ARCHITECT c4000 System

Quick Reference Guide

205946-101
Page ii of vi ARCHITECT c4000 System Quick Reference Guide 205946-101
Revision Status
The ARCHITECT c4000 System is manufactured and/or distributed by Abbott
Laboratories, U.S.A., Abbott Park, IL 60064. Please direct all inquiries concerning
information in this guide to the foregoing address.

REVISION STATUS
Part Number Revision Date Pages Revised and Added
205946-101 08/09 New document

This guide was developed and produced by ADD Commercial Training in Irving, TX.

ARCHITECT c4000 System Quick Reference Guide 205946-101 Page iii of vi

Disclaimers

Disclaimers
The information, documents and related graphics published herein (the “Information”) are
the sole property of Abbott Laboratories. Permission to use the Information is granted,
provided that the copyright notice appears on all copies; use of the Information is for
operation of ABBOTT products by Abbott trained personnel or informational use only;
the Information is not modified in any way; and no graphics are used separate from
accompanying text.

Each person assumes full responsibility and all risks arising from use of the Information.
The Information is presented “AS IS” and may include technical inaccuracies or
typographical errors. Abbott Laboratories reserves the right to make additions, deletions,
or modifications to the Information at any time without any prior notification.

All samples (printouts, graphics, displays, screens, etc.) are for information and
illustration purposes only and shall not be used for clinical or maintenance evaluations.
Data shown in sample printouts and screens do not reflect actual patient names or test
results.

Abbott Laboratories makes no representations or warranties about the accuracy and

reliability of the information contained in or printed from the ARCHITECT System
Computer Based Training CD-ROM.

Any product information in training materials should be used in conjunction with the
latest version of the Operations Manual. If discrepancies in information exist within
training materials or any other materials, the latest version of the Operations Manual takes
precedence.

The Information was developed to be used by Abbott Laboratories trained personnel, by

other persons knowledgeable or experienced with the operation and service of the product
identified, or under the direct supervision and with cooperation from Abbott Laboratories
technical support or service representatives.

In no event shall Abbott Laboratories or its affiliates be liable for any damages or losses
incurred in connection with or arising from the use of the Information by persons not fully
trained by Abbott Laboratories. This limitation shall not apply to those persons
knowledgeable or experienced with the operation and service of the product identified, or
under the direct supervision and with co-operation from Abbott Laboratories technical
sales or service representatives.

No part of this media may be reproduced, stored, retrieved, or transmitted in any form or
by any means without the prior written permission of Abbott Laboratories.

No confidential relationship shall be established in the event that any user of the
Information should make any oral, written or electronic response to Abbott Laboratories
(such as feedback, questions, comments, suggestions, ideas, etc.). Such response and any
information submitted therewith shall be considered non-confidential, and Abbott shall be
free to reproduce, publish or otherwise use such information for any purposes whatsoever
Page iv of vi ARCHITECT c4000 System Quick Reference Guide 205946-101
 Trademarks
including, without limitation, the research, development, manufacture, service, use, or sale
of products incorporating such information. The sender of any information to Abbott is
fully responsible for its content, including its truthfulness and accuracy and its non-
infringement of any other person's proprietary rights.

Abbott Laboratories is not engaged in rendering medical advice or services.

Updates to the Information may be provided in either paper or electronic format. Always
refer to the latest documents for the most current information.

Incremental manual updates may cause the Master Table of Contents page numbering to
change.

Trademarks
ARCHITECT, i1000SR, i2000SR, i2000, c8000, ci8200, c16000, ci16200, AxSYM, and
AEROSET are registered trademarks of Abbott Laboratories.

c4000 is a trademarkt of Abbott Laboratories.

All Abbott Laboratories product names and trademarks are owned by or licensed to
Abbott Laboratories, its subsidiaries or affiliates. No use of any Abbott trademark, trade
name, trade dress, or product name may be made without the prior written authorization of
Abbott Laboratories, except to identify the product or services of Abbott Laboratories. All
other trademarks, brands, product names, and trade names are the property of their
respective companies. All rights reserved.

Except as permitted above, no license or right, express or implied, is granted to any person
under any patent, trademark, or other proprietary right of Abbott Laboratories.

Copyright

Copyright 2009 Abbott Laboratories, Abbott Park, Illinois.

ARCHITECT c4000 System Quick Reference Guide 205946-101 Page v of vi

Warranty statement

Warranty statement
ABBOTT LABORATORIES MAKES NO REPRESENTATIONS OR WARRANTIES
OF ANY KIND OR NATURE WITH RESPECT TO THE INFORMATION. ABBOTT
LABORATORIES HEREBY DISCLAIMS ALL REPRESENTATIONS AND
WARRANTIES, WHETHER EXPRESS OR IMPLIED, CREATED BY LAW,
CONTRACT OR OTHERWISE, INCLUDING, WITHOUT LIMITATION, ANY
WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR
PURPOSE, TITLE OR NON-INFRINGEMENT. IN NO EVENT SHALL ABBOTT
LABORATORIES BE LIABLE FOR ANY DAMAGES OF ANY KIND OR NATURE,
INCLUDING, WITHOUT LIMITATION, DIRECT, INDIRECT, SPECIAL
(INCLUDING LOSS OF PROFIT) CONSEQUENTIAL OR INCIDENTAL DAMAGES
ARISING FROM OR IN CONNECTION WITH THE EXISTENCE OR USE OF THE
INFORMATION, REGARDLESS OF WHETHER ABBOTT LABORATORIES HAS
BEEN ADVISED AS TO THE POSSIBILITY OF SUCH DAMAGES.

Page vi of vi ARCHITECT c4000 System Quick Reference Guide 205946-101

 Overview

Overview
The information and procedures provided in the ARCHITECT c4000 Quick
Reference Guide will assist you in operating and maintaining your
ARCHITECT c4000 System. For more information, refer to the
ARCHITECT System Operations Manual.
When working with an ARCHITECT System, be sure to take the appropriate
precautions. Refer to the following sections in your ARCHITECT System
Operations Manual:
• For information about symbols used on the system, refer to Read me first:
System labeling.
• For informaiton about hazards, refer to Section 8: Hazards.

205946-101 205946-101 Page 1 of 116

Overview

NOTES

Page 2 of 116 ARCHITECT c4000 System Quick Reference Guide 205946-101

 General Procedures

General Procedures
Print a Report

To print reports, results, and other information, click the Print function key
that appears at the bottom of selected screens to access the Print options
window. From the Print options window, perform the following:
1. Select the desired report from the Report section.
2. Enter the number of copies. The default is 1.
3. Select Done.

The report is sent to the printer and the Print options window closes.

Cancel a Print Request

To cancel a print request, perform the following:

1. From the Snapshot screen, double-click the printer status button.
2. Select the report to be deleted from the queue.
3. Click Delete or Delete All.
4. Click Done.
If you attempt to cancel a print request that has a status of Printing, you must
wait until the printer starts printing the report before you click Done.

205946-101 205946-101 Page 3 of 116

General Procedures

NOTES

Page 4 of 116 ARCHITECT c4000 System Quick Reference Guide 205946-101

 Software Procedures

Software Procedures
Logging On as General Operator

To log on as a general operator:

1. Select F2 - Log on on the Snapshot screen. The Log on window appears.
2. In the User name field, enter your user name.
3. Select Done. The operator’s name appears in the upper left-hand corner of
the Snapshot screen.

Logging On as Administrator

To log on as the system administrator:

1. Select F2 - Log on on the Snapshot screen. The Log on window appears.
2. In the User name field, type ADMIN (all capital letters).

3. In the Password field, enter the system administrator password.

4. Select Done. ADMIN appears in the upper left-hand corner of the
Snapshot screen.

Logging Off

To log off:
1. Select F2 - Log on on the Snapshot screen. The Log on window appears.
2. Press the Delete key to delete the user name and click Done.
The operator name no longer appears on the Snapshot screen.

205946-101 205946-101 Page 5 of 116

Software Procedures
Accessing Online Operations Manual

To access the online operations manual from the system software, select
Operations Manual from the Overview menu.

Accessing Help? for Errors

You can access online help for error code messages in two ways:
1. Select the Error? help button on the Details for exceptions window.

2. Select the help button on the error message. Help? displays content
specific to the current error message.

Page 6 of 116 ARCHITECT c4000 System Quick Reference Guide 205946-101

 Daily Start Up

Daily Start Up
Perform the following procedures for each daily start up.
• Check the supply status and reagent inventory
• Replace and update supplies and reagents
• Perform daily maintenance
• Check calibration status. Calibrate expired assay calibrations and any
calibrations expiring during the shift

Check Reagent Inventory

Reagent Inventory
• Check reagent status from the Snapshot screen or the Reagent Status
screen
• Prepare and load reagents. Use reagent cartridge/bottle adapters if
required. Recalibration of the assay is required when a replacement
cartridge or bottle is placed in a different carousel.
• Unload empty or expired reagent cartridges. Always remove both R1 and
R2 for two-reagent assays.
• Update the reagent status screen by selecting F4-SCAN or initiating a run
on the processing module.
Ensure processing module is in an allowable status (Ready or Scheduled
Pause) when loading or unloading reagents
Refer to both the reagent insert and the on-line ARCHITECT System
Operations Manual (Section 5 Operating Instructions, Reagent Inventory
Management) for specific reagent preparation instructions.

205946-101 205946-101 Page 7 of 116

Daily Start Up
Replace and Update Supplies

Replace and Update Supplies (c System)

• Replace bulk solutions as needed

Bulk Solutions

Onboard
Solution Purpose Placement
Stability

ICT Reference ICT analysis Expiration date Weight platform in the Supply
Solution and daily on bottle center
maintenance

Alkaline Wash Wash cuvettes Expiration date Weight platform in the Supply
on bottle center

Acid Wash Wash cuvettes Expiration date Weight platform in the Supply
on bottle center

• Prepare and replace sample and reagent carousel solutions

Sample Wash Solution Area

Onboard
Solution Purpose Placement
Stability

*0.5% Acid Wash sample 1 day Position 1 on the sample

Wash solution probe (24 hours) wash solution area

Detergent A Wash sample 1 day Position 2 on the sample

probe (24 hours) wash solution area

Page 8 of 116 ARCHITECT c4000 System Quick Reference Guide 205946-101

 Daily Start Up

Reagent Supply Center Solutions

Onboard
Solution Purpose Placement
Stability

Detergent A Wash reagent Expiration Reagent supply center

probes date on bottle position A1 (as configured on
the Supply status screen)

*10% Detergent B Wash reagent 14 days Reagent supply center

probes position A2 (as configured on
the Supply status screen)

*0.5% Acid Wash Wash reagent 30 days Reagent supply center

Solution probes position A3 (as configured on
the Supply status screen)

ICT Sample ICT analysis 14 days Reagent supply center, any

Diluent position

Saline Sample dilution Expiration Reagent supply center

date on bottle position A1 (as configured on
the Reagent status screen)

* For more information on preparing solutions, see page 109.

• Empty the high-concentration waste bottle (if installed)
Ensure the processing module is in the allowable status.

205946-101 205946-101 Page 9 of 116

Daily Start Up
Daily Maintenance

Refer to the Maintenance and Utilities section in this Quick Reference

Guide or refer to the online ARCHITECT System Operations Manual.

Calibration

Refer to the Calibration and QC Orders section in this Quick Reference

Guide or refer to the online ARCHITECT System Operations Manual.

Page 10 of 116 ARCHITECT c4000 System Quick Reference Guide 205946-101

 Maintenance and Utilities

Maintenance and Utilities

Perform the following procedures for daily, weekly, monthly, and quarterly
maintenance. To begin, access the Maintenance screen. From the System menu,
select Maintenance.

Viewing the Maintenance Log

1. From the Maintenance screen, select the desired module.

2. Click F2 - Maint. Log.

3. Click the scroll down arrows to view more Maintenance records.

4. Use the previous/next buttons to display the desired month.

Performing a Maintenance Procedure

From the Maintenance screen, perform the following procedures:

1. Select the desired module.
2. Select the To do, Daily, Weekly, Monthly, Quarterly, or As needed tab.
3. Select the desired procedure from the MAINTENANCE
PROCEDURES column.
4. Select F5 - Perform.
5. Click OK to perform the procedure.
6. Select Proceed, and then follow the instructions in the INSTRUCTION
box.

Click the scroll down arrows to view more instructions if necessary.

7. Enter the required information in the User Input data entry box.
8. Select Continue.
9. Continue to follow the instructions in the INSTRUCTIONS box.
10. When maintenance procedures complete, print the report or select Done
to return to the Maintenance screen.
Select the Close Window button to perform maintenance on another
processing module or to access other screens.

205946-101 205946-101 Page 11 of 116

Maintenance and Utilities
Performing a System Backup

To perform a system software backup, perform the following instructions:

1. From the System menu, select Utilities.
2. Select F4 - Create backup.
You can create a total of three software backups. The fourth time you
create a backup, the system removes the backup with the oldest date and
replaces it with the new backup.
3. In the Comments field, enter a comment if desired.
4. Click Done to create the backup.

To copy the system software backup to a CD, perform the following

instructions:
1. From the System menu, select Diagnostics.
2. Select option button 5 for SCC.
3. Page down and select the Utilities tab.
4. Select 6004 Copy Backup Software.
5. Select F5 - Perform and follow the on screen instructions to copy to a
CD.

Page 12 of 116 ARCHITECT c4000 System Quick Reference Guide 205946-101

 Calibration and QC Orders

Calibration and QC Orders

Perform the following procedures to check the calibration status and run
calibrations and QC.
Checking Calibration Status

The ARCHITECT System provides several means by which the operator can
determine the status of calibration curves.
1. Select Calibration Status from the QC-Cal icon. The latest calibration
information is displayed for each assay and reagent lot currently loaded
on the system. Selecting the table header of “EXP DATE / TIME” allows
the operator to sort the table in the order of calibration dates and times.
2. Select F3-Find from the Calibration status screen to search calibration
curves using various criteria.
Order Calibration
1. From the Orders menu, select Calibration order.
2. In the C field, enter the carrier ID which is located on the bar code label
attached to the carrier and defined as one letter followed by three
numbers.
3. In the P field, enter the position. Enter 1-5 for the carrier.
4. In the Assays section, select the assays to be ordered.
5. Click F5 - Assay options to access the Assay options window.
6. Enter the information in the appropriate fields. The correct calibration lot
number and expiration date must be entered in order for it to appear on the
Calibration Curve window and the Cal Curve Details report.
The system assigns all selected assay calibrators to positions. It starts with
the C/P entered and assigns the calibrators in the next sequential carriers.
7. Click the up and down arrows on the Assay options window to display the
previous and next calibration orders.
8. Click Done.
9. Click F2 - Add order.
10. From the Order menu, click Order status.
11. Click F4 - Print to print Order List Report.
12. Load the calibrators as printed on the Order List Report.
13. Run the calibrators.

205946-101 205946-101 Page 13 of 116

Calibration and QC Orders
Review Calibration Details
1. From the Calibration status screen, select one or more assays.
2. Click F5 - Details.
This report can be configured to print automatically.

Print Calibration Reports

1. From the QC-CAL menu, select Calibration status.
2. Click F4 - Print.

Create Multiconstituent Control Order

1. From the Orders menu, select Control Orders.

2. Select the Multiconstituent option.
3. Enter a carrier ID in the C field.
4. Enter a position in the P field.
5. Select the Control list button, and then select the desired control.
6. If the desired lot number does not display in the lot box, select the Lot list
button, and then select the desired lot.
7. Select the desired Level check box.
8. Select the desired Panels and/or Assays.
9. Select F2 - Add order.
10. Repeat steps 2-10 for subsequent levels.

Create Single Analyte Control Order

1. From the Control order screen, select the Single analyte option.
2. Enter a carrier ID in the C field.
3. Enter a position in the P field.
All levels of the control you selected must fit in one carrier or carousel.
4. Select the desired assay from the Assays list.
5. If the desired lot number does not display in the lot box, select the Lot list
button, and then select the desired lot.
6. Select the desired Levels check box.
7. Select F2 - Add order.

Page 14 of 116 ARCHITECT c4000 System Quick Reference Guide 205946-101

 Calibration and QC Orders
Using the Automated Control Ordering Feature

1. Label a tube with the desired control bar code label.

2. Pour a sufficient amount of the control material into the tube (for single
use).
You may also pour the control material into a cup and insert the cup into
the bar code labeled tube.
3. Load the sample onto the RSH in a Running status.
4. The system scans the bar code label.
5. The SCC recognizes the bar code label as the configured control SID. It
then displays the order for the control on the Order status screen.
6. The system processes the control.

205946-101 205946-101 Page 15 of 116

Calibration and QC Orders

NOTES

Page 16 of 116 ARCHITECT c4000 System Quick Reference Guide 205946-101

 Create Patient Orders

Create Patient Orders

Perform the following procedures to create and print patient manual orders.

Create Manual Patient Orders

Perform the following instruction if the host is not connected or inoperable or

if the sample does not have a bar code label.
1. From the Orders menu, select Patient order.
2. In the C field, enter the carrier ID which is located on the bar code label
attached to the carrier and defined as one letter followed by three
numbers.
3. In the P field, enter the position. Enter 1-5 for the carrier.
4. In the SID field, enter the sample ID.
5. In the Panel section, select the appropriate panel(s). The assays included
in the panel you selected will automatically be selected.
6. In the Assays section, select the assays to be ordered.
7. Click F2 - Sample details to add patient information (optional).
8. Click F3 - Add order.

Create Patient Order - Bar Code Scanner

Perform the following instructions if you are using the bar code scanner to
create a patient order.
1. On the Patient order screen, ensure the cursor appears in the SID field.
2. Scan the bar code label on the patient sample tube.
3. Select the assays or panels you want to run.
Ensure the caps lock key is off to prevent an incorrect read of the SID.

205946-101 205946-101 Page 17 of 116

Create Patient Orders
Print Patient Orders

To print the order list report, perform the following instructions:

1. From the Order menu on the Snapshot screen, select Order status.
2. Click F4 - Print.
3. From the Reports available, select Order List Report.
4. Click Done.
The Order List Report displays the required sample volume to be loaded if
using a sample cup.

Page 18 of 116 ARCHITECT c4000 System Quick Reference Guide 205946-101

 Verify, Load, and Run

Verify, Load, and Run

Perform the following procedures to verify, load, and run samples on the
ARCHITECT c4000 System.
Load and Run Samples

1. Verify sample integrity, sufficient volume, and approved sample type per
assay-specific package inserts.
2. Determine RSH status. The RSH must be in Ready or Running status to
load samples.
3. If the RSH is in Ready, select F8 RUN.
The RSH may remain in the Running status unless you are performing
maintenance.
Verify PM in running status or orders will go to exceptions..

Load Carrier

1. Verify both of the indicators below the priority section are off.
2. Position the sample carrier so that the bar code labels are facing to the
right.
3. Push the carrier into the section until the amber indicator illuminates.

205946-101 205946-101 Page 19 of 116

Verify, Load, and Run
Remove Samples in Process

To remove samples in process you must first perform one of the following:

Pause the RSH

1. Click the sample handler graphic.

2. Click F7 - Pause and wait for the steady green indicator to illuminate.

Suspend the RSH

1. From the Sample status screen, select the patient sample.

2. Click F6 - Suspend and wait for the steady green indicator to illuminate.
3. After removing the desired sample, perform one of the following:
• Order reruns for the exceptions
• Reload tray for sample processing
Never remove or add samples or sample carriers on the RSH when an amber
indicator is illuminated

Page 20 of 116 ARCHITECT c4000 System Quick Reference Guide 205946-101

 Orders and Results

Orders and Results

Perform the following procedures to add or delete orders, process or delete
exceptions, review results and flags, print reports, and archive patient results.

Add Orders

You can add a test to an order if all tests for the SID are in Pending status. To
add a test to an existing order, perform the following instructions:
1. Select the Tests in process portion of the Processing Module graphic on
the Snapshot screen.
2. Verify that all tests for the desired SID are Pending.
3. From the Orders menu, select Patient order.
4. From the Patient orders screen, enter the SID in the SID field.
5. Select the assays or panels to be added to the order.
6. Select F3 - Add order.

Delete Orders

To delete a test from an existing order, perform the following instructions:

1. From the Order status screen, select the test to be deleted. The status must
be Pending to delete a test.
2. Select F6 - Delete.
If you delete a batch order, tests with a status of Running and Scheduled
continue processing. Additional tests for the batch order do not process.
3. Select OK.

205946-101 205946-101 Page 21 of 116

Orders and Results
Process Exceptions

When an exception occurs:

• The Exception status button displays on the Snapshot screen and indicates
the number of exceptions. You can select this button to display the
Exception status screen.
• The Exceptions icon blinks to indicate new exceptions exist. You can
select this icon, and the Exception status to display the Exception status
screen.

View Error Code Cause and Corrective Action

1. From the Exception status screen, select the desired test.

2. Click F5 - Details.
3. Click Error?. Content specific to the error message appears.

View and Rerun Exceptions

1. Click Exceptions status.

2. From the Exception status screen, determine the error code that caused
the exception and troubleshoot the error code according to instructions in
the ARCHITECT System Operations Manual.
3. Select the test to rerun.
4. Click F6 - Rerun.
5. From the Rerun options window, make any necessary entries, and then
click Done.

Delete Exceptions

1. Click Exceptions status.

2. From the Exception status screen, select the exception to be deleted.
3. Click F7 - Delete.
4. Click OK to delete the exception.

Page 22 of 116 ARCHITECT c4000 System Quick Reference Guide 205946-101

 Orders and Results
Review Results and Flags

From the Results menu, select Results review. The following flags appear in
the FLAG column:

Flag Description
EDIT The result was manually edited by the operator and
was not calculated by the system. (Edit can be
performed only if logged on as ADMIN.)
EXP* The result was measured using expired reagents,
Pre-Trigger, or Trigger solutions.
EXPC* The result was calculated using an expired
calibration curve.
A#1 The result was calculated using the only valid read
within the defined absorbance range.
A#2 The result was calculated using the only two valid
reads within the defined absorbance range.
CNTL* The result was calculated after the quality control
failed for the control name and control level.
< or > The result is outside the dynamic range or linear
range.
FLEX The result was calculated using the read data
measured during the flex read time.
LL or HH** The result is outside the defined extreme range.
PSHH (ICT The result may be affected by the ICT sample that
assays) was measured immediately prior to this sample
because the result of the previous sample was
above the extreme range. Rerun the sample to verify
that there was no affect.
LOW or HIGH** The result is outside the defined normal range.
* These flags carry over from a constituent result to a calculated result.

** A result is rounded to the reporting number of decimals for an assay,

and then compared against the range.

205946-101 205946-101 Page 23 of 116

Orders and Results
Find a Specific Patient Result

1. From the Results review screen, click F3 - Find or

2. From the Snapshot screen, click the Sample find icon.

3. Select and/or enter your search criteria.

4. Click Done to initiate the search.

Page 24 of 116 ARCHITECT c4000 System Quick Reference Guide 205946-101

 Orders and Results
View Patient Result Data and Add a Comment

1. From the Results review screen, select the desired results.

2. Click F5 - Details.
3. Type a comment in the Comment field.
4. Select Done to save the comment.
The C processing code displays in the code field. If the comment is added
in the Details for result screen, the comment appears with this test result
only, even if this SID is associated with other test results.

Rerun Tests

1. From the Results review screen, select the desired test.

2. Click F6 - Rerun.
3. From the Rerun options window, make any necessary entries, and then
click Done.
The system assigns the rerun code R to this test, and assigns an * to the
original test result.
4. Ensure the system status is Running.
5. Ensure the sample contains enough volume for the retest.
6. If necessary, remove the sample from the sample handler.
7. Place the sample on the RSH.

Delete a Test Result

1. From the Results review screen, select the test to be deleted.

2. Click F7 - Delete.
3. Click OK to confirm deletion.

Release Results

To release patient results to stored results, perform the following:

1. From the Results review screen, select the results desired. Click F2 -
Select all to highlight all results.
2. Click F8 - Release.

205946-101 205946-101 Page 25 of 116

Orders and Results
Retransmit Results to the Host
To retransmit a previously-released patient result to the host, perform the
following:
1. From the Stored results screen, select only the desired results.
If the host goes down while the results are being transmitted, click F3 -
Find from the Stored results screen. Then select the Pending Transmission
checkbox and click Done. Samples that ran while the host was down will
be listed.
2. Click F6 - Transmit to host.
3. Click OK to transmit the results to the host.

Archive Patient Results

To archive patient results, perform the following:

The processing module and RSH must be in Offline, Stopped, or Ready to
archive patient results.

1. Insert a CD-R or CD-RW in to the CD drive.

2. Select the desired patient results.
3. Click F8 - Archive.
4. Wait for the CD drive indicator light to turn off.
5. If you want the results to remain in the Stored results screen after
archiving, deselect Delete records after archive.
6. Click Done to archive the results.
Do not navigate to a different screen until the “0519 Data Archive Complete”
message displays.

Access Results from the CD

1. Put the CD into the CD drive of a stand-alone PC.

2. Double-click the My Computer icon on the desktop.
3. Double-click the CD drive.
4. Double-click the folder with the System Serial Number to open the folder.
5. Double-click on a file to open it in a spreadsheet. Files are named by the
date they were made.
6. Information as displayed on the Results details screen is available on the
CD.
Archived results cannot be retrieved from the ARCHITECT System.
Page 26 of 116 ARCHITECT c4000 System Quick Reference Guide 205946-101
 Configuration

Configuration
Before configuring settings, the system must be in the Ready status and you must
be logged in as System Administrator.
System Configuration

1. From the System menu, select Configuration.

2. From the Configuration screen, select the desired configuration settings.
3. Select the desired category.
4. Click F6 - Configure.
5. From the category window, change the appropriate settings.
6. Click Done to close the window.
Enter a Calibrator Concentration
Perform this procedure to enter a calibrator concentration(s) when you first
configure an assay or when you use a new lot of calibrator.
For this procedure, you will need a Calibrator value sheet.
1. From the Configuration screen, select QC/Cal settings, and then select
Calibrator Set.
2. Select the desired calibrator(s) from the Calibrator list, and then select
F6 - Configure.
3. Select F6 Configure.
Highlight each analyte.
4. Enter the concentrations for the new calibrators.
5. Use the previous/next buttons to display each assay if you selected more
than one, and then enter the concentrations for each. (optional)
6. Select Done to save your changes.
You can define up to four (4) different lots per calibrator set.

205946-101 205946-101 Page 27 of 116

Configuration
Configure a User-Defined Reagent Kit (Photometric)

Perform this procedure to create a reagent kit with a unique identifier for non-bar
coded reagents. This identifier allows the system to track the onboard stability and
remaining tests for a kit even if it is moved. It also allows the system to perform
reagent changeover when a cartridge is empty.
You must define at least one reagent kit before you can load the reagent in the
reagent supply centers.

1. From the Configuration screen, select Assay settings.

2. Select CC reagent settings from the Assay categories list on the
Configuration screen.
3. Select the desired reagent from the Reagents list, and then select F6-
Configure.
The Configure reagent (CC reagent settings) window appears. The
information is dependent on the reagent you selected.
4. Select the Lot number list button, and then perform one of the following:
• Select the desired lot from the list.
• Select New lot, and then enter a lot number (maximum of eight
alphanumeric characters) in the Lot number data entry box.
5. Enter a unique number in the Serial number data entry box.
You can define multiple serial numbers for each lot number to allow you to
load multiple kits of the same reagent. Each kit defined for a single lot
number must have a unique numeric identifier (serial number).
6. Enter a date in the Expiration date data entry box. (optional)
7. Select the R1 cartridge size list button, and then select the cartridge size.
8. Select the R2 cartridge size list button, and then select the cartridge size.
(optional)
9. Select Add kit to create the kit.
The new kit appears in the Configured kit list.
10. Select Done to save your changes.

Page 28 of 116 ARCHITECT c4000 System Quick Reference Guide 205946-101

 Configuration
Change Photometric Assay Calibrator Settings

To change photometric assay calibrator settings:

1. Select Calibrator set from the QC - Cal categories list on the
Configuration screen.
2. Select the desired calibrator set, and then select F6 - Configure.
The Configure calibrator set window displays.
3. Select the Lot number list button, and then select New Lot.
4. Enter a value in the Lot number data entry box.
5. Enter a value in the Expiration date data entry box (optional).
6. Select Select assays (optional).
The Select assays window displays.
a. Select the desired assay(s) from the list.
b. Select Done to return to the Configure calibrator set window.
The assay(s) display in the table.
8. Select the assay(s) from the table, and then select Define data.
9. Enter a value in the Concentration data entry box for each calibrator.
A concentration must be entered for each calibrator level regardless of
whether the level is used for the assay calibration.
10. Use the previous/next buttons to display each assayif you selected more
than one, and thenrepeat step 9 for each.
11. Select Done to return to the Configure calibrator set window.
The assay-specific data displays in the table.
12. Select Done to save your changes.

205946-101 205946-101 Page 29 of 116

Configuration

NOTES

Page 30 of 116 ARCHITECT c4000 System Quick Reference Guide 205946-101

 Component Replacement

Component Replacement
Perform the following procedures to remove and replace accessories as part of
recommended maintenance and perform verification procedures.

Maintenance Tools

To perform the component replacement procedures, you will need your

accessory kit and the following additional supplies:
• Absorbent towel
• Hemostat or clamp
• Lint-free tissue
• Cotton swabs
• Large beaker
• Gloves
• DI water

WARNING Potential Biohazard. This is an activity or area where you may

be exposed to potentially infectious material. For more details refer to the
ARCHITECT System Operations Manual, Section 8 Biological
Hazards.

WARNING Probe Stick Hazard. Probe Sharps Hazard. This is an activity

or area where you may be exposed to probes. For more details refer to the
ARCHITECT System Operations Manual, Section 8 Probes and
sharps.

CAUTION Chemical Hazard. This activity presents a chemical-related

hazard. For more details refer to the ARCHITECT System Operations
Manual, Section 8 Biological Hazards.

Reference

For information on component replacement, refer to the ARCHITECT

System Operations Manual.
1. Select the Index tab.
2. Enter component replacement.
3. Select a listing for the c System.

After replacing an accessory, complete the recommended verification

procedure to ensure that you have installed the part correctly.

205946-101 205946-101 Page 31 of 116

Component Replacement
ARCHITECT c4000 System Processing Center Components

The following illustration shows the locations of the processing center

components. Use this illustration when performing component replacement
procedures.

1 Sample Pipettor 7 Reagent supply center and cover

2 Reaction Carousel 8 Reagent 1 Pipettor

3 Lamp 9 Reagent 2 Pipettor

4 Mixer Unit 10 Sample Wash Solution Area

5 Cuvette Washer 11 High concentration waste pump

6 ICT Unit

Component replacement procedures consists of the following:

• Removal
• Replacement
• Verification

Page 32 of 116 ARCHITECT c4000 System Quick Reference Guide 205946-101

 Component Replacement
Replace the Sample Probe

It is recommended that you record and track the date of sample probe
installation to ensure you do not use the probe for longer than one year.

Prerequisite The processing module must be in the Ready status.

Estimated time required 20 minutes

Tools/materials required • Slotted screwdriver

• Absorbent towel

Replacement parts • LN 01G48-03 - Sample probe

• LN 02J51-01 - Reagent/Sample probe screw
(optional)

WARNING Potential Biohazard. This is an activity or area where you may

be exposed to potentially infectious material. For more details refer to the
ARCHITECT System Operations Manual, Section 8 Biological
Hazards.

WARNING Probe Stick Hazard. Probe Sharps Hazard. This is an activity

or area where you may be exposed to probes. For more details refer to the
ARCHITECT System Operations Manual, Section 8 Probes and
sharps.

CAUTION Chemical Hazard. This activity presents a chemical-related

hazard. For more details refer to the ARCHITECT System Operations
Manual, Section 8 Biological Hazards.

Removal

Prepare for Sample Probe Removal

Steps

1. Remove the sample wash solution carrier.

2. Initiate pipettors diagnostic procedure 1161 Probe Move to position the sample
pipettor over the sample wash solution area.

Reference
For information on preparing for sample probe removal, refer to the ARCHITECT
System Operations Manual, Section 9.

205946-101 205946-101 Page 33 of 116

Component Replacement
Removal (cont’d)

Remove the Sample Probe

Steps Graphic/Reference

1. Remove the sample pipettor

cover by gently squeezing the
squeeze points [1], to release
the locking tabs, and lifting the
cover [2].

2. Place an absorbent towel in the

sample carousel area under the
probe tip.

3. Use a slotted screwdriver to

slightly loosen the probe screw
[3].

4. Loosen, do not remove, the

probe screw [3] by hand until the
probe releases from the sample
pipettor.

5. Loosen, do not remove, the

screw [4] holding the sample
probe grounding wire [5] in
place.

6. Detach the grounding wire.

7. Gently disconnect the tubing [6]

from the top of the probe [7].

Reference
For information on removing the sample probe, refer to the ARCHITECT System
Operations Manual, Section 9.

Page 34 of 116 ARCHITECT c4000 System Quick Reference Guide 205946-101

 Component Replacement

Replacement

Install the Sample Probe

Steps Graphic/Reference

1. Attach the tubing [1] to the top

of the new sample probe [2].
Do not flare or stretch the tubing.
The tubing should fit firmly on the
sample probe. If the tubing is
loose or if the probe has been
replaced several times using the
same tubing, it is recommended
that you replace the sample
probe tubing.

2. Position the sample probe on

the alignment pins [3] and verify
the probe plate [4] is flush with
the plate on the sample pipettor.

3. Remove the probe screw [5]

from the old sample probe and
insert it into the new sample
probe. Finger tighten the screw
[5] to secure the probe in place.

4. Stabilize the pipettor and tighten

the screw with the slotted
screwdriver.

5. Attach the new sample probe

grounding wire [6] and tighten
the screw [7].

6. Complete pipettors diagnostic

procedure 1161 Probe Move to
return the sample pipettor to the
home position.

7. Remove the absorbent towel

from the sample carousel area.

Reference

For information on installing the sample probe, refer to the ARCHITECT System
Operations Manual, Section 9.

205946-101 205946-101 Page 35 of 116

Component Replacement

Replacement (cont’d)

Prepare for Operation

Steps Graphic/Reference

1. Perform as-needed
maintenance procedure 2132
Flush Water Lines.

2. Visually inspect the probe for

drips and inspect the sample
probe tubing and connections
for leaks.

If you observe drips or leaks,

repeat the installation
procedure.

3. Gently replace the pipettor

cover [1]. Ensure the tubing is
not pinched or kinked below the
pipettor cover.

4. Press down on the end of the

cover over the pipettor shaft [2]
until it snaps into place. The
pipettor cover must be
completely seated to ensure
correct liquid level sense
operation.

5. Reinstall the sample wash

solution carrier.

Reference

For information on preparing for operation, refer to the ARCHITECT System

Operations Manual, Section 9.

Page 36 of 116 ARCHITECT c4000 System Quick Reference Guide 205946-101

 Component Replacement

Verification

Calibrate the Sample Pipettor

Steps

1. Perform as-needed maintenance procedure 1120 Sample Pipettor Calibration.

2. Run quality control to verify performance prior to reporting patient results..

Reference

For information on as-needed maintenance 1120 Sample Pipettor Calibration, refer to

the ARCHITECT System Operations Manual, Section 9, As-needed Maintenance.

205946-101 205946-101 Page 37 of 116

Component Replacement

NOTES

Page 38 of 116 ARCHITECT c4000 System Quick Reference Guide 205946-101

 Component Replacement

Replace Reagent Probes

Prerequisite The processing module must be in the Ready status.

Estimated time required 20 minutes

Tools/materials required • Slotted screwdriver

Replacement parts • LN 01G47-03 - Reagent Probe

• LN 02J51-01 - Reagent/sample probe screw
(optional)

WARNING Potential Biohazard. This is an activity or area where you may

be exposed to potentially infectious material. For more details refer to the
ARCHITECT System Operations Manual, Section 8 Biological
Hazards.

WARNING Probe Stick Hazard. Probe Sharps Hazard. This is an activity

or area where you may be exposed to probes. For more details refer to the
ARCHITECT System Operations Manual, Section 8 Probes and
sharps.

CAUTION Chemical Hazard. This activity presents a chemical-related

hazard. For more details refer to the ARCHITECT System Operations
Manual, Section 8 Biological Hazards.

205946-101 205946-101 Page 39 of 116

Component Replacement

Removal

Prepare for Reagent Probe Removal

Steps Graphic / Reference

1. Locate the reagent pipettor.

See ARCHITECT c4000

processing center components
for pipettor locations.

- Access the R1 pipettor from the

back of the system.

- Access the R2 pipettor from the

back of the system.

2. Initiate pipettors diagnostic

procedure 1161 Probe Move to
move the reagent pipettor to an
accessible position.

Page 40 of 116 ARCHITECT c4000 System Quick Reference Guide 205946-101

 Component Replacement
Removal (cont’d)

Remove the Reagent Probe

Steps Graphic/Reference

1. Remove the reagent pipettor

cover by gently squeezing the
squeeze points [1], to release
the locking tabs, and lifting the
pipettor cover [2].

2. Use a slotted screwdriver to

slightly loosen the probe screw
[3].

3. Loosen, do not remove, the

probe screw [3] by hand until the
probe releases from the reagent
pipettor.

4. Loosen, do not remove, the

screw [4] holding the reagent
probe grounding wire [5] in
place.

5. Detach the grounding wire

6. Gently disconnect the tubing [6]

from the top of the probe [7].

205946-101 205946-101 Page 41 of 116

Component Replacement

Replacement

Install the Reagent Probe

Steps Graphic/Reference

1. Attach the tubing [1] to the top

of the new reagent probe [2].
Do not flare or stretch the tubing.
The tubing should fit firmly on the
reagent probe. If the tubing is
loose or if the probe has been
replaced several times using the
same tubing, it is recom ended
that you replace the reagent
probe tubing.

2. Position the new reagent probe

[2] on the alignment pins [3] and
verify the probe plate [4] is flush
with the plate on the reagent
pipettor.

3. Remove the probe screw [5]

from the old reagent probe and
insert it into the new reagent
probe. Finger tighten the screw
[5] to secure the probe in place.

4. Stabilize the pipettor and tighten

the screw with the slotted
screwdriver.

5. Attach the new reagent probe

grounding wire [6] and tighten
the screw [7].
Ensure the connector for the new
reagent probe grounding wire [6]
is positioned under the ring-
shaped connector [8] as shown.

6. Complete pipettors diagnostic

procedure 1161 Probe Move to
return the reagent probe to the
home position.

Page 42 of 116 ARCHITECT c4000 System Quick Reference Guide 205946-101

 Component Replacement
Replacement (cont’d)

Prepare for Operation

Steps Graphic/Reference

1. Perform as-needed
maintenance procedure 2132
Flush Water Lines.

2. Visually inspect the probe for

drips and inspect the reagent
probe tubing and connections
for leaks.

If you observe drips or leaks,

repeat the installation
procedure.

3. For the R2 reagent probe,

perform pipettors diagnostic
procedure 1161 Probe Move to
move the reagent pipettor to an
accessible position.

4. Gently replace the pipettor

cover [1]. Ensure the tubing is
not pinched or kinked below the
pipettor cover.

5. Stabilize the pipettor to prevent

it from dropping and causing
damage to the probe. Press
down on the end of the cover
over the pipettor shaft [2] until it
snaps into place. The pipettor
cover must be completely
seated to ensure correct liquid
level sense operation.

205946-101 205946-101 Page 43 of 116

Component Replacement

Verification

Calibrate the Reagent Pipettor

Steps

1. Perform the appropriate as-needed maintenance procedure:

• 1121 R1 Pipettor Calibration

• 1122 R2 Pipettor Calibration

2. Run quality control to verify performance prior to reporting patient results.

Page 44 of 116 ARCHITECT c4000 System Quick Reference Guide 205946-101

 Component Replacement

Replace the Sample Probe Tubing

Prerequisite The processing module must be in the Ready status.

Estimated time required 15 minutes

Tools/materials required Absorbent towel

Replacement parts LN 01G48-02 - Sample probe tubing

WARNING Potential Biohazard. This is an activity or area where you may

be exposed to potentially infectious material. For more details refer to the
ARCHITECT System Operations Manual, Section 8 Biological
Hazards.

WARNING Probe Stick Hazard. Probe Sharps Hazard. This is an activity

or area where you may be exposed to probes. For more details refer to the
ARCHITECT System Operations Manual, Section 8 Probes and
sharps.

CAUTION Chemical Hazard. This activity presents a chemical-related

hazard. For more details refer to the ARCHITECT System Operations
Manual, Section 8 Biological Hazards.

Removal

Prepare for Sample Probe Tubing Removal

Steps

1. Remove the sample wash solution carrier.

2. Initiate pipettors diagnostic procedure 1161 Probe Move to position the sample
pipettor over the sample wash solution area.

Reference

For information on the pipettors diagnostic procedure 1161 Probe Move, refer to the
ARCHITECT System Operations Manual, Section 9.

205946-101 205946-101 Page 45 of 116

Component Replacement
Removal (cont’d)

Remove the Sample Probe Tubing

Steps Graphic/Reference

1. Remove the sample pipettor

cover by gently squeezing the
squeeze points [1], to release
the locking tabs, and lifting the
cover [2].

2. Place an absorbent towel in the

sample carousel area under the
probe tip.

3. Unscrew the tubing from the

probe tubing connector [3].
Ensure the black o-ring inside
the tubing connector stays in
place.

4. Gently disconnect the tubing [4]

from the top of the probe [5].

Page 46 of 116 ARCHITECT c4000 System Quick Reference Guide 205946-101

 Component Replacement

Replacement

Install the Sample Probe Tubing

Steps Graphic/Reference

1. Attach the end of the new tubing

[1] to the top of the sample
probe [2].
Do not flare or stretch the new
tubing. The tubing should fit firmly
on the sample probe.

2. Verify the black o-ring is inside

the probe tubing connector [3].

3. Screw the opposite end of the

tubing [4] into the tubing
connector [3].

4. Complete pipettors diagnostic

procedure 1161 Probe Move to
return the sample pipettor to the
home position.

5. Remove the absorbent towel

from the sample wash solution
area.

Reference

For information on installing the sample probe tubing, refer to the ARCHITECT System
Operations Manual, Section 9.

205946-101 205946-101 Page 47 of 116

Component Replacement

Replacement (cont’d)

Prepare for Operation

Steps Graphic/Reference

1. Perform as-needed
maintenance procedure 2132 -
Flush Water Lines.

2. Visually inspect the probe for

drips and inspect the sample
probe tubing and connections
for leaks.

If you observe drips or leaks,

repeat the installation
procedure.

3. Gently replace the pipettor

cover [1]. Ensure the tubing is
not pinched or kinked below the
pipettor cover.

4. Press down on the end of the

cover over the pipettor shaft [2]
until it snaps into place. The
pipettor cover must be
completely seated to ensure
correct liquid level sense
operation.

5. Reinstall the sample carousel.

Reference

For information on preparing for operation, refer to the ARCHITECT System

Operations Manual, Section 9, As-needed Maintenance and Section 10.

Verification

Run quality control

Steps

1. Run quality control to verify performance prior to reporting patient results.

Page 48 of 116 ARCHITECT c4000 System Quick Reference Guide 205946-101

 Component Replacement

Replace the Reagent Probe Tubing

Prerequisite The processing module must be in the Ready status.

Estimated time required 15 minutes

Tools/materials required Absorbent towel

Replacement parts LN 01DG47-02 - Reagent probe tubing

WARNING Potential Biohazard. This is an activity or area where you may

be exposed to potentially infectious material. For more details refer to the
ARCHITECT System Operations Manual, Section 8 Biological
Hazards.

WARNING Probe Stick Hazard. Probe Sharps Hazard. This is an activity

or area where you may be exposed to probes. For more details refer to the
ARCHITECT System Operations Manual, Section 8 Probes and
sharps.

CAUTION Chemical Hazard. This activity presents a chemical-related

hazard. For more details refer to the ARCHITECT System Operations
Manual, Section 8 Biological Hazards.

Removal

Prepare for Reagent Probe Tubing Removal

Steps

1. Locate the reagent pipettor.

See ARCHITECT c4000 processing center components for pipettor locations.

- Access the R1 pipettor from the back of the system.

- Access the R2 pipettor from the front or back of the system.

2. Initiate pipettors diagnostic procedure 1161 Probe Move to move the reagent
pipettor to an accessible position.

205946-101 205946-101 Page 49 of 116

Component Replacement
Removal (cont’d)

Remove the Reagent Probe Tubing

Steps Graphic/Reference

1. Remove the reagent pipettor

cover by gently squeezing the
squeeze points [1], to release
the locking tabs, and lifting the
cover [2].

2. Place an absorbent towel under

the probe tip.

3. Gently disconnect the tubing [3]

from the top of the probe [4].

4. Gently disconnect the metal

connector [5] from the reagent
pipettor tubing [6]. Ensure the
protective sleeve remains on the
reagent pipettor tubing.

Page 50 of 116 ARCHITECT c4000 System Quick Reference Guide 205946-101

 Component Replacement

Replacement

Install the Reagent Probe Tubing

Steps Graphic/Reference

1. Attach the end of the new tubing

and metal connector [1] to the
reagent pipettor tubing [2]. The
tubing should be positioned as
shown, with the metal connector
on the left side and routed over
the top of the loop.

2. Verify the metal connector [3] is

inserted in the reagent pipettor
tubing [4] and not just in the
protective sleeve.

3. Attach the other end of the

tubing [5] to the reagent probe
[6].
NOTE: Do not flare or stretch the
new tubing. The tubing should fit
firmly in the reagent probe.

4. Complete pipettors diagnostic

procedure 1161 Probe Move,
page 10-661, to return the
reagent pipettor to the home
position.

5. Remove the absorbent towel.

205946-101 205946-101 Page 51 of 116

Component Replacement

Replacement (cont’d)

Prepare for Operation

Steps Graphic/Reference

1. Perform as-needed
maintenance procedure 2132 -
Flush Water Lines.

2. Visually inspect the probe for

drips and inspect the sample
probe tubing and connections
for leaks.

If you observe drips or leaks,

repeat the installation
procedure.

3. Gently replace the pipettor

cover [1]. Ensure the tubing is
not pinched or kinked below the
pipettor cover.

4. Stabilize the pipettor to prevent

it from dropping and causing
damage to the probe. Press
down on the end of the cover
over the pipettor shaft [2] until it
snaps into place. The pipettor
cover must be completely
seated to ensure correct liquid
level sense operation.

Reference

For information on preparing for operation, refer to the ARCHITECT System

Operations Manual, Section 9, As-needed Maintenance and Section 10.

Verification

Run quality control

Steps

1. Run quality control to verify performance prior to reporting patient results.

Page 52 of 116 ARCHITECT c4000 System Quick Reference Guide 205946-101

 Component Replacement

Replace the Lamp or Lamp Plate

Prerequisite Power off the processing module.

Estimated time required 15 minutes

Time does not include lamp warm up (30 minutes).

Tools/materials required • Phillips screwdriver

• Gloves

Replacement parts LN 09D45-02 - Lamp

WARNING Hot Surface. This is an activity or area where you may be

exposed to hot surfaces. For more details refer to the ARCHITECT
System Operations Manual, Section 8 Hot objects.

WARNING Electrical Shock Hazard. Never remove the lamp or lamp

plate with the processing module powered on. For more details refer to the
ARCHITECT System Operations Manual, Section 9 Electrical Hazards.

Removal

Prepare for Removal

Steps

Power off the processing module by using the main circuit breaker located at the rear of
the module.

For information, refer to the ARCHITECT System Operations Manual, Section 5.

205946-101 205946-101 Page 53 of 116

Component Replacement
Removal (cont’d)

Remove the Covers

Steps Graphic/Reference

WARNING: Wait at least five

minutes after turning the power off
to allow the lamp and the lamp
housing to cool.
NOTE: The lamp can be
accessed from the back of the
processing module.

1. Open the rear processing

module cover. Locate the lamp
housing cover [1] positioned in
the center of the reaction
carousel.

2. Remove the Phillips screw [2]

securing the cover in place and
remove the cover.

Page 54 of 116 ARCHITECT c4000 System Quick Reference Guide 205946-101

 Component Replacement
Removal (cont’d)

Remove the Terminal Cable Connections

Steps Graphic/Reference

1. Locate the terminal block [1].

2. Remove the transparent cover

[2] from the terminal block by
grasping both ends and lifting
up.

3. Using the Phillips screwdriver,

completely loosen the two
captive screws [3] securing the
two lamp cables [4] on the
terminal block.

4. Raise the screws [5] and lower

the lamp cables [4] completely
to allow you to disengage the
cables from the bottom of the
screws.

205946-101 205946-101 Page 55 of 116

Component Replacement

Remove the Lamp

Steps Graphic/Reference

WARNING: Wait at least five

minutes after turning the power off
to allow the lamp and the lamp
housing to cool. The lamp, lamp
housing, and heat absorbing filter
may be hot.

1. Completely loosen the lamp

plate [1] thumbscrew [2] located
towards the rear of the
processing module.

2. Lift the lamp plate and loosen

the other thumbscrew [3] to
remove the lamp from the plate.

3. Remove the lamp and cable

from the lamp housing.

Page 56 of 116 ARCHITECT c4000 System Quick Reference Guide 205946-101

 Component Replacement
Replacement

Install the Lamp Plate and Lamp

Steps Graphic/Reference

IMPORTANT: Wear gloves when

you perform the following steps.
Residual oil on the glass surface of
the lamp shortens the lamp life. The
glass surface may be cleaned with
ethanol, if necessary.

1. Insert the replacement lamp [1]

fitting the pins [2] into the pin
holes [3] on the lamp plate [4].

2. Verify the filament [5] is

perpendicular to the lamp plate
[4].

3. Tighten the thumbscrew [6] on

the lamp plate while the lamp is
fully inserted into the pin holes.

4. Insert the lamp assembly into

the housing [7], pressing it
against the leaf spring [8], and
down into the housing. Ensure
the lamp assembly is properly
seated into the housing.

5. Verify the lamp cables [9] are

through the slot behind the lamp
and are not pinched by the lamp
plate.

6. Tighten the thumbscrew [10] to

secure the lamp in place.

205946-101 205946-101 Page 57 of 116

Component Replacement

Replacement (cont’d)

Install the Terminal Cables

Steps Graphic/Reference

1. Raise the screws [1] and insert

the cables [2] under the screws.

2. Use the Phillips screwdriver to

tighten the two captive screws
[3] securing the two lamp cables
[4] on the terminal block.

3. Route the cable through the two

plastic cable clamps [5] to
ensure the cable does not
interfere with the rotation of the
reaction carousel.

4. Replace the transparent cover

[6] on the terminal block.

5. Power on the processing

module. The system control
center power MUST be on prior
to turning on the processing
module to ensure proper
initialization.

6. Check for stray light around

lamp housing cover.

Install the Processing Module Cover

Steps

1. Replace the lamp houseing cover.

2. Close the rear processing module cover.

Page 58 of 116 ARCHITECT c4000 System Quick Reference Guide 205946-101

 Component Replacement
Replacement (cont’d)

Prepare for Operation

Steps

1. Start up the processing module and/or sample handler to change the status of the
processing module and sample handler from Stopped to Ready.
The lamp must warm up 30 minutes prior to running assays.

2. Perform quarterly maintenance procedure 1003 - Change Lamp to document the

lamp change in the Maintenance log.

Reference

For information on preparing for operation, refer to the ARCHITECT System

Operations Manual, Section 5 and Section 9, Quarterly Maintenance.

Verification

Run quality control

Steps

1. Run quality control to verify performance prior to reporting patient results.

205946-101 205946-101 Page 59 of 116

Component Replacement

NOTES

Page 60 of 116 ARCHITECT c4000 System Quick Reference Guide 205946-101

 Component Replacement

Replace the Mixer

Prerequisite The processing module must be in the Ready status.

Estimated time required 5 minutes

Tools/materials required NA

Replacement parts • LN 09D59-02 - Mixer

WARNING Potential Biohazard. This is an activity or area where you may

be exposed to potentially infectious material. For more details refer to the
ARCHITECT System Operations Manual, Section 8 Biological
Hazards.

CAUTION Chemical Hazard. This activity presents a chemical-related

hazard. For more details refer to the ARCHITECT System Operations
Manual, Section 8 Biological Hazards.

Removal

Remove the Mixer

Steps Graphic/Reference

1. Open the rear processing

module cover.

2. Locate the appropriate mixer.

3. Unplug the cable [1] by pinching

the white connector [2].

4. Loosen the black thumbscrew

[3] on the top of the mixer
assembly.

5. Remove the mixer [4].

205946-101 205946-101 Page 61 of 116

Component Replacement
Replacement

Remove the Mixer

Steps Graphic/Reference

1. Orient the new mixer assembly

[1] so that the flat side faces
away from the mixer arm.

2. Align the positioning pins [2] on

the top of the mixer with the
holes on the mixer arm. Tighten
the black thumbscrew [3] until
the top of the mixer is flush with
the mixer arm.

3. Open the cable clip [4] from the

bottom and route the cable
through the clip.

4. Attach the cable connector to

the white connector [5] below
the mixer arm.
This connector is keyed and only
goes in one way.

Page 62 of 116 ARCHITECT c4000 System Quick Reference Guide 205946-101

 Component Replacement

Verification

Perform Diagnostic Procedure and Run Quality Control

Steps

1. Perform reaction mechanisms diagnostic procedure 3126 Mixer Vibration Test.

2. Run quality control to verify performance prior to reporting patient results.

205946-101 205946-101 Page 63 of 116

Component Replacement

NOTES

Page 64 of 116 ARCHITECT c4000 System Quick Reference Guide 205946-101

 Component Replacement

Replace the ICT Module or Probe

Prerequisite The processing module must be in the Ready status.

Estimated time required 15 minutes

Tools/materials required NA

Replacement parts • LN 09D63-03 - ICT probe

• LN 09D28-03 - ICT module
• LN 09F93-02 - ICT o-ring (optional)

WARNING Potential Biohazard. This is an activity or area where you may

be exposed to potentially infectious material. For more details refer to the
ARCHITECT System Operations Manual, Section 8 Biological
Hazards.

WARNING Probe Stick Hazard. Probe Sharps Hazard. This is an activity

or area where you may be exposed to probes. For more details refer to the
ARCHITECT System Operations Manual, Section 8 Probes and
sharps.

Removal

Remove the Covers

Steps Graphic/Reference

1. Lift the rear cover on the

processing module to access
the ICT module and probe.

2. Locate the ICT unit.

3. Loosen the two captive

thumbscrews [1] that secure the
black plate [2] in place.

4. Remove the black plate [2].

205946-101 205946-101 Page 65 of 116

Component Replacement
Removal (cont’d)
Remove the ICT Module and Probe

Steps Graphic/Reference

1. Loosen the thumbscrew [1] on the side of

the ICT holder [2] until the ICT module [3]
can be lifted up.

2. Disconnect the black electrical connector

[4] from the side of the module by pulling
it straight out.
3. Verify the connector is completely free
from the module.

4. Lift the ICT module [3] until the

connectors on the side of the ICT module
clear the ICT holder [2].

IMPORTANT: To avoid excessive

bending of the tube or probe, do not lift
the ICT module and probe all the way out
of the ICT holder.
5. Gently unscrew the ICT module [3],
rotating it clockwise, to free it from the top
connector [5].

6. Lift the ICT module and probe straight up

out of the ICT holder.
7. Unscrew the ICT probe holder [6] from
the ICT module.
8. Inspect the ports of the ICT module. The
black o-rings [7] MUST be present.

IMPORTANT: Running the system

without the black o-rings could affect
patient results.
9. Discard the ICT module if replacing;
otherwise, set it aside for use with the
new ICT probe.

10. Remove the ICT probe [8] from the probe

holder.
11. Discard the probe if replacing; otherwise
set it aside for use with the new ICT
module.

Page 66 of 116 ARCHITECT c4000 System Quick Reference Guide 205946-101

 Component Replacement
Replacement
Install the ICT Module and Probe

Steps Graphic/Reference

1. Remove the ICT module from the box, if

replacing the ICT module.
2. Record the expiration date found on the
ICT module box prior to discarding the
box.

It is recommended that you record and

track this date to ensure you do not use
the module on the c4000 System beyond
this date.

Once you install the ICT module on the

processing module, it is warranted for
15,000 samples or two months,
whichever occurs first.
3. Disconnect and discard the plastic tubing
attached to both ends of the ICT module.
4. Inspect the ports on the ICT module. The
black o-rings [1] MUST be present.

IMPORTANT: Running the system

without the black o-rings could affect
patient results.
5. Align the ICT module so that the gap [2]
between the side connectors is on top
and the label [3] is right-side up.
6. Place the ICT probe [4] into the probe
holder [5].
7. Attach the probe holder and probe to the
bottom of the ICT module (finger-tighten
only).

IMPORTANT: The o-rings may twist and

obstruct the flow through the ICT module
if this connection is overtightened.

205946-101 205946-101 Page 67 of 116

Component Replacement
Replacement (cont’d)
Install the ICT Module and Probe (cont’d)

Steps Graphic/Reference

8. Insert the ICT module [1] with the

probe [2] into the ICT holder [3]
until the connectors on the side of
the ICT module are just above the
top of the ICT holder [3].
9. Rotate the ICT module [1]
counterclockwise (finger tighten
only) to reattach the ICT module to
the top port [4] and to the
connector [5].
10. Allow the ICT module [1] to seat
fully down into the ICT holder [3]
so that the connectors are aligned
with the slot [6] in the ICT holder
[3].
11. Gently reconnect the black
electrical connector [7] to the ICT
module connectors. Ensure the
ICT module is completely plugged
into the connector.
12. Hold down the ICT module while
tightening the side thumbscrew [8]
until secure. Do not overtighten.
The ICT module could be
damaged.

Page 68 of 116 ARCHITECT c4000 System Quick Reference Guide 205946-101

 Component Replacement
Replacement (cont’d)

Prepare for Operation

Steps Graphic/Reference

1. Perform as-needed
maintenance procedure 6063
Flush ICT Module.

2. Inspect the tubing from the ICT

module for bubbles.

3. Inspect the ICT probe to ensure

it does not drip. If you observe
bubbles or drips, see Processing
module observed problems (c
System) in the ARCHITECT
System Operations Manual.

4. Reattach the black plate [1] by

securing it with the two
thumbscrews [2] on the top.

205946-101 205946-101 Page 69 of 116

Component Replacement

Verification

Calibrate ICT Assays and Run Quality Control

Steps

1. Calibrate ICT assays.

2. Run quality control samples to verify calibration.

Reference

For information on as-needed maintenance procedure 6063 Flush ICT Module, refer to
the ARCHITECT System Operations Manual, Section 9, As-needed Maintenance.

1. For information on observing bubbles and drips, refer to the ARCHITECT System
Operations Manual, Section 10, Processing module observed problems (c
System).

Page 70 of 116 ARCHITECT c4000 System Quick Reference Guide 205946-101

 Component Replacement
ARCHITECT c4000 System Supply and Pump Center Components

The following illustration shows the locations of the supply and pump center
components. Use this illustration when performing component replacement
procedures.

1 ICT reference pump 5 ICT aspiration pump

2 Wash solution pump 6 Cuvette wash pump

3 Bulk solutions 7 Probe wash pump

4 Sample, reagent 1 and

reagent 2 syringe drives

Component replacement procedures consists of the following:

• Removal
• Replacement
• Verification
205946-101 205946-101 Page 71 of 116
Component Replacement

NOTES

Page 72 of 116 ARCHITECT c4000 System Quick Reference Guide 205946-101

 Component Replacement
Replace the 1 mL Syringes

Replacing the 1 mL syringes on the ICT reference pump, ICT

aspiration pump, and wash solution pump consists of the following
procedures.
The same procedure is used to replace the 1 mL syringes in all three pumps.

Prerequisite The processing module must be in the Ready status.

Estimated time required 20 minutes

Tools/materials required Absorbent towel

Replacement parts • LN 09D41-02 - 1 mL syringe

The same 1 mL syringe is used for the ICT reference
pump, the ICT aspiration pump, and the wash
solution pump.

WARNING Potential Biohazard. This is an activity or area where you may

be exposed to potentially infectious material. For more details refer to the
ARCHITECT System Operations Manual, Section 8 Biological
Hazards.

CAUTION Chemical Hazard. This activity presents a chemical-related

hazard. For more details refer to the ARCHITECT System Operations
Manual, Section 8 Biological Hazards.

205946-101 205946-101 Page 73 of 116

Component Replacement
Removal

Locate the 1 mL Syringe to be Replaced

Steps

1. Open the supply center door.

Open the pump center door.

2. Locate the 1 mL syringe to be

replaced:
• ICT reference pump [1]
• Wash solution pump [2]
• ICT aspiration pump [3]

Page 74 of 116 ARCHITECT c4000 System Quick Reference Guide 205946-101

 Component Replacement
Removal (cont’d)

Remove the Plunger Shield and the 1 mL Syringe

Steps Graphic/Reference

1. Remove the clear plunger shield

[1] by removing the two black
knobs [2].

2. Pull the 1 mL syringe [3] forward

to remove it from the syringe
holder.

Detach and Replace the 1 mL Syringe

Steps Graphic/Reference

1. Place an absorbent towel under

the pump area to absorb any
liquid.

2. Unscrew the syringe assembly

[1] from the check valve [2].

3. Screw the new syringe

assembly [1] onto the check
valve [2].
Be sure to replace the syringe
and plunger (components of the
syringe assembly) as a pair.

205946-101 205946-101 Page 75 of 116

Component Replacement
Replacement

Reinstall the 1 mL Syringe and Plunger Shield

Steps Graphic/Reference

1. Reinstall the syringe [1].

2. Verify the plunger flange [2] is

below the U-shaped holder and
the bottom of the syringe barrel
is in the groove at the bottom of
the syringe holder [3].

3. Reinstall the clear plunger shield

[4] and secure it with the black
knobs [5].

4. Remove the absorbent towel

from the pump area.

Page 76 of 116 ARCHITECT c4000 System Quick Reference Guide 205946-101

 Component Replacement
Replacement (cont’d)

Prepare for Operation

Steps

1. Perform the following as-needed maintenance procedures to remove any air that
may be present:
• 6063 Flush ICT Module for the ICT reference and ICT aspiration pumps

• 2155 Flush Bulk Solutions for the wash solution pump

2. Visually check for leaks while performing the flush. If you observe drips or leaks,
repeat the installation procedure.

Verification

Run Quality Control

Steps

1. Run quality control to verify performance prior to reporting patient results.

205946-101 205946-101 Page 77 of 116

Component Replacement

NOTES

Page 78 of 116 ARCHITECT c4000 System Quick Reference Guide 205946-101

 Component Replacement
Replace Check Valves

Replacing the check valves on the ICT reference pump, ICT aspiration
pump, or wash solution pump consists of the following procedures.

Prerequisite The processing module must be in the Ready status.

Estimated time required 15 minutes

Tools/materials required Absorbent towel

Replacement parts • LN 09D35-02 - ICT Reference or ICT Aspiration

Check Valve
• LN 09D34-02 - Wash Solution Check Valve
The ICT reference and aspiration pumps use the
same list number. The wash solution pump uses a
different list number. Ensure the correct part is used.

WARNING Potential Biohazard. This is an activity or area where you may

be exposed to potentially infectious material. For more details refer to the
ARCHITECT System Operations Manual, Section 8 Biological
Hazards.

CAUTION Chemical Hazard. This activity presents a chemical-related

hazard. For more details refer to the ARCHITECT System Operations
Manual, Section 8 Biological Hazards.

205946-101 205946-101 Page 79 of 116

Component Replacement
Removal

Locate the Check Valve to be Replaced

Steps

1. Open the supply center and

pump center doors.

2. Locate the check valve to be

replaced:
• ICT reference pump [1]
• Wash solution pump [2]
• ICT aspiration pump [3]

Page 80 of 116 ARCHITECT c4000 System Quick Reference Guide 205946-101

 Component Replacement
Removal (cont’d)

Remove the Plunger Shield and the 1 mL Syringe

Steps Graphic/Reference

1. Remove the clear plunger shield

[1] by removing the two black
knobs [2].

2. Pull the 1 mL syringe [3] forward

to remove it from the syringe
holder.

205946-101 205946-101 Page 81 of 116

Component Replacement
Removal (cont’d)

Remove the Check Valve Tubing

Steps Graphic/Reference

1. Place absorbent towels under

the pump area to absorb any
liquid.

2. Disconnect the top [1] and side

[2] tubing from the check valve
[3].

Page 82 of 116 ARCHITECT c4000 System Quick Reference Guide 205946-101

 Component Replacement
Replacement

Replace the Check Valve

Steps Graphic/Reference

1. Unscrew the syringe body [1]

from the check valve [2].

2. Install the new check valve onto

the syringe, and finger-tighten.

Reinstall the Check Valve Tubing

Steps Graphic/Reference

Reattach the top [1] and side [2]

tubing to the check valve [3].

205946-101 205946-101 Page 83 of 116

Component Replacement
Replacement (cont’d)

Reinstall the 1mL syringe and plunger shield

Steps Graphic/Reference

1. Reinstall the 1 mL syringe [1].

2. Verify the syringe plunger flange

[2] is below the U-shaped holder
and the bottom of the syringe
barrel is in the groove at the
bottom of the syringe holder[3].

3. Reinstall the clear plunger shield

[4] and tighten the black knobs
[5] finger-tight.

4. Remove the absorbent towel

from the pump area.

Page 84 of 116 ARCHITECT c4000 System Quick Reference Guide 205946-101

 Component Replacement
Replacement (cont’d)

Prepare for Operation

Steps

1. Perform the following as-needed maintenance procedures to remove any air that
may be present:
• 6063 Flush ICT Module for the ICT reference and ICT aspiration pumps
• 2155 Flush Bulk Solutions for the wash solution pump

2. Visually check for leaks while performing the flush.

If you observe drips or leaks, repeat the installation procedure.

3. Perform quarterly maintenance procedure 6305 Change ICT Asp Check Valve to
document the ICT aspiration check valve replacement in the Maintenance log.

Reference

For information on preparing for operation, refer to the ARCHITECT System

Operations Manual, Section 9, As-needed and Quarterly Maintenance.

Verification

Run quality control

Steps

1. Run quality control to verify performance prior to reporting patient results.

205946-101 205946-101 Page 85 of 116

Component Replacement

NOTES

Page 86 of 116 ARCHITECT c4000 System Quick Reference Guide 205946-101

 Component Replacement
Replace Wash Solution Syringe O-Ring and Seal Tips 1 & 2

Prerequisite The processing module must be in the Ready status.

Estimated time required 15 minutes

Tools/materials required • Phillips screwdriver

• Slotted screwdriver
• 10 mm wrench
• Cotton swabs
• Absorbent towel

Replacement parts • LN 09D52-02 - Sample/wash solution syringe

o-ring
• LN 09D37-02 - Sample/wash solution syringe seal
tip #1
• LN 09D38-02 - Sample/wash solution syringe seal
tip #2

WARNING Potential Biohazard. This is an activity or area where you may

be exposed to potentially infectious material. For more details refer to the
ARCHITECT System Operations Manual, Section 8 Biological
Hazards.

CAUTION Chemical Hazard. This activity presents a chemical-related

hazard. For more details refer to the ARCHITECT System Operations
Manual, Section 8 Biological Hazards.

205946-101 205946-101 Page 87 of 116

Component Replacement
Removal

Remove the Clear Outer Plunger Shield

Steps Graphic/Reference

1. Open the supply center door.

2. Locate the wash solution pump.

3. Loosen and remove the black

knobs [1] securing the clear
outer plunger shield [2].

4. Remove the shield.

Page 88 of 116 ARCHITECT c4000 System Quick Reference Guide 205946-101

 Component Replacement
Removal (cont’d)

Disconnect the Wash Solution Syringe Block Tubing

Steps Graphic/Reference

1. Place an absorbent towel under

the pump area to absorb any
liquid.

2. Slide the 1 mL syringes [1] out of

their drive block; do not
disconnect them.

3. Unscrew the left-top grey

knurled connection [2] from the
top of the syringe block.
The tubing labeled 2, coming from
the instrument, connects to the
left-top connection [2]. The tubing
labeled 3, coming from the
instrument, connects to the right-
top connection [3]. Do not
interchange the tubing.

4. Unscrew the right-top grey

knurled connection [3].

5. Unscrew the grey knurled

connections [4] from the front of
the syringe block [5].
The tubing coming from the 1 mL
syringe on the left connects to the
left-front connection. The tubing
coming from the 1 mL syringe on
the right connects to the right-
front connection. Do not
interchange the tubing.

6. Ensure the black seals remain in

the syringe block when the grey
knurled connections are
disconnected.

205946-101 205946-101 Page 89 of 116

Component Replacement
Removal (cont’d)

Remove the Clear Inner Plunger Shield and Syringe Block

Steps Graphic/Reference

1. Remove the clear inner plunger

shield [1] by removing the two
Phillips screws [2] securing the
shield.

2. Use the slotted screwdriver to

loosen the slotted screw [3]
securing the clear syringe block
[4] in place. The screw is captive
and cannot be completely
removed.

3. Pull the syringe block forward to

allow the plungers to clear the
syringe drive.

4. Lift the syringe block up to

remove it from the module.

5. Identify the syringe needing the

new o-ring and seal tips.

Page 90 of 116 ARCHITECT c4000 System Quick Reference Guide 205946-101

 Component Replacement
Removal (cont’d)

Remove the Syringe Plunger

Steps Graphic/Reference

1. Use the 10 mm wrench to

loosen the nut [1] securing the
syringe plunger [2] on the
bottom of the syringe block [3].

2. Turn the nut by hand, once

loosened, until the syringe
plunger can be removed from
the syringe block.

205946-101 205946-101 Page 91 of 116

Component Replacement
Removal (cont’d)

Remove the O-Ring and Seal Tips 1 and 2

Steps Graphic/Reference

The plunger assembly includes the

following parts:
• O-ring[1]

IMPORTANT: The o-ring may

have remained in the syringe
block when removing the
plunger assembly.
• Seal tip 2 [2]
• Spacer [3]
• Seal tip 1 [4]
• Spring [5]
• Nut [6]
• Plunger [7]
• Plunger flange [8]

1. Remove the following. Set aside

or discard (except for spacer) if
being replaced:
• O-ring [1]
• Seal tip 2 [2]
• Spacer [3] - set aside, do not
discard
• Seal tip 1 [4]
Do not remove the spring.

2. Dry the interior of the syringe

barrel with a cotton swab and
dry the plunger completely with
an absorbent towel if liquid is
present.

Page 92 of 116 ARCHITECT c4000 System Quick Reference Guide 205946-101

 Component Replacement
Replacement

Install the O-Ring and Seal Tips 1 and 2

Steps Graphic/Reference

1. Install seal tip 1 [1] onto the

plunger so that it sits above the
spring, with the open side away
from the spring.

2. Install the spacer [2] so that it fits

into the open side of seal tip 1.

3. Install the seal tip 2 [3] on top of

the spacer with the open side
toward the spacer.

4. Install the o-ring [4] so that it fits

into the groove of the seal tip 2.
Do not push the o-ring out of
alignment. The o-ring must sit
flat against the inside of the
syringe block.

5. Press lightly to push all the

components together.

Install the Syringe Plunger

Steps Graphic/Reference

1. Install the plunger assembly into

the syringe block [1].

2. Tighten the nut [2] holding the

plunger assembly into the
syringe block until finger-tight.
The nut must be flush with the
plunger assembly. If the nut binds
when tightening, do not apply
excessive force. Back the nut out
a turn, and then, while pushing in
to apply pressure against the
spring, continue to tighten the nut.

3. Use the 10 mm wrench to further

tighten the nut [2] securing the
plunger [3]. Do not overtighten.

205946-101 205946-101 Page 93 of 116

Component Replacement
Replacement (cont’d)

Install the Syringe Block and Attach the Clear Inner Plunger Shield
Steps Graphic/Reference

1. Ensure a black seal remains in

each of the tubing ports in the
syringe block.

2. Hold the syringe block [1] so that

the slotted screw [2] faces you.

3. Align the syringe block to the

pins [3] on the syringe holder,
verifying that both plunger
flanges [4] are below the U-
shaped holders.

4. Hold the syringe block against

the alignment pins and tighten
the screw by hand until finger-
tight. Secure with a slotted
screwdriver.

5. Attach the clear inner plunger

shield [5] and tighten the Phillips
screws [6].

Page 94 of 116 ARCHITECT c4000 System Quick Reference Guide 205946-101

 Component Replacement
Replacement (cont’d)

Connect the Wash Solution Syringe Block Tubing

Steps Graphic/Reference

1. Connect the grey knurled

connection labeled 2 from the 1
mL syringe to the left-front port
[1].

2. Connect the grey knurled

connection labeled 2 coming
from the instrument to the left-
top port [2].

3. Connect the grey knurled

connection labeled 3 from the
syringe to the right-front port [3].

4. Connect the grey knurled

connection labeled 3 from the
instrument to the right-top port
[4].

5. Verify the 1 mL syringe tubing

connections did not loosen
during the removal and
replacement procedure.

6. Reinstall the 1 mL syringes [5]

into the syringe holder.

7. Ensure the plunger flange is

below the U-shaped holder and
that the bottom of the syringe
barrel is in the groove at the
bottom of the syringe holder.

205946-101 205946-101 Page 95 of 116

Component Replacement
Replacement (cont’d)

Install the Clear Outer Plunger Shield

Steps Graphic/Reference

1. Attach the clear outer plunger

shield [1] and tighten the black
knobs [2] until finger-tight.

2. Remove the absorbent towel

from the pump area.

Page 96 of 116 ARCHITECT c4000 System Quick Reference Guide 205946-101

 Component Replacement
Replacement (cont’d)

Prepare for Operation

Steps

1. Perform as-needed maintenance procedure 2132 Flush Water Lines to remove any
air that may be present.

2. Visually check for leaks while performing the flush.

If you observe drips or leaks, repeat the installation procedure.

3. Perform quarterly maintenance procedure 6302 Wash Syringe Maintenance to

document wash solution o-ring and seal tips 1 and 2 replacement in the Maintenance
log.

Reference

For information on preparing for operation, refer to the ARCHITECT System

Operations Manual, Section 9, As-needed and Quarterly Maintenance.

Verification

Run quality control

Steps

1. Run quality control to verify performance prior to reporting patient results.

205946-101 205946-101 Page 97 of 116

Component Replacement

NOTES

Page 98 of 116 ARCHITECT c4000 System Quick Reference Guide 205946-101

 Component Replacement
Replace Sample or Reagent Syringe O-Ring and Seal Tips 1 & 2

Prerequisite The processing module must be in the Ready status.

Estimated time required 15 minutes

Tools/materials required • Phillips screwdriver

• Slotted screwdriver
• 10 mm wrench
• Cotton swabs
• Absorbent towel

Replacement parts • LN 09D52-02 - Sample/wash solution syringe

o-ring
• LN 09D37-02 - Sample/wash solution syringe seal
tip #1
• LN 09D38-02 - Sample/wash solution syringe seal
tip #2
• LN 09D53-02 - Reagent syringe o-ring
• LN 09D39-02 - Reagent syringe seal tip #1
• LN 09D40-02 - Reagent syringe seal tip #2
The o-rings and seal tips 1 and 2 for the sample and
reagent syringes are different sizes. Be sure to install
the correct part in the appropriate syringe.

WARNING Potential Biohazard. This is an activity or area where you may

be exposed to potentially infectious material. For more details refer to the
ARCHITECT System Operations Manual, Section 8 Biological
Hazards.

CAUTION Chemical Hazard. This activity presents a chemical-related

hazard. For more details refer to the ARCHITECT System Operations
Manual, Section 8 Biological Hazards.

205946-101 205946-101 Page 99 of 116

Component Replacement
Removal

Locate the Syringe and Remove the Plunger Shield

Steps Graphic/Reference

1. Open the supply center door.

2. Locate the appropriate syringe:

• Sample syringe [1]

• R1 syringe [2]
• R2 syringe [3]

3. Remove the two Phillips screws

[4] securing the shield.

4. Remove the shield. [5]

Remove the Syringe Bracket

Steps Graphic/Reference

Remove the syringe bracket

holding the syringe plunger to the
drive block by removing the two
Phillips screws [1] on the syringe
bracket [2].
NOTE: Notice that these screws
are shorter than the screws from
the clear plunger shield. Do not
interchange the two sets of
screws.

Page 100 of 116 ARCHITECT c4000 System Quick Reference Guide 205946-101
 Component Replacement
Removal (cont’d)

Remove the Syringe Block

Steps Graphic/Reference

1. 1. Use the slotted screwdriver to

loosen the slotted screw [1]
securing the syringe block [2] in
place. The screw is captive and
cannot be completely removed.

2. Place an absorbent towel under

the syringe drive to absorb any
liquid.

3. Disconnect the tubing at the top

[3] and side [4] of the syringe
block by unscrewing the knurled
connections.

4. Ensure the black seal remains in

the syringe block once the
tubing is disconnected.

Remove the Syringe Plunger

Steps Graphic/Reference

1. Use the 10 mm wrench to

loosen the nut [1] securing the
syringe plunger [2] on the
bottom of the syringe block [3].

2. Turn the nut by hand, once

loosened, until the syringe
plunger can be removed from
the syringe block.

205946-101 205946-101 Page 101 of 116

Component Replacement
Removal (cont’d)

Remove the O-Ring and Seal Tips 1 and 2

Steps Graphic/Reference

The plunger assembly includes the

following parts:
• O-ring [1]
The o-ring may have remained in
the syringe block when removing
the plunger assembly.
• Seal tip 2 [2]
• Spacer [3]
• Seal tip 1 [4]
• Spring [5]
• Nut [6]
• Plunger [7]
• Plunger flange [8]

1. Remove the following. Set

aside or discard (except for
spacer) if being replaced:
• O-ring [1]
• Seal tip 2 [2]
• Spacer [3] - set aside, do not
discard
• Seal tip 1 [4]
Do not remove the spring.

2. Dry the interior of the syringe

barrel with a cotton swab and
dry the plunger completely with
an absorbent towel if liquid is
present.

Page 102 of 116 ARCHITECT c4000 System Quick Reference Guide 205946-101
 Component Replacement
Replacement

Install the O-Ring and Seal Tips 1 and 2

Steps Graphic/Reference

1. Install seal tip 1 [1] onto the

plunger so that it sits above the
spring, with the open side away
from the spring.

2. Install the spacer [2] so that it fits

into the open side of seal tip 1.

3. Install seal tip 2 [3] on top of the

spacer, with the open side
toward the spacer.

4. Install the o-ring [4] so that it fits

into the groove of seal tip 2. Do
not push the o-ring out of
alignment. The o-ring must sit
flat against the inside of the
syringe block.

5. Press lightly to push all the

components together.

205946-101 205946-101 Page 103 of 116

Component Replacement

Install the Syringe Plunger

Steps Graphic/Reference

1. Install the plunger assembly into

the syringe block [1].

2. Tighten the nut [2] holding

the plunger assembly into the
syringe block until finger-
tight.
The nut must be flush with the
plunger assembly. If the nut binds
when tightening, do not apply
excessive force. Back the nut out
a turn, and then, while pushing in
to apply pressure against the
spring, continue to tighten the nut.

3. Use the 10 mm wrench to further

tighten the nut [2] securing the
plunger [3].

Page 104 of 116 ARCHITECT c4000 System Quick Reference Guide 205946-101
 Component Replacement
Replacement (cont’d)

Install the Syringe Block

Steps Graphic/Reference

1. Hold the syringe block [1] so that

the slotted screw [2] faces you.

2. Ensure the black seals remain in

place in each port. Reconnect
the tubing coming from the
pipettor to the top [3] of the
syringe block and the tubing
from the syringe valve to the
side [4] by screwing the knurled
connections.

3. Align the syringe block to the

pins [5] on the syringe holder,
verifying that the plunger flange
is above the drive block [6].
Move any tubing out of the way.

4. Hold the syringe block against

the alignment pins and tighten
the screw [2] by hand until
finger-tight. Secure the screw
with a slotted screwdriver.

205946-101 205946-101 Page 105 of 116

Component Replacement

Install the Syringe Bracket and Plunger Shield

Steps Graphic/Reference

1. Attach the syringe bracket [1] to

connect the drive block and
syringe plunger.

2. Use the Phillips screwdriver to

install the screws [2].
Verify the shorter screws are
used in the bracket. Do not use
the longer screws for the plunger
shield.

3. Attach the clear plunger shield

[3] by tightening the two (2)
Phillips screws [4].

4. Remove the absorbent towel

from the syringe drive.

Page 106 of 116 ARCHITECT c4000 System Quick Reference Guide 205946-101
 Component Replacement
Replacement (cont’d)

Prepare for Operation

Steps

1. Perform as-needed maintenance procedure 2132 Flush Water Lines to remove any
air that may be present.

2. Visually check for leaks while performing the flush.

If drips or leaks are observed, repeat the installation procedure.

3. Perform quarterly maintenance procedure 6301 Sample Syringe Maintenance or

6303 Reagent Syringe Maintenance to document sample or reagent syringe o-ring
and seal tips replacement in the Maintenance log.
NOTE: Only perform this maintenance procedure if you replaced the o-ring and seal tips in
both the R1 and R2 syringes.

Reference

For information on preparing for operation, refer to the ARCHITECT System

Operations Manual, Section 9, As-needed and Quarterly Maintenance.

Verification

Run quality control

Steps

1. Run quality control to verify performance prior to reporting patient results.

205946-101 205946-101 Page 107 of 116

Component Replacement

NOTES

Page 108 of 116 ARCHITECT c4000 System Quick Reference Guide 205946-101
 Job Aids

Job Aids
ARCHITECT c4000 System - Solutions Used in Daily Operation

*Solution Preparation

Solution Preparation instructions Stability

0.5% Acid Wash Mix together: Same as the expiration of the

5 mL of Acid Wash Acid Wash bulk solution.
995 mL of Reagent Grade Type II water

10% Detergent B Mix together: 14 days.

50 mL of Detergent B
450 mL of Reagent Grade Type II water

ICT Cleaning Fluid Add 12 mL of ICT cleaning fluid to the 14 days at 2°C to 8°C after
ICT lyophilized cleaning solution bottle. preparation.
Mix gently by inversion.

Consult product labeling and Material Safety Data Sheets for safe handling
instructions.

CAUTION Chemical Hazard. This activity presents a chemical-related

hazard. For more details refer to the ARCHITECT System Operations
Manual, Section 8 Biological Hazards.

205946-101 205946-101 Page 109 of 116

Job Aids
ARCHITECT c4000 System - Solutions Used in Daily Operation (cont’d)

Bulk Solutions

Solution Purpose Onboard Stability Placement

ICT reference ICT analysis and Expiration date on Place bottle on the weight platform
solution daily maintenance bottle in the Supply center.

Alkaline Wash Wash cuvettes Expiration date on Place bottle on the weight platform
bottle in the Supply center.

Acid Wash Wash cuvettes Expiration date on Place bottle on the weight platform
bottle in the Supply center.

Sample Wash Solutions Area

Solution Purpose Onboard Stability Placement

0.5% Acid Wash sample 1 day Position 1 of the Sample Wash

Wash probe Solution Carrier
solution*

Detergent A Wash sample 1 day Position 2

probe

ICT Cleaning 6070 Daily NA Position 3 on the sample Wash

Fluid* Maintenance Solution Carrier (as directed in text
procedure of Daily Maintenance procedure).

* Refer to the Solutions Preparation table on page 109.

Page 110 of 116 ARCHITECT c4000 System Quick Reference Guide 205946-101
 Job Aids

ARCHITECT c4000 System - Solutions Used in Daily Operation (cont’d)

Reagent Supply Center Solutions

Solution Purpose Onboard Stability Placement

0.5% Acid Wash reagent 30 days Reagent Supply Center A3 (as

Wash probes configured on the Supply Status
solution* screen).

Detergent A Wash reagent Expiration date on Reagent Supply Center A1 (as

probes bottle configured on the Supply Status
screen).

10% Wash reagent 14 days Reagent Supply Center A2 (as

Detergent B* probes configured on the Supply Status
screen).

ICT sample ICT analysis 14 days Reagent Supply Center, any

diluent position.

Water Bath 6070 Daily Expiration date on Reagent Supply Center A4 (as
Additive Maintenance bottle directed in 6070 Daily
procedure Maintenance procedure).

Saline Sample dilution Expiration date on Reagent Supply Center, anu

bottle position (as configured on Reagent
Status screen).

* Refer to the Solutions Preparation table on page 109.

205946-101 205946-101 Page 111 of 116

Job Aids

NOTES

Page 112 of 116 ARCHITECT c4000 System Quick Reference Guide 205946-101
 Job Aids
ARCHITECT System Cycle Power Sequence

Step 1. Shutdown SCC Step 2. Power Off SCC Step 3. Power Off PM(s)

1. Ensure both Sample Handler and 1. Turn off power to SCC when screen 1. Turn off power to PM(s).
Processing Module(s) are either instructs you.
Ready, Stopped, or Offline. The power switch is a white lever or a
SCC Power button is located on front of black toggle switch. It is located above
2. Select F3-Shutdown from Snapshot the CPU. You may need to press the the power cord on the lower left rear of
screen. button for several seconds for the power the processing module(s).
to go off.
3. Select OK to confirm shutdown.

4. Press Ctrl+Alt+Delete keys when

message displays.

5. Select Shutdown the computer and

press OK when message displays.

Step 4. Power On SCC Step 5. Power On PM(s) Note

1. Turn power on to SCC. 1. Turn power on to PM(s). If PM(s) power is on when you power
on the SCC, communication will not be
2. Allow the system software to initialize. SH and PM(s) stay in Offline status properly established between the
approximately five minutes prior to system components, and the SH and
3. Wait for Snapshot screen to display. changing to Stopped. No user PM(s) status will remain Offline
intervention is needed at this time. indefinitely. If this occurs, power off the
No user intervention is needed during this
time. PM(s), wait 30 seconds, then power on
2. Select the Sampler Handler and
the PM(s).
Processing Module graphics.

3. Select F5-Start-up.

ARCHITECT c4000 System Quick Reference Guide 205946-101 Page 113 of 116
Job Aids
ARCHITECT System Processing Module and Sample Handler Status Sequence

* The Scheduled pause status applies to all processing modules, the RSH (retest sample handler) and the LAS (laboratory automation
system) carousel sample handler.

Page 114 of 116 ARCHITECT c4000 System Quick Reference Guide 205946-101
 Job Aids
ARCHITECT c System Processing Module Status and Associated Tasks

Scheduled
Offline Stopped Ready Running Initializing
Pause

Initiate a run No No Yes Yes* Yes No

Load reagents No No Yes Yes** No No

Load bulk solutions Yes Yes Yes No No No

Load onboard solutions Yes Yes Yes No No No

Empty waste Yes Yes Yes No No No

*In the Running status you do not need to initiate the run when samples are added.
**Check the reagent supply center access button to ensure access is permitted before this task (c4000).

ARCHITECT c4000 System Quick Reference Guide 205946-101 Page 115 of 116
Job Aids

NOTES

Page 116 of 116 ARCHITECT c4000 System Quick Reference Guide 205946-101