-59
8.7.1 Replace the Photometer Lamp................................................................ 8-59
8.7.2 Washing Cuvettes and the Cuvette Wheel.............................................. 8-63
8.8 Maintenance Performed Yearly or As Necessary.................................................... 8-67
8.8.1 Replace O-rings in the Wash Nozzle Supply Tube Mounting Joints........ 8-68
8.8.2 Replace Cuvettes.................................................................................... 8-70
8.8.3 Manually Wash the Reagent Probe......................................................... 8-72
8.8.4 Replace Sample Probe and Reagent Probe............................................ 8-73
8.8.5 Replace Mix bars..................................................................................... 8-76
8.8.6 Replace the Wash Nozzle Joint............................................................... 8-78
8.8.7 Replace Syringes..................................................................................... 8-82
8.8.8 Clean the inside of the STAT table unit
and Reagent Refrigeration Unit............................................................... 8-87
8.8.9 Replace the Antistatic Brush.................................................................... 8-89
8.8.10 Replace Rack ID labels........................................................................... 8-90
8.8.11 Replace the Sample Probe and Reagent Probe Tubes........................... 8-91
8.8.12 Execute a W1 (Auto-wash of the sample probe and cuvettes)................ 8-93
8.8.13 Replace Air Filters.................................................................................... 8-94
8.8.14 Replace Syringe cases and Syringe heads............................................. 8-95
8.8.15 Replace Packing in the Wash Nozzle Tube Mounting Joints................... 8-100
8.9 Resetting the system when switched to the stop mode
while performing maintenance................................................................................. 8-101
8.10 Using the BECKMAN COULTER SUPPORTVISION (BSV) (Option)........................... 8-102
8.10.1 Transmitting files with BSV...................................................................... 8-103
8.10.2 When the BECKMAN COULTER SUPPORTVISION (BSV)
connection is off....................................................................................... 8-104
8.11 AU480 Maintenance Schedule.................................................................................. 8-105


AU480 User Guide System Outline
Version 1.0
 Error Flags 9-1
9.1 Summary of Error Flags............................................................................................ 9-3
9.2 Error Flag Details ...................................................................................................... 9-5

Error Messages 10-1

Troubleshooting 11-1
11.1 Troubleshooting and Maintenance . ........................................................................ 11-3
11.2 Troubleshooting the System Data Problems ......................................................... 11-3
11.2.1 Data Problem Checklist .......................................................................... 11-3
11.2.2 Checking Abnormal Data ........................................................................ 11-4
11.2.3 Troubleshooting Software ....................................................................... 11-5
11.3 Troubleshooting the System - Reagents and Samples ......................................... 11-7
11.3.1 Sample Related Issues . ......................................................................... 11-7
11.3.2 Reagent Related Issues ......................................................................... 11-8
11.3.3 QC and Calibrator Related Issues .......................................................... 11-8
11.3.4 Wash Solution Related Issues ................................................................ 11-9
11.3.5 Deionized Water Related Issues ............................................................ 11-9
11.3.6 Other Causes of Abnormal Data . ........................................................... 11-9
11.4 Troubleshooting the System - Mechanical Problems . .......................................... 11-10
11.4.1 Syringe Problems ................................................................................... 11-10
11.4.2 Probe Problems ...................................................................................... 11-11
11.4.3 Abnormal Data Caused by Cuvette Wheel or Wash Nozzles ................. 11-12
11.4.4 Abnormal Data Caused by Photometer Lamp or Photometer Unit . ....... 11-13
11.4.5 Mixing Problems ..................................................................................... 11-13
11.4.6 Deionized Water Tank Problems . ........................................................... 11-13
11.4.7 Deionized Water or Filter Problems ........................................................ 11-14
11.4.8 Incubation Temperature Problems .......................................................... 11-14
11.4.9 Piping and Pump Problems .................................................................... 11-14
11.4.10 Reagent Refrigerator Problems .............................................................. 11-15
11.4.11 STAT Table Problems ............................................................................. 11-15
11.4.12 Rack Problems ....................................................................................... 11-15
11.5 Troubleshooting the System - System Problems .................................................. 11-16
11.5.1 TEMP REF HIGH Alarm for the Cooling Unit . ........................................ 11-16
11.5.2 Abnormal Sound from Inside the System................................................ 11-16
11.5.3 Empty Alarm for the Water Supply Tank.................................................. 11-17
11.5.4 Leaks from the Wash Solution Roller Pump............................................ 11-17
11.5.5 Barcode Errors . ...................................................................................... 11-18
11.5.6 Leaks from the Bottom of the System . ................................................... 11-18
11.5.7 No Wash Solution to Mix bars ................................................................ 11-18
11.5.8 Reagent Alarm when Sufficient Reagent Remains in Bottles ................. 11-18
11.5.9 Sample Alarm when Sufficient Sample Remains . .................................. 11-18
11.5.10 No Sample Cup Alarm when Sample Cup is Present . ........................... 11-19
11.5.11 No Sample Cup on the STAT Table ........................................................ 11-19
11.5.12 Printer Not Printing or Printer Light Not On ............................................ 11-19
11.5.13 Liquid Leaking from the Reagent Probe and Sample Probe .................. 11-19
11.5.14 Reagent Probe and Sample Probe not Aligned over the Cuvette . ......... 11-19
11.5.15 Error Flag # (Sample Level Detection Error) Displayed
in the Second Half of the Sample Dispense Operation .......................... 11-20
11.5.16 Sample Rack Jammed . .......................................................................... 11-20
11.5.17 Printer Problems ..................................................................................... 11-20
11.6 Troubleshooting the System - Data Processor Problems . ................................... 11-21
11.6.1 Menu Cannot be Selected ...................................................................... 11-21
11.6.2 Number Key Pad on Keyboard Does Not Work . .................................... 11-21
11.6.3 Keyboard Not Responding . .................................................................... 11-21
11.6.4 Inaccessible Floppy Disc ........................................................................ 11-22
11.6.5 Results Do Not Print Automatically ......................................................... 11-22
11.6.6 Online Auto-Output by Host Computer Not Executed . ........................... 11-22
11.6.7 Unsuccessful Movement of Data between the System
and the Host Computer............................................................................ 11-22


System Outline AU480 User Guide
Version 1.0
 11.7 Recovering from an Emergency Stop or Power Loss ........................................... 11-23
11.7.1 Performing an Emergency Stop . ............................................................ 11-23
11.7.2 Resetting the System after a Power Failure or an Emergency Stop....... 11-23

Menu Tree 12-1

12.1 Home Menu................................................................................................................. 12-2
12.2 Permanently Displayed Button Configuration and Function . .............................. 12-3
12.3 Menu Buttons Overview ........................................................................................... 12-4
12.4 Routine Menu............................................................................................................. 12-5
12.5 Calibration Menu........................................................................................................ 12-6
12.6 QC Menu..................................................................................................................... 12-7
12.7 Parameter Menu ........................................................................................................ 12-8
12.8 Maintenance Menu .................................................................................................... 12-9
12.9 System Menu ............................................................................................................. 12-10

AU480 Terminology 13-1

Index 14-1


AU480 User Guide System Outline
Version 1.0

System Outline AU480 User Guide
Version 1.0
Return to Main Table of Contents

1
Introduction

Thanks for choosing the Beckman Coulter AU480 system. This

automated chemistry analyzer measures analytes in samples, in
combination with appropriate reagents, calibrators, quality control (QC)
material and other accessories. This system is for in vitro diagnostic use
only.
To ensure optimal performance and prevent system failure, always
operate the system in accordance with the procedures outlined.
This chapter discusses the following.

Contents
1.1 Beckman Coulter Guarantee.........................................................................................1-2
1.2 Using this Guide............................................................................................................1-2
1.2.1 Assumptions.....................................................................................................1-2
1.2.2 Where to Start .................................................................................................1-3
1.2.3 System Installation ..........................................................................................1-3
1.2.4 Users New to Automated Analyzers ................................................................1-3
1.2.5 System Administrators . ...................................................................................1-3
1.3 Using the Online Help ..................................................................................................1-4
1.4 Printing this User Guide . .............................................................................................1-6
1.5 Typographical Conventions Used in this Guide ........................................................1-7
1.5.1 Tips, Cautions and Warnings . .........................................................................1-7
1.5.2 Software Paths.................................................................................................1-7
1.5.3 Software Buttons .............................................................................................1-8
1.5.4 Window Illustrations . .......................................................................................1-8
1.5.5 Notation of Units ..............................................................................................1-8

1-1
AU480 User Guide Introduction
Version 1.0
 Return to Main Table of Contents

1.1 Beckman Coulter Guarantee

Beckman Coulter guarantees this analyzer to be free from defects in materials or workmanship under
normal use for a period of one year commencing on the day of purchase. If the system is rendered
defective within the guarantee period, it is repaired onsite free of charge. The Beckman Coulter
guarantee does not include the following:

• Defect or damage caused by natural disasters such as fires or floods.

• Defect or damage caused by carelessness or abuse.

• Defect or damage resulting from maintenance performed by personnel not approved by

Beckman Coulter.

• Defect or damage caused by the use of consumables or fitting replacement parts not supplied
by Beckman Coulter.

• Malfunction caused by unauthorized disassembly.

• Corrosion of the electrical system caused by exposure to a system environment other than that
stated in this guide.

• Loss of stored data caused by inadequate or incorrect system maintenance.

Beckman Coulter is not liable for any consequential damages such as loss of profit or business that
might arise from the misuse of this system. Beckman Coulter offers a maintenance and repair service
after the guarantee period has expired.
For details, please contact Beckman Coulter Technical Services.
The service life of the instrument is 7 years. Avoid using the instrument over 7 years.

1.2 Using this Guide

This user guide explains how to use the system effectively and safely. It is also a maintenance and
troubleshooting guide and is intended as a primary source of reference for all AU480 users. This
includes all medical laboratory personnel who may operate any part of the system or might have to
prepare samples to be processed by the system. The following describes how to use this user guide:
1.2.1 Assumptions.....................................................................................................1-2
1.2.2 Where to Start .................................................................................................1-3
1.2.3 System Installation ..........................................................................................1-3
1.2.4 Users New to Automated Analyzers ................................................................1-3
1.2.5 System Administrators . ...................................................................................1-3

1.2.1 Assumptions
It is assumed that the user has a general understanding of biochemical analysis and specialist
knowledge of sample handling. This guide also assumes users have basic PC operating skills
and knowledge of the MS Windows® operating system. Users who have never used a PC or a PC
operating system should get basic PC skills training before using the system.

1-2
Introduction AU480 User Guide
Version 1.0
Return to Main Table of Contents

1.2.2 Where to Start

Before operating this system, users should receive training either directly from Beckman Coulter or
from someone who has already attended a Beckman Coulter-approved training course. While this user
guide deals with each system procedure in a step-by-step manner, it is not a substitute for training.
When looking for information related to a specific concept or topic, use the search function in the PDF
version of this guide, or the index at the back of this guide.
For information about how to use the online help, refer to section “1.3 Using the Online Help” in this
chapter.
When looking for information on a specific topic, use the index at the back of this guide. The index lists
every topic in alphabetical order, followed by the page number.
When looking for a specific chapter, either use the fast find tabs or the table of contents at the
beginning of the guide.

1.2.3 System Installation

This guide contains information related to the system environment and hardware, but it is not an
installation guide. Installation of the AU480 should be performed by Beckman Coulter approved
engineers only. There is therefore no installation information supplied with this system. To change any
aspect of the installation, please contact Beckman Coulter Technical Services or seek the help of a
Beckman Coulter-approved installation engineer.

1.2.4 Users New to Automated Analyzers

Read this users guide thoroughly before operating this system, even if the operator has completed a
Beckman Coulter-approved, instructor-led training course.

1.2.5 System Administrators

Read chapters 1, 2 and 3 carefully and follow the procedures outlined. The computer hardware and
software parameters should be part of an internal maintenance routine and all data produced by the
system should be backed up regularly with copies stored on-site and off-site.
Read the section “7.2.1 Setting a User Name and Password” in chapter 7.
This allows administrators to:

• Create a secure operating environment where unauthorized users cannot interfere with the
system while it is in operation.

• Track the actions of each user. When each user logs out, the period of time spent working on
the system is added to the alarm log list file. This file should be backed up regularly for security
reasons.

1-3
AU480 User Guide Introduction
Version 1.0
 Return to Main Table of Contents

1.3 Using the Online Help

This system is shipped with a PDF copy of this user guide. If any issues occur during system
operation, alarm descriptions, operating procedures, and other functional instructions may be
accessed using Online Help. To display the PDF version of this guide in Online Help, select the H e l p
icon on the window.
Help icon

Alarm List

Help windows are available to assist the operator in accessing alarm descriptions, how to use selected
menu functions, etc., as described in the table below. There are three types of help as shown in the
following table.

Type of Help Displayed Description

Operation Help Displays operating procedures.
Select the H e l p icon. When using a keyboard, press F 1
while holding down C t r l .
Alarm Help Displays alarm descriptions and corrective actions.
Select A l a r m L i s t to display the Alarm List window.
Select the H e l p icon on the Alarm List window.
For information about alarm descriptions, refer to chapter 10
“Error Messages”.
Tip Help Displays the range of input values such as analysis parameters.
When the mouse pointer is moved to the input area, the Tip help
will show.

To determine the function of a button, cursor over the button and a pop-up message
will indicate the button’s function.
TIP

1-4
Introduction AU480 User Guide
Version 1.0
Return to Main Table of Contents

This PDF file is viewed using the Adobe Acrobat® Reader® software. Major features of the Adobe
Acrobat® Reader® software include:

• Zoom in and out:

Use either the plus or minus button to the left and right of the percentage reading or click the
magnifier and then click the page. To decrease the size of the page, select the minus magnifier
from the drop-down list.

• Maximize and resize:

• To resize the reader window (e.g. to make it smaller), click the Restore Down button in the top
right-hand corner of the window.

Position the cursor at the edge of the window and when it changes to a double-ended arrow,
drag the borders of the window to the desired size. As the border is dragged, the size of the
document automatically zooms allowing more text to become readable.

• To expand the window to fit the full size of the window again, click the Maximize button.

• Browse from one page to another:

Use the Next Page and Previous Page buttons at the bottom of the window.

• Search for information by entering a search string:

Click the binoculars symbol. Enter the search string and click search.

• Close the Acrobat® Reader®:

• To close the PDF file when finished using it, click the X button in the top right-hand corner of the
Reader® window.

1-5
AU480 User Guide Introduction
Version 1.0
 Return to Main Table of Contents

1.4 Printing this User Guide

Printing of this guide is recommended. Print on double-sided A4 paper measuring not less than 110g/
cm2. The guide can be printed in either black and white, blue and black or full color. To print the guide
on both sides of the paper:
1. Click the printer icon on the top tool bar of the Adobe® Acrobat® Reader.
2. Click P r o p e r t i e s and select a high print quality.
3. Select P r i n t a l l p a g e s and select print E v e n Pa g e s O n l y .
4. When all even pages are printed, take them out and turn them printed side up. Then re-insert the
pages so that the header enters the feeder first. If the printer takes paper from the top of the input
hopper, reverse the order of the pages.

When even pages have been printed, allow the pages to dry before re-inserting them.
This prevents smears.
TIP

5. Select P r i n t a l l p a g e s and select print O d d Pa g e s O n l y .

6. When pages are printed, remove them and check that each odd page has printed on the back
of an even page. Check every page. If the printer takes paper from the top of the input hopper,
reverse the order of the pages.

1-6
Introduction AU480 User Guide
Version 1.0
Return to Main Table of Contents

1.5 Typographical Conventions Used in this Guide

This section describes the conventions used in the text of this guide:
1.5.1 Tips, Cautions and Warnings . .........................................................................1-7
1.5.2 Software Paths.................................................................................................1-7
1.5.3 Software Buttons .............................................................................................1-8
1.5.4 Window Illustrations . .......................................................................................1-8
1.5.5 Notation of Units ..............................................................................................1-8

1.5.1 Tips, Cautions and Warnings

This guide uses the following symbolic icons and terms according to the content
of information. Each convention and term indicates the level of its importance. A
thorough understanding of this information is necessary to use the system safely
and correctly.
For other precautions, refer to chapter 2 “Precautions, Installation and Specifications”.

This symbol indicates a warning. Warnings mean that care must be exercised. Failure
to follow these warnings may result in serious injury, degradation of system function
or generate incorrect sample data.
WARNING

This symbol indicates a caution. Cautions mean that appropriate care must be
taken. Failure to follow these cautions may result in minor injury, sub-optimal system
performance, operation or damage, which could lead to other hazards.
CAUTION

This symbol indicates a note. Book notes contain important supplementary

information that users should take into account when performing procedures or
TIP understanding concepts.

1.5.2 Software Paths

A software path is a sequence of options selected in the software interface in the order indicated.
Software paths in this guide are expressed as follows:
Select Routine>Test Requisition>Calibration.
Following this path, first click the Routine menu, then Test Requisition on that menu and finally
Calibration on the resulting submenu. Software buttons, such as System Status that are part of such a
sequence also use this blue font.
Button names on a software window are expressed as follows:
Select O K .

1-7
AU480 User Guide Introduction
Version 1.0
 Return to Main Table of Contents

1.5.3 Software Buttons

All buttons that appear in the software interface are part of a single procedural step and appear in a
large highlighted blue font. When the Maintenance Edit button is selected, for example, it appears as
follows:
1. Select M a i n t e n a n c e E d i t ( F 1 )
Some software buttons have a corresponding function key that can be accessed on the keyboard
instead of using the mouse, they appear in between brackets in every procedure.
The figure below illustrates a software window with a button bar.

F1 F2 F3 F4 F5 F6 F7 F8

1.5.4 Window Illustrations

• The use of partial window shots are used to enhance or reinforce understanding throughout this
guide.

• Illustrations are not intended to supersede printed instructions provided. Window shots
illustrated in this guide may differ from the actual appearance in font size or location relative to
other items on the displayed menu page.

1.5.5 Notation of Units

In this guide units are denoted with the International System of Units (SI). The conversion ratio is 1 Pa
= 0.102 kg/m2.

1-8
Introduction AU480 User Guide
Version 1.0
Return to Main Table of Contents

2
Precautions, Installation
and Specifications
Operators must understand how to operate the AU480 safely before
beginning to use the system.
This chapter provides instructions on:

Contents
2.1 Safe Use of the System.................................................................................................2-2
2.1.1 Observing Warning Labels ..............................................................................2-3
2.1.2 Preventing Fire and Damage ..........................................................................2-4
2.1.3 Preventing Electric Shocks...............................................................................2-4
2.1.4 Preventing Damage to Other Equipment and Facilities ..................................2-4
2.1.5 Preventing Personal and Serious Injury ..........................................................2-5
2.1.6 Preventing Infection . .......................................................................................2-6
2.1.7 Handling the Keyboard, Monitor and Mouse ...................................................2-6
2.1.8 Precautions for Operating the System ............................................................2-6
2.1.9 Ensuring Optimal Analytical Performance .......................................................2-7
2.1.10 Performing Important Checks at Analysis .......................................................2-7
2.1.11 Handling Reagents, Wash Solutions, Calibrators and QC Samples ...............2-8
2.1.12 Handling Samples ...........................................................................................2-9
2.1.13 Managing Liquid Waste .................................................................................2-10
2.1.14 Managing Solid Waste . .................................................................................2-10
2.1.15 Preventing Water Leaks ................................................................................2-10
2.1.16 Electromagnetic Wave and Noise Precautions .............................................2-10
2.1.17 Replacing Parts and Routine Maintenance ................................................... 2-11
2.1.18 Setting Analysis Parameters ......................................................................... 2-11
2.1.19 Precautions for using the analyzer independently . ....................................... 2-11
2.1.20 Cleaning contaminants from the covers ........................................................ 2-11
2.1.21 Other Precautions . ........................................................................................ 2-11
2.1.22 System Waste ............................................................................................... 2-11
2.2 Installation Environment Precautions ......................................................................2-12
2.2.1 Installation Environment ................................................................................2-12
2.2.2 System Specifications....................................................................................2-17
2.2.3 Installation Space Requirements . .................................................................2-24
2.2.4 System Connections . ....................................................................................2-25
2.3 System Labels and Displays .....................................................................................2-27
2.4 Trade Marks .................................................................................................................2-30

2-1
AU480 User Guide Precautions, Installation and
Version 1.0 Specifications
 Return to Main Table of Contents

2.1 Safe Use of the System

To ensure safe operation of this system follow all safety procedures contained in this user guide,
failure to follow these procedures could jeopardize the safety features of the system.
Be sure to read and follow the safety precautions carefully before using the system. If the system is
not operated following these precautions, the manufacturer or provider cannot be held liable for any
resulting damage or injury.
This section provides safety information on:
2.1.1 Observing Warning Labels ..............................................................................2-3
2.1.2 Preventing Fire and Damage ..........................................................................2-4
2.1.3 Preventing Electric Shocks...............................................................................2-4
2.1.4 Preventing Damage to Other Equipment and Facilities ..................................2-4
2.1.5 Preventing Personal and Serious Injury ..........................................................2-5
2.1.6 Preventing Infection . .......................................................................................2-6
2.1.7 Handling the Keyboard, Monitor and Mouse ...................................................2-6
2.1.8 Precautions for Operating the System ............................................................2-6
2.1.9 Ensuring Optimal Analytical Performance .......................................................2-7
2.1.10 Performing Important Checks at Analysis .......................................................2-7
2.1.11 Handling Reagents, Wash Solutions, Calibrators and QC Samples ...............2-8
2.1.12 Handling Samples ...........................................................................................2-9
2.1.13 Managing Liquid Waste .................................................................................2-10
2.1.14 Managing Solid Waste . .................................................................................2-10
2.1.15 Preventing Water Leaks ................................................................................2-10
2.1.16 Electromagnetic Wave and Noise Precautions .............................................2-10
2.1.17 Replacing Parts and Routine Maintenance ................................................... 2-11
2.1.18 Setting Analysis Parameters ......................................................................... 2-11
2.1.19 Precautions for using the analyzer independently . ....................................... 2-11
2.1.20 Cleaning contaminants from the covers ........................................................ 2-11
2.1.21 Other Precautions . ........................................................................................ 2-11
2.1.22 System Waste ............................................................................................... 2-11

2-2
Precautions, Installation and AU480 User Guide
Specifications Version 1.0
Return to Main Table of Contents

2.1.1 Observing Warning Labels

Use caution and observe and follow all warning labels attached to the system. Do not cover or remove
these labels. If the labels peel off or become illegible, please inform Beckman Coulter Technical
Services to have them replaced. Orange labels mean there is a risk of Serious Injury. Yellow labels
mean there is a risk of Personal Injury, Fire or Damage.
These are the warning labels:

Label Explanation
Electric shock: This symbol indicates an area of the system that should not be
accessed under any circumstances, due to risk of electrical shock.

High temperature danger: This symbol indicates the risk of burning by

touching the hot photometer lamp directly when replacing it.

Biological risks: This symbol indicates the use of biohazardous material. Wear
protective gear and follow universal precautions as dictated by local or
national regulations (CLSI GP17-A2, ISO15190 or 29CFR 1910.1030).

Laser radiation: This symbol warns that a laser is in use in this part of the
system.
To avoid eye injuries avoid looking directly into the laser beam.

Danger: This label indicates a potential hazard which, if not avoided, can
result in injury to an operator and/or serious property damage.

Personal injury: This symbol denotes areas where a risk of injury due to
system movement--fingers or other body parts should be kept clear of
these areas during system operation.

2-3
AU480 User Guide Precautions, Installation and
Version 1.0 Specifications
 Return to Main Table of Contents

2.1.2 Preventing Fire and Damage

• Install this system correctly in accordance with the installation environments and conditions
described in this guide.

• This system should only be installed by Beckman Coulter authorized personnel.

• If the analyzer installation needs to be altered, please contact the Beckman Coulter Sales or
Beckman Coulter Technical Services.

• Any malfunction or system error should be dealt with promptly by contacting Beckman Coulter
Technical Services.

• In the event of a system malfunction, the system must be completely powered off using the main
breaker located on the right side of the system prior to any repair service.

• If liquid is spilled on the system, turn off the main breaker located on the right side of the system
immediately. Wipe up the spill only after turning off the main system breaker.

• Do not use any flammable or combustible gases near the system. Due to risk of system
explosion.

• To ensure all power to the system is off, turn off the circuit breaker of the plug that the system is
connected to.

2.1.3 Preventing Electric Shocks

• Never remove surfaces secured by screws, including the rear and side covers.

• If liquid spills or leaks within the system, contact the Beckman Coulter Technical Services
immediately. Careless handling of liquids around the system may result in electric
shock.

2.1.4 Preventing Damage to Other Equipment and Facilities

The system should have a separate power outlet to avoid electrical noise from other devices.

2-4
Precautions, Installation and AU480 User Guide
Specifications Version 1.0
Return to Main Table of Contents

2.1.5 Preventing Personal and Serious Injury

Minor injury is any injury not requiring hospitalization or long term medical care. Serious injury is any
injury that requires long term medical care or hospitalization.

• When handling a reagent or wash solution, be sure to wear appropriate protective gear (rubber
gloves, goggles, mask, and protective clothing or other requirements in facility SOP(s)).

• Always operate the system with all covers closed.

• While the system is in operation, do not touch any moving parts.

• Never place fingers or hands into any openings.

• Observe the system labels and the precautions in this user guide.

• See the Personal Computer and Printer (option) Operation Manuals for information on operating
those devices safely.

• Some reagents and wash solutions used in this system are either strong acids or strong bases
(alkaline). Avoid contact with bare hands and clothing.

• Avoid personal injury by wearing rubber gloves when handling sample probe, reagent probe,
mix bars or any other part with sharp parts.

• When replacing the photometer lamp, allow at least five minutes cool down time for the lamp.
The photometer lamp operates at high temperatures. Direct contact with a hot lamp may cause
burns.

• When the system is powered on, avoid looking directly into the lens of the barcode readers.
Looking at the barcode reader light may result in eye damage.

Use of other controls and adjustments not specified in this guide may result in
hazardous radiation exposure.
CAUTION

• If the instrument is used over 7 years, there is a possibility of unexpected accidents such as that
the upper cover suddenly goes-down resulting in injury of an operators.
Avoid using the instrument over 7 years.

2-5
AU480 User Guide Precautions, Installation and
Version 1.0 Specifications
 Return to Main Table of Contents

2.1.6 Preventing Infection

• Always wear personal protective clothing when handling samples and racks, performing
maintenance and managing waste.

• Handle all patient samples as potentially infectious and follow universal precautions as dictated
by local or national regulations (Clinical and Laboratory Standards Institute CLSI GP17-A2,
ISO15190 or 29CFR 1910.1030).

• If infectious substances come in contact with the users skin, flush the area and seek medical
advice.

• Wipe off any spilled contaminant immediately from the system.

• If any of the reagents or samples are accidentally swallowed, seek medical advice.

• Wear appropriate protective clothing. If the user has an allergy to any of the chemicals used,
exercise special care to avoid an allergic reaction.

• While the system is operating, avoid touching the sample probe and wash nozzle.

2.1.7 Handling the Keyboard, Monitor and Mouse

• To keep the touch screen, keyboard, and mouse in good working order, prevent all liquids from
coming into contact with them.

• This system is not designed ergonomically for extended periods of keyboard activity. If users
spend long periods of time (longer than 30 minutes) refer to local RSI guidelines and adjust the
workstation as needed to ensure a comfortable position and take frequent breaks.

2.1.8 Precautions for Operating the System

• Be careful when setting reference materials and patient samples. Incorrect placement of
reference materials or patient samples may result in erroneous analysis.

• After transferring the analysis results to a host computer, check the sample numbers and
sample IDs. Transfer each piece of measurement data correctly.

• Operate this system in accordance with the procedures described in this guide. Improper
operation may cause improper results, but could result in system failure.

• To learn all about the system operations, attend a Beckman Coulter training course. The
operation of this system is intended for personnel who have completed the training course
offered by Beckman Coulter, or personnel who have been trained by those who have previously
attended Beckman Coulter training.

To determine the function of a button, cursor over the button, a pop-up message will
indicate the button’s function.
TIP

2-6
Precautions, Installation and AU480 User Guide
Specifications Version 1.0
Return to Main Table of Contents

2.1.9 Ensuring Optimal Analytical Performance

Substances such as Lipemia, Icterus and Hemolysis can interfere with test results. Refer to the
reagent package insert for specific substance interference information.

2.1.10 Performing Important Checks at Analysis

To ensure the validity of analytical data:

• Ensure system maintenance is performed adequately and repeat if necessary.

• Ensure the quality of deionized water is within specifications.

• Check the syringes and tubing for leaks.

• Check the tubing and syringes for leaks, clogging, and air-bubbles before analysis. For
example, unless probe washing and cuvette washing are performed sufficiently, incorrect
measurement may result.

• Check the samples for contaminants (dust, fibrin, etc.).

• Check the quantity of each sample and that no bubbles are present.

• Check the calibration for abnormality. Ensure that a valid up-to-date calibrator is being used.

• Check the quality control data.

• Check the individual analysis results for flags.

• Check the reaction data. If any flag (*, ?, @, $, D, B, !) is generated in relation to the reaction
OD, check the several reaction data processed immediately before and after the flagged result
for abnormality. In the presence of any abnormality, check the cuvette and the cuvette washing
station for possible overflows, then re-check the results processed before and after the flagged
result.

2-7
AU480 User Guide Precautions, Installation and
Version 1.0 Specifications
 Return to Main Table of Contents

2.1.11 Handling Reagents, Wash Solutions, Calibrators and QC

Samples
• To analyze samples, the appropriate reagent, reference material, and QC sample are required.
These products are produced commercially by reagent manufacturers. For information about
which reagent, etc., to use, consult the reagent manufacturer or distributor.

• Strictly adhere to any safety instructions supplied with reagents, calibrators, and QC samples.
Contact Beckman Coulter Technical Services for any questions concerning the safe handling of
any material to be used on this system.

• Consult the reagent manufacturer or distributor for the stability of the unsealed reagent, etc.

• To set reagents and others in the system, follow the instructions in this guide and those from the
reagent manufacturer or distributor. Check that there are no foreign substances in the reagent
and no bubbles on the reagent surface. Unless the reagent is set correctly, appropriate analysis
results cannot be obtained. This may result in damage to the system.

• Prepare reagents, wash solutions, calibrators and QC samples in accordance with the
Instructions For Use (IFU), paying particular attention to any reconstitution, mixing and
pretreatment instructions.

• Avoid excessive reagent agitation, which can cause bubbles. If bubbles are visible on the
surface of the reagent, remove them.

• After replacing the reagent be sure to perform calibration analysis. Unless calibration analysis is
performed, appropriate analysis results may be affected.

• Depending on the combination of reagents, liquid waste precipitate may develop. This may
cause clogging of drain tubing. Consult the relevant reagent manufacturer for details.

• Follow all applicable warnings or advice regarding carryover affects between analysis tests. If
a reagent is contaminated with another reagent during analysis operation, analysis results may
be affected. The actual effect of interference differs depending on the reagent. For detailed
information, contact the relevant reagent manufacturer or distributor. For information about how
to check the interference between analysis tests, contact Beckman Coulter Technical Services.

2-8
Precautions, Installation and AU480 User Guide
Specifications Version 1.0
Return to Main Table of Contents

2.1.12 Handling Samples

Samples available for analysis

• This system is designed to analyze serum, urine, and plasma samples. There may be some
samples that cannot be analyzed depending on the analysis test, reagent, and sample tubes
used. Refer to Beckman Coulter Technical Services for questions regarding reagent or sample
tube type.

• Use serum or plasma that is free of blood clots, or urine that is free from suspended matter. If
serum or urine that is not free of clots or suspended matter is used, the probe may clog and
adversely effects the analysis results.

• Chemicals present in the sample (medicine, anti-coagulant, preservative, etc.) may significantly
interfere with the samples.

• Highly viscous samples may impede the reliability of data.

Precautions in handling and storing samples

Refer to the package insert /IFU for sample collection and storage. Refrigeration of blood will increase
K (potassium) in the blood. Improper storage of samples may alter the analyte in a sample.

Pretreating samples

• Use only the blood collection tubes and sample tubes specified by Beckman Coulter.

• Serum and plasma specimens should be adequately centrifuged and then separated from
blood cells as soon as possible, to reduce the risk of adulteration. Prior to analysis, specimens
should be free from suspended matter, such as fibrin. While the system has a sophisticated clot
detection mechanism, this mechanism should not solely be relied upon, carefully inspect the
samples.

• Urine samples should be collected into appropriate preservatives and any suspended matter
removed by centrifugation prior to analysis (CLSI GP16-A2).

• Verify that any anticoagulants or collection devices that employ a barrier are compatible with the
test reagent being used. Please refer to the applicable reagents instructions for the specimen
types that are suitable for use. Take care when using sample tubes containing barriers or gels.
Verify the suitability of all collection devices in use.

• When using blood collection tubes containing a separating medium, pay attention to the amount
of serum to avoid contaminating the serum probes with the separating medium.

• Set up an appropriate amount of sample for correct sampling in the system according to this
guide.

• All samples should be protected from evaporation and contamination prior to analysis.

• Check the quantity of each sample, to prevent contact of the sample probe with the separating
medium which will block the sample probe. Make sure that no bubbles are present.

2-9
AU480 User Guide Precautions, Installation and
Version 1.0 Specifications
 Return to Main Table of Contents

2.1.13 Managing Liquid Waste

This system is designed to discard the condensed waste liquid and diluted waste liquid separately.

• Treat and handle all liquid waste as potentially infectious.

• Before disposal, some liquid waste and mixtures may require special treatment.
For proper waste disposal, refer to relevant local authority guidelines.

• Some substances in the reagents, quality control (QC) samples, reference materials, and
wash solutions are regulated under the pollution ordinance and effluent standard. Treat such
substances in accordance with the effluent standard applied to the facilities, consulting the
relevant reagent manufacturer or distributor.

2.1.14 Managing Solid Waste

• All solid waste should be handled as and treated potentially infectious.

• Before disposal some waste solids and mixtures may require special treatment. For proper
waste disposal, refer to relevant local authority guidelines.

2.1.15 Preventing Water Leaks

To prevent inadvertent water leaks, ensure water supply and drainage hoses are fitted by Beckman
Coulter authorized personnel in accordance with local guidelines.

2.1.16 Electromagnetic Wave and Noise Precautions

• Do not locate this system near equipment that generates extreme levels of noise.

• Do not use mobile or cordless telephones and transceivers in the room where the system is
installed.

• Do not use medical equipment that may be susceptible to malfunctions caused by EMF near the
analyzer DPR or monitor.

2-10
Precautions, Installation and AU480 User Guide
Specifications Version 1.0
Return to Main Table of Contents

2.1.17 Replacing Parts and Routine Maintenance

To ensure system performance, maintain and inspect the system periodically by replacing the parts
according to the instructions in this guide.

• Calibration of reagents might be required after replacement of key parts such as syringes or a
probe. After any part replacement or significant maintenance, it is strongly recommended that
QC analysis is performed. If any shifts are observed, calibrate the system.

• Have and follow a maintenance routine for this system, refer to chapter 8 “Maintenance” for
recommended maintenance. System performance and safe operation cannot be guaranteed, if
the system is not maintained using these guidelines.

• Create a maintenance routine for the computer software and hardware, including frequent
backing up data containing analysis parameters, results history and the alarm log list file. For
details on backing up data, refer to section “7.7.2 Management of Condition File” in chapter 7.

• Back-up discs should not be stored onsite. Keep one copy onsite for reference and one copy
offsite.

• To prevent infection from harmful software viruses, the computer hardware should be dedicated
to running the system software only and should never be connected to the Internet except when
instructed to do so by Beckman Coulter technical services.

• Only Beckman Coulter authorized engineers are authorized to replace the fuse near the breaker
on the rear side of the system.

2.1.18 Setting Analysis Parameters

Before using the system for the first time, parameters for the reagent and sample quality,
measurement wavelength, calibrator values, etc. must be set. Enter these parameters from the
Method Parameters provided in the package insert (IFU), to ensure optimum system performance. Any
update to these settings should be entered into the system immediately. For details on setting analysis
parameters, refer to chapter 4 “Configuring Tests”.

2.1.19 Precautions for using the analyzer independently

The computer hardware should be dedicated to running the system software only and should never
be connected to the Internet except when instructed to do so by Beckman Coulter, in order to isolate it
from harmful software viruses.

2.1.20 Cleaning contaminants from the covers

Wipe up spills with a damp or dry cloth.

2.1.21 Other Precautions

If the reagents or samples come into contact with the mucous membranes, or if they are accidentally
swallowed, immediately rinse or induce vomiting, then follow the instructions of the manufacturer or
distributor.

2.1.22 System Waste

The waste of this system requires special treatment before being discarded. Observe the laws
relatives to waste.

2-11
AU480 User Guide Precautions, Installation and
Version 1.0 Specifications
 Return to Main Table of Contents

2.2 Installation Environment Precautions

Although this is not an installation guide, it is still important to be aware of requirements. This section
describes:
2.2.1 Installation Environment ................................................................................2-12
2.2.2 System Specifications....................................................................................2-17
2.2.3 Installation Space Requirements . .................................................................2-24
2.2.4 System Connections . ....................................................................................2-25

2.2.1 Installation Environment

To operate this system safely and accurately, ensure that the installation room:

• Is not subject to direct sunlight.

• Is not excessively dusty or subject to large amounts of airborne particles. This system is
designed to withstand up to pollution degree 2 as defined by IEC and UL standards.

• Is level, with a gradient less than 1/200.

• Is not subject to vibration.

• Has a floor that can support at least 500 kg. This weight includes the personal computer
attached to the system.

• Is located less than 2,000 metres above sea level.

• Contains no corrosive gases.

Electrical and Noise Conditions

The power source must be prepared before delivery of this system. The site should:

• Have a power connector within 10 metres of the location of the system.

• The capacity of the circuit breaker on the power switchboard for this system should be equal to
20 amperes or 40 amperes (200 V/100 V).

• Have a power source with maximum voltage fluctuations (± 10%) and transient overvoltage less
than 2500V.

To avoid electrical damage to the system due to uneven current, use an

uninterruptible power supply (UPS) to connect the system to electrical power. For
TIP detailed information, contact Beckman Coulter Technical Services.

• Verify that the system is always grounded. The grounding terminal should conform to class
D (less than 100 Ω of grounding resistance) defined in the technical standards for electrical
facilities.

• Do not locate this system near equipment that generates extreme levels of electromagnetic or
electrical noise. Do not use mobile or cordless telephones and transceivers in the room where
the system is installed.

2-12
Precautions, Installation and AU480 User Guide
Specifications Version 1.0
Return to Main Table of Contents

• Do not use medical equipment that may be susceptible to malfunctions caused by EMF near the
analyzer DPR or monitor.

• Use only devices specified by Beckman Coulter to connect power scripts. Use of devices
not specified by Beckman Coulter may cause system malfunction.

Make sure to connect all the grounding terminals provided on the system and
distribution panel to earth. Failure to ground the terminals could cause electric shock
and system malfunction.
WARNING

Crimp terminal
Hole diameter: 5.4 mm

Power cable connection should be performed by Beckman Coulter authorized

technical personnel.

CAUTION • When connecting the power cables to the system, connect the grounding terminal
first. To disconnect the cables, disconnect the grounding terminal last.

• Connect the power cables to the distribution panel as shown below.

Gray White Green/yellow

Connect these terminals to the power
source specified for this system.

Connect this terminal

Terminal to class D grounding
board terminal.

Black Green
White
White Black
Green

2-13
AU480 User Guide Precautions, Installation and
Version 1.0 Specifications
 Return to Main Table of Contents

Temperature and Humidity Conditions When in Use

Ensure that:

• The temperature of the installation room is between 18 ºC and 32 ºC.

• The temperature does not fluctuate more than ± 2 ºC.

• The humidity is between 40% and 80% Relative Humidity (RH), and with no condensation.

• The site is well ventilated. Use ventilation equipment if necessary.

• The system is not exposed to direct airflow from air conditioners.

The heat the system outputs during operation is approximately 8,820 KJ per hour. When the
specified room temperature and humidity ranges fluctuate, the system data may not be reliable. If the
temperature in the room fluctuates excessively make sure adequate air conditioning is installed.

The installation site must be well ventilated. To insure proper location dimensions,
refer to section “2.2.3 Installation Space Requirements” in this chapter.
CAUTION

Temperature and Humidity Conditions When Not in Use

Ensure that:

• The temperature is between 5 ºC and 40 ºC.

• The humidity is between 15% and 90%.

Water Supply
The water supply and liquid waste facilities must be installed before.
This system uses deionized water. For installation of a deionizer and piping from the water supply
facility to the deionizer, consult an experienced vendor. Note, deionizer performance will be affected by
the quality of the water supply to the facility.
Ensure that:

• The system is within 10 metres of the deionized water outlet. A drain should be within 3 metres,
less than 1.5 metres high.

• The purity of the deionized water should have the electric conductivity of 2 µS/cm or less
(resistivity: 0.5 MΩ x cm or more).

• Water should be filtered using a filter of 0.5 µm or less.

• The temperature of the deionized water should be between 5 ºC and 28 ºC.

• The pressure of the deionized water should be between 0.49 x 105 Pa and 3.92 x 105 Pa (or 7 to
57 psi).

2-14
Precautions, Installation and AU480 User Guide
Specifications Version 1.0
Return to Main Table of Contents

The water consumption of the system is as follows:

• Average water consumption is approximately 20 liters per hour, whether a single or two reagent
test is being performed.

• Maximum water demand is approximately 0.6 liter per minute.

• Deionized water supplied to the system should not contain excessive air bubbles.
The system includes the following tubing:

• Water supply tube: Braided Tube 12 mm (ID) x 18 mm (OD), L=10 m

• Exhaust Air tube: 12 mm (ID) x 18 mm (OD), L=10 m

• Waste tubes: Braided Tube 15 mm (ID) x 18 mm (OD), L=10 m, 2 pieces

• If the tap water temperature exceeds the optimal temperature range for the
deionizer, consult the deionizer manufacturer.

CAUTION • When using the existing water supply piping and deionizer, verify that it is bacteria
and germ free.

• The water pressure for this system operates at a range from 0.49 x 105 to 3.92
x 105 Pa. For the correct water pressure for the deionizer, contact the deionizer
manufacturer.
TIP
• Use of a reverse osmotic membrane as the deionizer is recommended. For
detailed information, contact Beckman Coulter Technical Services.

2-15
AU480 User Guide Precautions, Installation and
Version 1.0 Specifications
 Return to Main Table of Contents

Drainage and Exhaust

Follow all regulations and ordinances for disposal of all liquid and infectious waste .
Some regulations and ordinances require that high pH liquids be separated,
WARNING neutralized, or pumped to holding tanks for transport to treatment facilities.

• The system discharges waste liquids by forced drain and moist air containing the components of
waste liquids.

• Condensed waste liquid: Mixture from cuvettes and sample probe wash solution.

• Diluted waste liquid: Waste liquid used for washing cuvettes, mix bars, etc.
The drainage and exhaust should meet the following conditions.

• The drain hole should be located within 10 m from this system.

• The drain should be connected to infectious waste collection tank as required by law.

• The drain must be located no higher than 1.5 m and the exhaust no higher than 0.1m above the
system installation floor.

• The ends of exhaust air hoses and the waste liquid hoses, which are inserted into the drain,
should be kept above the liquid level of the drain.

• Make sure the liquid waste hoses are not bent or crushed.

• The drain should be able to drain the following amount of waste liquids:
Condensed waste liquid: around 6 L/hour
Diluted waste liquid: around 14 L/hour

Quantity consumed of water

The water supply and drainage facilities must be installed before. This system uses deionized water. A
deionizer should be installed within 10 m from the water tap, and the drain should be located within 10
m of the water supply so that the drain hoses reach the system.
For information about a deionizer, contact the manufacturer.

2-16
Precautions, Installation and AU480 User Guide
Specifications Version 1.0
Return to Main Table of Contents

2.2.2 System Specifications

The following table summarizes the installation specifications.

Installation Specifications
1. System Dimensions
ANL: 1450 mm (W) x 770 mm (D) x 1205 mm (H)
2. Weight
ANL: 420 kg
3. Water Supply and Drainage Conditions
Electric conductivity of the deionized water 2.0 µS/cm or less
Water pressure Between 0.49 x 105 Pa and 3.92 x 105 Pa
Water consumption
Average 20 L/hour (50/60 Hz) 0.6 L/minute (50/60 Hz)
Maximum water demand
Water temperature 5 to 28 °C
Connection hose for water supply 12 mm x 18 mm x 10 m
Connection hose for concentrated and diluted 15 mm x 22 mm x 10 m
waste drain
Air exhaust hose 12 mm x 18 mm x 10 m
Drain height Less or equal 1.5 m from floor
4. Environmental Conditions (When in Use)
Temperature 18 to 32 °C
Fluctuation during measurement ±2 °C
Humidity 40 to 80% RH, no condensation
5. Power Source Conditions
Voltage, Frequency AC 208 V 50/60 Hz (USA)
AC 230 V 50/60 Hz (Europe)
AC 220 V 50/60 Hz (Asia)
AC 240 V 50/60 Hz (Australia)
Power Consumption 3.5 kVA

2-17
AU480 User Guide Precautions, Installation and
Version 1.0 Specifications
 Return to Main Table of Contents

The following table summarizes the general specifications:

General Specifications
1. Analytic Principle
Spectrum by a diffraction grating
2. Composition
Analyzer
Data processor.
3. Options
ISE
Printer
BECKMAN COULTER SUPPORTVISION (BSV) connection kit
Hand scanner
External storage device (HD)
Monitor arm unit
Water supply equipment
External wash solution unit
4. Sample Type
Serum Viscosities in the same range as serum.
Blood plasma
Urine
5. Number of Tests on Board
Maximum 60 (63 including ISE) at a time
6. Throughput
Maximum 400 (800 including ISE) tests/hour
200 samples/hour analyzing only ISE
7. Data Input Methods
Keyboard
Mouse
Touch screen display
Hand scanner (Option)
CD -R
Online (RS232C)
8. Data Output Methods
Display
Printer
Online (RS232C)
External storage device (HD) (Option)

This system is complies with IEC60825-1: 2001

2-18
Precautions, Installation and AU480 User Guide
Specifications Version 1.0
Return to Main Table of Contents

The following table summarizes the sampling specifications:

Sampling
1. Usable Sample Cups/Tubes (*1)
Micro-sample cup Hitachi cup (No.707-0313)
Available at outer circumference, and W1 or W2 at inner
circumference of STAT table.
Sample cups Hitachi cup (No. 716-0425) ISE-CAL, ISE-CLEAN, ISE-
SEL, and ISE-CRS can be set. at inner circumference
(ISE) of STAT table
Commercial sample tube
Length Inner diameter 55 to 102 mm
Outer diameter 9 to 15 mm
The maximum diameter of the brim of a sample 11.5 to 16 mm less than 17.5 mm
tube An adapter fitting to the outside diameter is required.
When setting at inner circumference (ISE) of STAT table,
outside diameter φ12.3 mm is only applicable. An adapter
is required additionally.
Nested cups Hitachi cup (No. 716-0415)
φ16 (OD) x 75 (length)
φ 16 (OD) x 100 (length)
available only on a rack.
2. Dead Volume for Sample Cup
Cups/Tubes Dead Volume
12.3 mm tube 200 µL or less (NIPRO CT-7)
15.4 mm tube 250 µL or less (NIPRO CT-10)
Hitachi cup 50 µL or less
Hitachi-micro cup 30 µL or less (Aspiration quantity: up to 25 µL)
Nested cups compatible 180 µL or less
3. Rack Loading Capacity
8 racks maximum
4. Sample Dispense System
The following functions are available:
Sample Repeat run with diluent capability
Liquid level detection
Crash detection
Microsyringe method
Clot detection
5. Dispensing Volume
1.0 to 25.0 µL in increments of 0.1 µL
(Repeat run dispensing volume 1.0 to 25 µL)
6. Rack Type
White rack (NE)
Yellow rack (NE)
Red rack (NE)
Orange rack (NE)
Green rack (NE)
Blue rack (NE)

*1: When set the lowest points of probe by the types of cup, there are use limitations for available
sample cups. For detailed information, refer to "5.4.3 Sample cup preparation" in chapter 5.

2-19
AU480 User Guide Precautions, Installation and
Version 1.0 Specifications
 Return to Main Table of Contents

The following table summarizes the reagent set and reagent dispensing specifications:

Reagent
1. Storage Capacity
1. Reagent refrigerator 76 (including Pre-treatment or diluent)
2. Concentrated Wash solution 2 L tank
3. ISE Buffer solution 2 L tank
4. ISE MID solution 2 L tank
5. ISE Reference solution 1 L tank
2. Refrigeration
Refrigeration temperature 4 to 12 °C
3. Reagent Setup Method
Turntable type
4. Types of Reagent
Normal-concentration reagent
high-concentration reagent
5. Reagent Dispense Mechanism
Micro-syringe type
Crash detecting function provided:
If the probe tip comes into contact with a reagent bottle, or other solid object, during probe down-feed,
the system automatically stops probe transfer operation. The dispense accuracy may be compromised
depending on the condition of the probe and may require replacement.
6. Number of Reagent Steps
Up to 2 steps
7. Dispensing Volume
10 to 250 µL in increments of 1 µL (At normal dispensing)
10 to 240 µL in increments of 1 µL (At dilution dispensing)

The following table summarizes the reaction specifications:

Reaction
1. Incubator
Dry bath method 37 °C with 88
Square glass cuvettes 5 x 5 mm (Inside diameter)
2. Reaction Volume
90 to 350 µL

3. Reaction TIme
Maximum 8 minutes and 37.5 seconds from sample dispense
4. Mixing Method
Rotating mix bar
5. Reaction Container
Square, glass cuvette (optical path length: 6 mm)
6. Incubator Temperature Control
Dry bath method
7. Reaction Line
Rotation disk type: 88 cuvettes

2-20
Precautions, Installation and AU480 User Guide
Specifications Version 1.0
Return to Main Table of Contents

The following table summarizes the measurement specifications:

Measurement
1. Photometric point
28 points
2. Type of Measurement
End point assay
Rate assay
Fixed point assay
Electrolyte method (ISE): The ISE is optional.
3. Optical System
Post spectroscopy (polychrometer)
4. Light Source
Halogen lamp: 12 V/20 W
Should be replaced every 1,000 hours as a guide
5. Detector
Silicone photodiode array
6. Measuring Range
0 to 3 Abs (10 mm optical path conversion)
7. Photometric Resolution
0.0001 Abs
8. Wavelength Range
340 to 800 nm (13 wavelengths)

The following table summarizes the data processing specifications:

Data Processor
1. Storage Capacity
Data storage Hard disc
Capacity 100,000 samples
Patient samples 9999 samples/index
Reaction Monitor 200,000 test and max of 10,000
test/index
Maximum 300 indexes
QC 999 samples/index
Maximum 300 indexes
Data storage Floppy disk
Capacity 500 samples (independ of index numbers)
2. Configuration of the Data Processor
Hard disk: 200 GB or larger
Memory capacity: 2 GB or more
Keyboard: 101-109 keyboard
17 inch touch screen display
CD-R drive
Printer (optional)

2-21
AU480 User Guide Precautions, Installation and
Version 1.0 Specifications
 Return to Main Table of Contents

The following table summarizes the computation specifications:

Computation
1. Calculations
Calibration
Calibration types
ACAL AA
ACAL AB
ACAL 2 to 7 AB
4 MC to 10 MC
MCAL MB
MCAL 2 to 7 MB
Calibration curve type
Straight Line
Polygonal Line
Quadratic Type
Tertiary Type
Tertiary Type (Reversed Function)
EIA TYPE 1 to 4
Spline
Correction
Water Blank correction
Reagent Blank correction
Two wavelength correction
Data correction
2. Quality Control
QC samples
Maximum of 10 types/test
Maximum of 100 types in total
QC checks
Shewhart day-to-day management (L-J method)
Multirule (Westgard method)
Twin plot
Riliback

The following table summarizes the input/output specifications:

Input/Output
1. Worksheet
Patient sample worksheet
Emergency sample worksheet
Repeat sample worksheet
QC worksheet
Calibration worksheet
2. Data Input/Output
Analysis result output Realtime, batch online
Data correction possible
Recalculation possible
3. Input/Output for External Devices
Online input/output RS232C
Offline output Floppy disc
CD-R
External storage device HD(option)

2-22
Precautions, Installation and AU480 User Guide
Specifications Version 1.0
Return to Main Table of Contents

The following table summarizes the ISE (optional) specifications:

ISE Optional
1. Measurement Method
Diluted ion-selective electrode method
2. Measurement Items
Na, K, and Cl ions in serum and urine
3. Throughput
200 samples/hour
4. Dispensed Sample Amount
20 µL (deionized water 10 µL)
5. Diluent Rate
32.4 times (deionized water 10 µL, buffer solution 618 µL)
6. Measurement Range (Unit: mmoI/L
Item Serum Urine
Na 50 to 200 10 to 400
K 1.0 to 10.0 2.0 to 200
Cl 50 to 200 15 to 400
7. Calibration Setting
Auto calibration
Measures the high-concentration standard solution and low-concentration standard solution, and performs
two-point calibration.
8. Data Correction
Manual calibration correction (M-CAL) and auto calibration correction (A-CAL, 3-point regression CAL) are
possible
9. Drift Correction
Auto correction
Measures the potential of the MID solution for each sample and corrects the drift.
10. Types and Standard Supply Intervals of Consumables.
Name Estimated Daily Consumption
Buffer solution for ISE (option) Approx. 180 mL (at 100 serum samples/day)
MID solution for ISE (option) Approx. 260 mL (at 100 serum samples/day)
REF solution for ISE (option) Approx. 35 mL (at 100 serum samples/day)
Cleaning solution for ISE (option) Approx. 1 mL (at 100 serum samples/day)

The following table summarizes the monitor arm unit (option) specifications:

Monitor arm unit (option)

1. Maximum weight of display
10 kg
2. Maximum weight of keyboard table
2 kg

2-23
AU480 User Guide Precautions, Installation and
Version 1.0 Specifications
 Return to Main Table of Contents

2.2.3 Installation Space Requirements

The System
This system requires space of at least 500 mm from the wall around it for safe installation and
maintenance.

500
AU480

1770
770
Analyzer
(ANL)

500 1450 500

500

2450
mm

Dimensions:

Width Depth Height Weight

Analyzer 1450 mm 770 mm 1205 mm 420 kg

Including ISE (option) and DPR (monitor and computer).

To set a printer (option), another space is required.
The height of DPR is approximately 1570 mm.
The depth (D) needs to have additional 20 mm for the joint of the monitor arm unit (option).

2-24
Precautions, Installation and AU480 User Guide
Specifications Version 1.0
Return to Main Table of Contents

2.2.4 System Connections

The following illustration shows the system connections.

Display/mouse/
keyboard/speaker

Host computer(serial)

DPR Printer(option)

ISE
ANL
(option) External memory unit
(HD) (option)

Hand scanner
(option)

Router (BSV)
(option)

Devices Connected to the system

Water supply equipment
connector
To main water valve
Water supply
equipment
(option) System rear face

1.5 m or less

To DPR
To Router(option)
Power cable
To Display (10m)
To Speaker

Drain hole Drain hole Concentrated waste liquid hose (10m)

Power strip Washing waste liquid hose (10m)

Water supply tube (10m)

Exhaust air hose (10m)

2-25
AU480 User Guide Precautions, Installation and
Version 1.0 Specifications
 Return to Main Table of Contents

Devices connected to the Computer

Display

Mouse
Hand scanner (option)
Keyboard

Printer(option)

External
memory unit
(HD) (option)
DPR Host
Speaker
computer

to ANL Router
(option)

The cable connecting between DPR and ANL is 5 m in length.

The printer should use a facility power outlet, not a system power outlet or it could trip
the system circuit breaker interrupting power.
CAUTION

2-26
Precautions, Installation and AU480 User Guide
Specifications Version 1.0
Return to Main Table of Contents

2.3 System Labels and Displays

Displays
The following pictograms represent the switches and the breaker unit.

ON OFF GND Terminal

Labels
The following labels are displayed on the system:

• Stripes: Orange stripes affixed to the system surface indicate the movement areas of the
mechanisms. Avoid these areas during operation.

• Warning labels: Draw attention to areas of the system where hazards exist and indicate that
care must be taken to avoid serious injury or death.

Background Colors of Warning Labels

The warning labels have the following background colors :

• Orange: Labels with an orange background indicate to use caution to avoid serious injury or
death. Failure to observe these warnings may led to serious degradation of system performance
or generation of incorrect sample data.

• Yellow: Labels with a yellow background indicate that care or action must be taken to avoid
minor injury, sub-optimal system performance, or damage, which could result in other hazards.

Label Explanation
Electric shock: This symbol indicates an area of the system that shold not be
accessed under any circumstances, due to risk of electrical shock.
(Labeling Position: near the inlet of the power cable at the rear side of the
analyzer)

High temperature danger: This symbol indicates the risk of burning by

touching the hot photometer lamp directly when replacing it.
(Labeling Position: near the light source lamp unit)

Biological risks: This symbol indicates the use of biohazardous material. Wear
protective clothing and follow universal precautions as dictated by local or
national regulations (CLSI GP17-A2, ISO15190 or 29CFR 1910.1030)
Risk of biohazardous materials such as sample probe, mix bars, sample rack,
cuvette washing nozzle, cuvette, sample probe washing bath, condensed
waste liquid drain hole, ISE pot, ISE roller tube, drain hole, etc.
(Labeling Position: on the surface of analyzer and on the real cover)

2-27
AU480 User Guide Precautions, Installation and
Version 1.0 Specifications
 Return to Main Table of Contents

Label Explanation
CLASS 1 LASER PRODUCT complies with IEC60825-1: 2001.
(Labeling Position: near the power outlet of PC at the rear side
of the analyzer)
CAUTION-CLASS 2 LASER RADIATION
WHEN OPEN AND INTERLOCKS DEFEATED
DO NOT STARE INTO THE BEAM.
(Labeling Position: near the CB interlock switch of rack feeder unit, near
the interlock switch of STAT table cover (L), near the interlock switch of
STAT table cover (S), and near the interlock switch of reagent
refrigerator lid)
CAUTION-CLASS 2 LASER RADIATION
WHEN OPEN DO NOT STARE INTO THE BEAM.
(Labeling Position: near the window of the laser light irradiation for reading
sample IDs of STAT table units, near the window of the laser light
irradiation for reading sample IDs of rack feeder unit)
Personal injury: This symbol indicates areas where a risk of injury due to
system movement is possible. Fingers or other parts of the body should be
kept clear of these areas during system operation.
• Danger of injury by moving parts of the sample probe, reagent probe,
mix bars, cuvette washing nozzle, etc.
(Labeling Position: on the surface of analyzer and on the real cover)
• Danger of injury by moving parts of the sample probe, etc.
(Labeling Position: near the sample syringe of the rack feeder unit)
• Danger of injury by moving parts of the S-syringe, R-syringe, etc.
(Labeling Position: near the S-syringe)
• Danger of injury by moving parts, such as the master wash solution
supply pump, etc.
(Labeling Position: near the master wash solution supply pump)
• Danger of injury by moving parts, such as the ISE roller pump unit, etc.
(Labeling Position: back of the ISE cover)
Danger: This label indicates a potential hazard which, if not avoided, can
result in injury to an operator and/or serious property damage.
• Danger of leak from water supply and discharge unit.
(Labeling Position: near the water outlet)
• To avoid electrical shock, do not remove the cover connector screws to
access the water supply unit.
(Labeling Position: near the power outlet of water supply unit (option))

2-28
Precautions, Installation and AU480 User Guide
Specifications Version 1.0
Return to Main Table of Contents

The label is attached

to inside of the lid.

2-29
AU480 User Guide Precautions, Installation and
Version 1.0 Specifications
 Return to Main Table of Contents

2.4 Trade Marks

The company names and product names used in this user guide are registered trade marks of their
respective companies.

2-30
Precautions, Installation and AU480 User Guide
Specifications Version 1.0
Return to Main Table of Contents

3
System Outline

This chapter provides a general overview of how the system functions.

It introduces key processes that are explained in later chapters of this
user guide.
It also describes the system hardware. This enables the operator to
better understand the technical composition of the system.

Contents
3.1 How the AU480 Analyzes Samples .............................................................................3-3
3.1.1 Reagent Blank .................................................................................................3-3
3.1.2 End Point Assay ..............................................................................................3-4
3.1.3 Rate Assay ......................................................................................................3-6
3.1.4 Fixed Point Assay ............................................................................................3-6
3.1.5 Quality Control..................................................................................................3-7
3.1.6 Summary of Calibration Types.......................................................................3-10
3.1.7 Principle of the ISE Measuring Method.......................................................3-10-4
3.2 Key Sub-Processes ....................................................................................................3-11
3.2.1 Computer Automation . .................................................................................. 3-11
3.2.2 Sample Identification .....................................................................................3-12
3.2.3 Sample Transfer ............................................................................................3-13
3.2.4 Reagent Transfer . .........................................................................................3-13
3.2.5 Reaction Fluid Mixing ....................................................................................3-13
3.2.6 Reaction Fluid Incubation and Washing ........................................................3-13
3.2.7 Measurement by Photometry ........................................................................3-13
3.3 Understanding and Handling Reagents, Calibrators and Controls .......................3-14
3.3.1 Reagents .......................................................................................................3-14
3.3.2 Sample diluent . .............................................................................................3-14
3.3.3 Calibrator .......................................................................................................3-14
3.3.4 QC control sample . .......................................................................................3-14
3.4 Understanding the System Hardware........................................................................3-15
3.4.1 System Switches and Buttons........................................................................3-17
3.4.2 Rack Feeder Unit............................................................................................3-18
3.4.3 Hand Scanner (Optional) . .............................................................................3-19
3.4.4 Sample Cups and Tubes ...............................................................................3-19
3.4.5 Racks . ...........................................................................................................3-20
3.4.6 Sample Transfer Unit......................................................................................3-21
3.4.7 Reagent Transfer Unit....................................................................................3-22
3.4.8 Mixing Unit......................................................................................................3-22
3.4.9 Incubation Bath Unit.......................................................................................3-23
3.4.10 Photometry Unit..............................................................................................3-23
3.4.11 Wash Nozzle Unit...........................................................................................3-24
3.4.12 Reagent Refrigeration Unit.............................................................................3-25
3.4.13 STAT Table Unit..............................................................................................3-26
3.4.14 Syringe Unit....................................................................................................3-28
3.4.15 Wash Solution Roller Pump Unit....................................................................3-28
3.4.16 Tank Storage..................................................................................................3-29

3-1
AU480 User Guide System Outline
Version 1.0
 Return to Main Table of Contents

3.4.17 Breakers and Fuses.......................................................................................3-30

3.4.18 ISE Unit (optional)..........................................................................................3-30
3.5 Understanding the Computer Software ....................................................................3-32
3.5.1 Graphical User Interface (GUI).......................................................................3-32
3.5.2 Main button bar .............................................................................................3-33
3.5.3 Processing Time ............................................................................................3-33
3.5.4 Measure Modes . ...........................................................................................3-34
3.5.5 Touch Screen and Keyboard .........................................................................3-35

3-2
System Outline AU480 User Guide
Version 1.0
Return to Main Table of Contents

3.1 How the AU480 Analyzes Samples

This system performs automated analysis of serum, plasma, and urine.
This section provides an overview of how the AU480 tests samples. It also describes the ISE
Measuring Method.

3.1.1 Reagent Blank .................................................................................................3-3

3.1.2 End Point Assay ..............................................................................................3-4
3.1.3 Rate Assay ......................................................................................................3-6
3.1.4 Fixed Point Assay ............................................................................................3-6
3.1.5 Quality Control..................................................................................................3-7
3.1.6 Summary of Calibration Types.......................................................................3-10
3.1.7 Principle of the ISE Measuring Method.......................................................3-10-4

3.1.1 Reagent Blank

To calculate a measurement value (reaction OD), the reagent blank OD (reagent OD at each
photometric point of P0 to P27) and the deionized water blank OD values (photocal data) is subtracted
from the measured OD of a sample reacted with a reagent.
By performing a reagent blank measurement the reagent blank OD values (RB) at all photometric
points shown in the following chart can be obtained.
Reagent blank measured uses the blue rack. Set sample on blue rack No.1 or blue rack No.2. On the
“Calibration Parameters” window, set serum, urine, other-1, and other-2 on either blue rack No.1 or
No.2.
The system measures one sample cup up to 4 times and determines the reagent blank data (reagent
blank OD value) using the average of 2 measurements after excluding the maximum and minimum
values among the four measurements.

OD Reagent Blank (Compared with water blank; example of 2 step analysis)

Reagent OD value
at the last point
(second data)
Reagent OD value at the first point (first data)

Deionized water blank (photocal data)

Photometric
P0 P1 P10 P11 P27 point
R1 Sample (Water) R2
Dispensing Dispensing Dispensing R1: First Reagent
R2: Second Reagent

The following describes the first point reagent OD value (first data) and last-point reagent OD value
(second data).

3-3
AU480 User Guide System Outline
Version 1.0
 Return to Main Table of Contents

First point reagent OD value (first data)

• First point reagent OD value (RB) = {first point measured OD value} -{deionized water blank
(photocal data)}

• If the first point reagent OD value is outside the reagent OD range that was set up in the reagent
parameters, abnormal flags “y” (for over range) and “u” (for under range) will be attached to the
data.

Last point reagent OD value (second data)

• Last point reagent OD value (RB) = {last point measured OD value} - {deionized water blank
(photocal data)}

• If the last point reagent OD value is out of the reagent OD range set up in the reagent
parameters, abnormal flags “Y” and “U” are added to the data.

3.1.2 End Point Assay

This section describes the end point assay.

1-point Assay
This is a general end point assay that determines the reaction mixture OD from the OD measured at a
specified photometric position.
Reaction mixture OD = OD (at specified position) - OD0 (at position 0)

OD

R1 0 S 1 2 3 4 5 6 7 8 27

3-4
System Outline AU480 User Guide
Version 1.0
Return to Main Table of Contents

2-point Assay (self-blank method)

An end point assay requires a sample blank adjustment. The OD values before dispensing the reagent
2 should be eliminated as the blank channel. The OD values of the blank channel is subtracted from
those measured after dispensing the reagent 2 to obtain correct data without influences from turbidity
or color of the serum.
The OD value in this assay is given by the following expression:
K2 = {R1. V / (R1.V + R2.V + S.V)}
K3 = {(R1.V + S.V) / (R1.V + R2.V + S.V)}
Reaction OD value = (Px - K2 × P0) - (K3 × Pz - K2 × P0)
This calculation result is defined as the reaction OD value.

OD

R1 0 S 1 2 .... 9 10 R211 .... 27

R1.V S.V Pz R2.V Px

R1.V: Reagent 1 dispense volume

R2.V: Reagent 2 dispense volume
S.V: Sample dispense volume
P0 : OD value at the first point
Pz : OD value before dispensing the reagent 2
Px : OD value after dispensing the reagent 2
In case of end assay (sample blank correction)
OD values (blank item values) including turbidity of serum or impurities by interference of the other test
items are measured first. Then, the blank item value is subtracted from the measured OD value of the
actual sample (OD value of the color item).
With this end assay (sample blank correction), higher accuracy data can be obtained than the 2 point
measuring even when turbidity of serum or impurities by interference of the other test items (dotted
line in the figure below) is unavoidable.
Reaction OD value = [Color item OD value (ODC)] – [Blank item OD value (ODB)]
Color reaction channel
OD

ODC

Serum blank channel

ODB

R1 S R2 27

3-5
AU480 User Guide System Outline
Version 1.0
 Return to Main Table of Contents

3.1.3 Rate Assay

This section describes the rate assay.

Rate Assay
This assay determines the rate of absorbance variation per minute by calculating the average of the
absorbance variations (ΔOD) between each photometric points using the least squares method.
OD

∆OD/min.
OD limit

R1 S R2 27

Double Rate Assay

This assay determines the rate of absorbance variation per minute by calculating the average of the
absorbance variations (ΔOD) between each photometric points using the least squares method.
Next, the system obtains the OD rate of the objective substance from the calculation expression
{ΔOD(2) - ΔOD(1)}/min.

OD

∆OD(2)/min.
∆OD(1)/min.

R1 S R2 27
[∆OD(2)-∆OD(1)]/min.

3.1.4 Fixed Point Assay

A fixed point assay measures the OD value at two specified photometry points. The two photometry
points are measured after the beginning of reaction between sample and reagent.
Reaction OD value = ODB - ODA

OD

R1 S R2 A B 27

3-6
System Outline AU480 User Guide
Version 1.0
Return to Main Table of Contents

3.1.5 Quality Control

A wide variety of quality control techniques is used to keep up daily inspection accuracy. In this
equipment, day-to-day control which is the most widely used accuracy control technique, twin plot
control for easier classification of system errors and accidental errors, and multi-rule quality control
for preventing detection of insignificant errors are designed in as standard software. This chapter
describes the twin plot control and multi-rule control. For details about the day-to-day control, refer to
“Check the Daily Variation Chart” in section “6.4.5 Checking QC” in chapter 6.

Twin Plot Control

Quality control serum whose normal region and the abnormal region form a pair with each other are
used. The following figure shows the control chart given in chapter 6, “Check the Daily Variation Chart”
in a two dimensional fashion with reference to two sample type.
Abnormal
region sample
+2SD

MEAN

-2SD

-2SD MEAN +2SD Normal region

sample

If the samples of normal region and abnormal region are within the control limit, and also both samples
are high values or low values, a check of calibration system should be made to determine system
errors.
If a high value of abnormal region is low, reagent degeneration is suspected. The twin plot control
technique offers the advantage of easy classification of a system error and an accidental error, but
it will be effective to make combined control with day-to-day control because there is a difficulty of
determining an aging change.

3-7
AU480 User Guide System Outline
Version 1.0
 Return to Main Table of Contents

Multi-Rule Control
In the day-to-day control, a control error is checked by examining the control chart, but it is difficult to
do confirmation of numerous test on a real time basis.
The multi-rule control technique makes it possible to speedily cope with an error realtime, as this
control method notifies the worker of just which rule an error, when generated, violates based on an
alarm flag.
When employing this control technique, it is necessary to prepare samples of both the normal region
and the abnormal region, just in the case of the previously introduced twin plot control. For details of
the multi-rule control, refer to the figure shown below.

Control OUT-OF-CONTROL REJECT RUN

Data
Yes Yes

No No No
12S Trend IN-CONTROL Trend

Yes No
No No No No
13S 22S R4S 41S Nx

Yes Yes Yes Yes Yes

OUT-OF-CONTROL REJECT RUN

Standard of judgement based on the multi-rule Shewhart technique. (Logic diagram Applicable to
Control Rules)

The Explanation of Symbols for the Multi-Rule Control and the Logics are as
follows

• 12S indicates that five judgment levels given in the accompanying table on the next page are
sequentially checked to see whether or not there is any violation of the applicable rule if one
piece of control is exceeding the control limit determined as ‘MEAN ±2 SD’.

• 13S is a judgment level for determining if one piece of control has exceeded the control limit
determined as ‘MEAN ±3 SD’. If it dose not exceed the control limit, an inquiry for judgment is
made to the next judgment level 22S. On the other hand, when it exceeds the control limit, it is
judged that the accuracy control has been properly made.

• 22S is a criteria level for judging whether or not the two continuous pieces of control data have
exceeded the control limit determined as ‘MEAN ±2 SD’ in one direction, if these are not beyond
the control limit, an inquiry is made to R4S for the next judgment level. On the other hand, if the
control is exceeded, it is judged that quality control has not been made properly.

The term “continuous” above, can have the following meanings.

• To be continuous in both directions for one identical control substance.

TIP • To have continuity of high-concentration and low-concentration between control

substances.

• R4S is a judgment level for determining whether either of two continuous pieces of data with high
and low concentrations has exceeded the control limit specified as “MEAN + 2SD” and whether
the other has exceeded the control limit of “MEAN –2SD”. In other words, it judges whether
the two continuous pieces of data have exceeded 4SD in the same range. If the data is within
the control limit, judgment is advanced to the next judgment level, 41S. If the data is out of the
control limit, quality control has not been properly attained.

3-8
System Outline AU480 User Guide
Version 1.0
Return to Main Table of Contents

• 41S is a judgment level for determining whether or not four continuous pieces of control data
have exceeded the control limit of either ‘MEAN +1 SD’ or ‘MEAN -1 SD’.If they have not
exceeded either control limit, an inquiry is made to the next judgment standard Nx for necessary
judgment, but if they have exceeded the limit, quality control has not been properly made.

• Nx is a judgment level for determining whether or not continuous N (7 to 10) pieces of control
data have sided to the control limit of either + mean side or - mean side. If they have not
exceeded the control limit, quality control has been properly made. But if they have exceeded
the control limit, it is judged, quality control has not properly been done. Since this Nx rule uses
a maximum of 10 pieces of previous data for judgment, the system’s hard disk stores those
pieces of data as QC stack values.

• Trend evaluates if 4 to 10 sequential results of measurement (parameter regulation: the results

includes measurement result of control data) which are the same control as the control data,
increases or decreases.
If an error is encountered through the 6 rules described above, an abnormal data flag is sent to
the printer (option) as a list or displayed on the window. The abnormal data flags and causes are
described below.

Control Limit Error Symbol Cause of Error

Exceeds 13S 2Q Random error
Exceeds 22S 3Q Systematic error
Exceeds R4S 4Q Random error
Exceeds 41S 5Q Systematic error
Exceeds Nx 6Q Systematic error
Trend abnormality 7Q Systematic error

Example of Control Errors According to the Multi-Rule Control are shown

below
22S: Systematic error extending over the
High value sample 13S
2 type concentration range
R4S: Random error
3SD
2SD
1SD
Mean
–1SD
–2SD
–3SD

41S: Systematic error extending 22S: Systematic error in the Day

over the 2 type concentration range high concentration region
Low value sample 22S: Systematic error extending over
the 2 type concentration range
3SD
2SD
1SD
Mean
–1SD
–2SD
–3SD

Nx: Systematic error in the Day

13S: Random error low concentration region

The following describes the possible causes and check items for the random errors and systematic
errors shown in the figure above. To deal with the errors, refer to the following:

3-9
AU480 User Guide System Outline
Version 1.0
 Return to Main Table of Contents

Random errors

• Poor dispensing accuracy (sample, reagent) Leakage from syringe, air introduced into piping
system, dirty probe, reagent eject position runout, etc.

• Poor photo metering accuracy

Lamp deterioration.

• Reagent degeneration
Reagent degeneration.

• Poor quality control sample

Mistaken sample, different lot, etc.

• Insufficient cleaning
Mixing rod cleaning improper or Insufficient.

• Poor mixing
Solenoid defective, cuvette holder defective.

Systematic errors

• Incorrect calibration
Incorrect reconstitution of calibratiors.

• Deteriorated reagent
Reagent degeneration, different lot, etc.

• Temperature
Improper temperature control.

3.1.6 Summary of Calibration Types

This system allows the operator to generate a maximum of 15 types of calibrations, depending on the
analysis test. Of them, 6 major types of calibration will be described in the following.

ACAL AA
OD ● Enter two kinds of standard liquid with a
different concentration or a value of the
ACAL OD2
calibrator, then set a calibration using
an OD value obtained from the automatic
calibration setting function.
ACAL OD1

● This can be applied to analysis items where

the calibration chart is a line but does not
pass through the origin (reagent blank).
CONC (An example analysis item: Calcium)
Concentration Concentration
value 1 value 2

3-10
System Outline AU480 User Guide
Version 1.0
Return to Main Table of Contents

ACAL AB
OD ● Enter the value of one kind of standard liquid
or the calibrator, then set a calibration
chart using an OD value obtained from the
ACAL OD
automatic calibration setting function.

● This can be applied to general calibrations

which are lines and pass through the origin
(reagent blank).

CONC
Concentration value

ACAL 7AB
OD

OD 7 ● By using 2 to 7 kinds of standard solutions

OD 6
or calibrator, and by entering the measured
OD values and concentration values, set a
OD 5
calibration chart.
OD 4

OD 3 ● This will be used for immunity items

OD 2 and turbidmetry items.

OD 1
OD 0 CONC
Concentration value 1

Concentration value 2

Concentration value 3

Concentration value 4

Concentration value 5

Concentration value 6

Concentration value 7

3-10-1
AU480 User Guide System Outline
Version 1.0
 Return to Main Table of Contents

MCAL MB
OD ● Set the calibration coefficient with the K factor.

● This is typically used for enzyme items

through the rate assay method.

CONC

MCAL 7MB
OD ● With a maximum of 7 points OD values and
the entered concentration value, set a calibration.
OD 7
● This will be applied to analysis items whose
OD 6
OD 5
calibration is not a line but each of the curved
OD 4 sections has a constant slope.
OD 3 Typically used for turbidmetry and immunity items.
OD 2
OD 1
CONC
Concentration value 1
Concentration value 2

Concentration value 3

Concentration value 4
Concentration value 5
Concentration value 6
Concentration value 7

3-10-2
System Outline AU480 User Guide
Version 1.0
Return to Main Table of Contents

ACAL nAB (single-point correction processing)

First, analyze one of multiple standard solutions for 2AB to 7AB. By using the ratio between the
reaction OD values of this standard solution and the previously measured standard solution, correct
the reaction OD values of other standard solutions, and then recreate the calibration chart.
Also, it is possible to correct the calibration chart with two points of OD0 and another OD value, if the
standard solution with a concentration of 0 is available.
Example 1: If none of multiple standard solutions has a concentration of 0

OD
● If the single-point correction is performed
OD3' for the CONC2 standard solution, execute
OD3 the following calculation.
OD2'
OD2 1. Perform the single-point correction.
OD1'
ODn' = ODn x OD2
OD1
OD2'

CONC 2. Recalculate for the calibration chart.

0 CONC1 CONC2 CONC3

Example 2: If any standard solution has a concentration of 0 ● If correction is performed with two points
of CONC1 and another (CONC3), execute
OD
the following calculation.
OD4'
OD4 1. Use the reaction OD values of CONC1
and CONC3 (OD1' and OD3') as they are.
OD3'
OD3
2. Correct each point as follows.
OD2'
OD2
OD1' ODn' = α x (ODn - OD1) + β
OD1
CONC OD3' - OD1'
0 CONC2 CONC3 CONC4 α = OD3 - OD1
ODn : previous OD value ODn' : OD value after correction β = OD1'

3-10-3
AU480 User Guide System Outline
Version 1.0
 Return to Main Table of Contents

3.1.7 Principle of the ISE Measuring Method

Sample and buffer solution are mixed using a specified dilution ratio in the dilution pot of the ISE unit
(optional). The mixture is aspirated and passed to the selection electrode (Na, K, Cl), and the potential
generated at the electrodes is measured. MID solution is passed between samples to measure the
reference potential for measuring and to prevent carry-over.

Calibration Processing on the ISE

During calibration of electrolyte measurement equipment (ISE), both MID solution and external
standard liquid (HIGH, LOW), which have a known concentration, are measured. The relationship
between the electrode potential and ion concentration at that time is obtained, and Na, K, and Cl
calibration setup coefficient S (slope) is calculated.

Manual calibration
Potential
difference (mV) Calibration CH : A known concentration of HIGH
STANDARD liquid used for calibration
EH-EM'

CL : A known concentration of LOW

STANDARD liquid used for calibration
EL-EM''

EH-EM' : A potential difference between HIGH

STANDARD liquid and MID solution

Concentration EL-EM'' : A potential difference between LOW

CL CH value STANDARD liquid and MID solution
(logarithm)
mmol/L
Set a calibration using a potential difference
between the two points of known concentration.

The slope check and update measurement in calibration are performed as described below.

• Slope check
Measure each standard solution once, and then check if the two kinds of measured values of H-
STD and L-STD are both within the limit values based on the previous calibration values. If both
are within the limit values, the measured values are judged as unfluctuating in comparison with
the previous ones.
If measured values are judged as unfluctuating, four-time measurements for each standard
solution necessary for calibration update after slope check can be omitted. If this is the case, the
previous slope value and MID solution correction factor are output as the calibration results.

• Calibration update measurement

If measured values are judged as fluctuating in comparison with the previous ones as the result
of the above slope check, each standard solution is measured four times, and the calibration is
updated.

3-10-4
System Outline AU480 User Guide
Version 1.0
Return to Main Table of Contents

Correction by M-CAL
M-CAL at the ISE is data correction using a calculation formula, Y = AX + B.
Coefficients A and B are obtained in the following way.
The following formula is based on the correlated regression between a measurement value from this
System without an M-CAL data correction and that using the conventional method or basic method.
Y = aX + b
Y is a measurement from this System, and
X is a reference value using the conventional method or basic method.
Transform the above equation,
X = (1 / a) Y - (b / a).
Thus, A = 1 / a, B = - b / a.

Correction by A-CAL
Y (measured value)
Y=aX+b ● Corrected value: c' - c
c'
Y=aX+b' ● b'=b-(c'-c)
c
a = factor
b = offset
b
b'
X (known concentration of a specimen subject to A-CAL)
C

Let a known concentration of a specimen for A-CAL be C, and let the measurement obtained by this
system from a specimen for A-CAL after an M-CAL correction be C´.
In order to make the known concentration of the specimen for A-CAL and a measurement obtained by
this System consistent, correct the difference between C and C´ using A-CAL. In this case Y = aX + b
will be
Y = aX + b´.
This A-CAL correction can be applied to values that have been subject to an M-CAL correction.

3-10-5
AU480 User Guide System Outline
Version 1.0
 Return to Main Table of Contents

3-10-6
System Outline AU480 User Guide
Version 1.0
Return to Main Table of Contents

3.2 Key Sub-Processes

3.2.1 Computer Automation . .................................................................................. 3-11
3.2.2 Sample Identification .....................................................................................3-12
3.2.3 Sample Transfer ............................................................................................3-13
3.2.4 Reagent Transfer . .........................................................................................3-13
3.2.5 Reaction Fluid Mixing ....................................................................................3-13
3.2.6 Reaction Fluid Incubation and Washing ........................................................3-13
3.2.7 Measurement by Photometry ........................................................................3-13

3.2.1 Computer Automation

The analysis process is controlled by software in the data processor unit. The system uses the
MS Windows® as a graphical interface, it allows the use of the touch screen as another means of
communicating with the system. While the computer manages the analysis process, systems are often
connected to a clinical laboratory host computer system. This allows analysis process to be proceed
as automatically exchanging the information of measured items and the test results for each sample.
The computer system allows the operator to:

• Save and load test data and parameter files with several kinds of media and devices. For more
details, refer to section “7.7 Data Management” in chapter 7.

• Enter test requisitions (programming each sample test).

• Monitor the sample status.

• Analyze and edit analysis results.

• Print analysis results.

• Track which users use the system and at which times.

• Enforce security by limiting the functions accessible to those required by the User’s task
requirements.

3-11
AU480 User Guide System Outline
Version 1.0
 Return to Main Table of Contents

3.2.2 Sample Identification

A test requisition is an instruction to perform specified tests on a sample. When a sample is placed
into the system, the test requisition information is used to link the sample to the required tests. The
system must be able to identify samples correctly. Basic information on the sample is coded in the
rack barcode. This barcode is used to identify the sample type (for example, serum, urine, others)
loaded on the rack. The system can also use sample barcodes to link test requisition information to
each sample to be tested.
There are three analysis modes for recognizing samples on racks.

Sequential mode
The sample barcode is not read in sequential mode. The system analyzes the first sample on the first
rack presented, using the information in the first test requisition. It uses the second test requisition for
the second sample on the rack and so on.
Samples should be placed on the racks in numerical order, without empty spaces on the rack. Running
the system in sequential mode (i.e. without reading sample barcode ID) is not recommended due to
the possibility of sample/result mismatch. If a sample must be run without sample barcode ID, please
be extremely careful and have additional cross checks in place.

To ensure correct sample analysis in sequential mode, make sure that there are no
vacant spaces in racks. Never mix different sample types on one rack.
WARNING

Rack No. analysis mode

Sample barcodes are not read in Rack No. analysis mode. The system reads the rack ID and assigns
the sample No. according to the cup position in the rack. The samples must be set in the rack in the
order entered for the samples at the time of sample requisition.
For example, when the samples from No. 1 to No. 10 are set on rack No. 1 and the samples from No.
11 to No. 20 are set on rack No. 2, sample No. 14 can be found in position 4 on rack No. 2 and sample
No. 57 can be found in position 7 on rack No. 6. In rack No. analysis mode, the racks can be placed
onto the feeder in any order.
In rack No. analysis mode, there is a danger that mistakes will be made when placing the samples in
the racks. This can cause mismatching of samples and results. Take time to perform crosschecks on
racks and samples.

Barcode (Sample ID) analysis mode

The system reads the sample barcode on each sample cup and then links this information to a
corresponding requisition to perform analysis. Samples can be in any order and vacant spaces are
allowed on the racks. It is critical to test results that sample barcodes match sample requisitions.

3-12
System Outline AU480 User Guide
Version 1.0
Return to Main Table of Contents

3.2.3 Sample Transfer

Primary sample tubes are loaded into sample racks or on the STAT table. The sample probe then
transfers the sample to the cuvette in which analysis is performed according to the test requisition.
If the sample volume uses a diluent, the diluent volume is determined on information set in the specific
test parameter information.
After dispensing, the sample probe is washed in the wash station with deionized water internally and
externally.

3.2.4 Reagent Transfer

The system has a reagent transfer probe that aspirates reagent from reagent bottles in the reagent
refrigerator then dispenses them into the cuvette in the incubation bath. The system uses information
set in the specific test parameters to determine reagent volume.
The reagent probe is washed internally and externally with deionized water, between each reagent
dispense, to ensure minimal reagent carryover.

3.2.5 Reaction Fluid Mixing

The mixing unit uses Teflon coated mix bars to mix the reaction fluid in the cuvette uniformly. The
mixing unit has two sets of mix bars, and while one set of mix bars is mixing, the other set is being
washed simultaneously.

3.2.6 Reaction Fluid Incubation and Washing

The cuvette holder is set in an incubation bath to keep the reaction temperature in the cuvette at a
constant level.
The reaction fluid in a cuvette after completion of photometry is aspirated by the wash nozzle unit, and
the cuvette is washed and dried.

3.2.7 Measurement by Photometry

Various chemical components in the sample and the measuring regents have a color reaction in the
cuvette. Light from a halogen bulb is passed through the detection fluid, and is separated into specific
components by a diffraction grating. This determines the optical density of the reaction fluid being
measured. Measurement is performed at 18 second intervals throughout the reaction period. The
measured values for the period and wavelengths defined in the specific test parameters are used for
concentration calculation.

3-13
AU480 User Guide System Outline
Version 1.0
 Return to Main Table of Contents

3.3 Understanding and Handling Reagents,

Calibrators and Controls
This section discusses the supplies used in the AU480.
3.3.1 Reagents .......................................................................................................3-14
3.3.2 Sample diluent . .............................................................................................3-14
3.3.3 Calibrator .......................................................................................................3-14
3.3.4 QC control sample . .......................................................................................3-14

3.3.1 Reagents
Beckman Coulter supplies are highly concentrated and ready to use reagents.
The system can use reagents, calibrators, and QC samples supplied by manufacturers other than
Beckman Coulter. Verify usability with the reagent manufacturer, dealer, etc.
Reagents are supplied in bottles of 15 mL, 30 mL, or 60 mL. Reagent bottles containing reagents are
set in the reagent refrigerator fixed by adapters depending on the size.
The barcode label of a set reagent bottle is read and registered with the system.

3.3.2 Sample diluent

For samples with a high concentration, a physiological saline solution or water can be used for
automatic diluent analysis. The diluent is set in a 60 mL bottle in the bottle setting position near the
reagent refrigerator. For further information refer to the package insert For Use (IFU).

3.3.3 Calibrator
When adding a new reagent, the system recognizes it by it’s barcode. A reagent can be calibrated
using only the calibrator(s).
Lot specific user calibration should also be performed in the following situations:

• When a reagent lot has been changed.

• When the same lot has been used on the system for a predefined number of days.

• QC recovery is outside specified limits.

• There has been major preventive maintenance, or critical part replacement,

and QC performance is affected.
For details on operation precautions, refer to section “2.1.11 Handling Reagents, Wash Solutions,
Calibrators and QC Samples” in chapter 2.

3.3.4 QC control sample

Quality Control (QC) analysis should be performed after calibration to verify the system is working
properly. QC analysis should also be performed at regular intervals for verification of system stability.
Perform this check using a QC sample from the QC supplier.
For details on operation precautions, refer to section “2.1.11 Handling Reagents, Wash Solutions,
Calibrators and QC Samples” in chapter 2.

3-14
System Outline AU480 User Guide
Version 1.0
Return to Main Table of Contents

3.4 Understanding the System Hardware

This section provides an overview of the main mechanisms in the AU480.
3.4.1 System Switches and Buttons........................................................................3-17
3.4.2 Rack Feeder Unit............................................................................................3-18
3.4.3 Hand Scanner (Optional) . .............................................................................3-19
3.4.4 Sample Cups and Tubes ...............................................................................3-19
3.4.5 Racks . ...........................................................................................................3-20
3.4.6 Sample Transfer Unit......................................................................................3-21
3.4.7 Reagent Transfer Unit....................................................................................3-22
3.4.8 Mixing Unit......................................................................................................3-22
3.4.9 Incubation Bath Unit.......................................................................................3-23
3.4.10 Photometry Unit..............................................................................................3-23
3.4.11 Wash Nozzle Unit...........................................................................................3-24
3.4.12 Reagent Refrigeration Unit.............................................................................3-25
3.4.13 STAT Table Unit..............................................................................................3-26
3.4.14 Syringe Unit....................................................................................................3-28
3.4.15 Wash Solution Roller Pump Unit....................................................................3-28
3.4.16 Tank Storage..................................................................................................3-29
3.4.17 Breakers and Fuses.......................................................................................3-30
3.4.18 ISE Unit (optional)..........................................................................................3-30

3-15
AU480 User Guide System Outline
Version 1.0
 Return to Main Table of Contents

Reagent transfer unit

Mixing unit Incubation bath part

Reagent refrigeration unit

Sample transfer unit

Wash nozzle unit

Photometry unit

Rack feeder unit

STAT table unit

Tank storage

Roller Pump unit Breaker and fuses

ISE unit (option)
System switches
and buttons
Syringe unit

Power supply unit

Water supply/drain unit

3-16
System Outline AU480 User Guide
Version 1.0
Return to Main Table of Contents

3.4.1 System Switches and Buttons

The buttons listed below are on the AU480.
• ON (sub power) button
• EM STOP (Emergency Stop) button
• RESET (Main power) button
• TABLE ROTATION/DIAG button

TABLE ROTATION/DIAG button

ON, EM STOP,
RESET button

ON (sub power) button

This O N button turns the system power on, the PC, the temperature control of the incubator, and the
regular prime of the ISE (optional) will start up.

EM STOP (Emergency Stop) button

When E M S t o p button is pressed, as in an emergency, the main power supply (secondary side
power supply) is switched off immediately. Power supply for the incubation bath and the reagent
refrigerator are also switched off. Power supply to the DPR is not switched off by pressing the EM
Stop button.

3-17
AU480 User Guide System Outline
Version 1.0
 Return to Main Table of Contents

RESET button
Use the R E S E T button to restore the main power supply following an emergency stop. To ensure
proper Analyzer and DPR synchronization after an Emergency Stop, restart the Windows operating
system by selecting the C t r l + A l t + D e l and following the prompts to shutdown the DPR. The
reagent refrigerator, incubator control, and regular wash on ISE rely on power from the main switch
and are reconnected using Re s e t . This button also resets the power failure detection circuit. The
power failure detection circuit alerts the user to any power failure that might have happened while the
main power on and sub-power off.

TABLE ROTATION/DIAG button

This button rotates the STAT table to place sample cups on the STAT table. Use this button also to
activate diagnostic or maintenance functions.

3.4.2 Rack Feeder Unit

Keep the sample protective covers closed at all times to prevent dirt and dust getting into the sample
cups on the feeder unit. Verify that the racks are placed on the rack supply unit with the rack barcode
facing the rack ID barcode reader on the inside of the feeder unit.

Sample
protection cover

Barcode reader
laser radiation
(Sample ID)

Rack

Surface where the Window for

rack ID label is applied reading rack ID

Rack supply unit

The following table summarizes the specifications for the barcode readers.

Barcode Reader Specifications

Wave length: 650 ± 10 nm
Maximum output: 6.2 mW
Pulse width: 0.18 µS
Frequency: 2.5 MHz
Class: 2
Scan rate: 100 ± 20 Hz

3-18
System Outline AU480 User Guide
Version 1.0
Return to Main Table of Contents

3.4.3 Hand Scanner (Optional)

The hand scanner is used to manually scan the 2 D barcode (Mastercurve) on the AU reagent.

The following table summarizes the specifications for the hand scanner:

Hand Scanner Specifications

Wave length: 630-680 nm
Output: 1.0 mW
Class: 2

3.4.4 Sample Cups and Tubes

The following are the sample cups and tubes that can be used in the AU480:

Sample Cups and Tubes

To use on rack and STAT Table: Hitachi cup (No.716-0425
MB0335), ACA cup (GB6350 and GB9684)
Sample cups
To use only on the STAT Table: Hitachi (No. 707-0313)
Sample cups must not have a slope barrel or a spitz tube
Total height of Tube and nested cup:
Rack: less than or equal to 112 mm
Nested cups
STAT Table: less than or equal to 102 mm.
Hitachi cup (No. 716-0425)
Outside diameter: 11.5 mm to 16 mm (less than or equal to 17.7 mm at the
collar)
Sample tubes
Inside diameter: 9 mm to 15 mm
Length: 55 mm to 102 mm

3-19
AU480 User Guide System Outline
Version 1.0
 Return to Main Table of Contents

3.4.5 Racks

Sample cups and tubes are placed in racks before analysis. The system identifies the rack type from
small magnets set in the bottom of each rack. Up to ten sample cups or tubes can be set into one
rack. For details on how to load racks, refer to section “5.4 Preparing Samples for Analysis” in chapter
5.
This system uses five types of racks:

White Rack
Use the white rack for normal patient samples, barcoded calibrators and barcoded QC samples. Three
different analysis modes can be selected for the identification of samples:
• Sequential mode
• Rack ID mode
• Barcode (Sample ID) mode
For information refer to section “3.2.2 Sample Identification” in this chapter.

Yellow Rack
Use the yellow rack for calibration analysis which measures reference materials and calculates data
for calibration curve. Choose one of the following two methods to identify each reference material
(calibrator).
• A method which the rack No. and the position of a cup on the rack are used for judgment
• A method which the barcode on a cup is used for judgment
For more information, refer to section “5.5 Calibrating Tests” in chapter 5.

Green Rack
Use the green rack for measurement of the quality control materials and for the quality control analysis
which manages the system condition.
Choose one of the following two methods to identify each reference material (calibrator).
• A method which the rack No. and the position of a cup on the rack are used for judgment
• A method which the barcode on a cup is used for judgment
For more information, refer to section “4.8 Configuring QC Analysis” in chapter 4.

Orange Rack
Use the orange rack for manual repeat runs, refer to section “4.6 Programming Repeat Tests” in
chapter 4.

3-20
System Outline AU480 User Guide
Version 1.0
Return to Main Table of Contents

Red Rack
Use the red rack for emergency samples, refer to section “6.5 Processing Emergency Samples” in
chapter 6.

Blue Rack
Use the blue rack for measuring (updating) the reagent blank, refer to section “4.7.1 Calibrator
Registration” in chapter 4.

3.4.6 Sample Transfer Unit

This unit includes the sample probe and the wash station for washing the sample probe.
The specimen in the sample cups set in the rack are dispensed by the sample probe to the cuvettes.
When the ISE (optional) is installed, dispensing to the sample dilution pot of the ISE part is also
performed.

Sample probe

Wash station

3-21
AU480 User Guide System Outline
Version 1.0
 Return to Main Table of Contents

3.4.7 Reagent Transfer Unit

The AU480 has a reagent transfer unit. The unit has one reagent probe. These units are responsible
for transferring the components required for performing assays into the cuvette wheel.
Each probe has a dedicated wash station. The reagent probe is washed internally and externally with
deionized water between each reagent dispense, to ensure minimal reagent carryover.

Reagent probe

Sample diluent bottle

Wash station

3.4.8 Mixing Unit

The AU480 has one mix bar unit containing 6 mix bars.
During operation one set of bars mixies, while the others are being washed with diluted wash solution
and rinsed with deionized water in the mix bar wash wells.

Mixing unit

3-22
System Outline AU480 User Guide
Version 1.0
Return to Main Table of Contents

3.4.9 Incubation Bath Unit

The incubator keeps the reaction temperature of the 88 cuvettes in the cuvette wheel at 37°C. A
cuvette is a made from quartz glass with a light path of 5 mm.
• Minimum reaction volume: 90 µL
• Maximum reaction volume: 350 µL

Incubator

3.4.10 Photometry Unit

This unit consists of a photometer halogen lamp, lenses, a diffraction grating, and a photo-detector to
perform photometry of reaction fluids in a cuvette.

Lamp

Never touch the photometer lamp or look directly into the photometer lamp when
illuminated.
WARNING

3-23
AU480 User Guide System Outline
Version 1.0
 Return to Main Table of Contents

3.4.11 Wash Nozzle Unit

The wash nozzle unit consists of six sets of three wash nozzles of different lengths, one single
aspiration nozzle and one single drying nozzle with white teflon tips. The longest wash nozzle
aspirates the mixture from the cuvette. The next longest dispenses the wash solution or water. The
shortest wash nozzle aspirates any excess wash solution or water, to prevent spillage.
The single aspiration nozzles removes all liquid from the cuvette and the drying nozzles dry the
cuvettes completely.
The dispensing sequence of the wash nozzles is as follows:

• Nozzle 1 and 2 - Diluted Wash Solution

• Nozzle 3 to 6 - Warm water

• Nozzle 7 - Aspiration

• Nozzle 8 - Drying

Wash nozzle FR
ON
T
8

3-24
System Outline AU480 User Guide
Version 1.0
Return to Main Table of Contents

3.4.12 Reagent Refrigeration Unit

The reagent refrigerator houses the reagents. The temperature is maintained between 4°C and 12°C
even when the system is shut down using the END key.
The reagent bottles are housed in trays that rotate to carry the bottles to the aspiration position. There
are 76 reagent spaces in the reagent refrigerator. 15 mL, 30 mL, and 60 mL bottles can be placed on
the unit, using the bottle supporters provided. The maximum number of 60 mL bottles to be set is 38
bottles at the inner circumference of the refrigerator.

Barcode reader
laser radiation
(Reagent ID)

Reagent refrigerator

Verify that the reagent bottles are always placed on the unit with the barcode side of
the bottle to the outer surface.
CAUTION Verify that all reagent bottle caps are removed before placing them in the unit.

The following table summarizes the specifications for the barcode readers.

Barcode Reader Specifications

Wave length: 650 ± 10 nm
Maximum output: 6.2 mW
Pulse width: 0.18 µS
Frequency: 2.5 MHz
Class: 2
Scan rate: 100 ± 20 Hz

3-25
AU480 User Guide System Outline
Version 1.0
 Return to Main Table of Contents

3.4.13 STAT Table Unit

The STAT table is used for short turn around time samples. The TA B L E R OTAT I O N / D I A G
button is used for rotating the STAT table unit.
The STAT table unit maintains its temperature between 4 °C and 12 °C when the system is shut down
using the END key.
In addition to Priority samples, STAT samples, QC, Calibration and ISE Calibrators can be set on the
STAT table.

Sample cup

STAT table cover

STAT table
Barcode reader
laser radiation
(Sample ID).

TABLE ROTATION/DIAG
button

Top view of STAT table

3-26
System Outline AU480 User Guide
Version 1.0
Return to Main Table of Contents

Hole Sample
No.1 to No.22 STAT sample, QC sample, Cal sample, and RB sample
S-H ISE Serum Standard Solution H
S-L ISE Serum Standard Solution L
U-H ISE Urine Standard Solution H
U-L ISE Urine Standard Solution L
CRS-H ISE CRS Standard Solution H
CRS-M ISE CRS Standard Solution M
CRS-L ISE CRS Standard Solution L
CLEAN ISE Cleaning solution
SEL-K ISE Electrode Check Liquid (K)
SEL-Na ISE Electrode Check Liquid (Na)
W1 W1 Sample probe wash solution
W2 W2 Sample probe wash solution

• The STAT table can only read barcodes on samples (if set up) that are placed on
the outer positions of the table. Always keep the cover on the table to maintain
the temperature on the table and to prevent any contaminates from entering the
CAUTION samples

• Samples should never be allowed to be stored on the STAT table.

The table below summarizes the barcode reader specifications.

Barcode Reader Specifications

Wave length: 650 ± 10 nm
Maximum output: 6.2 mW
Pulse width: 0.18 µS
Frequency: 2.5 MHz
Class: 2
Scan rate: 100 ± 20 Hz

3-27
AU480 User Guide System Outline
Version 1.0
 Return to Main Table of Contents

3.4.14 Syringe Unit

This system has a sample syringe, a reagent syringe, and an additional syringe for the ISE Buffer
solution, if the ISE option is installed.
Syringes are used to dispense the required volume of serum, urine, reagent, etc.

Sample syringe Fixing nut

ISE reagent syringe
Reagent syringe Mounting groove

Syringe case

Mounting groove
Fixing screws
Piston fixing screw

Electromagnetic
valve

Fixing nut
Attaches the syringe to the analyzer.

Case head
Attaches the syringe together with the syringe case.

Syringe case
Holds the syringe.

Piston fixing screw

Attaches the syringe piston to the syringe drive assembly.

3.4.15 Wash Solution Roller Pump Unit

This unit has a wash solution roller pump to supply the wash solution from the wash solution tank to
the diluted wash solution tank.

Pump Tubing
Wash Solution
roller pump

Connectors

3-28
System Outline AU480 User Guide
Version 1.0
Return to Main Table of Contents

3.4.16 Tank Storage

The tank storage has a deionized-water tank, a wash solution tank, and a diluted wash solution tank.
The solutions required for analysis are supplied from these tanks.
When ISE option is installed, a buffer solution tank, a MID solution tank, and a Reference solution tank
are included as ISE tanks.
• Deionized Water Tank
• Wash solution Tank
• Diluted wash solution Tank

Diluted wash
Deionized solution tank
water tank

Wash
solution tank

Deionized Water Tank

The deionized water tank has a capacity of 10 liters. A float switch indicates when the volume in the
tank is low and opens a valve to automatically fill it. Water conforming to CAP Type 1 water should be
provided by the facility’s deionized water system.

Wash Solution Tank

The wash solution tank has a capacity of 10 liters of wash solution. Dilution is automatically performed
from the wash solution in this tank to generate diluted wash solution.

Diluted Wash Solution Tank

The diluted wash solution tank has a capacity of 2 liters of diluted wash solution. Diluted wash solution
is used to wash cuvettes and mix bars.

3-29
AU480 User Guide System Outline
Version 1.0
 Return to Main Table of Contents

3.4.17 Breakers and Fuses

Main Power Switch

The main system breaker board allows the power in specific areas of the system to be isolated. The
System Main Power Switch is the main switch and automatically shuts down all the breaker switches.
All breaker switches should be in the ON position.

3.4.18 ISE Unit (optional)

Sample pot Mixing unit

Cl electrode
Na electrode
K electrode
Mixture aspiration
roller pump

Ref. Electrode MID roller pump Roller tubes

Sample pot
The sample and buffer solution are dispensed into the sample pot and mixed. For urine and serum,
the amount of dispensed is as follows:
• Buffer solution: 618 μl (fixed)
• Sample: 20 μL (fixed)
• Deionized water: 10 μL (fixed)

3-30
System Outline AU480 User Guide
Version 1.0
Return to Main Table of Contents

Mixing Unit
This unit mixes sample and buffer solution dispensed into the sample pot. It is equipped with two
liquid-level sensors to detect proper drainage.

Cl electrode, Na electrode and K electrode

These electrodes are used for measuring the potential of Cl, Na and K ions in the mixture and MID
solution. The concentrations of individual ions in the mixture can be calculated from the potential
differences between each ion in the mixture and in the MID solution.

REF electrode
This is the reference electrode with respect to the Cl, Na and K electrodes.

Pinch valve
This valve is used for alternately discharging the analyzed mixture and the mixture remaining in the
sample pot.

Roller pumps
There are two pumps; a roller pump which aspirates the mixture solution, and a roller pump which
dispenses the MID solution.

Roller tubes
These tubes are made of rubber and wrap around the roller pump. As the roller pump rotates, the
tubes are squeezed by the rollers on the pump, and solution is supplied or removed.

The ISE Reagent Bottles

REF solution tank

MID solution tank

Buffer solution tank

• Buffer solution bottle

Stores the buffer solution used for diluting the sample. The capacity of this container is 2 liters.
• MID solution bottle
Stores the MID solution. The MID solution is used to condition the electrodes between analysis.
The capacity of this container is 2 liters.
• Reference solution bottle
Stores the reference solution. The reference solution is used as a reference point in relation to
the three electrodes. The capacity of this container is 1 liter.

3-31
AU480 User Guide System Outline
Version 1.0
 Return to Main Table of Contents

3.5 Understanding the Computer Software

The data processor unit in this system is equipped with keyboard and mouse which are standard input
devices, and also a touch screen. The touch screen makes operation possible by touching window
directly.
3.5.1 Graphical User Interface (GUI).......................................................................3-32
3.5.2 Main button bar .............................................................................................3-33
3.5.3 Processing Time ............................................................................................3-33
3.5.4 Measure Modes . ...........................................................................................3-34
3.5.5 Touch Screen and Keyboard .........................................................................3-35

3.5.1 Graphical User Interface (GUI)

The system is controlled using the standard windows GUI.

C
This interface is composed of three main window display areas.

A. Action control area

The control buttons for start, stop, pause of analysis process and display of menus on the display.

B. Menu area
This is a display and operation area for each window chose from the menu list.
For details on a complete list of the functions available here, refer to chapter 12 “Menu Tree”.

C. Alarm area
The alarm messages for processing problems during system operation are displayed here.

3-32
System Outline AU480 User Guide
Version 1.0
Return to Main Table of Contents

3.5.2 Main button bar

The system can be navigated by using the main buttons:

Button Item Actions

Home Select this button to return to the Home
window.
Menu List Select this button to display the Menu list
window.
User menu Select this button to display the user
menu list window set by the user.
Mode Display area Displays the present mode and the time
left until completion of the operation.

Start Select this button to start analysis.

Pause Select this button to pause analysis.

Feeder Stop Select this button to stop the rack feeder.

Stop/Stand by Select this button to stop the analysis.

When stopped, this button can be used
to shift the system to standby mode.

Online Help Select this button to display online

operational help.

Logout Select this button to log out the user.

End Select this button to shut down system

operation and switch off the auxiliary
power supply.
Time Display area Displays the present date and time .

3.5.3 Processing Time

The analysis processing time is defined as the time from aspiration of a sample by the sample probe
until the end of measurement of applicable items.
The necessary time for rack analysis and Sample STAT Mode are approximately 8 minutes and 40
seconds.

3-33
AU480 User Guide System Outline
Version 1.0
 Return to Main Table of Contents

3.5.4 Measure Modes

The system measure modes displayed in the “Mode Display Area” are shown below.

Mode Contents
Initialization Once initialization has started. The operating system starts to
run the DPR program. The ANL program is also loaded on the
analyzer from the DPR.
Warm up When End Process is selected and the system shuts down, only
the refrigerators are maintained at operational temperatures.
After system initialization, the system waits for the operational
temperature of all other areas to be reached and become
stable. After the system temperature is stabilized, the operation
mode changes to Standby . Warm up time depends on the
environment temperature. The warm up time is approximately 20
minutes.
Standby When the system is ready to perform sample analysis, the
operation mode changes to Standby .
Analysis can be started.
Measure 1 Analysis starts when the rack set on the feeder, begins feeding
from rack feeder.
Measure 2 The rack supply from the rack feeder has stopped, analysis can
be restarted. When the system is set to Auto-Repeat Mode, the
system does not shift to Measure 2 mode. When all requested
repeat runs are performed and racks are not detected on the rack
feeder, the system shifts from Measure 1 to Standby . The
time from Standby to Measure 2 is approximately 25 minutes
after the last rack has been fed into the system. This period is 35
minutes if any of the samples require reprocessing.
Stop The operation mode changes to Stop due to either system or
operator error. Analysis cannot be started in Stop mode. When
the operation mode is changed to Stop , selecting S t o p /
S t a n d b y , changes the mode back to Standby . When the
operation mode has changed to Stop due to a system error,
remove the cause of the error and then select the S t o p /
S t a n d b y to change the operation mode back to Standby .
Pause The operation mode changes to Pause due to either system
or operator error. If some of the loaded racks are not analyzed
and remain on the rack feeder. The analysis can be restarted. If
system error occurs, check the cause of the error using the alarm
log list, take appropriate action, and then resume analysis by
pressing S t a r t .

If an analysis operation is forcibly stopped, i.e. the system changes to stop mode,
the analysis operation is aborted and any sample remains in the sample probe and
reagents remain in cuvettes as they are. When an analysis operation is forcibly
CAUTION stopped without changing to standby mode, eliminate the reagents in cuvettes
and the sample in the sample probe by performing W1 operation. For details on W1
execution procedure, refer to section "8.8.12 Execute a W1 (Auto-wash of the sample
probe and cuvettes)" in chapter 8.

3-34
System Outline AU480 User Guide
Version 1.0
Return to Main Table of Contents

3.5.5 Touch Screen and Keyboard

By touching the window the system permits selection of buttons and drop-down lists. This is the same
as a left click with the mouse.
The computer keyboard can also be used instead of selecting items using the touch screen or mouse.
The system can be operated by either the touch screen, mouse, or keyboard, in any combination. This
guide describes the operational procedures of the system using the touch screen and keyboard.

Key Button name

F9 Start key
F10 Pause key
F11 Feeder Stop key
F12 Stop/Standby key
Home Home key
Scroll Lock Menu List key
Pause Alarm clear key
End End key
Shift+End Log out
Ctrl+Home Help
PrintWindow Print Window key

3-35
AU480 User Guide System Outline
Version 1.0
 Return to Main Table of Contents

3-36
System Outline AU480 User Guide
Version 1.0
Return to Main Table of Contents

4
Configuring Tests

This chapter describes and illustrates how to add a new test to the
system.

Contents
4.1 Setting Analysis Mode . ................................................................................................4-2
4.1.1 Set the common conditions for analysis...........................................................4-2
4.1.2 Set the Rack Number Limit . ............................................................................4-5
4.1.3 Parameter Setting for STAT Table Analysis .....................................................4-6
4.2 Setting the System Time ..............................................................................................4-8
4.3 Entering Online Settings...............................................................................................4-9
4.3.1 Editing Online Conditions ................................................................................4-9
4.3.2 Setting the Online Protocol.............................................................................4-12
4.3.3 Editing Online Data Format............................................................................4-13
4.3.4 Editing an Online Item Number .....................................................................4-14
4.4 Entry of Test Items . ....................................................................................................4-15
4.4.1 Test Name Setting .........................................................................................4-15
4.4.2 Creating a New Profile . .................................................................................4-20
4.4.3 Adding the New Test to a Group . ..................................................................4-25
4.5 Setting Specific Test Parameters ..............................................................................4-28
4.5.1 Set General Tests ..........................................................................................4-29
4.5.2 LIH Test Setting .............................................................................................4-32
4.5.3 ISE (option) Test Setting ................................................................................4-34
4.5.4 Set Calculated Test Items...............................................................................4-35
4.5.5 Set the Range.................................................................................................4-37
4.6 Programming Repeat Tests .......................................................................................4-39
4.6.1 Repeat run Parameter Setting . .....................................................................4-40
4.6.2 Setting Specific Test Repeat-run Parameters . ..............................................4-42
4.7 Set Calibration Analysis . ...........................................................................................4-44
4.7.1 Calibrator Registration . .................................................................................4-45
4.7.2 Set the Specific Calibration Parameters . ......................................................4-48
4.7.3 Set Calibration Using the STAT Table . ..........................................................4-53
4.8 Configuring QC Analysis ...........................................................................................4-57
4.8.1 Requesting QC Analysis . ..............................................................................4-58
4.8.2 Set the Specific Quality Control Parameters .................................................4-59
4.8.3 Set Quality Control Using the STAT Table .....................................................4-64
4.9 Setting the Tests to be Checked ...............................................................................4-67
4.10 Preventing Contamination .........................................................................................4-69
4.10.1 Preventing Contamination Between Items ....................................................4-70
4.10.2 Preventing Contamination Between Sample Types ......................................4-72
4.10.3 Setting the Contamination Prevention Conditions by Analysis Items ............4-73
4.11 Setting up Data Lists ..................................................................................................4-74
4.11.1 Set the Basic Condition for Print ...................................................................4-74
4.12 Setting the test requisition format.............................................................................4-78
4.12.1 Setting the test requisition format...................................................................4-78
4-1
AU480 User Guide Configuring Tests
Version 1.0
 Return to Main Table of Contents

4.1 Setting Analysis Mode

Set the tube/patient identification method as barcode or sequential, repeat run method (Standard or
Auto), sample setting position on the STAT table, and other basic analysis conditions.

4.1.1 Set the common conditions for analysis...........................................................4-2

4.1.2 Set the Rack Number Limit . ............................................................................4-5
4.1.3 Parameter Setting for STAT Table Analysis .....................................................4-6

4.1.1 Set the common conditions for analysis

1. From the AU480 “Home” window select Menu List>System>System Condition>Analysis mode to
display the “System Condition: Analysis mode” window.

2. Select E d i t ( F 1 ) .
The window changes to edit mode.

4-2
Configuring Tests AU480 User Guide
Version 1.0
Return to Main Table of Contents

3. Using the drop down menus in the window, set the analysis parameters.

Item Options, set range Remarks

Test requisitions
Routine Sequential Sequential: Performs an item inquiry in the order
Emergency Rack Number of sample arrangement.
Barcode Rack Number: Performs an item inquiry in the
STAT order of rack Number and sample arrangement on
the rack.
Barcode: Performs an item inquiry according to
the barcode ID attached to the sample cups.
Sequential Sample Check box Set sample ID reading Yes/Number
ID Read When the inquiry method is other than “Barcode
analysis”, the sample ID is stored as sample
information.
Auto Repeat
Rack Disabled Disabled: After the first run, a repeat run list
STAT Enabled is generated, the operator then determines the
samples to be repeated manually. The repeat run
executed and judgment begins at the start of the
repeat run.
Enabled: The system automatically performs the
repeat run using the repeat run parameters.
S. ID Barcode*1:
The inquiry method can be set only in case of “Barcode analysis” or when “Sequential Sample ID Read” is select.

Barcode Type Selection from 7 types

Digits 0 to 26 digits Including the check digit
Check Mode No (No Chk. Chr.) No (No Chk. Chr.): Checking is not possible
No (With Chk. Chr. because barcodes without a check character are
Yes used.
No (With Chk. Chr.): Barcodes with check
characters are used, but checking is not done.
Yes: In case of check execution.
Others
Device No. Any 2-digit number
Default type Serum, Urine, Other-1 Selecting the sample type on any window, will
Other-2 display the selected types first.
STAT Operation Auto Auto: Auto Analysis Mode
Manual Manual: Sample Confirmation Mode
No Reagent Alarm Only / With Pause Alarm Only: Analysis is continued except for the
Operation respective item.
With Pause: Analysis is stopped for all tests and
the system shifts to Pause mode.
*1: Setting is available only when the inquiry method is “Barcode method” or “Sample ID Read” is checked.
For details of the analysis mode, refer to section “4.1 Setting Analysis Mode” in this chapter.

If the barcode type is “Multi Code” and the number of digits used is “No setting”, the
system interprets interleaved 2 of 5 as standard 2 of 5. For example, when the digits
at the label edge cannot be read because the label has been attached incorrectly,
CAUTION judgment cannot be made because of an recognition error. Make sure the labels are
correctly attached to the sample cups.

4-3
AU480 User Guide Configuring Tests
Version 1.0
 Return to Main Table of Contents

When the barcode type “ISBT128” has been selected: ISBT128” barcodes are
•

handled as “CODE128”. The check mode is set forcibly to “Yes”. The number of
used digits is fixed to “13”. The first and the last two characters of the barcode are
TIP disregarded automatically.
• When the barcode type is “MULTI CODE”, the barcode type to be read should be
set at the time of set-up. Maximum 4 types can be set.

• Maximum of 26 digits can be entered for a barcode. For details on barcode

specifications, refer to section “5.4.2 Sample Barcode Specifications” in chapter 5.
For details on barcode label attachment method, refer to section “5.4.4 Applying
Barcode Labels to Sample Cups” in chapter 5.

4. Select A l a r m S o u n d ( F 5 ) .
The “Alarm Sound” window appears.

5. Select the alarm sound to be used for “Announce”, “Caution”, and “Trouble” from the respective
drop-down list.

The selected alarm is played when P l a y is selected. The playback sound stops
after the specified time or when S t o p , O K or C a n c e l is pressed.
TIP

6. Select O K .
The “Alarm Sound” window is closed and alarm sound set as “Alarm Sound” on the edit window
is displayed.
7. Select C o n f i r m ( F 1 ) .
The set values are registered and the display returns to the reference window.

4-4
Configuring Tests AU480 User Guide
Version 1.0
Return to Main Table of Contents

4.1.2 Set the Rack Number Limit

For the patient sample rack, set the range of rack numbers that define the sample type categories.
1. From the AU480 “Home” window select Menu List>System>System Condition>Analysis mode to
display the “System Condition: Analysis mode” window.

2. Select E d i t ( F 1 ) .
The window changes to edit mode.
3. Enter the upper limit value for the rack number according to the following input value limitations
into the table “Rack No. Limit”.

Serum Urine Other-1 Other-2

<First Run> Routine 0 to 9999 Left column +1 to Left column +1 to *Left column +1 to
<First Run> 9999 9999 9999
Emergency
<Repeat Run> Same as above Same as above Same as above *Same as above
Routine
<Repeat Run> <Repeat Run> Same as above Same as above *Same as above
Emergency Routine +1 to 99

• In each column, only 0 can be used when up to 9999 is used in the column on the left.

• Columns with “*” have automatic setting. Input is not possible.

• When the sample setting method is “Mixed sample types possible”, setting the rack number
limits is not possible in the shaded part of the above table.
4. Select C o n f i r m ( F 1 ) .
The set values are registered.

4-5
AU480 User Guide Configuring Tests
Version 1.0
 Return to Main Table of Contents

4.1.3 Parameter Setting for STAT Table Analysis

Set the STAT table sample placement positions etc.
1. From the AU480 “Home” window select Menu List>System>System Condition>Analysis mode to
display the “System Condition: Analysis mode” window.

2. Select E d i t ( F 1 ) .
The window changes to edit mode.
3. Select the check method when starting STAT table analysis from the drop-down list of “STAT
Operation” of “Others”.

Option Explanations
Auto The system automatically recognizes the sample cups set on the STAT table and the IDs
when starting analysis.
Manual The operator starts confirming the placement of sample cups as well as barcode
identification on the STAT table before the start of analysis. This setting is performed
automatically when the “Test Requisition” is other than barcode ID.

4. Select the round to be set from the drop-down list of “Group” of “STAT Table Attribution”. Three
rounds can be selected.

4-6
Configuring Tests AU480 User Guide
Version 1.0
Return to Main Table of Contents

5. Enter the STAT table setting positions number 1 to 22 into “STAT Table Attribution” so that there is
no overlap. There are use limitations below depending on whether barcode IDs are used or not.

• Mixed sample types are allowable

The STAT table allows the mixing of different sample types.

Combination of barcode
STAT Table Attribution
ID (Yes or No)
STAT

Calibrator

QC

First Run

Repeat Position

Calibrator
Fixed Position of

Calibrator
Variable Position of

Control
Fixed Position of

Control
Variable Position of

Free Position
STAT Calibrator
Yes Yes Yes UNP* UNP UNP UNP
and control
No need for Only calibrator
No Yes Yes UP UNP UP UNP
defining the and control
set postions by
Other than above sample type UP UNP UNP

*UP: Use Possible

UNP: Use Not Possible

• Mixed sample types are not allowed

The STAT table does not allow the mixing of different sample types.

Combination of
STAT Table Attribution
barcode ID (Yes or No)
STAT

Calibrator

QC

First Run

Repeat Position

Calibrator
Fixed Position of

Calibrator
Variable Position of

Control
Fixed Position of

Control
Variable Position of

Free Position

Yes Yes Yes UNP UNP Only calibrator

Define the set
No Yes Yes UNP UNP and control
positions by UP UP
sample type
Other than above UP UNP UNP

When the sample setting method is “Mixed sample types possible”, some settings are not possible.
6. Select C o n f i r m ( F 1 ) .
The set values are registered.

During Calibration the position of the calibrator to be used in the test will be
automatically assigned to the set position when calibration is requested.
During QC the position of the control to be used in the test will be automatically
TIP assigned to the set position when QC is requested.

4-7
AU480 User Guide Configuring Tests
Version 1.0
 Return to Main Table of Contents

4.2 Setting the System Time

The system time at the time of analysis is added to the test data as the index time. When searching for
test data, the index time can be used as a search key.
For smooth saving and retrieval of test data, confirm the system time periodically and set the correct
time.

Setting the Date and Time

To set the date and time:
1. From the AU480 “Home” window select Menu List>System>System Condition>Set Date and
Time to display the “System Condition: Set Date and Time” window.

2. Select E d i t ( F 1 ) .
The window changes to edit mode.
3. Set “Date” and “Time” as 24 hour display.
4. Select C o n f i r m ( F 1 ) .
The set system time is enabled.

4-8
Configuring Tests AU480 User Guide
Version 1.0
Return to Main Table of Contents

4.3 Entering Online Settings

How the system communicates with a clinical laboratory host computer system can be set.
For example, whether information is transferred between a clinical laboratory system and the system’s
computer immediately, or in a batch, or not at all.

4.3.1 Editing Online Conditions ................................................................................4-9

4.3.2 Setting the Online Protocol.............................................................................4-12
4.3.3 Editing Online Data Format............................................................................4-13
4.3.4 Editing an Online Item Number .....................................................................4-14

4.3.1 Editing Online Conditions

The following operation permits the setting of I/O conditions as online conditions.
Test Requisition Information Receiving Method
The communication methods for receiving information concerning the following samples are set in
“Realtime”, “Batch”, and “None” respectively. To change the setting, select one from the drop-down list.
The default is “None”.

• Routine normal

• Routine repeat

• Emergency normal

• Emergency repeat

• STAT normal

• STAT repeat

4-9
AU480 User Guide Configuring Tests
Version 1.0
 Return to Main Table of Contents

Test Data Transmission Method

The communication methods for analysis results concerning the following samples are set in
“Realtime”, “Batch”, and “None” respectively. To change the setting, select one from the drop-down list.
The default is “None”.

• Routine normal

• Routine repeat

• Emergency normal

• Emergency repeat

• STAT normal

• STAT repeat

• STAT quick

• Reagent blank

• Calibration

• QC

4-10
Configuring Tests AU480 User Guide
Version 1.0
Return to Main Table of Contents

Use the following procedures to set reception of sample information and transmission of test data to
real-time or batch.
1. From the AU480 “Home” window select Menu List>System>Online>Set Up to display the “Online:
Set Up tab” window.

2. Select E d i t ( F 1 ) .
The window changes to edit mode.
3. Set the operating procedure following the message display.
4. Select C o n f i r m ( F 1 ) .
The set contents are registered.

4-11
AU480 User Guide Configuring Tests
Version 1.0
 Return to Main Table of Contents

4.3.2 Setting the Online Protocol

The online communication protocol can be assigned and set. Setting items and setting ranges are
shown below.

Setting item Setting range Initial value

T.R.I Receive Error Control Stop / Continue Stop
Results Transfer Error Control Stop / Continue Stop
Rack No./Cup pos. None / 4 / 5 4
Format Configuration 6/9 6
Zero Suppress Check/Unchecked Checked
Character Length 7/8 7
Parity Bit No / Even / Odd No
Stop Bit 1/2 1
Start Code (1st.) 01h to 1Fh 02h:STX
Start Code (2nd.) None / 01h to 1Fh None
End Code (1st.) 01h to 1Fh 03h:ETX
End Code (2nd.) None / 01h to 1Fh None
Text Length 256 / 512 / 1024 256
Device No. Unchecked / Checked Unchecked
Device No. 00 to 99 00
ETB Control Unchecked / Checked Unchecked
Bit/Sec. 4800 / 9600 9600
Class Class A / Class B Class A
Retry 0 to 3 3
BCC Check Unchecked / Checked Unchecked
<Time Out [×100msec.]> T1 001 to 99 20
<Time Out [×100msec.]> T2 00 to 99 15
<Time Out [×100msec.]> T3 00 to 99 15
<Time Out [×100msec.]> T4 00 to 99 20
<Time Out [×100msec.]> T5 00 to 99 20
<Time Out [×100msec.]> T6 00 to 99 10
<Time Out [×100msec.]> T7 00 to 99 20
Dilution Inf. Unchecked / Checked Unchecked
Reagent Inf. Unchecked / Checked Unchecked
R1-2 Use Unchecked / Checked Unchecked
Online Test No. Digit 2/3 2
No. of Data Marks 2/4 2
Cal. No./Control No. Digit 2/3 2

4-12
Configuring Tests AU480 User Guide
Version 1.0
Return to Main Table of Contents

Editing the Online Protocol

1. From the AU480 “Home” window select Menu List>System>Online>Protocol to display the
“Online: Protocol tab” window.

2. Select E d i t ( F 1 ) .
The window changes to edit mode.
3. Set the parameters in the “Protocol” tab window.
4. Select C o n f i r m ( F 1 ) .
The set contents are registered.

4.3.3 Editing Online Data Format

Set the additional information and digit number of data used for online communication.
1. From the AU480 “HOME” window select Menu List>System>Online>Format Configuration to
display the “Online: Format Configuration tab” window.

4-13
AU480 User Guide Configuring Tests
Version 1.0
 Return to Main Table of Contents

2. Select E d i t ( F 1 ) .
The window changes to edit mode.
3. Select the check box of item in “Used/Unused” to be used for online communication.
4. Select the digits for each items in “Others” from the drop-down list.
5. Select C o n f i r m ( F 1 ) .
The set contents are registered.

4.3.4 Editing an Online Item Number

The test items and item Nos. used for online communication can be assigned and set.
1. From the AU480 “Home” window select Menu List>System>Online>Online Test No. to display the
“Online: Online Test No. tab” window.

2. Select E d i t ( F 1 ) .
The window changes to edit mode.
3. Move the cursor to the set item.
4. Enter the “Online Test No.”.
5. Repeat steps 3 to 4 for each test item to be set.
6. Select C o n f i r m ( F 1 ) .
The set contents are registered.

4-14
Configuring Tests AU480 User Guide
Version 1.0
Return to Main Table of Contents

4.4 Entry of Test Items

4.4.1 Test Name Setting .........................................................................................4-15
4.4.2 Creating a New Profile . .................................................................................4-20
4.4.3 Adding the New Test to a Group . ..................................................................4-25

4.4.1 Test Name Setting

This menu allows the user to name each of the tests, define calculated tests, and define reagent ID
settings. A maximum of 120 tests can be programmed. The contents of this menu may be printed.

Editing the Test Name

1. From the AU480 “Home” window select Menu List>Parameters>Common Test Parameters>Test
Name>Test Name to display the “Test Name: Test Name tab” window.

2. Select E d i t ( F 1 ) .
The window
Up Arrow
changes to edit mode.
Down Arrow

3. Use and to scroll the list and select the cell for the test to be set.

4-15
AU480 User Guide Configuring Tests
Version 1.0
 Return to Main Table of Contents

4. Set the following items as required.

Setting item Setting contents Input limit

Name Recognizable abbreviation for each 6 characters
test
Long Name Full test name (up to 20 characters) 20 characters
Reagent ID A code for each reagent bottle A value of 3 digits (000 to 999)
Alarm Shots Number of tests remaining at which Any value from 1 to 200
point an alarm will be issued
Multi Reagent Switch Multi reagent switch for each test “Yes”, “No”
item

5. Repeat steps 3 and 4 for each test item to be set.

6. After input, select C o n f i r m ( F 1 ) .
The set contents are registered.

Changing the test name will affect all results with that test number retrospectively.
Any previously reported results (with the old name) will be assigned the new test
name and this extreme caution must be applied when making any changes to the test
CAUTION name.

DO NOT CHANGE THE TEST NAME WITHOUT NOTHING THE TIME AND DATE
THE CHANGE OCCURRED AND THEN ENSURING ANY RESULTS PRINTED OUT
PRIOR TO THIS TIME AND DATE ARE REVIEWED AND CORRECTLY IDENTIFIED.

• The test name cannot be edited for test Nos. 96 to 102.

• A maximum three test items used for LIH judgement can be set with the group
condition setting.
TIP
• Setting information for “Sample Blank” window and “Calculated Tests” window is
displayed in the remarks column.

Sample Blank setting

Interference from other substances in the serum may contribute to the optical density measured.
Sample blank correction is performed to remove this interference. Sample blank correction uses color
items (active reagent) and blank items (inert reagent). The OD value of Y obtained from the formula
Y = X – B (X is the OD value of a color item and B is the OD value of a blank item) is multiplied with a
factor. A maximum of 10 sample blank tests can be set.

4-16
Configuring Tests AU480 User Guide
Version 1.0
Return to Main Table of Contents

Editing the Sample Blank

1. From the AU480 “Home” window select Menu List>Parameters>Common Test Parameters>Test
Name>Test Name to display the “Test Name: Test Name tab” window.
2. Select Sa m p l e B l a n k ( F 5 ) .
The “Sample Blank” window appears.

3. Select the test item to assign a color item from the “Color Item” column drop-down list.
4. Select the test item to assign a blank item from the “Blank Item” column drop-down list.
5. Select Cl o s e .
The window closes and the setting contents are registered.

Test items without a test name and test items set to calculated test items cannot be
•

used for color items or blank items.

TIP

4-17
AU480 User Guide Configuring Tests
Version 1.0
 Return to Main Table of Contents

Programming Calculated Tests

Test results derived from known mathematical relationships among measurable tests may be
calculated by the software. This formula can combine the results of up to five separate tests together
with up to four constant values.
For details on formula setting, refer to section “4.5.5 Set the Range” in this chapter.
1. From the AU480 “Home” window select Menu List>Parameters>Common Test Parameters>Test
Name>Test Name to display the “Test Name: Name tab” window.
2. Select C a l c u l a t e d Te s t s ( F 6 ) .
The “Calculated Tests” window appears.

3. Move the cursor to the item to be set.

4. Select the setting item from the drop-down list.
Selecting the drop-down list will change the display to “Selected status (blue)” or “Deselected
status (gray)”.
5. Repeat step 3 and 4 for each test item to be set.
6. Select C l o s e .
The window closes and the settings will be registered.

• Tests used in the formula cannot be selected from color items, blank items, LIH,
calculated test items, and ISE tests.

TIP • In the case of an illegal entry, the cursor moves to the corresponding input column
without closing the window for corrections to be made.
Test items without a test name cannot be set to calculated test items.

4-18
Configuring Tests AU480 User Guide
Version 1.0
Return to Main Table of Contents

LIH Editing
Lipemia/Icterus/Hemolysis testing can be ran to judge sample integrity. To perform LIH testing the
reagent and analysis mode must be set.
1. From the AU480 “Home” window select Menu List>Parameter>Common Test Parameters>Test
Name to display the “Test Name: Test Name tab” window.
2. Select E d i t ( F 1 ) .
L I H ( F 7 ) appears.
3. Select L I H ( F 7 ) .
The “LIH” window appears.

4. In the LIH window select the reagent condition to be used for the LIH judgment from the “LIH
Reagent” drop-down list. Select either Dedicated or Non Dedicated.
5. Select C o n f i r m ( F 1 ) .
The window closes and the setting contents are registered.

4-19
AU480 User Guide Configuring Tests
Version 1.0
 Return to Main Table of Contents

4.4.2 Creating a New Profile

A profile is a group of tests that are usually requested at the same time. Using a profile reduces the
number of key strokes needed, as a single profile is selected instead of multiple tests. A maximum of
100 profiles (Number 0 to Number 99) can be registered for test items, RB/CAL, and quality controls,
and up to 99 test items can be registered in one profile.
Individual profiles can be assigned a name (profile name) according to the application.
For details on batch setting of multiple test items for a sample, refer to section “5.7.1 Group Setting” in
chapter 5.

Profile 0 is the default profile. This is automatically used when:

• There is a barcode read error.

TIP • There is no requisition found for a sample in sequential mode.

• There are online errors.

4-20
Configuring Tests AU480 User Guide
Version 1.0
Return to Main Table of Contents

Edit Profiles for Patient Samples

1. From the AU480 “Home” window select Menu List>Parameters>Common Test
Parameters>Profile>Sample to display the “Profile: Sample tab” window.

2. Select E d i t ( F 1 ) .
The window changes to edit mode.
3. Select the sample type to be set from the “Type” drop-down list. Select one out of “Serum”,
“Urine”, “Other-1”, and “Other-2”.
4. Select the profile number from the “Profile Name” drop-down list (0 is the default).
5. Enter the profile name to be set in the “Profile Name” blank. Up to 20 characters can be entered.
6. Select the test to be included in to the profile from the test item list. The selected column changes
to the selection color. The selected number is displayed in the column “Selected Tests”.
7. Repeat steps 3 to 6 for each profile to be set.
8. After profile setting, Select C o n f i r m ( F 1 ) .
The entered profile is registered.

4-21
AU480 User Guide Configuring Tests
Version 1.0
 Return to Main Table of Contents

RB/Calibration Profile Editing

1. From the AU480 “Home” window select Menu List>Parameters>Common Test
Parameters>Profile>RB/Calibration to display the test items set to profile Number 0 as a list on
the window.

2. Select E d i t ( F 1 ) .
The window changes to edit mode.
3. Select the profile Number from the drop-down list in “Profile Name” blank (0 is the default).
4. Enter the profile name to be set in the “Profile Name” blank. Up to 20 characters may be entered.
5. In the “Type” blank, select the type to be set from the drop-down list. Select either “Serum”,
“Urine”, “Other-1”, and “Other-2”.
6. From the Test Item list, select the item to be registered to the profile. The selected column
changes to the color corresponding to the calibration type which can be set (ACAL+RB, one-point
correction, or RB Only). The selected number is displayed in the column “Selected Tests”.
7. When the calibration type needs to be changed, Select C a l i b ra t i o n O p t i o n s ( F 5 ) .
The colors which can be set are displayed in the order of yellow for ACAL+RB, green for one-
point correction, and blue for RB only and the setting is changed.
8. Repeat steps 3 to 7 for each profile to be set.

4-22
Configuring Tests AU480 User Guide
Version 1.0
Return to Main Table of Contents

9. After profile setting, select the C o n f i r m ( F 1 ) .

The entered profile is registered.

• ACAL setting at the profile of RB/ACAL is not available without setting of calibration
conditions for each test item.
TIP • Depending on the analysis mode, the calibration type in step 7 may not be changed.

Quality Control Profile Editing

The profile name and the tests included in it can be set according to the following procedure.
1. From the AU480 “Home” window select Menu List>Parameters>Common Test
Parameters>Profile>QC to display a list of test items set for profile Number 0 on the window.

2. Select E d i t ( F 1 ) .
The window changes to edit mode.
3. Select the profile number from the “Profile Name” drop-down list (0 is the default).
4. Enter the profile name to be set in the “Profile Name” blank.
Up 20 characters can be entered.

4-23
AU480 User Guide Configuring Tests
Version 1.0
 Return to Main Table of Contents

5. Select the type to be set from the “Type” the drop-down list.
Select either “Serum”, “Urine”, “Other-1”, or “Other-2”.
6. Select the item to be registered from the Test Item to the profile from the Test Item list.
The selected number is displayed in the column “Selected Tests”.
7. Repeat steps 3 to 6 for each profile to be set.
8. After profile setting, Select C o n f i r m ( F 1 ) .
The entered profile is registered.

The selection status for the following profile Nos. becomes the initial status of
QC reception for each sample type.
• Number 87 : Serum: For group 1
TIP
• Number 88 : Serum: For group 2
• Number 89 : Serum: For group 3
• Number 90 : Urine: For group 1
• Number 91 : Urine: For group 2
• Number 92 : Urine: For group 3
• Number 93 : Other-1: For group 1
• Number 94 : Other-1: For group 2
• Number 95 : Other-1: For group 3
• Number 96 : Other-2: For group 1
• Number 97 : Other-2: For group 2
• Number 98 : Other-2: For group 3

4-24
Configuring Tests AU480 User Guide
Version 1.0
Return to Main Table of Contents

4.4.3 Adding the New Test to a Group

A test must be added to a group before it can be performed. A group is a preselected set of tests. A
specific set of tests can be accessed quickly by selecting a group.
Three groups can be set up, each with up to 60 photometric tests. When a group is selected to run,
the system verifies (during a reagent check) that reagents set in the group are present, and checks
their status.
Inactive tests and tests not in the group are not run and any errors related to these tests do not
appear.
For details on setting the same test item for multiple samples at the same time, refer to section “4.4.2
Creating a New Profile” in this chapter.

• The number of test items that can be registered are 61 when the LIH special reagent
is “Not Special Reagent” in the test name specification, and 64 when the ISE (option)
is installed.
TIP
• Test data is printed using the printer (option) in the order of the registered test items
for each group. LIH items and calculated test items are printed last.

4-25
AU480 User Guide Configuring Tests
Version 1.0
 Return to Main Table of Contents

Group Editing
Set a group name for each group, LIH analysis selection may or may not be possible, test items, etc.
according to the following procedures.
A test can be added to a group, an existing test removed and the test name edited.
1. From the AU480 “Home” window select Menu List>Parameters>Common Test
Parameters>Group of Tests to display the “Common Test Parameters: Group of Tests” window for
setting of group names and groups.

Left Hand Right Hand

2. Use and to select the round to be set from the “Group” drop-down list.
3. Select E d i t ( F 1 ) .
The window changes to edit mode.
To change a group name enter the new name up to 20 characters may be entered
4. Select Te s t I t e m S e t t i n g ( F 5 ) .
The “Test Item Setting” window appears.
5. Select the test name to change.
Each button select changes Select and Non-select alternately. Newly added test appends to the
end of order.
The number of test selected is shown in “Selected Tests”. Selected tests (maximum of 60 tests)
are shown in blue.
6. Select C o n f i r m .
7. To change the test order of the group, select E d i t ( F 1 ) , and then select the test to re-order.
The selected test is highlighted in blue.

4-26
Configuring Tests AU480 User Guide
Version 1.0
Return to Main Table of Contents

8. Select Fo r w a r d ( F 2 ) or B a c k w a r d ( F 3 ) to change the order.

When “Special Reagent“ has been specified for an LIH reagent in “4.4.1 Test Name
Setting”, “Test Item Setting” is not displayed on the window.
TIP

Up to three tests may be selected as special reagents for the LIH test.
9. Select L I H Te s t I t e m S e t t i n g ( F 6 ) .
The “LIH Test Item Setting” the window is displayed.
10. Select a test from the “LIH Test Item” drop-down list. A maximum of 3 items can be selected.
11. Select C l o s e .
The set contents are registered.
12. Confirm the round setting and select C o n f i r m ( F 1 ) .
The set contents are registered.

4-27
AU480 User Guide Configuring Tests
Version 1.0
 Return to Main Table of Contents

4.5 Setting Specific Test Parameters

Sample volume, reagent volume, and other analysis parameters are set by tests.

4.5.1 Set General Tests ..........................................................................................4-29

4.5.2 LIH Test Setting .............................................................................................4-32
4.5.3 ISE (option) Test Setting ................................................................................4-34
4.5.4 Set Calculated Test Items...............................................................................4-35
4.5.5 Set the Range.................................................................................................4-37

Incorrect specific test parameters will cause errors in analysis results, and can
lead to an incorrect diagnosis. Specific test parameter settings should be visually
verified against published settings, as well as analysis using materials with known
CAUTION concentrations.

• For details on displaying a list of set values, refer to “List Display” in section “4.5.1 Set General
Tests” in this chapter.

• For details on printing a list of set values, refer to section “7.8 Print the Set Contents” in chapter
7.

4-28
Configuring Tests AU480 User Guide
Version 1.0
Return to Main Table of Contents

4.5.1 Set General Tests

The analysis parameters for general biochemical tests are set. Before this setting, register the analysis
test name.
For details on registration of the analysis test name, refer to section “4.4 Entry of Test Items” in this
chapter.

Edit General Tests

1. From the AU480 “Home” window select Menu List>Parameters>Specific Test
Parameters>General to display the “Specific Test Parameters: General” window.

2. Select E d i t ( F 1 ) .
The window changes to edit mode.
3. Select the Test Name from the “Test Name” drop-down list at the top of the window.
4. Select the Type from the “Type” drop-down list.
Select either “Serum”, “Urine”, “Other-1”, or “Other-2”.

4-29
AU480 User Guide Configuring Tests
Version 1.0
 Return to Main Table of Contents

5. Enter the analysis parameters according to the following table.

Setting item Setting range Remarks

Operation Yes, No Turns on/off the operation of a test
according to sample type.
Sample Volume and Diluent Sample In steps of 0.1 µL
Dilution 0μL : 1.0 to 25.0 μL
10μL : 1.0 to 20.0 μL
Pre-Dilution Rate 1, 3, 5, 10, 15, 20, 25, 50, 75, 100
Reagent Volume and Reagent : 10 to 250 μL In steps of 1 µL
Dilution Diluent : 0,10 to 240 μL For R2, 0 can be set
Total of reagent volume and
diluent within 250µL

6. Set the remaining analysis conditions using the following table.

Setting item Setting range Remarks

Wave Length Pri. 340, 380, 410, 450, 480, 520, 540, This setting range of pri. and sec. are
Sec. 570, 600, 660, 700, 750, and 800nm the same.
Method END, RATE, FIXED, END1, RATE1,
FIXED1
Reaction Slope +, - + used for an increasing reaction curve
- used for a decreasing reaction curve
Measuring Point-1 First: 0 to 26 The photometry points are limited by
Measuring Point-2 Last: 1 to 27 the analysis mode.
Linearity limit 0, 1 to 100 Step of 1
Linearity check of the reaction curve
Lag Time Check YES, NO Only used for Rate or Rate1 methods
OD Limit -2.0000 to 3.0000 Only used for Rate, Rate1, Fixed and
Fixed 1 methods
Reagent OD Limit -2.0000 to 3.0000
Dynamic Range Low: -9999999 to 9999999 To input the figures after the decimal
High: Low value to 9999999 point, set the figures on the “Specific
Test Parameters: Range” window in
advance.
Correlation Factor A: -9999999 to 9999999 Correlation value = A x measuring
B: -9999999 to 9999999 value + B
Factor for Maker A: -9999999 to 9999999 The factor for Maker coefficient revises
B: -9999999 to 9999999 concentration value with an equation
of Y=AX+B. The difference between
the correlation is the fact that the
correlation correction is performed
after checking the dynamic range
while the Factor for Maker correction is
performed before checking the dynamic
range. Editing is not possible when the
login user level is “General user”.
Onboard Stability Days (0 to 999) and hours (0 to
Period 23)
LIH Influence Check YES, NO For each tests, set the judgment level
of chyle (L), icterus (I), and hemolysis
(H) to the level where the test result will
be affected by exceeding the level.
For the test data, which exceed the
judgment level, the data flag will be
added.
Lipemia +, ++, +++, ++++, +++++ Setting is possible only when the
LIH Influence Check is YES.
Icterus
Hemolysis

4-30
Configuring Tests AU480 User Guide
Version 1.0
Return to Main Table of Contents

7. Select C o n f i r m ( F 1 ) to save the settings.

List Display
Use the following procedures to confirm the test details for set analysis tests.
1. Select L i s t D i s p l a y ( F 7 ) .
The “List Display (test requisition)” window appears.
2. Select the sample from the “Sample” drop-down list.
3. Select up to six tests on the window.
Selected tests are highlighted in blue.
4. Select D i s p l a y .
The List Display showing the selected tests appears.
5. Select C l o s e to return to the list display selection window, select c l o s e again to return to the
specific test parameters window.

4-31
AU480 User Guide Configuring Tests
Version 1.0
 Return to Main Table of Contents

4.5.2 LIH Test Setting

When LIH is measured individually, set the analysis parameters and the judgment levels. Before
setting the judgment level, register the LIH reagent name.
For details on LIH reagent name registration, refer to “LIH Editing” in section “4.4.1 Test Name Setting”
in this chapter.

Edit the analysis parameters

1. From the AU480 “Home” window select Menu List>Parameters>Specific Test Parameters>LIH to
display the “Specific Test Parameters: LIH” window.

2. Select E d i t ( F 1 ) .
The window changes to edit mode.
In the “LIH Reagent” blank “Dedicated” or “Not dedicated” is displayed.

4-32
Configuring Tests AU480 User Guide
Version 1.0
Return to Main Table of Contents

3. Set each set value using the following table.

Setting item Setting range Remarks

Sample Volume and Dilution (*) Dilution Sample In steps of 0.1 µL
0 µL : 1.0 to 25.0 μL
10 µL : 1.0 to 20.0 μL
Reagent R1 (R1-1) Volume and Reagent : 10 to 250 μL In steps of 1 µL
Dilution (*) Diluent : 0,10 to 240 μL Total of reagent volume and
diluent within 250µL
Onboard Stability Period (*) Days (0 to 999) and hours (0 to 23)
LIH Judgment level The judgment level is set separately
for Lipemia, Icterus, and Hemolysis.
+ : 0.0 to 3.0
++ : + value to 3.0
+++ : ++ value to 3.0
++++ : +++ value to 3.0
+++++ : ++++ value to 3.0
(*): “Sample Volume” and “Diluent”, “Reagent R1(R1-1) Volume” and “Diluent”, and
“Onboard Stability Period” can be set only when “LIH reagent” is set as dedicated.

4. Select C o n f i r m ( F 1 ) .
The set contents are registered.

4-33
AU480 User Guide Configuring Tests
Version 1.0
 Return to Main Table of Contents

4.5.3 ISE (option) Test Setting

If ISE analysis Operation, Dynamic Range, and Correction Factor are set. The Sample Volume etc. is
fixed by the system and cannot be changed.
ISE is an option. In order to use the ISE the option must be enabled.

ISE Test Setting

1. From the AU480 “Home” window select Menu List>Parameters>Specific Test Parameters>ISE to
display the “Specific Test Parameters: ISE” window.

2. Select E d i t ( F 1 ) .
The window changes to edit mode.
3. Select “Yes” or “No” from the “Operation” drop-down list and set whether analysis is to be
performed or not.
4. In case of execution, set “Dynamic Range” and “Correlation Factor” using the following table.

Setting item Setting range Remarks

Dynamic Range Low: -9999999 to 999999
High: Low value to 999999
Correlation Factor A: -9999999 to 999999 Correlation value = A × measuring
B: -9999999 to 999999 value + B

5. Select C o n f i r m ( F 1 ) .
The set Contents are registered.

4-34
Configuring Tests AU480 User Guide
Version 1.0
Return to Main Table of Contents

4.5.4 Set Calculated Test Items

Set Calculated Test Items
1. From the AU480 “Home” window select Menu List>Parameters>Specific Test
Parameters>Calculated Tests to display the “Specific Test Parameters: Calculated Tests” window.

2. Select E d i t ( F 1 ) .
The window changes to edit mode.
3. Select the calculated test name from the “Calculated Test Name” drop-down list.
4. Select “Serum”, “Urine”, “Other-1”, or “Other-2” from the “Type” drop-down list.

4-35
AU480 User Guide Configuring Tests
Version 1.0
 Return to Main Table of Contents

5. Set the following items using the following table.

Setting item Setting range Remarks

Test Name Select the items required to perform Maximum 5 items can be set.
the calculated test.
Constant Constant type: Value Not set: -Value: Value input is made only when the
-9999999 to 9999999 Constant type is “Value”. Maximum
Patient Information 1: - 4 constants can be set.
Patient Information 2: -
Patient Information 3: -
Patient Information 4: -
Patient Information 5: -
Patient Information 6: -
Formula Calculated test formula Maximum of 20 characters.
Combination of +-*/()ABCDEabcd
QC Perform Yes, No Specification of execution or no
execution of quality control (*)

*: For details on setting quality control parameters, refer to section "4.8.2 Set the Specific Quality
Control Parameters" in this chapter.
6. Select C o n f i r m ( F 1 ) .
The set contents are registered.

4-36
Configuring Tests AU480 User Guide
Version 1.0
Return to Main Table of Contents

4.5.5 Set the Range

Test data can be compared with multiple judgment standards and displayed with the result added
to the test data. The judgment standard is called check range. This section explains the method for
setting the check range.
For details on error flag, refer to chapter 9 “Error Flags”.

Setting the Check Range

1. From the AU480 “Home” window select Menu List>Parameters>Specific Test Parameters>Range
to display the “Specific Test Parameters: Range” window.

2. Select E d i t ( F 1 ) .
The window changes to edit mode.
3. Select the test name to be set from the “Test Name” drop-down list.
4. Select either “Serum”, “Urine”, “Other-1”, or “Other-2”, from the “Type” drop-down list.

4-37
AU480 User Guide Configuring Tests
Version 1.0
 Return to Main Table of Contents

5. Select the flag or value from “Value/Flag” the drop-down list.

Setting item Setting range Remarks

Flag Select (flag) in qualitative item.
Judgment is performed depending on
“Level”.
Value Set to general biochemical item.
Judgment is performed depending on
“Specific Ranges”.

6. Set the decimal places of concentration. Select S e t D e c i m a l P l a c e s ( F 5 ) .

The “Set Decimal Places” window appears.

7. Select decimal places from the drop-down list and Select C l o s e .

The window display changes to decimal places setting.

All the concentration values will be displayed and printed by the digit number set in
this field.
TIP

8. Set “Level” or “Specific Ranges”.

Setting item Setting range Remarks

Level Low: -9999999 to 9999999 Concentration value of maximum 8
High: Low value to 9999999 digits including the decimal point.
See chapter 9 “Error Flags”

9. Select the check box in front of the “Specific Ranges” to be used for judgment.

Specific ranges Description

1 to 6 Set the normal ranges for Sex and Age range.
Only the range selected in check box is available to enter.
7 Set the normal range when ranges set in 1 to 6 are not applicable.
8 Set the normal range when patient information (sex and age) are not set.
It is the normal value printed on the report.

10. Set the values for Sex, Age, etc. of “Specific Ranges”.

Setting item Setting range Remarks

Specific Ranges Low: -9999999 to 9999999 Concentration value of maximum 8
High: Low value to 9999999 digits including the decimal point.

11. Set “Panic Value”.

Setting item Setting range Remarks

Panic Value Low: -9999999 to 9999999
High: -9999999 to 9999999
Judgement is performed
independent of the setting (flag or
value) for “Data judgment”.

12. When printing unit on the report, enter “Unit”.

13. Confirm the set values and select C o n f i r m ( F 1 ) .
The contents are registered.

4-38
Configuring Tests AU480 User Guide
Version 1.0
Return to Main Table of Contents

4.6 Programming Repeat Tests

4.6.1 Repeat run Parameter Setting . .....................................................................4-40
4.6.2 Setting Specific Test Repeat-run Parameters . ..............................................4-42
The AU480 allows either manual or automatic repeat sample analysis. This section describes how to
configure the repeat mode.
Normal repeat:
Analysis is performed in the same conditions for the initial analysis and sample volume.

Repeat run with dilution:

Analysis is performed with a smaller sample volume than the initial analysis.
1. The sample volume used for analysis is reduced with the same dilution rate as for the initial
analysis.
2. The dilution ratio is increased from the initial analysis.

Repeat run with condense:

Analysis is performed with a larger sample volume than the initial analysis.
1. The sample volume used for analysis is increased with the same dilution rate as for the
initial analysis.
2. The dilution ratio is decreased from the initial analysis.

4-39
AU480 User Guide Configuring Tests
Version 1.0
 Return to Main Table of Contents

4.6.1 Repeat run Parameter Setting

If Auto Repeat requisition is allowed the repeat results will overwrite the original defined data items.

Repeat run Common Parameters Setting

1. From the AU480 “Home” window select Menu List>Parameters>Repeat Parameters>Repeat
Common>Data Flag to display the “Repeat Common: Data Flag tab” window.

2. Select E d i t ( F 1 ) .
The window changes to edit mode.
3. Select “Yes” or “No” from the “Auto Repeat Requisition” drop-down list. The setting terminates
when “No” is selected. Go to step 6.
4. Select “Yes” or No” from the “Repeat Data over-writes Original Data Automatically” drop-down list.
When “Yes” is selected, the original data are overwritten by the repeat run data.
5. Select any error flag from “Select Data Flag” and set the repeat run decision parameters.

Setting item Setting range Remarks

OR mode Select for repeat when any of the selected
flags are set.
AND mode Select for repeat when all of the selected flag
conditions are met

6. When setting has been completed, confirm the set values and select C o n f i r m ( F 1 ) .
The set values are registered.
For details on error flag, refer to chapter 9 “Error Flags”.

4-40
Configuring Tests AU480 User Guide
Version 1.0
Return to Main Table of Contents

Repeat run Group Setting

To set conditions where multiple tests are set for analysis based on the condition of one test. For
example, when ALB is set as the deciding test and TP as a related test, when repeat run is judged
necessary for ALB, TP repeat run is judged necessary at the same time.
A maximum of 10 combinations of deciding tests and related tests can be set. A maximum of 5 related
tests may be defined per “deciding test” defined.
1. From the AU480 “Home” window select Menu List>Parameters>Repeat Parameters>Repeat
Common>Group to display the “Repeat Common: Group tab” window.

2. Select E d i t ( F 1 ) .
The window changes to edit mode.
3. Select “Deciding Test” and “Related Test” from the respective drop-down lists.
4. Confirm the set values and select C o n f i r m ( F 1 ) .
The set contents are registered.

• When the repeat range is exceeded, all “Deciding Test” and “Related Test” set in
“Repeat Common: Group Tab” window become objects for repeat run.

TIP • When reflex range is exceeded, only the “Related Test” set in the “Repeat Common:
Group Tab” window become objects for repeat run.

4-41
AU480 User Guide Configuring Tests
Version 1.0
 Return to Main Table of Contents

4.6.2 Setting Specific Test Repeat-run Parameters

Set the sample volume etc. by repeat run parameters for Repeat with dilution and Repeat with
condense.

Edit the specific repeat run parameters

1. From the AU480 “Home” window select Menu List>Parameters>Repeat Parameters>Repeat
Specific to display the “Repeat Parameters: Repeat Specific” window.

2. Select E d i t ( F 1 ) .
The window changes to edit mode.
3. Select the Test Name from the “Test Name” drop-down list.
4. Select either “Serum”, “Urine”, “Other-1”, or “Other-2” from the “Type” drop-down list.
5. Set “Repeat with diluent” or “Repeat with condense”. “Normal Repeat” cannot be edited.

Setting item Setting range Remarks

Sample Volume and Diluent Sample Sample Volume is in steps of 0.1
Dilution 0 µL : 1.0 to 25.0 µL µL
10 µL : 1.0 to 20.0 µL Select the diluent from the drop
down list.
Pre-Dilution Rate 1 to 100 (refer to the drop-down list)

4-42
Configuring Tests AU480 User Guide
Version 1.0
Return to Main Table of Contents

6. Setting the “Repeat Decision Range”.

Setting item Setting range Remarks

Repeat Decision Range Low: -9999999 to 9999999 Input required
Repeat Decision Range: Low value
to 9999999

7. Setting the “Reflex Range”.

Setting item Setting range Remarks

Reflex Range Low: -9999999 to 9999999 Repeat Input required
Decision Range: Low value to
9999999

8. When a dynamic range check is to be executed, select the check box “Dynamic Range Check”.

• The check indicates whether items of the dynamic range error are subject to the
repeat run selection.
• When the test data is below the Low value, Repeat with condense is recommended,
TIP
and when the test data exceeds the High value, Repeat with dilution is
recommended.

9. Confirm the set values and select C o n f i r m ( F 1 ) .

The set contents are registered.

4-43
AU480 User Guide Configuring Tests
Version 1.0
 Return to Main Table of Contents

4.7 Set Calibration Analysis

Before analysis starts, calibration analysis is performed to obtain calibration curves for each analysis
item from concentrations obtained from the absorbance of the mixture fluid. A sample with a known
concentration, used for calibration analysis, is called a calibrator. In this chapter, calibrators are
registered and the parameters for calibration analysis are set.

4.7.1 Calibrator Registration . .................................................................................4-45

4.7.2 Set the Specific Calibration Parameters . ......................................................4-48
4.7.3 Set Calibration Using the STAT Table . ..........................................................4-53
Calibration analysis can be performed using yellow racks or using the STAT table. When a barcode
label is attached to a calibrator, the calibrator can be set to any position on a yellow rack or on the
STAT table.

Incorrect calibration parameters for analysis testing will cause errors in analysis
results, and can lead to misdiagnosis. Specific test calibration parameter settings
should be visually verified against the published settings, as well as through analysis
CAUTION using materials with known concentrations.

• For details on displaying a list of set values, refer to “List Display” in section “4.7.2 Set the
Specific Calibration Parameters” in this chapter.

• For details on printing a list of set values, refer to section “7.8 Print the Set Contents” in chapter
7.

4-44
Configuring Tests AU480 User Guide
Version 1.0
Return to Main Table of Contents

4.7.1 Calibrator Registration

Register calibrators to be used with general tests and with ISE.

Calibrator registration and editing

1. From the AU480 “Home” window select Menu List>Parameters>Calibration
Parameters>Calibrators to display the “Calibration Parameters: Calibrators” window.

2. Select E d i t ( F 1 ) .
The window changes to edit mode.
3. When the calibrator is identified by a barcode, select the “Barcode Operation” check box.
4. Enter the information for the calibrator to be used according to the sample type. When “Barcode
Operation” is not selected, the setting position on the yellow rack is decided by the input order.

Setting item Setting range Remarks

Name Up to 20 characters
ID Up to 26 characters Alphanumerics, only at the time of
barcode use
Lot No. Up to 16 characters Alphanumeric
Expiration Date: YYYY/MM/DD

4-45
AU480 User Guide Configuring Tests
Version 1.0
 Return to Main Table of Contents

5. When samples for reagent blanks are used, enter the “RB Sample Information”.

Setting item Setting range Remarks

Name Up to 20 characters
ID Up to 26 characters Alphanumerics, only at the time of
barcode use
Serum, Urine, Other-1, Other-2 Enter a check for the sample type
for which this reagent blank sample
is to be used.

• The cup for the regent blank can be set for each sample type.
• When No.1 is selected, set the cup on the first cup position of the blue rack or RB
position of STAT table.
TIP
• When No.2 is selected, set the cup on the second cup position of the blue rack or RB
position of STAT table.

6. Select C o n f i r m ( F 1 ) .
The set values are registered.

4-46
Configuring Tests AU480 User Guide
Version 1.0
Return to Main Table of Contents

Change of the calibrator concentration value

When using the multi-calibrator, the concentration value of each item can be set all together.
The calibrator concentration value is entered on the “Specific Test Parameters” window, but the
concentration value of a registered calibrator can be changed from the “Calibrators” window.

When this function is used to change the calibrator concentration value without
going to the “Specific Test Parameters” window (especially multi-point calibration
curves etc.), always confirm the concentration values for errors in the “Specific Test
CAUTION Parameters” window.
For details on specific test parameters, refer to section “4.5 Setting Specific Test
Parameters” in this chapter.

1. From the AU480 “Home” window select Menu List>Parameters>Calibration

Parameters>Calibrators to display the “Calibration Parameters: Calibrators” window.
2. Select S e t C o n c Va l u e ( F 5 ) .
The “Set Conc Value” window appears.

3. Select the calibrator for which the concentration value is to be changed from the “Calibrator”
drop-down list. The analysis items using the selected calibrator and the concentration values of
their calibration curves are displayed.
4. Change the concentration values of the analysis items subject to change.
5. In case of a multi-point calibration curve, select the calibrator for a different point and repeat
changing.
6. Select C l o s e to close the “Set Conc Value” window.
The confirmation message for concentration change is displayed.
7. Select O K to close the confirmation message.
8. Select C o n f i r m ( F 1 ) .
The set values are registered.

4-47
AU480 User Guide Configuring Tests
Version 1.0
 Return to Main Table of Contents

4.7.2 Set the Specific Calibration Parameters

The calibrator to be used, the concentration values, and other calibration parameters are set for each
analysis test.

Set the Specific Calibration Parameters

1. From the AU480 “Home” window select Menu List>Parameters>Calibration
Parameters>Calibration Specific>General to display the “Calibration Specific: General tab”
window.

2. Select E d i t ( F 1 ) .
The window enters into edit mode.
3. Select the test from the “Test Name” drop-down list.
4. Select the type from the “Type” drop-down list.

When the “Use Serum Cal.” check box is selected, serum is to be used for calibration
of a test with a sample even if other than “Serum”.
TIP

5. Select the calibration curve type from the “Calibration Type” drop-down list. “Calibrator
Parameters” and other related input columns may change depending on the type of calibration
curve.
6. Select the formula approximating the calibration curve from the “Formula” drop-down list.

4-48
Configuring Tests AU480 User Guide
Version 1.0
Return to Main Table of Contents

7. Select the execution number from the “Counts” drop-down list. It is possible to perform the same
calibration analysis a maximum of four times and to decide the calibration curve from multiple
results.
8. Select “Calibrator Parameters” or “Point Cal. for Master Curve” as the calibrator to be used from
the “Calibrator” drop-down list.
9. Enter the required OD value, concentration value, and range (OD or factor). For the respective
values, refer to the parameter sheet supplied with the reagent etc.

Setting item Setting range Remarks

OD From -2.0000 to 3.0000
Conc From -9999999 to 9999999 Maximum 9 characters, including
decimal point and sign
Range OD range: -2.0000 to 3.0000 When the calibration curve is
Factor range: -9999999 to 9999999 2AB to 7AB: Set the OD range
AB or AA: Set the Factor range

10. Set the other calibration parameters according to the calibration curve type.

Setting item Setting range Remarks

MB Type Factor From -9999999 to 9999999 When the calibration curve is MB
1-point Calibration Point No setting or 1 to 7 When the calibration curve is 2AB
to 7AB
With Conc-0 Yes, No When the calibration curve is 2AB
to 7AB

11. Select slope check execution or no execution for the calibration curve from the drop-down list of
“Slope Check” and select the slope in case of checking.
12. When the calibration curve is AA, AB to 7AB, or 4MC to 10MC, and OD delta check is to be
performed for reagent blank and calibration, select the respective check box and enter the OD
delta check value.

Setting item Setting range Remarks

Reagent Blank From -2.0000 to 3.0000
Calibration From -2.0000 to 3.0000

When selecting the calibration type of 2 MB to 7 MB, the calibration curve can be
confirmed in Fa c t o r d i s p l a y ( F 5 ) .
TIP

4-49
AU480 User Guide Configuring Tests
Version 1.0
 Return to Main Table of Contents

13. Make the settings for advance calibration.

Calibration of multiple bottles of the same reagent set in the reagent refrigerator can
be performed together in advance. This is called advance calibration. Use only with
the specific AU reagent. For detailed information, contact Beckman Coulter Technical
TIP
Services.

Setting item Setting range Remarks

Operation Yes, No
Interval (RB/ACAL) Bottle/Bottle:
Execution of reagent blank and
calibration for all bottles.

Bottle/Lot:
Execution of reagent blank for all
bottles and perform a calibration
once per lot of reagent loaded on
the analyzer.

Lot/Lot: Execute
Reagent Blank and Calibration only
when a change in lot number is read
for that reagent.
Lot Calibration Check box
When setting new reagent bottle,
if the analyzer has the data for
calibration curve (reference data)
in the same lot, the data for
calibration curve of new bottle can
be generated automatically.

14. Set the calibration expiration in “Stability” as days and hours.

15. Confirm the input values and select C o n f i r m ( F 1 ) .
The set contents are registered.

List Display
When the calibration parameters have been set, the registered contents must be confirmed.
1. Select L i s t D i s p l a y ( F 7 ) .
The “List Display” (test requisition) window appears.
2. Select the sample type and the tests for detailed display. Maximum 6 test requisitions can be
selected.
3. Select D i s p l a y .
The “List Display” (set information display) window appears.
4. Select C l o s e .

4-50
Configuring Tests AU480 User Guide
Version 1.0
Return to Main Table of Contents

Set the calibration parameter for ISE tests

The calibrator for ISE tests (Na, K, Cl), the concentration values, and other calibration parameters are
set.
1. From the AU480 “Home” window select Menu List>Parameters>Calibration
Parameters>Calibration Specific>ISE to display the “Calibration Specific: ISE tab” window.

2. Select E d i t ( F 1 ) .
The window changes to edit mode.
3. Select “Serum” or “Urine” from the “Type” drop-down list.
4. Select “Calibration Type”, “Counts”, and “MCAL Factor Type” from the drop-down list. These three
settings are common for the three ISE tests and cannot be set individually. The other items which
can be set differ according to the set values.

Setting item Setting range Remarks

Calibration Type MCAL, ACAL Common for Na, K, and Cl
Counts From 1 to 4 Common for Na, K, and Cl
Only if “Calibration Type” is
“ACAL”, “Counts” can set.
MCAL Factor Type Manual, CRS Calibration. Common for Na, K, and Cl
When CRS Calibration is selected,
MCAL Factor is set automatically
depend on the result of CRS.

5. Enter the required factor in “MCAL Factor-A” and “MCAL Factor-B”.

These two settings are the factor to perform Ax+B correction calculation on the result of ISE
concentration value. There settings can be set only when Manual is selected from the “MCAL
Factor Type”. When CRS Calibration is selected, MCAL Factor is set automatically depend on
the result of CRS.
4-51
AU480 User Guide Configuring Tests
Version 1.0
 Return to Main Table of Contents

6. Enter calculation method for ACAL in “ISE Correction Type”.

7. Select the calibrator to be used from the “Calibrator” drop-down list.
8. Enter the required concentration value and the factor range (Low/High). For the respective
values, refer to the parameter sheet supplied with the reagent etc.

Setting item Setting range Remarks

Conc. -9999999 to 9999999 Set only when the calibration type
is ACAL.
Factor Range (Low/ High) -9999999 to 9999999 Set only when the calibration type
is ACAL.

9. When the calibration type is ACAL and OD delta check is to be performed, select “Yes” in the
“Allowable Range Check” drop-down list.
10. When the calibration type is ACAL and OD delta check is to be performed, set the OD delta check
value in “Allowable Range Check Value”.
11. Confirm the input values and select C o n f i r m ( F 1 ) .
The set contents are registered.

4-52
Configuring Tests AU480 User Guide
Version 1.0
Return to Main Table of Contents

4.7.3 Set Calibration Using the STAT Table

During analysis, a calibrator can be set on the STAT table to perform automatic calibration when the
reagent bottle is changed etc.
The following conditions are required to perform calibration using the STAT table.

• Set all calibrators registered for analysis tests, for which calibration is to be performed, on the
STAT table.

• Set the reagent blank samples to be used for the sample type.
When barcode operation has been set on the “Calibration Parameters: calibrators” window, the
calibrators set on the STAT table can be identified by barcode independent of the setting position.

The inside of the STAT table is refrigerated, but it is not intended for long-term storage
of samples. Calibrators should be set on the STAT table only for the shortest time
CAUTION required.

For details on calibrator registration and barcode operation setting, refer to section “4.7.1 Calibrator
Registration” in this chapter.

4-53
AU480 User Guide Configuring Tests
Version 1.0
 Return to Main Table of Contents

Register calibrators to be used for the STAT table

Register the calibrators to be used for each group.
1. From the AU480 “Home” window select Menu List>Parameters>Calibration Parameters>STAT
Table Calibration>Position to display the “STAT Table Calibration: Position tab” window.

2. Select E d i t ( F 1 ) .
The window changes to edit mode.
3. Select the group to be edited from the “Group” drop-down list.
4. Select the calibrator to be used from the “Calibrator” drop-down list. The display contents for the
numbers on the left side of the column “Calibrator” differ according to use or non use of barcodes.

Barcode operation Display Remarks

Available Position No. Fixed Number on the STAT table
Unavailable No. Sequentially from 1

5. Repeat step 4 for the number of set calibrators.

6. Confirm the input values and select C o n f i r m ( F 1 ) .
The set contents are registered.

4-54
Configuring Tests AU480 User Guide
Version 1.0
Return to Main Table of Contents

Edit the specific calibration parameters

Set the calibration method using the STAT table and when the calibration is performed for each test.
1. From the AU480 “Home” window select Menu List>Parameters>Calibration Parameters>STAT
Table Calibration>Calibration Specific to display the “STAT Table Calibration: Calibration Specific
tab” window.

2. Select E d i t ( F 1 ) .
The window changes to edit mode.
3. Select the round to be edited from the “Group” drop-down list.
4. Select either “Serum”, “Urine”, “Other-1”, or “Other-2” from the “Type” drop-down list.

4-55
AU480 User Guide Configuring Tests
Version 1.0
 Return to Main Table of Contents

5. Set the calibration parameters when Yes is set in the column “Available/Unavailable”.

Setting item Setting range Remarks

Calibration Mode None: STAT calibration is not performed.
All points: Calibration is performed for all points.
RB: Only reagent blank is performed.
Execution Type ACAL: Change Bottle No. /RB: Change
Bottle No.: Calibration is performed when the
bottle Number has changed.
ACAL: Change Lot No. /RB: Change Lot
No.: Calibration is performed when the lot Number
has changed.
ACAL: Change Lot No. /RB: Change
Bottle No.: Calibration is performed when the lot
Number has changed and reagent blank is performed
when the bottle Number has changed.

6. Confirm the input values and select C o n f i r m ( F 1 ) .

The set contents are registered.

4-56
Configuring Tests AU480 User Guide
Version 1.0
Return to Main Table of Contents

4.8 Configuring QC Analysis

It is necessary to verify system performance by measuring quality control samples.
4.8.1 Requesting QC Analysis . ..............................................................................4-58
4.8.2 Set the Specific Quality Control Parameters .................................................4-59
4.8.3 Set Quality Control Using the STAT Table .....................................................4-64
Check the performance of the AU480 regularly by analyzing QC samples. Each laboratory should
establish its own control frequency. A good laboratory practice is to test QC samples each time patient
samples are tested and each time calibration is performed. If any trends or sudden shifts in values are
detected, review all operating parameters.
QC analysis can be performed using green racks or using the STAT table. When a barcode label is
attached to a control, the control can be set to any position on a green rack or on the STAT table.
Each laboratory should also establish guidelines to ensure corrective action if controls do not recover
within the specified limits.

Erroneous analysis data can lead to erroneous diagnosis results. Always perform
QC analysis at the same time as analysis of general patient samples to confirm that
analysis is performed normally.
CAUTION

4-57
AU480 User Guide Configuring Tests
Version 1.0
 Return to Main Table of Contents

4.8.1 Requesting QC Analysis

QC requisition defines which QC samples the system is to analyze.

Edit Control
1. From the AU480 “Home” window select Menu List>Parameters>QC Parameters>Controls to
display the “QC Parameters: Controls” window.

2. Select E d i t ( F 1 ) .
The window changes to edit mode.
3. When the control is identified by a barcode, select the “Barcode Operation” check box.
4. Enter the information for the control to be used according to the sample type. When “Barcode
Operation” is not selected, the setting position on the green rack is decided by the input order.

Setting item Setting range Remarks

Name Up to 20 characters
ID Up to 26 characters Alphanumerics, only at the time of barcode use
Lot No. Up to 15 characters Alphanumeric
Expiration Date: YYYY/MM/DD
STAT Uses Enable Uneable Set whether control use with the STAT table is possible
or not.

5. Select C o n f i r m ( F 1 ) .
The set values are registered.

4-58
Configuring Tests AU480 User Guide
Version 1.0
Return to Main Table of Contents

4.8.2 Set the Specific Quality Control Parameters

Set the quality control method, the control to be used, the concentration value, and other quality
control parameters for each analysis test.
There are two quality control methods: single check using the mean value and the standard deviation
of the control and multiple check with multiple rule including the tendencies of past results in the
control.
The statistical values becoming the standard for each quality control can use the keyboard to enter or
can be calculated from past data.
For details on quality control, refer to section “3.1.5 Quality Control” in chapter 3.

Set the Specific Quality Control Parameters

1. From the AU480 “Home” window select Menu List>Parameters>QC Parameters>QC
Specific>Check to display the “QC Specific: Check tab” window.

2. Select E d i t ( F 1 ) .
The window changes to edit mode.
3. Select the test from the “Test Name” drop-down list.
4. Check each test of “Single Check Level” and “Multi Check Level” according to the quality control
to be performed.

4-59
AU480 User Guide Configuring Tests
Version 1.0
 Return to Main Table of Contents

5. Select the reference value to be used from “QC Mode”.

Setting item Setting range Remarks

Off Checking only with the quality
control data.
Preset Direct input of the reference value.
Cumulative The reference value is calculated
from the past cumulative data.

6. Confirm the input values and select C o n f i r m ( F 1 ) .

The set contents are registered.

4-60
Configuring Tests AU480 User Guide
Version 1.0
Return to Main Table of Contents

Reference value (preset) editing

Using the keyboard enter the reference values for quality control.
1. From the AU480 “Home” window select Menu List>Parameters>QC Parameters>QC
Specific>Preset to display the “QC Specific: Preset tab” window.

2. Select E d i t ( F 1 ) .
The window changes to edit mode.
3. Select the test from the “Test Name” drop-down list.
4. Select either “Serum”, “Urine”, “Other-1”, or “Other-2” from the “Type” drop-down list.
5. Select the control to be edited from the “Control” drop-down list.
6. Select the quality control method to be used (single check or multiple check) from the “Multi/
Single” drop-down list.
7. Enter the mean value, the standard deviation, and the range reference value.

4-61
AU480 User Guide Configuring Tests
Version 1.0
 Return to Main Table of Contents

8. When reference to past QC data is desired, select Q C S t a c k Re v i e w ( F 7 ) .

The “QC Stack Review” window is displayed and the maximum value and the minimum value for
the last 10 QC data are displayed.

9. Select C l o s e to close the “QC Stack Review” window.

10. Confirm the input values and select C o n f i r m ( F 1 ) .
The set contents are registered.

When calculated test items, etc. have been selected for Test Name, only controls
common for all analysis tests can be selected and edited.
TIP

Reference value (cumulative value) editing

How to set the reference for quality control by automatic calculation from past data:
1. From the AU480 “Home” window select Menu List>Parameters>QC Parameters>QC
Specific>Cumulative to display the “QC Specific: Cumulative tab” window.

4-62
Configuring Tests AU480 User Guide
Version 1.0
Return to Main Table of Contents

2. Select E d i t ( F 1 ) .
The window changes to edit mode.
3. Select the test from the “Test Name” drop-down list.
4. Select either “Serum”, “Urine”, “Other-1”, or “Other-2” from the “Type” drop-down list.
5. Select the control to be edited from “Control” the drop-down list.
6. Select the quality control method to be used (single check or multiple check) from the “Multi/
Single” drop-down list.
7. Select A d d s t o C u m u l a t i v e ( F 5 ) or N e w C u m u l a t i v e ( F 6 ) . A d d s t o
C u m u l a t i v e ( F 5 ) brings up the “Adds to Cumulative” window. N e w C u m u l a t i v e
( F 6 ) brings up the “New Cumulative” window.

8. Select the index date from the “Start Index” and “End Index” drop-down list and set the period for
the reference value calculation data.
9. Select O K and close the reference value calculation window. The calculated reference value
is displayed on the window. The period of the data used for calculation window is displayed in
“Period Cumulative”.
10. Confirm the input values and select C o n f i r m ( F 1 ) .
The set contents are registered.

When calculated test items, etc. have been selected for Test Name, only controls
common for all analysis tests can be selected and edited.
TIP

4-63
AU480 User Guide Configuring Tests
Version 1.0
 Return to Main Table of Contents

4.8.3 Set Quality Control Using the STAT Table

Controls to the STAT table can be set during analysis to perform QC analysis automatically at
specified intervals.
When barcode operation has been set on the “QC Parameters: Controls” window, the controls set to
the STAT table can be identified by barcode independent of the setting position.

The inside of the STAT table is refrigerated, but it is not intended for long-term storage
of samples. Controls should be set to the STAT table only for the shortest required
CAUTION time.

For details on barcode operation settings, refer to section “4.8.1 Requesting QC Analysis” in this
chapter.

4-64
Configuring Tests AU480 User Guide
Version 1.0
Return to Main Table of Contents

Registration of controls to be used with the STAT table

The controls to be used are registered by rounds.

If the Multi-Rule Control is used, register both controls.

TIP

1. From the AU480 “Home” window select Menu List>Parameter>QC Parameters>Stat Table
QC>Position to display the “STAT Table QC: Position tab” window.

2. Select E d i t ( F 1 ) .
The window changes to edit mode.
3. Select the round to be edited from the “Group” drop-down list.
4. Select the control to be used from the “Control” drop-down list. The displayed contents for the
numbers on the left side of the column “Control” differ according to use or no use of barcodes.

Barcode operation Display Remarks

Available Position No. Fixed Number on the STAT table
Unavailable No. Sequentially from 1

5. Repeat step 4 for the number of set controls.

6. Confirm the input values and select C o n f i r m ( F 1 ) .
The set contents are registered.

4-65
AU480 User Guide Configuring Tests
Version 1.0
 Return to Main Table of Contents

Editing of quality control performed at the STAT table

Setting the interval for performing quality control for each test.
1. From the AU480 “Home” window select Menu List>Parameters>QC Parameters>STAT Table
QC>QC Specific to display the “STAT Table QC: QC Specific tab” window.

2. Select E d i t ( F 1 ) .
The window changes to edit mode.
3. Select the group to be edited from the “Group” drop-down list.
4. Select either“Serum”, “Urine”, “Other-1”, or “Other-2”. from the “Type” drop-down list.
5. Select the unit for the interval at which QC analysis is to be performed from the “Cyclic Type”
drop-down list.

Setting item Display Remarks

None QC analysis is not performed during analysis.
Test Judgment is made by the test number of the respective
analysis test.
Sample Judgment is made by the number of samples.

6. Set the interval (count) for performing QC analysis from the “Count” drop-down list.
7. Select “Yes” from the “Execute after Calibration” drop-down list when QC analysis is to be
performed after calibration (reagent blank or ACAL analysis) is performed.
8. Confirm the input values and select C o n f i r m ( F 1 ) .
The set contents are registered.

4-66
Configuring Tests AU480 User Guide
Version 1.0
Return to Main Table of Contents

4.9 Setting the Tests to be Checked

Check in advance if a value obtained using calculation expressions and multiple analysis items is
within a set range. If the check result is outside the range, an error flag (flag) is added to the analysis
result.
For each sample type, a maximum of 10 types of calculation expressions can be set. Values from the
patient information can also be used for the calculation expressions.

Setting the Tests to be Checked

Set the operation expression for the tests to be checked.
1. From the AU480 “Home” window select Menu List>Parameters>Misc.>Checked Tests to display
the “Misc.: Checked Tests” window.

2. Select E d i t ( F 1 ) .
The window changes to edit mode.
3. Select the name of the test to be checked from the “Checked Tests Name” drop-down list or enter
a new test name to check.
4. Select the sample type from the “Type” drop-down list.
5. Select the “Check Name” check box to make test checking effective. Input is possible for each
item.
6. Select the analysis items to be used in the calculation from the “Test Name” drop-down lists A to
E.

4-67
AU480 User Guide Configuring Tests
Version 1.0
 Return to Main Table of Contents

7. Select the type of constant from the “Constant Type” drop-down list “a” to “d” of.

Option Explanation
None This constant is not used.
Value A value is set.
Patient information 1 to 6 When the patient information is a value, selection is
possible.

8. When “Value” has been selected, any value up to nine characters (including sign and decimal
point) can be entered for “Constant”.
9. Enter any calculation expression for “Formula”. Usable characters: +, -, *, /, (, ), A, B, C, D, E, a,
b, c, d (up to 20 characters)
10. Enter the upper limit value and the lower limit value into “Check Range”. Up to 9 characters,
including sign and decimal point can be entered.
11. Select C o n f i r m ( F 1 ) .
The set contents are registered.

Changing the decimal places for the test check range

1. Select S e t D e c i m a l P l a c e s ( F 4 ) on the edit window of the “Checked Tests” window.
The “Set Decimal Places” window appears.

2. Select the number of decimal places from the drop-down list.

3. Select C l o s e .
The window is closed and the check range value is changed.
4. Select C o n f i r m ( F 1 ) .
The set contents are registered.

4-68
Configuring Tests AU480 User Guide
Version 1.0
Return to Main Table of Contents

4.10 Preventing Contamination

While this system is provided with sufficient washing capability, mutual contamination may occur in
samples that are easily effected, or in analysis items with high sensitivity. The washing conditions etc.
can be set to prevent such contamination.

When contamination prevention conditions are set, the analysis processing speed
may decrease. Set the reagent after consulting with the package insert, manufacturer,
or the sales agent, etc.
CAUTION

4.10.1 Preventing Contamination Between Items ....................................................4-70

4.10.2 Preventing Contamination Between Sample Types ......................................4-72
4.10.3 Setting the Contamination Prevention Conditions by Analysis Items ............4-73

4-69
AU480 User Guide Configuring Tests
Version 1.0
 Return to Main Table of Contents

4.10.1 Preventing Contamination Between Items

Set the easily effected items and the contamination prevention conditions.
1. From the AU480 “Home” window select Menu List>Parameters>Misc.>Contamination
Parameters>Contamination Prevention to display the “Contamination Parameters: Contamination
Prevention tab” window.

2. Select E d i t ( F 1 ) .
The window changes to edit mode.
3. Select the effected analysis item from the “Preceding Test Name” drop-down list.
4. Select the type from the ‘“Type” drop-down list.
5. Select the effected analysis item from the “Following Test Name” drop-down list.
6. Select the type from the ‘“Type” drop-down list.
7. Select the washing fluid from the “Reagent Probe Cleaner Kind” drop-down list.

Option Explanation
Water Washing method using deionized water in the same way as the normal method.
CLN-1 The washing fluid set to “Detergent-1” is aspirated and used for washing.
CLN-2 The washing fluid set to “Detergent-2” is aspirated and used for washing.

8. Select the wash count from the “Wash Count” drop-down list. 5 is the maximum count which can
be set.

4-70
Configuring Tests AU480 User Guide
Version 1.0
Return to Main Table of Contents

9. Select one of the following from the “Effective of water cleaning” drop-down list.

Option Explanation
Yes This option considers that no contamination exists when reagent other than
the preceding test, wash solutions or water is dispensed more than the
count specified at “Wash Count” before dispensing the following test.
No Using this option, the system dispenses the following test only after
dispensing the
specified washing fluid for the counts specified in the “Wash Count”, even
when reagent other than the preceding test, wash solutions or water is
dispensed more than the count specified at “Wash Count”.

10. Select whether the mix bar and the cuvette used for the preceding test name
are to be used or not from the “Same use” drop-down list.

Option Explanation
Yes The ones used for the preceding test name are not used.
No The ones used for the preceding test name are also used.

11. Select E x i t ( F 1 ) .
The set contents are registered.

The example below shows difference between when “Effective of water cleaning” is
set to “Yes” and when set to “Not effective”.
• Settings other than “No” are:
TIP
• Preceding Test Name: A
• Following Test Name: B
• Reagent Probe Cleaner Kind: CLN-1 or CLN-2
• Wash Count: 5
In these settings, test sequence of two samples that require seven test items, A, B, C,
D, E, F and G is as following. In this sequence, “w” is a cycle of cleaner washing.
• Effective of water cleaning is “Yes”:
First sample: B, A, C, D, E, F, G
Second sample: B, A, C, D, E, F, G
• Effective of water cleaning is “No”:
First sample: B, A, C, D, E, F, G
Second sample: A, C, D, E, F, G, w, w, w, w, w, B
This is one example, and test sequence possibly changes depending on the settings.

4-71
AU480 User Guide Configuring Tests
Version 1.0
 Return to Main Table of Contents

4.10.2 Preventing Contamination Between Sample Types

The sample probe washing method can be set when the sample type changes.
1. From the AU480 “Home” window select Menu List>Parameters>Misc.>Contamination
Parameters>Carry-over Prevention (Type Changes) to display the “Contamination Parameters:
Carry-over Prevention (Type Changes) tab” window. A list of sample type combinations and
washing methods is displayed.

2. Select E d i t ( F 1 ) .
The window changes to edit mode.
3. Select the wash count for the sample probe from the “Wash Count” drop-down list for each
washing fluid. The maximum count which can be set is 6.

Option Explanation
Detergent-1 The washing fluid set to “Detergent-1” is aspirated and used for washing.
Water Washing method using deionized water in the same way as the normal method.

4. Select C o n f i r m ( F 1 ) .
The set contents are registered.

4-72
Configuring Tests AU480 User Guide
Version 1.0
Return to Main Table of Contents

4.10.3 Setting the Contamination Prevention Conditions by

Analysis Items
The sample probe washing conditions for any analysis item can be set before or after analysis.
1. From the AU480 “Home” window select Menu List>Parameters>Misc.>Contamination
Parameters>Carry-over Prevention (Test) to display the “Contamination Parameters: Carry-over
Prevention (Test) tab” window. All analysis items and their sample probe washing conditions are
displayed.

2. Select E d i t ( F 1 ) .
The window changes to edit mode.
3. Select the sample probe wash count from the “Pre-Dispense Wash Count” and “Post-Dispense
Wash Count” drop-down list for each washing fluid for the respective analysis item. The maximum
count which can be set is 6.
4. Select C o n f i r m ( F 1 ) .
The set contents are registered.

4-73
AU480 User Guide Configuring Tests
Version 1.0
 Return to Main Table of Contents

4.11 Setting up Data Lists

This system has three types of formatted print layouts (list types). When the real-time print format is
set, analysis data is printed automatically during analysis.
Printer is an option.

4.11.1 Set the Basic Condition for Print

Edit the list
1. From the AU480 “Home” window select Menu List>System>Format>List Format>Basic Condition
and display the “List Format: Basic Condition tab” window.

2. Select E d i t ( F 1 ) .
The window changes to edit mode.

4-74
Configuring Tests AU480 User Guide
Version 1.0
Return to Main Table of Contents

3. To edit existing lists, select the list to be edited from the “List Name” drop-down list. The list
format is displayed on the right side.
4. To create a new list, enter the desired list name into “List Name” window.
5. Select the list format from the “Data Format” drop-down list.
Lists output by selecting list types are as follows.

List Type List Name

Table Type Work List, Pending List, Data List (Report), Abnormal List
Enumeration Type Data List (Report), Abnormal List, Data Log List (Report)
Data List Type Data List
Result(Fix) Type Data List (Report), Abnormal List, Data Log List (Report)
Result(Seq.) Type Data List (Report), Abnormal List, Data Log List (Report)
Repeat List Type Repeat Work List, Repeat Pending List
Repeat Data List Type Repeat Data List

6. Select O K .
7. Select or enter the required setting items by the list format.
8. Select P r i n t I n f o r m a t i o n to display the “List Format: Print Information tab” window.
9. Select the information to be printed in the list.
10. Select Te s t I t e m to display on the “List Format: Test Item tab” window.
11. Select the test items to be printed by selecting them in the test items list. Successively selecting a
particular test item, toggles the item between selected and deselected.
12. Select L a y o u t to display the “Format: Layout tab” window.
13. Specify or move the information to be printed and arrange the layout. For details on layout editing
method, refer to section “Layout editing” in section “4.11.1 Set the Basic Condition for Print” in this
chapter.
14. Perform layout corrections as required.
15. Select C o n f i r m ( F 1 ) .
The set contents are registered.

4-75
AU480 User Guide Configuring Tests
Version 1.0
 Return to Main Table of Contents

Set the format for real-time printing

When the format is set, real-time printing is performed automatically during analysis.
Print formats must be defined to be available for selection in the Real-time List drop down menus. If
no suitable list type exists for a result function, the drop down menu is inaccessible.
For details on print format setting, refer to “Edit the list” in section “4.11.1 Set the Basic Condition for
Print” in this chapter.
1. From the AU480 “Home” window select Menu List>System>Format>List Format>Basic Condition
to display the “List Format: Basic Condition tab” window.

2. Select E d i t ( F 1 ) .
The window changes to edit mode.
3. Select Re a l t i m e L i s t ( F 5 ) .
The “Realtime List” window appears.

4. Select the print format from the “Patient”, “Calibration”, “Reagent Blank” and “QC”.

• Analysis data of specified sample types can be forcibly output to the printer (Option)
if corresponding check boxes are selected on the "Quick Output". This function is
recommended for immediate confirmation of the analysis data on printed pages.
TIP
• Selection of "Quickly" check box enables outputting analysis data of urgent test
items, for example, ISE items, at an early stage before outputting all test results in
case STAT samples are analyzed.

5. Select O K .
The “Realtime List” window is closed.
6. Select C o n f i r m ( F 1 ) .
The set contents are registered.

4-76
Configuring Tests AU480 User Guide
Version 1.0
Return to Main Table of Contents

Layout editing
1. From the AU480 “Home” window select Menu List>System>Format>List Format>Layout to
display the “List Format: Layout tab” window.

2. Select E d i t ( F 1 ) .
The window changes to edit mode.
3. Select “Page Header”, “Sample Information”, “Item Information”, “Line”, and “Comment” from the
“Print Info.” drop-down list.
4. Select C o n f i r m .
The window changes to print layout editing mode.
5. Specify the layout field coordinates by row and column of “Start Position”.
6. Select C o n f i r m .
The print information for output is displayed in the specification position.
7. Repeat steps 3 to 6 for each layout information to be printed.
8. Select C o n f i r m ( F 1 ) .
The set contents are registered.

4-77
AU480 User Guide Configuring Tests
Version 1.0
 Return to Main Table of Contents

4.12 Setting the test requisition format

The purpose of this section is to set the parameters to be entered on the Demographics tab window of
test requisition. The comments registered in the Comment Master Demographics can be used. Set the
Comment Master beforehand.
4.12.1 Setting the test requisition format...................................................................4-78
For details on comment master, refer to section “7.6 Using Comment Master” in chapter 7.

4.12.1 Setting the test requisition format

1. From the AU480 “Home” window select Menu List>System>Format>Requisition Format to display
the “Requisition Format” window.

2. Select E d i t ( F 1 ) .
The window changes to edit mode.
3. Select the parameters to be used sample ID, sex, age, etc.
4. When the sample ID is used, enter the “Digit” with 4 to 24.
5. When the patient information is used, select “Enable”. The Attribute and the following become
editable.
6. Enter Title in 20 digits or less. This title is displayed on the “Demographics tab” window of test
requisition.
7. Select Attribute (1 to 6) from the “Comment Master Selection” drop-down list.
(This “Attribute” is an attribute assigned to each comment in the Comment Master. Group
of the comments set to the same attribute (1 to 6) is displayed in the drop-down list of the
“Demographics tab” window of test requisition.)

4-78
Configuring Tests AU480 User Guide
Version 1.0
Return to Main Table of Contents

8. To download the patient information via online, select attribute (numeric character or alphabetical
character) from the “Attribute” drop-down list, and enter Digits. Maximum digit number is 20.
The title in step 6 above can be displayed on the table title (A and B in the figure below) on
“Sample Status” window (Home > Sample Status).

A B

9. Select attribute (None, 1 to 6) from the drop-down list of Representation-1 and Representation-2.

Settings of Representation-1 and -2

Representation-1 Other than None Other than None
Representation-2 None Other than None

Display of A and B in the settings above

A Sample No. (No change) Attribute title of Representation-1
B Attribute title of Representation-1 Attribute title of Representation-2

10. Select C o n f i r m ( F 1 ) .
Settings are registered.

4-79
AU480 User Guide Configuring Tests
Version 1.0
 Return to Main Table of Contents

4-80
Configuring Tests AU480 User Guide
Version 1.0
Return to Main Table of Contents

5
Preparing for Analysis

This chapter describes and illustrates how to prepare the system for
use.

Contents
5.1 Starting the System ......................................................................................................5-2
5.1.1 Switching on the System .................................................................................5-2
5.1.2 Logging into the System ..................................................................................5-3
5.1.3 Updating Index.................................................................................................5-4
5.2 Performing System Preparation ..................................................................................5-6
5.2.1 Confirm the Analyzer Status and the Reagent ................................................5-6
5.2.2 Check the Printer (Optional) and Paper ..........................................................5-7
5.2.3 Performing Daily Maintenance ........................................................................5-8
5.2.4 Preparing for ISE (Optional) ............................................................................5-9
5.3 Preparing the Reagent.................................................................................................5-15
5.4 Preparing Samples for Analysis . ..............................................................................5-19
5.4.1 Attaching Barcode Labels to Sample Racks .................................................5-19
5.4.2 Sample Barcode Specifications . ...................................................................5-20
5.4.3 Sample Cup Preparation ...............................................................................5-23
5.4.4 Applying Barcode Labels to Sample Cups ....................................................5-25
5.4.5 Sample Preparation . .....................................................................................5-26
5.4.6 Placing the Sample Cups/Tubes in the Rack ................................................5-27
5.4.7 Placing Racks on the Feeder.........................................................................5-32
5.5 Calibrating Tests .........................................................................................................5-34
5.6 Performing Quality Control (QC) ...............................................................................5-38
5.7 Sample Requisitions: Entering Data and Choosing Tests . ....................................5-42
5.7.1 Group Setting ................................................................................................5-43
5.7.2 Entering Manual Requisitions . ......................................................................5-45
5.7.3 Entering Batch Requisitions ..........................................................................5-46
5.7.4 Downloading Requisitions from a Host Computer . .......................................5-48
5.7.5 Entering Requisitions for Emergency Samples .............................................5-49
5.7.6 Delete Requisition..........................................................................................5-49

5-1
AU480 User Guide Preparing for Analysis
Version 1.0
 Return to Main Table of Contents

5.1 Starting the System

This section describes how to start the AU480.
5.1.1 Switching on the System .................................................................................5-2
5.1.2 Logging into the System ..................................................................................5-3
5.1.3 Updating Index.................................................................................................5-4

5.1.1 Switching on the System

There are two power switches on this system:

• The main power switch, which is the single power switch for the whole system, is located on
the right side of the system. Before the system is used for the first time, turn on the main power
switch and leave the switch on permanently while the system is in use.

• The ON button is located on the front of the system. This button controls power to the analyzer.
The ISE (option) does not have an O N button. The ISE (option) is automatically switched on when
the system starts up.

Switching on the System

1. Open the main deionized water supply valve.
2. Perform maintenance inspections. For details on maintenance inspections performed before
power on, refer to section “2.3 System Labels and Displays” in this chapter.
3. Press the O N button to power up the system. It takes approximately 20 minutes from the
initialization of the software to switch to standby mode. When starting up from an E M S TO P
it takes approximately 105 minutes to switch to standby mode.
4. Perform maintenance inspections. For details on maintenance inspections performed after power
on, refer to section “2.3 System Labels and Displays” in this chapter.

The Analyzer using Automatic Startup Function

The AU480 can start up at a specified time by setting the Automatic Startup Function. For details for
setting start up time, refer to "7.1 Using the Automatic Startup Function" in chapter 7.
If auto preparation is set when the analyzer performs automatic startup, the window displays the
performance progress.

5-2
Preparing for Analysis AU480 User Guide
Version 1.0
Return to Main Table of Contents

5.1.2 Logging into the System

The system can be set up with a security system that allows access to different parts of the system
according to preset user security levels. Once established, users must have a user name and
password, from the system administrator, before they can log in. Keep user passwords secret. Menus
that are inaccessible are greyed out. When the system is started, the login box appears automatically.
For details on system use authority setting, refer to section “7.2 Setting a User Login” in chapter 7.
To login:

Ask the system administrator to register a user name and a password.

The system cannot be used without a user name and a password.
For security reasons, use of the same user name and corresponding password by
CAUTION several users should be avoided.

1. Enter the “User Name”.

2. Enter the “Password”.
3. Select O K .
The “New Index” window appears.
4. Enter a new index as needed.
Refer to “5.2.4 Preparing for ISE (Optional)” in chapter 5.
5. Select O K .
The “Home” window appears.

5-3
AU480 User Guide Preparing for Analysis
Version 1.0
 Return to Main Table of Contents

5.1.3 Updating Index

To make large data easier for the retrieval, display, and output, the system can manage the group of
analyzed data with indexes for certain periods of time.
Each index is identified by the information of date and time set on data creation.
New indexes should be created regularly (usually daily).
The “New Index” window is displayed at system startup.

Set the index and group of tests, then select O K .

• Data index: this is a date and time used to label a set of test data.

• Group number: this indicates which group to be used. A group is a preselected set of tests.
When choosing a group, make only those tests available for use. Refer to section “4.4.3 Adding
the New Test to a Group” in this chapter.

The “New Index” window automatically sets names of indexes created by date and
time information of the window startup. If users set the date and time, use the drop-
down list.
TIP When the system is powering up, if the indexes and group of tests require
modification, the indexes and group of tests can be modified on the “Start Condition”
window.

Setting the Start Condition

The following items can be also set on the “Start Condition” window besides indexes and group of
tests set on the “New Index” window.

• Operator name.

• Start numbers of the samples to be tested, including “serum”, “urine”, “others-1”, and “others-2”.

5-4
Preparing for Analysis AU480 User Guide
Version 1.0
Return to Main Table of Contents

To change the start condition data after startup:

1. From the AU480 “Home” window select Menu List>Routine>Start Condition to display the “Start
Condition” window.

2. Select E d i t ( F 1 ) on the “Start Condition” window.

3. Enter the new starting data as required.
4. Select C o n f i r m ( F 1 ) to save these settings.
• Index can be set at any date or time.
Select I n d e x d a t e a n d t i m e ( F 8 ) .

TIP • Initial value of Start Sample No. can be set.

It is easy to set a different start sample No. on each system when using several
systems.
Select D e f a u l t S t a r t s a m p l e N o . ( F 7 ) .

5-5
AU480 User Guide Preparing for Analysis
Version 1.0
 Return to Main Table of Contents

5.2 Performing System Preparation

Before the selection of test items and preparation of samples, confirm the system status using the
following procedures.
5.2.1 Confirm the Analyzer Status and the Reagent ................................................5-6
5.2.2 Check the Printer (Optional) and Paper ..........................................................5-7
5.2.3 Performing Daily Maintenance ........................................................................5-8
5.2.4 Preparing for ISE (Optional) ............................................................................5-9

5.2.1 Confirm the Analyzer Status and the Reagent

The “Analyzer Status” window displays the reagent refrigerator temperature, the liquid quantity in each
tank, the rack status in the rack supply unit, etc.
When ISE (option) is installed, an outline of the ISE status is also displayed.
The remaining reagent quantity is displayed on the “Reagent Management” window.

Confirmation of the “Analyzer Status” window

Select A n a l y z e r S t a t u s on the “Home” window.
The “Analyzer Status” window is displayed.

For details on the “Analyzer Status” window, refer to “Check the Analyzer Status” in section “6.2
Monitoring Analysis” in chapter 6.

5-6
Preparing for Analysis AU480 User Guide
Version 1.0
Return to Main Table of Contents

5.2.2 Check the Printer (Optional) and Paper

If the printer runs out of paper during analysis or if the power to the printer is turned off, a printer error
will result. While a printer error exists, the data transferred to the printer will not print.

Check the Printer

Before starting daily analysis, be sure to check the printer.
1. Check that the printer power indicator is lit. If the indicator is not lit, press the Printer’s power
button.
2. Check that the “Print-enable” LED is lit. If the LED is not lit, press the “Printer’s enable” button.
If the “Print-enable” LED will not light by pressing the “Print-enable” button, a problem may have
occurred in the printer. After clearing the problem, press the “Print-enable” button again.
3. Check that the printer paper is correctly loaded and a sufficient amount of paper remains. If the
printer paper is not loaded correctly, reload it.

5-7
AU480 User Guide Preparing for Analysis
Version 1.0
 Return to Main Table of Contents

5.2.3 Performing Daily Maintenance

Periodic maintenance of the various system parts is required to maintain system performance.
Inspect and perform Daily Maintenance to ensure system performance and safety.
In addition to Daily Maintenance, any Weekly Maintenance, Maintenance Every Two Weeks, Monthly
Maintenance, Maintenance Every Three Months, Maintenance Performed Every Six Months and
Yearly Maintenance should be performed in the periodic time frame.
The maintenance intervals for the system are based on analysis of approximately 100 samples per
day. Depending on the number of samples analyzed daily and the environment conditions, the periodic
maintenance intervals may be shortened.

Before the power is ON

• Check sample syringe and reagent syringe for any leaks

• Check the wash solution roller pump unit any leak.

• Check the quantity of wash solution in the concentrated wash solution tank.

• Check the ISE (Option) reagent syringe for leaks.

After the power is ON

• Check and wash sample probe, reagent probe, and mix bars

• Check the Printer (Option) and Paper

• Check the quantity of liquid in the buffer solution container, MID solution container, and REF
solution container (each when ISE is installed)
For details on performing daily maintenance inspections, refer to section “8.3 Daily Maintenance” in
chapter 8.

To prevent injury or infection be sure to wear rubber gloves and other protective
equipment when performing maintenance.
For additional protection, observe the “WARNING” and “CAUTION” statements in this
CAUTION user guide.

5-8
Preparing for Analysis AU480 User Guide
Version 1.0
Return to Main Table of Contents

5.2.4 Preparing for ISE (Optional)

When using the ISE unit (option), prepare the standard solution for ISE or the control serum. Use
R E S E T button to turn power on for ISE drive, such as roller pump unit. Use O N (sub-power)
button to turn power on for ISE data processing unit.

Commercial Control Serum for the ISE (optional)

Take the following points into consideration when using the commercial control serum for the ISE.

• Commercial control serum contains additives for regulating the density of components, as
well as various preservatives. If these kinds of control serums are measured using an ion-
selective electrode, the added materials may adversely affect the electrode, and could cause
measurement errors including abnormal data.

• The commercial control serums that Beckman Coulter recommends are listed in the following
table. Changes in added components (especially preservatives) are likely.
Recommended Control Serums

Control serum Manufacturer

AU control level 1 Beckman Coulter Biomedical
AU control level 2 Beckman Coulter Biomedical

The following items affect the measurements:

• Errors may occur in normal samples depending on the amount dispensed.

CAUTION • The K and Cl electrodes are not affected by bilirubin, but small positive errors will
occur in the Na electrode.

• Positive errors will occur in the Cl electrode due to other halogen ions (Br, I).

• A positive error will be recognized in the K electrode for samples where the
hematocrit value is 65% or more. If a hemolytic sample is used, K shows an
excessively positive error.

• The measurements are not affected by ascorbic acid or lipemic (lipid emulsion
additives).

• Use the anticoagulant heparin Li or heparin Na. Any other anticoagulants may
cause an error in measured values. Use the anticoagulant immediately after
collecting blood.

• In order to prevent fluctuations due to the sample evaporation, blood serum and
plasma samples should be kept in a tightly-closed refrigerator. Also, samples
stored in a refrigerator should be measured after the temperature of the sample
has returned to room temperature.

5-9
AU480 User Guide Preparing for Analysis
Version 1.0
 Return to Main Table of Contents

Starting the ISE (option)

After starting the ISE, perform ISE Calibration.
1. Perform the procedure described in “5.1 Stating the System” in this chapter.
2. Open the front door.
3. Check that the liquid level of the solution in each of the following tanks is above the reference line
indicated 3 cm above the bottom of the tank.

• Buffer solution tank

• MID. solution tank

• REF. solution tank

An insufficient liquid alarm is generated when the level drops below the 3 cm line. After the alarm,
about 180 samples of MID. solution, about 600 samples of REF. solution, and about 240 samples of
Buffer solution can be dispensed.
For information about supplying the reagents, refer to “ISE User Guide”.

REF solution tank

MID solution tank

Buffer solution tank

ISE reagent syringe

5-10
Preparing for Analysis AU480 User Guide
Version 1.0
Return to Main Table of Contents

4. Inspect the ISE syringe and verify that reagent is not leaking. For information about inspecting the
ISE reagent syringe for leaks, refer to “ISE User Guide”.
5. Close the front door.
6. Open the STAT table cover (s).
7. Rotate the STAT table so that the positions of “S-H”, “S-L”, “U-H”, and “U-L” can be accessed by
pressing the TABLE ROTATION/DIAG button.

When setting the ISE standard solution on the STAT table, be careful not to mistake
the LOW and HIGH positions. If the solution is not set properly, appropriate analysis
results will not be obtained.
CAUTION

8. Dispense 1 mL of the ISE standard solution for serum and urine in the supplied HITACHI cups
and set them in the inner slot circle of the STAT table. For blood serum, standard solution “H”
should be set in the hole “S-H” and standard solution “L” should be set in hole “S-L”, and for
urine, standard solution “H” should be set in hole “U-H”, and standard solution “L” should be set in
hole “U-L”.
9. Close the STAT table cover (s).

5-11
AU480 User Guide Preparing for Analysis
Version 1.0
 Return to Main Table of Contents

Performing ISE Calibration

After analysis is started or if BUSY is displayed on the “ISE Maintenance: Calibration”

window, do not add the standard solution. Do not place the hand on the trace of the
sample probe.
CAUTION The ISE calibration takes the following time to update the calibration data.
Serum only: 4 minutes approx.
Urine only: 4 minutes approx.
Serum and urine: 7 minutes approx.

1. Check that the main cover and ISE cover are completely closed.
2. From AU480 “Home” window select Menu List>Maintenance>User Maintenance>ISE
Maintenance>Calibration to display the “ISE Maintenance: Calibration tab” window.

3. Select S e r u m / U r i n e s t a r t . To analyze just the serum, select S e r u m s t a r t , or to

analyze just the urine, select U r i n e s t a r t .
A window to start the calibration process will be displayed.
4. Select O K .
The ISE calibration process begins.
After processing has finished, the results are displayed in a list.

5-12
Preparing for Analysis AU480 User Guide
Version 1.0
Return to Main Table of Contents

5. Check the calibration results for abnormal data.

After analysis is started or if BUSY is displayed on the “ISE Maintenance: Calibration”

window, abnormal values are highlighted in yellow. Perform calibration again. If the
slope value exceeds the range of the following upper and lower limits, or if the MID
CAUTION solution correction factor falls outside the range of the following normal region, as the
result of calibration, check the ISE status to eliminate the cause of the anomaly, then
perform calibration again.
• Slope value

Lower limit Upper limit

Na, K 38.0 68.0
Cl -68.0 -38.0
• MID solution correction factor

Normal range
Na, K, Cl 0.800 to 1.200

For details on checking the ISE status, refer to section “6.15 Confirming the ISE (optional) status” in
chapter 6.

5-13
AU480 User Guide Preparing for Analysis
Version 1.0
 Return to Main Table of Contents

Performing ISE CRS Calibration

After analysis is started or if BUSY is displayed on the “ISE Maintenance: CRS

Calibration” window, do not add the standard solution. Do not place hands near or on
the trace of the sample probe.
CAUTION
The ISE CRS calibration takes approximately 6 minutes.

1. Check that the main cover and ISE cover are completely closed.
2. From AU480 “Home” window select Menu List>Maintenance>User Maintenance>ISE
Maintenance>CRS Calibration to display the “ISE Maintenance: CRS Calibration tab” window.

3. Select S t a r t .
The “CRS calibration” window opens.
Enter the standard solution value.
Select O K .

5. The ISE CRS calibration process begins. After processing has finished, the results are displayed
in a list.
6. Check the calibration results.

The ISE CRS calibration can be used the standard solution of two or three
concentrations. For setting the type of standard solution, contact Beckman Coulter
TIP Technical Services.

5-14
Preparing for Analysis AU480 User Guide
Version 1.0
Return to Main Table of Contents

5.3 Preparing the Reagent

The remaining reagent quantities are displayed on the “Reagent Management” window.

Reagent confirmation
1. From the AU480 “Home” window select Menu List>Routine>Reagent>Reagent
Management>Main to display the “Reagent Management: Main tab” window.

2. Select Re a g e n t C h e c k ( F 5 ) .
The “Reagent Check” window appears.

3. Select “Check all positions”.

4. Select “Read Reagent ID”.
5. Select S t a r t .
Reagent check starts. During the reagent check, "Checking" is displayed on the window. After
check completion, "Reagent check completed" is displayed.

5-15
AU480 User Guide Preparing for Analysis
Version 1.0
 Return to Main Table of Contents

6. The background color for the columns "Reagent Status" indicates an error status such as "No
remaining reagent", "No bottle", etc. for the reagent refrigerator. In case of orange indication,
confirm the "Reagent Management: Details" window. For details for the "Reagent Management:
Details" window, refer to "6.16 Managing Reagent Condition" in chapter 6.
7. If there is no remaining reagent, no bottle, etc., add a reagent bottle and repeat the reagent
check.

8. After completion of confirmation, Select C l o s e .

Reagent replacement
If the reagent volume is insufficient, remove the old reagent bottles and replace with a new set. Never
add new reagent to existing bottles.

Reagent preparation
Prepare reagent bottles with the reagents corresponding to the test items.
There are three types of reagent bottles that can be used with this system.

• 60 mL reagent bottle

• 30 mL reagent bottle

• 15 mL reagent bottle

Setting reagents into the reagent refrigerator

• Condensation can form on the walls of the reagent compartment in the bottle neck
or label area. If condensation is present, remove it using a dry paper towel.

WARNING • When using 15 mL bottles, ensure they are placed in the Reagent Tray with the
barcode facing out. Setting the bottles incorrectly may damage the bottle and
reagent probe.

• Verify that no bubbles exist in the bottles placed in the Reagent Tray. Bubbles
in the reagent may adversely affect reagent volume measurement and volume
aspiration.

For the following, make sure to set adapter:

• To set 15 mL reagent bottles outside the Reagent Tray.

CAUTION • To set 15 mL or 30 mL reagent bottles inside the Reagent Tray.

If an adapter is not used the reagent bottle will not be securely set. When setting
adapter, make sure to insert properly in reagent tray.

5-16
Preparing for Analysis AU480 User Guide
Version 1.0
Return to Main Table of Contents

A maximum of 76 bottles can be set to the reagent refrigerator.

When using 60 mL bottles a maximum of 38 can be set.
1. Open the main cover.
2. Lift and remove the reagent refrigerator lid.

Reagent refrigerator lid

Reagent bottle Reagent bottle

(15 mL) (30 mL)
Reagent bottle
(60 mL)

Partition Plate
Adapter

3. Set reagent bottles.

4. Replace the reagent refrigerator cover.
5. From the AU480 “Home” window select Menu List>Routine>Reagent>Reagent
Management>Main to display the “Reagent Management: Main tab” window.
6. Check the remaining reagent quantity.

When the barcode label on a reagent bottle is dirty or has moisture on it, barcode
reading errors can occur. Check the barcode label of the reagent bottle.
If the barcode label is dirty or has moisture adhering to it, wipe it off.
CAUTION

5-17
AU480 User Guide Preparing for Analysis
Version 1.0
 Return to Main Table of Contents

Cautions for use of commercial reagent bottles

When using commercial reagent bottles, lighter-colored bottles may not be detected
properly by the sensor. If this happens, apply the labels of the standard accessory to
the consumable reagent bottle as shown in the figure below. If the labels have been
CAUTION used up, order new MU9879 labels.
When using commercial reagent bottles, the remaining reagent volume displayed on
the window may differ from that actually remaining.
If stains or water drops are on the barcode label on the reagent bottle, a barcode read
error may result. If this occurs, check the barcode label on the reagent bottle and
thoroughly remove any stains or water drops.

Reagent bottle

Label

Precautions in Filling a Reagent Bottle with Reagent or Wash Solution

Observe the following precautions when handling reagent bottles.

• If a reagent bottle is fully filled with reagent or wash solution, the reagent or wash solution will
froth up. This may cause a detection error.

• When filling the reagent bottle with reagent or wash solution, do not exceed the top graduation
of the scale on the bottle.

• Verify that no bubbles exist in the bottles.

Top graduation

5-18
Preparing for Analysis AU480 User Guide
Version 1.0
Return to Main Table of Contents

5.4 Preparing Samples for Analysis

This section explains the following:
5.4.1 Attaching Barcode Labels to Sample Racks .................................................5-19
5.4.2 Sample Barcode Specifications . ...................................................................5-20
5.4.3 Sample Cup Preparation ...............................................................................5-23
5.4.4 Applying Barcode Labels to Sample Cups ....................................................5-25
5.4.5 Sample Preparation . .....................................................................................5-26
5.4.6 Placing the Sample Cups/Tubes in the Rack ................................................5-27
5.4.7 Placing Racks on the Feeder.........................................................................5-32
Before starting analysis, place samples in the sample cups and place them in the correct racks. The
method of preparing samples and racks differs in each laboratory and depends on local preferences.

5.4.1 Attaching Barcode Labels to Sample Racks

Without a barcode ID the system will not process a rack. Attach barcode labels to sample racks. (Units
mm)
1. Attach rack ID labels to the white, red, yellow, green, orange, and blue racks.

2. Attach the rack ID label to the front of the rack so that it is perfectly perpendicular.
Rack front
The label should not stick out 1±1
from the rack.
Rack ID label
(Stick the label on the rack in The label should not stick
parallel with the side face.) out from the rack.
1234

+1
0 0 The label cannot be
placed on the protruding
part of the rack.
Orient the label so the numbers
are located to the left if viewed
from the front. Rack side

Protruding part of the rack

5-19
AU480 User Guide Preparing for Analysis
Version 1.0
 Return to Main Table of Contents

5.4.2 Sample Barcode Specifications

Analysis can be performed using a barcode as the sample ID. These are the specifications of the
barcodes used to identify AU480 samples.

• Barcode type

• Character types

• Barcode digits

• Label dimensions

• Bar dimensions

• Check character

• Label quality

Barcode type
The sample barcode types are shown below.

• NW-7

• CODE 39

• CODE 128, ISBT-CODE 128

• I 2 of 5, S 2 of 5
Except for the ISBT-CODE 128, mixed reading of multiple codes is possible.

The barcode specifications conform to the following standards.

Barcode Observed standard

NW-7 JIS-X-0506, USS-NW7
I 2 of 5 JIS-X-0502, USS-I2/5
CODE 39 JIS-X-0503, USS-CODE 39
CODE 128 JIS-X-0504, USS-CODE 128
ISBT 128 ISBT 128

Character types
Barcode Character types
NW-7 0 to 9
CODE39 Alphanumeric characters, special symbols
CODE128 Alphanumeric characters, special symbols
ISBT-CODE128 Alphanumeric characters, special symbols
I2 of 5 0 to 9
S 2 of 5 0 to 9

5-20
Preparing for Analysis AU480 User Guide
Version 1.0
Return to Main Table of Contents

Barcode digits
Maximum 26 digits

Label dimensions
The sample labels should have the following dimensions. (Units: mm)

• Label length (A) < Test tube length -(5 + Y)

Y = 36 or
*7: Part hidden by rack insertion, or,
5: Upper and lower margin at the time of label attachment
(numbers marked with an asterisk (*) are for use of a rack.)

• Label width (B): Not regulated. However, the bars shall not be covered by wrapping around the
test tube.

• Barcode height (D) >= 10mm

• Right/left margin (M) = Shown below

Other than CODE 128: 3mm or more

CODE 128: 10 times the X dimension or 2.54, whichever is larger, or more (quiet zone)

• Barcode part(C) = A - (2 x M)
A

D B

C
M M

Bar dimensions
The bar space width is as shown below.

NB NS WB WS G X
(Narrow bar) (Narrow space) (Thick bar) (Wide space) (Gap) (Dimension)*
Minimum 0.165 to 0.2 mm 2.2 to 3.0 NB 2.2 to 3.0 NB NB to 3.0 NB
NB to 1.25 NB 0.191 and up
Maximum 0.2 to 0.5 mm 2.0 to 3.0 NB 2.0 to 3.0 NB NB to 3.0 NB

• In case of CODE128

5-21
AU480 User Guide Preparing for Analysis
Version 1.0
 Return to Main Table of Contents

Check character
One of the following three methods can be used as a check:
(1) Using the check methods of the following table. (Yes w/CHK CHR)
(2) Not using check characters. (No w/ No CHK CHR)
(3) Check characters are included, but no checking is done. (No w/CHK CHR)
Barcode Check character method
NW-7 Last digit, MODULUS-16
CODE39 Last digit, MODULUS-43
CODE128 Last digit, MODULUS-103
ISBT-CODE128
I2 of 5, S 2 of 5 Last digit, MODULUS-10

Check character is required for CODE128 and ISBT-CODE128.

When these barcodes are used, method 2 or 3 cannot be selected in the character check method
above.

Label quality
Barcode labels should be printed using the following standards to maintain reading accuracy.

• PCS value When NB (narrow bar) is 0.165 to 0.50 mm: A PCS value of 0.60 or more is required.
When NB (narrow bar) is 0.130 to 0.156 mm: A PCS value of 0.85 or more is required.
PCS value = (RL – R0) / RL
RL: Reflectance of white bars and margins
R0: Reflectance of black bars

• Reflection ratio of white bar and margin is 70% or more.

• There shall be no scratches, dropped patterns, blurring, voids (black points) or blemishes with a
diameter of 0.1 mm or more on a white bar.

5-22
Preparing for Analysis AU480 User Guide
Version 1.0
Return to Main Table of Contents

5.4.3 Sample Cup Preparation

For Specifications for sample cups that can be used on this system, refer to "2.2.2 System
Specifications" in chapter 2.
Benoject II sample cups cannot be used because of interference with the sample cups lid parts and do
not comply to the specifications for this system.
When barcoded sample cups are inserted into the rack, use sample cups where the outer diameter
with attached barcode label is 16.0 mm or less at the upper part of the rack.
Barcode label
Top view
φ16.0mm or less
Sample cup (outside diameter including
the barcode label)

Rack
Barcode label

Rack top

5-23
AU480 User Guide Preparing for Analysis
Version 1.0
 Return to Main Table of Contents

• Use sample cups that comply to the specifications for use in the rack where they
are set. When a sample cup does not satisfy the specifications for use, analysis
may not be performed.
CAUTION
• Depending on the height of sample cups, 5 points of the lowest points of probe
can be set. When performing the setting, the following 5 types of sample cups are
available to use.
• Hitachi cup (or ACA cup)
• 75 mm tube
• 75 mm tube + Hitachi cup
• 100 mm tube
• 100 mm tube + Hitachi cup

• If a sample cup with a lower bottom position is used, sample may not be
aspirated, or the dead volume may increase.
Also, if a sample cup with a different height is used, wrong types of cup may be
aligned.

Sample probe

Most shallow
sample cup

Lower point
of the sample
probe

Dead volume

5-24
Preparing for Analysis AU480 User Guide
Version 1.0
Return to Main Table of Contents

5.4.4 Applying Barcode Labels to Sample Cups

Attach barcode labels to the outside of the sample.
To apply barcode labels:
1. Affix the barcode labels onto the outside of the sample cup so the end of each label is at least 7
mm from the bottom of the cup.
2. Rub the label gently using a finger to ensure that it is firmly attached and will not peel off.
The inclination angle must be 5° or less.

Sample cup

Barcode Label

NE Rack

7mm minimum

Barcode labels that are too long or too short might not be identified by the
barcode reader.
Barcode labels must not protrude from the top of a sample cup. The label must be
CAUTION positioned perpendicularly. The angle can vary by a maximum of 5°.

5-25
AU480 User Guide Preparing for Analysis
Version 1.0
 Return to Main Table of Contents

5.4.5 Sample Preparation

Ensure there is sufficient sample for analysis in addition to the dead volume. To display the volume
needed for the required tests, from the AU480 “Home” window select Menu List>Routine>Test
Requisition>Sample>Test Requisition. The sample volume required for requisitioned tests is displayed
at the bottom right hand side, this does not include the dead volume.
The minimum dead volume required for sample detection varies depending on the sample cup/tube.
If the serum or plasma level is too low, transfer the serum or plasma to a smaller sample cup, to avoid
blood cells being aspirated. For information on dead volumes for different cup/tubes and on setting
cup type, see “5.4.6 Placing the Sample Cups/Tubes in the Rack” in this chapter.

Pay attention to the following items. The analysis results can be affected and system
trouble may occur.
• The sample should not contain fibrous material or fibrin.
CAUTION
• Ensure that there are no air bubbles in the sample.

• Dispense samples in the quantity required for analysis plus the dead volume.
• HITACHI cup: Required volume + 50 µL or more
• φ12.3 mm tube: Required volume + 200 µL or more
• φ15.4 mm tube: Required volume + 250 µL or more
• HITACHI-micro cup (STAT only): Required volume + 30 µL or more
• Nested cup* (Rack only): Required volume + 180 µL or more, 1 mL or less
*Nested cup use only HITACHI cups
The above necessary sample amount includes remainder (5 mL) for each test
item in addition to the sample amount necessary for analysis. When analyzing 20
tests/sample or more, set the required sample amount + 200 µL (provisional) to
suppress dilution by sample probe wash water.
When containers used for centrifuging are set as samples and analysis is performed,
check that a quantity of serum sufficient for analysis and the dead volume required
for sample detection are present. The dead volume required for sample detection is
4 mm down from the serum surface in the sample cup. When the serum quantity is
small, perform analysis after moving the sample to a smaller sample cup. When the
serum quantity is small, blood cells below the serum may be aspirated and defective
dispensing etc. may occur.

5-26
Preparing for Analysis AU480 User Guide
Version 1.0
Return to Main Table of Contents

5.4.6 Placing the Sample Cups/Tubes in the Rack

The following section provides information on the correct use of sample cups and tubes on the AU480.
Barcode labels in bad condition may cause them to be read incorrectly.
Replace barcode labels if any of the following conditions are observed.
• The Barcode label is smudged, scratched, or damaged.
CAUTION
• The Barcode is stained or dirty.

• The Barcode label is torn or peeling.

Setting Sample Cups into the Rack

Prepared sample cups are set into the rack as follows.
1. Place each sample in the correct rack. Racks are color coded. Each color indicates a different
type of analysis. See “Setting the Sample Order” in this section.
2. Look at each opening in the rack and ensure the barcode is aligned in the center. 2 mm is the
most each barcode should deviate from the center. If a barcode label is not aligned with the
opening in the rack, lift it out and replace it correctly.
The rack ID label is
applied to this surface.
Barcode label

The rack ID label is

Sample cup
applied to this surface.

Rack

Direction that rack moves

+2mm
Center
-2mm

Barcode label
Correct Incorrect Incorrect

3. Fit a rack adapter if required.

5-27
AU480 User Guide Preparing for Analysis
Version 1.0
 Return to Main Table of Contents

4. If using an adapter on the rack, ensure the openings allowing barcodes to be scanned are
aligned.
For details on replacing the rack ID labels, refer to section “8.8.10 Replace Rack ID labels” in
chapter 8.

• Do not mix different sample types on the same rack. When using sequential
mode, place the samples on the racks in strict numerical order and with no empty
positions. Barcode and Rack ID modes permit spaces.
CAUTION
• Do not use Benoject-II type sample tubes, because the caps of adjacent sample
cups interfere with each other. Use only cups with an outside diameter of 16 mm
or less in the rack.

• Running the system in sequential mode (i.e. without reading sample barcode
ID) is not recommended. There is a possibility of sample/result mismatch. If
the system is ran without the sample barcode ID, please be aware of the risks
involved. Contact Beckman Coulter Technical Services for more information.

• Use only NE racks.

NE racks have a window on the side to facilitate setting different sample cup types in
the rack and not compromise barcode readability.
TIP

5-28
Preparing for Analysis AU480 User Guide
Version 1.0
Return to Main Table of Contents

Using Adapters on Sample Racks

Place adapters that hold thin sample cups (approximately 11.5 to 13.5 mm) firmly into place on the
racks. Thicker sample cups (approximately 13.6 to 16 mm) do not need an adapter. To ensure a tube
fits correctly, place the tube into a rack with and without an adapter and determine which option holds
the tube most securely.
To insert an adapter:
1. Align the adapter opening and the rack opening.
2. Insert the adapter guide into the guide groove of the rack.
3. Push the adapter into the rack until a click is heard.
4. Ensure the adapter has engaged the rack.
Adapter lock
Guide
Slit

Adapter

Rack window
Push in
Guide groove

1 2 3 4 5 6 7 8 9 10

Rack

Slit

Toremoveanadapter:
1. Push the adapter lock lightly with a finger from the outside of the rack window to disengage the
lock.
2. When the upper edge of the adapter comes out from the rack, pull it out the rest of the way.
Adapter lock

Rack window

Push up lightly
with a finger

5-29
AU480 User Guide Preparing for Analysis
Version 1.0
 Return to Main Table of Contents

Setting the Sample Order

Samples must be set in order according to their type.

Yellow rack
Place calibrators of known concentration in racks according to the assigned calibrator number.
The calibrator number (1 to 200) corresponds to the rack ID of the yellow rack and the sample position
(1 to 10). For example, a yellow rack with the rack ID 1 has calibrator Nos. and sample positions from
1 to 10, and a yellow rack with the rack ID 2 has calibrator Nos. and sample positions from 11 to 20.

White rack
Set the sample cups following the analysis mode.

• Sequential analysis
Set samples in numeric order.

• Rack ID analysis
Set the samples sequentially with “1” as the first digit or as the first contained in the sequence
number of the sample number in the rack. For example, 1, 11, 21. If using calculation use “rack
number ×10–9”.

• Barcode analysis
Setting is possible in any order.

• For sequential analysis, set the sample cups in sample number order and without
any gaps in the white rack. When setting is done with gaps, the sample number
set at the time of requisition and the sample number determined automatically
CAUTION from the setting position on the white rack will not coincide and analysis will not be
performed normally.

• In sequential analysis or rack ID analysis, set all sample cups with samples
registered by requisition for normal analysis.

Depending on the setting, serum and urine can be set on the same rack.
TIP

Blue rack
Set sample cups with deionized water on the blue rack. Setting of calibrator parameters makes it
possible to set what to install at the first and the second position.
For details on setting the setting positions for sample cups, refer to section “4.7 Set Calibration
Analysis” in chapter 4.

Green rack
Set the control samples in order of the control numbers set as parameter.
The control number (1 to 100) corresponds to the rack ID of the green rack and the sample position (1
to 10). For example, a green rack with the rack ID 1 has control Nos. and sample positions from 1 to
10, and a green rack with the rack ID 2 has control Nos. and sample positions from 11 to 20.
For details on setting the setting positions for sample cups, refer to section “4.8 Configuring QC
Analysis” in this chapter 4.

5-30
Preparing for Analysis AU480 User Guide
Version 1.0
Return to Main Table of Contents

Orange rack
Set the sample cups on the orange rack in order of the repeat run analysis sample Nos. according
to the contents of the repeat run analysis work list. Set the sample cups without gaps from the first
position of the orange rack.

Red rack
There are no special restrictions for the setting sequence and the positions of sample cups. Sample
Nos. for emergency samples are assigned automatically in setting order.
For example, when analysis is performed with sample cups set to positions 1, 3, and 5 of the rack, the
sample Nos. E001, E002, and E003 are assigned in this order.

When red racks are used for sequential analysis, use a worksheet etc. to confirm that
the measuring data corresponds to the set samples.
CAUTION

Rack preparation
Prepare racks for setting the sample cups.
There are six rack types for the various applications, and the racks have different colors.

Rack types
The racks have different colors according to the application. This system identifies the rack type
from the combination of magnets set into the rack bottom. The rack colors, applications, and magnet
combinations are shown below.

Color Rack application Magnet

White For general patient sample analysis. Entirely white racks are used for ← ● ○ ○
analysis of general patient samples. Depending on the setting, use is also
possible for calibration analysis and for QC analysis.
Blue For reagent blank analysis. Used for calculation of reagent blanks for ← ● ○ ●
creation of calibration curves.
Yellow Used for calibration for automatic calibration curve setting (ACAL). Used ← ● ● ○
for creation of calibration curves. ACAL automatically sets calibration
curves from standard serum or standard fluid.
Green For QC analysis. Used for analysis of QC samples. ← ○ ○ ●
Orange For repeat run analysis. The methods for repeat run analysis with this ← ● ● ●
system are a method using a STAT table and a method using orange
racks. When many repeat run samples are to be analyzed at the same
time, orange racks are used.
Red For emergency sample analysis. The methods for emergency analysis ← ○ ● ○
with this system are a method using a STAT table and a method using red
racks. When many emergency samples are to be analyzed at the same
time, red racks are used.

←: Rack advance direction ●: Magnet present

5-31
AU480 User Guide Preparing for Analysis
Version 1.0
 Return to Main Table of Contents

5.4.7 Placing Racks on the Feeder

Up to 8 racks can be placed on the feeder. Close the cover of the rack feeder immediately when racks
are placed on the feeder.

Never look directly into the barcode readers. The readers use lasers that can cause
serious eye damage.
CAUTION

To set racks on the feeder:

1. Open the sample protective cover on the rack supply unit.
2. Set the prepared racks on the rack supply unit Figure.

Sample
protection cover

Surface where the

Rack rack ID label is applied

Rack supply unit

Top view of the rack feeder

CAUTION Rack identification sensor (white board)

A A

Up to 8

Rack setting position

Place a rack more to the right position than the figure shows. The rack feeder
does not operate properly when it is placed on the position A.

5-32
Preparing for Analysis AU480 User Guide
Version 1.0
Return to Main Table of Contents

3. Arrange the racks in color order.

Set in order of smallest calibrator No.
Set the sample cup Set in order of
with distilled water. smallest control No. Set in any order

1
Direction that
racks move
10

10

10

10

10

10
Blue Yellow Green White White Red
rack rack rack rack rack rack

White rack
In case of sequential analysis, set in sample number order to the rack. In case of rack ID analysis or
barcode ID analysis, the setting order is free.

Yellow rack
Set to a yellow rack in increasing order of the calibrator number set by parameter. When several
yellow racks are required for creation of calibration curves, set the yellow racks one after the other.

Green rack
When several green racks are required for QC, set the green racks one after the other consecutively in
numerical order.

5-33
AU480 User Guide Preparing for Analysis
Version 1.0
 Return to Main Table of Contents

5.5 Calibrating Tests

Before starting analysis, perform requisition for calibration analysis.

Procedures for requisition for calibration analysis

1. From the AU480 “Home” window select Menu List>Routine>Rack Requisition>Calibration to
display the “Rack Requisition: Calibration” window.

2. Select S t a r t E n t r y ( F 1 ) .
3. Select the sample type to be analyzed from the “Type” drop-down list. A list of registered
calibration items is displayed.
4. In case of item selection from a profile, perform one of the following operations.

• Select P r o f i l e to open the profile window and select a profile.

• Using the keyboard enter a profile name in the Profile blank.

The calibration items registered in each profile are displayed additionally.

5. For automatic judgment of calibration item selection by the system,
Select A u t o C a l / Q C Re q u i s i t i o n ( F 3 ) .
The system judges automatically from the reagent check results. The display color of the item in
the list of calibration items changes. If this setting is OK, go to step 7.

5-34
Preparing for Analysis AU480 User Guide
Version 1.0
Return to Main Table of Contents

6. To change a calibration item, Select the column “CAL” or “RB” in the item list and add or change
as required.

• Selecting the column “RB”, only “Reagent Blank” is performed.

• Selecting the column “CAL”, “Calibration” and “Reagent Blank” are both performed.
7. When QC for the selected calibration item is to be performed at the same time,
Select Q C S a m e Re q u i s i t i o n ( F 4 ) .
8. Select E x i t ( F 2 ) to cancel or the E n t r y ( F 1 ) to register the set contents.
The display returns to the reference window.

Perform requisition for advance calibration

Perform setting for batch calibration for the items to be subject to advance calibration.
For details on advance calibration setting, refer to section “4.7.2 Set the Specific Calibration
Parameters” in chapter 4.

This function cannot be executed when no items for advance calibration have been
set.
Use only with the specific reagent that Beckman Coulter provides. For detailed
TIP information, contact Beckman Coulter Technical Services.

1. From the AU480 “Home” window select Menu List>Routine>Rack Requisition>Calibration to

display the “Rack Requisition: Calibration” window.
2. Select S t a r t E n t r y ( F 1 ) .
3. Select I n d i v i d u a l Re q u i s i t i o n ( F 3 ) .
The “Sequence Bottle Selection” window opens and the items subject to advance calibration and
the reagent bottle information are displayed.

4. Select the type from the “Type” drop-down list.

5. Look at the order for “Seq.”, “Onboard Expiration”, etc. to judge the bottle for which calibration
should be made, and select by Selecting the column “CAL” for items for which Calibration and
Reagent Blank should be performed or the column “RB” for items for which only Reagent Blank is
to be performed.
The display color of a Selected part changes. The selection can be cancelled by selecting again.

5-35
AU480 User Guide Preparing for Analysis
Version 1.0
 Return to Main Table of Contents

6. Select C a n c e l to cancel the input.

7. Select C l o s e .
The window is closed and a list of set values is displayed.
8. Select E n t r y ( F 1 ) to register the settings.

5-36
Preparing for Analysis AU480 User Guide
Version 1.0
Return to Main Table of Contents

Requisition for Calibration Analysis with STAT table

1. Select Menu List>Routine>STAT Requisition>STAT Status to display the “STAT Requisition: STAT
Status” window.

2. Select C a l i b ra t i o n .
The “Calibration” window appears.

3. Perform calibration analysis according to the instructions for requisitioning for calibration analysis
while performing rack requisition.
5-37
AU480 User Guide Preparing for Analysis
Version 1.0
 Return to Main Table of Contents

5.6 Performing Quality Control (QC)

Quality control (QC) samples are used to verify system performance and are an integral part of any
diagnostic device.
Check the performance of the AU480 regularly by analyzing QC samples. Each laboratory should
establish its own control frequency. QC samples should be tested each time patient samples are
tested and each time calibration is performed. If any trends or sudden shifts in values are detected,
review all operating parameters.
Each laboratory should also establish guidelines to ensure corrective action if controls do not recover
within the specified limits.

Requesting QC Analysis
To perform QC analysis, follow these steps:
1. From the AU480 “Home” window select Menu List>Routine>Rack Requisition>QC to display the
“Rack Requisition: QC” window.

2. Select the sample type to be analyzed from the “Type” drop-down list. A list of registered QC
items is displayed.

5-38
Preparing for Analysis AU480 User Guide
Version 1.0
Return to Main Table of Contents

3. When item selection is from a profile, perform one of the following operations.

• Select P r o f i l e to open the profile window and select a profile.

• Use the keyboard to enter into the Profile blank.

The QC items registered for each profile are displayed additionally.

4. Select the items for which QC is to be executed and perform addition or change.
5. Select S t a r t E n t r y ( F 1 ) and register the set contents.
6. Confirm the QC sample setting position.
7. Select D i s p l a y Q C S e t ( F 6 ) .
The “Controls Set Position” window opens.
8. Confirm the rack number of green racks, the setting position, and the set QC sample. In case of
barcode ID analysis, setting can be done at any position. Confirm the ID.
9. Select C l o s e .
The window is closed.

Perform requisition for QC analysis for advance calibration items

Set the items for QC analysis with advance calibration is to be performed. For details on advance
calibration setting.

This function cannot be executed when items for advance calibration have not been
set.
Use this function only with the specific reagent provided by Beckman Coulter. For
TIP detailed information, contact Beckman Coulter Technical Services.

1. From the AU480 “Home” window select Menu List>Routine>Rack Requisition>QC to display the
“Rack Requisition: QC” window.
2. Select S t a r t E n t r y ( F 1 ) .
3. Select I n d i v i d u a l Re q u i s i t i o n ( F 3 ) .
The “Individual Requisition” window opens and the items subject to advance calibration along
with the reagent bottle information are displayed.
4. Select the type from the “Type” drop-down list.
5. To select all items, Select S e l e c t A l l .
The display color changes for all items.
6. For item selection, judge after looking at the “Seq.” order, the “Onboard Stability”, etc., and select
by selecting the test name. The display color of a selected part changes. The selection can be
cancelled by selecting the part again.
7. Select C a n c e l to cancel the setting.
8. Select C l o s e .
The window closes and a list of setting is displayed.
9. Select E n t r y ( F 1 ) .
The set values are registered and the display returns to the reference window.

5-39
AU480 User Guide Preparing for Analysis
Version 1.0
 Return to Main Table of Contents

Running QC Analysis with Barcodes

QC analysis can be performed using barcodes on the QC sample tubes. These are placed in the
green rack in any order.

Setting the control ID (barcode) for QC samples

In order to perform QC analysis by barcode, the control ID of the QC sample must be set on the “QC
Parameters: Controls” window.
From the AU480 “Home” window select Menu List>Parameters>QC Parameters>Controls to display
the “QC Parameters: Controls” window.
For details on setting contents, refer to section “4.8.1 Requesting QC Analysis” in chapter 4.

QC control sample setting

Set the QC samples to a green rack.
From the AU480 “Home” window select Menu List>Routine>Rack Requisition>QC to display the “Rack
Requisition: QC” window. Set the racks by following “Controls Set Position” window displayed by
selecting “D i s p l a y Q C S e t ( F 6 ) ” on the “Rack Requisition: QC” window.
For details on sample setting order, refer to section “5.4.6 Placing the Sample Cups/Tubes in the
Rack” in this chapter.

5-40
Preparing for Analysis AU480 User Guide
Version 1.0
Return to Main Table of Contents

Performing Requisition for QC analysis with STAT table

1. Select Menu List>Routine>STAT Requisition>STAT Status to display the “STAT Requisition: STAT
Status” window.

2. Select Q C .
The “QC” window appears.

3. Perform the QC analysis according to the instructions for QC analysis at the time of rack requisition.
For details on requisition for QC analysis, refer to section “5.6 Performing Quality Control (QC)” in this
chapter.
5-41
AU480 User Guide Preparing for Analysis
Version 1.0
 Return to Main Table of Contents

5.7 Sample Requisitions: Entering

Data and Choosing Tests
Each time analysis is performed, information must be entered about the patient samples and tests
must be chosen to perform on them. This information is called a requisition.
The system uses these requisitions to process each sample.
An understanding of how the system recognizes each sample is important.
When performing analysis using the ISE unit (optional), the ISE tests (Na, K, Cl) should be selected in
the normal test requisition operation described in this section.

If the calibrator or QC sample are to be analyzed together with the normal patient
sample (sample in the white rack), it is necessary to perform the requisition operation
TIP for calibration or QC in addition to that for normal tests described in this section.

5.7.1 Group Setting ................................................................................................5-43

5.7.2 Entering Manual Requisitions . ......................................................................5-45
5.7.3 Entering Batch Requisitions ..........................................................................5-46
5.7.4 Downloading Requisitions from a Host Computer . .......................................5-48
5.7.5 Entering Requisitions for Emergency Samples .............................................5-49
5.7.6 Delete Requisition..........................................................................................5-49

5-42
Preparing for Analysis AU480 User Guide
Version 1.0
Return to Main Table of Contents

5.7.1 Group Setting

When a group is set in advance, multiple test items can be set together by specifying a group for
a sample. Switching to different test items is possible by changing the group. A maximum of three
groups can be set for this system.

“Group of Tests” window

Set a group name and test items for each group.
1. From the AU480 “Home” window select Menu List>Parameters>Common Test
Parameters>Group of Tests to display the “Common Test Parameters: Group of Tests” window.

2. Specify the group to be set.

Select from the “Group” drop-down list or with and buttons.
3. Select E d i t ( F 1 ) .
To edit the “Group” of “Output Order” column. If the group name is to be changed, enter a new
group name.

5-43
AU480 User Guide Preparing for Analysis
Version 1.0
 Return to Main Table of Contents

4. Select Te s t I t e m S e t t i n g ( F 5 ) .
The “Test Item Setting” window appears.

5. Select the item number of the test item to be set. “Selected status” and “Deselected status” are
switched alternately.
6. Select C l o s e .
The test item with the entered item number is set as the test item of the group and is added to the
list. The printing order is set in order of selection.

To change the printing order, Select the test item to be changed and move it by
Selecting Fo r w a r d ( F 2 ) or B a c k w a r d ( F 3 ) .
TIP

7. Select C o n f i r m ( F 1 ) .
The set test item is registered to the respective group.

For test items set as calculated test items, group specification as a test item is not
allowed.
TIP

5-44
Preparing for Analysis AU480 User Guide
Version 1.0
Return to Main Table of Contents

5.7.2 Entering Manual Requisitions

Perform Manual Requisitions, if the tests are different for each individual sample. Settings for the
sample type must also be entered along with patient information and tests for each of the samples:
1. From the AU480 “Home” window select Menu List>Routine>Rack Requisition>Sample>Test
Requisition to display the “Sample: Test Requisition tab” window. The test items registered to the
group displayed in the “Group” window are displayed as a list.

“Sample Volume(µL)” does not include the dead volume. Approximate values are
shown.
CAUTION

2. Select S t a r t E n t r y ( F 1 ) .
The window changes to edit mode.
3. When an item not in the present group is to be selected, select the “Change Group Display”
check box. The test items for all groups are displayed on the item list.
4. Select sample kind, sample number, and type.
5. Enter sample ID, sample dilution rate, etc. as required.
6. Select the test item in the item list. The display color of a Selected test item changes. The
selection can be cancelled by selecting the test item again.

5-45
AU480 User Guide Preparing for Analysis
Version 1.0
 Return to Main Table of Contents

7. When selecting from a profile, perform one of the following operations.

• Select P r o f i l e to open the profile window and select a profile.

• Use the keyboard to enter a profile name into the P r o f i l e . blank and press enter.
8. Select D e m o g ra p h i c s to open the “Demographics tab” window and enter the patient
information.
9. Confirm the entered information and Select E n t r y ( F 1 ) .
The entered item selection information is registered.

10. Repeat steps 3 to 9 for each sample.

11. Select E x i t ( F 2 ) .

5.7.3 Entering Batch Requisitions

To perform the same tests on a number of samples, enter the requisitions in a single batch. Patient
information is entered for one sample and then reused for every other sample in the batch.
To enter batch requisitions:
1. From the AU480 “Home” window select Menu List>Routine>Rack Requisition>Sample>Test
Requisition to display the “Sample: Test Requisition tab” window.

2. Select S t a r t E n t r y ( F 1 ) .
3. Set the test items for batch requisition for one sample. For details on setting method, refer to
section “5.7.2 Entering Manual Requisitions” in this chapter.

5-46
Preparing for Analysis AU480 User Guide
Version 1.0
Return to Main Table of Contents

4. Select B a t c h E n t r y ( F 3 ) .
The “Batch Entry” window appears.

5. Enter “Number of Samples” or “Last Sample No.”.

6. Select O K .
When the batch requisition has been performed with “Number of Samples”, the test items for
the number of samples specified by “Number of Samples” are registered as a batch from the
presently displayed sample number on.
When batch requisition has been performed with “Last Sample No.”, the test items for the
samples from the presently displayed sample number to the “Last Sample No.” are registered as
a batch.
7. Select E x i t ( F 2 ) .

5-47
AU480 User Guide Preparing for Analysis
Version 1.0
 Return to Main Table of Contents

5.7.4 Downloading Requisitions from a Host Computer

Instead of entering requisitions into the system manually, requisitions can be downloaded from a
clinical laboratory host computer system. Downloading can be:

• Realtime: the system downloads and executes requisitions automatically.

• Batch: the system waits for a user to instruct it to download and execute requisitions.
For information on how to configure these modes, refer to section “4.3 Entering Online Settings” in
chapter 4 and “Specification of Host Online”.
To download batch requisitions from a host computer:
1. From the AU480 “Home” window select Menu List>Routine>Rack Requisition>Sample>Test
Requisition to display the “Sample: Test Requisition tab” window.

2. Select B a t c h Re q . f r o m H o s t ( F 7 ) .
The “Batch Req. from Host” window appears.
3. Select the “Sample Kind” from the drop-down list.
4. Enter the start “Sample number” and end “Sample number” this becomes the object that triggers
the download requisition information for the sample.
5. Select O K .
The download starts. A message is displayed while downloading.
6. Press E x i t ( F 2 ) when the download has been completed.
The display returns to the main window.

5-48
Preparing for Analysis AU480 User Guide
Version 1.0
Return to Main Table of Contents

5.7.5 Entering Requisitions for Emergency Samples

Normal system processing can be interrupted in order to process an emergency sample. If the
system is not connected to a clinical laboratory host computer system, test requisitions for emergency
samples must be entered manually. See “6.5 Processing Emergency Samples” in chapter 6.

5.7.6 Delete Requisition

1. Select S a m p l e D e l e t e ( F 6 ) in the “Sample” window.
“Sample Delete” window is displayed.

2. Switch the display of sample type by using or .

3. Select the check box of sample type to be deleted.
4. Specify the sample to be deleted through Search Sample No. or Search Sample ID.
5. Select D e l e t e .

5-49
AU480 User Guide Preparing for Analysis
Version 1.0
 Return to Main Table of Contents

5-50
Preparing for Analysis AU480 User Guide
Version 1.0
Return to Main Table of Contents

6
Performing Analysis

This chapter describes how to perform the different elements of

analysis.

Contents
6.1 Starting Analysis . .........................................................................................................6-2
6.2 Monitoring Analysis.......................................................................................................6-3
6.3 Disable a Test ................................................................................................................6-9
6.4 Check Results .............................................................................................................6-11
6.4.1 Check the Test Results .................................................................................. 6-11
6.4.2 Displaying Reaction Monitor . ........................................................................ 6-11
6.4.3 Check the Calibration and Reagent Blank ....................................................6-15
6.4.4 Check for Error Flags and Alarms .................................................................6-22
6.4.5 Check QC ......................................................................................................6-23
6.5 Processing Emergency Samples ..............................................................................6-29
6.5.1 Performing STAT Table Analysis . ..................................................................6-31
6.5.2 Simple STAT Mode ........................................................................................6-36
6.5.3 Using a Red Rack...........................................................................................6-37
6.6 Printing Results ..........................................................................................................6-39
6.7 Performing a Repeat Run . .........................................................................................6-42
6.7.1 Preparing to Run a Standard (Manual) Repeat Test .....................................6-43
6.7.2 Performing a Repeat Test on the STAT Table . ..............................................6-45
6.7.3 Performing Repeat Test Using an Orange Rack ...........................................6-45
6.7.4 Check the Repeat-Test Result Data ..............................................................6-46
6.8 Transferring Data to Another PC................................................................................6-48
6.9 Pausing Analysis Operation ......................................................................................6-49
6.10 Rack Supply Stop .......................................................................................................6-50
6.11 System Shutdown........................................................................................................6-51
6.12 Performing an Emergency Stop.................................................................................6-52
6.13 Editing Quality Control Data ......................................................................................6-53
6.14 Editing Analysis Data .................................................................................................6-56
6.14.1 Rewriting Patient Sample Data .....................................................................6-57
6.14.2 Correcting Patient Sample Data ....................................................................6-59
6.14.3 Recalculating Analysis Data Using a Changed Calibration Curve ................6-62
6.14.4 Transferring the Edited Data Online ..............................................................6-63
6.15 Confirming the ISE (optional) Status ........................................................................6-64
6.16 Managing Reagent Condition.....................................................................................6-67
6.16.1 Check Reagent Condition...............................................................................6-67
6.16.2 Editing and Managing Reagent Condition......................................................6-69
6.16.3 Set the reagent volumes required for daily analysis.......................................6-75

6-1
AU480 User Guide Performing Analysis
Version 1.0
 Return to Main Table of Contents

6.1 Starting Analysis

Make sure that daily maintenance has been performed and verify that the system is prepared for
analysis.
It takes about 8 minutes and 40 seconds for the first results to be calculated after sample has
dispensed. Analysis results can be arranged in report format, using a template, that can be printed
out when the process is complete. The system can also be programmed to print results as they are
produced or in batches after analysis. If a printer (option) is not available, results can be viewed on the
window as they are completed.
For details on preparation for a test, refer to chapter 5 “Preparing for Analysis”.
To start analysis:
1. Select H o m e to display “Home” window.
2. Check the analyzer to make sure there is no abnormality that may prevent from starting analysis.
3. Select S t a r t .
The “Start Test” window appears.
4. Edit the “Starting sample No.” as required.
5. Select the Te s t i n g button in “Start Test” window.
The system will self-check to determine if the test is possible, and the analysis will begin.
When the test is initiated, the mode display changes from “STANDBY” to “MEASURE1 ”.
When the test can not be initiated, the “Start Test” window will display a list of errors that have
occurred. Correct the displayed error(s) properly and return to Step 3.

6-2
Performing Analysis AU480 User Guide
Version 1.0
Return to Main Table of Contents

6.2 Monitoring Analysis

The system status is continuously updated while the system is operating. This means that progress
can constantly be monitored.

Check the Sample Status

In “Sample Status” window the operator can verify the conditions of each sample under test.
The operator can also verify if the test is terminated, if the test terminated with an error, and the time
when the test is expected to end, etc.
These conditions can be displayed and sorted by each sample number, rack position, etc. of the
samples.
To check the status, operate as follows:
1. From the AU480 “Home” window select Home>Sample Status to display the “Sample Status”
window.

2. Select the button of each condition to check. The following buttons can be selected:

• Status: Displays a list of test conditions of samples on the Analyzer.

• Detail: Displays a list of test conditions or test results for each test item of each sample.

• Realtime Display: This allows the analysis data to be displayed one by one starting with any
sample on which the test is completed.
3. Select H o m e to return to the previous “Home” window.

6-3
AU480 User Guide Performing Analysis
Version 1.0
 Return to Main Table of Contents

Check the Analyzer Status

The analyzer status window provides a view of the major units of the AU480. To monitor analyzer
status:
1. From the AU480 “Home” window select Home>Analyzer Status to display “Analyzer Status”
window.

2. After checking the analyzer status, select H o m e to return to the “Home” window.

In the “Analyzer Status” window the operator is allowed to check the following conditions.

6-4
Performing Analysis AU480 User Guide
Version 1.0
Return to Main Table of Contents

Analyzer Top Unit

• Reagent refrigerator status: The display color shows the status of each reagent refrigerator.
Display Color Status
Blue Normal
Yellow The temperature is outside the normal temperature range (4 to
12°C).
Red The top cover is open.

• Bath status: The display color shows the status of the Incubator.
Display Color Status
Blue Normal
Yellow Either the temperature is outside the normal temperature range
(37±0.3°C) or there is any cuvette under a non-fatal error.
Red There is any cuvette whose cuvette check result (in real time)
results in a fatal error.

• Diluent bottle: The display color shows the remaining quantity of each bottle.
Display Color Status
More than 50mL

More than 30mL and equal to or less than 50mL

More than 15mL and equal to or less than 30mL

Less than 15mL

No remaining reagent

When the test item that uses the wash solution is not a group
item

6-5
AU480 User Guide Performing Analysis
Version 1.0
 Return to Main Table of Contents

• STAT table: The display color shows the status of STAT table.
Display color Status
Blue Normal
Yellow The temperature is outside the normal temperature range (4 to
12°C).
Red The STAT cover is open.

• ISE (optional): The display color shows the status of ISE (optional).
Display color Status
Blue Normal
Yellow Where the ISE mode is STOP.
Red Where either the ISE cover is open or the ISE mode is BUSY.

Rack Feeder Top Unit

Sample dispensing
position
Rack buffer unit
Samples are received on
Middle position the left and moved to
the right for Storage
processing or Repeat
Reading ID Run queueing.
position
Rack storage position
Auto rerun position

• Rack Receiver: The display color shows the status of Rack Receiver.
Display color status
Blue Normal
Red Where the rack is full, or any mechanical error is brought up in
the rack feeder unit initial run.
Display within the Rack full When the rack is full.
square frame - (hyphen) When the rack is not full.

• Rack position display: The display color and position will depend on the rack type. Any rack
position which is not the subject of display will be shown in gray. The rack No. of the rack
concerned will be displayed.

6-6
Performing Analysis AU480 User Guide
Version 1.0
Return to Main Table of Contents

Analyzer Front Unit

• D.I. Water tank, [Link]. tank, and Det. tank: The display color shows the liquid quantity in each
tank.
Status color Status
Blue The liquid quantity is normal.
Yellow The liquid quantity is at overflow level.
Red The liquid quantity is short.

• ISE REF solution tank, ISE MID solution tank, and ISE BUF solution tank: The display color
shows the solution quantity in each tank.
Status color Status
Blue The solution quantity is normal.
Yellow The solution quantity is short.

6-7
AU480 User Guide Performing Analysis
Version 1.0
 Return to Main Table of Contents

Unit Status Descriptions

Display color
Unit
blue Yellow Red
Cover condition All the covers of R1, - Any of the covers
STAT (large), STAT of R1, STAT (large),
(small), and ISE STAT (small), and ISE
(optional) are closed. (optional) is opened.
Vacuum tank Normal - Full
Bath temperature Normal Outside the standard -
temperature range
Coolant Normal Outside the standard -
temperature temperature range
Printer Normal Error
LIS Comm*) Under realtime online Under batch -
communication. online communication
No communication
BECKMAN COULTER Connected Not connected -
SUPPORTVISION

*) LIS: Laboratory Information System

6-8
Performing Analysis AU480 User Guide
Version 1.0
Return to Main Table of Contents

6.3 Disable a Test

Specific tests can be set so they are not analyzed during analysis and that analysis of these tests is
stopped (masking). For example, masking of the following tests saves analysis time and reagents.

• Tests with failed calibration

• Samples already on the feeder with abnormal tests from QC during analysis
Once masking has been set, the masked samples are not analyzed even when manual requisition is
made from the normal sample requisition menu.

Test masking requires the following operation.

1. From the AU480 “Home” window select Menu List>Routine>Start Condition to display the “Start
Condition” window.

For details on start condition setting, refer to section “Setting the Start Condition” in chapter 5.
2. Select D i s a b l e ( F 7 ) .
The “Disable” window appears. A list of analysis items which can be masked is displayed.

6-9
AU480 User Guide Performing Analysis
Version 1.0
 Return to Main Table of Contents

3. Select the item No. of the analysis item to be set (masked analysis items are displayed in amber).
4. Select O K .
The set contents are registered. The display returns to the “Start Condition” window.

• Masking setting is also possible during analysis. Analysis of the tests will stop or
restart after masking operation.
TIP • The masking settings are effective until power OFF.

6-10
Performing Analysis AU480 User Guide
Version 1.0
Return to Main Table of Contents

6.4 Check Results

After results have been generated, it is important to review them for analytical validity. Follow these
procedures:
6.4.1 Check the Test Results .................................................................................. 6-11
6.4.2 Displaying Reaction Monitor . ........................................................................ 6-11
6.4.3 Check the Calibration and Reagent Blank ....................................................6-15
6.4.4 Check for Error Flags and Alarms .................................................................6-22
6.4.5 Check QC ......................................................................................................6-23

6.4.1 Check the Test Results

Check the test results against “Sample Status” window displayed or the analysis data print out.
For details on how to display the sample status window, refer to “Check the Sample Status” in section
“6.2 Monitoring Analysis” in this chapter.

6.4.2 Displaying Reaction Monitor

The analysis environment (sample type, reagent lot, etc.) of analysis data and its reaction process
(Reaction Monitor) can be confirmed and used for investigating data reliability, problems, etc. The data
which can be accessed are routine samples and ISE analysis data, as well as calibration data and QC
data.
1. From the AU480 “Home” window select Menu List>Routine>Data Monitor>Reaction
Monitor>Main to display the “Reaction Monitor: Main tab” window.

6-11
AU480 User Guide Performing Analysis
Version 1.0
 Return to Main Table of Contents

2. Enter the search parameters for the data to be displayed according to the following table.

Setting item Contents Remarks

Index Select a case from the displayed All registered index information is displayed from
drop-down list. the newest information down.
Test name Max. 120 test names out of the test All items become search objects when “ALL” is
names registered in the test name selected. However, Calculated Test Items cannot
parameters can be selected from the be selected.
drop-down list.
Cuvette No. The cuvette No. to be used at the Enter “*” when no cuvette is specified.
time of analysis is specified.
Value input range: 1 to 88
Preprocess
Cuvette No.
Mix bar No. The mix bars for reagent 1 (R11), Enter “*” when no mix bar is specified.
sample or reagent 2 (R21) used at
the time of analysis are specified.
Value input range: 1 to 4
The mix bar for preprocess used at
the time of pre-dilution are specified.
Normal Enter the search parameters for In case of display by direct jump from another
sample No. and sample ID for each window, the information from the window where
type. the jump is started is used as initial values for
None: The sample ID is not used type selection and sample number.
Repeat as the search criteria.
Partial Match: Retrieve the
Cal/QC sample whose sample ID has the In case of display by direct jump from another
same characters of the setting from window, the information from the window where
the header. the jump is started is used as initial values for
Complete match: Retrieve the type selection and sample number.
sample whose sample ID is match to
the setting completely.
Counts Select the check box of “Counts” of
search objects.
Sequence Select the check box of the When all boxes are not selected, the data
“Sequence”. matching the specified sample No. and the
Counts parameter are displayed.

3. Depending on the data to be searched, select G e n e ra l tab or I S E tab.

Search starts and the selected tab window is displayed. When there is no data, the No Data
message window is displayed. When “OK” is selected, the system returns to the “Reaction
Monitor: Main tab” window.

6-12
Performing Analysis AU480 User Guide
Version 1.0
Return to Main Table of Contents

4. When the “General tab” window is displayed, confirm the contents.

Sample Number

• Left column: The sample Number of the currently displayed reaction data is displayed.

• Right column: When the currently displayed reaction data is repeat run data, the sample
number. of the first run is displayed. Nothing is displayed in this column when the reaction
data are from first run.
A list of the displayed symbols is shown below.

Type Normal Run Repeat Run

Routine Serum (None) H
Urine U HU
Other-1 X HX
Other-2 Y HY
Emergency sample Serum E HE
Urine UE HUE
Other-1 XE HXE
Other-2 YE HYE
STAT sample Serum P HP
Urine UP HUP
Other-1 XP HXP
Other-2 YP HYP
QC Q
Cal A
RB R

6-13
AU480 User Guide Performing Analysis
Version 1.0
 Return to Main Table of Contents

5. Select G ra p h D i s p l a y ( F 5 ) .
The “Graph Display” window appears.

6. Select S c a l e C h a n g e ( F 6 ) .
The “Scale Change” window appears.
7. Select the display condition A u t o or M a n u a l .
Set a lower limit value and an upper limit value for the Y-axis. The set range is -2.000 to 3.000 (in
units of 0.001).

6-14
Performing Analysis AU480 User Guide
Version 1.0
Return to Main Table of Contents

6.4.3 Check the Calibration and Reagent Blank

When running the following procedure verify the calibration result.

Reference to present calibration and reagent blanks

1. From the AU480 “Home” window select Menu List>Calibration>Calibration Monitor>Status to
display the “Calibration Monitor: Status tab” window.

6-15
AU480 User Guide Performing Analysis
Version 1.0
 Return to Main Table of Contents

2. Select the sample type from the “Type” drop-down list. The present reagent blanks and calibration
status are displayed as a list. Items displaying “*” are items with an advanced calibration setting.

• Test list
List of analysis tests registered for each group.
Display Display color Status
No data Bottles without calibration data exist.
Updating failure Yellow Bottles with failed calibration updating exist.
Expired Bottles with expired calibration exist.
No display Sky Blue All bottles are normal.
No display White There are bottles for which reagent check has
not yet been performed and judgment is not
possible.

• List by sample types.

Display color Status
Yellow In case of no calibration data, failure or expired
White Reagent check has not yet been performed and judgment is not possible.
Gray Not display object
Sky Blue Normal

3. When the column Reagent Blank or Calibration is selected, the display shifts to the “RB History
tab” window or the “Calibration History tab” window, and the reagent blank or calibration graph is
displayed.
When there are multiple bottles, the most recent data is displayed.
4. When the R B D e t a i l tab or the C a l i b ra t i o n D e t a i l tab is selected, the “RB Detail”
window or the “Calibration Detail” window is displayed.
The detailed data of the history window is displayed.
5. Select the S t a t u s tab.
The window returns to the “Status tab” window.
6. For reference to the individual status when multiple bottles have been set, select R B / C A L
S e l e c t i o n ( F 2 ) to display the “RB/CAL Status” window.
The status is displayed by bottle.

6-16
Performing Analysis AU480 User Guide
Version 1.0
Return to Main Table of Contents

7. Select “Reagent Blank” or “Calibration” for reference. The display changes to the respective “RB
History tab” window or “Calibration History tab” window and the detailed information is displayed.

The display range for the list of tests to be displayed can be changed with the drop-
down list “Display” of the “Status tab” window.
• All: Displays all the test data of registered for the group
TIP
• Error: Displays data with an error in calibration or reagent blanks,

Changing the graph scale

The graph display size can be changed by selecting the “RB History tab” window or the “Calibration
History tab” window.
1. Select G ra p h S c a l e ( F 7 ) .
The “Graph Scale” window appears.

2. Select any one from the Number of Data Points 1 0 , 2 0 , and 3 0 . The number of data selected
is displayed in “Number of Data Points”.
3. Set the lower limit value for the Y Axis to “Lower” and the upper limit value for the Y Axis to
“Upper”.

When “Auto Scale” is selected, the upper limit value and the lower limit value
calculated by automatic scale calculation are displayed.
TIP

4. Select O K .
The graph is redrawn with the set scale.

6-17
AU480 User Guide Performing Analysis
Version 1.0
 Return to Main Table of Contents

Calibration editing for advanced calibration

The calibration data for tests where the advanced calibration interval has been set to “Lot/Lot”
can be created from other data or the data being used can be made invalid.
1. Select L OT t o L OT C a l i b ra t i o n ( F 1 ) on the “Calibration Details tab” window.
The “Lot to Lot Calibration” window appears.
Set base calibration data to create the new calibration data for the new reagent bottle. “Base”
calibration means when new bottle is added the calibration for the bottle is copied from base
calibration.

2. Select the Lot No. to be displayed from the “Lot No.” drop-down list. A list of calibration data for
the same reagent lot as the selected test is displayed. The check box for the presently used data
is selected and the calibration data status is displayed in the Comment column.

Comment Meaning
Base Calibration data for the first bottle of the respective lot
Analysis Calibration data for the second first bottle of the respective lot and
following bottles
Basic (Copy) Calibration data duplicated from “Basic Data”
Unuse (Copy) Calibration data once deleted from the basic data (Copy), selection is
not possible

3. Select the data and the calibration data to be used or delete them. The check box of the selected
data is checked.
4. Select O K .
The “Lot to Lot Calibration” window is closed and the settings are registered.

6-18
Performing Analysis AU480 User Guide
Version 1.0
Return to Main Table of Contents

Reference to past reagent blank data or calibration data

1. From the AU480 “Home” window select Menu List>Calibration>Calibration Monitor>Status to
display the “Calibration Monitor: Status tab” window.

2. Select the sample type from the “Type” drop-down list.

3. Select the column “Reagent Blank” or “Calibration”. The display changes to the “RB History tab”
window or the “Calibration History tab” window.
4. Select D a t a S e l e c t ( F 3 ) .
The “Data Select” window appears. The past reagent blank data or calibration data for the
currently selected test are displayed by index date and time.

5. Select the data to be referenced by selecting it and select O K .

The “Data Select” window is closed and details of the selected past reagent blank data or
calibration data are displayed.

6-19
AU480 User Guide Performing Analysis
Version 1.0
 Return to Main Table of Contents

Reference to Factor
1. From the AU480 “Home” window select Menu List>Calibration>Calibration Monitor>Status to
display the “Calibration Monitor: Status tab” window.

2 Select the sample type from the “Type” drop-down list.

3. Select Fa c t o r L i s t ( F 4 ) .
The “Factor List” window appears.
Factor A for tests where the approximation formula for the calibration curve is the type Y = AX + B
is displayed.
4. After confirmation of the factor, select C l o s e .
The “Factor List” window closes.

6-20
Performing Analysis AU480 User Guide
Version 1.0
Return to Main Table of Contents

Adding a comment
Comments registered in the comment master can be selected and added to calibration data or reagent
blank data.
This operation is common for the window tabs
1) RB History
2) RB Details
3) Calibration History
4) Calibration Details
Comments created with 1) or 2) are displayed for 1) and 2) both, and comments created with 3) or 4)
are displayed for 3) and 4) both.
1. Select C o m m e n t ( F 5 ) .
The window to edit a comment appears.

2. Select C o m m e n t .
The window to select a comment appears.

3. Select the comment to be set.

4. Select O K .
The window is closed and the selected comment is displayed in the window to edit a comment.
5. Enter a comment.
6. Select O K .
The window is closed and the entered comment is registered.
For details on comment entry, refer to section “7.6 Using Comment Master” in chapter 7.

6-21
AU480 User Guide Performing Analysis
Version 1.0
 Return to Main Table of Contents

6.4.4 Check for Error Flags and Alarms

If a problem occurred during analysis, the system appends a flag to the analysis results.
Check all generated results carefully for error flags and take the appropriate action.
For details on error flags, refer to chapter 9 “Error Flags”.

Check also, to see if an alarm occurred during analysis:

1. From the AU480 “Home” window select Menu List>Maintenance>Alarm log to display “Alarm log”
window.

From this window the following confirmation or operation can be performed.

• Referring to any alarm during the time other than the current period or date.

• Printing the alarm log.

2. Select H o m e .
This restores the “Home” window.

6-22
Performing Analysis AU480 User Guide
Version 1.0
Return to Main Table of Contents

6.4.5 Check QC
When the QC sample has been analyzed, check its result:
1. Check the daily variation chart.
2. Check the day-to-day variation chart.

3. Check the twin-plot chart.

Check the Daily Variation Chart

QC analysis results can compared by plotting the individual QC points from one index on a single
chart. Always review the daily variation chart after performing daily QC analysis.
To check the daily variation chart, follow the procedure below to use “Daily chart”.
1. From the AU480 “Home” window select Menu List>QC>QC Monitor>Daily Chart>Monitor List to
display the “Daily Chart: Monitor List tab” window.

The colors of “Data Review” indicate as follows:

• Error (pale orange): Indicates the existence of a data that was not measured as
QC sample properly.
TIP
• Outside the range(pale yellow): Indicates the existence of a data that exceeds a
“Single Check Level (Specific Quality Control Parameters)”. (The control of “Multi
Check Level” is displayed as the same.)

• Inside the range(pale green): There is no data applying to the above.

6-23
AU480 User Guide Performing Analysis
Version 1.0
 Return to Main Table of Contents

2. Select C h a n g e I n d e x ( F 1 ) .
The “Change Index” window appears.
3. Select the range of “Index” and “Sample Type” as the objectives of confirmation.
4. Select the item to be displayed.
5. Select C h a r t V i e w tab.
The selected daily variation chart appears.

6. Select the test name to display the data as the QC daily variation chart using the or
buttons.
This will bring up the QC daily variation chart of the selected test name preceding or following the
current test name.
7. Select P r i n t ( F 8 ) .
The “Print” window appears.
8. Select, as required, to specify the “Statistics”, “Detail Data”, “Graph” or “ with Comment”.
9. Select O K .
The print operation will commence. When any abnormal condition occurs, refer to chapter 11
“Troubleshooting”.

6-24
Performing Analysis AU480 User Guide
Version 1.0
Return to Main Table of Contents

Check the Day-to-Day Variation Chart

How QC results vary can be monitored over several days. The day-to-day variation chart compares
QC analysis results by plotting a number of days analyses or a combination of indexes on a chart that
displays the variation. All points for a specific control, within an index, are combined into a single point
for the day-to-day chart.
Select the indexes, to use, such as a few days, weeks or months.
To check the day-to-day variation chart: The following operation is required. The following procedure
applies to where “Day to Day chart” window is used.
1. From the AU480 “Home” window select Menu List>QC>QC Monitor>Day to Day Chart>Test
Select to display the “Day to Day Chart: Test Select tab” window.

2. Select the range of “Index” and “Type” as the objectives to confirm.

3. Select the item to be displayed.

6-25
AU480 User Guide Performing Analysis
Version 1.0
 Return to Main Table of Contents

4. Select C h a r t V i e w tab.
The selected day-to-day control chart appears.

5. Select the test name to display the data as the QC daily variation chart with using or .
This will bring up the QC daily variation chart of the selected test name preceding or following the
current test name.
6. Select P r i n t ( F 8 ) .
The “Print” window appears.
7. Select, as required, to specify the “Statistics”, “Data”, “Chart” or “Comment” and
“Current Test” or “All Test” information.
8. Select O K .
The print operation will commence.
When any abnormal condition occurs, refer to chapter 11 “Troubleshooting”.

6-26
Performing Analysis AU480 User Guide
Version 1.0
Return to Main Table of Contents

Check QC Results Using Twin Plot

Use the Twin Plot analysis to determine whether a QC variation is caused by the system or is a result
of a random error. QC analysis is usually performed using two QC samples:

• A sample in the reference range.

• A sample in the pathological range.

The twin plot function displays the first QC sample on the x-axis of a 2-dimensional plot and the
second QC sample on the y-axis. All points should fall within the 2SD range in the center of the twin
plot.
To view the Twin Plot display:
1. From the AU480 “Home” window select Menu List>QC>QC Monitor>Twin Plot Chart>Test select
to display the “Twin Plot Chart: Test Select tab” window.
2. Select the range of “Index” and “Type” as the objectives to confirm.
3. Select the test names to be displayed in the list of “Test Name”. This will change the display color
of the selected test names. Selecting again will cancel the selection.

When A l l Te s t s ( F 5 ) is selected, all the test names being displayed will be

selected accordingly.
When D e s e l e c t A l l Te s t s ( F 6 ) is selected, all the test names being
TIP displayed will be deselected accordingly.

4. Select Te s t tab.
The chart of day-to-day variation results appears.

• To display the daily statistical results, select D a i l y D a t a ( F 6 ) .

TIP • To print the daily statistical results, select P r i n t ( F 8 ) .

6-27
AU480 User Guide Performing Analysis
Version 1.0
 Return to Main Table of Contents

5. Select S a m p l e tab.
This makes the QC data displayed for each QC sample number. within the index.

To switch the QC sample No. to be displayed, select either or .

TIP

When any abnormal condition occurs, refer to chapter 11 “Troubleshooting”.

6-28
Performing Analysis AU480 User Guide
Version 1.0
Return to Main Table of Contents

6.5 Processing Emergency Samples

This section explains following:
6.5.1 Performing STAT Table Analysis . ..................................................................6-31
6.5.2 Simple STAT Mode ........................................................................................6-36
6.5.3 Using a Red Rack...........................................................................................6-37

Outline of analyzing emergency samples

Emergency samples can be processed by using the STAT table or red racks. If only few samples
are to be analyzed, they can be quickly processed through the use of the STAT table. If a number of
samples are to be analyzed, place them in the red racks.

Processing emergency samples with the STAT table: STAT Order window
Perform the requisition operation the same way as normal testing to advance to analysis. Use the
“STAT Order: STAT Requisition” window to requisition the sample and "STAT Order: STAT Status"
window to instruct the analyzer to initiate analysis.

Processing emergency samples with the STAT table: Simple STAT Mode
For details on setting the simple STAT mode with STAT table, refer to section “6.5.2 Simple STAT
Mode” in this section.

No more than five samples at a time cannot be analyzed on the Simple STAT Mode.
Once the analysis is started, extra samples cannot be added until the current analysis
TIP operation ends.

This is a STAT-specific mode that performs analysis when an operator is absent, during the night, or
on holidays. This mode is has more advantages than normal STAT analysis because the requisition
procedure is simple. Set the sample cup to be analyzed in position on the STAT table for the simple
STAT mode. Analysis using racks in this mode is not allowed.

Processing emergency samples in red racks

Set emergency samples in red racks for analysis.

When a centrifuged sample cup needs to remain on the Analyzer for another test,
make sure there is a sufficient quantity of the required serum for detecting and
analyzing the sample. The minimum sample quantity (dead volume) possible to be
CAUTION detected is measured for 4 mm down from the sample’s surface within the sample
cup. Also make sure there is enough quantity of sample required for the analysis.

If an ample quantity of serum cannot be secured, move it to a thinner sample cup (to increase the
depth of the serum) before starting analysis. If the serum’s depth is less than 4 mm, blood cells
accumulated under the serum may be aspirated instead. This may cause a dispense failure problem.

6-29
AU480 User Guide Performing Analysis
Version 1.0
 Return to Main Table of Contents

About the STAT table adapter

If using a specific adapter, a different diameter of sample cup can be set in the STAT table.
These kinds of adapters are provided depending on the outside diameter of the respective sample
cup. Install, in advance, any adapter suitable for the sample cup in use on the STAT table. Sample
cups whose diameters do not fall within the range in the following table cannot be used.

Diameter of sample cup possible to set Available adapter

Greater than diameter 13.5 mm and less than diameter 16 mm Adapter B
diameter 14 mm (ACA cup)
Greater than diameter 11.5mm and less than diameter 14 mm Adapter A
HITACHI cup

Do not use sample cups with varying diameter sizes during analysis. Attempting
to perform analysis with sample cups of varying diameter size during analysis may
CAUTION cause analyzer malfunctions including damage of sample probes, etc.

6-30
Performing Analysis AU480 User Guide
Version 1.0
Return to Main Table of Contents

6.5.1 Performing STAT Table Analysis

STAT table analysis differs depending if barcodes (ID) are being used or not used, and according to
automatic analysis mode or sample confirmation mode.
For details on barcode (ID) use, refer to section “4.1.1 Set the common conditions for analysis” in
chapter 4.

Test requisition procedure using the STAT Table

1. From the AU480 “Home” window select Menu List>Routine>STAT Requisition>Sample>Test
Requisition to display “Sample: Test Requisition tab” window.

The Sample dispense amount shown in the “Sample Volume(µL)” field is an

approximate value excluding the dead volume.
CAUTION

2. Enter the sample number into the “Sample No.” blank. Select the sample type from “Type” the
drop-down list.
3. Select S t a r t E n t r y ( F 1 ) .
This allows the operator to edit the “Test: Requisition tab” window items.

6-31
AU480 User Guide Performing Analysis
Version 1.0
 Return to Main Table of Contents

4. Enter to set the following items properly:

• Sample ID

• Sex

• Age (Years and Months)

• Analyte
5. Select E n t r y ( F 1 ) .
6. Repeat Step 2 to 5 for every emergency sample.
7. Select E x i t ( F 2 ) .

6-32
Performing Analysis AU480 User Guide
Version 1.0
Return to Main Table of Contents

If automatic analysis mode is being used.

1. From the AU480 “Home” window select Menu List>Routine>STAT Requisition>STAT Status to
display the “STAT Requisition: STAT Status” window.

2. Set the cups with STAT samples in ascending order by Sample Number. Automatic mode is only
available in barcode mode. In case of ID analysis, the sample or order is not restricted.
3. Select S TAT S t a r t ( F 1 ) .
The “STAT Start” window appears.
4. Confirm the “Start Sample No.”.
5. To change the Start Sample number, select Ve r i f y N e x t S a m p l e N o .
The “Edit Start Sample No.” window appears. Enter the “Start Sample No.” to edit.
6. Select S t a r t .
The system checks for the presence or absence of cups on the STAT table, barcode ID, etc. and
starts analysis. If a condition exists that prevents analysis from starting a message is displayed.
Take the specified measures to clear the condition and select S TAT S t a r t ( F 1 ) again.

6-32-1
AU480 User Guide Performing Analysis
Version 1.0
 Return to Main Table of Contents

Sample Confirmation Mode

1. From the AU480 “Home” window select Menu List>Routine>STAT Requisition>STAT Status to
display the “STAT Requisition: STAT Status” window.

2. Set the cups with STAT samples on the STAT table.

3. Select S TAT C h e c k ( F 3 ) .
The system confirms the presence or absence of cups on the STAT table, barcode ID, etc. In
case of problems with the setting status, a message is displayed. Take the specified measures
and select S TAT C h e c k ( F 3 ) again.
In case of ID analysis, go to step 6.

6-32-2
Performing Analysis AU480 User Guide
Version 1.0
Return to Main Table of Contents

4. When not using the ID analysis method, select S a m p l e A s s i g n m e n t ( F 4 ) .

The “Sample Assignment” window appears. The list of requisitioned samples is displayed on the
left side of the “Sample Assignment” window.

When assigning repeat sample, select “Repeat” at “Kind”. Since repeat sample is
displayed, select repeat sample to analyze.
TIP

5. Select O K .
6. Select S TAT S t a r t ( F 1 ) .
The “STAT Start” window appears.
7. To change the “Start Sample No.”, select E d i t S t a r t S a m p l e N o .
The “Edit Start Sample No.” window appears. Enter the Start Sample No. to be edited.
8. Select S t a r t .
Analysis is started.
If a condition exists that prevents analysis from starting a message is displayed. Take the
specified measures to clear the condition and select S TAT S TA RT ( F 1 ) again.

6-33
AU480 User Guide Performing Analysis
Version 1.0
 Return to Main Table of Contents

STAT analysis pause

The Dispensing operation can be paused to add STAT samples during STAT analysis operation etc.
Pausing is done between tests, and dispensing operation for new analysis is stopped.

• After pausing, do not remove any samples from the system and always restart
analysis. Incorrect analysis may result due to sample evaporation, and increased
concentration, etc.
CAUTION
• When the dispensing operation has been paused, do not remove racks from the
system and do not add samples to an intermediate position. A mismatch will occur
between the sample No. in the requisition information and the actual sample cup,
making correct analysis impossible.

• Once started the S TAT C h e c k ( F 4 ) operation cannot be paused. A

STAT check requires approximately 70 seconds.

TIP • The dispensing operation requires approximately 50 seconds before it can be

paused. However STAT analysis is not paused during dispensing RB/ACAL/QC.

1. From the AU480 “Home” window select Menu List>Routine>STAT Requisition>STAT Status to
display the “STAT Requisition: STAT Status” window.
2. Select S TAT Pa u s e ( F 2 ) .
The “Pause Confirmation Message” window appears.
3. Select O K .
The confirmation message window is closed and dispensing operation stops.
4. Perform STAT samples addition or other required operation.
5. Select S TAT S t a r t ( F 1 ) .
The “STAT Start” window appears.
6. Select O K .
Analysis is restarted.

ID editing
If an ID read error etc. occurs while running a STAT check, the ID information of a sample with an
abnormal ID can be edited.
Only samples that have not been anlyzed can be edited. Editing can be performed only when the
STAT table is stopped.
1. From the AU480 “Home” window select Menu List>Routine>STAT Requisition>STAT Status to
display the “STAT Requisition: STAT Status” window.
2 Select the sample with the ID error.
3. Select S a m p l e I D E d i t ( F 8 ) .
The “Sample ID Edit” window appears. The position of the sample with an abnormal ID on the
STAT table and its type are displayed.

4. Enter the correct barcode ID into the “Sample ID”.

5. Select O K .
The input value is registered and the “Sample ID Edit” window is closed.

6-34
Performing Analysis AU480 User Guide
Version 1.0
Return to Main Table of Contents

Emergency sample processing on the STAT table using sample cups with a
barcode label
Affixing a barcode label on sample cups
Affix the barcode label on the target sample cup following the example below.

Angle should be within 5° degrees.

Sample cup
The label should not stick out
Barcode

Label STAT table

How to set sample cups with each barcode label

Sample cups should be set with the barcode label facing outward in the hole provided at the outer
circumference of the STAT table.
The barcode is not read for
cups placed in the inner holes.
The sample cup should be placed
in an outer hole on the STAT table
with the barcode facing outward. 21

STAT table

6-35
AU480 User Guide Performing Analysis
Version 1.0
 Return to Main Table of Contents

6.5.2 Simple STAT Mode

Simple STAT mode is a special STAT analysis mode that permits analysis by simply following the
system instructions. When the system is set to simple STAT mode at night and on holidays, persons
not familiar with the system can perform analysis with few steps.
Start and stop of simple STAT mode
1. From the AU480 “Home” window select S i m p l e S TAT M o d e on the “Home” window to
display the “Simple STAT Mode” window. The system enters simple STAT mode.
If a condition exists that prevents analysis from starting when selecting S i m p l e S TAT
M o d e , a message is displayed. Take the specified measures to clear the condition and select
S i m p l e S TAT M o d e again.

2. Select E x i t .
Simple STAT Mode ends and return is made to the Home window.

Do not select E x i t until the current analysis operation ends. “Simple STAT Mode”
window will close and the analysis data cannot be confirmed if selecting E x i t
CAUTION before the current analysis operation ends.

Analysis in simple STAT mode

1. Select the “Pos.” check box of on the “Simple STAT Mode” window and select “Type” and “Profile”
from the drop-down list.
2. Open the STAT cover, and set all samples according to “Pos.” , and close the STAT cover.
3. Select N e x t .
4 The system starts automatically.
5. Select the D a t a D i s p l a y tab.
The analysis results are displayed when analysis has ended, a message prompting for removal
of samples is displayed. When a simple analysis window report has been selected, the analysis
results are sent to the printer (option) and printed
6 Select the M a i n tab.
When analysis ends a message prompting for sample removal is displayed.
7. Remove all samples, close the cover, and select E x i t .
The system confirms that the samples have been removed and simple STAT mode ends.

6-36
Performing Analysis AU480 User Guide
Version 1.0
Return to Main Table of Contents

6.5.3 Using a Red Rack

Test procedure using a red rack
1. From the AU480 “Home” window select Menu List>Routine>Rack Requisition>Sample>Test
Requisition to display “Sample: Test Requisition tab” window.

The Sample dispense amount shown in the “Sample Volume(µL)” field is an

approximate value excluding the dead volume.
CAUTION

2. Select “Emergency” from the “Sample Kind” drop-down list. Enter the sample number into the
“Sample No.” blank. Select the sample type from “Type” the drop-down list.
3. Select S t a r t E n t r y ( F 1 ) .
This allows the operator to edit the “Test: Requisition tab” window items.

6-37
AU480 User Guide Performing Analysis
Version 1.0
 Return to Main Table of Contents

4. Enter to set the following items properly:

• Sample ID

• Sex

• Age (Years and Months)

• Analyte
5. Select E n t r y ( F 1 ) .
6. Repeat Step 2 to 5 for every emergency sample.
7. Select E x i t ( F 2 ) .
8. Select Fe e d e r S t o p .
This makes the feeder stop.
9. Set the rack in position on the feeder.

Give red racks priority when placing them on the feeder belt with the other racks.
TIP

10. Select S t a r t .

6-38
Performing Analysis AU480 User Guide
Version 1.0
Return to Main Table of Contents

6.6 Printing Results

To print test results in the form of report (Test Ledger) or data log list, the report format must be
specified in advance.
For details on how to set the print format, refer to section “4.11.1 Set the Basic Condition for Print” in
chapter 4.

Printing Reports
To print patient data as a report:
1. From the AU480 “Home” window select Menu List>Routine>Sample Manager>Sample>Main to
display “Sample: Main tab” window.

2. Select D a t a S e a r c h ( F 3 ) .
The “Data Search” window appears.
3. Enter an appropriate search key such as index, sample No., sample information, etc. of the data
to be printed.
4. Select O K .
5. Select P r i n t ( F 8 ) .
The “Print” window appears.
6. Select “Data List No.”.

6-39
AU480 User Guide Performing Analysis
Version 1.0
 Return to Main Table of Contents

7. Select O K .
Printing begins.

In order to print:
• The report format must be specified in advance.

TIP • User’s can select and print any available predefined report, according to the
format selected in step 6.

Printing Other Sample Data

To print analyzed RB samples, calibrators, and quality control samples:
1. From the AU480 “Home” window select Menu List>Routine>Sample Manager>RB/CAL/ QC to
display the “Sample Manager: RB/CAL/QC” window.

2. Select the index of the RB/CAL/QC data to search from the “Index” drop-down list.
3. Select the “Sample Kind” check box of the samples desired.
4. Enter the sample No. range to query into “Search Sample No.”.

If left blank or empty no search criteria is used to perform the search.

TIP

5. Enter the QC No. (1 to 200) and the Cal No. (1 to 100) for “QC/Cal No.”.
When “*” is entered all numbers will be selected.

6-40
Performing Analysis AU480 User Guide
Version 1.0
Return to Main Table of Contents

6. Enter the sample ID for “Control/Calibrator ID”.

7. When searching for samples with tests that are pending transfer to online, select the “Data Not
Transferred to Host” check box, and when searching for samples with test that are pending
printing, select the “Data Not Printed” check box.

Work List Printing

Specify the data range and print the work list.
1. Set the search range for the sample numbers on the “Sample Manager: RB/CAL/ QC” window.
2. Select P r i n t ( F 8 ) .
3. Select the format for the work list to be printed from the “Print Format” drop-down list.
4. Select O K .
The work list begins printing.

Online transfer
When this system is connected online to a clinical laboratory host computer system, sample
information, patient information, etc. can be transferred online.

Before transfer, confirm that the system is online and connected to a clinical
laboratory host computer system.
CAUTION

1. Set the search range for the sample numbers on the “Sample Manager: RB/CAL/ QC” window.
2. Select O n l i n e Tra n s f e r ( F 7 ) and display the online transfer window.
3. Select O K .
Online transfer is performed.

Select O n l i n e Tra n s f e r S t o p ( F 7 ) to stop the transfer.

TIP

6-41
AU480 User Guide Performing Analysis
Version 1.0
 Return to Main Table of Contents

6.7 Performing a Repeat Run

6.7.1 Preparing to Run a Standard (Manual) Repeat Test .....................................6-43
6.7.2 Performing a Repeat Test on the STAT Table . ..............................................6-45
6.7.3 Performing Repeat Test Using an Orange Rack ...........................................6-45
6.7.4 Check the Repeat-Test Result Data ..............................................................6-46
There are two ways to perform a repeat a run:

• Manual (Standard): Analysis is repeated manually from a print out of the repeat run data file
called the repeat run work list. Samples to be re-run must be on an orange rack.

• Automatic: Analysis is repeated automatically with parameters read from the repeat run data
file, and ran using the white or red racks. A sample on the STAT table is also automatically re-
analyzed excluding simple STAT mode.
This section describes how to perform a standard (manual) repeat test executed manually.

The operator is allowed to set whether or not to automatically rewrite the original data
with the result data of the repeat test.
For details on how to set the repeat test, refer to section “4.6 Programming Repeat
TIP Tests” in chapter 4.

6-42
Performing Analysis AU480 User Guide
Version 1.0
Return to Main Table of Contents

6.7.1 Preparing to Run a Standard (Manual) Repeat Test

To select only the samples requiring a repeat run, verify the samples against the repeat run work list
printout. After checking the Repeat Run Work List printout, perform the repeat run.

Entering a Requisition for Repeat Run Analysis

1. From the AU480 “Home” window select Menu List>Routine>Repeat Run>Repeat Order to display
“Repeat Run: Repeat Order” window.

The sample dispense amount shown in the “Sample Volume(µL)” field is an

approximate value excluding the dead volume.
CAUTION

2. To use sample racks, select “Routine” or “Emergency” using S w i t c h of the “Sample Kind”.
Select “STAT” to access samples on the STAT table.
3. Enter the “Sample No.” of the sample to perform the repeat test.
4. When the system configuration allows for more than one sample type to be set on a rack, select
the type from the “Type” drop-down list.
5. Select S t a r t E n t r y ( F 1 ) .

6-43
AU480 User Guide Performing Analysis
Version 1.0
 Return to Main Table of Contents

6. Select items for repeat analysis. If sample for repeat analysis is diluted outside the analyzer,
use the setting on the "Sample Dilution Rate" window displayed by selecting Tra n s f e r t o
Host (F7).
Also, if executing diluent analysis per measurement item, keep selecting the item diluent analysis
is executed then switch the selection color by selecting Te s t D i l u t i o n ( F 8 ) .
7. Select E n t r y ( F 1 ) .
Once the settings have been entered, the window will display the information regarding the next
sample No.
8. Repeat the steps 3 through 7 for the number of samples to repeat.
9. After the requisition is completed, select E x i t ( F 2 ) .

• Repeat run list

The sample which needs a repeat run as a result of an analysis, will be extracted
as a sample may need a repeat run. It is possible to display the list of the samples
TIP which need repeat run. The samples which need a repeat run mean samples
whose repeat run sample No.’s have not been determined yet.

• Assigning repeat run sample No.

The data of a repeat run sample No. will not be sequential order. In this case, an
empty sample cup which is corresponds to the number of the sample deleted,
should be set on the orange rack. To avoid this process, change sample No. to
sequential.

• Batch extraction of repeat run

Samples which have data flag set at parameter will be automatically requested for
a repeat run.

• Initializing repeat run data

All the repeat run data will be deleted.

• List of untested samples

Displays the samples that are not analyzed. Samples that are not assigned a
sample No. will not be shown.

Printing and Checking the Repeat Run Work List

The system produces a repeat run work list. that can be printed and used to prepare the repeat
samples.
1. From the AU480 “Home” window select Menu List>Routine>Repeat Run>Repeat Order to display
“Repeat Run: Repeat Order” window.
2. To select samples for each rack, select “Routine” or “Emergency” from the “Sample Kind” drop-
down list. To select samples on the STAT table, select “STAT”.
3. Select P r i n t ( F 8 ) .
The “Print” window appears.
4. Select any print work list from the “Print Type” drop-down list.
This selection is possible when the corresponding item is included in the “Format”. If the
corresponding item is not included in the “Format” it is, proceed to Step 6.
5. Select any print format from the “Print Type” drop-down list.
6. Set the “Type” and “Search Sample ID” options.
7. Select P r i n t .
The repeat run work list begins printing.
8. Check the contents of the printed repeat run work list. Perform the repeat run requisition based
on the work list contents.

6-44
Performing Analysis AU480 User Guide
Version 1.0
Return to Main Table of Contents

6.7.2 Performing a Repeat Test on the STAT Table

Use the STAT table to run the repeat run.
1. Select the samples to be tested in the Repeat Run (Serum, Urine, Other-1, or Other-2) from the
repeat run work list printout.
2. Dispense the sample to be tested into the sample cups that will be set on the STAT table.
3. Open the STAT table cover(s).
4. Set the test sample cups on the STAT table using the repeat run requisition.
5. Return the STAT table cover to it’s original position.
6. Analysis the same as “6.5.1 Performing STAT Table Analysis” in this chapter.

Do not set repeat run sample cups in the Calibration or QC positions on the STAT
table. The Calibration and QC positions are factory default settings for the analyzer.
TIP

6.7.3 Performing Repeat Test Using an Orange Rack

Samples can be reloaded using the orange rack:
1. Select the samples for the repeat run (e.g. Serum, Urine, Other-1, or Other-2) using the repeat
run work list.
2. Place the test sample cups on the orange rack
Set the sample cup to analyze on the orange rack according to the repeat run requisition.
3. Start the analysis operation.
Repeat sample analysis begins.

6-45
AU480 User Guide Performing Analysis
Version 1.0
 Return to Main Table of Contents

6.7.4 Check the Repeat-Test Result Data

To verity the results of a repeat test. Check the data before and after the repeat test is ran.
During a repeat test any data that existed before the repeat test will be overwritten by the repeat test
data. After the repeat test is completed, the results may be printed.

The analyzer can be configured to overwite original data with the repeat run test data.
TIP

For details on how to set for overwriting with the repeat test data, refer to section “4.6.1 Repeat run
Parameter Setting” in chapter 4.

Overwriting the data

1. From the AU480 “Home” window select Menu List>Routine>Repeat Run>Repeat Data
Verification to display “Repeat Data Verification: Main tab” window.

2. Select S e a r c h ( F 3 ) .
The “Search” window appears.
3. Set the search condition.
4. Select O K .
The list of “Repeat Data Verification: Main tab” window will be updated.
5. Select the S a m p l e or Te s t tab, then select the repeat-test result to be overwritten from the
list.

6-46
Performing Analysis AU480 User Guide
Version 1.0
Return to Main Table of Contents

6. Compare the displayed data before and after the repeat test.
7. Select O v e r w r i t t e n b y Re p e a t ( F 5 ) .
The existing data before the repeat test will be overwritten by the repeat test data.

If the data is overwritten, the previous data is no longer available.

CAUTION

Printing the Overwritten Data

1. From the AU480 “Home” window select Menu List>Routine>Repeat Run>Repeat Data
Verification>Main to display the “Repeat Data Verification: Main tab” window.
2. Select P r i n t ( F 8 ) .
The “Print” window appears.
3. Select any print format from the “Print Format” drop-down list.
4. Select O K .
The print operation will commence.

Online Transfer of Overwritten Data

1. From the AU480 “Home” window select Menu List>Routine>Repeat Run>Repeat Data
Verification>Main to display the “Repeat Data Verification: Main tab” window.

2. Select O n l i n e Tra n s f e r ( F 7 ) .
The “Online Transfer” window appears.

6-47
AU480 User Guide Performing Analysis
Version 1.0
 Return to Main Table of Contents

6.8 Transferring Data to Another PC

To transfer data results to another computer:
1. From the AU480 “Home” window select Menu List>Routine>Sample Manager>Sample>Main to
display the “Sample: Main tab” window.

2. Select D a t a S e a r c h ( F 3 ) .
The “Data Search” window appears.
3. Set the search key for the output to be transferred online.
4. Select O K .
5. Select O n l i n e Tra n s f e r ( F 7 ) .
The “Online Transfer” window appears.
6. Select O K .
The data is batched and transferred

6-48
Performing Analysis AU480 User Guide
Version 1.0
Return to Main Table of Contents

6.9 Pausing Analysis Operation

The analyzer can be paused to add reagent and then resume analysis for the remaining items.

• Do not leave the system paused for long periods of time. When the analyzer is
paused for an extended period of time, the concentration of the samples in the
sample cups increases due to evaporation and can effect data results.
CAUTION
• Do not remove or add racks while the system is paused. Removing or adding
racks while the system is paused will cause a mismatch between the sample No.
in the requisition information and the actual sample cup, making correct analysis
impossible.

Pausing Analysis Operation

1. Select Pa u s e on the “Home” window during analysis.
The “Pause Execution” window appears.

2. Select O K .
The system pause message is displayed. If a sample is being analyzed, analysis of the sample
continues, when sample analysis is complete the system goes into pause mode.

Before replenishing reagents etc., make sure the system status is paused and the
system is stopped to avoid personal injury or damage to the reagent probe.
CAUTION

Cancellation of pause status

When analysis is restarted after a pause, the next sample to be analyzed after the one that was
undergoing analysis when pause was selected will begin analysis.
1. Select A n a l y s i s S t a r t on the “Home” window while analysis operation is paused.
The start window is displayed.
2. Select O K .
Analysis is restarted.

6-49
AU480 User Guide Performing Analysis
Version 1.0
 Return to Main Table of Contents

6.10 Rack Supply Stop

The rack feeder unit can be stopped when an Emergency rack etc. needs to be inserted, during
analysis.
When the rack feeder unit is stopped, analysis continues for the racks already fed by the rack feeder.

Do not leave the rack feeder supply unit stopped for extended periods of time. When
the feeder is stopped for an extended period of time the concentration of the samples
in the sample cups increases due to evaporation and the results will be affected.
CAUTION

Stop the rack feeder

1. Select Fe e d e r S t o p on the “Home” window during analysis operation.
The “Feeder Stop Execution” window appears.
2. Select O K .
The rack feed operation stop message is displayed.
Analysis of the racks already discharged from the rack feeder continues.

Analysis restart after feeder stop

1. With the rack feeder stopped, perform the same requisition for normal analysis. For details on
requisition for normal analysis, refer to section “5.7 Sample Requisitions: Entering Data and
Choosing Tests” in chapter 5.
2. Perform starting analysis operation. For details on starting analysis operation, refer to section “6.1
Starting Analysis” in this chapter.

6-50
Performing Analysis AU480 User Guide
Version 1.0
Return to Main Table of Contents

6.11 System Shutdown

Shutdown the system properly when the analysis of all samples is completed.
The temperatures of the reagent compartment, STAT table, and reaction bath (incubator) of this
Analyzer will be still maintained after shutdown. If the ISE (optional) has been installed, auto-wash will
automatically take place periodically on the ISE.
Shutdown can be attempted when running W2 or Photocal. When a shutdown is executed during W2
or Photocal operation, the system will be automatically shut down after the W2 or Photocal operation
is completed.
To shut down the system:
1. Make sure that all the sample analyses are completed.
2. Select H o m e .
The “Home” window appears.
3. Select E n d button on the keyboard.
The “End” window appears.

4. When the “Auto Power On” setting of “System Condition” has been activated, select “Set up Next
on-time”, select S e t t i n g and C o n f i r m .
5. Select Ye s .
This starts the shutdown procedure and terminates system operation as the standby power of
the Analyzer is turned to OFF.
6. Tighten the main valve of the deionized water to turn the deionized waster off.

Verify that the deionized water pipe is leak free when automatically executing a
test, or operation over night or on a holiday. In order to execute a test or operation
automatically, the deionized water supply valve must be left on.
CAUTION

The system can be set to automatically start up at a specified date and time and to
automatically execute an operation such as W1, etc.
TIP

For details on using the auto power on function, refer to section “7.1 Using the Automatic Startup
Function” in chapter 7.

6-51
AU480 User Guide Performing Analysis
Version 1.0
 Return to Main Table of Contents

6.12 Performing an Emergency Stop

To stop the analysis operation immediately, perform an emergency stop. When an emergency stop is
performed analysis stops within 9 seconds.

• When emergency stop is performed, the data being analyzed cannot be used.
Analysis has to be repeated.

CAUTION • Do not perform an end operation soon after an emergency stop. Reagent remains
in the cuvettes after an emergency stop that can cause system damage or
deterioration, incorrect analysis results, etc. Before performing end operation,
perform analysis or W1.

Emergency stop of analysis operation

1. Select S t o p / S t a n d b y on the “Home” window during analysis operation.
The “Emergency Stop Execution” window appears.

2. Select O K .
The emergency stop execution message is displayed, all analysis operations are stopped, and
the system goes to stop mode.
3. Remove the racks on the rack feed path.

Reset operation after emergency stop

1. Select S t o p / S t a n d b y on the “Home” window again in emergency stop condition (Stop
Mode).
The reset operation start window is displayed.
2. Select O K .
The system reset operation is performed. After the reset operation completes, the system goes to
Standby mode or Warm up mode.
3. Execute W1.
For details on W1 execution procedure, refer to section “8.8.12 Execute a W1 (Auto-wash of the
sample probe and cuvettes)” in chapter 8.

6-52
Performing Analysis AU480 User Guide
Version 1.0
Return to Main Table of Contents

6.13 Editing Quality Control Data

Analyzed QC data can be searched and edited.
Searches can be performed in sample units or item units.

Editing of quality control data means that the analyzed QC results will be changed. To
prevent an erroneous diagnosis due to numerous changes to the quality control data,
editing should be done carefully by a physician or the person in charge of the QC
CAUTION results.

When the QC analysis data results have been edited, confirm that the edited data
falls within the cumulative period. If it falls within the cumulative period, the editing
of the contents must be reflected in the cumulative values. To reflect the editing of
TIP contents in the cumulative values, update the cumulative values.

Searching for object data

Search for the data to be edited.
1. From the AU480 “Home” window select Menu List>QC>QC Data Review>Main to display the “QC
Data Review: Main tab” window.

2. Select “Index” from the drop-down list.

3. Set the “Search Sample No.”
Enter in the range from 000 to 999.

6-53
AU480 User Guide Performing Analysis
Version 1.0
 Return to Main Table of Contents

4. After setting the “Search Sample No”, select the S a m p l e or Te s t tab.

The search starts when the “Sample tab” window or “Test tab” window is selected. The search
results are displayed on the selected “Sample tab” window or “Test tab” window. When there
are no results to display, a warning message is displayed. Select O K to return to the “Main tab”
window.

5. Select E d i t ( F 1 ) .
6. Edit the QC data.
7. Select I n d e x C o m m e n t ( F 3 ) to add a comment to the QC data.
The “Index Comment” window appears.

8. Enter a comment.
When the “Comment Master” is selected, comments that are already registered may be selected.
For details on comment entry, refer to section “7.6 Using Comment Master” in chapter 7.
9. Select O K .
The entered comment is registered. When “Cancel” is selected, the comment is not registered
and the window is closed.
10. To add a comment by item, select Te s t C o m m e n t ( F 4 ) .
The “Test Comment” window appears.

6-54
Performing Analysis AU480 User Guide
Version 1.0
Return to Main Table of Contents

11. Enter the comment.

When the C o m m e n t M a s t e r is selected, comments that have already been registered
may be selected. For details on comment entry, refer to section “7.6 Using Comment Master” in
chapter 7.
12. Select O K .
The entered comment is registered. When C a n c e l is selected, the comment is not registered
and the window is closed.
13. If excluding the analyze data from calculation object of statistic, select D e l e t e ( F 2 ) .

When the D e l e t e ( F 2 ) function is performed, all the analyzed data of the

sample number selected in step 3 are excluded.
TIP

14. Select O K .
15. Select C o n f i r m ( F 1 ) .
The set contents are registered.

6-55
AU480 User Guide Performing Analysis
Version 1.0
 Return to Main Table of Contents

6.14 Editing Analysis Data

6.14.1 Rewriting Patient Sample Data .....................................................................6-57
6.14.2 Correcting Patient Sample Data ....................................................................6-59
6.14.3 Recalculating Analysis Data Using a Changed Calibration Curve ................6-62
6.14.4 Transferring the Edited Data Online ..............................................................6-63
If the analysis data is directly overwritten, the corrected data is displayed with the data flag "e"
indicating manual data correction. Also, if the analysis data has been edited using a correction
formula, the edited data is displayed with the data flag "c" indicating manual data correction.

• Direct rewriting of analysis data

• Editing of analysis data using a correction formula

• Recalculation of analysis data using a changed calibration curve

Editing of result data means that the analyzed QC results will be changed. To prevent
an erroneous diagnosis due to numerous changes to the quality control data, editing
CAUTION should be done carefully by a physician or the person in charge of the result data.

6-56
Performing Analysis AU480 User Guide
Version 1.0
Return to Main Table of Contents

6.14.1 Rewriting Patient Sample Data

1. From the AU480 “Home” window select Menu List>Routine>Sample Manager>Sample>Main to
display the “Sample: Main tab” window. A list of samples in the index is displayed.

2. Select the “Sample No.” and the sample to be edited. To select all the samples in the index,
select S e l e c t A l l .
3. To select other data, select D a t a S e a r c h ( F 3 ) .
The “Data Search” window appears.
4. Set the index of the patient data to be displayed and other search conditions from the drop-down
list.
5. Select O K .
The window is closed and the analyzed data in the selected index are displayed in a patient list.
6. Select the samples to be edited.

6-57
AU480 User Guide Performing Analysis
Version 1.0
 Return to Main Table of Contents

7. Select the S a m p l e tab or Te s t tab.

The search starts.
The search results are displayed on the selected “Sample tab” window or “Test tab” window.

8. Select E d i t ( F 1 ) .
The window can now be edited.
9. Select the sample to be edited. For reference to the used reagent lot etc., select D e t a i l
Information (F5).
10. Edit “Result” or “Data Flags”.
11. Select C o n f i r m ( F 1 ) .
The edited data are registered and the display returns to the reference window.

6-58
Performing Analysis AU480 User Guide
Version 1.0
Return to Main Table of Contents

6.14.2 Correcting Patient Sample Data

The correction formula Y = AX + B is used to correct the data of all samples in test units.
Y: Data after correction
X: Data before correction
A, B: An optional correction coefficient (9 digits, including sign and decimal point)
1. From the AU480 “Home” window select Menu List>Routine>Sample Manager>Sample>Main to
display the “Sample: Main tab” window.

2. A list of samples in the index is displayed.

6-59
AU480 User Guide Performing Analysis
Version 1.0
 Return to Main Table of Contents

3. To select other data, select D a t a S e a r c h ( F 3 ) .

The “Data Search” window appears.

4. Set the index of the patient data to be displayed and other search conditions from the drop-down list.
5. Select O K .
The window is closed and the analyzed data in the selected index are displayed in a patient list.
6. Select D a t a C o r r e c t i o n ( F 6 ) .
The “Data Correction” window appears.

6-60
Performing Analysis AU480 User Guide
Version 1.0
Return to Main Table of Contents

7. Select the tests to be corrected or “ALL” from the drop-down list “Test Name” list and select
Correction.
When a specific test has been selected, the window for setting a pair of coefficients A and B
opens.

When “ALL” has been selected, the window for setting the coefficients A and B for all tests opens.

8. Enter the coefficients A and B, and select O K .

The window is closed and returns to the reference window.

6-61
AU480 User Guide Performing Analysis
Version 1.0
 Return to Main Table of Contents

6.14.3 Recalculating Analysis Data Using a Changed Calibration

Curve
To edit the calibration curve in advance use “Calibration curve correction”.
For details on calibration curve correction, refer to section “6.4.3 Checking the Calibration and
Reagent Blank” in this chapter.
1. From the AU480 “Home” window select Menu List>Routine>Sample Manager>Sample>Main to
display the “Sample: Main tab” window.

2. Select Re c a l c u l a t e D a t a ( F 5 ) .
The “Recalculating” window appears.

3. Select the test to be recalculated from the “Test Name” drop-down list.
4. Select O K .
The analysis data are recalculated and rewritten.

6-62
Performing Analysis AU480 User Guide
Version 1.0
Return to Main Table of Contents

6.14.4 Transferring the Edited Data Online

To output data online, select “Batch Online” for “Result Transfer” on the “Online: Set Up” window. For
details on editing online conditions, refer to section “4.3.1 Editing Online conditions” in chapter 4.
1. From the AU480 “Home” window select Menu List>Routine>Sample Manager>Sample>Main to
display the “Sample: Main tab” window.

2. Select O n l i n e Tra n s f e r ( F 7 ) .
The “Online Transfer” window appears.
3. Select the transfer range.
4. Select O K .
The Online transfer is performed.

Select O n l i n e Tra n s f e r S t o p ( F 7 ) to stop the transfer.

TIP

6-63
AU480 User Guide Performing Analysis
Version 1.0
 Return to Main Table of Contents

6.15 Confirming the ISE (optional) Status

To start analysis with the ISE (option), ISE calibration or cleaning should be performed in advance.
To display the ISE calibration results as a list, display a slope chart, check for an ISE selection, or
execute its CRS calibration.

Check calibration result

1. From the AU480 “Home” window select Menu List>Maintenance>User Maintenance>ISE
Maintenance>Calibration to display the “ISE Maintenance: Calibration tab” window.

2. Select the sample type (Serum, Urine) from the “Type“ drop-down list.

6-64
Performing Analysis AU480 User Guide
Version 1.0
Return to Main Table of Contents

Confirm the window

• ISE Status The ISE operation mode is displayed.

Message Background color Meaning
READY Blue Ready to start analysis.
BUSY Red Analysis is in progress (ISE).
MEASURE Red Analysis is in progress (Except for ISE).
STOP Yellow The ISE is isolated.
INITIAL Yellow The ISE is initializing.

• Electrode Status
Indicates whether the most recent slope value is within the normal value range.
Background color Meaning
Blue All electrodes have a slope value within the normal range.
Yellow Multiple electrodes have a slope value out of the normal range, or
have no data.

• Reagent Status
Indicates whether the amount of the buffer solution, MID solution, and REF solution used for the
ISE is sufficient.
Background color Meaning
Blue All reagents have sufficient remaining amount.
Yellow Multiple reagents have an insufficient amount remaining.

• Date/Time
The date and time the calibration was executed.

• Slope
Indicates the slopes of calibration regarding each of Na, K, and Cl. A larger slope value indicates
a steeper slope, i.e. a larger potential.

• MID Solution Factor

A value which is obtained based on the concentration of the MID solution to establish a
reference for measuring Na, K, and Cl ion concentrations.

Check slope chart

Records of slope values obtained from calibration can be referred to in the form of polylines for each
Na, K, and Cl.
1. Select S l o p e C h a r t tab.
The “ISE: Slope Chart tab” window appears. The most recent 30 slope values will be displayed
in a chart. The Na, K, and Cl slope charts are identified by their specific color. Also, the display
range lies in the slope values from minimum to maximum. In the left of the chart the maximum
and minimum Na, K, and Cl slope values are displayed.
2. Select the sample type (Serum, Urine) from the “Type” drop-down list. For details on ISE status,
ISE electrode status, and ISE reagent status, refer to “Check calibration result” in this section.

6-65
AU480 User Guide Performing Analysis
Version 1.0
 Return to Main Table of Contents

Performing or Check selectivity check

1. Select the S e l e c t i v i t y C h e c k tab.
The “ISE: Selectivity Check tab” window appears. A list of the most recent 30 selectivity check
results are displayed.
2. Select C h e c k S t a r t .
The “Selectivity Check” window appears.
3. Select O K .
4. Confirm the check results.
Any values judged as abnormal from this check will be displayed with a yellow background.

• Operated date
Displays dates and times when selectivity checks were performed.

• Check concentrations
Displays the check solution concentration (Na, K) which were calculated from the results of
selectivity checks for each time.

• Allowable range
Displays the allowable range of check solution concentration.
For details on ISE status, ISE electrode status and ISE reagent status, refer to
“Check calibration result” in this section.

6-66
Performing Analysis AU480 User Guide
Version 1.0
Return to Main Table of Contents

Performing or Check CRS calibration

This provides over site of the operation of performing CRS calibration, the date of operation and the
check result.

The CRS calibration result can be automatically set to correction coefficient which is
for analyzing result.
TIP Confirm the calibration parameter setting of ISE tests.

For details on confirming the calibration parameter setting of ISE tests, refer to section “4.7.2 Set the
Specific Calibration Parameters” in this chapter.
1. Select the C R S C a l i b ra t i o n tab.
The “ISE: CRS Calibration tab” window appears. A list of the most recent 30 CRS calibration
results are displayed.
2. Select S t a r t .
The “CRS Calibration“ window appears.
3. Select O K .
4. Confirm the check results. Any values judged as abnormal from this check will be displayed with
a yellow background.

• Operated date
Displays dates and times when CRS calibration were performed.

• Factor
Displays the factor A (Na, K, CI) and factor B which were calculated from the results of each
CRS calibration.

• Normal range of factor A

Displays the normal range (Upper limit to Lower limit) of ISE factor value.
For details on ISE status, ISE electrode status and ISE reagent status, refer to “Check calibration
result” in this section.
5. To confirm the details, select D e t a i l I n f o r m a t i o n ( F 5 ) .
The “Detail Information” window appears.
6. After confirmation, select O K .

6-66-1
AU480 User Guide Performing Analysis
Version 1.0
 Return to Main Table of Contents

6-66-2
Performing Analysis AU480 User Guide
Version 1.0
Return to Main Table of Contents

6.16 Managing Reagent Condition

This menu allows referring and editing remaining volume, expiration, etc. of the reagents on the
analyzer.
6.16.1 Check Reagent Condition...............................................................................6-67
6.16.2 Editing and Managing Reagent Condition......................................................6-69
6.16.3 Set the reagent volumes required for daily analysis.......................................6-75

6.16.1 Check Reagent Condition

1. From the AU480 “Home” window select Menu List>Routine>Reagent>Reagent
Management>Main to display “Reagent management: Main tab” window.

• Position 77 is for sample diluent bottle. For details about the set position, refer to
“3.4.7 Reagent Transfer Unit” in chapter 3.

TIP • Position 78 is for washing sample probe. For details about the set position, refer to
“3.4.13 STAT Table Unit” in chapter 3.

6-67
AU480 User Guide Performing Analysis
Version 1.0
 Return to Main Table of Contents

2. Check the reagent condition in the column at the upper left on the window.
(1) (2) (3)

(4) (5)

Display Color Contents

(1) Accessible Light blue Displays if reagent bottles can be set. (Reagent Check
Inaccessible Red (F5) is effective in “Accessible”.)
(2) Unchecked Red Displays implementation of reagent check.
Checking Red
Checked Light blue
(3) Progress bar - Displays the status of reagent check.
Display appears only in checking.
(4) No Reagent Orange Necessity reagents for the current group are missing.
There is reagent(s) shorted.
Reagent short Yellow Necessity reagents are set.
No display Light blue
(5) - Displays the error level of the reagents in the reagent1.
Red Level 1
Orange Level 2
Yellow Level 3
Light blue Normal (No error)

3. Check the reagent status of each test.

(1) (2) (3) (4)

(5)

Display Color Contents

(1) Test name 1 - Test name, color item name and blank item name
registered in the round (*1).
(2) Test name 2 - In case of 2-tests/1-reagent, another test name is displayed.
(3) Number of shots, - The number of remaining shots or remaining vol. (ml) is
Remaining vol. displayed. The display can be changed alternately.
(4) Indicator - Remaining vol. is displayed in the indicator (*2).
(*3)R1 and R2 from top to bottom.
(5) Colors of the A display that works with (4) of the reagent condition of the
background step 2.
Orange Necessity reagents for the current group are missing.
Yellow There is reagent(s) that gets shorted.
Light blue Necessity reagents are set.

*1: Regarding LIH, only the dedicated reagents are displayed. ISE are not displayed.
*2: Displays reagent volumes regarded as a daily requirement of 100%.
For details on setting the reagent, refer to "6.16.3 Set the reagent volumes required for daily
analysis" in chapter 6.
*3: When several bottles for multi reagent switch, advanced calibration, and auto-calibration are
set on the tray, the total volume is displayed with only one indicator.
4. To change the display of the remaining volume, select “Shot” or “Volume” from the drop-down list
of “Shot/Vol” at the upper right on the window.
5. To change the sample type to be displayed, select sample type from the drop-down list of “Type”
at the upper right on the window.

6-68
Performing Analysis AU480 User Guide
Version 1.0
Return to Main Table of Contents

6.16.2 Editing and Managing Reagent Condition

Check detailed information of reagents
1. From the AU480 “Home” window select Menu List>Routine>Reagent>Reagent
Management>Details to display “Reagent management: Details tab” window.

Detailed information on the reagents such as onboard stability, expiration of RB and CAL, orders
of sequenced reagent bottle, etc. are displayed by test.

Display of “RB Stability Remaining” and “CAL Stability Remaining”

The remaining time is displayed in H (hours) up to 72 hours and in D (days) for over 72 hours.
(Ex. 4D for 75 hours)
When “RB Stability Remaining” and “CAL Stability Remaining” are set for reagents of 2-test/1-
reagent, the stability remaining are displayed as “test with small item No./test with large item No.”.

Display of the volume

The volume are displayed by Number of shots.

2. Select Position from the drop-down list of “Reagent Display” to display in the order of the bottle
position on the reagent tray. And select R1 or R2 form the drop-down list of “Content”.
3. Select sample type from the drop-down list of “Type” to change the kind of samples.

6-69
AU480 User Guide Performing Analysis
Version 1.0
 Return to Main Table of Contents

Check Reagent
This function checks the reagent remaining volume, reagent ID, etc. This function is enabled only
when “Accessible” has been displayed at the upper left on the window.
1. Select Re a g e n t C h e c k ( F 5 ) on “Reagent Management: Details tab” window.
The “Regent Check” window appears.

2. Select the check item to perform.

3. Select S t a r t .
Reagent checking operation starts.
4. When “Check Specified positions” has been selected, a window to select the positions is
displayed.
5. Select the tests to be checked.
6. Select O K .
Reagent checking operation starts.
7. After the reagent check completed, check the reagent status on “Reagent Management: Main
tab” window or “Reagent Management: Details Tab” window.

Setting Reagent Bottle information manually

1. Select E d i t ( F 1 ) on “Reagent Management: Details tab” window.
The “Reagent Edit” window appears.

2. Change the bottle position to edit by selecting or .

3. Select test name, type and bottle size from the drop-down list.
4. Select C l o s e .
Settings are registered.
5. Confirm the settings on “Reagent Management: Main tab” window or “Reagent Management:
Details Tab” window.

6-70
Performing Analysis AU480 User Guide
Version 1.0
Return to Main Table of Contents

Editing Reagent positions

This function sets the reagent positions to either the reagent ID reading position or the fixed reagent
position at which no reagent ID is read.
1. Select Po s i t i o n S e t t i n g ( F 2 ) on “Reagent Management: Details tab” window.
The “Edit ID / Fix Reagent” window appears.

2. Change the reagent position to be edited by selecting or .

Test name of the selected position is displayed.
3. Select either “Reagent ID” or “Fixed Reagent”.
4. Select C l o s e .
Setting is registered.
5. Confirm the settings on “Reagent Management: Main tab” window or “Reagent Management:
Details Tab” window.

Editing Reagent ID
This function edits reagent ID of the bottle that the reagent ID error occurred.
The edited reagent ID is effective until when the reagent ID is read correctly in the next reagent check.
If the reagent ID error occurred again, the reagent ID edited here remains effective.
1. Select I D E d i t ( F 3 ) on “Reagent Management: Details tab” window.
The “Edit Barcode ID” window appears.

The reagent position that failed to read ID and its ID are displayed.
2. Enter a correct ID.
3. Select O K .
The ID entered is registered.

6-71
AU480 User Guide Performing Analysis
Version 1.0
 Return to Main Table of Contents

Reading Master Curve

This function reads the 2D barcode of the AU reagent with the hand scanner (option) to read the
master curve information.
When there is no master curve information, The comment “No Master Curve” is displayed in a
comment column on “Reagent Management: Main tab” window.
This function needs the hand scanner (option). Contact Beckman Coulter Sales Department or Service
Department for the hand scanner.
1. Select Re a d M a s t e r C u r v e ( F 4 ) on “Reagent Management: Details tab” window.
The “Master Curve” window appears.

2. Scan the 2D barcode with the hand scanner.

The ID read, corresponding test name and reagent lot number are displayed on the window.
3. Select O K .
The scanned data is registered.

6-72
Performing Analysis AU480 User Guide
Version 1.0
Return to Main Table of Contents

Reagent History
This function displays combination of the bottles on the tray, lot no. of each bottle, etc. When
performing advance calibration, auto-calibration and sequence with the different condition displayed
here, delete the combination information of the bottles.
1. Select Re a g e n t H i s t o r y ( F 6 ) on “Reagent Management: Details tab” window.
The “Reagent History” window appears.

2. Select test to display from the drop-down list of Test Name.

3. Using the normal test, the display changes between color item and blank item alternately by
selecting or .
4. When deleting the combination, select D e l e t e or A l l D e l e t e .
A confirmation message appears.
5. Select O K .
Selected information is deleted.
6. Select C l o s e to close the window.

6-73
AU480 User Guide Performing Analysis
Version 1.0
 Return to Main Table of Contents

Check information before reagent check

Check the previous reagent information before renewing the information by the last reagent check.
Check the bottle setting status when the bottle setting error occurred.
1. Select P r e v i o u s S e t t i n g ( F 7 ) on “Reagent Management: Details tab” window.
The “Previous Setting” window appears.

2. Check the information and select C l o s e to close the window.

Initializing onboard stability

This function initializes onboard stability of the reagent at the fixed reagent position.
Initialize onboard stability when replacing the reagent bottles.

6-74
Performing Analysis AU480 User Guide
Version 1.0
Return to Main Table of Contents

6.16.3 Set the reagent volumes required for daily analysis

The maximum value of the indicator displayed in each reagent status of “Reagent management: Main
tab” window is shown by a percentile (basis) of the reagent volumes required for daily analysis.
The reagent volumes required for daily analysis can be set on the “Reagent Inventory: Auto” window.
1. From the AU480 “Home” window select Menu List>Routine>Reagent>Reagent Inventory>Auto to
display “Reagent Inventory: Auto” window.

Expected consumption of the reagent can be set by items and day of the week. Also, calculating
data, based on a result of analysis performed by the use of AU480, and entering test numbers on the
window can be available.

Calculate consumption based on an actual analysis result

1. Select sample types from drop-down list.
2. Select D i s p l a y Ra n g e ( F 3 ) .
The “Range” window is displayed.
3. Select the start index and the end index from each drop-down list.
4. Select O K .
The number of analysis test selected within index range is displayed on the list.
5. Select R 1 Vo l u m e or R 2 Vo l u m e .
The reagent consumption is automatically calculated based on an actual analysis result and then
displayed on the list by mL.
The reagent consumption is calculated by the following formula:
Actual analysis result × (the amount of reagent dispensing + the amount of surplus dispensing)
6. Select “Auto” from “Decision” on drop-down list.
The predicted reagent consumption calculated automatically is set as a maximum value of
indicator on reagent display.

6-75
AU480 User Guide Performing Analysis
Version 1.0
 Return to Main Table of Contents

Calculate consumption based on entered test numbers

1. From the AU480 “Home” window select Menu List>Routine>Reagent>Reagent Inventory>Manual
to display “Reagent Consumption management: Manual tab” window.
2. Select E d i t ( F 1 ) .
The window changes to edit mode.
3. Select the sample type from drop-down list.
4. Select the number of analysis test to change, and then enter the number of analysis.
5. Select F i n i s h e d i t ( F 1 ) .
The window changes to reference mode.
6. Select R 1 Vo l u m e or R 2 Vo l u m e .
The reagent consumption input is automatically calculated based on an actual analysis result and
then displayed on the list by mL.
7. Select “Manual” from “Predicted consumption calculating standard” on drop-down list.
The predicted reagent consumption calculated automatically is set as a maximum value of
indicator on reagent display.

6-76
Performing Analysis AU480 User Guide
Version 1.0
Return to Main Table of Contents

7
Additional Tasks

This chapter describes and illustrates how to perform tasks that can
arise from day to day.

Contents
7.1 Using the Automatic Startup Function .......................................................................7-2
7.2 Setting a User Login .....................................................................................................7-4
7.2.1 Setting a User Name and Password ...............................................................7-4
7.2.2 Delete Users.....................................................................................................7-6
7.2.3 Setting Menu Access Level .............................................................................7-7
7.2.4 Security Settings . ............................................................................................7-8
7.3 Creating a User Menu .................................................................................................7-10
7.4 Calculating Statistics .................................................................................................7-12
7.4.1 Viewing Data Statistics ..................................................................................7-12
7.4.2 Creating a Correlation Chart .........................................................................7-16
7.5 Calibration Verification................................................................................................7-19
7.5.1 Entering Material Parameters . ......................................................................7-19
7.5.2 Displaying the Verification Chart ...................................................................7-20
7.6 Using Comment Master...............................................................................................7-22
7.7 Data Management .......................................................................................................7-24
7.7.1 External Data Management . .........................................................................7-25
7.7.2 Management of Condition File ......................................................................7-27
7.7.3 Offline Conditions ..........................................................................................7-29
7.8 Print the Set Contents ................................................................................................7-31
7.9 Confirmation the Reagent Consumption . ................................................................7-32
7.9.1 Confirm the Reagent Consumption....................................................................7-32

7-1
AU480 User Guide Additional Tasks
Version 1.0
 Return to Main Table of Contents

7.1 Using the Automatic Startup Function

Approximately 20 minutes are required from power ON until analysis can start.
The system can be set to start automatically at a specified times on specified days of the week. For
details on maintenance routine, refer to chapter 8 “Maintenance”.
• Periodic maintenance of the system is required to ensure its full performance.

• The automatic start up function cannot open or close the main water valve, so the
CAUTION valve must be left on. Verify that the main water pipe is leak free when using the
automatic startup function to execute a test over night or on a holiday.

Perform all maintenance which requires the system to be power to be OFF before the system is
started automatically.

Edit
Set the time for Auto Power ON of the system.
1. From the AU480 “Home” window select Menu List>System>System Condition>Auto Power On to
display the “System Condition: Auto Power On” window. The auto start up time is displayed as a
list.

2. Select E d i t ( F 1 ) .
3. Select the check box of the desired day to start the Auto Power On function.
4. Set the date and the time from the drop-down list.
5. If Auto Preparation is to be performed, select the “Auto Preparation” check box.

7-2
Additional Tasks AU480 User Guide
Version 1.0
Return to Main Table of Contents

6. Repeat steps 3 to 5 for each day to be set.

7. Select C o n f i r m ( F 1 ) .
The set contents are registered.

7-3
AU480 User Guide Additional Tasks
Version 1.0
 Return to Main Table of Contents

7.2 Setting a User Login

7.2.1 Setting a User Name and Password ...............................................................7-4
7.2.2 Delete Users.....................................................................................................7-6
7.2.3 Setting Menu Access Level .............................................................................7-7
7.2.4 Security Settings . ............................................................................................7-8
Only authorized users should be allowed to use this system. To prevent unauthorized use of the
system, enable the login in function and assign each authorized user a login name and password.
Assign a level of access to each authorized user.
A maximum of 30 user names can be set.

7.2.1 Setting a User Name and Password

1. From the AU480 “Home” window select Menu List>System>System Condition>Login
Condition>User Setting to display the “Login Condition: User Setting tab” window. User names
and levels are displayed as a list.

2. Select E d i t ( F 1 ) .

7-4
Additional Tasks AU480 User Guide
Version 1.0
Return to Main Table of Contents

3. Select A d d i t i o n o f U s e r ( F 2 ) .
The “Addition of User” window appears.

4. Enter the “User Name”. Upper and lower case characters can be used up to 20 characters.
5. Enter the new user’s password in “Password”.
Upper and lower case characters can be used up to 20 characters. Use of a Password is
optional.
6. For confirmation, re-enter the password entered in step 5 in “Confirm”.
7. Select the “User Level”. Select 1 to 10 from the drop-down list. A smaller value means a higher
level of access to other menus and operations.
8. Select O K .
9. Repeat steps 3 to 8 for each user.
10. Select C o n f i r m ( F 1 ) .
11. Select O K .
The set contents are registered.

Functions and menus that are not accessible mean that the user’s “User Level”
does not allow them to access these items. If the user needs access to these items
TIP change the user’s “User Level”.

For details on setting the level of each menu, refer to section “7.2.3 Setting Menu Access Level” in this
chapter.

7-5
AU480 User Guide Additional Tasks
Version 1.0
 Return to Main Table of Contents

Changing User Name and Password

1. Select E d i t ( F 1 ) .
2. Select the user name to be changed from the list of “Register user list”.
3. Select M o d i f y ( F 3 ) .
The “Modify” window appears.

4. Change the “User Name”.

5. Select the “Change” check box. The password may be changed.
6. Enter the “Current password”.
7. Enter the “New password”.
8. For confirmation, re-enter the password entered in step 7 in “Confirm”.
9. Change the “User Level”. Select 1 to 10 from the drop-down list. A smaller value means a higher
level of access to other menus and operations.
10. Select O K .
11. Select C o n f i r m ( F 1 ) .
12. Select O K .
The set contents are registered.

When the password for the user who is logged-in needs to be changed, change it in
the “System Condition: Password” window.
TIP

7.2.2 Delete Users

1. Select E d i t ( F 1 ) .
2. Select the user name to be deleted and select D e l e t e ( F 4 ) .
The delete message is displayed.
3. Select O K .
The user name is deleted.
4. Select C o n f i r m ( F 1 ) .
5. Select O K
The registered contents are deleted.

7-6
Additional Tasks AU480 User Guide
Version 1.0
Return to Main Table of Contents

7.2.3 Setting Menu Access Level

Only one user should have access to the parameters menus. This is menu level one. A maximum of
30 login names and 10 levels of access can be added.
There are 10 menu levels from 1 to 10. 1 is the highest level and 10 is the lowest level. The higher a
menu level is, the more user can be restricted.

Use the following procedures to set menu access levels.

1. From the AU480 “Home” window select Menu List>System>System Condition>Login
Condition>Access Level to display the “Login Condition: Access Level tab” window.

2. Select E d i t ( F 1 ) .
3. Select the menu item to be edited.
4. Set the menu level within the range from 1 to 10 from the drop-down list.
5. Repeat steps 3 to 4 until menu level setting has been completed.
6. Select C o n f i r m ( F 1 ) .
The “Confirmation” window appears.
7. Select O K .
The settings are registered and the menu is closed. If there is any conflict in access levels
between a parent menu and a child menu, an alarm window is displayed and the window returns
to the edit window.

When setting menu levels, always set lower access levels for parent menus than the
child menu levels.
When a higher access level is set for a parent menu than that of a child menu, the
CAUTION child menu may not be selected.

7-7
AU480 User Guide Additional Tasks
Version 1.0
 Return to Main Table of Contents

7.2.4 Security Settings

Perform security settings such as setting an expiration date for a password or an automatic window
lock function to lock the computer after a specified time to prevent operation by any unauthorized
persons, etc.

Security Settings
1. From the AU480 “Home” window select Menu List>System>System Condition>Login
Condition>Security to display the “Login Condition: Security tab” window.

2. Select E d i t ( F 1 ) .
3. To set an expiration date for a password, select the “Password Expiration Date” check box.
4. Enter the number of days that the password will be effective before it has to be changed.
5. To auto lock the window, select the Enable check box next to “Auto Lock”.
6. Select the period of computer idle time that must pass before the auto lock function is activated,
select from 5 to 60 minutes,
7. To enable the auto login function without inputting a user name at system start up, select the
“Enable” check box next to “Auto Login”.
8. Select the user name to set up for auto login from “Auto Login User” drop-down list.

7-8
Additional Tasks AU480 User Guide
Version 1.0
Return to Main Table of Contents

9. Select C o n f i r m ( F 1 ) .
10. Select O K .
The set values are registered.

• The password expiration date is effective for all user names.

TIP • Auto login cannot be used when auto lock is enabled.

7-9
AU480 User Guide Additional Tasks
Version 1.0
 Return to Main Table of Contents

7.3 Creating a User Menu

The User menu function allows selection of up to 16 windows that are used frequently and allows
creation of a short cut to them in one menu, called the user menu. This saves time when using the
system.

Edit
1. From the AU480 “Home” window select Menu List>System>User Menu to display the “System:
User Menu” window.

2. Select E d i t ( F 1 ) and select the blue button.

The “User Menu Entry” window appears.

3. Select the window to be registered on the user menu list from the “Select Screen” drop-down list.

7-10
Additional Tasks AU480 User Guide
Version 1.0
Return to Main Table of Contents

4. Select D e c i d e .
The window selection contents are decided.
5. Enter the custom window name into the “Display Data”. Up to 16 characters maybe entered.
6. Select E n t r y .
7. Select C o n f i r m ( F 1 ) .
The set contents are registered.

Delete in a Shortcut from the User Menu

To remove a shortcut from a user menu:
1. From the AU480 “Home” window select Menu List>System>User Menu to display the “System:
User Menu” window.
2. Select E d i t ( F 1 ) .
The “User Menu Entry” window appears. Select the window to be deleted from the “Select
Screen” drop-down list.
3. Select D e l e t e .
4. Select C o n f i r m ( F 1 ) .
The specified contents are deleted.

7-11
AU480 User Guide Additional Tasks
Version 1.0
 Return to Main Table of Contents

7.4 Calculating Statistics

Access statistics by:

7.4.1 Viewing Data Statistics ..................................................................................7-12

7.4.2 Creating a Correlation Chart .........................................................................7-16

7.4.1 Viewing Data Statistics

The Data Statistics function allows a review of key statistics of a patient sample results over a
specified time period.
To select samples to be used to generate sample statistics:
1. From the AU480 “Home” window select Menu List>Routine>Data Monitor>Data Statistics>Main
to display the “Data Statistics: Main tab” window.

2. Select the index range from the “Index” drop-down lists.

3. Select “Search all samples” or “Search the designated sample”.
4. Enter the search parameters such as Sample Kind, sample No., sample ID, patient information
(sex, age range, Patient Information 1 to 6), etc.

7-12
Additional Tasks AU480 User Guide
Version 1.0
Return to Main Table of Contents

5. Select S t a t i s t i c s tab to display the “Data Statistics: Statistics tab” window.

The data corresponding to the search range is displayed in the display format.

6. To sort the displayed data, select S o r t i n g L i s t ( F 1 ) .

The “Display Options” window appears.

7. Select the item to sort and select O K .

The order of the displayed data changes.
8. Select the item to displayed as a chart.

7-13
AU480 User Guide Additional Tasks
Version 1.0
 Return to Main Table of Contents

9. Select C h a r t V i e w tab to display the “Data Statistics: Chart View tab” window.
The search result is displayed as a graph.

10. To change the graph display parameters, select G ra p h S c a l e ( F 5 ) .

The “Graph Scale” window appears.

11. Select “Number of Display” and “X Scale” and select O K .

The graph display changes.

7-14
Additional Tasks AU480 User Guide
Version 1.0
Return to Main Table of Contents

12. To see extracted data, select D a t a V i e w to display the “Data View tab” window.

13. To generate the bar charts, select H i s t o g ra m to display the “Data Statistics: Histogram tab”
window.

14. Select the test name from the “Test Name” drop-down list to display the result.
15. Select C h a n g e D i s p l a y Ra n g e ( F 5 ) to change the range.

7-15
AU480 User Guide Additional Tasks
Version 1.0
 Return to Main Table of Contents

7.4.2 Creating a Correlation Chart

The Correlation Chart allows a comparison of two tests on the same samples within a specified time
period.
To create a correlation chart:
1. From the AU480 “Home” window select Menu List>Routine>Data Monitor>Correlation
Chart>Main to display the “Correlation Chart: Main tab” window.

2. Select the index range from the “Index” drop-down lists.

3. Set the respective Test Name for “X Axis Test Name” and “Y Axis Test Name”.
4. Select “Search all samples” or “Search the designated sample”.
5. Enter the search parameters such as sample kind, sample No., sample ID, patient information
(sex, age range, Patient Information 1 to 6), etc.
6. Select D a t a V i e w tab.
The chart display object samples are searched on the basis of the parameters specified in steps
2 to 5.

7-16
Additional Tasks AU480 User Guide
Version 1.0
Return to Main Table of Contents

7. To exclude data from the correlation chart, select D a t a V i e w tab to display the “Correlation
Chart: Data View tab” window.

8. Move the cursor to the item to be excluded and select it.

9. Select S e l e c t / D e s e l e c t ( F 5 ) .
The color of the item column changes and the item is deleted from the chart. If S e l e c t /
D e s e l e c t ( F 5 ) is selected again, the item is restored.
10. Select C h a r t V i e w tab to display the “Correlation Chart: Chart View tab” window.
The correlation chart is displayed.

7-17
AU480 User Guide Additional Tasks
Version 1.0
 Return to Main Table of Contents

11. To change the display size of the correlation chart, select G ra p h S c a l e ( F 5 ) .

The “Graph Scale” window appears.

• When A u t o is selected, the correlation chart is displays the maximum range of all the data.

• When M a n u a l is selected, set a lower limit value and an upper limit value for the X-axis and
the Y-axis. Only the specified part of the correlation chart is displayed enlarged.

7-18
Additional Tasks AU480 User Guide
Version 1.0
Return to Main Table of Contents

7.5 Calibration Verification

A calibration verification graph displays the variance from true values calculated when standard
material is run on the system. Three replicates can be plotted of each test level (maximum of six
levels).
To perform a calibration verification, follow these steps:
7.5.1 Entering Material Parameters . ......................................................................7-19
7.5.2 Displaying the Verification Chart ...................................................................7-20

7.5.1 Entering Material Parameters

To enter information concerning the standard material:
1. From the AU480 “Home” window select Menu List>Calibration>Calibration Verification>Material
Parameter to display the “Calibration Verification: Material Parameter” window.

2. Select E d i t ( F 1 ) .
The window changes to edit mode.
3. Select the test name from the “Test Name” drop-down list.
4. Select the type from the “Type” drop-down list.
5. Enter material name for the “Material Name” of the Level 1. Enter up to 10 characters.
6. When the sample barcode is used, enter “Material ID”. Enter up to three kinds using up to 20
characters.

7-19
AU480 User Guide Additional Tasks
Version 1.0
 Return to Main Table of Contents

7. Select the “Evaluate” check box to include the material for calibration verification.
Uncheck to exclude the registered material.
8. Enter the “Expected Value” and “Tolerance Value” (refer to the materials leaflet for specifications).
9. Repeat from the step 5 to the step 8 for from level 2 to level 6 to register the materials.
10. Select C o n f i r m ( F 1 ) to save the settings.

7.5.2 Displaying the Verification Chart

Once the required data has been entered, display the verification chart:
1. From the AU480 “Home” window select Menu List>Calibration>Calibration
Verification>Calibration Verification>Select Sample to display the “Calibration Verification: Select
Sample tab” window.

2. Select the index from “Index” the drop-down list.

3. Select the type from the “Type” drop-down list.
4. Select the test name from the “Test Name” drop-down list.
5. Sample No. for the “S No.”, enter registered Sample ID for the “S ID”, or select I D S e t ( F 6 )
which reads sample ID of the registered materials for verification.

7-20
Additional Tasks AU480 User Guide
Version 1.0
Return to Main Table of Contents

6. Select C h a r t D i s p l a y tab to display a graph of the observed versus the expected values.
All specified levels are displayed on the graph:

7. Change the “Material No.” on the upper right corner of the window to refer to the values of the
other materials.
8. Verify the correlatively and reagent lots, and enter the “Analyst” and “Note” information as
needed. Up to 20 characters can be used for “Analyst” and up to 60 characters can be used for
“Note”.
9. Select C o n f i r m ( F 1 ) to register the settings, the window returns to the reference window.

In step 6, a warning window appears when the objective verification materials are not
found. Select O K to return to the step 5, and enter the correct verification materials.
TIP

7-21
AU480 User Guide Additional Tasks
Version 1.0
 Return to Main Table of Contents

7.6 Using Comment Master

Entering a list of standard comments in the comment master, provides a list of standard comments
that can easily be added where necessary, rather than have to re-enter them manually each time they
are needed.
If each menu item is executed, comments that have been registered in the Comment Master are
added to the target data.
To add a comment
1. From the AU480 “Home” window select Menu List>System>Comment Masters to display the
“System: Comment Masters” window.

2. Select E d i t ( F 1 ) .
3. Select the comment attribute from the “Attribute” drop-down list.

7-22
Additional Tasks AU480 User Guide
Version 1.0
Return to Main Table of Contents

4. Enter the “Comment”.

• If the “Attribute” is informational it can have up to 6 comments tied to it. Select from lines 1
Information through 6 information and enter the comment using up to 20 characters.

• If the “Attribute” is other, enter it as a string using up to 50 characters.

• When the “Attribute” is not used, the previously entered comment information is kept, but new
entries are not allowed.

The comments set as “Information-1” to “Information-6” in the “Attribute” drop-

down list will be displayed in the “STAT Requisition: Sample” window and “Format:
Requisition Format” window.
TIP The attribute of the comments displayed in the “Sample” window can be selected in
“Format: Requisition Format” drop-down list.
The comment set as “Others” in “Attribute” drop-down list will be displayed in window
other than the “Sample” window.

5. Select C o n f i r m ( F 1 ) .
The set contents are registered.

7-23
AU480 User Guide Additional Tasks
Version 1.0
 Return to Main Table of Contents

7.7 Data Management

This section explains following:
7.7.1 External Data Management . .........................................................................7-25
7.7.2 Management of Condition File ......................................................................7-27
7.7.3 Offline Conditions ..........................................................................................7-29
Data can be backed up and stored in an external storage media to be used to recover analysis and
operational data if the computer’s hard disk becomes inoperable .
From the external data management window, analysis results can be transferred to an external
storage media in index units.
For details on setting conditions to save or output the analysis results, refer to section “7.7.3 Offline
conditions” in this chapter

External storage device

Transfer data using the following external storage media

• Floppy disk

• CD-R

• External storage devices (HD) (option) connected by USB hard disk

• The system only uses 2HD floppy disks to transfer data. 2DD floppy disks are
formatted differently and are incompatible with the system’s drive.

CAUTION • The system only uses CD-R disks to transfer data transfer using the CD drive.
CD-RW and DVD disks are incompatible with the CD drive and cannot be used.

Data which can be managed

The following sample types can be transferred.

• Patient samples (normal samples, emergency samples, STAT samples)

• Repeat Run samples

• RB samples, calibrator, quality control samples

• Assorted analysis conditions

7-24
Additional Tasks AU480 User Guide
Version 1.0
Return to Main Table of Contents

7.7.1 External Data Management

The following operations are commonly performed in the “External Data Management: Patient
tab” window, the “External Data Management: Repeat run tab” window, and the “External Data
Management: QC/Cal. tab” window.

Storage of patient samples (normal samples, emergency samples, STAT

samples)
1. From the AU480 “Home” window select Menu List>System>External Data Management>External
Data Management>Patient to display the “External Data Management: Patient tab” window.

2. Select the index from the “Index” drop-down list.

3. Select the check box of a sample to save data.

To display the emergency samples or STAT samples, select .

TIP

7-25
AU480 User Guide Additional Tasks
Version 1.0
 Return to Main Table of Contents

4. Select E x e c u t e ( F 7 ) .
The “Data Output” window indicating data is now being searched appears. After searching, the
“Data Output” window appears to select an external storage media for output.

5. Select “Media Select”.

If selecting “FD”, the “Format” check box will be available by pressing C t r l + A l t + F at the
same time.

If the floppy disk needs to be formatted, select the “Format” check box.
TIP

6. Select O K .
The “Data Output” window appears and displays a confirmation message.
7. Select O K .
Output starts.
The “Data Output” window displays a comment and the transaction progress.

• A confirmation or warning message appears depending on transaction progress.

• A comment indicating output transaction has been successfully completed

TIP appears on the “Data Output” window.

8. Select O K .
To go back to the “External Data Management: Patient tab” window.
9. Select O K .
To remove USB media, go to step 10.
To remove other media, remove it from data processor.
10. Select Re m o v e ( F 4 ) .
The “Remove” window appears.
After the transaction Completed, the “Remove” window displays O K message.

7-26
Additional Tasks AU480 User Guide
Version 1.0
Return to Main Table of Contents

7.7.2 Management of Condition File

The system can input or output assorted parameters to an internal back up folder or an external
storage media.
The following operations are commonly performed in the “External Data Management: Patient
tab” window, the “External Data Management: Repeat run tab” window, and the “External Data
Management: QC/Cal. tab” window.
Method of saving files
1. From the AU480 “Home” window select Menu List>System>External Data Management>File
Management to display the “External Data Management: File Management tab” window.

2. Select file operation from “Operation”.

If selecting “Save Files to HD”, a parameter file will be saved in a temporary folder. If
saving to external memory media, select “Save Files to External Media”.
TIP

3. Select F i l e S e l e c t ( F 6 ) .
The “File Select” window appears.
4. Select files for output.
5. Select O K .
The selected contents in steps 4 and 5 are displayed on the “External Data Management: File
Management tab” window.

7-27
AU480 User Guide Additional Tasks
Version 1.0
 Return to Main Table of Contents

6. Select E x e c u t e ( F 7 ) .
The “Execute” window appears.
7. Select media for output in the “Execute” window.
If selecting media other than FD, go to step 10. If selecting “FD”, the “Format” check box will be
available by pressing C t r l + A l t + F at the same time.

If the floppy disk needs to be formatted, select the “Format” check box.
TIP

8. Select O K .
The “Execute” window displays transaction complete message.
9. Select O K .
The transaction selected on the step 2 starts. When the transaction completes, a transaction
complete message appears.
10. Select O K .
The “External Data Management: File Management tab” window appears.
11. Select Re m o v e ( F 4 ).
The “Remove” window appears. After the transaction is completed, the “Remove” window
displays a transaction complete message.
12. Select O K .
Remove the media connected to the USB port.

If loading the saved parameter file, select “Load Files from HD” or “Load Files from
External Media” from “Operation”.
• If selecting “Load Files from HD”, the parameter file saved in temporary folder in
TIP HD will be loaded.

• If selecting “Load Files from External Media”, the parameter file saved in external
media will be loaded.

7-28
Additional Tasks AU480 User Guide
Version 1.0
Return to Main Table of Contents

7.7.3 Offline Conditions

The Offline Output function enables sample and patient information to be saved on floppy disc for use
on other computers. Data can be saved from normal, repeat or QC and calibration analyses.

• Setting Common Conditions in this section

• Data Output Conditions in this section.

1. From the AU480 “Home” window select Menu List>System>External Data Management>Offline
Format>Common Condition to display the “Offline Format: Common Condition” window.

7-29
AU480 User Guide Additional Tasks
Version 1.0
 Return to Main Table of Contents

Setting Common Conditions

1. Select E d i t ( F 1 ) .
The window changes to edit mode.
2. Set a Volume label for the data storage device.
3. Select a name for the data storage folder and a data storage method from each drop-down list.
4. Select the Parameter storage folder from the drop-down list.
5. Select a field delimiter from the drop-down list.
6. Select the Format Type for FD and External Memory Unit from the drop-down list.
7. Select C o n f i r m ( F 1 ) .
Set values are registered, and the window goes returns to the previous window.

Data Output Conditions

1. From the AU480 “Home” window select Menu List>System>External Data Management>Offline
Format>Data Output Condition to display the “Offline Format: Data Output Condition” window.

2. Select E d i t ( F 1 ) .
The window changes to edit mode.
3. Select output conditions from each drop-down list.
4. Select I t e m O r d e r ( F 5 ) .
The “Item Order” window appears.
5. Select the tests for offline output.
6. Select O K to return to the previous window.
7. Select C o n f i r m ( F 1 ) .
Setting values are registered, and the window changes returns the previous.

7-30
Additional Tasks AU480 User Guide
Version 1.0
Return to Main Table of Contents

7.8 Print the Set Contents

When P r i n t ( F 8 ) is displayed on the window, the contents that have been set can be printed.
1. When the printer power indicator light on the printer is not lit, make sure the printer (option) is
turned on and the power cord is connected correctly.
2. Verify that the printer has paper.
3. Select P r i n t ( F 8 ) .
The “Print Start” window appears. When “Start” window is displayed, go to step 4.
4. Set print option on the window.
5. Select O K .
Printing starts.

To cancel printing, select C A N C E L during printing.

TIP

7-31
AU480 User Guide Additional Tasks
Version 1.0
 Return to Main Table of Contents

7.9 Confirmation the Reagent Consumption

Confirm the reagent consumption used for analysis in the analyzer.

7.9.1 Confirm the Reagent Consumption

1. From the AU480 "Home" window select Menu List>Routine>Reagent>Reagent Consumption to
display "Reagent Consumption" window.

2. Select the sample type from drop-down list.

3. Select D i s p l a y Ra n g e ( F 3 ) to display the “Display range” window.
4. Select the start index and the end index from each drop-down list.
5. Select O K .
The number of cumulative tests is displayed.

Confirm the Reagent Consumption by the number of the reagent dispensing

1. Select “Test Shots” after setting the index range and sample type.
The number of the reagent dispensing is displayed in item/sample type.
2. Select R 1 Vo l u m e or R 2 Vo l u m e .
The reagent consumption is displayed on the list.
The reagent consumption is calculated by the following formula:
Actual analysis result × (the amount of reagent dispensing + the amount of surplus dispensing)

Confirm the Reagent Consumption by the number of the measured sample

1. Select “Test Total” after setting the index range and sample type.
The number of measured sample is displayed in item/sample type.
2. Calculate the reagent consumption based on the number of the measured sample displayed.

7-32
Additional Tasks AU480 User Guide
Version 1.0
Return to Main Table of Contents

8
Maintenance

The maintenance frequency described in this chapter is based on

analysis of 2,000 or less tests per day. Laboratories may have to
increase the amount of maintenance required depending upon number
of tests and local environmental condition.
This chapter illustrates how to keep the system operating in good
condition through periodic maintenance procedures.

Contents
8.1 Using the Routine Maintenance Schedule .................................................................8-3
8.2 Maintenance Log............................................................................................................8-4
8.2.1 Adding a Maintenance Task.............................................................................8-4
8.2.2 Updating the Maintenance Register.................................................................8-6
8.2.3 Viewing Maintenance History...........................................................................8-7
8.3 Daily Maintenance..........................................................................................................8-8
8.3.1 Inspect the Syringes for Leaks and Proper Installation....................................8-8
8.3.2 Inspect the Wash Solution Roller Pump Unit for Leaks ................................. 8-11
8.3.3 Inspect and Replenish the Concentrated Wash Solution ..............................8-13
8.3.4 Inspect, Clean and Prime the Sample, Reagent Probes, and Mix Bars.........8-15
8.3.5 Inspect the Printer (option) and Paper............................................................8-18
8.4 Weekly Maintenance....................................................................................................8-19
8.4.1 Manual cleaning the Sample Probe and Mix bars..........................................8-20
8.4.2 Perform a W2 (Automatic Washing of each Probe,
Mix bar and Cuvettes, etc.).............................................................................8-24
8.4.3 Perform a Photocal.........................................................................................8-27
8.4.4 Clean the Sample Pre-diluent Bottle..............................................................8-30
8.5 Monthly Maintenance..................................................................................................8-31
8.5.1 Clean the Sample Probe and Reagent Probe Wash Stations........................8-32
8.5.2 Clean the Mix Bar Wash Station.....................................................................8-35
8.5.3 Clean the Wash Nozzle Unit and Check the Tube Mounting Joints...............8-37
8.5.4 Clean the Deionized Water Filter and the Sample Probe Filter......................8-42
8.5.5 Clean the Sample Probe Filter.......................................................................8-45
8.6 Maintenance Every Three Months..............................................................................8-48
8.6.1 Clean the Air Filters........................................................................................8-49
8.6.2 Replace the Deionized Water Filter................................................................8-50
8.6.3 Replace the Sample Probe Filter and O-Ring................................................8-52
8.6.4 Clean the Deionized Water Tank....................................................................8-54
8.6.5 Replace the Wash Solution Roller Tube.........................................................8-57
8.7 Maintenance Performed Every Six Months...............................................................8-59
8.7.1 Replace the Photometer Lamp.......................................................................8-59
8.7.2 Washing Cuvettes and the Cuvette Wheel.....................................................8-63
8.8 Maintenance Performed Yearly or As Necessary.....................................................8-67
8.8.1 Replace O-rings in the Wash Nozzle Supply Tube Mounting Joints...............8-68
8.8.2 Replace Cuvettes...........................................................................................8-70
8.8.3 Manually Wash the Reagent Probe................................................................8-72

8-1
AU480 User Guide Maintenance
Version 1.0
 Return to Main Table of Contents

8.8.4 Replace Sample Probe and Reagent Probe..................................................8-73

8.8.5 Replace Mix bars............................................................................................8-76
8.8.6 Replace the Wash Nozzle Joint......................................................................8-78
8.8.7 Replace Syringes...........................................................................................8-82
8.8.8 Clean the inside of the STAT table unit and Reagent Refrigeration Unit........8-87
8.8.9 Replace the Antistatic Brush...........................................................................8-89
8.8.10 Replace Rack ID labels..................................................................................8-90
8.8.11 Replace the Sample Probe and Reagent Probe Tubes..................................8-91
8.8.12 Execute a W1 (Auto-wash of the sample probe and cuvettes).......................8-93
8.8.13 Replace Air Filters..........................................................................................8-94
8.8.14 Replace Syringe cases and Syringe heads....................................................8-95
8.8.15 Replace Packing in the Wash Nozzle Tube Mounting Joints........................8-100
8.9 Resetting the system when switched to the stop mode
while performing maintenance.................................................................................8-101
8.10 Using the BECKMAN COULTER SUPPORTVISION (BSV) (Option).......................... 8-102
8.10.1 Transmitting files with BSV...........................................................................8-103
8.10.2 When the BECKMAN COULTER SUPPORTVISION (BSV)
connection is off............................................................................................8-104
8.11 AU480 Maintenance Schedule..................................................................................8-105

Failure to perform user maintenance according to the instructions within this User
Guide can adversely affect system performance and might invalidate the service
agreement.
CAUTION

8-2
Maintenance AU480 User Guide
Version 1.0
Return to Main Table of Contents

8.1 Using the Routine Maintenance Schedule

To ensure optimal performance, users should perform planned maintenance on the system.
On “8.11 AU480 Maintenance Schedule” Beckman Coulter recommends that users place a CHECK
MARK after each task when that task is completed.

8-3
AU480 User Guide Maintenance
Version 1.0
 Return to Main Table of Contents

8.2 Maintenance Log

The Maintenance Log allows user to create a planned maintenance schedule by:
8.2.1 Adding a Maintenance Task.............................................................................8-4
8.2.2 Updating the Maintenance Register.................................................................8-6
8.2.3 Viewing Maintenance History...........................................................................8-7

8.2.1 Adding a Maintenance Task

Users can add tasks to the list of mandated activities. To add a maintenance task, do the following:
1. From the AU480 “Home” window select Menu List>Maintenance>User Maintenance>Analyzer
Maintenance>Maintenance to display the “Analyzer Maintenance: Maintenance tab” window.

Single Operation buttons

2. Select the next free position from the maintenance activity list.

8-4
Maintenance AU480 User Guide
Version 1.0
Return to Main Table of Contents

3. Select M a i n t e n a n c e E d i t ( F 1 ) .
The “Item Edit” window appears.

4. Enter the work name in the “Maintenance” column.

5. Select the unit of execution interval from the “Frequency” drop-down list and enter the interval
value (1 to 180) with the keyboard in the field.

The upper limit of the operation interval for each maintenance is displayed in “Limit”.
Specify a value of “Period” within the range based on “Limit”.
TIP

6. Select O K .
This registers the settings entered.

8-5
AU480 User Guide Maintenance
Version 1.0
 Return to Main Table of Contents

8.2.2 Updating the Maintenance Register

After performing maintenance tasks, maintenance records should be updated.
1. From the AU480 “Home” window select Menu List>Maintenance>User Maintenance>Analyzer
Maintenance>Maintenance to display the “Analyzer Maintenance: Maintenance tab” window.

2. Select the maintenance task to check in the displayed list.

3. Select U p d a t e .
A confirmation window appears.
4. Select O K .
This automatically enters the current date on the maintenance task and sets the next due date.

If the update in step 3 and 4 is not performed after performing maintenance, moving
on to other operation or window may be impossible.
TIP

8-6
Maintenance AU480 User Guide
Version 1.0
Return to Main Table of Contents

8.2.3 Viewing Maintenance History

The system keeps track of the previous ten completed maintenance tasks.
To view maintenance history for an item:
1. From the AU480 “Home” window select Menu List>Maintenance>User Maintenance>Analyzer
Maintenance>Maintenance to display the “Analyzer Maintenance: Maintenance tab” window.

2. Select the maintenance task to check in the work list.

3. Select M a i n t e n a n c e H i s t o r y ( F 2 ) .
When the “Maintenance History” window is displayed, the last ten maintenance dates, the next
due data, and the User Name are displayed.

4. Select O K .
The “Analyzer Maintenance: Maintenance” window appears.

8-7
AU480 User Guide Maintenance
Version 1.0
 Return to Main Table of Contents

8.3 Daily Maintenance

To obtain the highest performance from the system and to use it safely, be sure to perform the
following daily maintenance.

Record

• Record the maintenance done in the “Maintenance Schedule”.

• After performing maintenance tasks, select the performed maintenance task from list displayed
on “Analyzer Maintenance: Maintenance” window and update performed date. For details on
updating the maintenance record, refer to section “8.2.2 Updating the Maintenance Register” in
this chapter.

Maintenance routines
To obtain the highest performance from the system and to use it safely, be sure to perform the
following daily maintenance.
If O N (sub-power) is off, Beckman Coulter recommends that these maintenance procedures are
performed before powering up the system.
8.3.1 Inspect the Syringes for Leaks and Proper Installation....................................8-8
8.3.2 Inspect the Wash Solution Roller Pump Unit for Leaks ................................. 8-11
8.3.3 Inspect and Replenish the Concentrated Wash Solution ..............................8-13

After the power is on

8.3.4 Inspect, Clean and Prime the Sample, Reagent Probes, and Mix Bars.........8-15
8.3.5 Inspect the Printer (option) and Paper............................................................8-18

Always wear personal protective equipment when performing any maintenance

procedure. To avoid injury and infection, observe the “WARNING” and “CAUTION”
CAUTION notations described in this User’s Guide.

8.3.1 Inspect the Syringes for Leaks and Proper Installation

The system utilizes a sample syringe, a reagent syringe, and an optional ISE syringe. The sample and
reagent syringes are responsible for accurately measuring the volume of sample or reagent to be used
in a reaction. The ISE syringe is responsible for measuring the correct volume of buffer for the ISE.
Although the syringes may be different sizes and serve different functions, the proper performance can
be gauged in the same way for each.
Inspect all components of the syringes, including the syringe case head, the syringe case, the fixing
nut and the piston fixing screw for leaks and proper installation.

8-8
Maintenance AU480 User Guide
Version 1.0
Return to Main Table of Contents

Procedure for checking for leak at the Sample, reagent and ISE Syringes
The procedure for checking the sample syringe and reagent syringe.

Materials:
Clean dry cloth or paper towel

1. Ensure the system ON (sub-power) is off or the system is in Warm up, Standby , or Stop
mode.
2. Open the right door.

Sample Syringe
ISE reagent Syringe
Fixing nut
Reagent Syringe
Fixing screws

Case head
Syringe case

Piston fixing screw

Possible leakage locations

3. Using the cloth or paper towel, search the top and bottom connections of the syringe case head,
the syringe case, and the bottom fixing screw for leaks.
Replace the case head, if any cracks are found on it. After the replacement proceed to step 8.

Make sure that the syringe case is not contaminated with any strong alkali such as
wash solution, etc. If the syringe case is contaminated with a strong alkali, it may be
broken.
CAUTION If the case comes in contact with the strong alkali, remove the syringe case and flush
the contamination.

For details on replacing the syringe, refer to section “8.8.7 Replace Syringes” in this chapter.
4. Wipe the bottom part of the syringe case, the contact part of the case head and syringe case, and
the fixing screw part with a dry cloth or paper towel to check for any leaks from them.
If any leak is found, wipe around the syringe case with a clean dry cloth.

If hands come in contact with any liquid, wash them thoroughly with water
immediately.
CAUTION

8-9
AU480 User Guide Maintenance
Version 1.0
 Return to Main Table of Contents

5. Determine if the case head is loose by turning the syringe case with fingers.

• If loosen, turn the syringe case clockwise against the case head to tighten them.

• If a leak happened previously, check the bottom of the syringe to see if any more leaks
occur after 5 minutes have passed.
6. Determine if the two fixing screws, the fixing nut, or the piston fixing screw are loose on the
syringes.
If loose, tighten the item, check for leaks on the bottom of the syringe after 5 minutes have
passed.
7. Visually check the inside of the syringe case for any leak.
If there is a leak, replace the syringe. Then, advance to step 8.
8. Close the right front door of the analyzer.

If any leak persists even after tightening, replace the syringe with a new one.
CAUTION

For details on syringe replacement, refer to section “8.8.7 Replace Syringes” in this chapter.

After turning the system power on by pressing the ON button, update the performed
date by selecting I n s p e c t s a m p l e s y r i n g e f o r l e a k s and
I n s p e c t r e a g e n t s y r i n g e f o r l e a k s on the “Analyzer
TIP Maintenance: Maintenance tab” window.

For details on updating the maintenance date, refer to section “8.2.2 Updating the Maintenance
Register” in this chapter.

8-10
Maintenance AU480 User Guide
Version 1.0
Return to Main Table of Contents

8.3.2 Inspect the Wash Solution Roller Pump Unit for Leaks
The wash solution roller pump draws concentrated wash solution from the bottle and supplies it to the
diluted wash solution bottle where it is diluted to a 2% solution. If the pump leaks, concentrated wash
solution may be diluted improperly. Therefore, always check the wash solution roller pump unit for
leaks prior to starting analysis.

Procedure for checking for any leak from wash solution roller pump unit
Materials :
Clean dry cloth

1. Ensure the system ON (sub-power) is off or the system is in Warm up , Standby , or Stop
mode.
2. Open the left door.

Roller tube

Wash solution
roller pump

Connectors

If the user’s hands or fingers come in contact with any liquid, wash them thoroughly
with water immediately.
CAUTION

3. Visually inspect the wash solution roller pump tube for any cracks.
If a crack is found replace the wash solution roller tube. After the replacement proceed to step 6.
4. Blot the peripheral part of the wash solution roller tube at its connections with a clean dry cloth to
detect any leaks.
If a leak is found wipe up the liquid with a dry cloth and re-inspect the wash solution roller pump
to find the origin of the leak.
5. Verify the tube connections are tight.
If loose, turn the connector of the wash solution roller tube clockwise to tighten the connector. In
five minutes after tightening it to remedy a leak, if any, check the wash solution roller tube again
for any more leaks.

8-11
AU480 User Guide Maintenance
Version 1.0
 Return to Main Table of Contents

6. Close the left door.

If any leak persists even after being re-tightened, replace the wash solution roller
pump tubing with a new one.
CAUTION

For details on replacement of the wash solution roller pump tube, refer to section “8.6.5 Replace the
Wash Solution Roller Tube” in this chapter.

After turning the system power on, update the maintenance performed date by
selecting I n s p e c t P u m p Ro l l e r f o r l e a k s on the “Analyzer
TIP Maintenance: Maintenance tab” window.

For details on updating the maintenance date, refer to section “8.2.2 Updating the Maintenance
Register” in this chapter.

8-12
Maintenance AU480 User Guide
Version 1.0
Return to Main Table of Contents

8.3.3 Inspect and Replenish the Concentrated Wash Solution

If the concentrated wash solution level is low, operation of the system will be interrupted. To avoid
transferring the system into Pause mode, always observe the level of concentrated wash solution. If
it is found to be low, replenish the concentrated wash solution.
Materials:

• Concentrated wash solution

• Clean dry cloth

Inspect the concentrated wash solution level

1. Ensure the system ON (sub-power) is off or the system is in Warm up , Standby , or Stop
mode.
2. Open the left door.

Wash solution tank

3. Find the small mark etched on the concentrated wash solution tank (approximately 200 mL).
At that level, the volume of concentrated wash solution is insufficient.
Verify that the level is sufficient for the day’s workload. As a reference, for a laboratory that runs
2,000 tests per day, consumption of concentrated wash solution is generally 0.5 L/day.
4. Close the left door.

8-13
AU480 User Guide Maintenance
Version 1.0
 Return to Main Table of Contents

Replenishing the Concentrated Wash Solution

• When removing the concentrated wash solution cap, wear gloves to prevent
hands from coming in contact with the concentrated wash solution. If hands or
clothes come in contact with concentrated wash solution, wash them with water
WARNING immediately. If the concentrated wash solution comes into contact with the eyes or
mouth, flush with water and consult a doctor immediately.

• If the concentrated wash solution is splashed or accidentally spills, wear gloves

and wipe the area with a dry cloth or paper towel. If any spill is left untreated, it
may generate toxic gas and may cause parts of the analyzer to corrode.

1. Shut down the system selecting E n d .

2. Pull the wash solution tank forward to access the wash solution tank cap.

Dripping may occur when the level sensor is removed from the tank. If it does, wipe
the area with a dry cloth or paper towel wearing rubber gloves.
CAUTION

3. Unscrew the wash solution tank cap, and remove the cap and connector from the wash solution
tank.

Wash solution tank

4. Place the wash solution tank cap and connector in a new bottle of wash solution. Tighten the cap.
5. Place the new bottle of wash solution back on the analyzer.
6. Close the left door.

After turning the system power to on, update the maintenance date by selecting
I n s p e c t c o n c e n t ra t e d w a s h s o l u t i o n l e v e l on the
TIP “Analyzer Maintenance: Maintenance tab” window.

For details on updating the maintenance date, refer to section “8.2.2 Updating the Maintenance
Register” in this chapter.

8-14
Maintenance AU480 User Guide
Version 1.0
Return to Main Table of Contents

8.3.4 Inspect, Clean and Prime the Sample, Reagent Probes, and
Mix Bars
The probes are responsible for delivering precise quantities of either reagent or sample to the
cuvettes. And mix bars are responsible for mixing the solution. If they are clogged, bent, or otherwise
damaged, proper analysis may not be achieved.
Prior to starting analysis inspect the sample, reagent probes, and mix bars for damage or deterioration
as well as verify proper operation of each.
Materials:
Alcohol prep

Inspect the Sample, Reagent Probes, and Mix Bars for Damage or Deterioration
1. Ensure the system is in Warm up , Standby , or Stop mode.
2. Open the main cover.
3. From the AU480 “Home” window select Menu List>Maintenance>User Maintenance>Analyzer
Maintenance>Maintenance to display the “Analyzer Maintenance: Maintenance tab” window.

8-15
AU480 User Guide Maintenance
Version 1.0
 Return to Main Table of Contents

4. In the Maintenance Item list select the item to inspect or clean, then select the Single Operation
button for the maintenance item.

The items to be The list of

Single Operation button
checked or cleaned maintenance items
Sample probe Inspect & clean sample probe Replacing Sample Probe
Reagent probe Inspect & clean reagent probe Replacing Reagent Probe/
Syringe
Mix bar Inspect & clean mix bars Replacing Mixing Bar
5. Set number of times to perform cleaning and select O K .

The items to be
The items to be set
checked or cleaned
Sample probe The number of times the wash water is drained: 3 or more
Reagent probe The number of times the wash water is drained: 3 or more
Mix bar The number of operation: 1

6. Press the TA B L E R OTAT I O N / D I A G button.

The items to be
Operation
checked or cleaned
Sample probe The water will be ejected from each probe tip. Check that the water is ejected
Reagent probe straight and like a string. If the water is sprayed or is not ejected straight from
any probe tip, wash the probe.
Mix bar The mixing unit rotates and moves up and down, and they will be cleaned with
diluted wash solution and water.

OK NG

If the dispense is incorrect after the probes have been primed, replace the probes.
CAUTION

For details on replacing the sample probe and reagent probe, refer to section “8.8.4 Replace Sample
Probe and Reagent Probe” in this chapter.
7. After inspecting and cleaning has completed, select U p d a t e .
A confirmation window appears.
8. Select O K .
9. Close the main cover.

8-16
Maintenance AU480 User Guide
Version 1.0
Return to Main Table of Contents

Check the Sample probe, reagent probe, and the Mix Bars for Damage
1. Visually inspect the sample probe, reagent probe or mix bars and verify that they are not bent or
damaged.
If the sample probe, reagent probe or mix bar is bent or damaged, replace it with new one.

• For details on replacement of sample probe and reagent probe, refer to section “8.8.4
Replace Sample Probe and Reagent Probe” in this chapter.

• For details on how to replace the mix bars, refer to section “8.8.5 Replace Mix bars” in this
chapter.
2. Press the O N button to turn the system power to on.
The analyzer begins initialization.

When the Analyzer starts, select S t o p / S t a n d b y in the “Home” window. The

analyzer enters Stop mode.
Next select S t o p / S t a n d b y in the “Home” window.
TIP This analyzer starts the initialization process.

3. Make sure that the sample probe, reagent probe and mix bars do not come in contact with the
wash station wells during the initialization.
When the sample probe, reagent probe or mix bar does not align correctly in the wash station
wells, system damage may occur, contact Beckman Coulter Technical Services.

Manually Clean the Sample Probe, Reagent Probe, and the Mix Bars
Clean any contaminants or crystallization adhered to the sample probe, reagent probe, and mix bar.

Materials:

• Ethyl alcohol (Ethanol)

• Clean cloth or paper towel

Be careful not to bend the probes or mix bars while cleaning them.
CAUTION

Wipe the outside surface of the sample probe, reagent probe or mix bar with a clean cloth or paper
towel soaked in ethyl alcohol (ethanol).

8-17
AU480 User Guide Maintenance
Version 1.0
 Return to Main Table of Contents

8.3.5 Inspect the Printer (option) and Paper

Before starting daily analysis, verify the printer is turned on and that there is a sufficient amount of
paper in the printer.
For additional information on printer usage, refer to the “Printer User Guide” supplied with the printer.

After turning the system power on by pressing the ON button, update the performed
date by selecting I n s p e c t p r i n t e r & p a p e r on the “Analyzer
TIP Maintenance: Maintenance tab” window.

For details on updating the maintenance date, refer to section “8.2.2 Updating the Maintenance
Register” in this chapter.

8-18
Maintenance AU480 User Guide
Version 1.0
Return to Main Table of Contents

8.4 Weekly Maintenance

Record

• Record the maintenance actions performed in the “Maintenance Schedule”.

• After performing maintenance tasks, select the performed maintenance task from list displayed
on the “Analyzer Maintenance: Maintenance” window and update the performed date. For
details on updating the maintenance record, refer to section “8.2.2 Updating the Maintenance
Register” in this chapter.

Maintenance routines
Perform the following tasks every week:
8.4.1 Manual cleaning the Sample Probe and Mix bars..........................................8-20
8.4.2 Perform a W2 (Automatic Washing of each Probe,
Mix bar and Cuvettes, etc.).............................................................................8-24
8.4.3 Perform a Photocal.........................................................................................8-27
8.4.4 Clean the Sample Pre-diluent Bottle..............................................................8-30

Always wear personal protective equipment when performing any maintenance

procedure. To avoid infection or injury observe and follow the “WARNING” and
“CAUTIONS” in this User’s Guide.
CAUTION

8-19
AU480 User Guide Maintenance
Version 1.0
 Return to Main Table of Contents

8.4.1 Manual cleaning the Sample Probe and Mix bars

If probes or mix bars become contaminated or stained, carryover between reagents or
samples may result. If there are stains or crystallization on the outside of the sample
probe, reagent probe, or mix bars, clean the part with an alcohol prep as needed.
CAUTION To prevent contamination and ensure proper analysis and results, clean the sample
probe, reagent probe, and mix bars as needed.

Procedure for Washing Sample Probe

Materials:

• Ethyl alcohol (Ethanol)

• Clean cloth or paper towel

• Mandolin string (Standard accessory)

1. Verify that the system is in the Warm up or Standby mode.

2. Open the main cover.
3. From the AU480 “Home” window select Menu List>Maintenance>User Maintenance>Analyzer
Maintenance>Maintenance to display the “Analyzer Maintenance: Maintenance tab” window.

4. Select M a n u a l Wa s h i n g S a m p l e P r o b e from the list of maintenance items.

5. Select Re p l a c i n g S a m p l e P r o b e from the “Single Operation” buttons.
The “Start” window appears.
6. Enter 3 or more as the number of times the wash water is drained and select O K .

8-20
Maintenance AU480 User Guide
Version 1.0
Return to Main Table of Contents

7. Press the TA B L E R OTAT I O N / D I A G button.

Liquid will be drained from the sample probe, and the sample probe will be washed.
8. Disconnect the probe connector.

When handling the sample probe, do not bend or damage the tip of the probe.
CAUTION

9. Holding the probe connector by hand, pull the probe upward.

Discard any of the water in the probe wash well.

Probe connector

Sample probe

TABLE ROTATION
/DIAG button

10. Wipe off any contamination on the probe with a clean cloth or paper towel damped with ethyl
alcohol (ethanol).
11. Insert the mandolin string into the nozzles from the probe tip to clean the nozzles.
12. Re-insert the probe into their original position.
13. Tighten the probe connectors to secure each probe. Tighten the connectors firmly to ensure that
no liquid leaks from the joints.
14. Press the TA B L E R OTAT I O N / D I A G button.
Water will be ejected from the probe tip. Verify that the water is ejected straight like a string.
If the water spray is wide or is not ejecting straight from the probe tip, replace the probe.
15. Select U p d a t e .
A confirmation window appears.
16. Select O K .
For information about how to replace the sample probe and reagent probe, refer to section “8.8.4
Replace Sample Probe and Reagent Probe” in this chapter.

8-21
AU480 User Guide Maintenance
Version 1.0
 Return to Main Table of Contents

Procedure for Washing the Mix bars

Materials:

• Ethyl alcohol (Ethanol)

• Clean cloth or paper towel

1. Pull the six mix bars upward from the mixing unit.

Mix bar

Mixing unit

TABLE ROTATION
/DIAG button

2. Gently wipe off any stains on the mix bars with a clean cloth or paper towel soaked with ethyl
alcohol (ethanol).

When inserting the mix bars into the mixing unit, be careful not to scratch the bars.
CAUTION

3. Re-insert the mix bars into their original position from the top of the unit. Rotate each bar slightly
to engage the notch on the mix bar with the gear in the hole on the mixing unit.

The shapes of mix bars are different as follows:

• The mix bar for R1 and S, MU9599: screw type

CAUTION • The mix bar for R2, MU8267: L-shaped type

Set each mix bar at proper position.

mix bar for R1 and S

mix bar for R2

S 3 R1
R2
4

2
R2

R1 1 S mix bar for R2

mix bar for R1 and S

8-22
Maintenance AU480 User Guide
Version 1.0
Return to Main Table of Contents

4. From the AU480 “Home” window select Menu List>Maintenance>User Maintenance>Analyzer

Maintenance>Maintenance to display the “Analyzer Maintenance: Maintenance tab” window.
5. Select C l e a n m i x b a r from the list of maintenance items.
6. Select Re p l a c i n g m i x i n g b a r from the “Single Operation” buttons.
The “Start” window appears.
7. Enter 3 or more as the number of times the wash water is drained and select O K .
8. Press the TA B L E R OTAT I O N / D I A G button.
9. Select U p d a t e .
A confirmation window appears.
10. Select O K .
11. Close the main cover.

8-23
AU480 User Guide Maintenance
Version 1.0
 Return to Main Table of Contents

8.4.2 Perform a W2 (Automatic Washing of each Probe, Mix bar

and Cuvettes, etc.)
The sample probe, reagent probe, mix bars, and cuvettes get contaminated after frequent operation,
this contamination will affect analysis results.
To rectify this problem perform a W2 to automatically wash cuvettes, etc. with wash solution, and then
execute photocal measurement to check if any cuvette is still contaminated. Cuvettes that register an
abnormal value during a photocal should be washed or replaced.
For details on executing a photocal, refer to section “8.4.3 Perform a Photocal” in this chapter.

Procedure for executing W2 (Automatic washing of each probe, Mix bar, and
cuvette, etc.)
It takes about 25 minutes from start to finish to perform a W2.
The W2 is accomplished by running an acidic wash solution or alkaline wash solution through the
system. Each week the chemical used will be alternated. The acidic wash solution removes stains that
are formed by protein deposits left in the cuvettes. The alkaline wash solution removes a very small
quantity of inorganic substances such as metallic ions as well as any bacterial contamination.

• The alkaline and the acid should never be mixed; all wash solution
containers onboard the instrument should contain the same chemical. The
mixture of the acidic wash solution and the alkaline wash solution results
WARNING in the formation of chlorine gas, which is highly toxic. To avoid such risk,
clearly label containers designated for the acidic wash solution and the
alkaline wash solution and ensure that all positions requiring W2 cleaning
chemicals contain the same chemical.

• To perform a W2, prepare a 1 N concentration of hydrochloric acid as the

acidic wash solution and a sodium hypochlorite solution with a 0.5% effective
concentration of chlorine as the alkaline wash solution. Discard any old Sodium
Hypochlorite solution. Always prepare a fresh Sodium Hypochlorite solution for
each procedure.
Exercise care for the following points:
• Keep hands and clothing from coming into contact with the wash solution.
If the operator’s hands or clothing come into contact with the wash solution, rinse
it off immediately with water. If the wash solution comes into contact with the eyes
or mouth rinse it, immediately with water and consult a doctor.

• Avoid spilling wash solution on the system.

If wash solution is accidentally spilled on the system, wipe the effected area with a
cloth or paper towel dampened with water, and then wipe two to three times with a
dry cloth or paper.

8-24
Maintenance AU480 User Guide
Version 1.0
Return to Main Table of Contents

Materials:

• 60 mL plastic reagent bottle, quantity 1

• Cleaning Chemical
70 mL of 1N hydrochloric acid or 70 mL of sodium hypochlorite solution with a 0.5% effective
concentration of chlorine.

• Sample tube, quantity 1

1. Open the main cover.

2. Fill one 60 mL bottle and one sample tube with the cleaning chemical chosen for this week’s
procedure. (If sodium hypochlorite was used on the previous W2, use hydrochloric acid for this
one.) The bottle should be filled with approximately 60 mL. The liquid level should be below in the
neck of the bottle. The sample tube should be filled with approximately 10 mL.
3. Place the 60 mL bottle in the W2 bottle setting position on the instrument as the following diagram
entails. Place the sample tube in W2 position in the STAT table unit.

Wash solution bottle

The W2 bottle setting position

Avoid spilling the wash solution when handing the reagent bottle. If the wash solution
is accidentally spilt, wipe the effected area with a cloth or paper towel dampened with
a water. Then, wipe the area two to three times with a dry cloth or paper.
CAUTION

4. Ensure the system is in Standby or Stop mode.

8-25
AU480 User Guide Maintenance
Version 1.0
 Return to Main Table of Contents

5. From the AU480 “Home” window select Menu List>Maintenance>User

Maintenance>Analyzer Maintenance>Maintenance to display the “Analyzer Maintenance:
Maintenance tab” window.

W2

6. Select W 2 ( F 6 ) from the bottom right corner of the window.

The “W2 Start” window appears.

7. If the photocal is required after the W2 finishes, place a check mark next to the “After W2 ends,
perform the photocal” prompt. If the ISE cleaning procedure is required during the W2, place a
check mark next to the “ISE Cleaning” prompt and refer to the ISE maintenance chapter in the
ISE section for instructions on how to clean the ISE.

8-26
Maintenance AU480 User Guide
Version 1.0
Return to Main Table of Contents

8. Select O K .
The W2 will start and will require 25 minutes to complete. A countdown may be viewed in the
mode display window.

Gas maybe generated from a reagent wash solution bottle. After the W2 is completed,
remove the reagent wash solution bottle from the system immediately.
CAUTION

9. At completion of the W2, the photocal will automatically start, if it was selected in step 4. If
not selected, at completion of W2, the instrument enters the Standby mode. At this point,
immediately remove the plastic bottles containing cleaning chemicals. For information on how to
execute a Photocal, refer to section “8.4.3 Perform a Photocal” in this chapter.

8.4.3 Perform a Photocal

After the thorough cleaning provided by the W2, the photocal should be performed. The photocal is a
check on the integrity of the cuvettes. It will detect dirt, stains, or scratches, identifying cuvettes that
require cleaning or replacing.
The photocal may be started from the W2 Start window. If it was not selected there, it may be started
in the following way.
After the photocal has been executed, an audible alarm is issued, if a cuvette fails the photocal check.
Cuvettes that show an abnormal value in the photocal measurement should be washed again or
replaced with new ones.

Procedure for executing Photocal measurement

To obtain optimal results, always perform photocal measurement only when the
photometer lamp has been stabilized after system startup. The photometer lamp
needs approximately 20 minutes to stabilize after system start up.
CAUTION

8-27
AU480 User Guide Maintenance
Version 1.0
 Return to Main Table of Contents

1. Ensure the system is in Standby mode.

2. From the AU480 “Home” window select Menu List>Maintenance>User Maintenance>Analyzer
Maintenance>Maintenance to display the “Analyzer Maintenance: Maintenance tab” window.

Photocal

3. Select P h o t o c a l ( F 7 ) .
The “Photocal Start” window appears.

4. Select “ALL Cuvettes” to perform the check entirely and select O K . (If individual cuvettes fail,
they may be cleaned or replaced and checked again by selecting their specific number.) Refer to
section “8.8.2 Replace Cuvettes” in this chapter.
5. Select O K .
The photocal measurement starts. It takes approximately 22 minutes to measure all cuvettes. For
specific cuvette, it takes approximately 4 minutes.
The system automatically moves to Standby mode after the photocal measurement is complete.
The maintenance list will be updated automatically when all cuvettes are measured.

The first photocal value after lamp replacement date is updated is saved automatically
as a reference value.
TIP

8-28
Maintenance AU480 User Guide
Version 1.0
Return to Main Table of Contents

Procedure for checking the Photocal measurement

Materials:
Lens cleaning paper

1. Ensure the system is in Standby mode.

2. From the AU480 “Home” window select Menu List>Maintenance>User Maintenance>Analyzer
Maintenance>Maintenance to display the “Analyzer Maintenance: Photocal Monitor tab” window.
Cuvette numbers appear on the window.

• Cuvettes failing the Mean Check appear in red.

• Cuvettes failing the Cuvette Check appear in green.

• Cuvettes failing the Photometer Check appear in orange

3. Check the cuvettes displayed by color and number.

• Green: Cuvette check

This checks the cuvettes for scratches and finger prints. The absorbance of each cuvette is
measured by all wavelength.
Instruments checks whether difference of the absorbance mean value between the first half
part and the latter half part is within 0.01 Abs.

• Red: Mean Check

Instrument checks for contamination or stains and whether the difference between the
value of each cuvette and the mean value of all cuvettes at the Photocal is 0.03 Abs or less.
Remove the cuvettes with error indication, and wipe their photometric surfaces carefully
with lens cleaning paper. If the same error occurs even after the surface is wiped, replace
the cuvette with a new one.

8-29
AU480 User Guide Maintenance
Version 1.0
 Return to Main Table of Contents

• Orange: Lamp Check

The photometer lamp is deteriorating and needs to be replaced.

• First, the mean value of the absorbance of each wavelength of all cuvettes is
measured.
Instrument checks whether the mean value of the each wavelength is 1.7 Abs or less.
• The mean value of the Photocal value of all cuvettes immediately after the replacement
of the lamp is memorized as a reference value.
Instrument checks whether the difference between the mean value and the reference
value at the Photocal is the constant value or less.
Replace the lamp when the lamp check error occurs for all cuvettes.
When the lamp check error and the cuvette check error occur at the same time, or when the lamp
check error and the mean check error occur at the same time, remove the cuvettes with error
indication, and wipe their photometric surfaces carefully with lens cleaning paper. If the same
error still occurs even after the surface is wiped, replace the cuvette with a new one.

For details on removal and replacement of cuvette, refer to section “8.8.2 Replace Cuvettes” in
this chapter.

8.4.4 Clean the Sample Pre-diluent Bottle

When the sample diluent (saline solution or deionized water, etc.) is used continuously without the
sample pre-diluent bottle being washed, germs and bacteria will grow in the sample pre-diluent bottle,
resulting in defective data.
To maintain the reliability of analysis data, wash the sample pre-diluent bottle every week.

Procedure for Clean the Sample Pre-diluent Bottle

Materials:

• Sample diluent (e.g. saline solution or deionized water)

• Sodium hypochlorite solution with an effective chlorine concentration of 0.5%

Before Testing
Before starting analysis, rinse the sample pre-diluent bottle with the sample diluent (for example,
saline solution or deionized water, etc.) and wash the whole bottle in the diluent, and then to fill the
bottle with new sample pre-diluent solution.

Weekly washing
Wash the sample pre-diluent bottle in a sodium hypochlorite solution with an effective chlorine
concentration of 0.5% every week.

After turning the system power on by pressing the ON button, update the
maintenance performed date by selecting C l e a n s a m p l e P r e -
TIP d i l u e n t b o t t l e on the “Analyzer Maintenance: Maintenance tab” window.

For details on updating the maintenance date, refer to section “8.2.2 Updating the Maintenance
Register” in this chapter.

8-30
Maintenance AU480 User Guide
Version 1.0
Return to Main Table of Contents

8.5 Monthly Maintenance

Record

• Record the maintenance procedures performed in the “Maintenance Schedule”.

• After performing maintenance tasks, select the performed maintenance task from list displayed
on “Analyzer Maintenance: Maintenance” window and update performed date. For details on
updating the maintenance record, refer to section “8.2.2 Updating the Maintenance Register” in
this chapter.

Maintenance routines
Perform the following tasks every month:
8.5.1 Clean the Sample Probe and Reagent Probe Wash Stations........................8-32
8.5.2 Clean the Mix Bar Wash Station.....................................................................8-35
8.5.3 Clean the Wash Nozzle Unit and Check the Tube Mounting Joints...............8-37
8.5.4 Clean the Deionized Water Filter and the Sample Probe Filter......................8-42
8.5.5 Clean the Sample Probe Filter.......................................................................8-45

Always wear personal protective equipment when performing any maintenance

procedure. To avoid injury and infection, observe and follow all the “WARNINGS” and
“CAUTIONS” throughout this User’s Guide.
CAUTION

8-31
AU480 User Guide Maintenance
Version 1.0
 Return to Main Table of Contents

8.5.1 Clean the Sample Probe and Reagent Probe Wash Stations
Probe wash wells clean the outside surface of the probe by rinsing each probe tip in deionized water.
Dirty wash wells could result in improperly cleaned probes, which, in turn, could contaminate reagents
or samples. To maintain the reliability of the instrument and prevent contamination, clean the wash
wells once each month.

Procedures for Clean the Sample Probe and Reagent Probe Wash Stations
Materials:

• Sodium hypochlorite solution with an effective chlorine of approx. 0.5%

• Cotton swab

• Pipette or injector

1. Open the main cover.

2. Ensure the system is in Standby mode.
3. From the AU480 “Home” window select Menu List>Maintenance>User Maintenance>Analyzer
Maintenance>Maintenance to display the “Analyzer Maintenance: Maintenance tab” window.

8-32
Maintenance AU480 User Guide
Version 1.0
Return to Main Table of Contents

4. Select the item to be cleaned from the list of maintenance items. And select the related button for
that maintenance procedure from the “Single Operation” buttons.

The items The list of

Single Operation button
to be washed maintenance items
Sample probe wash Clean sample probe wash well Cleaning Wash Tank
station
Reagent probe wash Clean reagent probe wash well
station

The sample probe and reagent probe will move while performing this procedure.
Avoid touching these probes during the procedure.
CAUTION

5. Press the TA B L E R OTAT I O N / D I A G button.

This makes the sample probe and reagent probe move to the position of the cuvette.

• Avoid spilling sodium hypochlorite solution outside the wash station. If spilled,
wipe it off immediately.

CAUTION • While cleaning the inside of the wash well, avoid touching the sample probe and
reagent probe.

6. While pouring 1 or 2 mL sodium hypochlorite solution into the sample probe wash station and
reagent probe wash station use different cotton swabs to clean the inside of each wash station.

Reagent probe

Reagent probe
wash station Sample probe

TABLE ROTATION Sample probe wash station

/DIAG button

7. Select the related maintenance button from the “Single Operation” buttons.

The item to be washed Single Operation buttons

Sample probe wash station Replacing Sample Probe
Reagent probe wash station Replacing Reagent Probe/Syringe

8-33
AU480 User Guide Maintenance
Version 1.0
 Return to Main Table of Contents

8. Enter 3 or more as the number of times the wash water is drained for each probe and select O K .
9. Press the TA B L E R OTAT I O N / D I A G button.
The wash water will be sprayed in the sample probe wash station and reagent probe wash
stations. If the wash solution is not properly drained from the drain hole or if a stain still remains in
the wash stations, repeat steps 4 to 9.
10. Select U p d a t e .
A confirmation window appears.
11. Select O K .
12. Close the main cover.

8-34
Maintenance AU480 User Guide
Version 1.0
Return to Main Table of Contents

8.5.2 Clean the Mix Bar Wash Station

If the mix bar wash stations are not cleaned regularly, residual foreign matter accumulates in the well
lowering washing performance. This causes contamination and reduces the reliability of analysis data.
Stained mix bars may contaminate samples. To maintain the reliability of analysis data, and to prevent
samples from being contaminated, clean the mix bar wash stations every month.

Procedure for Clean the Mix Bar Wash Station

Materials:

• Squirt bottle with freshly prepared sodium hypochlorite solution with 0.5% effective
concentration of chlorine

• Cotton swabs

1. Open the main cover.

2. Ensure the system is in Standby mode.
3. From the AU480 “Home” window select Menu List>Maintenance>User Maintenance>Analyzer
Maintenance>Maintenance to display the “Analyzer Maintenance: Maintenance tab” window.

4. Select C l e a n m i x b a r w a s h w e l l s from the list of maintenance items.

The “Single Operation” buttons appear to the right of the Maintenance items list.
5. Select Re p l a c i n g m i x i n g b a r from the “Single Operation” buttons.
The “Start” window appears.
6. Enter 3 or more as the number of times the wash water is drained and select O K .
7. Press the TA B L E R OTAT I O N / D I A G button.
The wash water will be sprayed in the mix bar wash stations from the nozzles.

8-35
AU480 User Guide Maintenance
Version 1.0
 Return to Main Table of Contents

8. Pull the mix bars upward from the mixing unit.

Mix bar

Mixing unit

Mix bar wash station

TABLE ROTATION
/DIAG button

Avoid spilling the sodium hypochlorite solution outside the mix bar wash station. If it is
spilled, wipe it up immediately.
CAUTION

9. Clean the inside of the mix bar wash stations using a cotton swab dampened with sodium
hypochlorite solution.
10. Press the TA B L E R OTAT I O N / D I A G button.
The wash water will be sprayed in the mix bar wash stations. If the wash solution is not properly
drained from the drain hole or if a stain still remains in the wells, repeat steps 9 to 10.
11. After the washing has been completed, insert the six mix bars from the top into the holes provided
on the mixing unit.
After inserting each mix bar, turn it to engage the bar in the notch on the mix bar engaged with
the gear in the hole of the mixing unit.

The shapes of mix bars are different as follows:

• The mix bar for R1 and S, MU9599: screw type

CAUTION • The mix bar for R2, MU8267: L-shaped type

Set each mix bar at proper position.

mix bar for R1 and S

mix bar for R2

S 3 R1
R2
4

2
R2

R1 1 S mix bar for R2

mix bar for R1 and S

12. Select U p d a t e .
A confirmation window appears.
13. Select O K .
14. Close the main cover.

8-36
Maintenance AU480 User Guide
Version 1.0
Return to Main Table of Contents

8.5.3 Clean the Wash Nozzle Unit and Check the Tube Mounting
Joints
The wash nozzle unit consists of eight nozzles, responsible for aspirating liquid out of the cuvettes,
and dispensing liquid into the cuvettes. If any of the nozzles become clogged, their functionality may
suffer, resulting in inefficient cleaning of the cuvettes.
The tube mounting joints should be inspected for cracks or leaks. If any damage exists, the aspiration
and dispense by nozzles could be affected.

Procedure for clean the wash nozzle unit and checking the tube mounting
joints
Materials:

• Dry, clean cloth or paper towel

• Sonicator filled with deionized water

Removing the wash nozzle station and checking the tube mounting joints
1. Open the main cover.
2. Ensure the system is in Standby or Warm up mode.
3. From the AU480 “Home” window select Menu List>Maintenance>User Maintenance>Analyzer
Maintenance>Maintenance to display the “Analyzer Maintenance: Maintenance tab” window.

4. Select C l e a n a n d i n s p e c t w a s h n o z z l e from the list of maintenance items.

5. Select Re p l a c i n g Wa s h N o z z l e from the “Single Operation” buttons and press O K .

8-37
AU480 User Guide Maintenance
Version 1.0
 Return to Main Table of Contents

6. Press the TA B L E R OTAT I O N / D I A G button.

The system aspirates liquid from the wash nozzle unit tubing.
7. Repeat step 6 two or three times until the liquid in the wash nozzle unit tubing is completely
removed.

Always drain the water remaining in the wash nozzles before cleaning or replacing
the tube mounting joints. If the tube mounting joints are loosened prior to draining the
remaining water, the water will spill out of the nozzle.
CAUTION

8. Open the rear cover.

9. Loosen the four grey manifolds and remove them from their mounting positions.

• A total of six O-rings are used inside the water supply tube mounting joint of the
wash nozzle station. When the joints have been removed, make sure that there
are six O-rings inside the joint. If an O-ring is missing, check the back of the joint
CAUTION to ensure the O-ring is not stuck, or the area around the tube mounting joint. If it
cannot be found, install a new O-ring (MU9638) in the place concerned.

• When loosening the knob on the wash nozzle station, do not loosen the
positioning screws on either side of the knob. These screws are used for
positioning the wash nozzle station.

For detailed information about cleaning or replacing an O-ring of the tube mounting joint, refer to
section “8.8.1 Replace O-rings in the Wash Nozzle Supply Tube Mounting Joints” in this chapter.

Tube mounting joint

(A total of six O-rings are
used inside the tubes)
Wash nozzle
station

Knob

Positioning screws

Rear cover

10. Loosen the silver knob holding the wash nozzle unit in place. Loosen the knob until it stops
turning, lift the wash nozzle up and over the fitting screws. Take care not to bump or bend the
nozzles.

8-38
Maintenance AU480 User Guide
Version 1.0
Return to Main Table of Contents

11. Remove the wash nozzle unit along with the tubing and inspect the joints for cracks. If a crack is
found the joint should be replaced.

wash nozzle joint

Tubes

Wash nozzle station

For details, refer to section “8.8.6 Replace the Wash Nozzle Joint” in this chapter.

Cleaning and remounting the wash nozzle unit

• When cleaning the wash nozzle station using a Sonicator filled with deionized
water, do not damage the wash nozzles.

CAUTION • When handling a wash nozzle do not damage the nozzle.

• When mounting the wash nozzle station do not bring the nozzle tips into contact
with the cuvette wheel cover.

1. Sonicate the wash nozzle unit in deionized water for 15 minutes.

Only the nozzle portion needs to be submerged.
Take care not to get the springs above the nozzles wet. If water does get into the springs, dry
them well using a towel or canned air.
2. Remove the wash nozzle unit from the sonicator and dry the nozzles thoroughly.

A sonicator filled with deionized water is recommended for cleaning the wash nozzles.
If a sonicator filled with deionized water is not available, use tap water. While pouring
water into the wash nozzles, clean each nozzle hole using the supplied mandolin
TIP string.
After washing in water, wipe up water drops using a paper towel or dry cloth.

8-39
AU480 User Guide Maintenance
Version 1.0
 Return to Main Table of Contents

3. Inspect the O-rings of the manifolds.

• Check that all six O-rings are properly inserted in individual grooves.

• Verify that they are not ripped or overstretched.

• Look for dust or wash solution crystals around each O-ring. If faults are found with O-rings
they should be replaced.
For detailed procedures on cleaning or replacing an O-ring of the tube mounting, refer to
section “8.8.1 Replace O-rings in the Wash Nozzle Supply Tube Mounting Joints” in this
chapter.

If the following precautions are not followed, tests may not be performed properly, or
may result in system damage.
• When installing the tube mounting joints, verify that the joints are in the right
CAUTION position.

• When attaching a wash nozzle to the tube mounting, joint tighten the wash nozzle
station firmly. If the wash nozzle station is not tightened sufficiently, water leaks
will result.

• Make sure any tubes that must run from the nozzles or tube mounting joint are not
missing.

• Do not damage any of the joints and tubes. Damaged parts may cause leaks and
contaminate or flood the cuvette.

4. Replace each of the manifolds into its original position. Match the colored dot on the manifold
with the one next to its position. Tighten the manifolds without cross threading them. Also take
care not to over tighten them.
5. Close the rear cover.
6. Select Prime Washing-line from the “maintenance operation” buttons, and select O K . Then
press the green TA B L E R OTAT I O N / D I A G button to start the function. The air in the
tubing is purged as the wash nozzle unit moves up and down. Verify this movement is completed
without interference.
7. Close the Main Cover.
8. Select U p d a t e .
A confirmation window appears.
9. Select O K .
10. Select W 1 ( F 5 ) .
The “W1 Start” window appears.
11. Select S t a r t .

8-40
Maintenance AU480 User Guide
Version 1.0
Return to Main Table of Contents

Tubing Diagram
Follow the diagram to reconnect any broken or disconnected tube mounting joints.

Tube mounting joint

Wash nozzle station

4
1 3 5

2 6
2
1
8
3

4
Wash
nozzles 5

Knob
7

1 4 4
3 5

1 3 2 6

1
2 8

4 5

5
7 6

7 3 2
4

8 6 5

8-41
AU480 User Guide Maintenance
Version 1.0
 Return to Main Table of Contents

8.5.4 Clean the Deionized Water Filter and the Sample Probe
Filter
The deionized water filter and sample probe filter may collect various materials from the external water
system. This can lead to deterioration in system performance, and sub-optimal assay performance. To
prevent this perform the following procedure at least monthly.

Procedure for Clean the Deionized Water Filter and the Sample Probe Filter
Materials:

• Dry, clean cloth

• Drainage pan

• Sonicator filled with deionized water

Removing the deionized water filter and the sample probe filter
Turn off the O N (sub-power) button to the system before starting this procedure.
If this procedure is performed with the O N (sub-power) on, deionized water will be
supplied through the supply tube and the float switch in the deionized water tank will
CAUTION activate and water will drain continuously from the tube.

1. Perform an E n d P r o c e s s .
2. Open the left door.
3. Position a drainage pan on the floor under the deionized water tank to catch spilled water.
4. Pull the deionized water tank out far enough to allow the tubes to be accessed.
5. Remove the water supply tube.

Loosen the filter case over the drainage pan. The deionized water in the filter case
drains from the joint. If the deionized water is spilled on the system, connector, etc.,
immediately wipe it off with a dry, clean cloth.
CAUTION

6. Remove the cap of the filter case over the drainage pan by unscrewing it. Water will drip from it.
7. Remove the deionized water filter from its case and place it into the sonicator.

8-42
Maintenance AU480 User Guide
Version 1.0
Return to Main Table of Contents

8. Locate the sample probe filter case directly to the left of the deionized water tank and remove it
from the bracket.

Water supply tube

Filter case

Deionized water filter

Drainage pan
Cap of filter case

Cleaning and mounting the deionized water filter

1. Press the grey buttons of the quick disconnect and pull to remove the tubes from the top and
bottom of the filter case.
2. Unscrew the filter case over the drainage pan and remove the sample probe filter.
3. Place the sample probe filter in the sonicator.
4. Sonicate the deionized water filter and the sample probe filter in deionized water for 10 minutes.
5. Reinsert the deionized water filter into its case and tighten the cap.
6. Reinsert the water supply tube in the deionized water tank.
7. Push the tank back into the analyzer.
8. Reinsert the sample probe filter into the filter case.
9. Tighten the filter case firmly.
10. Reconnect the quick release valves by forcing the tubes into their connections until a distinct click
is heard.
11. Fit the filter case into its retainer.
12. Wipe any spilled water from the analyzer surface and remove the drainage pan.
13. Press the ON button. The system powers up and initializes.

8-43
AU480 User Guide Maintenance
Version 1.0
 Return to Main Table of Contents

14. From the AU480 “Home” window select Menu List>Maintenance>User Maintenance>Analyzer
Maintenance>Maintenance to display the “Analyzer Maintenance: Maintenance tab” window.

15. Select P r i m e Wa s h i n g - l i n e from the maintenance operation buttons, and then O K .

Press the TA B L E R OTAT I O N / D I A G button. Watch as the prime is performed and
repeat the prime by pressing the green button again until all bubbles are removed from the line.
16. Select U p d a t e .
A confirmation window appears.
17. Select O K .
18. Select W 1 ( F 5 ) .
The “W1 Start” window appears.
19. Select S t a r t .
20. Close the left front door of the analyzer.

8-44
Maintenance AU480 User Guide
Version 1.0
Return to Main Table of Contents

8.5.5 Clean the Sample Probe Filter

If dust, debris, and scale accumulates on the sample probe filter, the system may return abnormal
analysis data. To obtain appropriate analysis results, clean the sample probe filter every month.

Procedure for Clean the Sample Probe Filter

Materials:

• Dry, clean cloth

• Drainage pan

• Sonicator filled with deionized water

• Deionized water

Removing the sample probe filter

Turn off the O N (sub-power) button to the system before starting this procedure.
If this procedure is performed with the O N (sub-power) on, deionized water will be
supplied through the supply tube and the float switch in the deionized water tank will
CAUTION activate and water will drain continuously from the tube.

1. Shut down the system selecting E n d .

2. Open the left front door of the analyzer.
3. Place the drainage pan under the unit so that the liquid from the deionized water drainage hose
does not spill onto the floor.
4. Pull the filter case toward the front and remove it from the clip.

Loosen each joint from the filter case over the drainage pan. The deionized water in
the filter case drains from the joint. If deionized water spills on the system, connector,
etc., immediately wipe it up with a dry, clean cloth.
CAUTION

8-45
AU480 User Guide Maintenance
Version 1.0
 Return to Main Table of Contents

5. Press each button for the two connecting hoses and remove the hoses from the filter case.

Joint
Connecting Hose
Button Holder

Filter case

Button
Joint
Drainage pan

When removing the sample probe filter, do not lose the O-ring.
CAUTION

6. Unscrew the top of the filter case.

7. Remove the sample probe filter from the filter case.
8. Remove the filter positioning insert from the case.

Filter Positioning Insert

Sample probe filter

O-ring

Filter case

Cleaning and attaching the sample probe filter

1. Wash the sample probe filter, filter case, and filter positioning insert in the Sonicator filled with
deionized water for approximately 10 minutes. Use water for washing.
If a Sonicator filled with deionized water is not available, use tap water. While pouring water into
the filter, clean the scale and dust stuck to the parts using a toothbrush.
2. Wash the sample probe filter, filter case, and filter positioning insert in deionized water.
3. Insert the filter positioning insert into the case head, and insert the sample probe filter into the
filter case.
4. Tighten the filter case firmly.

Do not connect the filter case to the joints upside down.

If the filter case is connected upside down, dust, etc., in the case will enter the system
CAUTION and will cause a data error.

8-46
Maintenance AU480 User Guide
Version 1.0
Return to Main Table of Contents

5. Connect the joints of the water hoses to the filter case.

Push each joint together until a “click” is heard.
6. Push the filter case into the filter case clip.
7. Remove the drainage pan.
Dispose of any water that spilled into the pan.
8. Press the O N button to turn the system power to on.
The Warm up mode is entered after the initialization.
9. From the AU480 “Home” window select Menu List>Maintenance>User Maintenance>Analyzer
Maintenance>Maintenance to display the “Analyzer Maintenance: Maintenance tab” window.

10. Select C l e a n s a m p l e p r o b e f i l t e r from the list of maintenance items.

11. Select P r i m e Wa s h i n g - l i n e from the “Single Operation” buttons.
The “Start” window appears.
12. Select O K .
13. Press the TA B L E R OTAT I O N / D I A G button.
14. Repeat step 13 two or three times until the air is completely removed from the sample probe.
15. Select U p d a t e .
A confirmation window appears.
16. Select O K .
17. Select W 1 ( F 5 ) .
The “W1 Start” window appears.
18. Select S t a r t .
19. Close the left front door of the analyzer.

8-47
AU480 User Guide Maintenance
Version 1.0
 Return to Main Table of Contents

8.6 Maintenance Every Three Months

Record

• Record the maintenance actions in the “Maintenance Schedule”.

• After performing maintenance tasks, select the performed maintenance task from list displayed
on “Analyzer Maintenance: Maintenance” window and update performed date. For details on
updating the maintenance record, refer to section “8.2.2 Updating the Maintenance Register” in
this chapter.

Maintenance routines
Perform the following tasks every three months:
8.6.1 Clean the Air Filters........................................................................................8-49
8.6.2 Replace the Deionized Water Filter................................................................8-50
8.6.3 Replace the Sample Probe Filter and O-Ring................................................8-52
8.6.4 Clean the Deionized Water Tank....................................................................8-54
8.6.5 Replace the Wash Solution Roller Tube.........................................................8-57

Always wear personal protective equipment when performing any maintenance

procedure. To avoid injury and infection, observe and follow all the “WARNINGS” and
CAUTION “CAUTIONS” throughout this User’s Guide.

8-48
Maintenance AU480 User Guide
Version 1.0
Return to Main Table of Contents

8.6.1 Clean the Air Filters

The air filters must be kept clean to ensure that adequate clean air can enter the system for cooling.
Any dust or dirt should be removed promptly. Replace any broken filters immediately as needed.

Procedure for Clean the Air Filter

Make sure the filters are always installed in the system. If filters are missing, heaters
and the power supplies get dusty, which can cause a short circuit and fire.
CAUTION

1. Shut down the system selecting E n d .

And press the E M S TO P button to turn off the main power.
2. Remove the four air filters.

Air Filters

3. Wash the air filters with water, then dry them in the air.
4. Replace air filters if they are broken.
5. Insert the air filters.
6. Press R E S E T button and O N button to turn on the system power.

• The air filters can be cleaned with a vacuum cleaner, without being removed. If an
air filter is deformed during cleaning, flatten it into the original position.

TIP • Update the performed date by selecting C l e a n a i r f i l t e r s on the

“Analyzer Maintenance: Maintenance tab” window.

For details on updating the maintenance date, refer to section “8.2.2 Updating the Maintenance
Register” in this chapter.

8-49
AU480 User Guide Maintenance
Version 1.0
 Return to Main Table of Contents

8.6.2 Replace the Deionized Water Filter

To obtain correct analysis data by keeping the filter function, the deionized water filter should be
replaced every three months, using this procedure.

Procedure for Replace the Deionized Water Filter

Materials:

• New deionized water filter ZM3079

• Drainage pan

Turn off the O N (sub-power) button to the system before starting this procedure.
If this procedure is performed with the O N (sub-power) on, deionized water will be
supplied through the supply tube and the float switch in the deionized water tank will
CAUTION activate and water will drain continuously from the tube.

1. Shut down the system selecting E n d .

2. Close the water outlet valves.
3. Open the left front door of the analyzer.
4. Remove the deionized water filter.
For details on removing the deionized water filter, refer to section “8.5.4 Clean the Deionized
Water Filter and the Sample Probe Filter” in this chapter.
5. Insert a new deionized water filter into the filter case.
6. Replace the filter case cap and tighten it firmly.
7. Insert the water supply tube into the deionized water tank.
8. Replace the deionized water tank in the system.
9. Remove the drainage pan.
Dispose of any water spilled in the pan.
10. Press the O N button to turn the system power to on.
The Warm up mode is entered after the initialization.

8-50
Maintenance AU480 User Guide
Version 1.0
Return to Main Table of Contents

11. From the AU480 “Home” window select Menu List>Maintenance>User Maintenance>Analyzer
Maintenance>Maintenance to display the “Analyzer Maintenance: Maintenance tab” window.

12. Select Re p l a c e D e i o n i z e d W. F i l t e r from the list of maintenance items.

13. Select P r i m e Wa s h i n g - l i n e from the “Single Operation” buttons.
The “Start” window appears.
14. Select O K .
15. Press the TA B L E R OTAT I O N / D I A G button.
16. Repeat step 15 until the air is completely removed from the sample probe, reagent probe, and
wash nozzle.
17. Select U p d a t e .
A confirmation window appears.
18. Select O K .
19. Select W 1 ( F 5 ) .
The “W1 Start” window appears.
20. Select S t a r t .
21. Close the left front door of the analyzer.

8-51
AU480 User Guide Maintenance
Version 1.0
 Return to Main Table of Contents

8.6.3 Replace the Sample Probe Filter and O-Ring

To maintain the filter function and to obtain appropriate analysis results, replace the sample probe filter
every three months.

Replace the Sample Probe Filter and O-Ring

Materials:

• New sample probe filter ZM3079

• Drainage pan

• New O-ring MU9637

• Clean dry cloth

Turn off the O N (sub-power) button to the system before starting this procedure.
If this procedure is performed with the O N (sub-power) on, deionized water will be
supplied through the supply tube and the float switch in the deionized water tank will
CAUTION activate and water will drain continuously from the tube.

1. Shut down the system selecting E n d .

2. Open the left front door of the analyzer.
3. Remove the sample probe filter. Check the O-ring. If it is scratched or cut, replace it.
For details on removing the sample probe filter, refer to section “8.5.5 Clean the Sample Probe
Filter” in this chapter.
4. Insert a new sample probe filter into the filter case.
5. Tighten the filter case firmly.

Do not connect the filter case to the joints upside down. If the filter case is connected
upside down, dust, etc., in the case will enter the system and will cause a data error.
CAUTION

6. Connect the joint on the deionized water drainage hose.

Push the joint all the way until a click is heard.
7. Mount the filter case on the holder.
8. Remove the drainage pan.
Dispose of the drained water in the drainage pan.
9. Press the O N button to turn the system power to on.
The Warm up mode is entered after the initialization.
10. From the AU480 “Home” window select Menu List>Maintenance>User Maintenance>Analyzer
Maintenance>Maintenance to display the “Analyzer Maintenance: Maintenance tab” window.
11. Select Re p l a c e s a m p l e p r o b e f i l t e r from the list of maintenance items.
12. Select P r i m e Wa s h i n g - l i n e from the “Single Operation” buttons.
The “Start” window appears.
13. Select O K .
14. Press the TA B L E R OTAT I O N / D I A G button.
As the deionized water flows through the tube, the air in the tube will be purged.
15. Repeat step 14 until the air in the sample probe is completely removed.

8-52
Maintenance AU480 User Guide
Version 1.0
Return to Main Table of Contents

16. Select U p d a t e .
A confirmation window appears.
17. Select O K .
18. Select W 1 ( F 5 ) .
The “W1 Start” window appears.
19. Select S t a r t .
20. Close the left front door of the analyzer.

8-53
AU480 User Guide Maintenance
Version 1.0
 Return to Main Table of Contents

8.6.4 Clean the Deionized Water Tank

If scale or other deposits have accumulated on the deionized water tank, contaminated deionized
water will be supplied, and therefore correct analysis will not be performed. Clean the deionized water
tank every three months.

If quality deionized water cannot be obtained from the deionizer, the diluted wash
solution tank may need to be cleaned in addition to the deionized water tank.
TIP For detailed information, contact Beckman Coulter Technical Services.

Procedure for Clean the Deionized Water Tank

Materials:

• Dry, clean cloth

• Drainage pan

• Deionized water

Procedure for pulling out the deionized water filter

Turn off the O N (sub-power) button to the system before starting this procedure.
If this procedure is performed with the O N (sub-power) on, deionized water will be
supplied through the supply tube and the float switch in the deionized water tank will
CAUTION activate and water will drain continuously from the tube.

1. Shut down the system selecting E n d .

2. Open the left front door of the analyzer.
3. Position a drainage pan on the floor to catch spilled liquid from the deionized water drainage
hose.
4. Remove the joint on the deionized water drainage hose and disconnect the connector (879) of
the float switch.

Deionized water tank

Connector

Float switch Holder

Joint

Deionized water
drainage hose

Filter case
Drainage pan

5. Loosen the cap, then remove the float switch.

8-54
Maintenance AU480 User Guide
Version 1.0
Return to Main Table of Contents

6. Remove the tube from the deionized water tank.

If water spills when removing the float switch and tubes, immediately wipe the area
with a dry cloth or paper, etc.
TIP

Cap

Float switch

Deionized water tank

Tube

7. Drain the deionized water in the tank.

Discard the pumped-out deionized water.
8. Draw the deionized water tank out of the system.

Cleaning and replacing the deionized water tank

1. Flush the inside of the tank, tube, and the outside of float switch with water, and then wipe off the
moisture with a clean dry cloth.

Be sure to fill the deionized water tank with deionized water before turning the system
power to on. If the pump operates with no water in the tank, a malfunction may result.
CAUTION

2. Fill the deionized water tank with approximately 5L of deionized water.

3. Insert the water supply tube and the float switch into the deionized water tank.
4. Replace the deionized water tank in the system.

8-55
AU480 User Guide Maintenance
Version 1.0
 Return to Main Table of Contents

5. Reconnect the joints on the two deionized water drainage hoses.

Push the joints together until a click is heard.
6. Connect the float switch connector (868) to its original position.
7. Press the O N button to turn the system power to on.
The Warm up mode is entered after the initialization.
8. From the AU480 “Home” window select Menu List>Maintenance>User Maintenance>Analyzer
Maintenance>Maintenance to display the “Analyzer Maintenance: Maintenance tab” window.

9. Select C l e a n d e i o n i z e d - w a t e r t a n k from the list of maintenance items.

10. Select P r i m e Wa s h i n g - l i n e from the “Single Operation” buttons.
The “Start” window appears.
11. Select O K .
12. Press the TA B L E R OTAT I O N / D I A G button.
13. Repeat step 12 until the air is completely removed from the sample probe, reagent probe, and
wash nozzle.
14. Select U p d a t e .
A confirmation window appears.
15. Select O K .
16. Select W 1 ( F 5 ) .
The “W1 Start” window appears.
17. Select S t a r t .
18. Close the left front door of the analyzer.

8-56
Maintenance AU480 User Guide
Version 1.0
Return to Main Table of Contents

8.6.5 Replace the Wash Solution Roller Tube

The roller tube will deteriorate gradually due to abrasion and vibration by the roller pump. If the roller
tube is used for an extended period, it can break. Replace the roller tube with a new one every three
months.

When attach/detach the wash solution roller tube, wear rubber gloves in advance to
prevent contact with the wash solution. Also do not splash the liquid in the tube over
the peripheral area. If hands or clothing come into contact with the wash solution,
CAUTION wash them immediately with water. Should wash solution get splashed accidentally in
the eyes or mouth, rinse it immediately with water and consult a physician.

Procedure for Replace the Wash Solution Roller Tube

Materials:
New roller tubes MU9623

1. Verify that the system is in Warm up or Standby mode.

2. Open the left front door of the analyzer.

Be sure to operate in the above described conditions. Otherwise, the wash solution
may be discharged from the connection tube when the roller tube is disconnected.
TIP

3. From the AU480 “Home” window select Menu List>Maintenance>User Maintenance>Analyzer

Maintenance>Maintenance to display the “Analyzer Maintenance: Maintenance tab” window.

4. Select Re p l a c i n g P u m p Ro l l e r Tu b e s from the list of maintenance items.

5. Select Re p l a c i n g Ro l l e r P u m p t u b i n g from the “Single Operation” buttons and
select O K .
6. Press the TA B L E R OTAT I O N / D I A G button.
The roller pump rotates in the reverse direction, making the wash solution in the tube return to the
wash solution tank.

8-57
AU480 User Guide Maintenance
Version 1.0
 Return to Main Table of Contents

7. Make sure that no wash solution remains in the tube, disconnect the roller tube for wash solution
from the roller pump unit.

Rounding direction of roller pump

(Normal)
roller tube

Wash solution
roller pump

8. Remove the roller tube from the relay tubes by turning the connectors.

Wash solution
Roller tube roller pump

ID No.

ID No.

TABLE ROTATION
/DIAG button
Roller tube connectors Relay tubes

9. Attach the connectors of new roller tube to each relay tubes.

Turn the connectors to tighten them.
10. Wrap the roller tube around the roller pump, and then place the tube connectors into the grooves
on the roller pump side.
Make sure the numbers on the relay tube ends are the same as those indicated near the grooves
on the pump bracket.
11. Press the TA B L E R OTAT I O N / D I A G button.
The roller pumps rotate in the normal direction, filling each tube with master wash solution.
12. Select U p d a t e .
13. Select O K .
14. Close the left front door of the analyzer.

8-58
Maintenance AU480 User Guide
Version 1.0
Return to Main Table of Contents

8.7 Maintenance Performed Every Six Months

Record

• Record the maintenance actions in the “Maintenance Schedule”.

• After performing maintenance tasks, select the performed maintenance task from list displayed
on “Analyzer Maintenance: Maintenance” window and update performed date.
For details on updating the maintenance record, refer to section “8.2.2 Updating the
Maintenance Register” in this chapter.

Maintenance routines
To obtain the best possible performance of this analyzer and use it safely, be sure to perform the
following tasks every six months:
8.7.1 Replace the Photometer Lamp.......................................................................8-59
8.7.2 Washing Cuvettes and the Cuvette Wheel.....................................................8-63

Always wear personal protective equipment when performing any maintenance

procedure. For consideration of other than infection, observe the respective
“WARNING” and “CAUTION” described in the main text.
CAUTION

8.7.1 Replace the Photometer Lamp

If the light intensity of the photometer lamp decreases, incorrect analysis result will result.
Replace the photometer lamp every 1,000 hours as a guide. However, if the alarm message
“Photometer lamp deteriorated” or “Photometer lamp broken” is displayed, replace the light source
lamp even before 1,000 hours.
After replacing the lamp be sure to perform photocal measurement to check that the lamp functions
correctly.

• To prevent electric hazards, be sure to turn off the ON (sub-power) button to the
system before Replace the Photometer Lamp.

WARNING • Wait 5 minutes or more after the system shutdown process has been completed.
Do not touch the lamp with bare hands until the photometer lamp has cooled down
completely. The lamp is very hot and can cause burns.

• Never touch the glass of the photometer lamp with bare hands. If oil from the skin
or fingerprints are left on the glass, they will burn. This changes the light intensity
of the lamp and decreases the measuring accuracy.
CAUTION
• To remove fingerprints, shut down the system and wait at least 5 minutes.
Check that the photometer lamp has cooled down completely, then wipe off the
fingerprints with a soft cloth dampened with ethyl alcohol (Ethanol).

8-59
AU480 User Guide Maintenance
Version 1.0
 Return to Main Table of Contents

Procedure for Replace the Photometer Lamp

Materials:
New photometer lamp MU9888

1. Shut down the system selecting E n d and more than five minutes have passed since the system
termination process was executed.
When the system is currently active, execute the termination process and allow at least five
minutes.
2. Open the main cover.

When removing the lamp unit cover, do not bump the cover against the reagent
probe.
CAUTION

3. Remove the lamp unit cover.

4. Loosen the two knobs on the terminals, then disconnect the two lamp cords from the terminals.

Silver lamp holder Knobs

Lamp cords

5. Loosen the silver lamp holder ring by turning it counterclockwise, then pull the photometer lamp
out.

Photometer lamp

Silver lamp holder

8-60
Maintenance AU480 User Guide
Version 1.0
Return to Main Table of Contents

6. Align the notches on the black guide key and the notch on the new photometer lamp with the
protrusion at the top of the lamp receptacle. Insert the lamp into the receptacle.

Protrusion

Notch

Guide key
Lamp receptacle
Collar notch

Tighten the silver lamp holder ring securely. If the silver lamp holder is loose, accurate
analysis data cannot be obtained.
CAUTION

7. Turn the silver lamp holder ring clockwise to secure the photometer lamp.
8. Connect each lamp wire to a terminal, and tighten the two knobs. The wires may connect to either
terminal.
9. Replace the lamp unit cover.
10. Close the main cover.

After Replace the Photometer Lamp, be sure to perform the photocal measurement to
make sure it is functioning correctly.
CAUTION

11. Press the O N button to turn the system power to on.

After replacing the photometer lamp, perform a photocal measurement to check the
lamp. To obtain optimal analysis data, do not start a photocal measurement until the
CAUTION photometer lamp has stabilized for approximately 20 minutes after system startup.

8-61
AU480 User Guide Maintenance
Version 1.0
 Return to Main Table of Contents

12. From the AU480 “Home” window select Menu List>Maintenance>User Maintenance>Analyzer
Maintenance>Consumption to display the “Analyzer Maintenance: Maintenance tab” window.

13. Select Re p l a c i n g P h o t o m e t e r l a m p from the list of consumable part.

14. Select U p d a t e .
A confirmation window appears.
15. Select O K to reset the used period.
16. Start a photocal measurement approximately 20 minutes after system startup.
For details on a photocal measurement, refer to section “8.4.3 Perform a Photocal” in this
chapter.

• The first photocal value is saved automatically as a reference value after

maintenance date is updated.

TIP • Errors may be encountered as a result of the photocal measurement. If so, they
may be caused by the following. Examine the number of the cuvette with errors
and take appropriate action as follows:

• Numerous errors have occurred.

The photometer lamp may not be set correctly or the new photometer lamp
may be defective.
Set the photometer lamp again.

• Random errors have occurred.

The photometer lamp has been replaced correctly, but some cuvettes may be
stained.
Clean the cuvettes that caused the error. If the error is not corrected even after
cleaning the cuvettes, replace them.

8-62
Maintenance AU480 User Guide
Version 1.0
Return to Main Table of Contents

8.7.2 Washing Cuvettes and the Cuvette Wheel

If the cuvettes and cuvette wheel are not washed for an extended period of time, the contaminants,
such as the serum or the scale will be difficult to clean. The contaminants on a cuvette result in a
photometric error. Be sure to wash the cuvettes and cuvette wheel every six months.

Procedure for Washing Cuvettes and the Cuvette Wheel

Materials:

• Wash solution

• L wrench

• Paper towel

Removing the cuvette wheel and cuvettes

1. Shut down the system selecting E n d . And press the E M S TO P button to turn off the main
power.
2. Open the main cover.
3. Open the rear cover.

• When handling a wash nozzle take care not to damage the nozzle.

• When removing the wash nozzle station be careful not to bring the nozzle tips into
CAUTION contact with the cuvette wheel cover.

• When loosening the knob on the wash nozzle station, do not loosen the
positioning screws on both sides of the knob. These screws are used for
positioning the wash nozzle station.

4. Loosen the knob on the wash nozzle station. Remove the wash nozzle station and hang it on the
nearby hook.

Hook

Wash nozzle
station

Knob

FR Cuvette wheel cover

ON
T
positioning marks

8-63
AU480 User Guide Maintenance
Version 1.0
 Return to Main Table of Contents

5. Manually turn the mixing unit approximately 60° so that the mix bars do not block the cuvette
wheel and cover.

Mixing unit
Cuvette wheel cover

The green positioning marks

NT
FRO

When removing the cuvette wheel cover, do not damage the sample probe, reagent
probe, and mix bars.
CAUTION

6. Lift the cuvette wheel cover slowly to remove it.

The cuvette wheel is secured with two fixing screws as shown in the figure below.
7. Remove the two screws in the cuvette wheel. Then screw them into the two holes on the cuvette
wheel, located as shown in the figure below.

Cuvette wheel cover

Holes
Screws
Holes

Cuvette wheel
ONT
FR The green positioning mark

When removing the cuvette wheel, do not bring it into contact with peripheral devices.
CAUTION

8. Use the two screws as handles to lift the cuvette wheel.

8-64
Maintenance AU480 User Guide
Version 1.0
Return to Main Table of Contents

9. Lift the cuvette wheel to remove it.

• When removing cuvettes, do not scratch them.

• Never touch the photometric face of a cuvette. If the photometric face is stained by
CAUTION fingerprints, etc., the photometric data will be inaccurate.

10. Insert a L wrench into each cuvette hole from the bottom of the cuvette wheel, then push out each
cuvette. Remove all of the 88 cuvettes from the wheel.

Cuvette

L wrench

Cuvette
Photometric
face

Frosted
glass face

11. Close the cuvette wheel cover, rear cover, and main cover.

Washing and mounting cuvettes and the cuvette wheel

When washing cuvettes do not scratch them. If a cuvette is scratched, the

photometric data will be inaccurate.
CAUTION

1. Soak the cuvette in the 50-times diluent of wash solution for 8 hours.
Wash the cuvette wheel completely with tap water.

To wash the cuvette wheels, do not use any wash solution. Otherwise, the metallic
plating on the cuvette wheel may be removed.
CAUTION

2. After thoroughly washing the cuvette wheel with tap water, rinse it in the deionized water.
3. Either dry the cuvettes and cuvette wheel in a dryer or completely wipe off the moisture remaining
on the outside surface of the cuvette using such as paper towel that will not leave any residue.
Then, mount the cuvettes on the cuvette wheel.

Properly mount all of the 88 cuvettes on the cuvette wheel. If even a single cuvette is
not mounted on the cuvette wheel, the mixture, reagent, wash solution, etc., will spill
on the cuvette wheel. This will disable analysis.
CAUTION When mounting cuvettes, do not scratch them.
Never touch the photometric face of a cuvette. If the photometric face is stained by
fingerprints, etc., the photometric data will be inaccurate.

8-65
AU480 User Guide Maintenance
Version 1.0
 Return to Main Table of Contents

4. Push each cuvette all the way to the bottom of the cuvette wheel by hand.
5. Replace the cuvette wheel in the original position.
6. Mount the cuvette wheel cover in place.
7. Remove the wash nozzle station from the hook and install it in the original position. Tighten the
knob to secure the wash nozzle station.
8. Close the rear and main cover.
9. Press the R E S E T button. After 10 seconds, press the O N button to turn on the system power.
The Warm up mode is entered after the initialization.
10. From the AU480 “Home” window select Menu List>Maintenance>User Maintenance>Analyzer
Maintenance>Maintenance to display the “Analyzer Maintenance: Maintenance tab” window.

11. Select Wa s h i n g C u v e t t e s & C u v e t t e W h e e l from the list of maintenance

items.
12. Select U p d a t e .
A confirmation window appears.
13. Select O K .
14. Close the main cover.

After washing the cuvettes, be sure to perform a photocal measurement to check if

the cuvettes are washed correctly.
To obtain appropriate analysis data, do not start a photocal measurement until the
CAUTION photometer lamp has stabilized after starting the system. The photometer lamp will
stabilize approximately 20 minutes after system startup.

15. Perform a photocal measurement.

For details on how to execute a photocal measurement, refer to section “8.4.3 Perform a
Photocal” in this chapter.

8-66
Maintenance AU480 User Guide
Version 1.0
Return to Main Table of Contents

8.8 Maintenance Performed Yearly or As Necessary

This section describes the procedures used to perform yearly or irregular maintenance, such as those
for replacing damaged parts.

Record

• Record the maintenance actions in the “Maintenance Schedule”.

• After performing maintenance tasks, select the performed maintenance task from list displayed
on “Analyzer Maintenance: Maintenance” window and update performed date. For details on
updating the maintenance record, refer to section “8.2.2 Updating the Maintenance Register” in
this chapter.

Yearly Maintenance
8.8.1 Replace O-rings in the Wash Nozzle Supply Tube Mounting Joints...............8-68

Maintenance performed as necessary

8.8.2 Replace Cuvettes...........................................................................................8-70
8.8.3 Manually Wash the Reagent Probe................................................................8-72
8.8.4 Replace Sample Probe and Reagent Probe..................................................8-73
8.8.5 Replace Mix bars............................................................................................8-76
8.8.6 Replace the Wash Nozzle Joint......................................................................8-78
8.8.7 Replace Syringes...........................................................................................8-82
8.8.8 Clean the inside of the STAT table unit and Reagent Refrigeration Unit........8-87
8.8.9 Replace the Antistatic Brush...........................................................................8-89
8.8.10 Replace Rack ID labels..................................................................................8-90
8.8.11 Replace the Sample Probe and Reagent Probe Tubes..................................8-91
8.8.12 Execute a W1 (Auto-wash of the sample probe and cuvettes).......................8-93
8.8.13 Replace Air Filters..........................................................................................8-94
8.8.14 Replace Syringe cases and Syringe heads....................................................8-95
8.8.15 Replace Packing in the Wash Nozzle Tube Mounting Joints........................8-100

Always wear personal protective equipment when performing any maintenance

procedure. For precautions against other than infection, observe the descriptions of
“WARNING” and “CAUTION” given in this user guide.
CAUTION

8-67
AU480 User Guide Maintenance
Version 1.0
 Return to Main Table of Contents

8.8.1 Replace O-rings in the Wash Nozzle Supply Tube Mounting

Joints
Replace each O-ring in the wash nozzle mounting joints with a new one every year.
When installing the tube mounting joints of the wash nozzle station, check the following items.

• All the six O-rings (see the figure below) should be seated in each groove.

• Any foreign matters such as dust or wash solution crystals should not be observed on and
around each O-ring.
If any O-ring comes off from the groove, properly fit it in the original position again. Also, if any foreign
matter is found on an O-ring, clean it.

O-ring

Procedure for replacing O-rings

To replace the O-rings, observe the following procedure.

Materials:

• Dry, clean cloth or paper towel

• A pair of tweezers

• O-rings, MU9638

1. Select Re p l a c i n g O R i n g o f t h e Wa s h N o z z l e from the list of maintenance

items.
2. Select Re p l a c i n g Wa s h N o z z l e from the “Single Operation” buttons and select O K .
3. Press the TA B L E R OTAT I O N / D I A G button.
4. Repeat step 3 two or three times until the liquid in the tube of the wash nozzle unit has been
completely removed.
5. Open the rear cover.

8-68
Maintenance AU480 User Guide
Version 1.0
Return to Main Table of Contents

6. Remove the supply mounting joint (behind the wash nozzle station).

Tube mounting
joint
Tube mounting A total of six
joint pieces of
O-rings are
used inside
the tubes
Wash nozzle FFRR
OONT
station T

7. Wipe off the stain around each O-ring with a dry clean cloth or paper towel.
8. Remove the O-rings with tweezers and set new O-rings (MU9638) in place.
9. Mount the supply mounting joint in the original position.

If the O-rings are used for an extended period of time without being cleaned or if the
joint cover has been closed without the O-rings set properly in each groove, wash
solution crystals will form, causing scratches on cuvettes. Be sure to check the O-
CAUTION rings along with the monthly maintenance of the wash nozzle station.

10. Select U p d a t e .
A confirmation window appears.
11. Select O K .
12. Select W 1 ( F 5 ) .
The “W1 Start” window appears.
13. Select S t a r t .
14. Close the rear cover.

8-69
AU480 User Guide Maintenance
Version 1.0
 Return to Main Table of Contents

8.8.2 Replace Cuvettes

Stained or scratched cuvettes cause a photometric error. To obtain the optimal analysis results from
the Analyzer, replace the cuvette from which the stain on the photometric surface will not be removed
even after cleaning or that has been scratched. Also replace the cuvette for which an error has been
displayed as the result of Photocal measurement.

Procedure for Replace Cuvettes

Materials:

• New cuvette, MU8465

• L wrench

Make sure that all the removed cuvettes are remounted in place without any
omission. Even if one of the cuvettes is missing, the mixture, reagent, or wash
solution will spill into the cuvette wheel, hampering the analysis to be successfully
CAUTION performed.
When mounting cuvettes on the cuvette wheel, exercise care so as not to scratch
them.
Never touch the photometric surface on a cuvette. If the photometric surface is
stained by fingerprints, etc., the photometric data will be incorrect. When handling a
cuvette, pinch its frosted glass surfaces.

1. Perform the following step depending on the types of errors.

• After replacing the cuvettes a photocal error occurs:

a. Verify that the system is in Warm up or Standby mode.
b. Open the main cover and replace the cuvettes.

• After replacing the cuvettes an error occurs other than a photocal error:
a. Shut down the system selecting E n d . And press the E M S TO P button to turn off
the main power.
b. Open the main cover and replace the cuvettes.
Press the R E S E T button. After 10 seconds, press the O N button to turn on the
system power.
After the initialization, it is changed to the Warm up mode.

8-70
Maintenance AU480 User Guide
Version 1.0
Return to Main Table of Contents

2. From the AU480 “Home” window select Menu List>Maintenance>User Maintenance>Analyzer

Maintenance>Maintenance to display the “Analyzer Maintenance: Maintenance tab” window.

3. Select Re p l a c e C u v e t t e s from the list of maintenance items.

4. Select U p d a t e .
A confirmation window appears.
5. Select O K .

After replacing a cuvette, always check that the cleaning of the cuvette has been
properly performed by executing a Photocal measurement. To obtain optimal analysis
results, always perform Photocal measurement only when the photometer lamp
CAUTION has been stabilized since the startup of the Analyzer. The photometer lamp will be
stabilized in about 20 minutes after system startup.

6. Perform a Photocal measurement.

For details on Perform a Photocal, refer to section “8.4.3 Perform a Photocal” in this chapter.

8-71
AU480 User Guide Maintenance
Version 1.0
 Return to Main Table of Contents

8.8.3 Manually Wash the Reagent Probe

If the reagent probe is contaminated, contamination between samples and
contamination between reagents may occur, and thus correct analysis results will not
be obtained.
CAUTION To prevent contamination between samples or contamination between reagents, wash
the reagent probe.

Procedure for Washing Reagent Probe

To wash the reagent probe, observe the following procedure.
Materials:

• Ethyl alcohol (Ethanol)

• Clean cloth or paper towel

• Mandolin string (Standard accessory)

1. Verify that the system is in Warm up or Standby mode.

2. Open the main cover.
3. From the AU480 “Home” window select Menu List>Maintenance>User Maintenance>Analyzer
Maintenance>Maintenance to display the “Analyzer Maintenance: Maintenance tab” window.
4. Select M a n u a l Wa s h i n g Re a g e n t P r o b e s from the list of maintenance items.
5. Select Re p l a c i n g Re a g e n t P r o b e / S y r i n g e from the “Single Operation” buttons.
The “Start” window appears.
6. Enter 3 or more as the number of prime cycle and select O K .
7. Press the TA B L E R OTAT I O N / D I A G button.
Liquid will be drained from the reagent probe, and the probe will be washed.
8. Disconnect the probe connector.

When replacing the reagent probe, do not bend or damage the probe tip.
CAUTION

9. While holding connecting part of the probe connector by hand, pull the reagent probe upward.
Discard the wash solution in the reagent probe into the wash station well.
10. Wipe off the contamination on the probe tip with a clean cloth or paper towel damped with ethyl
alcohol (ethanol).
11. Insert the supplied mandolin string into the nozzles from the probe tip to clean the nozzles.
12. Plug the reagent probe into its original place from the top.
13. Tighten the probe connectors to secure each probe.
Tighten the connectors firmly to ensure that no liquid leaks from the joints.

8-72
Maintenance AU480 User Guide
Version 1.0
Return to Main Table of Contents

14. Press the TA B L E R OTAT I O N / D I A G button.

The water is ejected from the probe tip. Verify that the water ejects like one straight line.
If the water is sprayed widely or does not eject straight from each probe tip, replace the probe.
15. Select U p d a t e .
A confirmation window appears.
16. Select O K .

8.8.4 Replace Sample Probe and Reagent Probe

Replace the sample probe or the reagent probe if they become damaged, or if the stream of liquid
during priming is consistently not straight or coherent.

Procedure for replacing the sample probe and reagent probe

Replace the sample probe and reagent probe in the same procedure. The replacing procedure
common to the sample probe and reagent probe is described below.

Materials:

• New sample probe, MU9934

• New reagent probe, MU9958

• Check that the sample probe is just above the wash station and then replace it
with a new one. Liquid dripping will occur during displacement of the probe.

CAUTION • When handling the sample probe or reagent probe, exercise care not to bend or
damage the probe tip.

1. Verify that the system has entered Warm up or Standby mode.

2. Open the main cover.
3. Loosen to disconnect the probe connector.

8-73
AU480 User Guide Maintenance
Version 1.0
 Return to Main Table of Contents

4. Pull the sample probe upward while holding the portion to be connected with the probe connector
with fingers.
Discharge the water in the sample probe or reagent probe to the wash station.

Reagent probe connectors

Reagent probe Probe connector

Sample probe
Sample probe wash station

5. Insert a new sample probe or reagent probe into the probe connector from above.
6. Tighten the probe connector to attach it to the sample probe or reagent probe.
Be sure to tighten the connector firmly so that no liquid leaks from the joint.
7. From the AU480 “Home” window select Menu List>Maintenance>User Maintenance>Analyzer
Maintenance>Maintenance to display the “Analyzer Maintenance: Maintenance tab” window.

8. Select the maintenance item from the list of maintenance items, then select the related button
from the “Single Operation” buttons.

The items to The list of

Single Operation button
be replaced maintenance items
Sample probe Replacing Sample Probe Replacing Sample Probe
R probe Replacing Reagent Probe Replacing Reagent Probe/Syringe

8-74
Maintenance AU480 User Guide
Version 1.0
Return to Main Table of Contents

9. Set the number of operation, etc., and select O K .

The items to be replaced The items to be set

Sample probe The number of times the wash water is drained: 3 or more
R probe The number of times the wash water is drained: 3 or more

10. Press the TA B L E R OTAT I O N / D I A G button.

This makes the sample probe or reagent probe eject water from its tip. At this time check that the
water is ejected straight downward and like a single string from the probe tip.
Check also that the water is ejected correctly into the hole of the wash station. If it is not, loosen
the probe connector once and rotate the probe so that the probe tip is directed to the wash
station hole, then retighten the probe connector. Then, recheck the probe for the dispense state
and dispense position of the water.
11. Select U p d a t e .
A confirmation window appears.
12. Select O K .
13. Close the main cover.

Analyze quality control material, and check the data.

TIP

8-75
AU480 User Guide Maintenance
Version 1.0
 Return to Main Table of Contents

8.8.5 Replace Mix bars

If a mix bar is damaged or remains stained even after washing, replace it with a new one.

Procedure for Replace Mix bars

Materials:
New mix bar for R1 and S MU9599
New mix bar for R2 MU8267

DO NOT replace a mix bar while the mixing unit drive is operating. It may cause
personal injury.
CAUTION

1. Verify that the system has entered Warm up or Standby mode.

2. Open the main cover.
3. Pull out the mix bar to be replaced.

Mix bar

Mixing unit

Exercise care so as not to scratch the mix bar when inserting it into the mixing unit.
CAUTION

8-76
Maintenance AU480 User Guide
Version 1.0
Return to Main Table of Contents

4. Insert a new mix bar into the mixing unit from above.
After inserting the mix bar, rotate it slightly to engage the notch on the mix bar with the gear in the
hole of the mixing unit.

The shapes of mix bars are different as follows:

• The mix bar for R1 and S, MU9599: screw type

CAUTION • The mix bar for R2, MU8267: L-shaped type

Set each mix bar at proper position.

mix bar for R1 and S

mix bar for R2

S 3 R1

R2
4

2
R2
R1 1 S mix bar for R2

mix bar for R1 and S

5. From the AU480 “Home” window select Menu List>Maintenance>User Maintenance>Analyzer

Maintenance>Maintenance to display the “Analyzer Maintenance: Maintenance tab” window.
6. Select Re p l a c e m i x b a r s from the list of maintenance items.
7. Select Re p l a c i n g m i x b a r from the “Single Operation” buttons.
The “Start” window appears.
8. Enter 3 or more as the number of times the diluted wash solution and water is drained, and select
OK.
9. Press the TA B L E R OTAT I O N / D I A G button.
10. Select U p d a t e .
A confirmation window appears.
11. Select O K .
12. Close the main cover.

8-77
AU480 User Guide Maintenance
Version 1.0
 Return to Main Table of Contents

8.8.6 Replace the Wash Nozzle Joint

If any wash nozzle joint of the wash nozzle joint station is damaged or cracked, liquid will remain in
the cuvettes and wash solution will drip from the wash nozzle joint. This may result in an analysis data
error. To prevent analysis data errors, immediately replace the damaged wash nozzle joint.

Replace the Wash Nozzle Joint

Materials:
New wash nozzle joint, ZM1131 (3 pieces per set)

1. Open the main cover.

2. Verify that the system has entered Warm up or Standby mode.
3. From the AU480 “Home” window select Menu List>Maintenance>User Maintenance>Analyzer
Maintenance>Maintenance to display the “Analyzer Maintenance: Maintenance tab” window.

4. Select Re p l a c i n g Wa s h N o z z l e J o i n t Tu b e s from the list of maintenance

items.
5. Select Re p l a c i n g Wa s h N o z z l e from the “Single Operation” buttons and select O K .
6. Press the TA B L E R OTAT I O N / D I A G button.
The liquid in the tubing on the wash nozzle station is drained.
7. Repeat step 6 two or three times until the liquid in the wash nozzle is completely removed.
8. Open the rear cover.

8-78
Maintenance AU480 User Guide
Version 1.0
Return to Main Table of Contents

9. Loosen and remove the four tube mounting joints from the wash nozzle station.

Tubes

Tube mounting
joint
A total of six
Knob pieces of
O-rings are
used inside
the tubes
Tube mounting joint Positioning pin

Wash nozzle
FFRR
station OONT
T

• When handling the wash nozzles, do not damage the nozzles.

• When removing the wash nozzle station, be careful not to bring the nozzle tips into
CAUTION contact with the cuvette wheel cover.

• When loosening the knob on the wash nozzle station, do not loosen the
positioning screws on both sides of the knob. These screws are used to position
the wash nozzle station.
10. Loosen the knob on the wash nozzle station, then remove the wash nozzle station along with the
tubing. Put it on an appropriate surface such as a table.

Remove old wash nozzle joint and mount new wash nozzle joint one by one. If a
wrong nozzle and tube are connected at both ends of a wash nozzle joint, correct
CAUTION analysis cannot be performed.

8-79
AU480 User Guide Maintenance
Version 1.0
 Return to Main Table of Contents

11. Remove the wash nozzle joint to be replaced.

Always drain the water remaining in the wash nozzles before cleaning or replacing the
tube mounting joints. Loosing any tube mounting joint without draining the remaining
water may cause the water to spills out of the nozzle.
CAUTION

Wash nozzle joint

Tube

Wash nozzle joint

ZM1131

Wash nozzle
station

8-80
Maintenance AU480 User Guide
Version 1.0
Return to Main Table of Contents

12. Insert the tube into one end of a new wash nozzle joint, and then insert the nozzle into the other
end of the wash nozzle joint.
Position both ends of the tube and nozzle in the center of the wash nozzle joint. Allow
approximately 1 mm between the ends of the tube and nozzle.

Cross-sectional View

Tube
Wash nozzle
Position both joint
ends of the tube
and nozzle in the Approx. 1mm
Wash nozzle station center of the wash
nozzle joint
Nozzle

• When handling the wash nozzles, do not damage the nozzles.

• When mounting the wash nozzle station, be careful not to bring the nozzle tips into
CAUTION contact with the cuvette wheel cover.

• At the time of attaching tube mounting joints, be careful not to cross the tubes. If
they are crossing, a nozzle gets pulled diagonally and it might become unable to
wash properly

13. Remount the wash nozzle station in place.

14. Close the rear cover.
15. Select U p d a t e .
A confirmation window appears.
16. Select O K .
17. Select W 1 ( F 5 ) .
The “W1 Start” window appears.
18. Select S t a r t .
19. Close the main cover.

8-81
AU480 User Guide Maintenance
Version 1.0
 Return to Main Table of Contents

8.8.7 Replace Syringes

This section explains replacing the following syringes:

• Sample syringe

• Reagent syringe

Replace syringes when:

• Movement of the syringe is either very stiff or very loose.

• The syringe head is chipped, worn or damaged in any way.

• Leaks occur even after maintenance and correct installation.

• The S-syringe and R-syringe are identified with the piston shaft diameter.
Piston shaft diameter: D

D = 5mm: R syringe
CAUTION
D = 2mm: S syringe

Do not remove the piston from a new syringe. If the piston is removed the
performance of the syringe can be unreliable.

Procedure for replacing the syringes

Use the same procedure to replace a sample syringe and a reagent syringe. Follow these procedures:

• Removing the Old Syringe.

• Installing a New Syringe.

• Priming New Syringe.

Materials:

• New sample syringe, ZM0111

• New reagent syringe, ZM0112

Removing the Old Syringe

To replace a syringe, remove the old syringe first. To do this:
1. Open the right front door of the analyzer.
2. Verify that the system has entered Warm up or Standby mode.
3. Loosen the piston fixing screw located at the bottom of the syringe to be replaced.
4. Loosen the fixing nut on top of the syringe for which the piston fixing screw has been loosened.

8-82
Maintenance AU480 User Guide
Version 1.0
Return to Main Table of Contents

5. Pull the syringe case frontward to remove the syringe unit carefully from the mounting grooves.

Fixing nut

Mounting groove

Fixing screws
Syringe case

Mounting groove
Piston fixing screw

• Do not apply excessive force to the fixing screws when removing the syringe
case. If an excessive force is applied to the fixing screws, the syringe case may
be damaged.
CAUTION
• When removing the syringe case, exercise care not to bend the tube.

6. Remove the syringe from its case by turning it counter-clockwise while holding the case head and
syringe case by hands.
7. Pull out the syringe from the case head.
Be careful that the O-ring does not fall out of the head and get lost. If it remains in the syringe
head, remove it carefully with tweezers.

Case head
O-ring

Syringe
ZM0111/ZM0112

Syringe case

8-83
AU480 User Guide Maintenance
Version 1.0
 Return to Main Table of Contents

Installing a New Syringe

After removing the old syringe, a new one can be installed. To do this:
1. Insert the new syringe into the case head.

Never apply a strong alkali such as the AU wash solution alkali to the syringe case
and case head. The strong alkali adhering to the syringe case and case head will
cause cracks on them.
CAUTION If the strong alkali has adhered to, remove the syringe case and case head and wash
them with water.

2. Mount the syringe case on the case head. Screw the syringe case onto the syringe, until the head
comes into light contact. Then turn it an extra 45 to 60 degrees.
3. Insert the syringe into the mounting groove by holding the case head. Tighten the fixing nut while
pressing the case head with fingers.

Mounting groove
Fixing nut
Fixing screws

Case head
Syringe case
Piston fixing screw

4. Tighten the piston fixing screw.

8-84
Maintenance AU480 User Guide
Version 1.0
Return to Main Table of Contents

Priming a New Syringe

Priming any new syringes is mandatory. To do this:
1. From the AU480 “Home” window select Menu List>Maintenance>User Maintenance>Analyzer
Maintenance>Maintenance to display the “Analyzer Maintenance: Maintenance tab” window.

2. Select the maintenance item from the list of maintenance items, then select the related button
from the “Single Operation” buttons.

The item to be replaced The list of maintenance items Single Operation button
S syringe of the sample syringe Replacing Sample Syringe Replacing Sample Syringe
R syringe of the reagent syringe Replacing Reagent Syringe Replacing Reagent Probe/
Syringe
3. Set the number of operation, etc., and select O K .

The item to be replaced The items to be set

S syringe of the sample syringe The number of operation: 260
R syringe of the reagent syringe The number of operation: 5 or more

4. Press the TA B L E R OTAT I O N / D I A G button.

The deionized water will flow through the tube and the air in the tube will be purged.

• In case of the reagent syringe, repeat step 4 until the air in the tube has been completely
purged.

• It takes 4 to 30 minutes from start to finish of replacing the sample syringe. In order to stop
the operation, press the TA B L E R OTAT I O N / D I A G button. At this time an abort
error alarm will generate. Perform alarm clear process without any corrective action.
5. Set the number of times the wash water is drained to 260, then select O K .
6. Press the TA B L E R OTAT I O N / D I A G button.

8-85
AU480 User Guide Maintenance
Version 1.0
 Return to Main Table of Contents

7. Remove the syringe case again.

Loosen the piston fixing screw and fixing nut and remove the syringe case from the syringe.
8. Move the piston of the syringe up and down slowly by hand, and confirm that there are no
bubbles on the syringe head.
If bubbles are still present, move the piston up and down until the bubbles are purged.

Do not move the piston by hand without mounting the syringe on the syringe case.
Doing so will not retain the accuracy due to deformation of the piston and shorten the
service life.
CAUTION

Case head

Confirm that
no bubbles
are attached.

Syringe

Syringe case

9. Mount the syringe case assembly on the case head.

10. Select U p d a t e .
A confirmation window appears.
11. Select O K .
12. Close the right front door of the analyzer.

Analyze quality control material, and check the data.

TIP

8-86
Maintenance AU480 User Guide
Version 1.0
Return to Main Table of Contents

8.8.8 Clean the inside of the STAT table unit and Reagent
Refrigeration Unit
The insides of the STAT table unit and the Reagent Refrigeration unit are exposed to drops of samples
and reagents, contact with outside air, and condensation. These conditions are likely to breed bacteria
and fungi.
Clean the inside of those units when a reagent or sample is spilled there or as appropriate after visual
check of the inside.

Procedure for cleaning the inside of the STAT table unit or reagent refrigeration
unit

Materials:

• Dry, clean cloth

• Ethyl alcohol (ethanol)

Procedure for cleaning the STAT table unit inside

There is a window inside of STAT table, which is used for reading barcode. Be careful
not to contaminate it when clean the unit. If the glass becomes dirty, it will not be able
to read barcode.
CAUTION

1. Verify that the system is in Warm up or Standby mode.

2. Open the main cover and open the STAT table cover.
3. Loosen the two fixing screws near the center of the STAT table with fingers. Remove the STAT
table by lifting the central column. Set the STAT table aside in a safe place.
4. Wipe the condensation and stains from the wall, bottom, and central area inside the STAT table
unit with a dry clean cloth.
Also wipe the condensation and stains from the STAT table just removed.
5. Wipe the same components again with a clean cloth dampened with ethyl alcohol (ethanol).
6. Replace the STAT table.
Engage the guide hole on the STAT table with the guide pin on the table unit. Then tighten the
two fixing screws finger-tight.
7. Replace the STAT table cover and close the main cover.
8. From the AU480 “Home” window select Menu List>Maintenance>User Maintenance>Analyzer
Maintenance>Maintenance to display the “Analyzer Maintenance: Maintenance tab” window.
9. Select C l e a n i n g I n s i d e o f S TAT C o m p a r t m e n t from the list of maintenance
items.
10. Select U p d a t e .
11. Select O K .

8-87
AU480 User Guide Maintenance
Version 1.0
 Return to Main Table of Contents

Clean the inside of the Reagent Refrigeration unit

There is a window inside of STAT table, which is used for reading bar code. Be careful
not to contaminate it when clean the unit. If the glass becomes dirty, it will not be able
CAUTION to read bar code.

1. Verify that the system is in Warm up or Standby mode.

2. Open the main cover and remove the reagent refrigerator lid.
3. Remove the reagents along with the reagent tray and gently place the tray in a safe place.
4. With a dry clean cloth, wipe the condensation and stains from the wall, bottom, and central area
inside the reagent refrigeration unit.
5. Wipe the same components again with a clean cloth dampened with ethyl alcohol (ethanol).
6. Replace the reagents and reagent tray.
7. Replace the reagent refrigerator lid and close the main cover.
8. From the AU480 “Home” window select Menu List>Maintenance>User Maintenance>Analyzer
Maintenance>Maintenance to display the “Analyzer Maintenance: Maintenance tab” window.
9. Select C l e a n i n g I n s i d e o f Re a g e n t Re f r i g e ra t o r from the list of
maintenance items.
10. Select U p d a t e .
11. Select O K .

8-88
Maintenance AU480 User Guide
Version 1.0
Return to Main Table of Contents

8.8.9 Replace the Antistatic Brush

The antistatic brush reduces static electricity from sample tubes. In doing so it can become
contaminated, reducing its effectiveness. This causes an error in liquid-level detection of samples.
When the antistatic brush is contaminated, replace it with a new one.

Procedure for Replace the Antistatic Brush

Materials:
New antistatic brush, MU8525

1. Verify that the system is in Warm up or Standby mode.

2. Open the main cover.
3. Remove the cover of rack feeder unit.
4. Loosen the fixing screw at the top of the antistatic brush to remove it.

Antistatic brush

Fixing screws

5. Mount a new antistatic brush and tighten the fixing screw.

6. Replace the cover of the rack feeder and close the main cover.
7. From the AU480 “Home” window select Menu List>Maintenance>User Maintenance>Analyzer
Maintenance>Maintenance to display the “Analyzer Maintenance: Maintenance tab” window.
8. Select Re p l a c e a n t i - s t a t i c b r u s h from the list of maintenance items.
9. Select U p d a t e .
10. Select O K .

8-89
AU480 User Guide Maintenance
Version 1.0
 Return to Main Table of Contents

8.8.10 Replace Rack ID labels

If a rack ID label is used with it remaining scratched, stained, or deteriorated with time, may cause a
read error will result. Replace the rack ID label with a new one.

Rack ID labels are deteriorated with time.

If a rack ID read error occurs in a label used for an extended period of time and if
the label shows none of the following anomalies, the label is assumed to have been
CAUTION deteriorated due to discoloration, reduction in reflectivity, etc. If this is the case,
replace all the labels that have been used for the same period of time as the label
concerned.
• The barcode on a label has become chipped, faint, or scratched due to abrasion,
scraping, etc.

• A label has been stained or blurred due to adhesion of foreign matters (liquid or
solid).

• A label has been peeled or torn.

Procedure for Replace Rack ID labels

Materials:

• New rack ID label

• Paper cutter

• If it is difficult to remove a label, dampen the label with water and use a tool to
scrape it off, such as a razor blade or scissors. Do not scratch the rack surface.

CAUTION • Never use an organic solvent such as ethyl alcohol (ethanol) because it will alter
the quality of the plastic surface on a rack.

• If water is used, wipe it off completely so that no moisture remains on the rack.

1. Remove the rack ID label.

2. Stick a new rack ID label on the rack.

When replacing rack ID labels, do not use labels with the same rack ID on more than
one rack.
CAUTION This could result in confusion between samples.

Update the performed date by selecting Re p l a c i n g Ra c k I D l a b e l on

the “Analyzer Maintenance: Maintenance tab” window.
TIP

For details on updating the maintenance date, refer to section “8.2.2 Updating the Maintenance
Register” in this chapter.

8-90
Maintenance AU480 User Guide
Version 1.0
Return to Main Table of Contents

8.8.11 Replace the Sample Probe and Reagent Probe Tubes

Replace tubing on sample probe and reagent probe that is leaking or broken.

Procedure for Replace the Sample Probe and Reagent Probe Tubes
The procedure for replacing sample probe and reagent probe tubing is the same for both probes.

Materials:
New tubing tube for sample probe MU0262
New tubing tube for sample probe MU0261

Liquid will drip during displacement of the probe. Before beginning, make sure the
probes are above the wash station.
CAUTION

1. Verify that the system has entered Warm up or Standby mode.

2. Open the main cover.
3. Loosen the connectors on each end of the tubing.
4. Tighten each connector firmly to ensure that no liquid leaks from the joints.
5. From the AU480 “Home” window select Menu List>Maintenance>User Maintenance>Analyzer
Maintenance>Maintenance to display the “Analyzer Maintenance: Maintenance tab” window.
6. Select the maintenance item from the list of maintenance items, then select the related button
from the “Single Operation” buttons.

The items to The list of

Single Operation button
be replaced maintenance items
Sample probe Replacing Sample Probe Tubes Replacing Sample Probe
R probe Replacing Reagent Probe Tubes Replacing Reagent Probe/Syringe
The “Start” window appears.
7. Set the number of operation, etc., and select O K .

The items to be replaced or

The items to be set
cleaned
Sample probe The number of times the wash water is drained: 3 or more
R probe The number of times the wash water is drained: 3 or more

8-91
AU480 User Guide Maintenance
Version 1.0
 Return to Main Table of Contents

8. Press the TA B L E R OTAT I O N / D I A G button.

9. Select U p d a t e .
A confirmation window appears.
10. Select O K .
11. Close the main cover.

Reagent
Probe Tube

Sample
Probe Tube

8-92
Maintenance AU480 User Guide
Version 1.0
Return to Main Table of Contents

8.8.12 Execute a W1 (Auto-wash of the sample probe and

cuvettes)
If analysis is forcibly stopped, sample remains in the sample probe and reagents remain in cuvettes.
Remove these liquids by performing a W1 operation.
1. From the AU480 “Home” window select Menu List>Maintenance>User Maintenance>Analyzer
Maintenance>Maintenance to display the “Analyzer Maintenance: Maintenance tab” window.

2. Select W 1 ( F 5 ) .
The “W1 Start” window appears.
3. Select S t a r t .
The W1 operation starts to clean the inside of cuvettes. This operation requires approximately
nine minutes.

8-93
AU480 User Guide Maintenance
Version 1.0
 Return to Main Table of Contents

8.8.13 Replace Air Filters

When the air filters have been broken, replace them.

Procedure for Replacing the Air Filter

Materials:
New air filters

• Air filter: MU9593

• Air filter: MU8447

Make sure the filters are always installed in the system. If filters are missing, heaters
and the power supplies get dusty, which can cause a short circuit and fire.
CAUTION

1. Shut down the system selecting E n d .

And press the E M S TO P button to turn off the main power.
2. Remove the targeted air filters.

MU9593

MU8447

3. Insert the new air filters.

Press the R E S E T button. After 10 seconds, press the O N button to turn on the
system power. Update the performed date by selecting C l e a n a i r f i l t e r s
TIP on the “Analyzer Maintenance: Maintenance tab” window.

For details on updating the maintenance date, refer to section “8.2.2 Updating the Maintenance
Register” in this chapter.

8-94
Maintenance AU480 User Guide
Version 1.0
Return to Main Table of Contents

8.8.14 Replace Syringe cases and Syringe heads

The syringe cases and case heads explained in this section are:

• For S syringe of sample syringe

• For R syringe of reagent syringe

Replace syringe cases when:

• The syringe head is chipped, worn or damaged in any way.

• Leaks occur even after maintenance and correct installation.

Replacing the syringe cases

Use the same procedure to replace S-syringe case for the sample syringe and R-syringe case for the
reagent syringe. Follow these procedures:

• Remove the Old Syringe case.

• Install a New Syringe case.

• Prime the Syringe.

Materials:

• New syringe case and case head

For S-syringe of sample syringe: ZM0229
For R-syringe of reagent syringe: ZM0229

Remove the Old Syringe case and Case head

1. Open the right front door of the analyzer.
2. Verify that the system is in Warm up or Standby mode.
3. Disconnect the two tubing connectors from the case head.
4. Loosen the piston fixing screw located at the bottom of the syringe.

8-95
AU480 User Guide Maintenance
Version 1.0
 Return to Main Table of Contents

5. Loosen the fixing nut on top of the syringe for which the piston fixing screw has been loosened.
6. Carefully pull the syringe case forward to remove the syringe unit from the mounting grooves.

Fixing nut

Mounting groove

Fixing screws
Syringe case

Mounting groove
Piston fixing screw

• Do not apply excessive force to the fixing screws when removing the syringe
case. If an excessive force is applied to the fixing screws, the syringe case may
be damaged.
CAUTION
• When removing the syringe case, exercise care not to bend the tube.

7. While holding the case head and syringe case, turn the syringe case counterclockwise to remove it.
8. Pull out the syringe from the case head.
Be careful that the O-ring does not fall out of the head and get lost. If it remains in the syringe
head, remove it carefully with tweezers.

Case head
O-ring

Syringe
ZM0111/ZM0112

Syringe case

8-96
Maintenance AU480 User Guide
Version 1.0
Return to Main Table of Contents

Install a New Syringe case and Case head

1. Insert the syringe into the new case head.

Never apply a strong alkali such as the AU wash solution alkali to the syringe case
and case head. Strong alkali adhering to the syringe case and case head will cause
cracks.
CAUTION If any strong alkali is present, remove the syringe case and case head and wash them
with water.

2. Mount the new syringe case on the case head. Screw the syringe case onto the syringe, until the
head comes into light contact. Then tighten it an extra 45 to 60 degrees.
3. Hold the case head and insert the syringe into the mounting groove. Hold the case head in place
and tighten the top fixing nut.

Mounting groove
Fixing nut
Fixing screws

Case head
Syringe case
Piston fixing screw

4. Tighten the piston fixing screw at the bottom of the syringe.

5. Reconnect the two tubes to their original positions on the case head.
Tighten the connectors securely to avoid leaks.

8-97
AU480 User Guide Maintenance
Version 1.0
 Return to Main Table of Contents

Prime a New Syringe

Prime any new syringes when replace the syringe case and case head.
1. From the AU480 “Home” window select Menu List>Maintenance>User Maintenance>Analyzer
Maintenance>Maintenance to display the “Analyzer Maintenance: Maintenance tab” window.

2. Select the maintenance item from the list of maintenance items, then select the related button
from the “Single Operation” buttons.
A confirmation window appears.

The item to be replaced The list of maintenance items Single Operation button
S syringe case of the sample Replace Sample Syringe Replacing Sample
syringe case Syringe
R syringe case of the reagent Replace Reagent Syringe Replacing Reagent Probe/
syringe case Syringe
3. Set the number of operation, etc., and select O K .
The item to be replaced The items to be set
S syringe case of the sample syringe The number of operation: 260
R syringe case of the reagent syringe The number of operation: 5 or more

4. Press the TA B L E R OTAT I O N / D I A G button.

Deionized water flows through the tubing and air in the tubing is purged.

• For the reagent syringe, repeat step 4 until the air in the tube has been completely purged.

• It takes 12 to 44 minutes from start to finish of replacing the sample syringe. In order to stop
the operation, press the TA B L E R OTAT I O N / D I A G button. At this time an abort
error alarm will generate. Perform alarm clear process without any corrective action.
5. Set the number of times the wash water is drained to 260, then select O K .
6. Press the TA B L E R OTAT I O N / D I A G button.

8-98
Maintenance AU480 User Guide
Version 1.0
Return to Main Table of Contents

7. If air remains in the line, remove the syringe case again.

Loosen the piston fixing screw and fixing nut and remove the syringe case from the syringe.
8. Move the piston of the syringe up and down slowly by hand, and confirm that there are no
bubbles on the syringe head.
If bubbles are still found, move the piston up and down until the bubbles are purged.

Do not move the piston by hand without mounting the syringe on the syringe case.
Doing so will reduce accuracy due to deformation of the piston and shorten the
service life of the syringe.
CAUTION

Case head

Confirm that
no bubbles
are attached.

Syringe

Syringe case

9. Mount the syringe case assembly on the case head.

10. Select U p d a t e .
A confirmation window appears.
11. Select O K .
12. Close the right front door of the analyzer.

Analyze quality control material, and check the data.

TIP

8-99
AU480 User Guide Maintenance
Version 1.0
 Return to Main Table of Contents

8.8.15 Replace Packing in the Wash Nozzle Tube Mounting Joints

When inspecting a Wash Nozzle Tube Mounting Joint, replace the packing if it is chipped or broken.

Materials:

• New packing MU8427

• A pair of tweezers

1. Remove the wash nozzle station.

For details on removing the wash nozzle station, refer to section “8.5.3 Clean the Wash Nozzle
Unit and Check the Tube Mounting Joints” in this chapter.
2. Remove the packing with tweezers from the tube mounting joints.
3. Mount new packing on the tube mounting joint.

• When mounting the tube to the mounting joints, make sure it is in the correct
position.

CAUTION • When attaching a wash nozzle to the tube mounting joint tighten the cap firmly. If
the cap is not tightened sufficiently, water leaks will result.

• Place the packing in the groove of the tube mounting joint.

4. Mount wash nozzle tube mounting joints into their original position.

Groove of the tube

mounting joint

5. From the AU480 “Home” window select Menu List>Maintenance>User Maintenance>Analyzer

Maintenance>Maintenance to display the “Analyzer Maintenance: Maintenance tab” window.
6. Select Re p l a c e Pa c k i n g i n T h e Wa s h N o z z l e J o i n t from the list of
maintenance items.
7. Select U p d a t e .
A confirmation window appears.
8. Select O K .

8-100
Maintenance AU480 User Guide
Version 1.0
Return to Main Table of Contents

8.9 Resetting the system when switched to the stop

mode while performing maintenance
When the system is in stop mode, reset it with the following procedure.
1. Remove the cause of the error.
2. Confirm that the “Analyzer Maintenance: Maintenance tab” window is displayed from the AU480
“Home” window in following order: Menu List>Maintenance>User Maintenance>Analyzer
Maintenance>Maintenance.
3. Select U p d a t e .
4. Select C a n c e l .
5. Select the S t o p / S t a n d b y .
After initialization, the system enters Warm up or Standby mode.

8-101
AU480 User Guide Maintenance
Version 1.0
 Return to Main Table of Contents

8.10 Using the BECKMAN COULTER SUPPORTVISION

(BSV) (Option)
BECKMAN COULTER SUPPORTVISION (BSV) allows operators to transmit manually the AU480’s
various parameters to the Beckman Coulter service center. The Beckman Coulter service center
can check operating status and perform troubleshooting of problems with analysis data with this
information.
Transmittable parameters and data on the BSV menu include the following:

• Files such as analysis parameters and system settings in the parameter menu.

• Analysis data

• Files such as the operation and alarm logs.

• Other files about the program version, etc.

This section explains following:

8.10.1 Transmitting files with BSV.........................................................................................8-103
8.10.2 When the BECKMAN COULTER SUPPORTVISION (BSV) connection is off...........8-104

This function is an option. A separate support contract is needed to use this function.
For details, please contact Beckman Coulter Sales.
CAUTION

• The BSV connection is always on after start-up, when the contract is closed.

• The BSV function does not transmit personal information such as patient
TIP information.

8-102
Maintenance AU480 User Guide
Version 1.0
Return to Main Table of Contents

8.10.1 Transmitting files with BSV

1. From the AU480 “Home” window select Menu List>Maintenance>User Maintenance>BSV to
display the “User Maintenance: BSV” window.

2. Check the display of F5 to confirm that the connection status of the BSV is on.

Display of F5 Connection status of the BSV

Stop Connected
Connect Not connected

If BSV is not connected, select C o n n e c t . Then select O K . Confirm that the status changes
to Stop.
3. In the Output window, select the check boxes of the data to be transmitted.
4. Select F i l e Tra n s f e r ( F 8 ) .
A transmission start confirmation message appears.
5. Select O K to transmit the files.
The transmission is complete when the message “Please wait” disappears.

8-103
AU480 User Guide Maintenance
Version 1.0
 Return to Main Table of Contents

8.10.2 When the BECKMAN COULTER SUPPORTVISION (BSV)

connection is off
In the step 2 of Transmitting files with BSV, when the BECKMAN COULTER SUPPORTVISION (BSV)
connection is off, connect to BECKMAN COULTER SUPPORTVISION (BSV) following the procedure
below.
1. Select C o n n e c t ( F 5 ) .
The BSV connection confirmation window appears.
2. Select O K to connect.
3. Confirm that F5 key changed to “Stop”.

8-104
Maintenance AU480 User Guide
Version 1.0
Return to Main Table of Contents

8.11 AU480 Maintenance Schedule

Date (below)
Maintenance Month Year:
Daily 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31
Inspect the Syringes
for Leaks and Proper
Installation
Inspect The Wash
Solution Roller Pump Unit
for Leaks
Inspect and Replenish
the Concentrated Wash
Solution
Inspect, Clean and Prime
the Sample, Reagent
Probes, and Mix Bars
Inspect the Printer (option)
and Paper
Weekly 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31
Manual cleaning the
Sample Probe and Mix
bars
Perform a W2 (Automatic
washing of each Probe,
Mix bar, and cuvettes,
etc.)
Perform a Photocal
Clean the Sample Pre-
diluent Bottle
Monthly 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31
Clean the Sample Probe
and Reagent Probe Wash
Stations
Clean the Mix Bar Wash
Station
Clean the Wash Nozzle
Unit and Check the Tube
Mounting Joints
Clean the Deionized
Water Filter and the
Sample Probe Filter
Clean the Sample Probe
Filter
Every Three Months 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31
Clean the Air Filters
Replace the Deionized
Water Filter
Replace the Sample
Probe Filter and O-Ring
Clean the Deionized
Water Tank
Replace the Wash
Solution Roller Tube

8-105
AU480 User Guide Maintenance
Version 1.0
 Return to Main Table of Contents

Date (below)
Maintenance Month Year:
Every Six Months 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31
Replace the Photometer
Lamp
Washing Cuvettes and the
Cuvette Wheel
Yearly or As
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31
Necessary
Replace O-rings in the
Wash Nozzle Supply Tube
Mounting Joints
Replace Cuvettes
Manually Wash the
Reagent Probe
Replace Sample Probe
and Reagent Probe
Replace Mix bars
Replace the Wash Nozzle
Joint
Replace Syringes
Clean the inside of the
STAT table unit and
Reagent Refrigeration Unit
Replace the Antistatic
Brush
Replace Rack ID labels
Replace the Sample
Probe and Reagent Probe
Tubes
Execute a W1 (Auto-wash
of the sample probe and
cuvettes)
Replace Air Filters
Replace Syringe cases
and Syringe heads
Replace Packing in
the Wash Nozzle Tube
Mounting Joints

8-106
Maintenance AU480 User Guide
Version 1.0
Return to Main Table of Contents

9
Error Flags

Error flags are generated by the system when it encounters a condition

that can affect the result. This condition can range from minor warnings
to severe errors that require immediate attention. It is important that
the operator reviews each flag as it is generated and identifies the root
cause, and takes appropriate action.
No result should be reported with an unresolved, unexpected flag.
When in doubt, always consider repeating the sample analysis, and
diluting it if necessary.
This chapter contains a list of all error flags in order priority,
suggestions of their cause, and action to take.

Contents
9.1 Summary of Error Flags................................................................................................9-3
9.2 Error Flag Details ..........................................................................................................9-5
d (QC result is excluded from QC accumulation batch by user)...................................9-5
e (Result is edited by user) ..........................................................................................9-5
( (Shortage of detergent has detected on contamination analysis) ..............................9-5
Wa (Result has been analyzed by erroneous cuvette) . ...............................................9-5
R (Insufficient reagent has been detected) ..................................................................9-6
# (Insufficient sample has been detected) ...................................................................9-6
% (Clot has been detected) . ........................................................................................9-6
? (Result is unable to calculate by mechanical error) ..................................................9-7
n (LIH test has not been performed) ............................................................................9-7
l (Result may be affected by lipemia) ...........................................................................9-7
i (Result may be affected by icterus) ............................................................................9-8
h (Result may be affected by hemolysis) .....................................................................9-8
Y (Reagent blank OD is higher than high setting OD at last photometric point) ..........9-8
U (Reagent blank OD is lower than low setting OD at last photometric point) .............9-8
y (Reagent blank or routine OD is higher than high setting OD
at first photometric point) .................................................................................9-9
u (Reagent blank or routine OD is lower than low setting OD
at first photometric point) .................................................................................9-9
@ (OD is higher than 3.0) ..........................................................................................9-10
$ (Effective photometric points are less than three points,
unable to determine linearity for result) .........................................................9-10
D (Reaction OD is higher than maximum OD) ........................................................... 9-11
B (Reaction OD is lower than minimum OD) . ............................................................9-12
* (Linearity check has detected in abnormal on rate method) ....................................9-13
& (Prozone pre-check has detected in abnormal) ......................................................9-13
Z (Prozone check has detected in abnormal) ............................................................9-14
E (Overreaction check has detected in abnormal on rate assay) ..............................9-14
Fx (OD result is higher than high setting value at dynamic range) ............................9-14
Gx (OD result is lower than low setting value at dynamic range) . .............................9-14
! (OD result is unable to calculate concentration) ......................................................9-15
) (Result is calculated by calibration factor/RB that have been calculated
by different reagent lot) . ................................................................................9-15

9-1
AU480 User Guide Error Flags
Version 1.0
 Return to Main Table of Contents

a (Onboard stability of reagent is expired) .................................................................9-15

ba (No valid calibration/RB values are existed) .........................................................9-16
bh (The latest calibration/RB has not been used) ......................................................9-16
bn (Result is converted to concentration by Master-curve) ........................................9-16
bz (Result is converted to concentration by calibration curve that is for Prozone) . ...9-16
F (Result is higher than high setting value at dynamic range) ...................................9-17
G (Result is lower than low setting value at dynamic range) .....................................9-17
ph (Result is higher than high setting value at panic range) ......................................9-17
pl (Result is lower than low setting value at panic range) ..........................................9-17
T (Inter-item check has detected in abnormal) . .........................................................9-18
P (Positive) .................................................................................................................9-18
N (Negative) ...............................................................................................................9-18
H (Result is higher than high setting value at normal range) .....................................9-18
L (Result is lower than low setting value at normal range) .........................................9-18
J (Result is higher than high setting value at repeat decision range) . .......................9-19
K (Result is lower than low setting value at repeat decision range) ...........................9-19
fh (Result is higher than high setting value at repeat run reflex range) . ....................9-19
fl (Result is lower than low setting value at repeat run reflex range) . ........................9-19
Va (Deviation of multiple measurements check is out of range).................................9-19
xQ (Multi-rule QC has detected failure on one control) ..............................................9-20
1Q (QC result is out of single check within Multi-rule QC) .........................................9-20
2Q (QC result is out of 13s control range within Multi-rule QC) .................................9-21
3Q (QC result is out of 22s control range within Multi-rule QC)..................................9-21
4Q (QC result is out of R4s control range within Multi-rule QC) ................................9-22
5Q (QC result is out of 41s control range within Multi-rule QC) .................................9-22
6Q (Consecutive QC results are out of preset number
at one side of mean within Multi-rule QC) .....................................................9-23
7Q (QC results are increasing or decreasing consecutively within Multi-rule QC) . ...9-23
S (Original result has been replaced by repeat result)................................................9-24
/ (Result is being analyzed or not analyzed yet) ........................................................9-24
r (Result has been transferred to LIS (HOST Computer)
through on-line communication) ....................................................................9-24
c (Result has been corrected by user) .......................................................................9-24

9-2
Error Flags AU480 User Guide
Version 1.0
Return to Main Table of Contents

9.1 Summary of Error Flags

The following table summarizes the error flags in order of priority:

Flag Cause
d QC result is excluded from QC accumulation batch by user.
e Result is edited by user.
( Shortage of detergent has detected on contamination analysis.
Wa Result has been analyzed by erroneous cuvette.
R Insufficient reagent has been detected.
# Insufficient sample has been detected.
% Clot has been detected.
? Result is unable to calculate by mechanical error.
n LIH test has not been performed.
l Result may be affected by lipemia.
i Result may be affected by icterus.
h Result may be affected by hemolysis.
Y Reagent blank OD is higher than high setting OD at last photometric point.
U Reagent blank OD is lower than low setting OD at last photometric point.
y Reagent blank or routine OD is higher than high setting OD at first photometric point.
u Reagent blank or routine OD is lower than low setting OD at first photometric point.
@ OD is higher than 3.0.
$ Effective photometric points are less than three points, unable to determine linearity for result.
D Reaction OD is higher than maximum OD.
B Reaction OD is lower than minimum OD.
* Linearity check has detected in abnormal on rate method.
& Prozone pre-check has detected in abnormal.
Z Prozone check has detected in abnormal.
E Overreaction check has detected in abnormal on rate assay.
Fx OD result is higher than high setting value at dynamic range.
Gx OD result is lower than low setting value at dynamic range.
! OD result is unable to calculate concentration.
) Result is calculated by calibration factor/RB that have been calculated by different reagent lot.
a Onboard stability of reagent is expired.
ba No valid calibration/RB values are existed.
bh The latest calibration/RB has not been used.
bn Result is converted to concentration by Master-curve.
bz Result is converted to concentration by calibration curve that is for Prozone.
F Result is higher than high setting value at dynamic range.
G Result is lower than low setting value at dynamic range.
ph Result is higher than high setting value at panic range.
pl Result is lower than low setting value at panic range.
T Inter-item check has detected in abnormal.
P Positive.
N Negative.
H Result is higher than high setting value at normal range.
L Result is lower than low setting value at normal range.
J Result is higher than high setting value at repeat decision range.
K Result is lower than low setting value at repeat decision range.
fh Result is higher than high setting value at repeat run reflex range.

9-3
AU480 User Guide Error Flags
Version 1.0
 Return to Main Table of Contents

Flag Cause
fl Result is lower than low setting value at repeat run reflex range.
Va Deviation of multiple measurements check is out of range.
xQ Multi-rule QC has detected failure on one control.
1Q QC result is out of single check within Multi-rule QC.
2Q QC result is out of 13s control range within Multi-rule QC.
3Q QC result is out of 22s control range within Multi-rule QC.
4Q QC result is out of R4s control range within Multi-rule QC.
5Q QC result is out of 41s control range within Multi-rule QC.
6Q Consecutive QC results are out of preset number at one side of mean within Multi-rule QC.
7Q QC results are increasing or decreasing consecutively within Multi-rule QC.
S Original result has been replaced by repeat result.
/ Result is being analyzed or not analyzed yet.
r Result has been transferred to LIS (HOST Computer) through on-line communication.
c Result has been corrected by user.

9-4
Error Flags AU480 User Guide
Version 1.0
Return to Main Table of Contents

9.2 Error Flag Details

d (QC result is excluded from QC accumulation batch by user)

QC data has been manually excluded from calculation by the user. This flag is applied
in Menu List>QC>QC Data Review. For details on excluding QC data, refer to section
“7.5.1 Entering Material Parameters” in chapter 7.

Action:

No action is specifically required. Prior to excluding any QC data, investigate and

record the cause of the anomalous value, as dictated by laboratory standard Operating
Procedures.

e (Result is edited by user)

Data has been edited.

• For details on editing results, refer to section “6.14 Editing Analysis Data” in
chapter 6.

• For details on viewing analysis results, refer to section “6.4.2 Displaying Reaction
Monitor” in chapter 6.

Action:

No action is specifically required. Review any edited or changed data carefully prior to
reporting results.

( (Shortage of detergent has detected on contamination analysis)

One or more wash solutions set in contamination parameters in the reagent refrigerator
are empty. Contamination parameters are suspended for the related cleaning solution.
Carry-over might have occurred on tests that have this flag.

Action:

1. Fill the wash solution bottles.

2. Analyze the flagged tests again.

Wa (Result has been analyzed by erroneous cuvette)

The result has been analyzed with an erroneous cuvette.

Action:

1. Wash the erroneous cuvette and perform a photocal.

2. If the error still occurs, replace the cuvette.

3. Repeat analysis.

9-5
AU480 User Guide Error Flags
Version 1.0
 Return to Main Table of Contents

R (Insufficient reagent has been detected)

Level detectors cannot detect reagent.

Action:

1. Review all results generated immediately prior to this flag for consistency and
validity (especially low or high results), and repeat if necessary.

2. Place new reagent onto the system and repeat analysis.

3. If the error occurs in spite of sufficient reagent, the reagent bottle may contain
bubbles. If so remove the bubbles and perform another reagent check.

4. Wipe the reagent bottle opening if it is wet and inspect the reagent probe, clean
or replace as necessary. For details on inspecting, cleaning and priming reagent
probe and wash stations, refer to sections “8.3.4 Inspect, Clean and Prime the
Sample, Reagent Probes, and Mix bars” on and “8.5.1 Clean the Sample Probe
and Reagent Probe Wash Stations” in chapter 8.

5. Ensure the reagent probe is correctly installed and connected.

# (Insufficient sample has been detected)

The sample probe cannot detect liquid. This is caused by one of the following:

• Insufficient sample volume.

• Malfunction of the sample level detection system.

Action:

1. Review all other results that were generated on the same sample prior to
generating the # flag to verify validity and consistency-no extremely low or high
values.

2. Add more sample to the sample cup, and repeat the test.

3. Wipe the probe with an alcohol swab and check the probe is attached correctly.

4. Replace the sample probe. For details on replace a sample probe, refer to section
“8.8.4 Replace Sample Probe and Reagent Probe” in chapter 8.

% (Clot has been detected)

The sample probe has become blocked or partially blocked during sample aspiration.

Action:

1. Review all other results that were generated on the same sample prior to
generating the # flag to verify validity and consistency-no extremely low or high
values.

2. Verify that the sample is free of clots, and remove any present. If necessary,
centrifuge the sample and repeat analysis.

3. If the error still occurs, wash the sample probe.

For details on replacing the sample probe, refer to section “8.8.4 Replace Sample
Probe and Reagent Probe” in chapter 8.

9-6
Error Flags AU480 User Guide
Version 1.0
Return to Main Table of Contents

? (Result is unable to calculate by mechanical error)

A result cannot be calculated for this samples because:

• The absorbance of the sample is above 3.0 OD.

• In a rate reaction, fewer than three photometric readings satisfy the assay criteria
specified in the specific test parameters.

• Outer cuvette walls or the cuvette wheel is wet.

Action:

1. The sample can be severely lipemic, icteric, hemolytic or can contain excessively
large amounts of the analyte being tested. Dilute the sample and run the test
again.

2. Verify the reagent condition.

3. The system generates error codes or Execute action followed by the contents to
identify the malfunction. Once the problem is solved, repeat analysis.
If the issue persists contact Beckman Coulter Technical Services.

4. Check the reaction data including those processed immediately before and after
the flagged result. In the presence of any abnormality, check the cuvette and
the cuvette washing nozzles for possible overflows, then re-check the results
processed before and after the flagged results.
If the issue persists, contact Beckman Coulter Technical Services.

n (LIH test has not been performed)

The LIH test has not been performed.

Action:

1. Examine the sample and repeat if necessary.

2. Check the LIH reagent.

l (Result may be affected by lipemia)

The result may be affected by lipemia.

Action:

Follow laboratory procedure for lipemic samples.

9-7
AU480 User Guide Error Flags
Version 1.0
 Return to Main Table of Contents

i (Result may be affected by icterus)

The result may be affected by bilirubin.

Action:

Follow laboratory procedure for icteric samples.

h (Result may be affected by hemolysis)

The result may be affected by hemolysis.

Action:

Follow laboratory procedure for hemolytic samples.

Y (Reagent blank OD is higher than high setting OD at last

photometric point)
Reagent blank OD is higher than the reagent OD limit range defined for the
last photometric point. This is set in Menu List>Parameters>Specific Test
Parameters>General. This could be caused by:
• Reagent expired.
• Reagent contamination.

• Improperly prepared reagents.

Action:

1. Check the reagent expiration date.

2. Check the reagent condition.

3. Replace the reagent and repeat analysis.

U (Reagent blank OD is lower than low setting OD at last

photometric point)
Reagent blank OD is lower than the reagent OD limit range defined for the
last photometric point. This is set in Menu List>Parameters>Specific Test
Parameters>General. This could be caused by:

• Reagent expired.

• Reagent contamination.

• Improperly prepared reagents.

Action:

1. Check the reagent expiration date.

2. Check the reagent condition.

3. Replace the reagent and repeat analysis.

9-8
Error Flags AU480 User Guide
Version 1.0
Return to Main Table of Contents

y (Reagent blank or routine OD is higher than high setting OD at

first photometric point)
Reagent OD at P0 in reagent blank or normal analysis is higher than the
reagent OD limit range defined for the first photometric point. This is set in Menu
List>Parameters>Specific Test Parameters>General. This could be caused by:

• Reagent expired.

• Reagent contamination.

• Improperly prepared reagents.

Action:

1. Check the reagent expiration date.

2. Check the reagent condition.

3. Replace the reagent and repeat analysis.

u (Reagent blank or routine OD is lower than low setting OD at first

photometric point)
Reagent OD at P0 in reagent blank or normal analysis is lower than the reagent
OD limit range defined for the first photometric point. This is set in Menu
List>Parameters>Specific Test Parameters>General. This could be caused by:

• Reagent expired.

• Reagent contamination.

• Improperly prepared reagents.

Action:

1. Check the reagent expiration date.

2. Check the reagent condition.

3 Replace the reagent and repeat analysis.

9-9
AU480 User Guide Error Flags
Version 1.0
 Return to Main Table of Contents

@ (OD is higher than 3.0)

An abnormally high value. A reaction OD has exceeded 3.0. In a dual wavelength
measurement, an error occurs if either of the two wavelengths exceed 3.0 OD. This is
caused by:

• Sample quality.

• Faulty photometer lamp.

• Wet outer cuvette walls or cuvette wheel.

Action:

1. The sample can be severely lipemic, icteric, hemolytic or can contain excessively
large volumes of the analyte being tested. Dilute the sample and repeat analysis.

2. Perform a photometer check to assess the condition of the lamp. Replace the
lamp if the results are out of range.

3. Check the system (syringes, probes and so on).

4. Check the reaction data including those processed immediately before and after
the flagged result. In the presence of any abnormality, check the cuvette and
the cuvette washing nozzles for possible overflows, then re-check the results
processed before and after the flagged results.
If the issue persists, contact Beckman Coulter Technical Services.

$ (Effective photometric points are less than three points, unable to

determine linearity for result)
Fewer than three read points of a rate reaction are within the acceptable optical density
range specified. In order to calculate a rate reaction properly, at least three readings
must be taken before reaching maximum or minimum optical density. If these optical
density limits are exceeded, the reaction might go into substrate depletion due to a high
concentration or a problem with the condition of the reagent. Linearity calculations are
not made when this error occurs.

Action:

1. The sample can be severely lipemic, icteric, hemolytic or can contain excessively
large volumes of the analyte being tested. Dilute the sample and repeat analysis.

2. Verify the reagent.

3. Check the system (syringes, probes and so on).

4. Check the reaction data including those processed immediately before and after
the flagged result. In the presence of any abnormality, check the cuvette and
the cuvette washing nozzles for possible overflows, then re-check the results
processed before and after the flagged results.
If the issue persists, contact Beckman Coulter Technical Services.

9-10
Error Flags AU480 User Guide
Version 1.0
Return to Main Table of Contents

D (Reaction OD is higher than maximum OD)

In one or more values among photometric values below, the optical density of a
specified read point has exceeded the maximum optical density value range.

• The optical density of a specified read point FST+2, first photometry point plus
two, (a positive reaction rate method)

• The optical density of a specified read point LST+2, last photometry point plus
two, (a negative reaction rate method)

• The optical density of a specified point(first photometry point, a fixed method)

Action:

1. The sample may be severely lipemic, icteric, hemolytic or may contain

excessively large volumes of the analyte being tested. Dilute the sample and run
the test again.

2. Ensure the reagent has not expired.

3. If this flag is generated for several assays, the lamp might need to be replaced.
Perform a photometer check (See “8.4.3 Perform a Photocal” in chapter 8), to
assess the condition of the photometer lamp.

4. Check the reaction data including those processed immediately before and after
the flagged result. In the presence of any abnormality, check the cuvette and
the cuvette washing nozzles for possible overflows, then re-check the results
processed before and after the flagged results.
If the issue persists, contact Beckman Coulter Technical Services.

9-11
AU480 User Guide Error Flags
Version 1.0
 Return to Main Table of Contents

B (Reaction OD is lower than minimum OD)

In one or more values among photometric values below, the optical density of a
specified read point has gone under the minimum optical density value range.

• The optical density of a specified read point FST+2, first photometry point plus
two, (a negative reaction rate method)

• The optical density of a specified read point LST+2, (a positive reaction rate
method)

• The optical density of a specified point(first photometry point, a fixed method)

Action:

1. The sample may be severely lipemic, icteric, hemolytic or may contain

excessively large volumes of the analyte being tested. Dilute the sample and run
the test again.

2. Ensure the reagent has not expired.

3. If this flag is generated for several assays, the lamp might need to be replaced.
Perform a photometer check, to assess the condition of the photometer lamp. For
details on how to check perform a photometer, refer to section “8.4.3 Perform a
Photocal” in chapter 8.

4. Check the reaction data including those processed immediately before and after
the flagged result. In the presence of any abnormality, check the cuvette and
the cuvette washing nozzles for possible overflows, then re-check the results
processed before and after the flagged results.
If the issue persists, contact Beckman Coulter Technical Services.

9-12
Error Flags AU480 User Guide
Version 1.0
Return to Main Table of Contents

* (Linearity check has detected in abnormal on rate method)

This flag is generated when the rate of a reaction varies by more than the defined %
variance, as defined in Menu List>Parameters>Specific Test Parameters>General and
is therefore deemed non-linear. Possible causes are:

• Contaminated reagent.

• Unusually high result.

• Defective cuvettes.

• Light source lamp deteriorated.

• Dirty or defective mix bars.

• Reagent syringe or probe alignment problem.

• Sample probe misalignment.

• Outer cuvette walls or the cuvette wheel is wet.

Action:

1. Dilute the sample and run it again or perform a diluted repeat run.

2. Replace reagent if contaminated or out-of-date.

3. Clean all mix bars and check them for damage. Replace any that have scratches
or chips to their teflon coating.

4. Run the photometer check to determine lamp condition. If OK, check cuvette
condition.

5. Replace the photometer lamp, perform photo-calibration and perform a

photometer check.

6. Check the reaction data including those processed immediately before and after
the flagged result. In the presence of any abnormality, check the cuvette and
the cuvette washing nozzles for possible overflows, then re-check the results
processed before and after the flagged results.
If the issue persists, contact Beckman Coulter Technical Services.

& (Prozone pre-check has detected in abnormal)

The data for prozone judgement is abnormal.

Action:

Dilute the sample and repeat analysis.

If the issue persists contact Beckman Coulter Technical Services.

9-13
AU480 User Guide Error Flags
Version 1.0
 Return to Main Table of Contents

Z (Prozone check has detected in abnormal)

The data check equation for any one of logic check 1, 2 or 3 is satisfied. This is often
caused by an abnormally high concentration of analyte in a sample.

Action:

Dilute the sample and repeat analysis.

E (Overreaction check has detected in abnormal on rate assay)

In the rate assay, the result is judged as an error by checking an overreaction in which
the reaction was finished in an excessively short time. This is often caused by an
abnormally high concentration of analyte in a sample.

Action:

Dilute the sample and repeat analysis.

Fx (OD result is higher than high setting value at dynamic range)

No concentration could be calculated. The OD of the sample exceeded the OD of the
upper limit of the dynamic range.

Action:

Dilute the sample and repeat analysis.

Gx (OD result is lower than low setting value at dynamic range)

No concentration could be calculated. The OD of the sample is lower than the OD of the
low limit of the dynamic range.

Action:

1. Review the result in the clinical context of the patient and repeat if necessary.

2. Check the reagent probe and vials for proper position.

3. Check the reagents for bubbles.

9-14
Error Flags AU480 User Guide
Version 1.0
Return to Main Table of Contents

! (OD result is unable to calculate concentration)

The system has failed to calculate a result.

Action:

If this is a single sample issue, repeat and dilute if necessary.

If multiple samples are affected, review all operating parameters such as:

• Sample Integrity

• Calibration

• Reagent quality

• General system issues

Check the reaction data including those processed immediately before and after the
flagged result. In the presence of any abnormality, check the cuvette and the cuvette
washing station for possible overflows, then re-check the cuvette and the cuvette
washing nozzles.
If the issue persists contact Beckman Coulter Technical Services.

) (Result is calculated by calibration factor/RB that have been

calculated by different reagent lot)
The reagent lot number does not match the calibrated reagent lot number.

Action:

1. Calibrate the reagent used in the test that generated the flag.

2. Calculate the results manually by selecting Menu List>Routine>Sample

Manager>Main and use “Recalculating” function.

a (Onboard stability of reagent is expired)

The reagent has either expired or has been onboard beyond the period defined in the
Specific Test parameters.

Action:

Replace the reagents as soon as possible, perform a reagent check and perform a
calibration if necessary.

9-15
AU480 User Guide Error Flags
Version 1.0
 Return to Main Table of Contents

ba (No valid calibration/RB values are existed)

Lot-specific user calibration has expired. Review calibration in Menu
List>Calibration>Calibration Monitor.

Action:

1. Carefully review any results generated with this flag and repeat if necessary.

2. Perform lot-specific user calibration as soon as possible.

For details on calibrating tests, refer to section “6.7 Performing a Repeat Run” in
chapter 6.

bh (The latest calibration/RB has not been used)

Lot-specific user calibration has either not been performed, or has not been successful.
Review calibration in Menu List>Calibration>Calibration Monitor.

Action:

Results can be erroneous and should not be reported.

1. Perform lot-specific user calibration.

2. Repeat analysis samples using a valid calibration.

For details on calibrating tests, refer to section “6.7 Performing a Repeat Run” in
chapter 6.

bn (Result is converted to concentration by Master-curve)

Lot-specific user calibration has either not been performed, or has not been successful.
The system has used the lot-specific master curve to generate the result. Review
calibration in Menu List>Calibration>Calibration Monitor.

Action:

Results can be erroneous and should not be reported.

1. Perform lot-specific user calibration.

2. Repeat analysis samples using a valid calibration.

For details on calibrating tests, refer to section “6.7 Performing a Repeat Run” in
chapter 6.

bz (Result is converted to concentration by calibration curve that is

for Prozone)
The system has used the calibration curve for prozone data to generate the result. It is
similar to real result and should be used to estimate the dilution rate for repeat run.

Action:

Carefully review any results generated with this flag and repeat the analysis in diluted
mode.

9-16
Error Flags AU480 User Guide
Version 1.0
Return to Main Table of Contents

F (Result is higher than high setting value at dynamic range)

The concentration of the sample is above the dynamic range high limit. Set in Menu
List>Parameters>Specific Test Parameters>General.

Action:

Dilute the sample with the appropriate sample diluent and re-analyze.

Samples should be diluted so that they yield a value in the middle of the measuring
range.

G (Result is lower than low setting value at dynamic range)

The concentration of the sample is below the dynamic range low limit, set in Menu
List>Parameters>Specific Test Parameters>General. Or the reagent was not pipetted
properly.

Action:

1. Review the result in the clinical context of the patient and repeat if necessary.

2. Check the reagent probe and reagent bottle for proper position.

3. Check the reagents for bubbles.

ph (Result is higher than high setting value at panic range)

The result higher than the upper panic value. This is set in Menu
List>Parameters>Specific Test Parameters>Range.

Action:

This denotes that the result is outside user-defined panic ranges. Take immediate
action on behalf of the laboratory in accordance with local operating procedures.

pl (Result is lower than low setting value at panic range)

The result lower than the low panic value. This is set in Menu List>Parameters>Specific
Test Parameters>Range.

Action:

This denotes that the result is outside user-defined panic ranges. Take immediate
action on behalf of the laboratory in accordance with local operating procedures.

9-17
AU480 User Guide Error Flags
Version 1.0
 Return to Main Table of Contents

T (Inter-item check has detected in abnormal)

An abnormality has been detected by the checked tests i.e. result exceeds the check
range specified in Menu List>Parameters>Misc.>Checked Tests.

Action:

1. Repeat analysis.

2. Follow laboratory protocol for abnormal test results.

P (Positive)
Qualitative result: Sample result exceeds the upper value. This is set in Menu
List>Parameters>Specific Test Parameters>Range.

Action:

No action required.

N (Negative)
Qualitative result: Sample result is lower than the low value. This is set in Menu
List>Parameters>Specific Test Parameters>Range.

Action:

No action required.

H (Result is higher than high setting value at normal range)

Result value is higher than value entered for level High in Specific Ranges in Menu
List>Parameters>Specific Test Parameters>Range.

For details on setting reference intervals, refer to section “4.5.5 Set the Range” in
chapter 4.

Action:

Follow laboratory protocol for abnormal test results.

L (Result is lower than low setting value at normal range)

Result value is lower than value entered for level Low in Specific Ranges in Menu
List>Parameters>Specific Test Parameters>Range.

For details on setting reference intervals, refer to section “4.5.5 Set the Range” in
chapter 4.

Action:

Follow laboratory protocol for abnormal test results.

9-18
Error Flags AU480 User Guide
Version 1.0
Return to Main Table of Contents

J (Result is higher than high setting value at repeat decision range)

The result exceeds the repeat decision range. This is set in Menu
List>Parameters>Repeat Parameters>Repeat Specific.

Action:

Execute user defined action.

K (Result is lower than low setting value at repeat decision range)

The result is lower than the repeat decision range. This is set in Menu
List>Parameters>Repeat Parameters>Repeat Specific.

Action:

Execute user defined action.

fh (Result is higher than high setting value at repeat run reflex

range)
The generated result is higher than a user specified reflex range, set in Menu
List>Parameters>Repeat Parameters>Repeat Specific.

Action:

Execute user defined action.

fl (Result is lower than low setting value at repeat run reflex range)
The generated result is lower than a user specified reflex range, set in Menu
List>Parameters>Repeat Parameters>Repeat Specific.

Action:

Execute user defined action.

Va (Deviation of multiple measurements check is out of range)

The precision of replicates exceeds allowable range (set as analysis parameters).

Action:

Perform the appropriate maintenance:

• Check syringes.
For details on inspecting syringes and tubes for air bubbles and leaks, refer to
sections “8.3.1 Inspect the Syringes for Leaks and Proper Installation” and “8.3.2
Inspect the Wash Solution Roller Pump Unit for Leaks”, in chapter 8

• Check sample probe.

For details on how to check sample probe, refer to section “8.3.4 Inspect, Clean
and Prime the Sample, Reagent Probes, and Mix bars” on in chapter 8.

• Check for signs of system contamination.

9-19
AU480 User Guide Error Flags
Version 1.0
 Return to Main Table of Contents

xQ (Multi-rule QC has detected failure on one control)

If one of the two pairs of data, in multirule QC, is out of range, the other piece of data is
flagged. This is set in Menu List>Parameter>QC Parameters>QC Specific.

For details on setting single or multi-check QC rules (all samples), refer to section “4.8.2
Set the Specific Quality Control Parameters” in chapter 4.

Action:

If QC results fall outside the acceptable range, investigate the cause before deciding
whether to report patient results. If any trends or sudden shifts in values are detected,
review all operating parameters.

Follow standard laboratory procedure for out-of-range QC results such as:

• Repeat with fresh QC material.

• Perform calibration as required.

• Undertake maintenance as appropriate.

1Q (QC result is out of single check within Multi-rule QC)

One point of QC data exceeds the limit defined in the Single Check Level on the check
tab in Menu List>Parameters>QC Parameters>QC Specific.

For details on setting single or multi-check QC rules (all samples), refer to section “4.8.2
Set the Specific Quality Control Parameters” in chapter 4.

Action:

If QC results fall outside the acceptable range, investigate the cause before deciding
whether to report patient results. If any trends or sudden shifts in values are detected,
review all operating parameters.

Follow standard laboratory procedure for out-of-range QC results such as:

• Repeat with fresh QC material.

• Perform calibration as required.

• Undertake maintenance as appropriate.

9-20
Error Flags AU480 User Guide
Version 1.0
Return to Main Table of Contents

2Q (QC result is out of 13s control range within Multi-rule QC)

One point of QC data exceeds the ±3SD limit defined in the Multi Check Level on the
Check tab in Menu List>Parameters>QC Parameters>QC Specific.

For details on setting single or multi-check QC rules (all samples), refer to section “4.8.2
Set the Specific Quality Control Parameters” in chapter 4.

Action:

If QC results fall outside the acceptable range, investigate the cause before deciding
whether to report patient results. If any trends or sudden shifts in values are detected,
review all operating parameters.

Follow standard laboratory procedure for out-of-range QC results such as:

• Repeat with fresh QC material.

• Perform calibration as required.

• Undertake maintenance as appropriate.

3Q (QC result is out of 22s control range within Multi-rule QC)

Two contiguous QC data points exceed the control limit of ±2SD in the same direction.
This is set in Multi Check Level on the Check tab in Menu List>Parameters>QC
Parameters>QC Specific.

For details on setting single or multi-check QC rules (all samples), refer to section “4.8.2
Set the Specific Quality Control Parameters” in chapter 4.

Action:

If QC results fall outside the acceptable range, investigate the cause before deciding
whether to report patient results. If any trends or sudden shifts in values are detected,
review all operating parameters.

Follow standard laboratory procedure for out-of-range QC results such as:

• Repeat with fresh QC material.

• Perform calibration as required.

• Undertake maintenance as appropriate.

9-21
AU480 User Guide Error Flags
Version 1.0
 Return to Main Table of Contents

4Q (QC result is out of R4s control range within Multi-rule QC)

One of the two consecutive high and low concentration QC data points exceeds the
control limit of +2SD and the other exceeds the control limit of -2SD. This is set in Multi
Check Level on the Check tab in Menu List>Parameters>QC Parameters>QC Specific.

For details on setting single or multi-check QC rules (all samples), refer to section “4.8.2
Set the Specific Quality Control Parameters” in chapter 4.

The difference between two controls exceeds 4SD. This is set in Multi Check Level on
the Check tab in Menu List>Parameters>QC Parameters>QC Specific.

For details on setting single or multi-check QC rules (all samples), refer to section “4.8.2
Set the Specific Quality Control Parameters” in chapter 4.

Action:

If QC results fall outside the acceptable range, investigate the cause before deciding
whether to report patient results. If any trends or sudden shifts in values are detected,
review all operating parameters.

Follow standard laboratory procedure for out-of-range QC results such as:

• Repeat with fresh QC material.
• Perform calibration as required.
• Undertake maintenance as appropriate.

5Q (QC result is out of 41s control range within Multi-rule QC)

Four consecutive QC data point results have exceeded the 1SD limit. This is set in Multi
Check Level on the Check tab in Menu List>Parameters>QC Parameters>QC Specific.

For details on setting single or multi-check QC rules (all samples), refer to section “4.8.2
Set the Specific Quality Control Parameters” in chapter 4.

Action:

If QC results fall outside the acceptable range, investigate the cause before deciding
whether to report patient results. If any trends or sudden shifts in values are detected,
review all operating parameters.

Follow standard laboratory procedure for out-of-range QC results such as:

• Repeat with fresh QC material.

• Perform calibration as required.

• Undertake maintenance as appropriate.

9-22
Error Flags AU480 User Guide
Version 1.0
Return to Main Table of Contents

6Q (Consecutive QC results are out of preset number at one side of

mean within Multi-rule QC)
Results for a preset number (7-10) of consecutive data points falls either above
or below the mean. This is set in Multi Check Level on the Check tab in Menu
List>Parameters>QC Parameters>QC Specific.

For details on setting single or multi-check QC rules (all samples), refer to section “4.8.2
Set the Specific Quality Control Parameters” in chapter 4.

Action:

If QC results fall outside the acceptable range, investigate the cause before deciding
whether to report patient results. If any trends or sudden shifts in values are detected,
review all operating parameters.

Follow standard laboratory procedure for out-of-range QC results such as:

• Repeat with fresh QC material.
• Perform calibration as required.
• Undertake maintenance as appropriate.

7Q (QC results are increasing or decreasing consecutively within

Multi-rule QC)
Results for a preset number (4-10) of consecutive data points tends to increase
or decrease. This is set in Multi Check Level on the Check tab in Menu
List>Parameters>QC Parameters>QC Specific.

For details on setting single or multi-check QC rules (all samples), refer to section “4.8.2
Set the Specific Quality Control Parameters” in chapter 4.

Action:

If QC results fall outside the acceptable range, investigate the cause before deciding
whether to report patient results. If any trends or sudden shifts in values are detected,
review all operating parameters.

Follow standard laboratory procedure for out-of-range QC results such as:

• Repeat with fresh QC material.
• Perform calibration as required.
• Undertake maintenance as appropriate.

9-23
AU480 User Guide Error Flags
Version 1.0
 Return to Main Table of Contents

S (Original result has been replaced by repeat result)

A sample test has been repeated and this repeat result has replaced the previous result
to become the final result.

Action:

No action required.

/ (Result is being analyzed or not analyzed yet)

The test was not performed, even though it was requested (usually because of a
reagent shortage), or the result has not been reacted yet.

Action:

Review all results generated immediately prior to this flag for consistency and validity
(especially low or high results) and repeat if necessary.

1. Place new reagent onto the system and repeat analysis.

2. Inspect the reagent probe, clean or replace as necessary.

3. Ensure the reagent probe is correctly installed and connected.

r (Result has been transferred to LIS (HOST Computer) through on-

line communication)
Action:

No action required.

c (Result has been corrected by user)

Data has been corrected in the Data Correction window.

For details on correcting results, refer to section “6.14 Editing Analysis Data” in chapter
6.

Action:

No action specifically required. Review any edited or changed data carefully prior to
reporting results.

9-24
Error Flags AU480 User Guide
Version 1.0
Return to Main Table of Contents

10
Error Messages

This chapter describes the error messages that operators can

encounter.

Contents
After checking cups on STAT table, please perform STAT check
in STAT status menu. . ...................................................................................10-3
After checking printer, please resume printer in XXXX menu.
XXXX: window name. ....................................................................................10-3
After closing the reagent refrigerator lid, please perform reagent check. ..................10-3
Calibration requisition is renewed. Please set new calibrator on STAT table. . ..........10-3
Calibration stability is expired.
Please open Calibration requisition menu and requisition the item. . ............10-3
Calibration stability will be expired soon. ...................................................................10-4
Concentrated waste tank full ......................................................................................10-4
Cuvette Error found. Please check it at User Maintenance. ......................................10-4
Diluted Wash Solution short. ......................................................................................10-4
Dispensed STAT sample exists. .................................................................................10-4
Error sample(s) exists. Please check sample(s) in STAT Status menu. ....................10-5
Host communication in progress ................................................................................10-5
Incorrect Parameter is found. Please open [MM...MM] menu
and check the parameters. MM...MM: Menu name........................................10-5
Liquid remains in Vacuum tank. .................................................................................10-5
No Cup to be processed on STAT table. ....................................................................10-6
No deionized water. Please check water outlet valve. ...............................................10-6
No Master Curve is scanned. Please check it at Reagent Management. ..................10-6
No Photocal Data. Please perform photocal at User Maintenance. ...........................10-6
No Reagent volume. Please check it at Reagent Management. . ..............................10-7
Please check STAT Status and set calibrators as needed. ........................................10-7
Please check STAT Status and set controls to be needed. . ......................................10-7
Please check STAT Status and set RB cup as needed. . ...........................................10-7
Please perform Reagent Check. ................................................................................10-8
Printing in Progress. ...................................................................................................10-8
QC requisition is renewed. Please set new control on STAT table. ...........................10-8
QC requisition is renewed. Please set new control. ...................................................10-8
Rack collection area full .............................................................................................10-8
RB stability is expired. Please open Calibration requisition menu
and requisition the item. ................................................................................10-9
RB stability will be expired soon. . ..............................................................................10-9
Reagent error found. Please check it at Reagent Management. ...............................10-9
Reagent is expired. Please check Reagent Management
and set new reagent in the refrigerator. . .......................................................10-9
Reagent with the new reagent lot is added. ...............................................................10-9
R Probe wash solution is not set. .............................................................................10-10
S Probe diluent is not set. ........................................................................................10-10

10-1
AU480 User Guide Error Messages
Version 1.0
 Return to Main Table of Contents

S Probe wash solution is not set. .............................................................................10-10

Temperature of the Incubator is outside or exceeds the normal range. ...................10-10
Temperature of the refrigerator is over (under) the normal range. ...........................10-10
Test has no Calibration Data. Please open Calibration requisition menu
and requisition the item. ..............................................................................10-10
Test has no RB Data. Please open Calibration requisition menu
and requisition the item. .............................................................................. 10-11
Test items are set as Disabled at Start Condition. ................................................... 10-11
The cover of Dispensing Position is open. ............................................................... 10-11
The cover of Rack Supply Unit is open. ................................................................... 10-11
The cover of reagent refrigerator is open. ................................................................ 10-11
The large cover of STAT table is open. ....................................................................10-12
The sample on STAT table is incorrect. Please check it on STAT status menu. ......10-12
The small cover of STAT table is open. ....................................................................10-12
The volume is reached to Alarm volume. Please check it
at Reagent Management. ............................................................................10-12
Wash Solution short. ................................................................................................10-12
Waste Tank full..........................................................................................................10-13
Error Messages In the “Comment” column.......................................................................10-14
Error Messages using the “HOME” menu.........................................................................10-16
Error Messages Using the Start menu or Shifting to Another mode..............................10-19
Messages Starting STAT.....................................................................................................10-26
STAT Table Tab Comments.................................................................................................10-28

10-2
Error Messages AU480 User Guide
Version 1.0
Return to Main Table of Contents

After checking cups on STAT table, please perform STAT check in STAT status
menu.
Cause:

The STAT table cover is open or parameter has been changed.

Action:

1. Check that the sample cups have been set in place on the STAT table.

2. Perform STAT check operation on the “STAT Status” window.

After checking printer, please resume printer in XXXX menu. XXXX: window
name.
Cause:

The printer status is abnormal.

Action:

Resume printing on the “Analyzer Status” window.

After closing the reagent refrigerator lid, please perform reagent check.
Cause:

After opening the reagent refrigerator lid, reagent check has not been performed.

Action:

Perform reagent check on the “Reagent Management” window.

Calibration requisition is renewed. Please set new calibrator on STAT table.

Action:

1. Check the “STAT Status” window to set the calibrators again.

2. If the “STAT Operation” has been set to “Manual” on the “Analysis Mode” window,
perform STAT check.

Calibration stability is expired. Please open Calibration requisition menu and

requisition the item.
Cause:

Calibration data has expired.

Action:

1. Implement a calibration requisition on the “Calibration” window.

2. Perform calibration analysis.

10-3
AU480 User Guide Error Messages
Version 1.0
 Return to Main Table of Contents

Calibration stability will be expired soon.

Cause:

Calibration data is just close to expiration.

Action:

1. Implement a calibration requisition on the “Calibration” window.

2. Perform calibration analysis.

Concentrated waste tank full

Cause:

The tank is full of concentrated waste liquid.

Action:

Contact Beckman Coulter Technical Services.

Cuvette Error found. Please check it at User Maintenance.

Cause:

An anomaly has been found in the cuvette.

Action:

Check the cuvette on the “User Maintenance” window.

Diluted Wash Solution short.

Action:

There is insufficient diluted wash solution. Check and replenish if necessary.

Dispensed STAT sample exists.

Cause:

The sample has been dispensed at the sample position where the “STAT Table
attribution” was set to “First Run” or “Repeat Run”.

Action:

1. Check the sample on the “STAT Status” window, and remove the sample cup.

2. If the “STAT Operation” has been set to “Manual” on the “Analysis Mode” window,
perform STAT check.

10-4
Error Messages AU480 User Guide
Version 1.0
Return to Main Table of Contents

Error sample(s) exists. Please check sample(s) in STAT Status menu.

Cause:

An anomaly has been found in a sample that has been set on the STAT table.

Action:

1. Check the error information on the “STAT Status” window.

2. Take an appropriate action for the error.

3. If the “STAT Operation” has been set to “Manual” on the “Analysis Mode” window,
perform STAT check.

Host communication in progress

Cause:

The analyzer is under communication with the host computer.

Action:

Check the analyzer for the status of communication with the host computer on the
“Analyzer Status” window.

Incorrect Parameter is found. Please open [MM...MM] menu and check the
parameters. MM...MM: Menu name.
Cause:

An error occurs in parameter check on either of parameter-related windows.

Action:

Check the parameters according to the indication.

Liquid remains in Vacuum tank.

Cause:

Waste liquid exists in the vacuum tank.

Action:

Contact Beckman Coulter Technical Services.

10-5
AU480 User Guide Error Messages
Version 1.0
 Return to Main Table of Contents

No Cup to be processed on STAT table.

Cause:

No sample has been set on the STAT table.

Action:

Set the samples to be analyzed.

No deionized water. Please check water outlet valve.

Cause:

Displayed when deionized water tank is empty.

Unless the deionized water replenished in 20 minute after alarmed, the system will
change to STOP mode for safety and will need to be restarted.

Action:

1. Check the water outlet valve.

2. If no abnormality is found in the water outlet system, contact Beckman Coulter

Technical Services.

No Master Curve is scanned. Please check it at Reagent Management.

Cause:

Reagent bottles with new lots of reagents have been set.

Action:

1. Check them in detail on the “Reagent Management” window.

2. Read the data of master curves for the required tests with a hand-held scanner.

No Photocal Data. Please perform photocal at User Maintenance.

Cause:

No Photocal data exists.

Action:

Perform Photocal measurement on the “User Maintenance” window.

10-6
Error Messages AU480 User Guide
Version 1.0
Return to Main Table of Contents

No Reagent volume. Please check it at Reagent Management.

Cause:

A test cannot be performed due to insufficient reagent required for analysis.

Action:

1. Check it in detail on the “Reagent Management” window.

2. Replenish reagent as needed.

Please check STAT Status and set calibrators as needed.

Cause:

The calibrators required for the calibration analysis are not set on the STAT table.

Action:

1. Check the calibrators required on the “STAT Status” window.

2. Set the calibrators on the STAT table.

3. If the “STAT Operation” has been set to “Manual” on the “Analysis Mode” window,
perform STAT check.

Please check STAT Status and set controls to be needed.

Cause:

The controls required for the QC analysis are not set to the STAT table.

Action:

1. Check the controls required on the “STAT Status” window

2. Set the controls in the STAT table.

3. If the “STAT Operation” has been set to “Manual” on the “Analysis Mode” window,
perform STAT check.

Please check STAT Status and set RB cup as needed.

Cause:

The RB cup required for the reagent blank analysis is not set on the STAT table.

Action:

1. Check the RB cup required on the “STAT Status” window.

2. Set the RB cup in the STAT table.

3. If the “STAT Operation” has been set to “Manual” on the “Analysis Mode” window,
perform STAT check.

10-7
AU480 User Guide Error Messages
Version 1.0
 Return to Main Table of Contents

Please perform Reagent Check.

Cause:

The reagent refrigerator lid is opened or a parameter is changed.

Action:

Perform reagent check on the “Reagent Management” window.

Printing in Progress.
Cause:

Batch print or real-time print is being performed in standby mode.

Action:

Check the printer status on the “Analyzer Status” window.

QC requisition is renewed. Please set new control on STAT table.

Action:

1. Check the “STAT Status” window to set the control sample again.

2. If the “STAT Operation” has been set to “Manual” on the “Analysis Mode” window,
perform a STAT check.

QC requisition is renewed. Please set new control.

Action:

1. Check the control setting positions on the “STAT Status” window to set the control
again.

2. If the “STAT Operation” has been set to “Manual” on the “Analysis Mode” window,
perform a STAT check.

Rack collection area full

Cause:

The rack storage unit is full of racks.

Action:

Remove the rack from the rack storage.

10-8
Error Messages AU480 User Guide
Version 1.0
Return to Main Table of Contents

RB stability is expired. Please open Calibration requisition menu and

requisition the item.
Cause:

Reagent blank data has expired.

Action:

1. Implement a reagent blank requisition on the “Calibration” window.

2. Perform reagent blank analysis.

RB stability will be expired soon.

Cause:

Reagent blank data is just close to expiration.

Action:

1. Implement a reagent blank requisition on the “Calibration” window.

2. Perform reagent blank analysis.

Reagent error found. Please check it at Reagent Management.

Cause:

An error has been found in setting reagent bottles.

Action:

Check reagent bottle location on the “Reagent Management” window.

Reagent is expired. Please check Reagent Management and set new reagent in
the refrigerator.
Cause:

An expired reagent bottle has been found.

Action:

1. Check reagents in detail on the “Reagent Management” window.

2. Replace the expired reagent bottles with a new reagent bottle.

3. After adding a new reagent bottle, check the reagent.

Reagent with the new reagent lot is added.

Reagent bottles with new lots of reagents have been added.

10-9
AU480 User Guide Error Messages
Version 1.0
 Return to Main Table of Contents

R Probe wash solution is not set.

Action:

Add the reagent probe wash solution.

S Probe diluent is not set.

Action:

Add the sample diluent.

S Probe wash solution is not set.

Action:

Add the sample probe wash solution.

Temperature of the Incubator is outside or exceeds the normal range.

Cause:

When analysis is started, no correct analysis data can be output due to abnormal
temperature in the cuvette.

Action:

Check the incubator cover.

Temperature of the refrigerator is over (under) the normal range.

Cause:

The reagent refrigerator temperature is abnormal.

Action:

Check the refrigerator cover.

Test has no Calibration Data. Please open Calibration requisition menu and
requisition the item.
Cause:

No calibration data exists. Calibration analysis failed.

Action:

1. Implement a calibration requisition on the “Calibration” window.

2. Perform calibration analysis.

10-10
Error Messages AU480 User Guide
Version 1.0
Return to Main Table of Contents

Test has no RB Data. Please open Calibration requisition menu and requisition
the item.
Cause:

No reagent blank data exists. Otherwise, a reagent blank analysis failed to be made.

Action:

1. Implement a reagent blank requisition on the “Calibration” window.

2. Perform reagent blank analysis.

Test items are set as Disabled at Start Condition.

Cause:

There exist tests for which masking has been set on the “Start Condition” window. The
disabled test items will not be analyzed.

The cover of Dispensing Position is open.

Cause:

The rack unit cover is open.

Action:

Close the cover.

The cover of Rack Supply Unit is open.

Cause:

The rack supply unit cover is open.

Action:

Close the cover.

The cover of reagent refrigerator is open.

Cause:

The reagent 1 refrigerator lid is open.

Action:

Close the cover.

10-11
AU480 User Guide Error Messages
Version 1.0
 Return to Main Table of Contents

The large cover of STAT table is open.

Cause:

The large STAT table cover (L) is open.

Action:

Close the STAT table cover (L).

The sample on STAT table is incorrect. Please check it on STAT status menu.
Cause:

Error sample(s) exists on the STAT table.

Action:

1. Check the error information on the “STAT Status” window.

2. Take an appropriate action for the error.

3. If the “STAT Operation” has been set to “Manual” on the “Analysis Mode” window,
perform STAT check.

The small cover of STAT table is open.

Cause:

The STAT table cover (S) is open.

Action:

Close the STAT table cover (S).

The volume is reached to Alarm volume. Please check it at Reagent

Management.
Cause:

The remaining number of reagent shots has been reduced under the specified number.

Action:

1. Check reagents in detail on the “Reagent Management” window.

2. Add a new reagent bottle.

3. After adding a new reagent bottle, check the reagent.

Wash Solution short.

Action:

There is insufficient wash solution. Check and replenish if necessary.

10-12
Error Messages AU480 User Guide
Version 1.0
Return to Main Table of Contents

Waste Tank full

Cause:

The tank is full of waste liquid.

Action:

Contact Beckman Coulter Technical Services.

10-13
AU480 User Guide Error Messages
Version 1.0
 Return to Main Table of Contents

Error Messages In the “Comment” column

To verify an error message in the comment column:
Select Menu List>Routine>Reagent>Detail

Reagent Related Errors Descriptions

Reagent ID Error A reagent error occurred.
Undefined Reagent The reagent is not programmed in the group.
Incorrect reagent ID The edited reagent ID is incorrect.
Incorrect Bottle Size The edited bottle size is incorrect.
Overlapped Reagent Position The position is occupied by multiple bottles.
Bottle Set Miss The reagent bottle is placed on a different position while in
Pause mode.
No Reagent No bottle is detected on fixed position during the reagent check.
Same Reagent Bottle “The same lot # and bottle # are present within the same item.
However, when the lot # and the bottle # are not defined, it will not
be an error.”
No Lot No. / Bottle No. No lot # and bottle # are defined on the item that is set to the
Advance Cal and Auto Cal.
Expired The reagent date has expired.
Onboard Expired The reagent on-board stability has expired.
“Unpaired Reagent” No pair bottles are present in the REF comportment.
R1(R1-1) Unset The R1 of the R1/R2 pair is missing.
R2(R2-1) Unset The R2 of the R1/R2 pair is missing.
“No Reagent (XXXXXX,YY)“ “No common reagent is present. The display is as follows.
XXXXXX,YY
XXXXXX : Common reagent
YY : Position”
Dilution Unset Pre-Dilution is not defined.
No Color Reagent (XXXXXX) The color reagent (TBIL of DBIL) is missing.
No Blank Reagent (XXXXXX) The blank reagent (TBIL of DBIL) is missing.
No T-Hb Reagent
No Pretreatment
Over Max Bottle “(1) When there is no setting on the [ Lot to Lot calibration ], there
are more than 6 series of bottle switching
(2) When there is a setting on the [ Lot to Lot calibration ], there
are more than 3 series of switching.”
No Master Curve No master curve is present on the lot.
No Volume to Process No reagent left for analysis while in Measure 1 mode.
No Volume in the Bottle No reagent left in the bottle.
Lack of Volume Reagent shots is less than the specific shots on the item.
No Calibration Data No calibration data for a lot or bottle
No CAL Data for Reference When in use of Lot to Lot calibration, no calibration data on the lot.
CAL. Failed Calibration failed.
CAL. Stability Expired Calibration stability expired.
CAL. Expired soon Calibration expires in a few (pre-programmed) hours.
No RB Data No RB data for a lot bottle.
RB Failed Reagent blank failed.
RB stability expired Reagent blank expired.
RB Expired soon RB expires in a few (pre-programmed) hours.
The following messages are statements, not errors.
Errors related to the reagents Descriptions
ID Edit The position that has failed ID reading is edited.

10-14
Error Messages AU480 User Guide
Version 1.0
Return to Main Table of Contents

Reagent Related Errors Descriptions

[ Position occupied ] *1 The reagent position is occupied by a large bottle.
This message is not fixed, may change to another message later.

10-15
AU480 User Guide Error Messages
Version 1.0
 10-16
Error Messages using the “HOME” menu
This table details the error message, menu to refer to, and the actions to be taken when an error message appears when the Home button is selected.
“No.” indicates that the newer numbers are higher priority than the older numbers.
“Level = 0 or 1” indicates that the analysis can/may not be performed. “Level = 2 or 3” indicates a “Notification (Information).
“Actions to be taken” in the popup display after the message is selected.

Main Message (Big

Error Messages
No. Level Sub Message (Small Letters) Refer to Menu Actions to be taken
Letters)
1 0 Reagent Check not Measurement cannot be started. None Check Reagent Management menu and
performed. perform Reagent Check.
2 0 STAT Check not Measurement cannot be started. None Check STAT Status menu and perform STAT
performed. Check.
3 0 Incorrect Parameter(s). Measurement cannot be started. Menu names Check the setting of the parameter menus.
4 0 Under Online “Measurement cannot be started. None Wait for a while till online communication is
communication. (Note: This is within Standby mode.)” closed.
5 0 Under Printing. “Measurement cannot be started. None Wait for a while till printing is finished.
(Note: This is within Standby mode.)”
6 0 No S-Probe Wash Measurement cannot be started. None Check Reagent Management menu and set a
Solution. required wash solution.
7 0 Photocal not performed. Measurement cannot be started. None Perform Photocal with User Maintenance
menu.
8 0 Incorrect Cuvette(s)) Measurement cannot be started. None Check User Maintenance menu and
exchange incorrect cuvette(s)).
9 0 The other abnormalities Measurement cannot be started. Check Analyzer Status menu.
in Analyzer.
10 1 No Reagent(s). Measurement of the following test(s) Item No. / Name Check Reagent Management menu and set
cannot be performed. required reagent(s).
11 1 No Diluted Solution. Measurement of the following test(s) Item No. / Name Check Reagent Management menu and set a
cannot be performed. required diluted solution.
12 1 No R-Probe Wash Measurement of the following test(s) Item No. / Name Check Reagent Management menu and set a
Solution. cannot be performed. required wash solution.

Version 1.0
AU480 User Guide
Return to Main Table of Contents
 Main Message (Big
No. Level Sub Message (Small Letters) Refer to Menu Actions to be taken
Letters)

Version 1.0
13 1 Maintenance not Measurement may not be performed None Check User Maintenance menu and perform
performed. correctly. required maintenance.
14 1 No Master Curve. Measurement of the following test(s) Item No. / Name Check Reagent Management menu and set a

AU480 User Guide

cannot be performed. required Master Curve.
15 1 No RB Data. Measurement of the following test(s) Item No. / Name Measure RB about the test(s) selected by the
cannot be performed. Reagent Check.
16 1 No Calibration. Measurement of the following test(s) Item No. / Name Measure Calibration about the test(s)
cannot be performed. selected by the Reagent Check.
17 1 Reagent Expired. Measurement is performed by the Item No. / Name Check Reagent Management menu and
reagent of expiration. perform Reagent Check.
Return to Main Table of Contents

18 1 ISE STOP ISE measurement cannot be None Shift ISE to Ready mode.
performed.
19 1 Daily Calibration not ISE may not be measured correctly. None Perform Daily Calibration.
performed.
20 1 ISE selectivity check not ISE may not be measured correctly. None Perform Selectivity check.
performed.
21 1 ISE slope range over. ISE may not be measured correctly. None Perform Daily Calibration.
22 1 ISE selectivity check ISE may not be measured correctly. None Perform Selectivity check.
error.
23 1 Consumption needs to Measurement may not be performed None Check User Maintenance menu and perform
be exchanged. correctly. required maintenance.
24 2 Masking Item exist. Measurement of the following test(s) Item No. / Name Cancel Masking with Start Condition menu to
cannot be performed. perform measurement.
25 2 Reagent Short. Measurement of the following test(s) Item No. / Name Check Reagent Management menu and set
becomes impossible soon. required bottle(s).
26 2 Reagent Expires Soon. Measurement of the following test(s) Item No. / Name Check Reagent Management menu and set
becomes impossible soon. required bottle(s).
27 2 RB Data Expires Soon. Measurement of the following test(s) Item No. / Name Check Reagent Management menu and

Error Messages
becomes impossible soon. measure RB about the test.
28 2 Calibration Expires Measurement of the following test(s) Item No. / Name Check Reagent Management menu and
Soon. becomes impossible soon. measure Calibration about the test.

10-17
 10-18
Main Message (Big
No. Level Sub Message (Small Letters) Refer to Menu Actions to be taken
Letters)
29 2 Diluted Solution Short. Measurement of the following test(s) Item No. / Name Check Reagent Management menu and refill
becomes impossible soon. a required diluted solution.
30 2 R-Probe Wash Solution R-Probe Wash Solution becomes Item No. / Name Check Reagent Management menu and refill
Short. empty soon. The following items may a required wash solution.
not be measured correctly.

Error Messages
31 2 S-Probe Wash Solution S-Probe Wash Solution becomes None Check Reagent Management menu and refill
Short. empty soon. Measurement may not be a required wash solution.
performed correctly.
32 2 The other abnormalities Measurement can be started. None Check Analyzer Status menu.
in Analyzer.
33 2 ISE MID Solution Short. ISE may not be measured correctly. None Exchange MID Solution bottle.
34 2 ISE BUF Solution Short. ISE may not be measured correctly. None Exchange BUF Solution bottle.
35 2 ISE REF Solution Short. ISE may not be measured correctly. None Exchange REF Solution bottle.
36 3 Under Online “Measurement can be re-started. None System Status can be confirmed with
communication. (Note: This is within Measure mode.)” Analyzer Status menu.
37 3 Under Printing. “Measurement can be re-started. None System Status can be confirmed with
(Note: This is within Measure mode.)” Analyzer Status menu.
38 3 Incorrect Bottle(s). Measurement can be started. None Check Reagent Management menu and
remove incorrect bottle(s).
39 3 Empty Bottle(s). Measurement can be started. R1/R2 Check Reagent Management menu and
remove empty bottle(s).

Version 1.0
AU480 User Guide
Return to Main Table of Contents
 Error Messages Using the Start menu or Shifting to Another mode
The table below details any error messages and their explanation when the Start button is selected.

Version 1.0
Level Check timing (When is it checked?)
1 → Fatal Error “○” indicates as “Check”.

AU480 User Guide

Messages Explanations 2 → No Fatal Error “×” indicates as “No Check”
3 → Notification “M1→PAUSE Start by
(Information) Standby → M1 M2 → M1
M2→PAUSE” ANL
Incorrect parameter is found. Please “””MMM….MM”” indicates the second 1 ○ × × ×
open [MM....MM/NN....NN] menu level menu.
and check the parameters. “”NNN….NN”” indicates the third level
menu.”
Return to Main Table of Contents

After checking printer, please When unexpected state in present, 1 ○ × × ×

resume printer in Analyzer Status refer to the user’s guide, section
menu. [Link].2.
Under printing to printer. The printer is busy in batch printing 1 ○ × × ×
when in stan d by mode.
Under communicating with HOST. The HOST communication is busy in 1 ○ ○ ○ ×
batch import or export when starting
from stand b y mode.
Please perform Reagent Check. No “Reagent check” has been made. 1 ○ × ○ ×
After checking cups on STAT table, “STAT check” is required on the STAT 1 ○ ○ ○ ×
please perform STAT check in STAT status.
status menu.
The main cover of STAT table is 1 ○ ○ ○ ×
open.
The sub cover of STAT table is “1. Starting measure from rack 1 ○ ○ ○ ×
open. When items that are defined “”Auto
Cal”” or Auto QC”” are in the round,
the small cover on the STAT table is
open.

Error Messages
2. Starting measure from STAT
When the small cover on the STAT
table is open. “

10-19
 10-20
Level Check timing (When is it checked?)
1 → Fatal Error “○” indicates as “Check”.
Messages Explanations 2 → No Fatal Error “×” indicates as “No Check”
3 → Notification “M1→PAUSE Start by
(Information) Standby → M1 M2 → M1
M2→PAUSE” ANL
The cover of reagent refrigerator is The cover is open on the R1 REF. 1 ○ ○ ○ ×
open.

Error Messages
ISE cover is open. 1 ○ ○ ○ ×
The cover of Rack Feeder is open. 1 ○ ○ ○ ×
The cover of Dispensing Position is 1 ○ ○ ○ ×
open.
The cover of repeat position is open. 1 ○ ○ ○ ×
No deionized water. Please check 1 ○ ○ ○ ×
water supply valve.
Wash Solution short 1 ○ ○ ○ ×
Diluted Wash Solution short 1 ○ ○ ○ ×
Full of Waste tank. 1 ○ ○ ○ ×
Full of Conc Waste tank 1 ○ ○ ○ ×
Liquid is remained in Vacuum tank. 1 ○ ○ ○ ×
Full of rack at Rack Collection. 1 ○ ○ ○ ×
Temperature of the refrigerator is The temperature will be checked when 1 ○ ○ ○ ×
over(under) the normal range. “Fatal error” is set on the maker setting
in the system maintenance menu.
No Photocal Data. Please perform The photocal will be checked when 1 ○ ○ ○ ×
photocal at User Maintenance. “Fatal error” is set on the maker setting
in the system maintenance menu.
Cuvette Error found. Please check it The “Scratch check” / “Cuv check” / 1 ○ ○ ○ ×
at User Maintenance. “Lamp check” / “Dispersion check” will
be checked when “Fatal error” is set
on the maker setting in the system
maintenance menu.

Version 1.0
AU480 User Guide
Return to Main Table of Contents
 Level Check timing (When is it checked?)
1 → Fatal Error “○” indicates as “Check”.
Messages Explanations 2 → No Fatal Error “×” indicates as “No Check”

Version 1.0
3 → Notification “M1→PAUSE Start by
(Information) Standby → M1 M2 → M1
M2→PAUSE” ANL

AU480 User Guide

No Reagent. Please check it at The reagent rest volume will be 1 ○ ○ ○ ×
Reagent Management. checked when “STOP” is set on the
analysis mode parameter on the
system condition menu.
No S Probe Wash Solution. 1 ○ ○ ○ ○
The sample on STAT table is When items that are defined “Auto 1 ○ × × ○
incorrect. Please check it on STAT Cal” or Auto QC” are in the round, the
status menu. samples on the STAT will be located
Return to Main Table of Contents

wrong positions or not in present.

Calibration requisition is renewed. When items that are defined “Auto 2 ○ × × ○
Please set new calibrator on STAT Cal” is in the round, there will be cups
table. to be required for the renew by the
calibration requisition.
QC requisition is renewed. Please When items that are defined “Auto 2 ○ × × ○
set new control on STAT table. QC” is in the round, there will be cups
to be required for the renew by the QC
requisition.
Temperature of the incubator bath is The temperature will be checked when 2 ○ ○ ○ ×
over(under) the normal range. “No fatal error” is set on the maker
setting in the system maintenance
menu.
Temperature of the refrigerator is 2 ○ ○ ○ ×
over(under) the normal range.
The small cover of STAT table is “When either case is met, the small 2 ○ × × ×
open. cover will not be checked.
1. Items that are defined “”Auto QC””
or “”Auto QC”” is in the round.

Error Messages
2. The main cover already is open.”
ISE Status is stop. 2 ○ ○ ○ ×

10-21
 10-22
Level Check timing (When is it checked?)
1 → Fatal Error “○” indicates as “Check”.
Messages Explanations 2 → No Fatal Error “×” indicates as “No Check”
3 → Notification “M1→PAUSE Start by
(Information) Standby → M1 M2 → M1
M2→PAUSE” ANL
ISE slope is zero [MMM....MM, “””MMM….MM”” indicates the item 2 ○ ○ ○ ×
NN....NN] name.
“”NNN….NN”” indicates the sample

Error Messages
kind.”
ISE slope is over(under) the range “””MMM….MM”” indicates the item 2 ○ ○ ○ ×
[MMMMMM, NN....NN] name.
“”NNN….NN”” indicates the sample
kind.”
ISE select error(Na) 2 ○ ○ ○ ×
ISE select error(K) 2 ○ ○ ○ ×
Reagent error found. Please check Refer to the below table for more 2 ○ ○ ○ ×
it at Reagent Management. details regarding the “Reagent Error”.
No Reagent volume to analyze The reagent rest volume will be 2 ○ ○ ○ ×
anymore. Please check it at checked when “CONTINUE” is set on
Reagent Management. the analysis mode parameter on the
system condition menu.
Master Curve is not scanned. There will be bottles in present that 2 ○ ○ ○ ×
Please check it at Reagent have not the master curve.
Management.
Reagent is expired. Please check In the R1 REF. 2 ○ ○ ○ ×
Reagent Management and set new
reagent in the refrigerator.
Onboard Stability is expired. Please In the R1 REF. 2 ○ ○ ○ ×
check Reagent Management and
set new reagent in the refrigerator.
Test has no RB Data. Please open 2 ○ ○ ○ ×
Calibration Requisition menu and
requisition the test.

Version 1.0
AU480 User Guide
Return to Main Table of Contents
 Level Check timing (When is it checked?)
1 → Fatal Error “○” indicates as “Check”.
Messages Explanations 2 → No Fatal Error “×” indicates as “No Check”

Version 1.0
3 → Notification “M1→PAUSE Start by
(Information) Standby → M1 M2 → M1
M2→PAUSE” ANL

AU480 User Guide

Test has no Calibration Data. Please 2 ○ ○ ○ ×
open Calibration Requisition and
requisition the test.
Calibration stability is expired. 2 ○ ○ ○ ×
Please open Calibration Requisition
menu and requisition the test.
“RB stability is expired. Please open 2 ○ ○ ○ ×
Calibration Requisition and
Return to Main Table of Contents

requisition the test.”

No R Probe wash solution at 2 ○ ○ ○ ×
Reagent Management menu.
No Diluent. Please check it at 2 ○ ○ ○ ×
Reagent Management menu.
No Photocal Data. Please perform “This is the same with the message 2 ○ ○ ○ ×
photocal at User Maintenance. No. 1022.
However, the ‘Cuv check’ will be
checked when ‘No fatal error’ is set
on the maker setting in the system
maintenance menu.”
Cuvette Error found. Please check it “This is the same with the message 2 ○ ○ ○ ×
at User Maintenance. No. 1022.
However, the ‘Cuv check’ will be
checked when ‘No fatal error’ is set
on the maker setting in the system
maintenance menu.”
Maintenance item is expired. Please 2 ○ ○ ○ ×
perform maintenance.

Error Messages
Please check STAT Status and set 3 ○ ○ ○ ○
RB cup to be needed.

10-23
 10-24
Level Check timing (When is it checked?)
1 → Fatal Error “○” indicates as “Check”.
Messages Explanations 2 → No Fatal Error “×” indicates as “No Check”
3 → Notification “M1→PAUSE Start by
(Information) Standby → M1 M2 → M1
M2→PAUSE” ANL
Please check STAT Status and set 3 ○ ○ ○ ○
calibrators to be needed.

Error Messages
Please check STAT Status and set 3 ○ ○ ○ ○
controls to be needed.
Overflow of Diluted wash solution. 3 ○ ○ ○ ×
Please check the tank.
Overflow of Deionized water. Please 3 ○ ○ ○ ×
check the tank.
ISE MID Solution short 3 ○ ○ ○ ×
ISE BUF Solution short 3 ○ ○ ○ ×
ISE BUF Solution short 3 ○ ○ ○ ×
Calibration stability will be expired 3 ○ ○ ○ ×
soon.
RB stability will be expired soon. 3 ○ ○ ○ ×
The volume is reached to Alarm 3 ○ ○ ○ ×
volume. Please check it at Reagent
Management.
Lack of S Probe Wash Solution. 3 ○ ○ ○ ×
Please check it at Reagent
Management.
Lack of R Probe Wash Solution. 3 ○ ○ ○ ×
Please check it at Reagent
Management.
Lack of Diluent. Please check it at 3 ○ ○ ○ ×
Reagent Management.
Test item(s) is set as “Disabled” at 3 ○ ○ ○ ×
Start Condition.

Version 1.0
AU480 User Guide
Return to Main Table of Contents
 Level Check timing (When is it checked?)
1 → Fatal Error “○” indicates as “Check”.
Messages Explanations 2 → No Fatal Error “×” indicates as “No Check”

Version 1.0
3 → Notification “M1→PAUSE Start by
(Information) Standby → M1 M2 → M1
M2→PAUSE” ANL

AU480 User Guide

Maintenance item will be expired 3 ○ ○ ○ ×
soon. Please check it.
No rack at Rack Set Pos. 1 × × × ○
Incorrect rack at Rack Set. Please 1 × × × ○
remove it.
Incorrect rack at Normal Lane. 1 × × × ○
Please remove it.
Return to Main Table of Contents

Incorrect rack at buffer. Please 1 × × × ○

remove it.
Incorrect rack at Rack Return. 1 × × × ○
Please remove it.
Incorrect rack at Repeat Run Lane. 1 × × × ○
Please remove it.
Please check the alarm. 1 × × × ○
Unable to start. Please wait. 1 × × × ○

Error descriptions of the Message

No. 1161

Reagent ID Error R2(R2-1) Unset

Incorrect reagent ID No common reagent
Incorrect Bottle Size Dilution Unset
Overlapped Reagent Position No Color Reagent
Bottle Set Miss No T-Hb Reagent

Error Messages
No Reagent No Pretreatment
Same Reagent Bottle Over Max Bottle

10-25
 10-26
Messages Starting STAT
To verify Error Messages when starting STAT:
Select Menu List>STAT Requisition>STAT Status>Start STAT (F1)

Error Level
1 → Fatal Error
2 → No Fatal Error
3 → Notification (Information)

Error Messages
Auto Analysis mode Normal mode
Messages Explanations
“Check “Check
“Check “Check “Check
No.1 No.1
No.2 No.3 No.2
(Start (Start
(Start by (Not in (Start by
STAT STAT
ANL)” use)” ANL)”
analysis)” analysis)”
These are the same descriptions 1 1
with the Messages (M Start).
These are the same descriptions 1 1
with the Messages (M Start).
The sample on STAT table is “When either case is met, the message will come up. 2 1 1 1
incorrect. Please check it on STAT 1. Sample(s) that are attached on the level 1 are in
status menu. present.
2. Other IDs are in present.”
No Cup to be processed on STAT “When either case is met, the message will come up. 1 1 1
table. 1. No cups on the STAT table.
2. No samples on the STAT table that will be able to
measure.”
Calibration requisition is renewed. There are cups to be required for the renew by the 2 2 2
Please set new calibrator on STAT calibration requisition.
table.
QC requisition is renewed. Please There are cups to be required for the renew by the QC 2 2 2
set new control on STAT table. requisition.
These are the same descriptions 2 2
with the Messages (M Start).

Version 1.0
AU480 User Guide
Return to Main Table of Contents
 Error Level
1 → Fatal Error
2 → No Fatal Error

Version 1.0
3 → Notification (Information)
Auto Analysis mode Normal mode
Messages Explanations

AU480 User Guide

“Check “Check
“Check “Check “Check
No.1 No.1
No.2 No.3 No.2
(Start (Start
(Start by (Not in (Start by
STAT STAT
ANL)” use)” ANL)”
analysis)” analysis)”
These are the same descriptions 2 2
with the Messages (M Start).
Please check STAT Status and set When one of the RB cup positions has no cup, the 3 3 3 3
Return to Main Table of Contents

RB cup to be needed. message will come up.

Please check STAT Status and set 3 3 3 3
calibrators to be needed.
Please check STAT Status and set 3 3 3 3
controls to be needed.
Error sample(s) exists. Please The error message will be displayed on the “Comment” 3 3 3 3
check sample(s) in STAT Status tab in the “STAT status” menu. For more information
menu. refer to “STAT Table Tab Comments” table in this
chapter.
Dispensed STAT sample exists. There are samples in present that have already been 3 3 3 3
analyzed.
These are the same descriptions 3 3
with the Messages (M Start).

Error Messages
10-27
 10-28
STAT Table Tab Comments
If the following error is received when starting STAT,
Error sample(s) exists. Please check sample(s) in STAT Status menu.
To verify the cause of the error Select Menu List>Routine>STAT Requisition>STAT Status
*1 The “Priority” column lower numbers are higher priority than the older numbers
*2 Level 1 → Fatal Error
Level 2 → No Fatal Error

Error Messages
Level 3 → Notification (Information)
Priority Error Level
Sample Kinds Bar code Label Explanations
*1 Messages *2
Routine Not in use of 1 No 2 “Sample has not been assigned.
sample bar code label assignment (This message will not be displayed under the “”Auto analysis mode””.)”
2 No cup 2 Cup that is already assigned has been removed.
3 Dispense 2 “Sample has not been dispensed.
failed (This is not available as of 12/14, this may be changed later.)”
In use of bar 1 Broken ID 2 Same ID is read consecutively.
code label
2 Same ID 2 “Same ID exists on the STAT table.
(This will apply both original run and repeat run.)”
3 Different ID 2 Sample has been replaced with another while it is being analyzed.
4 ID Read Error 2 ID reading is failed with the STAT check.
5 No cup 2 Sample has been removed while it is being analyzed.
6 Dispense 2 “Sample has not been dispensed.
failed (This is not available as of 12/14, this may be changed later.)”
7 Edited ID 2 ID has been edited after failed ID reading.

ACAL Sample Not in use of 1 No cup 2 Sample has been removed while it is being analyzed.
bar code label
2 Cup exists 2 Unexpected cup exists.

Version 1.0
AU480 User Guide
Return to Main Table of Contents
 *1 The “Priority” column lower numbers are higher priority than the older numbers
*2 Level 1 → Fatal Error
Level 2 → No Fatal Error

Version 1.0
Level 3 → Notification (Information)
Priority Error Level
Sample Kinds Bar code Label Explanations

AU480 User Guide

*1 Messages *2
3 Cup to be 2 When Cal test requisition has been changed from the previous cal setting (Cal # ,
changed position), the message will generate for reminding the change.
4 Dispense 2 “Sample has not been dispensed.
failed (This is not available as of 12/14, this may be changed later.)”
In use of bar 1 Broken ID 1 Same ID is read consecutively.
code label
Return to Main Table of Contents

2 Duplicated ID 1 Same calibrator ID is assigned on the STAT table.

3 Different ID 1 Calibrator has been replaced with another while it is being analyzed.
4 ID Read Error 2 ID reading is failed with the STAT check.
5 Undefined ID 2 Calibrator ID exists that has not been assigned.
6 Cal Set Miss 2 Calibrator is placed in a wrong position.
7 No cup 2 Sample has been removed while it is being analyzed.
8 Unnecessary 2 Unnecessary calibrator has on the STAT table against the CAL test requisitions.
cup
9 Dispense 2 “Sample has not been dispensed.
failed (This is not available as of 12/14, this may be changed later.)”
10 Edited ID 2 ID has been edited after failed ID reading.
Sample Kinds Bar code Priority Error Level Explanations
Messages
QC Sample Not in use of 1 No cup 2 Sample has been removed while it is being analyzed.
bar code label
2 Cup exists 2 Unexpected cup exists.
3 Cup to be 2 When QC test requisition has been changed from the previous QC setting (QC # ,
changed position), the message will generate for reminding the change.

Error Messages
4 Dispense 2 “Sample has not been dispensed.
failed (This is not available as of 12/14, this may be changed later.)”

10-29
 10-30
*1 The “Priority” column lower numbers are higher priority than the older numbers
*2 Level 1 → Fatal Error
Level 2 → No Fatal Error
Level 3 → Notification (Information)
Priority Error Level
Sample Kinds Bar code Label Explanations
*1 Messages *2
In use of bar 1 Broken ID 1 Same ID is read consecutively.

Error Messages
code label
2 Duplicated ID 1 Same QC control ID is assigned on the STAT table.
3 Different ID 1 QC control has been replaced with another while it is being analyzed.
4 ID Read Error 2 ID reading is failed with the STAT check.
5 Undefined ID 2 QC control ID exists that has not been assigned.
6 QC Set Miss 2 QC control is placed in a wrong position.
7 No cup 2 Sample has been removed while it is being analyzed.
8 Unnecessary 2 Unnecessary QC control has on the STAT table against the QC test requisitions.
cup
9 Dispense 2 “Sample has not been dispensed.
failed (This is not available as of 12/14, this may be changed later.)”
10 Edited ID 2 ID has been edited after failed ID reading.
RB Sample Not in use of 1 No cup 2 Sample has been removed while it is being analyzed.
bar code label
2 Unnecessary 2 Unnecessary cup is placed on the STAT table.
cup

Version 1.0
AU480 User Guide
Return to Main Table of Contents
Return to Main Table of Contents

11
Troubleshooting

This chapter can assist in locating and solving any problems that may
occur when operating the AU480.

Contents
11.1 Troubleshooting and Maintenance ...........................................................................11-3
11.2 Troubleshooting the System Data Problems ...........................................................11-3
11.2.1 Data Problem Checklist ................................................................................. 11-3
11.2.2 Checking Abnormal Data . ............................................................................. 11-4
11.2.3 Troubleshooting Software . ............................................................................ 11-5
11.3 Troubleshooting the System - Reagents and Samples ...........................................11-7
11.3.1 Sample Related Issues ................................................................................. 11-7
11.3.2 Reagent Related Issues ................................................................................ 11-8
11.3.3 QC and Calibrator Related Issues . ............................................................... 11-8
11.3.4 Wash Solution Related Issues . ..................................................................... 11-9
11.3.5 Deionized Water Related Issues ................................................................... 11-9
11.3.6 Other Causes of Abnormal Data ................................................................... 11-9
11.4 Troubleshooting the System - Mechanical Problems ...........................................11-10
11.4.1 Syringe Problems ........................................................................................ 11-10
11.4.2 Probe Problems . ......................................................................................... 11-11
11.4.3 Abnormal Data Caused by Cuvette Wheel or Wash Nozzles . .................... 11-12
11.4.4 Abnormal Data Caused by Photometer Lamp or Photometer Unit ............. 11-13
11.4.5 Mixing Problems .......................................................................................... 11-13
11.4.6 Deionized Water Tank Problems ................................................................. 11-13
11.4.7 Deionized Water or Filter Problems . ........................................................... 11-14
11.4.8 Incubation Temperature Problems . ............................................................. 11-14
11.4.9 Piping and Pump Problems ......................................................................... 11-14
11.4.10 Reagent Refrigerator Problems . ................................................................. 11-15
11.4.11 STAT Table Problems .................................................................................. 11-15
11.4.12 Rack Problems ............................................................................................ 11-15
11.5 Troubleshooting the System - System Problems ..................................................11-16
11.5.1 TEMP REF HIGH Alarm for the Cooling Unit .............................................. 11-16
11.5.2 Abnormal Sound from Inside the System..................................................... 11-16
11.5.3 Empty Alarm for the Water Supply Tank....................................................... 11-17
11.5.4 Leaks from the Wash Solution Roller Pump................................................. 11-17
11.5.5 Barcode Errors ............................................................................................ 11-18
11.5.6 Leaks from the Bottom of the System ......................................................... 11-18
11.5.7 No Wash Solution to Mix bars ..................................................................... 11-18
11.5.8 Reagent Alarm when Sufficient Reagent Remains in Bottles . .................... 11-18
11.5.9 Sample Alarm when Sufficient Sample Remains ........................................ 11-18
11.5.10 No Sample Cup Alarm when Sample Cup is Present ................................. 11-19
11.5.11 No Sample Cup on the STAT Table ............................................................. 11-19
11.5.12 Printer Not Printing or Printer Light Not On ................................................. 11-19

11-1
AU480 User Guide Troubleshooting
Version 1.0
 Return to Main Table of Contents

11.5.13 Liquid Leaking from the Reagent Probe and Sample Probe ....................... 11-19
11.5.14 Reagent Probe and Sample Probe not Aligned over the Cuvette ............... 11-19
11.5.15 Error Flag # (Sample Level Detection Error) Displayed
in the Second Half of the Sample Dispense Operation ............................... 11-20
11.5.16 Sample Rack Jammed ................................................................................ 11-20
11.5.17 Printer Problems . ........................................................................................ 11-20
11.6 Troubleshooting the System - Data Processor Problems ....................................11-21
11.6.1 Menu Cannot be Selected ........................................................................... 11-21
11.6.2 Number Key Pad on Keyboard Does Not Work .......................................... 11-21
11.6.3 Keyboard Not Responding .......................................................................... 11-21
11.6.4 Inaccessible Floppy Disc ............................................................................. 11-22
11.6.5 Results Do Not Print Automatically . ............................................................ 11-22
11.6.6 Online Auto-Output by Host Computer Not Executed ................................. 11-22
11.6.7 Unsuccessful Movement of Data between the System
and the Host Computer................................................................................ 11-22
11.7 Recovering from an Emergency Stop or Power Loss ...........................................11-23
11.7.1 Performing an Emergency Stop .................................................................. 11-23
11.7.2 Resetting the System after a Power Failure or an Emergency Stop............ 11-23
)

11-2
Troubleshooting AU480 User Guide
Version 1.0
Return to Main Table of Contents

11.1 Troubleshooting and Maintenance

Regular preventative maintenance is essential for optimum system performance. A significant number
of problems outlined in this chapter are caused by neglecting to perform preventative maintenance
and required care.
For each aspect of troubleshooting, useful information can be found by referring to the corresponding
section of the maintenance chapter.
For details on maintenance, refer to chapter 8 “Maintenance”.

11.2 Troubleshooting the System Data Problems

The following can identify data problems:
11.2.1 Data Problem Checklist ................................................................................. 11-3
11.2.2 Checking Abnormal Data . ............................................................................. 11-4
11.2.3 Troubleshooting Software . ............................................................................ 11-5

11.2.1 Data Problem Checklist

Before troubleshooting, answer the following questions:

• Has the data printout been interpreted correctly?

For details on performing analysis, refer to chapter 6 “Performing Analysis”.

• Is the data flagged?

For details on error flags, refer to chapter 9 “Error Flags”.

• Is the calibration out of range?

For details on checking calibration, refer to section “7.5 Calibration Verification” in chapter 7.

• Is QC out of range?
For details on checking QC, refer to section “6.4 Check Results” in chapter 6.

• Is data inconsistent?
This might be caused by maintenance tasks that are overdue. For details on maintenance, refer
to chapter 8 “Maintenance”.

Abnormal Data Analysis Using Routine Menu

Compare the reaction processes of samples showing normal data and of samples showing abnormal
data with the “Reaction Monitor” of the “Routine” menu and identify the difference between them.
After performing a precision run for data confirmation, use “Data Statistics” of the “Routine” menu to
obtain the results for mean value, SD, CV, range, etc.

• For details on operating procedure for the “Reaction Monitor” menu, refer to section “6.4.2
Displaying Reaction Monitor” in chapter 6.

• For details on operating procedure for the “Data Statistics” menu, refer to section “7.4
Calculating Statistics” in chapter 7.

11-3
AU480 User Guide Troubleshooting
Version 1.0
 Return to Main Table of Contents

Abnormal Data Analysis Using the Calibration Monitor Menu

Compare the calibration data for which normal data is obtained with the calibration data for which
abnormal data is generated, using the “Calibration Monitor” menu, then identify the difference between
them.
For details on operating procedure for the “Calibration Monitor” menu, refer to section “6.4.3 Check the
Calibration and Reagent Blank” in chapter 6.

Abnormal Data Analysis Using QC Monitor Menu

Compare the test with data that seems to be abnormal with the control reference designated in the
parameters using the “QC Monitor” menu. Judge the data reliability for that test. If the test may include
abnormal data due to low data reliability, identify the cause of abnormal data: a systematic error or a
random error (accidental error).
Confirm the meaning of the error flags of the multi-rule check. After confirmation, check the data again
from the point of view of the meaning of the error flags.

• For details on operating procedure for the “Quality Control” menu, refer to section “5.6
Performing Quality Control (QC)” in chapter 5.

• For details on meaning of error flags and countermeasures, refer to chapter 9 “Error Flags” and
section “6.4 Check Results” in chapter 6.

Abnormal Data Analysis Using Photocal Monitor Menu

Check for an abnormal cuvette using the “Photocal Monitor” menu.
Check that the cuvette where abnormal data is generated is identical to that recognized to be
abnormal by the “Photocal Monitor” menu.
If no abnormal cuvette is recognized by the “Photocal Monitor” menu, or if the cuvette where abnormal
data is generated and that recognized to be abnormal by the “Photocal Monitor” menu are not
identical, perform the photocal measurement again. After the measurement, check the measurement
result in the same described above, using the “Photocal Monitor” menu.
For details on how to use the “Photocal Monitor” menu, refer to section “8.4.3 Perform a Photocal” in
chapter 8.

11.2.2 Checking Abnormal Data

Check the following:

• QC Monitor: Compare the test with the normal QC data and identify the differences. Check QC
parameters by selecting Menu List>Parameters>QC Parameters>QC Specific. For details on
entering quality control (QC) parameters, refer to section “4.5 Setting Specific Test Parameters”
in chapter 4.

• Error Flags: Check the error flag definition. For details on error flags, refer to chapter 9 “Error
Flags”.

• Calibration Monitor: Use the calibration monitor to check the differences in measured counts
and factor readings between the normal and abnormal calibration data. For details on calibrating
tests, refer to section “5.5 Calibrating Tests” in chapter 5.

11-4
Troubleshooting AU480 User Guide
Version 1.0
Return to Main Table of Contents

11.2.3 Troubleshooting Software

Troubleshoot abnormal data by checking the following:

• Check Patient Data.

• Verify Parameters (Checking the relationship between the analysis condition and symptom).

• Re-check the Measurement Data.

• Check the Calibration and the Reagent Blank.

• Check Monitor Progress.

• Check Photocal Measurement Data.

Check Patient Data

If abnormal data is recognized:

• In a single test: If abnormal data is found, check the QC and calibrator material for expiration
date. Check reagent stability also.

• In all tests: If abnormal data is found, check wash solution quality and deionized water purity.

If the cause of abnormal data cannot be determined after checking patient data, try to determine if the
problem occurs at certain intervals during testing.

• Does the problem occur after a specific sequence of reagent bottles is used?
This can indicate the deterioration of reagents.

• Do the patient samples have something in common? Was a certain anticoagulant used?

Verify Parameters (Checking the relationship between the analysis condition

and symptom)
Verify the parameters if abnormal data is found in a single test or some tests.
If abnormal data is found in some tests, compare the analysis conditions (parameters) of the tests that
have abnormal data with each other to identify a common parameter(s). There is a high possibility that
the common parameters may result in abnormal data.
If a data error affects all the samples for a specific analysis test, check if the analysis parameters for
the specific analysis test that includes the error have been correctly set.

Recheck the Measurement Data

If the cause of abnormal data cannot be determined after checking the parameters, recheck the
measurement data to identify the frequency of abnormal data, common analysis sequence, common
items of samples, etc.

11-5
AU480 User Guide Troubleshooting
Version 1.0
 Return to Main Table of Contents

Check the Calibration and the Reagent Blank

Check whether the calibration and the reagent blank is causing the abnormal data to occur:

• In a single test: Compare normal calibration data with abnormal calibration data to identify the
difference between them, using the “Calibration Monitor” window. For details on the calibration
monitor, refer to section “6.4.3 Check the Calibration and Reagent Blank” in chapter 6.

Check the reagent blank the same way it was checked for calibration data.
TIP

• In some tests: Identify the commonalities between calibrators. If all abnormalities are derived
from the same calibrator, the calibrator may be the cause of the abnormal data.
If there are no commonalities, perform abnormal data analysis in the same way that it was
performed in the above case using the “Calibration Monitor” menu. Check the reagent blank in
the same way that it was checked for the calibration data.

• In all tests: There is a strong possibility that the calibration analysis itself is causing the
abnormal data. Check the reagent probe or syringes, deionized water, calibration material and
common hardware. For details on how to check error flags, refer to chapter 9 “Error Flags”.

Check Reaction Progress

Identify which reaction progress causes abnormal data using the “Reaction Monitor” menu.
For details on how to check reaction progress, refer to section “6.4.2 Displaying Reaction Monitor” in
chapter 6.

Check Photocal Measurement Data

Check the photocal measurement data to identify an abnormality with cuvettes or a photometer using
the “Photocal Monitor” menu.
For details on how to check reaction progress, refer to section “8.4.3 Perform a Photocal” in chapter 8.

11-6
Troubleshooting AU480 User Guide
Version 1.0
Return to Main Table of Contents

11.3 Troubleshooting the System - Reagents and

Samples
The following section outlines specific system issues that can lead to erroneous results.
11.3.1 Sample Related Issues ................................................................................. 11-7
11.3.2 Reagent Related Issues ................................................................................ 11-8
11.3.3 QC and Calibrator Related Issues . ............................................................... 11-8
11.3.4 Wash Solution Related Issues . ..................................................................... 11-9
11.3.5 Deionized Water Related Issues ................................................................... 11-9
11.3.6 Other Causes of Abnormal Data ................................................................... 11-9

11.3.1 Sample Related Issues

The following two items cause most data problems:

• Sample evaporation: This can cause unusually high results. Store samples properly, and keep
sample caps closed tightly if they need to be stored for a short period before analysis.

• Incorrect sample handling: Refer to the relevant Instructions for use (IFU) supplied with
reagents to find the correct procedures for sample collection, handling and storage.

Please note the following sample requirements:

• This system is designed to analyze serum, plasma and urine. If problems are encountered when
analyzing a specific test, or when using a specific reagent, refer to the relevant reagent IFU or
contact Beckman Coulter Technical Services.

• Use serum or plasma that is adequately separated from cells, and urine that is free of
suspended matter, to prevent the sample probe from becoming blocked and adversely affecting
analysis.

• Check that blood samples are sufficiently coagulated before serum separation. Remove any
suspended fibrin before placing serum on the system.

• If there is any suspended matter present in urine to be tested, perform centrifugal separation to
precipitate the suspended matter before testing the specimens.

• If a sample requires pretreatment depending on the analysis test, refer to the relevant reagent
IFU.

• A minimum quantity of sample is required for analysis. Ensure that an appropriate quantity of
sample is available for analysis. For details on entering specific test parameters, refer to section
“5.4.5 Sample Preparation” in chapter 5.

• To prevent sample evaporation, do not leave samples uncovered for an extended period of time.
Evaporation can lead to biased results being observed.

• Bubbles on the surface of samples, QC and calibrator material, may result in level sensing
problems. Ensure all bubbles are removed from the surface of the sample before placing onto
the system.

• Ensure that the sample cups and racks are set properly. For details on preparing samples for
analysis, refer to section “5.4.6 Placing the Sample Cups/Tubes in the Rack” in chapter 5.

11-7
AU480 User Guide Troubleshooting
Version 1.0
 Return to Main Table of Contents

• Check the serum for the extent of hemolysis, lipemia, bilirubin, etc.

• When the serum was concentrated or deteriorated, or the QC sample was incorrectly
reconstituted, replace the serum or dissolve the new QC sample, then repeat analysis.

11.3.2 Reagent Related Issues

Check the following if reagents cause data problems:

• Correct reagent was not used: Use the correct reagent to analyze serum, urine, or other
samples using this system.

• Reagent not stored properly: The correct methods for storing reagents, calibrators, and
controls are provided in each reagent IFU. Follow these instructions. If reagents, calibrators and
reagents are not stored properly, results will be incorrect even if used within effective periods.

• Reagent on board stability expired: Consult the relevant reagent IFU, or Beckman Coulter
Technical Services for the stability of the opened product. If the reagent has expired, replace it.
For details on replacing reagents, refer to section “5.2.1 Confirm the Analyzer Status and the
Reagent” in chapter 5.

• Reagents not placed into the system correctly: Place reagents in the system. Unless the
reagents are placed in the system properly, accurate results may not be obtained and the
system can be damaged. For details on preparing for analysis, refer to section “5.2.1 Confirm
the Analyzer Status and the Reagent” in chapter 5 and the relevant reagent IFU.

• Reagent interference between analysis tests: If a reagent has become contaminated by

another reagent during analysis, results can be affected. The degree of interference depends
on the reagent. For detailed information, consult the relevant reagent IFU or contact Beckman
Coulter Technical Services.

• Reagent has expired: Never use expired reagents.

• Liquid level sensor does not function properly during reagent aspiration:
Bubbles in the reagent bottle can cause problems with liquid level detection. Remove bubbles in
the reagent bottle. See the reagent IFU for instructions.

11.3.3 QC and Calibrator Related Issues

Check the following items for general QC and calibrator issues:

• Ensure that the material was stored and prepared correctly.

• Check the open-bottle date and expiration date.

• Ensure that the material has not been exposed to the air for an extended period of time, or
shows any visible evidence of deterioration.

• Ensure that the correct material is in the correct position in the rack. For details on performing
daily startup checks, refer to section “5.4 Preparing Samples for Analysis” in chapter 5.

11-8
Troubleshooting AU480 User Guide
Version 1.0
Return to Main Table of Contents

11.3.4 Wash Solution Related Issues

The correct wash solution was not used: Contact Beckman Coulter Technical Services.

• Correct wash solution not used: Use only the Beckman Coulter Wash Solution specific to this
system.

• Diluted wash solution tank has been contaminated: For details on how to clean the diluted
wash solution tank, refer to section “8.6.4 Clean the Deionized Water Tank” in chapter 8.

• Wash solution was changed: Contact Beckman Coulter Technical Services.

11.3.5 Deionized Water Related Issues

Check the following if the deionized water causes data problems:

• Check water quality by checking if the facilities deionized water supply system needs to be
serviced.

• If the deionized water tank is contaminated. For details on Replace the Deionized Water Filter,
refer to section “8.6.4 Clean the Deionized Water Tank” in chapter 8.

• If the deionized water filter is dirty. For details on Clean the Deionized Water Filter and the
Sample Probe Filter, refer to section “8.5.4 Clean the Deionized Water Filter and the Sample
Probe Filter” in chapter 8.

11.3.6 Other Causes of Abnormal Data

Abnormal data can arise if periodic maintenance is not performed or is overdue. Be sure to perform all
maintenance routines along with regular preventative maintenance.
For details on maintenance, refer to chapter 8 “Maintenance”.

• Water purity, conductivity and environmental specifications are incorrect for this system.
For details on precautions, installation and specifications, refer to section “2.2.1 Installation
Environment” in chapter 2 or contact Beckman Coulter Technical Services.

• This system is designed to use specific sample probe, reagent probe and cuvettes supplied by
Beckman Coulter. Use only genuine Beckman Coulter parts.

• A mosquito coil or insecticides were used in the vicinity of the system: It may markedly affect
the cholinesterase (CHE). If an abnormality is experienced, replace the sample cups, reagents,
and reagent bottles with new ones. Also wash the sample probe, reagent probe, Mix bars, and
cuvettes.

• For details on how to wash the sample probe, reagent probe, and Mix bars, refer to
sections “8.3.4 Inspect, Clean and Prime the Sample, Reagent Probes, and Mix bars” and
“8.8.3 Manually Wash the Reagent Probe” in chapter 8

• For details on how to wash the cuvettes, refer to section “8.7.2 Washing Cuvettes and the
Cuvette Wheel” in chapter 8.

11-9
AU480 User Guide Troubleshooting
Version 1.0
 Return to Main Table of Contents

11.4 Troubleshooting the System - Mechanical

Problems
Erroneous results can also be caused by hardware malfunctions.
For details on cleaning and replacing system parts, refer to chapter 8 “Maintenance” .
11.4.1 Syringe Problems ........................................................................................ 11-10
11.4.2 Probe Problems . ......................................................................................... 11-11
11.4.3 Abnormal Data Caused by Cuvette Wheel or Wash Nozzles . .................... 11-12
11.4.4 Abnormal Data Caused by Photometer Lamp or Photometer Unit ............. 11-13
11.4.5 Mixing Problems .......................................................................................... 11-13
11.4.6 Deionized Water Tank Problems ................................................................. 11-13
11.4.7 Deionized Water or Filter Problems . ........................................................... 11-14
11.4.8 Incubation Temperature Problems . ............................................................. 11-14
11.4.9 Piping and Pump Problems ......................................................................... 11-14
11.4.10 Reagent Refrigerator Problems . ................................................................. 11-15
11.4.11 STAT Table Problems .................................................................................. 11-15
11.4.12 Rack Problems ............................................................................................ 11-15

11.4.1 Syringe Problems

Check for:

• Water leaking at syringes: Tighten the syringe cases and case heads of the sample and
reagent syringes by hand. For details on replace syringes, refer to section “8.8.7 Replace
Syringes” in chapter 8.

• Bubbles in the tubing connected to the syringe: Select Menu List>Maintenance>User

Maintenance>Analyzer Maintenance>Maintenance. Then select P r i m e Wa s h i n g - l i n e
and press TA B L E R OTAT I O N / D I A G button to start removing air from the tubing. For
details on replace syringes, refer to section “8.8.7 Replace Syringes” in chapter 8.

• General Syringe Troubleshooting:

a. Ensure the top and bottom screws are tightened.
b. Ensure the probes are not blocked.
c. Ensure the bottom screw is tight up against the piston.
d. Ensure there is a smooth resistant pull.
e. Ensure the correct syringe is used.
f. Ensure one O-ring is being used, and that it is not damaged.
g. Ensure the syringe is fitted to the system properly.
h. Check the tubing connected to the syringe head for scratches, folds or leaks.
i. Check the teflon tip of the syringe for wear.

11-10
Troubleshooting AU480 User Guide
Version 1.0
Return to Main Table of Contents

11.4.2 Probe Problems

Check for:

• Reagent probe leaking from loose probe connectors: Tighten the probe connectors. Verify
that the tubing is firmly connected.

• Reagent probe blocked: Drain deionized water from the blocked probe and ensure that it
drains properly.

• Reagent probe bent or damaged: Replace the probe. For details on replacing reagent probe,
refer to section “8.8.4 Replace Sample Probe and Reagent Probe” in chapter 8.

• Sample aspiration position of the sample probe incorrect: The sample probe moves down
to aspirate sample. The maximum distance the probe can move downward is defined in the
system software, but can be changed by a service engineer. If it is set incorrectly, the probe
might hit the bottom. Contact Beckman Coulter Technical Services.

• Reagent probe not aligned over refrigerator: If the reagent probe is hitting the reagent bottle
or refrigerator cover, examine the reagent probe for abnormalities. If it is bent, replace it. If it is
not bent and the reagent aspiration position is still not right, contact Beckman Coulter Technical
Services. For details on replacing reagent probe, refer to section “8.8.4 Replace Sample Probe
and Reagent Probe” in chapter 8.

• Sample probe or reagent probe not aligned over the cuvette: If the sample probe or reagent
probe are coming into contact with the cuvettes, examine the sample probe or reagent probe for
abnormalities. If a probe is bent, replace it. If it is not bent but still not aligned properly, contact
Beckman Coulter Technical Services. For details on replacing reagent probe, refer to section
“8.8.4 Replace Sample Probe and Reagent Probe” in chapter 8.

• Abnormal wash position of reagent probe and sample probe: If the reagent probe is hitting
the wash stations, examine it for bends. If a probe is bent, replace it. If it is not bent but the
probe wash position is still abnormal, contact Beckman Coulter Technical Services.

• General trouble shooting on reagent probe and sample probe:

a. Ensure water is dispensed in a straight stream.
b. Ensure the metal cap screws for the probe connections are tight.
c. Verify that the probe tubing is free of air bubbles.

• General trouble shooting on reagent transfer unit and sample transfer unit: Verify no drops
remain on the path of the transfer.

11-11
AU480 User Guide Troubleshooting
Version 1.0
 Return to Main Table of Contents

11.4.3 Abnormal Data Caused by Cuvette Wheel or Wash Nozzles

• Scratches, fingerprints, stains, or foreign matter on the cuvettes: Wash the cuvettes. If
abnormal data is not corrected after washing, replace the cuvettes.

• For details on washing cuvettes, refer to section “8.7.2 Washing Cuvettes and the Cuvette
Wheel” in chapter 8.

• For details on Replace Cuvettes, refer to section “8.8.2 Replace Cuvettes” in chapter 8.

• Some cuvettes were damaged: Replace the related cuvettes.

For details on Replace Cuvettes, refer to section “8.8.2 Replace Cuvettes” in chapter 8.

• The outside of the cuvette and/or the cuvette wheel was wet or flooded: Check the tube
joints for looseness. Tighten the loosened tube joints. The wash nozzles may be clogged. Clean
the wash nozzles.
For details on how to clean the wash nozzles, refer to section “8.5.3 Clean the Wash Nozzle
Unit and Check the Tube Mounting Joints” in chapter 8.

• The wash water and wash solution dripping from the washing nozzles: Check the tube
joints on the wash nozzles for looseness. Tighten the loose tube joints. The wash nozzles may
be clogged. Clean the wash nozzles.
For details on how to clean the wash nozzles, refer to section “8.5.3 Clean the Wash Nozzle
Unit and Check the Tube Mounting Joints” in chapter 8.

• After washing the cuvettes, a large amount of water remained in the cuvettes: Check
the tube joints on the wash nozzles for looseness. Tighten the loosened tube joints. The wash
nozzles may be clogged. Clean the wash nozzles.
For details on how to clean the wash nozzles, refer to section “8.5.3 Clean the Wash Nozzle
Unit and Check the Tube Mounting Joints” in chapter 8.

• The tube in the master wash solution tank floats: Straighten the tube, then insert it toward
the tank bottom so that it does not come into contact with the tank opening.

• The system has trouble with the level sensor in master wash solution tank or the wash
solution tank: Connect the level sensor connector firmly, and bring the tube in the tank out of
contact with the level sensor. If the trouble is not corrected after conforming the above state, the
level sensor needs to be replaced. Contact the nearest Beckman Coulter Service Network.

• Some cuvettes are contaminated with foreign matter: Clean the cuvettes. If abnormal data is
not corrected after washing the cuvettes or if any cuvettes are broken, replace those cuvettes.

• For details on washing cuvettes, refer to section “8.7.2 Washing Cuvettes and the Cuvette
Wheel” in chapter 8.

• For details on cuvettes replacement, refer to section “8.8.2 Replace Cuvettes” in chapter 8.

11-12
Troubleshooting AU480 User Guide
Version 1.0
Return to Main Table of Contents

11.4.4 Abnormal Data Caused by Photometer Lamp or Photometer

Unit
• The quality of the photometer lamp has deteriorated: Check the record of photocal
measurement results for abnormal data. If an abnormal data is encountered, replace the
photometer lamp.

• For details on the photocal measurement result record, refer to section “8.4.3 Perform a
Photocal” in chapter 8.

• For details on Replace the Photometer Lamp, refer to section “8.7.1 Replace the
Photometer Lamp” in chapter 8.

• The photometer lamp does not stay constantly lit: Perform the photocal measurement 2
times to check the difference between 2 sets of measurement data. If there is a great difference
between them, the photometer lamp may be defective. Replace the lamp. For details on
Replace the Photometer Lamp, refer to section “8.7.1 Replace the Photometer Lamp” in chapter
8.

11.4.5 Mixing Problems

• The mix bars are contaminated: Wash the mix bars.
For details on washing the mix bars, refer to section “8.3.4 Inspect, Clean and Prime the
Sample, Reagent Probes, and Mix bars” in chapter 8.

• The teflon coating on the mix bars are chipped: Replace the mix bars.
For details on how to replace mix bars, refer to section “8.8.5 Replace Mix bars” in chapter 8.

• The mixing unit malfunctions, there is abnormal noise from the system during the mixing
motion: If there is an audible abnormal noise coming from the system, check for bent mix bars,
if none are found contact Beckman Coulter Technical Services.

• The wash water and wash solution are not properly drained from the mix bar wash
station: Contact Beckman Coulter Technical Services.

• The mix bars are not properly installed on the mixing unit, the mixing of the sample and
reagents was insufficient: install the mix bars properly again.
For details on mounting mix bars, refer to section “8.8.5 Replace Mix bars” in chapter 8.

11.4.6 Deionized Water Tank Problems

Check for:

• The Deionized water tank is contaminated or dirty: If there are signs of particulate
contamination on the inside of the tank, clean the tank thoroughly.
For details on Replace the Deionized Water Filter, refer to section “8.6.4 Clean the Deionized
Water Tank” in chapter 8.

• Residual wash solution remains in the Deionized Water Tank after cleaning: Clean the tank
again and rinse thoroughly with deionized water.

11-13
AU480 User Guide Troubleshooting
Version 1.0
 Return to Main Table of Contents

11.4.7 Deionized Water or Filter Problems

Check water quality by performing a water quality check. Check for:

• Water conductivity too high: Check water quality by performing a water quality check. Always
ensure that the deionized water conductivity is within specifications.

• Tap water below 5 °C used: Always ensure that water supply to the deionizer is above 5 °C.
For detailed information, contact Beckman Coulter Technical Services.

• Dirty, stained or blocked filters: Clean the deionized water filter and the reagent probe filter.
Replace filters if data continues to be abnormal after cleaning. For details on Replace the
Deionized Water Filter, refer to section “8.6.2 Replace the Deionized Water Filter” in chapter 8.

11.4.8 Incubation Temperature Problems

Check the following:

• Check that there is adequate space surrounding the system for air to circulate effectively.
Ensure this space is in accordance with Beckman Coulter recommendations outlined. For
details on installation environment, refer to section “2.2.4 System Connections” in chapter 2.

• Ensure the room temperature is between 18 °C and 32 ° C. Contact Beckman Coulter Technical
Services.

• The cuvette wheel was left detached for an extended period of time after detaching from the
system. Analysis was started immediately after the cuvette wheel was replaced on the system: If
the cuvette wheel is left detached for an extended period, allow one hour or more after replacing
it before starting analysis.

11.4.9 Piping and Pump Problems

The filters in each part were dirty or clogged: Clean the deionized water filter and the sample probe
filter. If abnormal data is not corrected after cleaning filters, replace the filters.

• For details on how to clean the deionized water filter, refer to section “8.5.4 Clean the Deionized
Water Filter and the Sample Probe Filter” in chapter 8.

• For details on how to clean the sample probe filter, refer to section “8.5.5 Clean the Sample
Probe Filter” in chapter 8.

• For details on how to replace the deionized water filter, refer to section “8.6.2 Replace the
Deionized Water Filter” in chapter 8.

• For details on how to replace the sample probe filter, refer to section “8.6.3 Replace the Sample
Probe Filter and O-Ring” in chapter 8.

11-14
Troubleshooting AU480 User Guide
Version 1.0
Return to Main Table of Contents

11.4.10 Reagent Refrigerator Problems

If the reagent refrigerator temperature is out of range:
1. Select A n a l y z e r S t a t u s and check the reagent refrigerator temperature.
2. Open the reagent refrigerator and ensure the reagent bottles are cool.

11.4.11 STAT Table Problems

If the STAT table temperature is out of range:
1. Select A n a l y z e r S t a t u s and check the STAT table temperature.
2. Check that the two STAT table covers (large and small) are mounted properly. If STAT analysis
samples are set and removed frequently, the temperature in the STAT table will be increased.

11.4.12 Rack Problems

Check for the following general problems:

• Ensure the rack is clean and no surface is sticky.

• Check barcode positioning.

• Ensure the correct number of magnets are in the bottom of the rack. Compare the configuration
of magnets on the underside of the rack with that of another rack of the same color. The
configuration should be identical. If a magnet is missing, do not use that rack until it is replaced.

• Ensure the rack was loaded correctly.

• For details on attaching the barcode label to the sample rack, refer to section “5.4.1
Attaching Barcode Labels to Sample Racks” on page 5-3.

• For details on placing the sample cups/tubes in the rack, refer to section “5.4.6 Placing the
Sample Cups/Tubes in the Rack” in chapter 5.

Rack advance direction

11-15
AU480 User Guide Troubleshooting
Version 1.0
 Return to Main Table of Contents

11.5 Troubleshooting the System - System Problems

11.5.1 TEMP REF HIGH Alarm for the Cooling Unit .............................................. 11-16
11.5.2 Abnormal Sound from Inside the System..................................................... 11-16
11.5.3 Empty Alarm for the Water Supply Tank....................................................... 11-17
11.5.4 Leaks from the Wash Solution Roller Pump................................................. 11-17
11.5.5 Barcode Errors ............................................................................................ 11-18
11.5.6 Leaks from the Bottom of the System ......................................................... 11-18
11.5.7 No Wash Solution to Mix bars ..................................................................... 11-18
11.5.8 Reagent Alarm when Sufficient Reagent Remains in Bottles . .................... 11-18
11.5.9 Sample Alarm when Sufficient Sample Remains ........................................ 11-18
11.5.10 No Sample Cup Alarm when Sample Cup is Present ................................. 11-19
11.5.11 No Sample Cup on the STAT Table ............................................................. 11-19
11.5.12 Printer Not Printing or Printer Light Not On ................................................. 11-19
11.5.13 Liquid Leaking from the Reagent Probe and Sample Probe ....................... 11-19
11.5.14 Reagent Probe and Sample Probe not Aligned over the Cuvette ............... 11-19
11.5.15 Error Flag # (Sample Level Detection Error) Displayed
in the Second Half of the Sample Dispense Operation ............................... 11-20
11.5.16 Sample Rack Jammed ................................................................................ 11-20
11.5.17 Printer Problems . ........................................................................................ 11-20

11.5.1 TEMP REF HIGH Alarm for the Cooling Unit

• If there is a problem with the reagent storage refrigerator unit, check that there is adequate
space surrounding the system for air to circulate effectively. Ensure this space is in accordance
with Beckman Coulter recommendations outlined. For details on installation environment
precautions, refer to section “2.2.4 System Connections” in chapter 2.

• Ensure the room temperature is from 18°C to 32° C. If the problem persists, contact Beckman
Coulter Technical Services.

11.5.2 Abnormal Sound from Inside the System

Check for:

• Air bubbles trapped in tubing: Check the deionized water filter. If it is stuck, replace it.

• Deionized Water Tank Empty alarm: The ion-exchange capability of the deionizer can be
insufficient. Replace the deionizer if it is not up to standard. Check the deionized water filters. If
they have become dirty or blocked, clean or replace them.

• For details on Clean the Deionized Water Filter and the Sample Probe Filter, refer to
section “8.5.4 Clean the Deionized Water Filter and the Sample Probe Filter” in chapter 8.

• For details on Replace the Deionized Water Filter, refer to section “8.6.2 Replace the
Deionized Water Filter” in chapter 8.

• If the cock at the bottom of wash solution tank is OFF: the wash solution will not be
generated. For this situation, open the cock.

• For all other sources of noise such as a faulty circulation pump, radiator fan, air pump, 24V
power supply fan or pump, contact Beckman Coulter Technical Services.

11-16
Troubleshooting AU480 User Guide
Version 1.0
Return to Main Table of Contents

11.5.3 Empty Alarm for the Water Supply Tank

• The ion exchange capability of the deionizer is insufficient: Check if the deionizer meets the
specification. If the deionizer does not meet the specification, replace it.
For detailed information, consult the deionizer maker.

• The deionized water filter is clogged: Check the deionized water filters with a finger to check
for sliminess. If the filter surface is slimy, the filter may be clogged. Clean the deionized water
filter.
For details on how to clean the deionized water filter, refer to section “8.5.4 Clean the Deionized
Water Filter and the Sample Probe Filter” in chapter 8.

11.5.4 Leaks from the Wash Solution Roller Pump

Roller tube

Wash solution
roller pump

Connector

Relay tubes

• The roller tubes may be deteriorated: Check the roller tubes for cracks due to deterioration. If
deteriorated, replace the roller tubes.
For details on replacing the roller tube, refer to section “8.6.5 Replace the Wash Solution Roller
Tube” in chapter 8.

• The connector connecting tubes may be loose: Make sure the connectors that connect tubes
are not lose, tighten the connectors firmly if loose.

11-17
AU480 User Guide Troubleshooting
Version 1.0
 Return to Main Table of Contents

11.5.5 Barcode Errors

Check for:

• Barcode reader dirty: Wipe the window of refrigerator for reagents and STAT using paper towel
and 70% Isopropanol.

• Barcode labels on sample cups, racks or reagent bottles discolored: Wipe barcode labels
clean. Replace any sample or rack barcodes that are worn or damaged.

• Barcode labels seriously damaged:

• On sample cups or racks: Replace any barcodes that are worn or damaged.

• On reagents: Discard the reagent or contact Beckman Coulter Technical Services.

• Barcode labels are falling off the sample cups or are not affixed properly:
For details on how to put barcodes on properly, refer to sections “5.4.4 Applying Barcode Labels
to Sample Cups” and “5.4.1 Attaching Barcode Labels to Sample Racks” in chapter 5.

While the system is turned on, avoid looking directly into the laser beam emitted from
the barcode reader. Looking directly into the laser beam can cause eye damage.
CAUTION

11.5.6 Leaks from the Bottom of the System

Check for:

• Wash line obstructed: Check for obstructions in the wash stations for sample probe and
reagent probe. Clean them if any blockages are found. For details on maintenance, refer to
chapter 8 “Maintenance” .

• Waste line not installed properly: If the waste line is leaking or if the tube itself is too long,
contact Beckman Coulter Technical Services.

11.5.7 No Wash Solution to Mix bars

The deionized water filters may be clogged: Check the deionized water filters using a finger to check
for sliminess. If the filter surface is slimy, the filter may be clogged. Clean the deionized water filter.
For details on how to clean the deionized water filter, refer to section “8.5.4 Clean the Deionized Water
Filter and the Sample Probe Filter” in chapter 8.

11.5.8 Reagent Alarm when Sufficient Reagent Remains in Bottles

The liquid level sensor could be faulty. See the alarm online help, and contact Beckman Coulter
Technical Services.

11.5.9 Sample Alarm when Sufficient Sample Remains

There is a possibility that sample probe doesn't more down to the liquid level of the reagent due to
incorrect detection of the height of the cup. Make sure an inappropriate cup is not used or the cup is
appropriately set.
If an error still occurs, contact Beckman Coulter Technical Services.

11-18
Troubleshooting AU480 User Guide
Version 1.0
Return to Main Table of Contents

11.5.10 No Sample Cup Alarm when Sample Cup is Present

Unspecified cup or adapter used: Check that the appropriately specified sample cups were used in
each rack.
Also, check that the adapter for the blood collection tube is used.

11.5.11 No Sample Cup on the STAT Table

• The related test was not selected during the requisition operation, or the requisition setup
information did not meet the sample cup position on the STAT table: Repeat the requisition
operation.

• The sample cup set on the STAT table did not use the appropriate adapter: Check if the sample
cup is set properly for the STAT table. If it is not, set the sample cup again using an adapter
appropriate for the sample cup diameter.

• An unspecified sample cup was used: Check if the sample cups specified by the STAT table are
used. If they are not, use the specified sample cups.

11.5.12 Printer Not Printing or Printer Light Not On

See the printer manual for assistance with all printer troubleshooting.

• Printer is disconnected. Check the plug and socket and connecting lead.

• Printer toner empty and needs to be replaced.

• Ensure the online button is on.

• Ensure paper is loaded properly.

11.5.13 Liquid Leaking from the Reagent Probe and Sample Probe
Verify that the Reagent probe and Sample probe is installed correctly:
1. Select Menu List>Maintenance>User Maintenance>Analyzer Maintenance.
2. Select P r i m e Wa s h - L i n e to check the reagent probe and sample probe.
3. Select O K to dispense water from the reagent probe and sample probe. If the deionized water
does not dispense normally, the reagent probe and sample probe might improperly installed.
Check the reagent probe and sample probe installation.

11.5.14 Reagent Probe and Sample Probe not Aligned over the
Cuvette
Check if the Reagent probe or Sample probe is bent: Examine the probe and replace it if it is bent.
For details on replacing reagent probe, refer to section “8.8.4 Replace Sample Probe and Reagent
Probe” in chapter 8.

11-19
AU480 User Guide Troubleshooting
Version 1.0
 Return to Main Table of Contents

11.5.15 Error Flag # (Sample Level Detection Error) Displayed in

the Second Half of the Sample Dispense Operation
Check if the sample volume is too low: Ensure there is sufficient sample for the requested tests.
The dead volume for the different tests has to be considered. For details on sample preparation, refer
to section “5.4.5 Sample Preparation” in chapter 5.
1. Select Menu List>Maintenance>User Maintenance>Analyzer Maintenance>Maintenance.
2. Select S y s t e m 2 tab and verify that the appropriate setting for the type of sample tube being
used is displayed for each rack type.
Check if the sample volume is sufficient for the following cups:

• HITACHI cup: Required volume + 50 µL or more

• φ12.3 mm tube: Required volume + 200 µL or more

• φ15.4 mm tube: Required volume + 250 µL or more

• HITACHI-micro cup (STAT only): Required volume + 30 µL or more

• Nested cup* (Rack only): Required volume + 180 µL or more

*Nested cup use only HITACHI cup.
The above necessary sample amount includes remainder (5 µL) for each test item in addition
to the sample amount necessary for analysis. When analyzing 20 tests/sample or more, set the
required sample amount + 200 µL (provisional) to suppress dilution by sample probe wash water.

11.5.16 Sample Rack Jammed

Check for:

• Contamination on the rack: Verify that nothing has fallen onto the rack and that the rack ID
label, or sample ID labels have not peeled off, causing the rack jam.

• Rack feeder unit sticky or dusty: Clean surfaces with deionized water using a lint free
dampened cloth.

11.5.17 Printer Problems

Check for:

• Analysis started while printer was offline.

• Printer turned off while analysis was in progress.

• Printer is out of paper.

a. Turn on the printer and ensure it is online.
b. Load paper if needed.
c. To printout results use Sample Manager.
d. Select P r i n t e r C o n t r o l ( F 5 ) .
e. Select Re s u m e to begin printing data from analysis. When printing is finished, the
system moves to Standby mode.

11-20
Troubleshooting AU480 User Guide
Version 1.0
Return to Main Table of Contents

11.6 Troubleshooting the System - Data Processor

Problems
The following lists potential data processor problems:
11.6.1 Menu Cannot be Selected ........................................................................... 11-21
11.6.2 Number Key Pad on Keyboard Does Not Work .......................................... 11-21
11.6.3 Keyboard Not Responding .......................................................................... 11-21
11.6.4 Inaccessible Floppy Disc ............................................................................. 11-22
11.6.5 Results Do Not Print Automatically . ............................................................ 11-22
11.6.6 Online Auto-Output by Host Computer Not Executed ................................. 11-22
11.6.7 Unsuccessful Movement of Data between the System
and the Host Computer................................................................................ 11-22

11.6.1 Menu Cannot be Selected

• Function is inaccessible: Menu items which are greyed out are inaccessible. Contact the
facilities system administrator to increase the level of access to the system.

• System software crashes: To reset the system:

a. Press C T R L + A l t + D e l e t e together.
b. Select S h u t d o w n .
c. Once the PC shuts down, press E M S TO P , then R E S E T , then Po w e r O n
to resume operation.

• Contact Beckman Coulter Technical Services if crashes become frequent.

11.6.2 Number Key Pad on Keyboard Does Not Work

Num Lock is not selected: Press the Num Lock key and then check that the LED light over Num
Lock on the keyboard is on.

11.6.3 Keyboard Not Responding

Possible causes:

• Keyboard cable: Verify that the cable connector is in the right socket in the back of the
computer (color coded).

• System crash: For details on system crash, refer to section “11.6.1 Menu Cannot be Selected”
in this chapter.

• System busy: The system might be saving data or performing a series of tasks simultaneously.
Wait for a few minutes until the system is ready. If this happens frequently, contact Beckman
Coulter Technical Services.

• Data processing, such as data saving, is being executed: Wait until data processing has
been completed.

• Electrical Noise: If a buzz is audible from the socket, take out the plug and replace it firmly.
Consult the Internal Systems Department.

11-21
AU480 User Guide Troubleshooting
Version 1.0
 Return to Main Table of Contents

11.6.4 Inaccessible Floppy Disc

Check for:

• The floppy disc is not formatted properly: Format the floppy disc by selecting Menu
List>System>External Data Management>External Data management. Select the way desired
to initialize the diskette: For parameters or data, select M e d i a I n i t i a l i z e ( F 2 ) .
For details on saving information to disc, refer to section “7.7.1 External Data Management” in
chapter 7. Formatted, 2HD 1.44 MB of disc should be used:

• Floppy disc is write-protected: Slide the tab on the disc cover. If the diskette is punched, put
in a new blank unpunched diskette. Consult internal systems department for the facility.

• Floppy disc is damaged: If writing is continuously unsuccessful, the floppy disc is probably
damaged. Use a new disc.

• Floppy disc drive damaged: If the floppy disc is new and properly formatted and data cannot
successfully saved, the floppy disc drive might be broken. Contact Beckman Coulter Technical
Services.

11.6.5 Results Do Not Print Automatically

Check for:

• Realtime output is not set: Set the realtime output of reports from System>Format>List
Format.
For details on how to set the realtime output, refer to section “4.11.1 Set the Basic Condition for
Print” in chapter 4.

• Printer is not available during analysis (out of paper, printer is turned off, printer is off-
line.): Turn on the printer to make sure it is on -line (set papers as necessary).
a. Select Home>Analyzer Status.
b. Select P r i n t e r C o n t r o l ( F 5 ) .
c. Select Re s u m e to start printing the analyzed data.

11.6.6 Online Auto-Output by Host Computer Not Executed

Check for:

• I/F cable to the host computer disconnected: Connect the cable.

• Host I/O parameters incorrectly modified: Set the appropriate I/O parameters by selecting
the Online window.

• For details on how to set host I/O parameters, refer to section “4.3 Entering Online Settings” in
chapter 4 and “Specification of Host Online”.

11.6.7 Unsuccessful Movement of Data between the System and

the Host Computer
Check if:

• I/F cable to a clinical laboratory host computer system disconnected: Connect the cable
correctly.

• I/F cable defective: Take an appropriate action such as replacement or repair.

11-22
Troubleshooting AU480 User Guide
Version 1.0
Return to Main Table of Contents

11.7 Recovering from an Emergency Stop or Power

Loss
In the event of power failure or an emergency stop, the main power is cut off immediately. Power to
the incubator and reagent refrigerator is also cut off.
11.7.1 Performing an Emergency Stop .................................................................. 11-23
11.7.2 Resetting the System after a Power Failure or an Emergency Stop............ 11-23

If an emergency stop or power failure occurs during a measure mode, the data
generated is unusable. Sample analysis must be performed again. If the system
is without power for a lengthy period of time after a power loss or emergency stop,
CAUTION check reagent integrity before restoring analysis.

11.7.1 Performing an Emergency Stop

To perform an emergency stop:
1. Press the E M S TO P button on the front of the system to turn off all power to the system.
2. Press C T R L + A l t + D e l e t e to access the “Window’s Security” window, select the Task
Manager button
3. In the Task Manger window Select S h u t d o w n to close all running software and shutdown
the PC.

11.7.2 Resetting the System after a Power Failure or an

Emergency Stop
After power failure or emergency stop follow the steps below to reset the system

Resetting the System

Print the repeat run work list, then check the samples required to perform repeat run.
1. Press the R E S E T button on the front of the system.
2. Wait 10 seconds and press the O N button to load the software.
“Program down load to analyzer” is displayed.
“End process was not completed at previous shut down. Database retrieval is required.” is then
displayed as an alarm (Select O K to remove it).

RESET button

11-23
AU480 User Guide Troubleshooting
Version 1.0
 Return to Main Table of Contents

Checking Samples
1. Select S a m p l e S t a t u s on the “Home” window to display the “Sample Status” window.
2. Select S t a t u s .
Displays a list of test conditions of samples on the Analyzer.
Confirm the sample number which is finished data output.

Checking Reagents
1. From the AU480 “Home” window select Menu List>Routine>Reagent>Reagent
Management>Main to display the “Reagent Management: Main tab” window.
2. Select Re a g e n t C h e c k ( F 5 ) .
The “Reagent Check” window appears.
3. Select “Check all positions”.
4. Select “Read reagent ID”.
5. Select S t a r t . Reagent check starts and “Checking” is displayed on the window. After check
completion, “Reagent check completed” is displayed.

11-24
Troubleshooting AU480 User Guide
Version 1.0
Return to Main Table of Contents

12
Menu Tree

This chapter provides a reference to the menu options available on the

AU480.

Contents
12.1 Home Menu...................................................................................................................12-2
12.2 Permanently Displayed Button Configuration and Function .................................12-3
Group of Function Selection Buttons .........................................................................12-3
Group of System Control Buttons ..............................................................................12-3
Group of Alarm Related Buttons ................................................................................12-3
Group of Other Buttons ..............................................................................................12-3
12.3 Menu Buttons Overview .............................................................................................12-4
12.4 Routine Menu...............................................................................................................12-5
12.5 Calibration Menu..........................................................................................................12-6
12.6 QC Menu.......................................................................................................................12-7
12.7 Parameter Menu ..........................................................................................................12-8
12.8 Maintenance Menu . ....................................................................................................12-9
12.9 System Menu . ...........................................................................................................12-10

12-1
AU480 User Guide Menu Tree
Version 1.0
 Return to Main Table of Contents

12.1 Home Menu

The “Home” window appears when the system starts up. The menus displayed on the “Home”
window are referred to as “Home menus”. Users can advance to various menus from this window.
The list of menus included in the “Home menu” is indicated below. Also, individual menu functions are
summarized.

Home Menus

Menu Submenu Option

Home Menu Sample Status
A real-time display used to monitor
the status of samples during analysis
as well as their print status.
Analyzer Status
Used to display the analyzer status.
Simple STAT mode
Allows an untrained operator to run a
sample using the STAT table.

12-2
Menu Tree AU480 User Guide
Version 1.0
Return to Main Table of Contents

12.2 Permanently Displayed Button Configuration

and Function
The multiple function buttons located at the upper and lower outside of the Home menus are always
displayed whatever menu is selected.

Group of Function Selection Buttons

Button Button name Function
Home Displays the Home window.

Menu List Displays the menu list.

User Menu Displays the user menu list.

Group of System Control Buttons

Button Button name Function
Start Starts or restarts analysis.

Pause Temporarily stops sampling.

Feeder Stop Temporary stops the rack feeder

during analysis.

Stop/Standby Transfers the system to the Stop

mode and transfers from Stop back to
Standby.

Group of Alarm Related Buttons

Button Button name Function
Alarm List Displays the alarm list.

Alarm Clear Button for silencing an alarm and

clearing the alarm display field.

Group of Other Buttons

Button Button name Function
Help Displays the Help window.

Logout Facilitates operator login and logout.

End Shuts down the system.

12-3
AU480 User Guide Menu Tree
Version 1.0
 Return to Main Table of Contents

12.3 Menu Buttons Overview

To perform parameter setup necessary for analysis, requisition concerning analysis, and check for
analysis results after operation, select a menu from various menu buttons at the left side of the “Menu
List” window.
The display contents of submenus displayed to the right vary depending on the selected menu.

12-4
Menu Tree AU480 User Guide
Version 1.0
Return to Main Table of Contents

12.4 Routine Menu

The “Routine menu” is a group of basic operation menus for performing test. Unless the basic setup is
performed beforehand with the [Parameters] menu, some submenus cannot be used.

Menu Submenu Option

Routine Start Condition
Used to set the index date and
time, start sample number,
etc., before starting analysis.
Reagent Reagent Management
Used to check the quantity of reagent and the
number of tests available in a bottle.

Reagent Inventory
Sets up the reference value for each day of the
week to perform a daily check.

Reagent Consumption
Displays the number of shots consumed each
day for each reagent.
Rack Requisition Sample
Used to set the sample numbers and analysis
items required for rack analysis.
Calibration
Used to set the requisitions for calibration for
rack analysis.
QC
Used to set the requisitions for quality control
analysis for rack analysis.
STAT Requisition STAT Status
Use to view the status of the STAT table and
start STAT sample analysis.
Sample
Performs requisition of patient samples to be
analyzed on the STAT table.
Calibration
Performs requisition of calibrators to be
analyzed on the STAT table.
QC
Performs requisition of QC samples to be
analyzed on the STAT table.
Repeat Run Repeat Order
Used to requisition repeat samples.
Repeat Data Verification
Used to view repeat results and perform
overwriting of the data.

12-5
AU480 User Guide Menu Tree
Version 1.0
 Return to Main Table of Contents

Menu Submenu Option

Routine Sample Manger Sample
Used to display analysis results, perform data
correction, print data list and batch transfer data
online.
RB/CAL/QC
Used to print and batch transfer RB/ CAL/QC
results online.
Data Monitor Reaction Monitor
Displays information about reaction processes of
analysis results.
Data Statistics
Displays key statistics of patient sample results
and the results of a test within one index as bar
charts.
Correlation Chart
Displays a correlation chart.

12.5 Calibration Menu

The “Calibration menu” is a group of menus for displaying and managing calibration results and
histories.

Menu Submenu Option

Calibration Calibration Monitor
Displays calibration results as
a graph or a data list.
Calibration Verification Calibration Verification
Verifies the calibration performance.

Material Parameter
Set Parameters for calibration verification.

12-6
Menu Tree AU480 User Guide
Version 1.0
Return to Main Table of Contents

12.6 QC Menu
The “QC menu” is a group of menus for displaying and editing quality control (QC) results and
histories.

Menu Submenu Option

QC QC Monitor Daily Chart
Display the QC data variation within the same
or between index dates as a daily chart.
Day to Day Chart
Display the QC data variation within the same
or between index dates as a day to day chart.
Twin Plot Chart
Display the QC data variation of two QC
samples as a twin plot chart.
QC Data Review
Used to edit QC result.

12-7
AU480 User Guide Menu Tree
Version 1.0
 Return to Main Table of Contents

12.7 Parameter Menu

The “Parameters menu” is a group of menus for setting various parameters such as the analysis
method. Be sure to set those parameters before using this system for the first time. To set the system
own conditions, use the “System menu”.

Menu Submenu Options

Parameters Common Test Test Name
Parameters Used for basic parameters such as test name
and reagent ID.
Profile
Used to select specified test items for one
profile. Multiple profile setting for samples, RB/
Calibration and QC is possible.
Group of Tests
Used to set the round name and test items for
each round.
Specific Test General
Parameters Used to set detailed parameters for general test
items.

LIH
Used to set detailed parameters for the Lipemia/
Icterus/Hemolysis test.
ISE
Used to set detailed parameters for the ISE test.
Calculated Tests
Used to set detailed parameters for calculated
tests.
Range
Used to set parameters for the reference range
of each test.
Repeat Parameters Repeat Common
Used to set the common parameters for a repeat
run analysis.
Repeat Specific
Used to set the repeat and reflex decision ranges
and the repeat dilution rate of repeat run analysis
for individual test items.
Calibration Parameters Calibrators
Used to set common calibrator parameters such
as name, ID and Lot number.
Calibration Specific
Used to set specific calibration parameters for
individual test items.
STAT Table Calibration
Used to set parameters for calibration analysis
using the STAT Table.

12-8
Menu Tree AU480 User Guide
Version 1.0
Return to Main Table of Contents

Menu Submenu Options

Parameters QC Parameters Controls
Used to set the common parameters for a quality
control analysis.
QC Specific
Used to set the average value and standard
deviation of the control sample for quality control
of individual items.
STAT Table QC
Used to set parameters for QC analysis using
the STAT Table.
Misc. Checked Tests
Used to set parameters for logic checked tests.

Contamination Parameters
Used to set parameters for contamination of tests
Data Check Parameters
Used to set parameters for data check such as
diagnosis of prozone. For detailed information,
contact Beckman Coulter Sales or Technical
Services.

12.8 Maintenance Menu

The “Maintenance menu” is a group of menus that are used for daily maintenance of the system. It
allows the user to plan a maintenance schedule and check for a generated alarm.

Menu Submenu Options

Maintenance User Maintenance ANL Maintenance
Used to display the maintenance schedule and
provide instruction on maintenance procedures.
ISE Maintenance
Used to display the maintenance schedule
of the ISE unit and provide instruction on ISE
maintenance procedures.
BSV
Displays the connection status of the BECKMAN
COULTER SUPPORTVISION (BSV) and
transmits the AU480’s various files.
Alarm Log
Chronologically lists the alarm
that have accrued.

12-9
AU480 User Guide Menu Tree
Version 1.0
 Return to Main Table of Contents

12.9 System Menu

The “System menu” is a group of menus used for setting the print format, use/nonuse of barcode,
optional conditions, etc.

Menu Submenu Options

System Online
Used to set the parameters for
online communication between
a host computer and the
system.
Format Requisition Format
Used to enter the sample requisition
parameters.
List Format
Used to set the common format parameters for
printing the pending list, work list, repeat list and
the data list.
Comment Masters
Used to customize the
comments appended to the
analysis results.
System Condition Analysis mode
Used to set the analysis mode, barcode
definition, auto/standard repeat and so on.
Set Date and Time
Used to set the system date and time.
Auto Power On
Used to set the auto power on time for each day
of the week.

Password
Used to set and change passwords
Login Condition
Used to set login information.
User Menu
Used to set a menu as a user
menu.
External Data External Data Management
Management Saves the analysis data on an external storage
device or media.
File Management
Used to save and up load parameter files on an
external storage device or media.
Offline Format
Used to set the output format of results and
save data in a delimited format for use in
external applications (spreadsheets, etc).

12-10
Menu Tree AU480 User Guide
Version 1.0
Return to Main Table of Contents

13
AU480 Terminology

ACAL
Abbreviation for auto-calibration. It represents the automatic creation of calibration curves.
A calibration curve is automatically created using the yellow rack. It is mainly used for the analysis
tests in the end point assay method.

Advanced Calibration
Calibration of multiple bottles of the same reagent set in the reagent refrigerator can be performed
together in advance.

Alarm Shots
The Alarm Shots function enables the operator to set the number of remaining reagent shots which
when reached, prompts a system alarm.

Auto Power On
Allows the operator to set a time when the analyzer will automatically power on.

Calibration Curve
The calibration curve is calculated from calibrator. A curve that is generated, before measurement, to
calculate the unknown analyte concentration in a sample.

Calibration Trace
The calibration trace is a graph that displays a record of calibration of each analyte.

Calibrator
Material with a known value which is used to establish the measurement relationship.

Consumable
Consumable are materials required by the system such as photometer lamps, etc.

Cuvette
A transparent glass vessel with one side face frosted, which is used as a reaction vessel between a
sample and a reagent.

Dead volume
Sample volume that cannot be aspirated by the system but remains in the tube/cup. The dead volume
depends on the type of cup/tube that is used.

13-1
AU480 User Guide Terminology
Version 1.0
 Return to Main Table of Contents

Disabling (a Test)
To select tests to be left out of an analysis run during analysis. This feature is used if calibration or QC
fails but samples are already on the rack feeder and the system is running.

END (End Point Assay)

There are three types of end-point assay:

• One-point assay is a general end-point assay that determines the optical density of the
reaction mixture from the optical density measured at a specified photometric measuring
point.

• Two Point (Self-blank method) assay provides sample blank adjustment. The optical
density values before dispensing reagent are eliminated as the sample blank. This optical
density value is then subtracted from those calculated after dispensing the second reagent.
Any contribution to the final reaction OD from the sample (turbidity, icterus etc.) is removed
to improve measurement reliability.

• Blanked End Assay measures the blank channel and then subtracts this from the
measured optical density, to calculate the actual optical density of the reaction. This
requires an additional blank. END1 does not use reagent blank absorbance as the
reference for measurement data at each photometric point.

Error Flag
Symbols that appear beside analysis results, indicating that a problem or an error has occurred during
analysis. The generated result must be reviewed.

FIXED (Fixed Point Assay)

Fixed-Point Assay is a method of calculation that determines the difference between the optical
densities at two specific time points within a reaction.
FIXED1 does not use reagent blank absorbance as the reference for measurement data at each
photometric point.

Group
Group is a category in which a combination of arbitrary analysis tests has been set up. Set
a desired group using the “Common Test Parameters: Group of Tests” window. Select Menu
List>Parameters>Common Test Parameters>Group of Tests to display the “Common Test Parameters:
Group of Tests” window.
For example, designate the analysis tests frequently used for the routine analysis to Group 1, and the
analysis tests used for the specific analysis to Group 2. Perform routine analysis under Group 1 and
switch to Group 2 for specific analysis as required. Then, the specific analysis tests can be accessed
quickly.

LAG_TIME Check
If a reaction is terminated too quickly, effective data at two points or more may not be acquired. In such
case, the system can be set up to calculate the analysis result using the data in the lag phase.
Used for the analysis tests in the rate assay method.

LIH Testing
Performs test of lipemia (L), icterus (I), and hemolysis(H) in serum. LIH is the symbol used for testing
Lipemia (L), Icterus (I), and Hemolysis (H).

13-2
Terminology AU480 User Guide
Version 1.0
Return to Main Table of Contents

Linearity
Ability of a measuring method to generate test results that are proportional to the analyte
concentration in a sample.

MCAL
Abbreviation for manual calibration. It defines manual creation of calibration curves. A calibration curve
is created by manually entering the individual data. It is mainly used for the analysis tests in the rate
assay method.

Photocal Measurement
This measurement checks the stain, scratches, etc. on the cuvettes to obtain appropriate analysis
results. Confirm the photocal data obtained from a photocal measurement on the “Analyzer
Maintenance Photocal Monitor tab” window.

• For details on performing photocal measurement, refer to section “8.4.3 Perform a Photocal” in
chapter 8.

QC Monitor
The QC Monitor gives an instant visual summary of QC analysis results.

QC Sample
Material used to verify the performance characteristics of an in vitro diagnostic medical device.

Quality Control (QC) Analysis

The process of analyzing samples with known concentrations of analytes in order to test the quality of
reagents, calibrators, equipment and procedures.

RATE (Rate Assay)

• Normal rate assay measures the variation in the rate of absorbance per minute by calculating
the average change in absorbance between each two photometric points, using the least
squares method.

• Double rate assay determines the rate of absorbance variation per minute by calculating the
average of the absorbance variations between each two measuring points, using the least
squares method. The rate of absorbance before dispensing reagent 2 is subtracted from those
calculated after dispensing the second reagent.
RATE1 does not use reagent blank absorbance as the reference for measurement data at each
photometric point.

RB
Abbreviation for reagent blank.
In routine analysis the reagent blank serves as the reference value for the reagents at each
photometric point of individual analysis tests. It also becomes the Y-segment data of calibration curves
created by ACAL.

Reagent
A reagent is a combination of chemicals that react with the target analyte in the AU480, which uses
two reagents, R1 and R2.

13-3
AU480 User Guide Terminology
Version 1.0
 Return to Main Table of Contents

Reagent ID
The system identifies reagents placed on board the system using the barcode.

Reflex Testing
Reflex testing enables a test to be automatically run by linking it to a repeat flag generated by another
test. Up to 10 sets of tests can be programmed as Reflex tests. Therefore, if a test generates a value
outside of a given range, another complementary test is automatically performed.

Repeat Run
A repeat run is a process whereby samples are tested again, either manually or automatically by the
system.

Sample Diluent
Solution used for manual or automatic diluent of samples.

Standard Deviation
Most commonly used measure of statistical dispersion. Simply put, in multiple measurements of the
same sample, it measures how spread out the values are.

Test Requisitions
An instruction to perform tests on a sample. When a sample is placed into the system, the test
requisition information is used to link the sample to the required tests.

Twin Plot
Twin Plot is used to determine whether a problematic variation in QC is caused by the system or just a
random error. QC analysis is usually performed using two controls: normal, and pathological. The twin
plot function displays the first control on the x-axis of a 2-dimensional plot and the second control on
the y-axis.

W1
Abbreviation for automatic wash of cuvettes.
Usually, W1 is used for cuvette washing before and after daily analysis.
If analysis operation was forcibly stopped, W1 is used to remove the sample remaining in the cuvette
and to wash the cuvettes.

W2
Abbreviation of automatic wash of cuvettes, sample probe, and reagent probe.
Perform W2 operation weekly. After performing W2, be sure to perform Photocal measurement.
This alternates between the usage of either 10% sodium hypochlorite or 1N HCI.
For details on W2, refer to section “8.4.2 Perform a W2 (Automatic Washing of each Probe, Mix bar
and Cuvettes, etc.)” in chapter 8.

13-4
Terminology AU480 User Guide
Version 1.0
Return to Main Table of Contents

Index

Symbols
1-point Assay 3-4
B
Backup of Condition File 7-27
14
2-point Assay 3-5 Backup of data 7-24
Barcode (Sample ID) analysis mode 3-12
A Barcode analysis 4-3
Bath status 6-5
ACAL 13-1 Beckman Coulter Guarantee 1-2
Adapters 5-29 Between Items 4-70
Adobe Acrobat® Reader® 1-5 Between Sample Types 4-72
alarm description 1-4 Breakers 3-30
Alarm Help 1-4 by Analysis Items 4-73
Alarm Shots 4-16, 13-1
Alarm Sound 4-4
Analysis
C
1-point Assay 3-4 Calculated Tests 4-18, 4-35
2-point Assay 3-5 calibration
Double Rate Assay 3-6 Advance Calibration 13-1
end assay 3-5 Calibration Analysis 4-44
End Point Assay 3-4 Calibration editing for advanced calibration 6-
Fixed Point Assay 3-6 18
Quality Control (QC) Analysis 13-3 Calibration Trace 13-1
Rate Assay 3-6 Calibration Verification 7-19
sample blank correction 3-5 Check the Calibration 6-15
self-blank method 3-5 Material Parameters 7-19
Analysis Mode Reference to calibration data 6-19
Analysis Mode 3-12, 4-2 Reference to Factor 6-20
Barcode (Sample ID) analysis mode 3-12 Reference to present calibration 6-15
Rack No. analysis mode 3-12 Verification Chart 7-20
Sequential mode 3-12 Calibrator 4-52, 13-1
Analyzer Front Unit 6-7 Calibrator Registration 4-45
Applying Barcode Labels 5-25 Change of the calibrator concentration 4-47
AU480 Handling Calibrators 2-8
Assumptions 1-2 Cancellation of pause status 6-49
Auto Power ON 7-2, 13-1 Change of the calibrator concentration 4-47
Shutdown the system 6-51 Checked Tests 4-67
System Specifications 2-17 check range 4-37
Automatic Startup Function 7-2 Check the Analyzer Status 6-4
automatic window lock function 7-8 Check the Printer 5-7
Auto Repeat 4-3 Check the Sample Status 6-3
Auto STAT Operation 4-6 Check the Test Results 6-11
cleaning the Mix bars 8-20
cleaning the Probe 8-20
cleaning the STAT table unit inside 8-87

14-1
AU480 User Guide Index
Version 1.0
 Return to Main Table of Contents

Clean the Air Filters 8-49

Clean the Deionized Water Filter 8-42
F
Clean the Deionized Water Tank 8-54 Factor for Maker 4-30
Clean the inside of the Reagent Refrigeration unit FIXED 13-2
8-88 Fixed Point Assay 3-6, 13-2
Clean the Mix Bar Wash Station 8-35 for the STAT table 4-54
Clean the Sample Pre-diluent Bottle 8-30
Clean the Sample Probe Filter 8-45
Clean the Wash Nozzle 8-37
G
Clean the Wash Station 8-32 General Tests 4-29
Comment Master 7-22 Graphical User Interface (GUI) 3-32
commercial reagent bottles 5-18 Group 5-43, 13-2
Consumable 13-1 Group Editing 4-26
contamination prevention 4-69 Guarantee 1-2
Correlation 4-30, 7-16
Cuvette 13-1
H
D Handling Samples 2-9
Handling the Keyboard, Monitor and Mouse 2-6
Daily Maintenance 8-8 Help
Daily Variation Chart 6-23 Alarm Help 1-4
Data Lists 4-74 Operation Help 1-4
Data Statistics 7-12 Tip Help 1-4
Data Transmission Method 4-10
Date and Time 4-8
Day-to-Day Variation Chart 6-25
I
Dead volume 13-1 Important Checks at Analysis 2-7
Default type 4-3 Incubation Bath Unit 3-23
Deionized Water Tank 3-29 Index 5-4
Diluent bottle 6-5 Inspect the Mix bars 8-15
Diluted Wash Solution Tank 3-29 Inspect the Printer 8-18
Disabling (a Test) 13-2 Inspect the Probes 8-15
Displaying Reaction Monitor 6-11 Inspect the Syringe 8-8
display online operational help 3-33 Inspect the Wash Solution Roller Pump 8-11
Displays 2-27 Installation
Double Rate Assay 3-6 Installation Environment 2-12
Drainage and Exhaust 2-16 Space 2-24
Dynamic Range 4-30 ISE
Check slope chart 6-65
E Correction Factor 4-34
CRS Calibration 5-14, 6-64
Electrical and Noise Conditions 2-12 Dynamic Range 4-34
Electromagnetic Wave and Noise Precautions ISE Calibration 5-10
2-10 ISE Test 4-34
emergency stop Performing or Check selectivity check 6-66
emergency stop 6-52, 11-23 ISE Unit (optional) 3-30
Reset operation after emergency stop 6-52
EM STOP (Emergency Stop) button 3-17
end assay 3-5
K
End Point Assay 3-4, 13-2 Keyboard 3-35
Ensuring Optimal Analytical Performance 2-7
Error Flag 9-1, 13-2
Error Messages 10-1
Execute a W1 8-93
executing Photocal 8-27
External storage device 7-24

14-2
Index AU480 User Guide
Version 1.0
Return to Main Table of Contents

L O
Labels 2-27 OD Limit 4-30
Lag Time Check 4-30, 13-2 Offline conditions 7-29
Layout editing 4-77 ON (sub power) button 3-17
leak at Syringe 8-9 Onboard Stability 4-30
LIH Online Help 1-4
LIH Influence Check 4-30 Online Item Number 4-14
LIH Judgment level 4-33 Online Protocol 4-12
LIH Test 4-32, 13-2 Online transfer 6-41
Reagent Volume 4-33 Overwriting the data 6-46
Sample Volume 4-33
Linearity 13-3
Linearity limit 4-30
P
Log in 5-3 parameters
calibration parameters 4-48
M Quality Control Parameters 4-59
Test Parameters 4-28
Maintenance Password Expiration Date 7-8
Adding a Maintenance Task 8-4 Pause analysis 3-34
Daily Maintenance 5-8, 8-8 Pausing Analysis 6-49
Maintenance Every Three Months 8-48 Pausing Analysis Operation 6-49
Maintenance Log 8-4 Perform a W2 8-24
Maintenance Performed Every Six Months 8-59 Performing STAT Table Analysis 6-31
Maintenance Performed Yearly or As Necessary Photocal Measurement 13-3
8-67 Photometry Unit 3-23
Monthly Maintenance 8-31 pictograms 2-27
Routine Maintenance 2-11 power switches 5-2
Updating the Maintenance Register 8-6 Pre-Dilution Rate 4-30
Viewing Maintenance History 8-7 Precautions for Operating the System 2-6
Weekly Maintenance 8-19 Preventing Damage to Other Equipment 2-4
Managing Liquid Waste 2-10 Preventing Electric Shocks 2-4
Managing Solid Waste 2-10 Preventing Fire and Damage 2-4
Manually Wash the Reagent Probe 8-72 Preventing Infection 2-6
Manual STAT Operation 4-6 Preventing Personal and Serious Injury 2-5
MCAL 13-3 Preventing Water Leaks 2-10
Measure Mode print format 4-74
Measure 1 3-34 Printing Other Sample Data 6-40
Measure 2 3-34 Processing Time 3-33
Pause 3-34 Profile 4-20
Standby 3-34
Stop 3-34
Warm up 3-34
Q
Measuring Point-1 4-30 QC Analysis 4-57
Measuring Point-2 4-30 QC Monitor 13-3
Menu Access Level 7-7 QC Sample 13-3
Method 4-30 QC sample
Multi Reagent Switch 4-16 Handling QC Samples 2-8
quality control (QC)
N Editing Quality Control Data 6-53
Quality Control Profile 4-23
No Reagent Operation 4-3 Quality Control Using the STAT Table 4-64
Normal repeat 4-39 Requesting QC Analysis 5-38
requisition for QC analysis for advance calibra-
tion items 5-39

14-3
AU480 User Guide Index
Version 1.0
 Return to Main Table of Contents

R Replace the Sample Probe and Reagent Probe

8-91
Rack Feeder Top Unit 6-6 Replace the Sample Probe Filter 8-52
Rack Feeder Unit 3-18 Replace the Wash Nozzle Joint 8-78
rack ID labels 5-19 Replace the Wash Solution Roller Tube 8-57
Rack No. analysis mode 3-12 Replacing Parts 2-11
Rack Number 4-5 Replenishing the Concentrated Wash Solution
Racks 3-20 8-14
rack setting order 5-33 requisition
RATE 13-3 Batch Requisitions 5-46
Rate Assay 3-6 Manual Requisitions 5-45
RB 13-3 requisition for advance calibration 5-35
RB/Calibration Profile 4-22 requisition for calibration 5-34
Reaction Slope 4-30 Requisition for Calibration Analysis with STAT
Reagent 5-17 table 5-37
Handling Reagents 2-8 Requisition for QC analysis with STAT table
Reagent 13-3 5-41
reagent bottles 5-17 Requisition for Repeat Run 6-43
Reagent ID 13-4 Requisitions for Emergency Samples 5-49
Reagent OD Limit 4-30 Test Requisitions 13-4
Reagent Refrigeration Unit 3-25 Requisition Information Receiving Method 4-9
Reagent refrigerator status 6-5 RESET button 3-18
Setting reagents 5-16 restart after feeder stop 6-50
Reagent Blank Routine Maintenance 2-11
Reagent Blank 3-3
Reference to Factor 6-20
Reference to reagent blank data 6-19
S
reference to reagent blanks 6-15 S. ID Barcode 4-3
Reagent confirmation 5-15 Sample
real-time printing 4-76 Precautions in handling and storing samples
Reference value (cumulative value) 4-62 2-9
Reference value (preset) 4-61 Pretreating samples 2-9
Reflex Range 4-43 Samples available for analysis 2-9
Reflex Testing 13-4 Sample Barcode 5-20
Registration of controls to be used with the STAT sample blank 3-5
table 4-65 sample blank correction 3-5
repeat run Sample Cup 5-23
Repeat Run 13-4 Sample Cups and Tubes 3-19
Repeat run Group Setting 4-41 sample data
Repeat run parameters 4-42 Correcting Patient Sample Data 6-59
Repeat run with condense 4-39 Recalculating Analysis Data 6-62
Repeat run with dilution 4-39 Rewriting Patient Sample Data 6-57
Repeat Tests 4-39 Transferring the Edited Data 6-63
Repeat Run Work List 6-44 sample diluent 3-14, 13-4
Replace Air Filters 8-94 Sample Order 5-30
Replace Cuvettes 8-70 Sample Transfer Unit 3-21
Replace Mix bars 8-76 sample volume 4-30, 5-26
Replace O-rings in the Wash Nozzle 8-68 see if an alarm occurred 6-22
Replace Packing in the Wash Nozzle Tube self-blank method 3-5
Mounting Joints 8-100 Sequential analysis 4-3
Replace Rack ID labels 8-90 Sequential mode 3-12
Replace Sample Probe and Reagent Probe 8-73 Set the analysis parameters 4-3
Replace Syringe cases and Syringe heads 8-95 Setting Password 7-4
Replace Syringes 8-82 Setting User Name 7-4
Replace the Antistatic Brush 8-89 shut down system operation 3-33
Replace the Deionized Water Filter 8-50 Shutdown the system 6-51
Replace the Photometer Lamp 8-59 Simple STAT Mode 6-36

14-4
Index AU480 User Guide
Version 1.0
Return to Main Table of Contents

Standard Deviation 13-4 position of the probe 11-11

Start Condition 5-4 Power Failure 11-23
STAT Operation 4-3 probes leaking 11-11
STAT table Processor Problems 11-21
automatic analysis mode 6-32-1 Reagent Refrigerator Problems 11-15
ID editing 6-34 Results Do Not Print 11-22
Sample Confirmation Mode 6-32-2 room temperature 11-14
STAT analysis pause 6-34 Sample Rack Jammed 11-20
STAT table 6-6 sample requirements 11-7
STAT table sample placement positions 4-6 STAT table temperature 11-15
STAT Table Unit 3-26 Syringe Problems 11-10
STAT table adapter 6-30 Verify Parameters 11-5
stop the analysis 3-34 Water Tank Dirty 11-13
stop the rack feeder 3-34 Tubing Diagram 8-41
Syringe Unit 3-28 Twin Plot 13-4
System Installation 1-3 Typographical Conventions 1-7
System Switches and Buttons 3-17
U
T Unit Status Descriptions 6-8
TABLE ROTATION/DIAG button 3-18 Updating Index 5-4
Tank Storage 3-29 User Guide
Temperature and Humidity Conditions 2-14 Printing this User Guide 1-6
Test Name 4-15 user level 7-4
Transfer of Overwritten Data 6-47 User Menu 7-10
troubleshooting using the analyzer independently 2-11
Abnormal Sound 11-16
Barcode Errors 11-18
Bubbles in the syringe 11-10
W
Check for an abnormal cuvette 11-4 W1 13-4
Checking Abnormal Data 11-4 W2 13-4
Check Patient Data 11-5 Warning Labels 2-3
Check the Calibration 11-6 Washing Cuvettes and the Cuvette Wheel 8-63
Check the Calibrator 11-8 Wash Nozzle Unit 3-24
Check the Deionized Water 11-9 Wash Solution
Check the photocal measurement data 11-6 Handling Wash Solutions 2-8
Check the QC 11-8 Wash Solution Roller Pump Unit 3-28
Check the reagents 11-8 Wash Solution Tank 3-29
Compare the calibration data 11-4 Water Supply 2-14
Compare the reaction processes 11-3 Wave length 4-30
Data Problem Checklist 11-3 ways to perform a repeat 6-42
Emergency Stop 11-23 Weekly Maintenance 8-19
hardware malfunctions 11-10 Work List Printing 6-41
identify data problems 11-3
Incubation Temperature 11-14
Keyboard Not Responding 11-21
Leaking from a probe 11-19
leaking from syringes 11-10
Leaks from the System 11-18
Leaks from the wash solution roller pump 11-17
Menu Cannot be Selected 11-21
Mix bars 11-13
mixing unit malfunctions 11-13
No Sample Cup on the STAT Table 11-19
No wash solution to Mix bars 11-18
Online Auto-Output Not Executed 11-22
Photometer Lamp 11-13

14-5
AU480 User Guide Index
Version 1.0