Automated Hematology Analyzer

XN-L series

XN-530/XN-430
/XN-330
General Information

This manual provides important safety information and specifications of the instrument.
Read this manual before using the instrument.

The following manuals are provided as Instructions for Use:

• General Information
• Basic Operation
• Troubleshooting

Code No. AC044589 en-eu

PRINTED IN JAPAN
Date of issue or revision: 03/2023
Software Version: Ver. 5 onwards

© SYSMEX CORPORATION
 Revision History

Revision History

06/2016
Initial issue
Software version: Ver. 5

02/2017
Software version: Ver. 5

05/2017
Software version: Ver. 5

01/2018
Software version: Ver. 5

08/2018
Software version: Ver. 5

06/2019
Software version: Ver. 5

04/2020
Software version: Ver. 5

03/2022
Software version: Ver. 5
Updated manuals: Basic Operation, General Information, Troubleshooting

03/2023
Software version: Ver. 5
Updated manuals: Basic Operation, General Information
Changes are listed below:

Revised section Page

Chapter 1 Introduction 7
2.10 Cybersecurity 21
2.12 Notice to the user 30
3.1 Analyzer 36

The following sections from the previous version were removed:

- 2.10 Computer viruses
- 2.11 Use of other software

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 Revision History

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Table of Contents

Revision History 3

Chapter 1 Introduction 7
1.1 Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
1.2 Overview of the system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
1.3 Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
1.4 About the manuals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
1.5 Symbols used in the manuals. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
1.6 Symbols related to the products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
1.7 Trademarks. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

Chapter 2 Safety Information 15

2.1 General information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
2.2 Installation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
2.3 Electromagnetic compatibility (EMC) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
2.4 Avoiding infection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
2.5 Handling of reagents and quality control materials. . . . . . . . . . . . . . . . . . . . . . 18
2.6 Laser. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
2.7 Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
2.8 Disposal of materials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
2.9 Operators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
2.10 Cybersecurity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
2.11 Markings on the instrument . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
2.12 Notice to the user . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

Chapter 3 Part Names and Functions 31

3.1 Analyzer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
3.2 Monitor (XN-530) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38

Chapter 4 Installation 39
4.1 Preparing for installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
4.2 Installation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40

Chapter 5 Instrument Specifications 43

5.1 Product specifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
5.2 Performance characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
5.3 System limitations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
5.4 Supported sample tubes and sampler adapter. . . . . . . . . . . . . . . . . . . . . . . . . 66
5.5 Barcode labels (XN-530) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
5.6 ID barcode specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70
5.7 Functional descriptions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72

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Chapter 6 Supplies, Accessories, and Options 81

6.1 Supplies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81
6.2 Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81
6.3 Options. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82

Chapter 7 Reagents 83
7.1 General information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83
7.2 List of specified reagents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83
7.3 CELLPACK DCL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84
7.4 CELLPACK DST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85
7.5 SULFOLYSER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86
7.6 Lysercell WDF . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87
7.7 Fluorocell WDF . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88
7.8 CELLCLEAN AUTO . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89
7.9 Control blood (XN-L CHECK). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90
7.10 Calibrator (XN CAL) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91

Chapter 8 Service Data and Research

Parameters 93
8.1 Checking service data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93
8.2 Checking research parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97

Index 99

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 Chapter 1 Introduction

Chapter 1 Introduction

Thank you for purchasing the Automated Hematology Analyzer XN-L series.
Please read this manual carefully before operating this product.
Keep this manual in a safe place for future reference.

Note:
• Data generated by the XN-L series is not intended to replace professional judgment in the determination
of a diagnosis or in monitoring patient therapy.
• Operate the instrument as instructed. Reliability of test results cannot be guaranteed if there are any
deviations from the instructions in this manual. If the instrument fails to function properly as a result of
either the user's operation not specified in the manual or the user's utilization of a program not specified
by Sysmex, the product warranty would not apply.

In vitro diagnostic medical device

Contact Addresses

1-5-1 Wakinohama-Kaigandori, Chuo-ku, Kobe 651-0073, Japan

Authorized Representative / Importer to EU

Europe, Middle East and Africa

Bornbarch 1, 22848 Norderstedt, Germany

Tel: +49 40 5 27 26-0 / Fax: +49 40 5 27 26-100

Authorized Representatives
Americas

577 Aptakisic Road, Lincolnshire, IL 60069, U.S.A.

Tel: +1-224-543-9500 / Fax: +1-224-543-9505
Asia-Pacific

9 Tampines Grande #06-18 Singapore 528735

Tel: +65-6221-3629 / Fax: +65-6221-3687

Ordering of Supplies and Replacement Parts

If you need to order supplies or replacement parts, please contact your local
Sysmex representative.

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Service and Maintenance

Please contact the Service Department of your local Sysmex representative.

The system described in this manual is marked with the CE mark, which
confirms compliance with the applicable requirements of:
• Directive 98/79/EC on in vitro diagnostic medical devices
• Directive 2011/65/EU on the restriction of the use of certain hazardous
substances in electrical and electronic equipment and its related amending
directives including (EU) 2015/863 amending Annex II of Directive 2011/65/EU
• Directive 2014/53/EU relating to the making available on the market of radio
equipment

The system described in this manual is compliant with applicable Technical

Regulations of the Eurasian Economic Union.

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1.1 Intended use

The XN-L series are automated hematology analyzers for in vitro diagnostic use in clinical laboratories. Only human
blood or control blood should be run. Any other use is regarded as non-specified.
Use only the reagents and cleaning fluids indicated in this manual.
If the instrument fails to function properly as a result of either the user's operation not specified in the manual or the
user's utilization of a program not specified by Sysmex, the product warranty does not apply.

1.2 Overview of the system

This instrument is a hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical
laboratories.
This instrument enables quantitative, identification, and existence ratio analysis of tangible components of blood (red
blood cells, white blood cells, platelets and other cells) by means of electrical impedance, laser light scattering and
fluorescent labeling.

XN-530

XN-430 XN-330

XN-530 XN-430 XN-330

Sampler analysis type Closed analysis type Open analysis type
WDF ✓
Channels RBC/PLT ✓
HGB ✓
[Whole Blood] ✓
Analysis mode
[Pre-Dilution] ✓

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1.3 Parameters
This instrument reports the following parameters.

● Diagnostic parameters
[Whole Blood] mode / [Pre-Dilution] mode
Detector/Channel Parameter
WDF WBC, NEUT#, LYMPH#, MONO#, EO#, BASO#, NEUT%, LYMPH%, MONO%, EO%, BASO%,
IG#, IG%
RBC/PLT RBC, HCT, MCV*1, MCH*1, MCHC*1, PLT, RDW-SD*2, RDW-CV*2, MicroR*3,4, MacroR*3,4,
PDW*2, MPV*1, P-LCR*2, PCT*2
HGB HGB

*1 Parameter calculated from an equation. For details, see the following.

(➤P.77 "Chapter 5: 5.7.3 Parameters and channels")
*2 Parameters calculated from an equation from the distribution. For details, see the following.
(➤P.77 "Chapter 5: 5.7.3 Parameters and channels")
*3 Parameters calculated from an equation from the distribution.
*4 Analysis is not possible in [Pre-Dilution] mode.

WBC (WBC-C, WBC-D)

WBC-C reflects the count of white blood cells by forward scattered light and side scattered light in the WDF
channel. WBC-D reflects the count of white blood cells by forward scattered, side scattered and fluorescent light in
the WDF channel. WBC-D is the default parameter for WBC in CBC+DIFF whereas WBC-C is the default
parameter for WBC in CBC only. Both parameters, WBC-C and WBC-D, are fully validated, diagnostic parameters.

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1.4 About the manuals

1.4.1 List of manuals

The following manuals are provided with this instrument.

Type Description
General Information This manual provides important safety information and
(this manual) specifications of the instrument.
Read this manual before using the instrument.
Basic Operation Read this manual to operate the instrument.
Instructions for The explanations in this manual assume that you have
Use already read "General Information".
Troubleshooting Read this manual when you encounter a problem, and to
perform instrument maintenance.
The explanations in this manual assume that you have
already read "General Information".

1.4.2 Points to note about the manuals

• You may not reprint the contents of the manuals in whole or in part without permission.
• The names of patients, doctors, etc., mentioned in the manuals do not represent actual people in any way.
• Images in these instructions for use related to the product are for illustration purposes only and may not
exactly match with what is found on the product itself.
• While we have taken all possible precautions to ensure quality in the content of this manual, please contact
the Service Department of your local Sysmex representative if you find any errors or omissions.

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1.5 Symbols used in the manuals

Risk of infection
Indicates the presence of a biohazardous material or condition.

Warning!
High risk. Ignoring this warning could result in personal injury to the operator.

Caution!
Average risk. Ignoring this warning could result in property damage. Intended to avoid damage and
incorrect measuring results.

Caution, Hot!
Indicates risk of burns and other injuries if the warning is not observed.

Caution!
Failure to observe this warning may result in instrument damage due to electrostatic discharge from your
body.

Information
Minor risk. Considerations that should be observed when operating this instrument.

Note:
Background information and practical tips.

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1.6 Symbols related to the products

In vitro diagnostic medical device Concentrated reagent

Manufacturer Keep away from sunlight

Authorized representative
Use no hooks
in the European Community

Consult instructions for use This way up

Temperature limitation Keep dry

Biological risks Stacking limit by number

Use by Fragile; handle with care

Batch code Corrugated recycles

By prescription only*
Catalogue number * In compliance with U.S. FDA
requirements

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1.7 Trademarks
• Sysmex is a trademark of SYSMEX CORPORATION, Japan.
• CELLPACK, CELLCLEAN, Fluorocell, SULFOLYSER, and Lysercell are trademarks of SYSMEX CORPORATION.
• ISBT128 (International Society of Blood Transfusion) is copyrighted by and is used under License Agreement with
ICCBBA, Inc.
• Windows is a trademark or registered trademark of Microsoft Corporation in the United States and other countries.
• Other company names and product names in the manuals are the registered trademarks or trademarks of their
respective owners.

The fact that a trademark is not explicitly indicated in this manual does not authorize its use.
TM and ® are not explicitly indicated in the manuals.

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 Chapter 2 Safety Information

Chapter 2 Safety Information

This chapter explains precautions for safe use of this instrument.

2.1 General information

Warning!
• Keep your hair, fingers and clothing away from the instrument that are in operation.
You may get injured if caught in the instrument.
• Do not spill blood samples or reagents into the instrument, or get any metals such as staples or clips,
inside the instrument.
Doing so could cause a short-circuit and a smoke emission.
• The operator should not touch any electrical circuitry inside the cover.
The risk of electrical shock is especially high when your hands are wet.
• The instrument must not be connected to a power outlet other than that specified on the rating plate.
Please note that the instrument must be grounded.
Failure to do so may result in fire or electrical shock.
• Avoid damage to the power cable: do not place any heavy object on the power cable or pull on it.
Doing so may cause fire or shock due to an electrical short or break in the wiring.
• In the unlikely event that the instrument emits an unusual odor or smoke, immediately turn OFF the main
switch and unplug the power cable. Then contact your Sysmex service representative.
Continued use of the instrument in such conditions could result in fire, electrical shock or personal injury.

Caution!
• When handling the sampler adapter (XN-530) and sample tubes, take care not to spill the sample.
• Do not lean against the instrument.
The resulting impact could damage the instrument or cause it to tip over.
• For maintenance tasks that require a washing solution, always use CELLCLEAN AUTO. If CELLCLEAN
AUTO is not used, the instrument will not be cleaned sufficiently and problems may result.
* It is also possible to use CELLCLEAN in place of CELLCLEAN AUTO. In this case, use 4 mL of
CELLCLEAN manually dispensed into a clean sample tube. As this manual assumes that
CELLCLEAN AUTO is used, substitute "CELLCLEAN" whenever "CELLCLEAN AUTO" appears.
• Do not analyze coagulated blood.

cTÜVus mark indicates that the equipment is tested and certified to comply with the electrical and
fire safety regulations controlled by the US and Canadian governments.
Those tests were conducted thoroughly by TÜV Rheinland that is accredited as a Nationally
Recognized Testing Laboratory (NRTL) by OSHA (The Occupational Safety and Health
Administration) in the United States, and by SCC (Standards Council of Canada) in Canada.

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2.2 Installation

Warning!
• Your Sysmex technical representative will unpack, install, and test initial operation of the instrument.
• This instrument must not be connected to a power outlet rated at anything other than specified on the
rating plate. Please note that the instrument must be grounded.
Failure to do so may result in fire or electrical shock.
• Switch OFF the power supply before connecting any peripheral devices (host computer, printer, etc.).
Failure to do so may result in electrical shock or damage to instrument. In addition, an abnormal stop
may occur if a device is connected while the instrument is running.

Caution!
• Install in a location where water will not splash or spray onto the instrument.
• Install in a location where the instrument will be protected from high temperature, humidity, dust and
direct sunlight.
• Do not install in a location subject to vibration.
• Do not subject the instrument to intense shock or vibration.
• Install the instrument in a well-ventilated place.
• Avoid installing the instrument near equipment that emits electrical interference, such as a radio or
centrifuge.
• Do not install the instrument near an area where chemicals are stored or gases are emitted.
• Do not use the instrument in a location where electroconductive gases, flammable gases, or anesthetics
that contain oxygen, hydrogen, or other flammable gases are present.
• Install the instrument indoors.
The instrument is intended for indoor use only.
• Place the reagent container at a level no more than 1 meter above or below the bottom of the analyzer.
Do not place reagents on top of the instrument.
• The instrument uses the common reagents for the XN series; however, a different spout set is used. Be
sure to use the correct spout set.

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2.3 Electromagnetic compatibility (EMC)

This instrument complies with the following IEC (EN) standards:
• IEC61326-2-6:2005 (EN61326-2-6:2006)
Electrical equipment for measurement, control and laboratory use - EMC requirements
• EMI (Electromagnetic Interference) For this standard the requirements of class A are fulfilled.
• EMS (Electromagnetic Susceptibility) For this standard the minimum requirements with regards to susceptibility are
fulfilled.
• This equipment has been designed and tested to CISPR11 Class A. In a domestic environment it may cause a
radio interference, in which case, you may need to take measures to mitigate the interference. The electromagnetic
environment should be evaluated prior to operation of the device.
Do not use this device in close proximity to sources of strong electromagnetic radiation (e.g. unshielded intentional
RF sources), as these may interfere with the proper operation.

This instrument includes an RFID (Radio-Frequency Identification Device) module.

• RFID device: PC-1160002
• Intended use: This RFID module is an electromagnetic induction type non-contact IC can read and write RFID tag data.
• Frequency band: 13.56 MHz
• Maximum radio-frequency power: 23.9 dBuV/m at 3 m (QP)

Caution!
This equipment has been tested and found to comply with the limits for a Class A digital device, pursuant to
part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful
interference when the equipment is operated in a commercial environment. This equipment generates,
uses, and can radiate radio frequency energy and, if not installed and used in accordance with the
instruction manual, may cause harmful interference to radio communications. Operation of this equipment
in a residential area is likely to cause harmful interference in which case the user will be required to correct
the interference at his own expense.

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2.4 Avoiding infection

Risk of infection
• When performing any task on the instrument, such as testing, maintenance, preparation, or post processing,
be sure to wear adequate personal protective equipment, such as protective gloves, a protective mask,
protective eyewear, and a lab coat. Wash your hands with antiseptic solution after completing the task.
There is a risk of infection.
• Be sure to connect the instrument’s drain tubing to a waste fluid tank at the facility or other dedicated
waste container.
If connecting the tubing to a waste fluid tank at the facility, use a tank with a nipple to which the drain
tubing can be attached or a tank with other means of securing the tubing in place so as to avoid the risk
of waste fluid spillage. In addition, exercise care so as to avoid such spillage, for example by regularly
verifying that the tube remains properly secured in place.
• Never touch waste, or parts that have come in contact with waste, with your bare hands.
If you inadvertently come in contact with potentially infectious materials or surfaces, immediately rinse
the skin with large amounts of water, and then follow your laboratory's prescribed cleaning and
decontamination procedures.
• Use appropriate care when handling samples and quality control materials.
In the event that an infectious material gets in the eyes or an open wound, rinse with large amounts of
water and seek immediate medical attention.
• Exercise caution when handling waste fluid. If waste fluid comes in contact with your body or clothes,
wash thoroughly.
• Do not dispose of waste fluid while analysis is in progress.

2.5 Handling of reagents and quality control materials

Warning!
• CELLPACK diluent is an electrical conductor. If diluent is spilled inadvertently near electrical cables or
appliances, there is a risk of electrical shock. Switch OFF the instrument, unplug the power cable, and
wipe off the liquid.
• Be sure to use CELLCLEAN AUTO only when rinsing the inside of the instrument.
• CELLCLEAN AUTO contains sodium hypochlorite.
If CELLCLEAN AUTO comes in contact with the instrument's surface, it may corrode its finish.
Immediately wipe off with a damp cloth.

Caution!
Follow the directions on the reagent container.

For other cautionary points, see Chapter 7.

(➤P.83 "Chapter 7 Reagents")

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2.6 Laser

Warning!
The analyzers have a semiconductor laser unit that is located inside the instrument. To avoid physical risk
of injury from the laser, access is limited to authorized Sysmex technical representative.

2.7 Maintenance

Information
When performing maintenance, use only the tools specially authorized by Sysmex.

2.8 Disposal of materials

2.8.1 Waste Disposal

Risk of infection
After becoming waste at end-of-life, this instrument and its accessories are regarded as infectious. They
are therefore exempted from EU directive 2012/19/EU (Waste Electrical and Electronic Equipment
Directive) and may not be collected by public recycling to prevent possible risk of infection of personnel
working at those recycling facilities.

Warning!
• Do not dispose of the instrument, accessories, and consumables via public recycling.
• Incineration of contaminated parts is recommended.
• Please contact your authorized local Sysmex representative to receive further instructions for disposal.
Follow local legal requirements at all times.

Caution!
Waste effluents from the instrument may contain dangerous substances and decision about disposal only
has to be made by local water authority.

Waste end-of-life equipment should not be disposed of as unsorted municipal waste. It should be
collected separately.

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2.8.2 Decontamination

Warning!
Before decontaminating the instrument, be sure to turn off the power supply and unplug the power cord.
This is necessary to avoid the risk of electric shock. When cleaning the instrument, always wear adequate
personal protective equipment, such as protective gloves, a protective mask, protective eyewear, and a lab
coat. After decontamination, wash your hands carefully with antiseptic solution first and with soap
afterwards. Do not decontaminate the instrument’s internal components. Internal decontamination should
only be executed by your authorized local Sysmex representative.

Information
• Decontamination of the instrument’s outer surfaces should be performed in the following situations:
- Immediately after contamination with potentially infectious material
- In advance of repair or maintenance by your authorized local Sysmex representative
• Wear adequate personal protective equipment, such as protective gloves, a protective mask, protective
eyewear, and a lab coat.
• Wipe and clean contaminated surfaces with a common pH-neutral detergent solution until all visible
traces of contaminants, such as dried blood or urine, are removed.
• Wipe the contaminated surfaces by using one of the following disinfectants* and allow adequate contact
time:
- Sodium hypochlorite (between 0.05 % and 0.5 %)
- 70 % ethanol or 70 % isopropyl alcohol
• Wipe the surfaces with a wet cloth dampened with distilled water to remove any remaining disinfectant
on the surfaces.
• Take care to prevent moisture from reaching the inside of the instrument.
• Take care to avoid applying any liquid close to or on the instrument’s touchscreen.
• As a final step, wipe the instrument with a dry disposable cloth.
* Make sure that you wet a cloth with the disinfectant before use. Do not apply the solutions directly to the
instrument surfaces. Doing so may cause damage to the surfaces or failure of the instrument. Although
the use of these solutions may cause some discoloration of the instrument coating, this does not affect
the use, safety, or performance of the instrument itself.

2.9 Operators

Caution!
• The instrument must only be used by properly trained personnel.
• In the event that a malfunction of the instrument occurs, take the measures indicated in the Instructions
for Use. Further resolution should be referred to your Sysmex technical representative.

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2.10 Cybersecurity

Warning!
Please note the following points to ensure cybersecurity.
• Install the device in a locked and access-controlled area.
• For external connection terminals that will not be used, please consider installing physical protections.
• Properly manage account information such as user IDs and passwords, and conduct periodic reviews.
• Be careful not to share your user account information with another party.
• Do not use this device to browse Internet websites or use other online services, except as specified by
Sysmex.
• Use a dedicated line or VPN to connect to an external network, and do not connect directly to the
Internet.
• Do not connect the device to a wireless network unless authorized by Sysmex.
• Do not use the device for any purpose other than that for which it is intended.
• Do not make any changes to the settings that are not described in this manual.
• If you are using external media such as USB storage devices, please ensure that they are not infected
with a virus.
• If you notice any suspicious behavior that may indicate a virus, please contact your authorized local
Sysmex representative.
• Do not install any software on this device other than software approved by Sysmex.
• Please note that we cannot be held responsible for any problems that may occur with this product if you
use any unauthorized software.

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2.11 Markings on the instrument

Front and side views (XN-530)

(1) (2)

(1) Surfaces

Risk of infection
Treat all parts and surfaces of the instrument as posing a risk of infection.

(2) Right view

Warning!
Never insert your hand when the power of the analyzer is turned ON. There is a risk of injury.

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Interior view (XN-530)

(3)

(4)

(5)

(2) (1)

(1) Sampler adapter holder (right)

Risk of infection
Treat all parts and surfaces of the instrument as posing a risk of infection.

(2) Sampler adapter holder (left)

Risk of infection
Treat all parts and surfaces of the instrument as posing a risk of infection.

(3) Sampler adapter holder (interior)

Risk of infection
Treat all parts and surfaces of the instrument as posing a risk of infection.

(4) Sampler adapter holder (interior)

Warning!
Never insert your hand when the power of the analyzer is turned ON. There is a risk of injury.

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(5) Sample tube holder

Risk of infection
Treat all parts and surfaces of the instrument as posing a risk of infection.

Front, interior, and side views (XN-430)

(2) (3) (1)

Front view Side view

(1) Right view

Warning!
Never insert your hand when the power of the analyzer is turned ON. There is a risk of injury.

(2) Side of sample tube holder

Caution!
Never insert your hand. There is a risk of injury.

(3) Sample tube holder

Risk of infection
Treat all parts and surfaces of the instrument as posing a risk of infection.

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Front and side views (XN-330)

(2) (1)
Front view Side view

(1) Right view

Warning!
Never insert your hand when the power of the analyzer is turned ON. There is a risk of injury.

(2) Surfaces

Risk of infection
Treat all parts and surfaces of the instrument as posing a risk of infection.

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Left interior (Common)

(1)

(2) (3)

Example: XN-530

(1) Semiconductor laser unit

Warning!
The analyzers have a built-in semiconductor laser unit. To avoid the risk of eye injury, the laser is covered
by a protective shielded box cover to prevent access by other than service technicians.

(2) Fluorocell WDF dye cover

Warning!
Do not touch the nozzle.
There is a risk of injury.

(3) Unused Fluorocell dye cover

Warning!
Do not touch the nozzle.
There is a risk of injury.

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Right interior and top interior (Common)

(1)
(3)

(2)

Example: XN-530

(1) RBC detector cover

Warning!
To avoid electrical shock, unplug the power cable before servicing. An electrical shock could occur.

(2) Air pump unit (top)

Warning!
To avoid electrical shock, unplug the power cable before servicing. An electrical shock could occur.

(3) Air pump unit (top)

Caution, Hot!
The surface of the air pump is hot. Do not touch. There is a risk of burn injury.

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Rear view (Common)

(1)

(2)

(3)

Example: XN-530

(1) Interface connector

Caution!
Failure to observe this warning may result in instrument damage due to electrostatic discharge from your
body.

(2) Periphery of main power supply

Warning!
• To avoid electrical shock, unplug the power cable before servicing. An electrical shock could occur.
• Replace only with fuses of the specified type and current rating.

(3) Waste fluid outlet nipple

Risk of infection
Treat all parts and surfaces of the instrument as posing a risk of infection.

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Pneumatic unit (Option)

PU-17 is an in-vitro diagnostic accessory to supply vacuum and pressure for Sysmex devices. It is used by
healthcare professionals and properly trained personnel. For appropriate use of the product, refer to the
corresponding instructions for use of applicable Sysmex devices.

(3)

(2)

(1)

Front view Rear view

(1) Pneumatic unit

Risk of infection
Treat all parts and surfaces of the instrument as posing a risk of infection.

(2) Power connector

Warning!
• To avoid electrical shock, unplug the power cable before servicing.
An electrical shock could occur.
• Use only a fuse of the specified type and rating.
Doing so could cause a smoke emission and a fire.

(3) Exhaust vent

Caution!
Do not obstruct the exhaust vent on the back of the pneumatic unit.

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2.12 Notice to the user

For a patient or user or third party in the European Union and in countries with identical regulatory regime (Directive
98/79/EC on In vitro Diagnostic Medical Devices); if, during the use of this device or as a result of its use, a serious
incident has occurred, please report it to the manufacturer and/or its authorized representative in the European Union
and to your national competent authority.
Reports to the authorized representative in the European Union, Sysmex Europe SE, must be sent by email to:
[email protected], or by post to Sysmex Europe SE, Bornbarch 1, 22848 Norderstedt, Germany.

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Chapter 3 Part Names and Functions

This chapter explains an external view and overview of the instrument.

3.1 Analyzer
Front view (XN-530)
(10) (6) (7)

(1) (2) (3) (5) (4) (8) (9) (11)

(1) Sampler start/stop switch

Press to start sampler analysis. Press to stop sampler analysis while sampler analysis is in progress.
(2) Mode switch
Press to switch between manual analysis mode and sampler analysis mode. Press while sampler analysis is in
progress to change to manual analysis mode after analysis of the current sample is completed.
(3) Power switch
Turn the instrument power ON.
For procedures on turning OFF the instrument power, see "Basic Operation".
(➤Basic Operation, "Chapter 1: 1.3 Shutdown")
(4) Sampler adapter holder (right)
Use to load sample tubes for sampler analysis mode.
(5) Sampler adapter holder (left)
Use to load sample tubes for sampler analysis mode.

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(6) Sampler adapter status indicator LED

Indicates the status of the sampler adapter holder (right) / (left).

Not lit All sample tubes in the sampler adapter have been analyzed, or there is no
sampler adapter in the sampler adapter holder.
The sampler adapter holder can be opened.
Green Sampler adapter received state
The sampler adapter holder can be opened.
Flashing green Analysis in progress
The sampler adapter holder cannot be opened.
Wait until analysis is finished and then open the sampler adapter holder.
Red Error occurring
The sampler adapter holder can be opened.
Flashing red Error occurring
The sampler adapter holder cannot be opened.
Wait until the sampler adapter status indicator LED lights solid red and then open
the sampler adapter holder. For details on errors, see "Troubleshooting".
(➤Troubleshooting, "Chapter 1: 1.1 Error message list (in alphabetical order)")

(7) Manual analysis status indicator LED

Indicates the status of manual analysis.

Not lit Sampler analysis mode

Green Manual analysis is possible.
Flashing green Aspirating a sample (during manual analysis).
Red Error occurring

(8) Start switch

Press to start manual analysis.
(9) Sample tube holder
Use to load sample tubes for manual analysis mode.
(10) Sampler cover (front)
The cover can be removed for maintenance. The cover is not secured at the bottom. Take care not to drop the
cover when removing it.
(11) Sampler cover (manual unit)
Open to load sample tubes for manual analysis mode.

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Front view (XN-430)

(1)
(3)
(4)

(5)

(6)
(2)

(1) Touchscreen
Use to operate the instrument and configure settings. The instrument status and analysis results can also be
checked.
(2) Power switch
Turn the instrument power ON.
For procedures on turning OFF the instrument power, see "Basic Operation".
(➤Basic Operation, "Chapter 1: 1.3 Shutdown")
(3) Analysis status indicator LED
Indicates the status of the analysis.

Green Analysis is possible.

Flashing green Aspirating a sample.
Red Error occurring

(4) Start switch

Press to start analysis.
(5) Sample tube holder open/close switch
Press to open and close the sample tube holder.
(6) Sample tube holder
Open to load sample tubes.

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Front view (XN-330)

(1)
(3)

(4)
(2)
(5)

(1) Touchscreen
Use to operate the instrument and configure settings. The instrument status and analysis results can also be
checked.
(2) Power switch
Turn the instrument power ON.
For procedures on turning OFF the instrument power, see "Basic Operation".
(➤Basic Operation, "Chapter 1: 1.3 Shutdown")
(3) Analysis status indicator LED
Indicates the status of the analysis.

Green Analysis is possible.

Flashing green Aspirating a sample.
Red Error occurring

(4) Aspiration pipette

Aspirates a sample.
(5) Start switch
Press to start analysis.

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Left view (Common)

(1)

(a)

Example: XN-530
(1) Dye holder
Holds the fluorescence reagent.
(a) Fluorocell WDF holder

Right view (Common)

(2)

(1)

Example: XN-530

(1) Right cover

Open to inspect and perform maintenance on the inside of the analyzer.
(2) Lock
Lock for opening/closing of the right cover.

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Right interior (Common)

(1)

(2)
(4)

(3)

Example: XN-530
(1) Air pump unit
Adjusts the air pressure that is supplied inside the instrument.
(2) RBC detector cover
Contains an RBC detector.
(3) Pneumatic trap chamber
Prevents reagent and other fluids from flowing into the air pump unit when an abnormality occurs in the
instrument.
(4) Piercer (XN-530/XN-430)
The piercer moves to the sample tube to aspirate the sample during analysis.

Rear view (Common)

(3) (12) (14)

(1) (2) (4)

(13)

(9)

(5)

(6)

(7)

Example: XN-530 (8) (10) (11)

(1) RS-232C port

Use to connect the instrument to a host computer.
(2) Monitor connection port (VGA)
Use to connect to a monitor (XN-530 only).
(3) LAN port
Use to connect to a host computer or to the network service (optional) provided by Sysmex.

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(4) USB port

Use to connect to a monitor (XN-530 only), hand-held barcode reader (option), or printer (option). Insert a USB
memory stick to back up and restore various types of files.
(5) Fuse holder
Use a 250 V, 10 A (time lag) fuse.
(6) Main power switch
Turn the main power of the instrument ON/OFF.

Caution!
Do not turn this switch ON/OFF repeatedly within a short time.
This may overload the fuse and cause it to blow.

(7) AC power inlet

Supplies power using the provided power cable.
(8) DCL aspiration nipple
CELLPACK DCL or diluted CELLPACK DST is aspirated through this nipple.
(9) SLS aspiration nipple
SULFOLYSER is aspirated through this nipple. Connect to a SULFOLYSER container.
(10) WDF aspiration nipple
Lysercell WDF is aspirated through this nipple. Connect to a Lysercell WDF container.
(11) Waste fluid outlet nipple
Waste fluid is discharged through this nipple. Connect to a drain or waste container.
(12) RU-20 tank sensor connection port
Used for communication with the RU-20 tank sensor.

Information
If the RU-20 supply tank is not connected, connect an anti-static electricity connector to the RU-20 tank sensor
connection port. Do not remove this connector.

(13) Port for pneumatic unit control

Output port for turning the pneumatic unit (option) ON/OFF. Connects the pneumatic unit control input connector
of the pneumatic unit.
(14) Port for waste container full sensor
Connect to the waste container full sensor (option).

Information
If the waste container full sensor (option) is not connected, connect an anti-static electricity connector to the port
for the waste container full sensor. Do not remove this connector.

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3.2 Monitor (XN-530)

(1)

(2) (3) (4) (5) (6) (7) (8)

Left view Front view Rear view
(1) OSD (on-screen display) operation buttons
Use to adjust the image quality.
(➤Troubleshooting, "Chapter 2: 2.18 Adjusting the monitor image quality (XN-530)")
(2) Status LED
Indicates the status of the monitor.

Not lit Power OFF

Green Power ON, video signal input
Orange Power ON, no video signal input*
* When there is no video signal input, [NO SIGNAL] appears and then the monitor enters the non-display state.
(3) Power switch
Turns the power of the monitor ON/OFF.
(4) Monitor (touchscreen)
Use to operate the instrument and configure settings. The instrument status and analysis results can also be
checked.
(5) AC power inlet
Supplies power using the provided power cable.
(6) Security slot
Use to connect a commercially available anti-theft cable.
(7) RGB port
Connect the monitor to the analyzer. (Video signal)
(8) USB port
Connect the monitor to the analyzer. (Touchscreen signal)

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Chapter 4 Installation

This chapter provides information regarding installation of the instrument.

4.1 Preparing for installation

The instrument is installed or moved by Sysmex service representatives. The following is a list of things to do
beforehand to prepare for the installation or move.

• Secure ample space for installation, with safety considerations.

For the installation space, see the following.
(➤P.41 "4.2.4 Installation space")
• Note the weight of this instrument. Make sure that the floor and/or the equipment on which the instrument is to be
installed can withstand the weight.
• The power cable for this instrument is 2.0 m long. Use a nearby dedicated power outlet.
• Once this instrument is delivered, check the condition of its packaging as soon as possible.

Information
If the packaging has been damaged in any way, contact your Sysmex representative as soon as possible.

• Keep the instrument in its packaging in a dry place until it is time for installation. Store upright.

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4.2 Installation

4.2.1 Cautions on installation

The instrument and associated equipment are installed by your Sysmex technical representative. In case
relocation becomes necessary after installation, contact your Sysmex technical representative.
Problems resulting from moving of the instrument by anyone other than a Sysmex technical representative are
not covered by the Warranty even within the warranty period.

4.2.2 Grounding
The safety plug of the power cord of the device must be connected to a properly grounded power outlet. An appropriate
adaptor and plug type should be used in your region.
For details, please contact authorized local Sysmex representatives.

Warning!
• Be sure to ground this instrument.
Improper grounding may cause electrical shock.
• Never exceed socket capacity.
Failure to do so may cause a fire.

Caution!
Use the power cable that comes with the instrument. Do not use the power cable to supply power to any
equipment other than the instrument.

4.2.3 Installation environment

• Use the instrument in an ambient temperature within the range of 15 to 35°C.
• Relative humidity should be within the range of 20 to 85%.
• If ambient temperature and relative humidity are not within the suggested range, air-condition the
environment.
For other conditions, see Chapter 2. (➤P.16 "Chapter 2: 2.2 Installation")

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4.2.4 Installation space

To allow sufficient space for maintenance, install the monitor unit on the left side of the analyzer. (XN-530 only)
Install the instrument with a clearance of at least 30 cm at the back.

Component Width (mm) Depth (mm) Height (mm) Weight (kg)

Analyzer (XN-530) Approx. 450 Approx. 660 Approx. 450 Approx. 53
Monitor (XN-530) Approx. 267 Approx. 205 Approx. 240 Approx. 3
Analyzer (XN-430) Approx. 450 Approx. 460 Approx. 440 Approx. 35
Analyzer (XN-330) Approx. 450 Approx. 460 Approx. 510 Approx. 35

Approx. Approx.
240 450

Approx. Approx.
267 205
Approx.
Approx. 660
450

XN-530

Approx. Approx.
440 510

Approx. Approx. Approx.

460 450 Approx.
450
460

XN-430 XN-330

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Chapter 5 Instrument Specifications

This chapter explains technical information such as specifications and principles.

5.1 Product specifications

Physical specifications (Analyzer)
Dimensions and weight XN-530: Approx. 450 (W) x Approx. 660 (D) x Approx. 450 (H) mm, Approx. 53 kg
XN-430: Approx. 450 (W) x Approx. 460 (D) x Approx. 440 (H) mm, Approx. 35 kg
XN-330: Approx. 450 (W) x Approx. 460 (D) x Approx. 510 (H) mm, Approx. 35 kg
Electrical rating Voltage: 100 to 240 V AC
Frequency: 50/60 Hz
Power consumption:
XN-530: 250 VA
XN-430/XN-330: 235 VA
Protection type: Class I
Operating environment Ambient temperature: 15 to 35°C (also applies to supplied reagents*)
Relative humidity: 20 to 85%
Atmospheric pressure: 70 to 106 kPa
Pollution degree: 2
* Excluding CELLPACK DST.
Noise level 60 dB or less
Excludes sound during clamping and release of sample tubes, and alarm sounds.
Storage conditions Ambient temperature: -10 to 60°C
Relative humidity: 10 to 95% (no condensation)
Atmospheric pressure: 70 to 106 kPa
Laser class Class I (IEC60825-1:2014, IEC60825-1:2007)
Safety standards IEC61010-1, IEC61010-2-081, IEC61010-2-101

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Physical specifications (Monitor (XN-530))

Dimensions and weight Approx. 267 (W) x Approx. 205 (D) x Approx. 240 (H) mm, Approx. 3 kg
Monitor thickness: 52.5 mm
Electrical rating Voltage: 100 to 240 V AC
Frequency: 50/60 Hz
Power consumption: 36 VA
Protection type: Class I, limited to indoor use
Over-voltage category: Category II
Storage conditions Ambient temperature: -10 to 60°C
Relative humidity: 10 to 95% (no condensation)
Atmospheric pressure: 70 to 106 kPa
I/F specifications Video signal I/F: Analog RGB signal (0.7 VP-P)
Touch signal I/F: USB 2.0 compliant
I/F connectors Video signal (analog RGB) input: Mini Dsub 15 pin (female)
Touchscreen signal I/F (USB): USB 2.0 B connector
AC power input: 3-prong plug
Supported resolutions SVGA 800 x 3 (H) x 600 (V)
Screen size 26.4 cm (10.4 type) diagonal
Display colors 16,200,000 colors
Brightness 315 cd/m2 or more (typ 450 cd/m2)
Contrast ratio (CR) 900:1
Angle of view -60° to 80° (vertical), -80° to 80° (horizontal)
Backlight LED
Touch detection method 4-wire analog resistive film type

Throughput
[Whole Blood] mode When using the XN-530, the values below are for the case where the barcode reading
function and Repeat/Rerun/Reflex function are not used.
CBC: approx. 60 samples/hour
CBC+DIFF: approx. 60 samples/hour
[Pre-Dilution] mode CBC: approx. 60 samples/hour
CBC+DIFF: approx. 60 samples/hour

Aspirated sample volume

[Whole Blood] mode Sampler analysis: 25 µL
Manual analysis: 25 µL
Micro sample analysis: 25 µL
Analysis using a micro collection tube: 25 µL
Analysis using an RBT micro collection tube: 25 µL
[Pre-Dilution] mode Micro sample analysis: 70 µL
Analysis using a micro collection tube: 70 µL

Diagnostic parameters
For diagnostic parameters, see Chapter 1. (➤P.10 "Chapter 1: 1.3 Parameters")

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5.2 Performance characteristics

Measuring Interval and display range
The Measuring Interval comprises the range of measured quantities in which the measurement can be performed
with specified precision. It is set from the Limit of Quantitation (LoQ) as the Lower Limit of the Measuring Interval to
the upper limit of Linearity as the Upper Limit of the Measuring Interval.

Parameters Measuring Interval Display range Units

[Whole Blood] mode
WBC NA*3 0.00 to 999.99 x 103/μL
WBC-C 0.03 to 440.00 0.00 to 999.99 x 103/μL
WBC-D 0.03 to 440.00 0.00 to 999.99 x 103/μL
RBC 0.01 to 8.60 0.00 to 99.99 x 106/μL
HGB 0.1 to 26.0 0.0 to 30.0 g/dL
HCT 0.1 to 75.0 0.0 to 100.0 %
*1
MCV NA 0.0 to 999.9 fL
MCH NA*1 0.0 to 999.9 pg
*1
MCHC NA 0.0 to 999.9 g/dL
PLT 2 to 5000 0 to 9999 x 103/μL
RDW-SD NA*2 0.0 to 999.9 fL
RDW-CV NA*2 0.0 to 999.9 %
*2
MicroR NA 0.0 to 100.0 %
*2
MacroR NA 0.0 to 100.0 %
*2
PDW NA 0.0 to 999.9 fL
MPV NA*1 0.0 to 999.9 fL
*2
P-LCR NA 0.0 to 999.9 %
PCT 0.01 to 3.00 0.00 to 99.99 %
NEUT# 0.03 to 440.00 0.00 to 999.99 x 103/μL
LYMPH# 0.03 to 440.00 0.00 to 999.99 x 103/μL
MONO# 0.03 to 440.00 0.00 to 999.99 x 103/μL
EO# 0.03 to 440.00 0.00 to 999.99 x 103/μL
BASO# 0.03 to 440.00 0.00 to 999.99 x 103/μL
*1
NEUT% NA 0.0 to 100.0 %
*1
LYMPH% NA 0.0 to 100.0 %
*1
MONO% NA 0.0 to 100.0 %
*1
EO% NA 0.0 to 100.0 %
BASO% NA*1 0.0 to 100.0 %
IG# 0.03 to 440.00 0.00 to 999.99 x 103/μL
IG% NA*1 0.0 to 100.0 %
*1 Not applicable, as this parameter is calculated from an equation.
*2 Not applicable, as this parameter is calculated using an equation from a distribution.
*3 Not applicable, measuring interval of WBC applies WBC-C / WBC-D.

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Measuring Interval and display range (continued)

Parameters Measuring Interval Display range Units
[Pre-Dilution] mode
*3
WBC NA 0.00 to 999.99 x 103/μL
WBC-C 0.04 to 100.00 0.00 to 999.99 x 103/μL
WBC-D 0.04 to 100.00 0.00 to 999.99 x 103/μL
RBC 0.01 to 8.60 0.00 to 99.99 x 106/μL
HGB 0.2 to 26.0 0.0 to 30.0 g/dL
HCT 0.1 to 75.0 0.0 to 100.0 %
MCV NA*1 0.0 to 999.9 fL
MCH NA*1 0.0 to 999.9 pg
*1
MCHC NA 0.0 to 999.9 g/dL
PLT 5 to 1000 0 to 9999 x 103/μL
*2
RDW-SD NA 0.0 to 999.9 fL
*2
RDW-CV NA 0.0 to 999.9 %
*2
MicroR NA 0.0 to 100.0 %
*2
MacroR NA 0.0 to 100.0 %
PDW NA*2 0.0 to 999.9 fL
*1
MPV NA 0.0 to 999.9 fL
*2
P-LCR NA 0.0 to 999.9 %
PCT 0.01 to 3.00 0.00 to 99.99 %
NEUT# 0.04 to 100.00 0.00 to 999.99 x 103/μL
LYMPH# 0.04 to 100.00 0.00 to 999.99 x 103/μL
MONO# 0.04 to 100.00 0.00 to 999.99 x 103/μL
EO# 0.04 to 100.00 0.00 to 999.99 x 103/μL
BASO# 0.04 to 100.00 0.00 to 999.99 x 103/μL
NEUT% NA*1 0.0 to 100.0 %
*1
LYMPH% NA 0.0 to 100.0 %
*1
MONO% NA 0.0 to 100.0 %
EO% NA*1 0.0 to 100.0 %
*1
BASO% NA 0.0 to 100.0 %
IG# 0.04 to 100.00 0.00 to 999.99 x 103/μL
IG% NA*1 0.0 to 100.0 %
*1 Not applicable, as this parameter is calculated from an equation.
*2 Not applicable, as this parameter is calculated using an equation from a distribution.
*3 Not applicable, measuring interval of WBC applies WBC-C / WBC-D.

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Limit of Blank, Limit of Detection, and Limit of Quantitation

Limit of Blank (LoB), Limit of Detection (LoD) and Limit of Quantitation (LoQ) for the parameters counted directly
meet the specifications in the following table, when evaluated according to CLSI EP17-A2.

[Whole Blood] mode

Limit of blank Limit of detection Limit of
Parameters Units
(LoB) (LoD) quantitation (LoQ)
WBC-C 0.01 0.02 0.03 x 103/μL
WBC-D 0.00 0.01 0.03 x 103/μL
RBC 0.00 0.00 0.01 x 106/μL
HGB 0.0 0.0 0.1 g/dL
PLT 0 1 2 x 103/μL
HCT 0.0 0.0 0.1 %
PCT 0.00 0.01 0.01 %
NEUT# 0.00 0.01 0.03 x 103/μL
LYMPH# 0.00 0.01 0.03 x 103/μL
MONO# 0.00 0.01 0.03 x 103/μL
EO# 0.00 0.01 0.03 x 103/μL
BASO# 0.00 0.01 0.03 x 103/μL
IG# 0.00 0.01 0.03 x 103/μL

[Pre-Dilution] mode
Limit of blank Limit of detection Limit of
Parameters Units
(LoB) (LoD) quantitation (LoQ)
WBC-C 0.02 0.03 0.04 x 103/μL
WBC-D 0.00 0.01 0.03 x 103/μL
RBC 0.00 0.00 0.01 x 106/μL
HGB 0.0 0.1 0.2 g/dL
PLT 2 3 5 x 103/μL
HCT 0.0 0.1 0.1 %
NEUT# 0.00 0.01 0.03 x 103/μL
LYMPH# 0.00 0.01 0.03 x 103/μL
MONO# 0.00 0.01 0.03 x 103/μL
EO# 0.00 0.01 0.03 x 103/μL
BASO# 0.00 0.01 0.03 x 103/μL
IG# 0.00 0.01 0.03 x 103/μL

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Linearity
[Whole Blood] mode Linearity can be assessed by testing levels of a parameter with a known concentration
using peripheral blood or by using commercially available materials qualified for use on
the XN-L. The specification is indicated as ‘regression coefficient’ and ‘percentage
variation’.
WBC-C R2 = 0.95 or more (0.00 to 440.00 x 103/μL)
within ±3%, or within ±0.30 x 103/μL (0.00 to 100.00 x 103/μL)
within ±6% (100.01 to 310.00 x 103/μL)
within ±11% (310.01 to 440.00 x 103/μL)
WBC-D R2 = 0.95 or more (0.00 to 440.00 x 103/μL)
within ±3%, or within ±0.30 x 103/μL (0.00 to 100.00 x 103/μL)
within ±6% (100.01 to 310.00 x 103/μL)
within ±11% (310.01 to 440.00 x 103/μL)
RBC R2 = 0.95 or more (0.00 to 8.60 x 106/μL)
within ±2% or ±0.03 x 106/μL (0.00 to 8.00 x 106/μL)
within ±4% or ±0.06 x 106/μL (8.01 to 8.60 x 106/μL)
HGB R2 = 0.95 or more (0.00 to 26.0 g/dL)
within ±2%, or within ±0.2 g/dL (0.0 to 26.0 g/dL)
HCT R2 = 0.95 or more (0.0 to 75.0%)
within ±3%, or within ±1.0 HCT (0.0 to75.0%)
PLT R2 = 0.95 or more (0 to 5000 x 103/μL)
within ±5%, or within ±10 x 103/μL (0 to 1000 x 103/μL)
within ±6% (1001 to 5000 x 103/μL)
PCT R2 = 0.95 or more (0.00 to 3.0%)
NEUT# R2 = 0.95 or more (0.00 to 440.00 x 103/μL)
within ±3%, or within ±0.30 x 103/μL (0.00 to 100.00 x 103/μL)
within ±6% (100.01 to 310.00 x 103/μL)
within ±11% (310.01 to 440.00 x 103/μL)
LYMPH# R2 = 0.95 or more (0.00 to 440.00 x 103/μL)
within ±3%, or within ±0.30 x 103/μL (0.00 to 100.00 x 103/μL)
within ±6% (100.01 to 310.00 x 103/μL)
within ±11% (310.01 to 440.00 x 103/μL)
MONO# R2 = 0.95 or more (0.00 to 440.00 x 103/μL)
within ±3%, or within ±0.30 x 103/μL (0.00 to 100.00 x 103/μL)
within ±6% (100.01 to 310.00 x 103/μL)
within ±11% (310.01 to 440.00 x 103/μL)
EO# R2 = 0.95 or more (0.00 to 440.00 x 103/μL)
within ±3%, or within ±0.30 x 103/μL (0.00 to 100.00 x 103/μL)
within ±6% (100.01 to 310.00 x 103/μL)
within ±11% (310.01 to 440.00 x 103/μL)
BASO# R2 = 0.95 or more (0.00 to 440.00 x 103/μL)
within ±3%, or within ±0.30 x 103/μL (0.00 to 100.00 x 103/μL)
within ±6% (100.01 to 310.00 x 103/μL)
within ±11% (310.01 to 440.00 x 103/μL)
IG# R2 = 0.95 or more (0.00 to 440.00 x 103/μL)
within ±3%, or within ±0.30 x 103/μL (0.00 to 100.00 x 103/μL)
within ±6% (100.01 to 310.00 x 103/μL)
within ±11% (310.01 to 440.00 x 103/μL)

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Linearity (continued)
[Pre-Dilution] mode WBC-C R2 = 0.95 or more (0.00 to 100.00 x 103/μL)
within ±10%, or within ±0.40 x 103/μL (0.00 to 100.00 x 103/μL)
WBC-D R2 = 0.95 or more (0.00 to 100.00 x 103/μL)
within ±10%, or within ±0.40 x 103/μL (0.00 to 100.00 x 103/μL)
RBC R2 = 0.95 or more (0.00 to 8.00 x 106/μL)
within ±8%, or within ±0.12 x 106/μL (0.00 to 8.00 x 106/μL)
HGB R2 = 0.95 or more (0.00 to 26.0 g/dL)
within ±5%, or within ±0.5 g/dL (0.0 to 26.0 g/dL)
HCT R2 = 0.95 or more (0.0 to 75.0%)
within ±4%, or within ±2.0 HCT (0.0 to 75.0%)
PLT R2 = 0.95 or more (0 to 1000 x 103/μL)
within ±10%, or within ±20 x 103/μL (0.0 to 1000 x 103/μL)
PCT R2 = 0.95 or more (0.00 to 3.0%)
NEUT# R2 = 0.95 or more (0.00 to 100.00 x 103/μL)
within ±10%, or within ±0.40 x 103/μL (0.00 to 100.00 x 103/μL)
LYMPH# R2 = 0.95 or more (0.00 to 100.00 x 103/μL)
within ±10%, or within ±0.40 x 103/μL (0.00 to 100.00 x 103/μL)
MONO# R2 = 0.95 or more (0.00 to 100.00 x 103/μL)
within ±10%, or within ±0.40 x 103/μL (0.00 to 100.00 x 103/μL)
EO# R2 = 0.95 or more (0.00 to 100.00 x 103/μL)
within ±10%, or within ±0.40 x 103/μL (0.00 to 100.00 x 103/μL)
BASO# R2 = 0.95 or more (0.00 to 100.00 x 103/μL)
within ±10%, or within ±0.40 x 103/μL (0.00 to 100.00 x 103/μL)
IG# R2 = 0.95 or more (0.00 to 100.00 x 103/μL)
within ±10%, or within ±0.40 x 103/μL (0.00 to 100.00 x 103/μL)

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Trueness
For validation of Trueness the bias has been calculated: The relative difference of the mean of the measurements
performed for Intermediate Precision and the determined true value as external mean value (EQA). Trueness is
defined for parameters with internationally recognized reference methods only.

Parameter XN CHECK Level 1 XN CHECK Level 2 XN CHECK Level 3

WBC-C Within mean ±9% Within mean ±9% Within mean ±9%
WBC-D Within mean ±10% Within mean ±8% Within mean ±8%
RBC Within mean ±5% Within mean ±5% Within mean ±5%
HGB Within mean ±4% Within mean ±4% Within mean ±4%
HCT Within mean ±10% Within mean ±10% Within mean ±10%
PLT Within mean ±39% Within mean ±15% Within mean ±13%

Total Analytical Error

Total Analytical Error is determined by considering the target value of an EQA as true value. The bias between the
considered true value and the repeated measurement of the QC material was calculated. The specifications stated in
the table were met. Total Analytical Error is only determined for parameters where a reference method exists.

Parameter XN CHECK Level 1 XN CHECK Level 2 XN CHECK Level 3

WBC-C Within mean ±10% Within mean ±9% Within mean ±9%
WBC-D Within mean ±10% Within mean ±8% Within mean ±8%
RBC Within mean ±5% Within mean ±5% Within mean ±5%
HGB Within mean ±4% Within mean ±4% Within mean ±4%
HCT Within mean ±10% Within mean ±10% Within mean ±10%
PLT Within mean ±40% Within mean ±15% Within mean ±13%

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Precision (Repeatability)
[Whole Blood] mode Indicated as a coefficient of variation (95% reliability) of peripheral blood or control
blood analyzed repeatedly 10 times or more.
WBC-C 3.0% or less (4.00 x 103/μL or more)
WBC-D 3.0% or less (4.00 x 103/μL or more)
RBC 1.5% or less (4.00 x 106/μL or more)
HGB 1.5% or less
HCT 1.5% or less
MCV 1.5% or less
MCH 2.0% or less
MCHC 2.0% or less
PLT 4.0% or less (100 x 103/μL or more)
RDW-SD 3.0% or less
RDW-CV 3.0% or less
MicroR 18.0% or less, or within ±1.0 MicroR
MacroR 18.0% or less, or within ±1.0 MacroR
PDW 10.0% or less
MPV 4.0% or less
P-LCR 18.0% or less
PCT 6.0% or less
NEUT# 8.0% or less (1.20 x 103/μL or more)
LYMPH# 8.0% or less (0.60 x 103/μL or more)
MONO# 20.0% or less (0.20 x 103/μL or more)
EO# 25.0% or less, or within ±0.12 x 103/μL
BASO# 40.0% or less, or within ±0.06 x 103/μL
NEUT% 8.0% or less (30.0 NEUT% or more, WBC 4.00 x 103/μL or more)
LYMPH% 8.0% or less (15.0 LYMPH% or more, WBC 4.00 x 103/μL or more)
MONO% 20.0% or less (5.0 MONO% or more, WBC 4.00 x 103/μL or more)
EO% 25.0% or less, or within ±1.5 EO% (WBC 4.00 x 103/μL or more)
BASO% 40.0% or less, or within ±1.0 BASO% (WBC 4.00 x 103/μL or more)
IG# 25.0% or less, or within ±0.12 x 103/μL (IG# 0.10 x 103/μL or more)
IG% 25.0% or less, or within ±1.5 IG% (2.0 IG% or more, WBC 4.00 x 103/μL
or more)

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Precision (Repeatability) (continued)

[Pre-Dilution] mode Indicated as a coefficient of variation (95% reliability) of a diluted sample of peripheral
blood or control blood analyzed repeatedly 10 times or more.
WBC-C 5.0% or less (4.00 x 103/μL or more)
WBC-D 5.0% or less (4.00 x 103/μL or more)
RBC 4.5% or less (4.00 x 106/μL or more)
HGB 4.5% or less
HCT 4.5% or less
MCV 4.5% or less
MCH 4.5% or less
MCHC 6.0% or less
PLT 12.0% or less (100 x 103/μL or more)
RDW-SD 6.0% or less
RDW-CV 6.0% or less
MicroR 36.0% or less, or within ±2.0 MicroR
MacroR 36.0% or less, or within ±2.0 MacroR
PDW 20.0% or less
MPV 8.0% or less
P-LCR 36.0% or less
PCT 12.0% or less
NEUT# 16.0% or less (1.20 x 103/μL or more)
LYMPH# 16.0% or less (0.60 x 103/μL or more)
MONO# 40.0% or less (0.20 x 103/μL or more)
EO# 40.0% or less, or within ±0.12 x 103/μL
BASO# 50.0% or less, or within ±0.06 x 103/μL
NEUT% 16.0% or less (30.0 NEUT% or more, WBC 4.00 x 103/μL or more)
LYMPH% 16.0% or less (15.0 LYMPH% or more, WBC 4.00 x 103/μL or more)
MONO% 40.0% or less (5.0 MONO% or more, WBC 4.00 x 103/μL or more)
EO% 40.0% or less, or within ±2.5 EO% (WBC 4.00 x 103/μL or more)
BASO% 50.0% or less, or within ±1.5 BASO% (WBC 4.00 x 103/μL or more)
IG# 75.0% or less, or within ±0.36 x 103/μL (IG# 0.10 x 103/μL or more)
IG% 75.0% or less, or within ±4.5 IG% (2.0 IG% or more, WBC 4.00 x 103/μL
or more)

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Intermediate Precision
The Intermediate Precision indicated as coefficients of variation meets specifications shown in the following table,
when control materials as sample are measured (20 days x 2 runs x 2 replicates) according to CLSI EP05-A3.
Parameter XN CHECK Level 1 XN CHECK Level 2 XN CHECK Level 3
WBC-C 10% or less 9% or less 9% or less
WBC-D 10% or less 8% or less 8% or less
RBC 5% or less 5% or less 5% or less
HGB 4% or less 4% or less 4% or less
HCT 10% or less 10% or less 10% or less
MCV 5% or less 5% or less 5% or less
MCH 9% or less 8% or less 8% or less
MCHC 15% or less 14% or less 14% or less
PLT 80% or less 15% or less 9% or less
RDW-SD 10% or less 10% or less 10% or less
RDW-CV 10% or less 10% or less 10% or less
MicroR 60% or less 70% or less 80% or less
MacroR 50% or less 40% or less 40% or less
PDW 80% or less 16% or less 12% or less
MPV within mean ± 9.0 fL 9% or less 7% or less
P-LCR within mean ± 30.0 P-LCR% 50% or less 50% or less
PCT 116% or less 30% or less 25% or less
NEUT% 20% or less 15% or less 15% or less
NEUT# 20% or less 15% or less 15% or less
LYMPH% 40% or less 20% or less 20% or less
LYMPH# 40% or less 20% or less 20% or less
MONO% 80% or less 60% or less 50% or less
MONO# 80% or less 60% or less 50% or less
EO% 50% or less 50% or less 50% or less
EO# 50% or less 50% or less 50% or less
BASO% 78% or less 78% or less 78% or less
BASO# 78% or less 78% or less 78% or less
IG% 30% or less 30% or less 25% or less
IG# 30% or less 30% or less 25% or less

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Precision (Reproducibility)
Validation of Reproducibility has been performed over several days by using three different analyzers, and control
materials. The values are indicated as a coefficient of variation or range.
Parameter XN CHECK Level 1 XN CHECK Level 2 XN CHECK Level 3
WBC-C 10% or less 9% or less 9% or less
WBC-D 10% or less 8% or less 8% or less
RBC 5% or less 5% or less 5% or less
HGB 4% or less 4% or less 4% or less
HCT 10% or less 10% or less 10% or less
MCV 5% or less 5% or less 5% or less
MCH 9% or less 8% or less 8% or less
MCHC 15% or less 14% or less 14% or less
PLT 80% or less 15% or less 9% or less
RDW-SD 10% or less 10% or less 10% or less
RDW-CV 10% or less 10% or less 10% or less
MicroR 60% or less 70% or less 80% or less
MacroR 50% or less 40% or less 40% or less
PDW 80% or less 16% or less 12% or less
MPV within mean ± 9.0 fL 9% or less 7% or less
P-LCR within mean ± 30.0 P-LCR% 50% or less 50% or less
PCT 116% or less 30% or less 25% or less
NEUT% 20% or less 15% or less 15% or less
NEUT# 20% or less 15% or less 15% or less
LYMPH% 40% or less 20% or less 20% or less
LYMPH# 40% or less 20% or less 20% or less
MONO% 80% or less 60% or less 50% or less
MONO# 80% or less 60% or less 50% or less
EO% 50% or less 50% or less 50% or less
EO# 50% or less 50% or less 50% or less
BASO% 78% or less 78% or less 78% or less
BASO# 78% or less 78% or less 78% or less
IG% 30% or less 30% or less 25% or less
IG# 30% or less 30% or less 25% or less

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Accuracy
[Whole Blood] mode Indicated as the average of the difference between the value from analysis of at least
100 samples of peripheral blood, and the value from analysis using a standard
instrument.
WBC within ±3%, or within ±0.30 x 103/μL
RBC within ±2%, or within ±0.03 x 106/μL

Indicated as the average of the difference between the value from analysis of at least
100 samples of peripheral blood and the value from analysis using a standard
instrument or the international standard method (HGB standard analysis method of the
cyanmethemoglobin method based on the ICSH (International Council for
Standardization in Haematology)) advisory.
HGB within ±2%, or within ±0.2 g/dL

Indicated as the average of the difference between the value from analysis of at least
100 samples of peripheral blood and the value from analysis using a standard
instrument or the international standard method (standard analysis method based on
the ICSH (International Council for Standardization in Haematology)) advisory.
HCT within ±3%, or within ±1.0 HCT

Indicated as the average of the difference between the value from analysis of at least
100 samples of peripheral blood and the value from analysis using a standard
instrument.
MCV within ±3%, or within ±2.0 fL

Indicated as the average of the difference between the value from analysis of at least
100 samples of peripheral blood and the value from analysis using a standard
instrument or the international standard method (flow cytometry method based on the
ICSH (International Council for Standardization in Haematology)) advisory.
PLT within ±5%, or within ±10 x 103/μL

Indicated as the average of the difference between the value from analysis of at least
100 samples of peripheral blood and the value from analysis using a standard
instrument.
MicroR within ±20%, or within ±2.0 MicroR
MacroR within ±20%, or within ±2.0 MacroR
MPV within ±5%, or within ±1.0 fL (PLT 100 x 103/μL or more)
PCT within ±5%, or within ±0.03 PCT (PLT 100 x 103/μL or more)

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Accuracy (continued)
[Whole Blood] mode Indicated as a correlation coefficient with the reference data when 100 or more
(continued) samples of peripheral blood are analyzed. The reference data is a standard instrument
or standard analysis method of white blood cell 5 differentiation by flow cytometry.
NEUT% r = 0.90 or more
LYMPH% r = 0.90 or more
MONO% r = 0.75 or more
EO% r = 0.80 or more
BASO% r = 0.50 or more
IG% r = 0.80 or more

Indicated as the average of the difference between the value from analysis of at least
100 samples of peripheral blood and the value from analysis using a standard
instrument.
NEUT# within ±3%, or within ±0.30 x 103/μL
LYMPH# within ±3%, or within ±0.30 x 103/μL
MONO# within ±3%, or within ±0.30 x 103/μL
EO# within ±3%, or within ±0.30 x 103/μL
BASO# within ±3%, or within ±0.30 x 103/μL
NEUT% within ±3.0 NEUT%
LYMPH% within ±3.0 LYMPH%
MONO% within ±2.0 MONO%
EO% within ±1.0 EO%
BASO% within ±1.0 BASO%
IG# within ±3%, or within ±0.30 x 103/μL
IG% within ±1.5 IG%

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Accuracy (continued)
[Pre-Dilution] mode Indicated as the average of the difference between the value from analysis of at least
100 diluted samples of peripheral blood and the value from analysis using a standard
instrument.
WBC within ±10%, or within ±0.40 x 103/μL
RBC within ±8%, or within ±0.12 x 106/μL

Indicated as the average of the difference between the value from analysis of at least
100 diluted samples of peripheral blood and the value from analysis using a standard
instrument or the international standard method (HGB standard analysis method of the
cyanmethemoglobin method based on the ICSH (International Council for
Standardization in Haematology)) advisory.
HGB within ±5%, or within ±0.5 g/dL

Indicated as the average of the difference between the value from analysis of at least
100 diluted samples of peripheral blood and the value from analysis using a standard
instrument or the international standard method (standard analysis method based on
the ICSH (International Council for Standardization in Haematology)) advisory.
HCT within ±4%, or within ±2.0 HCT

Indicated as the average of the difference between the value from analysis of at least
100 diluted samples of peripheral blood and the value from analysis using a standard
instrument.
MCV within ±4%, or within ±3.0 fL

Indicated as the average of the difference between the value from analysis of at least
100 diluted samples of peripheral blood and the value from analysis using a standard
instrument or the international standard method (flow cytometry method based on the
ICSH (International Council for Standardization in Haematology)) advisory.
PLT within ±10%, or within ±20 x 103/μL

Indicated as the average of the difference between the value from analysis of at least
100 diluted samples of peripheral blood and the value from analysis using a standard
instrument.
MicroR within ±40%, or within ±3.0 MicroR
MacroR within ±40%, or within ±3.0 MacroR
MPV within ±7%, or within ±1.5 fL (PLT 100 x 103/μL or more)
PCT within ±7%, or within ±0.04 PCT (PLT 100 x 103/μL or more)

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Accuracy (continued)
[Pre-Dilution] mode Indicated as a correlation coefficient with the reference data when 100 or more diluted
(continued) samples of peripheral blood are analyzed. The reference data is a standard instrument
or standard analysis method of white blood cell 5 differentiation by flow cytometry.
NEUT% r = 0.70 or more
LYMPH% r = 0.70 or more
MONO% r = 0.60 or more
EO% r = 0.60 or more
BASO% r = 0.50 or more
IG% r = 0.80 or more

Indicated as the average of the difference between the value from analysis of at least
100 diluted samples of peripheral blood and the value from analysis using a standard
instrument.
NEUT# within ±10%, or within ±0.40 x 103/μL
LYMPH# within ±10%, or within ±0.40 x 103/μL
MONO# within ±10%, or within ±0.40 x 103/μL
EO# within ±10%, or within ±0.40 x 103/μL
BASO# within ±10%, or within ±0.40 x 103/μL
NEUT% within ±3.0 NEUT%
LYMPH% within ±3.0 LYMPH%
MONO% within ±2.0 MONO%
EO% within ±1.0 EO%
BASO% within ±1.0 BASO%
IG# within ±10%, or within ±0.40 x 103/μL

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Carryover
[Whole Blood] mode / Carryover is assessed by testing high levels of a parameter from peripheral blood or
[Pre-Dilution] mode control blood three times followed by a diluent with low levels of a parameter. High to
Low Carryover is calculated as follows:

(1st Low - 3rd Low)

Carryover = [ ] x 100
(3rd High - 3rd Low)

WBC-C 1.0% or less

WBC-D 1.0% or less
RBC 1.0% or less
HGB 1.0% or less
HCT 1.0% or less
PLT 1.0% or less
NEUT# 1.0% or less
LYMPH# 1.0% or less
MONO# 1.0% or less
EO# 1.0% or less
BASO# 1.0% or less
IG# 2.0% or less, or 0.05 x 103/μL or less

Note:
If a low level sample is analyzed after a high level sample, the analysis results may be affected by carryover
within the range of the carryover rate indicated in the table.

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Mode Comparison
For evaluating Mode Comparison, peripheral blood samples have been analyzed on an XN-L series device. A linear
regression analysis has been performed to judge the comparability of the different measurement modes on an XN-L
series device.
[Whole Blood] mode versus [Pre-Dilution] mode
Parameter Correlation coefficient (r) Average bias (%)
WBC-C 0.90 or more ±10
WBC-D 0.90 or more ±10
RBC 0.95 or more ±5
HGB 0.95 or more ±5
HCT 0.90 or more ±10
PLT 0.95 or more ±15
RDW-SD 0.90 or more ±20
RDW-CV 0.90 or more ±15
MicroR 0.60 or more ±50
MacroR 0.60 or more ±100
PDW 0.70 or more ±30
P-LCR 0.80 or more ±30
PCT 0.80 or more ±20
NEUT% 0.90 or more ±8
LYMPH% 0.90 or more ±10
MONO% 0.70 or more ±15
EO% 0.90 or more ±15
BASO% 0.40 or more ±80
IG% 0.40 or more ±80

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Method Comparison
For evaluating Method Comparison, peripheral blood samples have been analyzed on XN-L series and XN series.
A linear regression analysis has been performed to judge the comparability of two methods.
Parameter Correlation coefficient (r) Average bias (%)
WBC-C* 0.95 or more ±8
WBC-D 0.95 or more ±8
RBC 0.95 or more ±5
HGB 0.95 or more ±5
HCT 0.90 or more ±8
PLT 0.95 or more ±10
RDW-SD 0.90 or more ±10
RDW-CV 0.90 or more ±15
MicroR 0.60 or more ±50
MacroR 0.60 or more ±60
PDW 0.80 or more ±20
P-LCR 0.80 or more ±30
PCT 0.80 or more ±10
NEUT% 0.90 or more ±8
LYMPH% 0.90 or more ±15
MONO% 0.70 or more ±30
EO% 0.90 or more ±15
BASO% 0.50 or more ±80
IG% 0.40 or more ±80
* WBC-C is compared with WBC of XN series.

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Sample stability with time after blood collection

Parameter Stability Range Units 18 to 26°C 2 to 8°C
WBC within ±10.0% x 103/μL 72 hours -
6
RBC within ±5.0% x 10 /μL 72 hours -
HGB within ±5.0% g/dL 72 hours -
HCT within ±5.0% % 8 hours -
within ±8.0% % - 24 hours
within ±15.0% % 24 hours -
MCV within ±5.0% fL 8 hours -
within ±8.0% fL - 24 hours
within ±15.0% fL 24 hours -
PLT within ±10.0%, or within ±30 x 103/μL x 103/μL 48 hours -
MicroR within ±36.0%, or within ±2.0 MicroR % 8 hours -
within ±36.0%, or within ±2.0 MicroR % - 24 hours
MacroR within ±36.0%, or within ±2.0 MacroR % 8 hours -
within ±36.0%, or within ±2.0 MacroR % - 24 hours
NEUT% within ±8.0 NEUT% % 48 hours -
LYMPH% within ±7.0 LYMPH% % 48 hours -
MONO% within ±4.0 MONO% % 48 hours -
EO% within ±3.0 EO% % 48 hours -
BASO% within ±1.0 BASO% % - 12 hours
within ±1.0 BASO% % 24 hours -
IG% within ±2.0 IG% % 24 hours -

Note:
The sample used is stored at 18 to 26°C or in a refrigerator (2 to 8°C).
In the case of a refrigerated sample, the sample is returned to room temperature prior to analysis. Some
samples may not fall within the above range, depending on the storage conditions.

Software specifications
Data storage capacity Samples stored: 100,000 samples
Patient information: 10,000 records
Wards registered: 200 wards
Doctor names registered: 200 names
Analysis registration function: 2,000 records
Calibration log: 20 records per analyzer
QC files: 99 files per analyzer
(300 plots per file)
Reagent replacement log: 5,000 records
Maintenance log: 5,000 records
Quality control (QC) X-bar control (L-J control): 300 plots x 96 files
X-barM control: 300 plots x 3 files

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5.3 System limitations

5.3.1 Possible sample interferences

● WBC
If any of the following conditions are present, the system may erroneously report a low white blood cell count.
• Leukocyte aggregation

If any of the following conditions are present, the system may erroneously report a high white blood cell count.
• Platelet aggregation
• Poor hemolysis
• Erythroblast
• Erythrocyte aggregation (Cold agglutinin)
• Chylemia
• Cryoprotein
• Cryoglobulin
• Fibrin
• Giant platelets

● RBC
If any of the following conditions are present, the system may erroneously report a low red blood cell count.
• Erythrocyte aggregation (Cold agglutinin)
• Microerythrocytes
• Fragmented red blood cells

If any of the following conditions are present, the system may erroneously report a high red blood cell count.
• Leukocytosis (> 100,000/µL)
• Giant platelets

● HGB
If any of the following conditions are present, the system may erroneously report a high hemoglobin value.
• Leukocytosis (> 100,000/µL)
• Lipemia
• Abnormal protein

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● HCT
If any of the following conditions are present, the system may erroneously report a low hematocrit value.
• Erythrocyte aggregation (Cold agglutinin)
• Microerythrocytes
• Fragmented red blood cells

If any of the following conditions are present, the system may erroneously report a high hematocrit value.
• Leukocytosis (> 100,000/µL)
• Severe diabetes
• Uremia
• Spherocytosis

● PLT
If any of the following conditions are present, the system may erroneously report a low platelet count.
• Platelet aggregation
• Pseudothrombocytopenia
• Giant platelets

If any of the following conditions are present, the system may erroneously report a high platelet count.
• Microerythrocytes
• Fragmented red blood cells
• Fragmented leukocytes
• Cryoprotein
• Cryoglobulin

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Interfering substances
Whole blood interference - EDTA-2K
Interfering substances studies for Bilirubin C, Bilirubin F, Hemolytic Hemoglobin, Lipemia (intralipid) and Chyle
interferents were performed on the XN-L series.

A total of 6 whole blood EDTA-2K samples were collected from 3 donors each. All tubes were centrifuged and
150 µL of plasma removed from each. Each interferent was diluted to (0%, 20%, 40%, 60%, 80%, and 100%)
and then 150 µL of each dilution was added to the centrifuged tubes (from a single donor). The tubes were
mixed and measured 3 consecutive times for WBC, RBC, HGB, HCT, and PLT on the XN-L series.

Bilirubin C interference
There was no significant Bilirubin C interference up to a concentration of 42.2 mg/dL for WBC, RBC, HGB, HCT,
and PLT parameters.

Bilirubin F interference
There was no significant Bilirubin F interference up to a concentration of 40.0 mg/dL for WBC, RBC, HGB, and
HCT parameters, and up to a concentration of 8.0 mg/dL for PLT parameter.

Hemolysis interference
There was no significant hemolysis interference up to a concentration of 1018.0 mg/dL for WBC, RBC, HCT, and
PLT parameters, and up to a concentration of 203.6 mg/dL for HGB parameter.

Intralipid interference
There was no significant intralipid interference up to a concentration of 2.00 g/dL for WBC, RBC, and HCT
parameters, up to a concentration of 1.00 g/dL for PLT parameter, and up to a concentration of 0.20 g/dL for HGB
parameter.

Chyle interference
There was no significant chyle interference up to a concentration of 2800 FTU for WBC*1, RBC, HGB, and HCT
parameters, and up to a concentration of 1680 FTU for PLT parameter. A significant chyle interference at a
concentration of 560 FTU for WBC*2 parameter.

Allowable change rate:

The Allowable Change Rate is the allowable bias for each measurand. Bias outside the ranges listed below is
considered an interference.

WBC RBC HGB HCT PLT

Change rate within ±10.9% within ±3.2% within ±2.8% within ±2.8% within ±9.1%

The concentration that showed no significant interference was judged by the change rate based on the criteria
from the CLSI document H26-A2 under Biological variation (%CV) for all listed parameters.

*1 The white blood cell count calculated from the WDF channel (CBC+DIFF mode).
*2 The total white blood cell count calculated from the forward scattered light and the side scattered light of the
WDF channel (CBC mode).

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5.4 Supported sample tubes and sampler adapter

This section explains the sample tubes you can use with this instrument.

5.4.1 Supported sample tubes (XN-330)

● Regular sample tubes

Diameter (a) φ11 to 15 mm
Length (b) 85 mm or less
b

a
5.4.2 Supported sample tubes (XN-530/XN-430)

● Regular sample tubes b

Length including the cap (a) 70 to 85 mm

Diameter including the cap (b) φ11 to 15 mm
With the exception of micro analysis, use the tube with the cap on. a

Example: Sample tubes verified for correct operation

• VENOJECT II (Terumo)*
• Hemogard (BD)
• VACUETTE (Greiner)
• Monovette (SARSTEDT)

* Reusable caps cannot be used.

Risk of infection
Depending on the structure and material of the sample tube cap, the sample may ooze from the pierced
part of the cap.

Caution!
When performing sampler analysis using VENOJECT II (Terumo), fold the film seal so that it does not
protrude horizontally before placing in the rack.
Otherwise, there is a risk that the seal will interfere with an adjacent sample tube and cause it to fall from
the rack.

Note:
An adapter is needed when using a φ15 mm sample tube. For details, please contact your local Sysmex
service representative.
• For XN-530 manual analysis / XN-430 analysis: XS adapter_ ASSY (for φ15) 05357228
• For XN-530 sampler analysis: Adapter_ASSY No. 14 (15MM DIA) AR970823

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● Micro collection tubes

Standard micro collection tube shapes are shown below.
Compatible dimensions vary depending on the shape of the micro collection tube. The following are guidelines.
It will be necessary to check using the actual micro collection tube.

Type A Type B Type C

φ13 mm or less φ13 mm or less φ13 mm or less

36 to 46 mm
36 to 50 mm

28 to 48 mm

35 mm or more
35 mm or more

27 mm or more
φ8 mm or less

20 mm

8.5 mm
20 mm

φ9.8 to 10.8 mm φ10.0 to 11.0 mm

φ7.4 to 7.8 mm

The cap is not included in the dimensions. Open the cap during analysis.

Example: Sample tubes verified for correct operation

• CAPIJECT CJ-NA (Terumo)
• The BD Microtainer Tube with BD Microgard Closure 365974 (BD)
• CAPIJECT II CJ-2DK (Terumo)*
• MiniCollect 450532 (Greiner)*

* The analyzer needs an adjustment if using the CAPIJECT II and MiniCollect. Please contact your Sysmex
service representative.

● RBT micro collection tube (RBT: Raised Bottom Tube)

Micro collection tube that can be used for whole blood analysis on the XN-530 and XN-430. Allowable
dimensions are the same as for regular sample tubes.
When using for sampler analysis, close the cap.

Example: Sample tubes verified for correct operation

• Microtainer MAP363706 (BD)

Caution!
Do not use a non-specified sample tube.
For information on using sample tubes not described here, contact your Sysmex service representative.

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5.4.3 Supported sampler adapter

Regular sample tubes and RBT micro collection tubes can
only be used with a Sysmex sampler adapter.

50 mm

100 mm
85 mm

● Sample tube setup

Depending on the sample tube type, the metal fitting must be attached to the back of the sampler adapter.

Other regular sample tube

RBT micro collection tube

SARSTEDT sample tube

Protrusion
Metal
fitting

Example: Setup for other regular sample tubes

Caution!
• Use the sampler adapter with the metal fitting attached in the correct position for your sample tube type.
• Do not remove the attached metal fittings.
Reattaching metal fittings may cause screw loosening due to enlargement of screw holes.

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5.5 Barcode labels (XN-530)

To correctly read a barcode using a sampler, the barcode label
must be attached in the correct position. 5 mm or
Attach the barcode label to the sample tube so that the barcode more
is within the area shown on the right. Within
40 mm

5 mm or
21 mm or 16 mm or more
more more

Caution!
When attaching barcode labels, pay attention to the points below.
Incorrect attachment may cause barcode misreading and sample mix-ups.
• Attach the label so that the bars of the barcode are horizontal.
• Do not attach multiple labels.
• Do not allow the label to become wrinkled.
• Make sure that the label does not extend past the bottom of the sample tube.
• Make sure that the barcode label does not peel off the sample tube.
• Make sure that the labeled sample tubes can be inserted into and removed from the rack with ease.
• Do not write any text in the margins of a barcode label.

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5.6 ID barcode specifications

This section explains the specifications of barcode labels that can be read by the hand-held barcode reader and the
barcode reader on the XN-530 sampler.

5.6.1 Acceptable barcodes

The types of barcodes that can be used and check digit support are listed below.

Caution!
For the XN-530 only, use a check digit whenever possible when reading barcodes on sample tubes. There
is a risk of incorrect reading of the barcode if a check digit is not used. To set a check digit, see "Basic
Operation".
(➤Basic Operation, "Chapter 7: 7.9.4 Barcode reader settings (XN-530)")

Sample numbers
Barcode types Check digits Number of digits
ITF None Max. 22 digits (sample No.)
Modulus 10 Max. 21 digits (sample No.) + 1 digit (check digit) = Max. 22 digits
CODABAR/NW7 None Max. 22 digits (sample No.)
Modulus 11 Max. 22 digits (sample No.) + 1 digit (check digit) = Max. 23 digits
Weighted
modulus 11
Modulus 16
CODE39 None Max. 22 digits (sample No.)
Modulus 43 Max. 22 digits (sample No.) + 1 digit (check digit) = Max. 23 digits
JAN/EAN/UPC Modulus 10 12 digits (sample No.) + 1 digit (check digit) = 13 digits
ISBT128 Modulus 103 Max. 22 digits (sample No.) + 1 digit (check digit) = Max. 23 digits
CODE128 Modulus 103 Max. 22 digits (sample No.) + 1 digit (check digit) = Max. 23 digits

Information
When using CODE128, do not use the following codes.

Code CODE A CODE B Code CODE A CODE B

95 US DEL 101 FNC 4 CODE A
96 FNC 3 FNC 3 102 FNC 1 FNC 1
97 FNC 2 FNC 2 103 START(CODE A)
98 SHIFT SHIFT 104 START(CODE B)
99 CODE C CODE C 105 START(CODE C)
100 CODE B FNC 4

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Note:
In CODE128, any one of the characters "A", "B", "C", "a", "b" or "c" can be used for the start/stop code.

Quality control (QC)

Barcode types Check digits Number of digits
CODE128 Modulus 103 3 digits (fixed character string [QC-]) + 8 digits (lot
number) + 1 digit (check digit) = 12 digits

Note:
The CODE128 barcode for quality control is a special Sysmex code used for control blood.

5.6.2 Automatic assignment of sample numbers

A sample number is automatically assigned to samples when a barcode label read error occurs or when
analysis begins while the analysis order was still being downloaded.
An automatically assigned sample number starts with a symbol that distinguishes it from other sample numbers.

Number starting with [ERR.] Assigned when a barcode label read error occurs.
A barcode label read error also occurs when a number includes
characters that cannot be used. When a serial number is assigned and
the limit number is exceeded, the number returns to [00....01].
Number starting with [QC] Assigned to a QC sample with a lot number or to a QC file.
[BACKGROUNDCHECK] Assigned to a background check sample.
Number starting with [PRE-CHK] Assigned to a precision check sample.
Number starting with [CAL-CAL] Assigned to samples calibrated by calibrator calibration.

Information
Sample numbers starting with [QC] whose lower 4 digits are one of the following numbers are assigned.
• "1401", "1402", "1403": XN-L CHECK

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5.7 Functional descriptions

This device performs hematology analyses based on the Hydrodynamically focussed DC detection method, the flow
cytometry method (using a semiconductor laser), and SLS-hemoglobin method.

5.7.1 Analysis principles

Hydrodynamically focussed DC detection method

The RBC detector counts RBC and PLT via the Recovery tube
Hydrodynamically focussed DC detection method. Front sheath reagent
At the same time, the hematocrit (HCT) is calculated via the
RBC pulse height detection method.
Inside the detector, the sample nozzle is positioned in front of
the aperture and in line with the center. After diluted sample is
forced from the sample nozzle into the conical chamber, it is
surrounded by front sheath reagent and passes through the
aperture center.
After passing through the aperture, the diluted sample is sent Sample nozzle Aperture

to the recovery tube. This prevents the blood cells in this area
from drifting back, and prevents the generation of false platelet pulses. The Hydro Dynamic Focusing method
improves blood cell count accuracy and repeatability. Because the blood cells pass through the aperture in a
line, this method also prevents the generation of abnormal blood cell pulses.

Flow cytometry method using semiconductor laser

Cytometry is used to analyze physiological and chemical
characteristics of cells and other biological particles. Flow Blood cell

cytometry is a method used to analyze those cells and

particles as they are passed through extremely small flow Sheath reagent
cells.
Flowcell Sample nozzle
A blood sample is aspirated and measured, diluted to the
specified ratio, and labeled. The sample is then fed into the
flow cells by the sheath flow mechanism.
This mechanism improves cell count accuracy and repeatability. Since the blood cell particles pass in a line
through the center of the flow cell, the generation of abnormal blood pulses is prevented and flow cell
contamination is reduced.

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A semiconductor laser beam is directed onto the blood cells passing through the flow cell. The forward
scattered light, side scattered light and side fluorescence are captured by the relevant photodiode. These
lights are converted into electrical pulses, thus making it possible to obtain blood cell information.

Side Fluorescence
System
Photodiode

Spectral filter
Flow cell Side light collector
lens Semiconductor
laser
Forward Scattered
Light System

Photodiode Collimator lens

Forward light
Condenser lens
collector lens
Spectral filter
Side light collector
lens
Photodiode

Side Scattered Light

System

• Forward Scattered Light and Side Scattered Light

When obstacles pass through a light path, the light beam scatters from each obstacle in various directions.
This phenomenon is called light scattering. By detecting the scattered light, it is possible to obtain information
on cell size and material properties.
Likewise, when a laser beam is directed onto blood cell particles, light scattering occurs. The intensity of the
scattered light depends on factors such as the particle diameter and viewing angle. This instrument detects
forward scattered light, which provides information on blood cell size; and side scattered light, which provides
information on the cell interior (such as the size of the nucleus).

• Side Fluorescence
When light is directed onto fluorescent material, such as labelled blood cells, light of longer wavelength than
the original light is produced. The intensity of the fluorescence increases as the concentration of the marker
becomes higher. By measuring the intensity of the fluorescence emitted, you can obtain information on the
degree of blood cell labelling. Fluorescence is emitted in all directions. This instrument detects the
fluorescence that is emitted sideways.

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SLS-Hemoglobin Method
In the past, the mainstream methods for automatically measuring hemoglobin were the cyanmethemoglobin
method and oxyhemoglobin method. These methods have both advantages and disadvantages when they
are used with a large, fully automated instrument such as this instrument.
The cyanmethemoglobin method was recommended by the International Council for Standardization in
Haematology (ICSH) in 1966 as an international standard method. However, because the hemoglobin
conversion speed of this method is slow and multiple-sample processing is a requirement for automation, this
method is not appropriate for automatic analysis. Moreover, the method uses cyanide compounds, which are
poisonous, as reagents, and thus the liquid waste must be treated, making the method undesirable from an
environmental perspective.
Currently this is not considered to be an appropriate analysis method for a large fully automatic instrument
that discharges large amounts of liquid waste.

In contrast, the hemoglobin conversion speed of the oxyhemoglobin method is fast, as blood hemoglobin is
instantly converted into oxyhemoglobin. In addition, it does not use poisonous substances such as cyanide,
and thus is a suitable method for performing automatic analysis. The method cannot, however, convert
methemoglobin into oxyhemoglobin, which is not a problem for normal human blood, but will result in values
that are lower than the true values for samples that contain large amounts of methemoglobin, such as control
blood samples.

The SLS-hemoglobin method is an analysis method that makes use of the advantages of the two
aforementioned methods.
As with the oxyhemoglobin method, the hemoglobin conversion speed of the SLS-hemoglobin method is fast
and the method does not use poisonous substances, making it a suitable method for automation.
Further, since methemoglobin can be analyzed, control samples such as control blood containing
methemoglobin can also be accurately analyzed.

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5.7.2 Hydraulic diagram

Whole blood mode

Whole blood aspiration pump

CELLPACK DCL Optical detector

Fluorocell WDF
20 μL
* CBC+DIFF mode only

Reaction chamber

11.0 μL CBC mode (approx. 1:92)

Lysercell WDF
CBC+DIFF mode (approx. 1:94)
1.0 mL

FCM
Sheath fixed-quantity syringe

RBC detector

CELLPACK DCL 4.0 μL RBC/HGB sample chamber (approx. 1:501)

2.0 mL 1.0 mL

Diluted sample: 1.0 mL

Whole blood sample (25 μL)

SULFOLYSER
0.5 mL
HGB cell (approx. 1:751)

CELLPACK DCL

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Pre-dilution mode

Whole blood aspiration pump

CELLPACK DCL Optical detector

Fluorocell WDF
20 μL
* CBC+DIFF mode only

Reaction chamber

Lysercell WDF 38.0 μL CBC mode (approx. 1:191)

CBC+DIFF mode (approx. 1:195)
1.0 mL

FCM
Sheath fixed-quantity syringe

RBC detector

CELLPACK DCL 9.0 μL RBC/HGB sample chamber (approx. 1:1563)

2.0 mL 1.0 mL

Diluted sample: 1.0 mL

1:7 diluted sample (70 μL)

SULFOLYSER
0.5 mL
HGB cell (approx. 1:2340)

CELLPACK DCL

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5.7.3 Parameters and channels

WBC analysis

WDF channel
The WDF channel is a channel primarily for classifying white SFL
blood cells.
By flow cytometry method using a semiconductor laser, a
2-dimensional scattergram is drawn, with the X-axis Lymphocytes Monocytes

representing the intensity of the side scattered light (SSC),

and the Y-axis representing the intensity of the side Neutrophils
fluorescence (SFL). Eosinophils
This scattergram displays clusters of lymphocytes,
monocytes, eosinophils, neutrophils, basophils, and debris.
SSC
Basophils
Debris

RBC/PLT analysis

RBC distribution
The RBC (red blood cell count) is calculated as a particle count between 2 discriminators (lower discriminator
(LD) and upper discriminator (UD)), which are automatically set up in the ranges of 25 to 75 fL and 200 to 250
fL, respectively.
The particle size distribution is checked for abnormal relative frequencies at each discriminator level,
abnormal distribution width, and the existence of more than 1 peak.
In this instrument, the RBC distribution width (RDW) is expressed in the following 2 ways.

● RDW-SD
With the peak height assumed to be 100%, the distribution
width at the 20% frequency level is RDW-SD.
100%
The unit used is fL (femtoliter) (1 fL = 10-15 L).

20%

RDW

● RDW-CV
With points L1 and L2 found at a frequency of 68.26% of the
68.26% of total
total distribution area, RDW-CV is calculated from the distribution area
following equation:

L2-L1
RDW-CV (%) = x 100
L2+L1

(L1) (L2)

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● MCV (Mean cell volume)

The MCV is calculated from the RBC and HCT, using the following equation:
HCT (%)
MCV (fL) = x 10
RBC (x 106/μL)

● MCH (Mean cell hemoglobin)

The MCH is calculated from the RBC and HGB, using the following equation:
HGB (g/dL)
MCH (pg)= x 10
RBC (x 106/μL)

● MCHC (Mean cell hemoglobin concentration)

The MCHC is calculated from the HCT and HGB, using the following equation:
HGB (g/dL)
MCHC (g/dL) = x 100
HCT (%)

PLT particle size distribution

The PLT (platelet count) is measured as a particle count between 2 discriminators (lower discriminator (LD) and
upper discriminator (UD)), which are automatically set up in the ranges of 2 to 6 fL and 12 to 30 fL, respectively.
PLT particle size distributions are checked for abnormalities, including abnormal relative frequencies at the
lower discriminator, abnormal distribution widths, and the existence of more than 1 peak.

● PDW (Platelet distribution width)

With the peak height assumed to be 100%, the distribution
100% P-LCR
width at the 20% frequency level is PDW.
The unit used is fL (femtoliter) (1 fL = 10-15 L).

● P-LCR (Platelet-Large Cell Ratio)

The P-LCR is the ratio of large platelets that are larger than 20%
the 12 fL discriminator. It is calculated as a ratio comparing
the number of particles between the fixed discriminator (LD) (12 fL) (UD)
(12 fL) and UD, to the number of particles between LD and PDW
UD.

● MPV (Mean Platelet Volume)

The MPV is calculated from the following equation:

PCT (%)
MPV (fL) = x 1000
PLT (x 104/µL)

PCT: PCT is called the platelet hematocrit or platelet volume ratio, and is weighted toward the PLT frequency.

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Particle size distribution expression

The impression given by a particle size distribution can vary greatly, depending on the way in which it is
expressed. The width of a particle size distribution requires particular attention because it can appear
completely different, depending on the expression used for the distribution.
The instrument utilizes a conventional particle size distribution expression (normal expression) and a particle
size distribution expression method that enables the user to obtain a large amount of information from the
particle size distribution intuitively (normal cell size range expression).

● Normal expression
With the peak of the particle size distribution set as full scale (maximum height when the particle size
distribution is displayed), this method of expression normalizes and expresses the distribution.

• Features: Patterns of particle size distributions whose counts are different can be viewed on the
same scale.
Widths of particle size distribution can be compared intuitively.
• Supported display area: RBC and PLT particle size distributions

RBC PLT

● Normal cell size range expression

This method of expression does not consider the peak of the particle size distribution as the full scale
(maximum height when the particle size distribution is displayed). Instead, it normalizes the distribution, with
the peak of the normal cell size range, which was calculated empirically, set as the full scale. At the same
time, this method overlays the normal range of the particle size distribution.
If, however, the peak of the particle size distribution is higher than the peak of the normal cell size range, the
expression is made with the distribution peak set as full scale. In this case, the normal cell size range is
proportionally smaller than the height of the particle size distribution peak.
A normal cell size range can be obtained by superposing the particle size distributions of a large number of
healthy people and then utilizing the region from the 10th percentile to the 90th percentile.

• Features: The viewer can intuitively see the size of the particle count from the particle size
distribution.
If the particle size distribution deviates from the normal range, the viewer knows instantly
that the particle size distribution pattern is abnormal.
• Supported display area: RBC and PLT particle size distributions if settings are preset to normal range

RBC PLT

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Chapter 6 Supplies, Accessories, and Options

This chapter describes the supplies, accessories, and options.

6.1 Supplies

Part number Item name

26677681 Fuse 50T100H
05104711 Air pump set No. 1

6.2 Accessories

Part number Item name Quantity

AA835013 Intake Tube_ASSY No. 58 (For DCL 10 L) 1
CH037047 Intake Tube_ASSY No. 60 (For WDF 2 L bottle) 1
AE677153 Intake Tube_ASSY No. 62 (For SLS 500 mL bottle) 1
26571535 Power Cable TA-6P(A)+TA-5(A) H05VV-F 1 (XN-530: 2)
AF812533 Basic Operation 1
BA229091 Troubleshooting 1
AC044589 General Information 1
46235205 Brush (with cap) 1
46231221 Opener No. 2 (Use to open CELLPACK DCL) 1
26677681 Fuse 50T100H 2
44253387 Tube 6x4 2m
44253405 Tube 9x6 5m
26644618 Tie wrap CV-100 10
BL006232 Tray No. 258 (Bottle stand) 1
BT850247 Cap No. 559 (Special opener for CELLCLEAN AUTO) 1
CP976529 Adapter No. 328 (Sampler adapter) 2 (XN-530 only)
BQ750561 Interrupter plate No. 395 (Metal fitting) 2 (XN-530 only)
66387687 Phillips head tapping screw bind M3×8 2 (XN-530 only)
AY707257 TM104-SYX01 (Monitor) 1 (XN-530 only)
04315817 Cable No. 3497 (Anti-static electricity connector for RU port) 1
96308015 Cable No. 2188 (Anti-static electricity connector for waste 1
container full sensor)
BK659140 Label No. 1689 1 (XN-430/XN-330 only)

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6.3 Options

Item name Description

Graphic printer Prints lists of analysis information and results.
Prints distributions, scattergrams and other analysis results, and hard
List printer copies of screens.

Waste container full sensor Detects when the waste container is full.
Hand-held barcode reader Scans a barcode on a sample tube and automatically inputs the
sample number.
Pneumatic unit (PU-17) Supplies positive/negative pressure to the instrument.

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 Chapter 7 Reagents

Chapter 7 Reagents

This chapter describes the reagents that are used with the instrument.

7.1 General information

All reagents used in this instrument are exclusively for use with Sysmex equipment. Do not use them for any other
purpose. Please follow the warnings for handling and using each of the reagents correctly.

7.2 List of specified reagents

● Reagents
Storage Usage Shelf life after
Product name Composition
temperature temperature first opening
CELLPACK DCL 2 to 35°C 15 to 35°C 60 days Sodium chloride 0.7%
Tris buffer 0.2%
EDTA-2K 0.02%
CELLPACK DST 15 to 30°C 60 days Sodium chloride 15.7%
Tris buffer 4.3%
EDTA-2K 0.4%
SULFOLYSER 1 to 30°C 15 to 35°C 60 days Sodium lauryl sulfate 1.7 g/L
Lysercell WDF 2 to 35°C 90 days Organic quaternary ammonium salts 0.07%
Nonionic surfactant 0.17%
Fluorocell WDF 90 days Polymethine pigment 0.002%
Methanol 3.0%
Ethylene glycol 96.9%
CELLCLEAN AUTO 1 to 30°C — Sodium hypochlorite
(Effective chlorine concentration 5.0%)

● Control blood and calibrator

Storage Usage Shelf life after
Product name
temperature temperature first opening
XN-L CHECK 2 to 8°C 15 to 35°C 15 days
XN CAL 4 hours

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7.3 CELLPACK DCL

Intended use
For in vitro diagnostic use only
CELLPACK DCL is a reagent for measuring the numbers and sizes of RBC and platelets by the Hydrodynamically
focussed DC detection method. With the addition of the specified lyse reagent for hemoglobin concentration
determination, it can also be used to analyze hemoglobin concentration. Also it can be used as a sheath fluid for
FCM detector.
This reagent is to be used by connecting to an automatic hematology analyzer specified by Sysmex.

Warnings and precautions

Caution!
1. The reliability of the analysis values cannot be guaranteed if the reagent is used outside of the written
intended use, or not according to the written directions for use.
2. When replacing the reagent, do not refill and use the same container.
3. Handle the reagent with care to prevent air bubbles from forming. If air bubbles form, analysis may not
be performed normally.
4. Do not use expired reagents, as the reliability of the analysis values cannot be guaranteed.
5. If the reagent is removed after it has been connected (i.e. opened), it may become contaminated with
bacteria and other particles, causing its performance to deteriorate. Therefore, reconnecting an open
reagent is not recommended.
6. NEVER use this reagent on human body. Avoid contact with skin and eyes, and avoid ingestion. If it
comes in contact with the skin, rinse skin thoroughly. If it gets in the eye, rinse with large amounts of
water, and seek immediate medical attention. In the unlikely event that it was ingested, seek immediate
medical attention.

Examination procedure
Use CELLPACK DCL at 15 - 35°C. If an analysis is performed at a temperature over 35°C or under 15°C, you
may not be able to obtain accurate results. Connect the CELLPACK DCL container to the designated place on
the instrument. For details, see "Troubleshooting". (➤Troubleshooting "Chapter 2: 2.12 Replacing the reagent")

Storage and shelf life of unopened product

Storage and shelf life after first opening
Store CELLPACK DCL at 2 - 35°C, away from direct sunlight. If the reagent has not been opened, it can be kept
until the expiration date printed on the reagent container. For shelf life after opening (connecting to the
instrument), refer to the expiration date printed on the reagent container or reagent specifications.
(➤P.83 "7.2 List of specified reagents") Replace the reagent if it is showing signs of contamination or instability,
such as cloudiness or discoloration. If frozen, thaw and mix thoroughly before use.

Disposal procedures
1 If crushing the container when disposing of fluid, make sure that any remaining fluid has been completely
removed from the container before crushing.
2 Disposal procedures should meet requirements of applicable local regulations.

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7.4 CELLPACK DST

Intended use
For in vitro diagnostic use only
CELLPACK DST is a reagent for measuring the numbers and sizes of RBC and platelets by the Hydrodynamically
focussed DC detection method. With the addition of the specified lyse reagent for hemoglobin concentration
determination, it can also be used to analyze hemoglobin concentration. Also it can be used as a sheath fluid for
FCM detector.
This reagent is to be used by connecting to a reagent preparation device specified by Sysmex.

Warnings and precautions

Caution!
1. This reagent is a concentrated reagent. Use this reagent by connecting to a reagent preparation device
specified by Sysmex.
2. The reliability of the analysis values cannot be guaranteed if the reagent is used outside of the written
intended use, or not according to the written directions for use.
3. When replacing the reagent, do not refill and use the same container.
4. Handle the reagent with care to prevent air bubbles from forming. If air bubbles form, analysis may not
be performed normally.
5. Do not use expired reagents, as the reliability of the analysis values cannot be guaranteed.
6. If the reagent is removed after it has been connected (i.e. opened), it may become contaminated with
bacteria and other particles, causing its performance to deteriorate. Therefore, reconnecting an open
reagent is not recommended.
7. NEVER use this reagent on human body. Avoid contact with skin and eyes, and avoid ingestion. If it
comes in contact with the skin, rinse skin thoroughly. If it gets in the eye, rinse with large amounts of
water, and seek immediate medical attention. In the unlikely event that it was ingested, seek immediate
medical attention.
8. Before use, please read the Safety Data Sheet carefully.

Examination procedure
Use CELLPACK DST at 15 - 30°C. If an analysis is performed at a temperature over 30°C or under 15°C, you
may not be able to obtain accurate results. Connect the CELLPACK DST container to the designated place on
the reagent preparation device. For details, see "Troubleshooting".
(➤Troubleshooting, "Chapter 2: 2.12 Replacing the reagent")

Storage and shelf life of unopened product

Storage and shelf life after first opening
Store CELLPACK DST at 2 - 35°C, away from direct sunlight. If the reagent has not been opened, it can be kept
until the expiration date printed on the reagent container. For shelf life after opening (connecting to the
instrument), refer to the expiration date printed on the reagent container or reagent specifications.
(➤P.83 "7.2 List of specified reagents") Replace the reagent if it is showing signs of contamination or instability,
such as cloudiness or discoloration. Do not use a reagent that is suspected to have been frozen.

Disposal procedures
1 If crushing the container when disposing of fluid, make sure that any remaining fluid has been completely
removed from the container before crushing.
2 Disposal procedures should meet requirements of applicable local regulations.

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7.5 SULFOLYSER
Intended use
For in vitro diagnostic use only
SULFOLYSER is a reagent for the automated determination of hemoglobin concentration of blood with Sysmex
automated hematology analyzers.

Warnings and precautions

Caution!
Avoid contact with skin and eyes. In case of skin contact, flush the area with water. In case of contact with
eyes, rinse immediately with plenty of water and seek medical advice. If swallowed, seek medical advice
immediately.

Examination procedure
1. Allow the container of SULFOLYSER to equilibrate to environmental temperature (15 - 35°C).
2. Loosen and remove the cap on the SULFOLYSER container.
3. Attach the Dispenser Kit to the SULFOLYSER container. Tighten the cap. Connect the SULFOLYSER line
from the instrument to the Dispenser Kit.
4. Prime the SULFOLYSER through the hydraulic system of the instrument by cycling the instrument several
times in the whole blood mode to fill all SULFOLYSER tubing with reagent and to remove air bubbles in the
lines.
For details, see "Troubleshooting". (➤Troubleshooting, "Chapter 2: 2.12 Replacing the reagent")

Storage and shelf life of unopened product

Storage and shelf life after first opening
Store SULFOLYSER at 1 - 30°C, away from direct sunlight. If the reagent has not been opened, it can be kept
until the expiration date printed on the reagent container. For shelf life after opening (connecting to the
instrument), refer to the expiration date printed on the reagent container or reagent specifications. (➤P.83
"7.2 List of specified reagents") Replace the reagent if it is showing signs of contamination or instability, such
as cloudiness or discoloration.

Disposal procedures
1 If crushing the container when disposing of fluid, make sure that any remaining fluid has been completely
removed from the container before crushing.
2 Disposal procedures should meet requirements of applicable local regulations.

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7.6 Lysercell WDF

Intended use
For in vitro diagnostic use only
Lysercell WDF is a reagent used in combination with Fluorocell WDF. By hemolyzing red blood cells with
Lysercell WDF and dyeing the white blood cell components with Fluorocell WDF, the counts and percentages of
neutrophils, lymphocytes, monocytes, eosinophils, and basophils are analyzed. This reagent is to be used by
connecting to an automated hematology analyzer specified by Sysmex.

Warnings and precautions

Caution!
1. The reliability of the analysis values cannot be guaranteed if the reagent is used outside of the written
intended use, or not according to the written directions for use.
2. Handle the reagent with care to prevent air bubbles from forming. If air bubbles form, analysis may not
be performed normally.
3. Do not use expired reagents, as the reliability of the analysis values cannot be guaranteed.
4. If the reagent is removed after it has been connected (i.e. opened), it may become contaminated with
bacteria and other particles, causing its performance to deteriorate. Therefore, reconnecting an open
reagent is not recommended.
5. NEVER use this reagent on human body. Avoid contact with skin and eyes, and avoid ingestion. If it
comes in contact with the skin, rinse skin thoroughly. If it gets in the eye, rinse with large amounts of
water, and seek immediate medical attention. In the unlikely event that it was ingested, seek immediate
medical attention.

Examination procedure
Use Lysercell WDF at 15 - 35°C. If an analysis is performed at a temperature over 35°C or under 15°C, you may
not be able to obtain accurate counts and percentages of neutrophils, lymphocytes, monocytes, eosinophils,
and basophils. Connect the Lysercell WDF container to the designated place on the instrument. For details, see
"Troubleshooting". (➤Troubleshooting, "Chapter 2: 2.12 Replacing the reagent")

Storage and shelf life of unopened product

Storage and shelf life after first opening
Store Lysercell WDF at 2 - 35°C, away from direct sunlight. If the reagent has not been opened, it can be kept
until the expiration date printed on the reagent container. For shelf life after opening (connecting to the
instrument), refer to the expiration date printed on the reagent container or reagent specifications.
(➤P.83 "7.2 List of specified reagents") Replace the reagent if it is showing signs of contamination or
instability, such as cloudiness or discoloration. Do not use a reagent that is suspected to have been frozen.

Disposal procedures
1 If crushing the container when disposing of fluid, make sure that any remaining fluid has been completely
removed from the container before crushing.
2 Disposal procedures should meet requirements of applicable local regulations.

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7.7 Fluorocell WDF

Intended use
For in vitro diagnostic use only
Fluorocell WDF is to be used to label the leukocytes in diluted and lysed blood samples for determination of the
WBC differential with Sysmex automated hematology analyzers.

Warnings and precautions

Caution!
1. Wear gloves and a lab coat for protection. Avoid contact with skin and eyes.
2. In case of skin contact, rinse immediately with plenty of soap and water.
3. In case of contact with eyes, rinse immediately with water or normal saline, occasionally lifting upper and
lower lids until no evidence of dye remains. Obtain medical attention.
4. If swallowed, seek medical advice immediately.
5. Do not breathe vapor. In case of accident or you feel unwell, seek medical advice immediately (show the
label where possible).
6. Before use, please read the Safety Data Sheet carefully.

Examination procedure
1. Put a Fluorocell WDF cartridge in the prescribed position and then connect the Fluorocell WDF line.
2. Do not remove the IC tag until disposal. All the product information is managed by the IC tag on the label.
3. After setting, reset of the package is not recommended. Removing the reagent cartridge from the analyzer
may cause deterioration of the reagent by contamination and opening in a sealing film.
For details, see "Troubleshooting". (➤Troubleshooting, "Chapter 2: 2.12 Replacing the reagent")

Storage and shelf life of unopened product

Storage and shelf life after first opening
Store Fluorocell WDF in a dark place at 2 - 35°C. If the reagent has not been opened, it can be kept until the
expiration date printed on the package insert. For shelf life after opening (connecting to the instrument), refer to
the expiration date printed on the package insert or reagent specifications. (➤P.83 "7.2 List of specified
reagents") Do not use a reagent that is suspected to have been frozen.

Disposal procedures
1 Tightly seal the spout of a cartridge before disposing to prevent residual reagent solution leaks. You may use
tape to secure the spout.
2 Disposal procedures should meet requirements of applicable local regulations.

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7.8 CELLCLEAN AUTO

Intended use
For in vitro diagnostic use only
CELLCLEAN AUTO is to be used as a strong alkaline detergent to remove SYSMEX lysing reagent, cellular
residuals and blood proteins remaining in the hydraulics of XN series/XN-L series automated hematology
analyzer and SP-10 automated hematology slide preparation unit.

Warnings and precautions

Warning!
Avoid contact with skin and eyes. In case of skin contact, flush the area with water. In case of contact with
eyes, rinse immediately with plenty of water and seek medical advice.
Before use, please read the Safety Data Sheet carefully.

Storage and shelf life of unopened product

Storage and shelf life after first opening
Store CELLCLEAN AUTO at 1 - 30°C, away from direct sunlight.
Do not use a reagent that is suspected to have been frozen.

Disposal procedures
1 After use, there will be a hole in the film that seals the top of the tube. Exercise caution, as residual fluid may
leak from the hole.
2 Disposal procedures should meet requirements of applicable local regulations.

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7.9 Control blood (XN-L CHECK)

Intended use
For in vitro diagnostic use only
XN-L CHECK is intended to be used as a control for complete blood cell count (CBC), white blood cell
differential and reticulocyte parameters on Sysmex XN-L series instruments.

Warnings and precautions

Risk of infection
Always wear protective garments and gloves when using control blood. Also, wash your hands after
completing the process.
The basic blood used in the control blood has tested negative for HBs antigen, HCV/HIV-1/HIV-2
antibodies, and serologic tests for syphilis. However, there are no tests that can completely rule out any
infections. In addition, it has not been tested for other viruses. Therefore, handle the control blood with the
same level of care you would use when handling other blood samples that may be infectious.

Caution!
1. Minimize the time that the product is left at room temperature.
Leaving the product at room temperature for a prolonged period of time will cause deterioration.
2. If suspected to have been frozen, the product cannot be used, as analysis results will be affected.

Storage and shelf life of unopened product

Storage and shelf life after first opening
Store the control blood in a dark refrigerated place at 2 - 8°C.
If it has not been opened, the product can be kept until the expiration date printed on the vial label and outer box.
For shelf life after opening, refer to the package insert or reagent specifications. (➤P.83 "7.2 List of specified
reagents")

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7.10 Calibrator (XN CAL)

Intended use
For in vitro diagnostic use only
Used for the calibration of the analyzer for WBC, RBC, HGB, HCT, and PLT.

Warnings and precautions

Risk of infection
Always wear protective garments and gloves when using calibrator. Also, wash your hands after
completing the process.
The basic blood used in the calibrator has tested negative for HBs antigen, HCV/HIV-1/HIV-2 antibodies,
and serologic tests for syphilis. However, there are no tests that can completely rule out any infections. In
addition, it has not been tested for other viruses. Therefore, handle the control blood with the same level of
care you would use when handling other blood samples that may be infectious.

Caution!
1. Minimize the time that the product is left at room temperature.
Leaving the product at room temperature for a prolonged period of time will cause deterioration.
2. If suspected to have been frozen, the product cannot be used, as analysis results will be affected.

Storage and shelf life of unopened product

Storage and shelf life after first opening
Store the calibrator in a dark refrigerated place at 2 - 8°C.
If it has not been opened, the product can be kept until the expiration date printed on the vial label and outer box.
For shelf life after opening, refer to the package insert or reagent specifications. (➤P.83 "7.2 List of specified
reagents")

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 Chapter 8 Service Data and Research Parameters

Chapter 8 Service Data and Research Parameters

This chapter describes service data and research parameters.

8.1 Checking service data

Service data of samples within the [Sample Explorer] list can be reviewed by selecting the [Service] tab of the [Data
Browser] screen*.

* Even when the data is masked in other confirmation screens, the values are displayed. When analysis is not
executed on the channel for which the displayed item is measured, the data is not displayed.

Information
Data displayed on the [Service] tab is for the purpose of monitoring the status of the instrument. These data
must not be used for diagnosis of patients.

Touch the [Service] tab in the [Data Browser] screen to display the following screen.

Service data

[Data Browser] screen ([Service] tab)

The [Service] tab consists of 4 screens. To change the screen, touch the [Switch] button on the toolbar and change
using the submenu that appears.

[RBC/PLT] Displays the details of RBC/PLT data.

[WDF] Displays the details of WDF data.
[HARDWARE] Displays the details of HARDWARE data.
[ADJUSTMENT] Displays the details of ADJUSTMENT data.

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8.1.1 [RBC/PLT] service data

To display the information below, touch the [Switch] button - [RBC/PLT] on the toolbar.

[Sampling Data] This sampling data is used to monitor the occurrence of sudden noise. If the difference
between the maximum value and the minimum value constitutes a proportion of the total
sampling value that exceeds the specified range, a sampling error will occur.
• The particle count of the RBC/PLT channel measured at fixed intervals appears in the
column below [RBC] and [PLT].
• The data of maximum of 32 measurements is displayed.
• The total particle count appears at the bottom of the table.
• The total count is normalized by a multiple of the value in the parentheses so that the
total particle count falls into the range of 0 to 9999.
[Reference Data]
[R-MFV] Most frequent value for the red blood cell volume. (Units: fL)
[P-MFV] Most frequent value for the platelet volume. (Units: fL)
[L-MCV] MCV of the larger distribution of the 2 peak RBC distributions.
[S-MCV] MCV of the smaller distribution of the 2 peak RBC distributions.
[L-RBC] The red blood cell count of the larger distribution of the 2 peak RBC distributions.
[S-RBC] The red blood cell count of the smaller distribution of the 2 peak RBC distributions.
[PLT-I] The platelet count measured from the RBC/PLT channel (PLT distribution).
[Discri]
[RBC-LD] The position of the lower discriminator of the RBC distribution. (Numerical value from 0 to
49 with 49 full scale)
[RBC-MD] The position of the discriminator that separates the 2 peak RBC distributions into a
distribution with a smaller MCV and a distribution with a larger MCV.
(Numerical value from 0 to 49 with 49 full scale)
[RBC-UD] The position of the upper discriminator of the RBC distribution. (Numerical value from 0
to 49 with 49 full scale)
[PLT-LD] The position of the lower discriminator of the PLT distribution. (Numerical value from 0 to
39 with 39 full scale)
[PLT-UD] The position of the upper discriminator of the PLT distribution. (Numerical value from 0 to
39 with 39 full scale)
[HGB] Hemoglobin values appear in 4 formats in the right column.
[Sample] Optical density of the sample converted by A/D conversion.
[Blank] Optical density of a blank sample converted by A/D conversion.
[Distribution]
[RBC] If the RBC distribution is abnormal, abnormal distribution information will be displayed.
[PLT] If the PLT distribution is abnormal, abnormal distribution information will be displayed.
[RBC]
[Clog] Electronically detected numerical value indicating the amount of clogging in the RBC
detector.
[Bubble] Electronically detected numerical value indicating the amount of air bubbles in the RBC
detector.

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8.1.2 [WDF] service data

To display the information below, touch the [Switch] button - [WDF] on the toolbar.

[Sampling Data] This sampling data is used to monitor the occurrence of sudden noise. If the difference
between the maximum value and the minimum value constitutes a proportion of the total
sampling value that exceeds the specified range, a sampling error will occur.
• The particle count of the WDF channel measured at fixed intervals appears in the
column below [WDF].
• The data of maximum of 16 measurements is displayed.
• The total particle count appears at the bottom of the table.
• The total count is normalized by a multiple of the value in the parentheses so that the
total particle count falls into the range of 0 to 9999.
[Scattergram Sensitivity]
[WDF-X] The side scattered light intensity of the WBC area in the WDF scattergram.
[WDF-Y] The fluorescence intensity of the WBC area in the WDF scattergram.
[NE-SSC] The side scattered light intensity of the NEUT area in the WDF scattergram.
[NE-SFL] The fluorescence intensity of the NEUT area in the WDF scattergram.
[WDF-WX] The side scattered light distribution width index of the WBC area in the WDF scattergram.
[WDF-WY] The fluorescence distribution width index of the WBC area in the WDF scattergram.
[LY-X] The side scattered light intensity of the LYMPH area in the WDF scattergram.
[LY-Y] The fluorescence intensity of the LYMPH area in the WDF scattergram.
[Reference Data]
[WBC-D] The white blood cell count measured from the WDF channel.
[TNC-D] The total nucleated cell count (white blood cell count + nucleated red blood cell count)
measured from the WDF channel.
[DLT-WBCD] The ratio of WBC-D to WBC-C.
[iRBC-WDF#]* The iRBC particle count measured from the WDF channel.
[Cell 1] Total particle count measured in the WDF channel.
[Cell 2] The particle count plotted in the WDF scattergram.
[Laser Current]
[LD driver] The current of the LD driver.

* The availability of analysis functions depends on your system configuration.

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8.1.3 [HARDWARE] service data

To display the information below, touch the [Switch] button - [HARDWARE] on the toolbar.

[Unit Counter] Displays the operation count of each unit.

• [Total] shows the operation count of the overall analyzer. [Piercer] displays the
operation count after piercer replacement.
[Temperature] Displays the temperature of each unit.
• [Environment Temp.] is the surrounding temperature.
[Pressure] Displays pressure data at any set monitor timing.
[Laser] The sum of the laser oscillation time is displayed.
[Aspiration Sensor] Data used for monitoring of blood aspiration is displayed.
[RBC/HGB Drain Data used for monitoring of RBC/HGB analysis sample discharge is displayed.
Sensor]

8.1.4 [ADJUSTMENT] service data

A list of the items used for sensitivity adjustment appears in the ADJUSTMENT screen.
For items that are the same as in other screens, the same data is displayed.
To display the information below, touch the [Switch] button - [ADJUSTMENT] on the toolbar.

[WDF]
[WDF-X] The side scattered light intensity of the WBC area in the WDF scattergram.
[WDF-Y] The fluorescence intensity of the WBC area in the WDF scattergram.
[WDF-Z] The forward scattered light intensity of the WBC area in the WDF scattergram.
[LY-X] The side scattered light intensity of the LYMPH area in the WDF scattergram.
[LY-Z] The forward scattered light intensity of the LYMPH area in the WDF scattergram.

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8.2 Checking research parameters

Research parameters are displayed on a gray background on the [Sample Explorer] screen and the [Data Browser]
screen.

Information
Analysis results of research parameters are indicated by a gray background to distinguish them from diagnostic
parameters to be reported. Analysis results of research parameters must not be used for the diagnosis of patients.

8.2.1 WBC research parameters

The WBC research parameters below can be set to be displayed.

TNC The total nucleated cell count (white blood cell count + nucleated red blood cell count).
WBC-C The total white blood cell count measured from the forward scattered light and the
side scattered light of the WDF channel.
TNC-C The total nucleated cell count (white blood cell count + nucleated cell count)
measured from the forward scattered light and the side scattered light of the WDF
channel.
WBC-D The white blood cell count measured from the WDF channel.
TNC-D The total nucleated cell count (white blood cell count + nucleated red blood cell
count) measured from the WDF channel.
WBC-D&* The particle count obtained by subtracting iRBC from WBC-D.
NRBC# The nucleated red blood cell count.
NRBC% The ratio of the nucleated red blood cell count.
NEUT#& The particle count obtained by subtracting IG# from NEUT#.
NEUT%& The ratio of the particle count obtained by subtracting IG# from NEUT# to the white
blood cell count.
LYMP#& The particle count obtained by subtracting HFLC# from LYMPH#.
LYMP%& The ratio of the particle count obtained by subtracting HFLC# from LYMPH# to the
white blood cell count.
HFLC# The particle count of the upper LYMPH area in the WDF scattergram.
HFLC% The ratio of the particle count of the upper LYMPH area in the WDF scattergram to
the white blood cell count.
NE-SSC The side scattered light intensity of the NEUT area in the WDF scattergram.
NE-SFL The fluorescence intensity of the NEUT area in the WDF scattergram.
NE-FSC The forward scattered light intensity of the NEUT area in the WDF scattergram.
LY-X The side scattered light intensity of the LYMPH area in the WDF scattergram.
LY-Y The fluorescence intensity of the LYMPH area in the WDF scattergram.
LY-Z The forward scattered light intensity of the LYMPH area in the WDF scattergram.
MO-X The side scattered light intensity of the MONO area in the WDF scattergram.
MO-Y The fluorescence intensity of the MONO area in the WDF scattergram.
MO-Z The forward scattered light intensity of the MONO area in the WDF scattergram.

* The availability of analysis functions depends on your system configuration.

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 Chapter 8 Service Data and Research Parameters

NE-WX The side scattered light distribution width index of the NEUT area in the WDF scattergram.
NE-WY The fluorescence distribution width index of the NEUT area in the WDF scattergram.
NE-WZ The forward scattered light distribution width index of the NEUT area in the WDF scattergram.
LY-WX The side scattered light distribution width index of the LYMPH area in the WDF scattergram.
LY-WY The fluorescence distribution width index of the LYMPH area in the WDF scattergram.
LY-WZ The forward scattered light distribution width index of the LYMPH area in the WDF scattergram.
MO-WX The side scattered light distribution width index of the MONO area in the WDF scattergram.
MO-WY The fluorescence distribution width index of the MONO area in the WDF scattergram.
MO-WZ The forward scattered light distribution width index of the MONO area in the WDF scattergram.

8.2.2 RBC/PLT research parameters

The RBC/PLT research parameters below can be set to be displayed.

PLT-I The platelet count measured from the RBC/PLT channel (PLT distribution).

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 Index

Index

A H
Acceptable barcodes .........................................70 Hydraulic diagram ............................................. 75
Accessories........................................................81
Accuracy I
[Pre-Dilution] mode........................................57 ID barcode specifications .................................. 70
[Whole Blood] mode ......................................55 Installation ......................................................... 39
Analyzer .............................................................31 Preparing for installation ............................... 39
Aspirated sample volume Intended use ....................................................... 9
[Pre-Dilution] mode........................................44 Introduction ......................................................... 7
[Whole Blood] mode ......................................44
Automatically assigned numbers .......................71 L
Avoiding infection...............................................18 Laser ................................................................. 19
Laser class ........................................................ 43
B Limit of Blank, Limit of Detection, and Limit of
Barcode labels ...................................................69 Quantitation
Barcodes [Pre-Dilution] mode ....................................... 47
Quality control (QC).......................................71 [Whole Blood] mode ..................................... 47
Sample numbers ...........................................70 Linearity
[Pre-Dilution] mode ....................................... 49
C [Whole Blood] mode ..................................... 48
Calibrator ...........................................................91 Lysercell WDF ................................................... 87
Carryover
[Pre-Dilution] mode........................................59 M
[Whole Blood] mode ......................................59 Maintenance...................................................... 19
CELLCLEAN AUTO ...........................................89 Manuals............................................................. 11
CELLPACK DCL ................................................84 Markings on the instrument............................... 22
CELLPACK DST ................................................85 Measuring Interval and display range
Checking service data........................................93 [Pre-Dilution] mode ....................................... 46
Control blood......................................................90 [Whole Blood] mode ..................................... 45
Cybersecurity .....................................................21 Monitor .............................................................. 38

D N
Dimensions and weight Noise level......................................................... 43
Analyzer.........................................................43 Notice to the user .............................................. 30
Monitor (XN-530) ...........................................44
Disposal of materials..........................................19 O
Operating environment...................................... 43
E Operators .......................................................... 20
Electrical rating Options.............................................................. 82
Analyzer.........................................................43 Overview of the system....................................... 9
Monitor (XN-530) ...........................................44
Electromagnetic compatibility (EMC) .................17 P
Parameters........................................................ 10
F
Fluorocell WDF ..................................................88
Functional descriptions ......................................72

G
Grounding ..........................................................40

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100
 Index

Performance characteristics.............................. 45 Service data

Accuracy ....................................................... 55 [ADJUSTMENT]............................................ 96
Intermediate Precision .................................. 53 [HARDWARE] ............................................... 96
Limit of Blank ................................................ 47 [RBC/PLT]..................................................... 94
Limit of Detection .......................................... 47 [WDF]............................................................ 95
Limit of Quantitation...................................... 47 Software specifications
Linearity ........................................................ 48 Data storage capacity ................................... 62
Measuring Interval and display range........... 45 Quality control (QC) ...................................... 62
Method Comparison ..................................... 61 Storage conditions
Mode Comparison ........................................ 60 Analyzer ........................................................ 43
Precision (Repeatability)............................... 51 Monitor (XN-530) .......................................... 44
Precision (Reproducibility) ............................ 54 SULFOLYSER................................................... 86
Sample stability with time after blood Supplies............................................................. 81
collection.......................................... 62 Symbols used in the manuals ........................... 12
Software specifications ................................. 62 System limitations ............................................. 63
Total Analytical Error .................................... 50
Trueness....................................................... 50 T
Precision (Repeatability) Throughput
[Pre-Dilution] mode ....................................... 52 [Pre-Dilution] mode ....................................... 44
[Whole Blood] mode ..................................... 51 [Whole Blood] mode...................................... 44
Product specifications ....................................... 43 Trademarks ....................................................... 14
Analyzer........................................................ 43
Aspirated sample volume ............................. 44 X
Carryover ...................................................... 59 XN CAL ............................................................. 91
Monitor (XN-530) .......................................... 44 XN-L CHECK..................................................... 90
Throughput ................................................... 44

R
Reagents..................................................... 18, 83
List ................................................................ 83
Research parameters........................................ 97
RBC/PLT....................................................... 98
WBC ............................................................. 97

S
Safety information ............................................. 15
Safety standards ............................................... 43
Sample numbers ............................................... 71
Sample tubes (XN-330)..................................... 66
Sample tubes (XN-530/XN-430) ....................... 66
Sampler adapter................................................ 68

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 Legal information

Legal information
Importer to EU

Sysmex Europe SE

Bornbarch 1, 22848 Norderstedt, Germany

Phone: +49 40 5 27 26-0 / Fax: +49 40 5 27 26-100
www.sysmex-europe.com

Responsible person for United Kingdom of Great Britain and Northern Ireland

Oxford Gene Technology (Operations) Ltd.

Begbroke Science Park, Begbroke Hill, Woodstock Road,

Begbroke, Oxfordshire, OX5 1PF, UK

The system described in this manual is compliant with the Medical Devices
Regulations 2002.