Edition: 94

Chapter 1 Specifications
1.1 Name & Model.....................................................................................................................................1
1.1.1 Common Name..................................................................................................................1
1.1.2 Brand Name.......................................................................................................................1
1.1.3 Model .................................................................................................................................1

1.2 Definitions............................................................................................................................................1

1.3 Configurations and System Extendability ............................................................................................1

1.3.1 Analyzer Configurations.....................................................................................................1
1.3.2 Reagent Configurations .....................................................................................................3
1.3.3 Control Blood and Calibrator..............................................................................................7
1.3.4 Others ................................................................................................................................7

1.4 Interface with Other Instruments .........................................................................................................7

1.4.1 Analyzers ...........................................................................................................................8
1.4.2 Pneumatic Unit...................................................................................................................8
1.4.3 IPU .................................................................................................................................8

1.5 System Extendability (Peripherals)......................................................................................................9

1.5.1 Options...............................................................................................................................9

1.6 System Extendability (Software)..........................................................................................................9

1.6.1 System Variations ..............................................................................................................9
1.6.2 Security soft (Option) .........................................................................................................9

1.7 Intended Use .......................................................................................................................................9

1.7.1 Intended Use......................................................................................................................9
1.7.2 Average Number of Analysis .............................................................................................9
1.7.3 Special Mode Specifications ..............................................................................................9

1.8 Analysis Principle ..............................................................................................................................10

1.8.1 Blood Volumetric Method .................................................................................................10
1.8.2 WBC/NRBC/BASO Measurement ...................................................................................10
1.8.3 DIFF Measurement ..........................................................................................................10
1.8.4 WPC/HPC Detection........................................................................................................10
1.8.5 RET/PLT-O Measurement................................................................................................10
1.8.6 RBC/ PLT-I Measurement ................................................................................................10
1.8.7 HGB Measurement ..........................................................................................................10
1.8.8 PLT-F Measurement ........................................................................................................10

1.9 Measurement Parameters .................................................................................................................11

1.9.1 Measurement Mode and Required Sample Volume ........................................................11
1.9.2 Measurement Discret0 Mode and Measurement Channels.............................................12
1.9.3 Measurement Discrete Mode & Measurement Channels ................................................16
1.9.4 Size of RBC Detector Block aperture/nozzle and FCM Detector Block flow cell/nozzle ..16

1.10 Measurement & Display Ranges .....................................................................................................16

XN-1000/2000 S/M 1 July 2015

1.11 Reproducibility .................................................................................................................................16

1.12 Accuracy..........................................................................................................................................16
1.12.1 Blood Cell Count (WBC, RBC).......................................................................................16
1.12.2 Hemoglobin (HGB).........................................................................................................16
1.12.3 Hematocrit (HCT)...........................................................................................................16
1.12.4 Blood Cell Classifications (NEUT%, LYMPH%, MONO%, EO%, BASO%, IG%, NRBC) .....17
1.12.5 Reticulocyte Parameters (RET#, RET%, LFR, MFR, HFR, IRF, RET-He).....................17
1.12.6 Platelet Parameters (PLT, IPF%) ...................................................................................17

1.13 Linearity ...........................................................................................................................................17

1.14 Carryover.........................................................................................................................................17

1.15 Stability ............................................................................................................................................18

1.15.1 Temperature Stability .....................................................................................................18
1.15.2 Within Day Stability ........................................................................................................18
1.15.3 Day to Day Stability........................................................................................................18
1.15.4 Voltage Stability..............................................................................................................18
1.15.5 Within Day Stability after Collecting Blood .....................................................................18

1.16 Throughput ......................................................................................................................................18

1.16.1 Whole Blood (WB) Mode (Sampler Analysis, Manual Analysis, Micro Determination Anal-
ysis) ...............................................................................................................................18
1.16.2 Dilution Mode .................................................................................................................19

1.17 Reagent Consumption.....................................................................................................................20

1.18 Traceability ......................................................................................................................................20

1.19 Noise ...............................................................................................................................................20

1.20 Dimension and Weight ....................................................................................................................21

1.21 Environmental Requirements ..........................................................................................................21

1.22 Power Supply ..................................................................................................................................21

1.23 Safety Protection .............................................................................................................................21

1.24 Containers for Sample.....................................................................................................................22

1.24.1 Sample Tube (normal) ...................................................................................................22
1.24.2 Micro Tube .....................................................................................................................22

1.25 Analysis ...........................................................................................................................................22

1.26 Rinse Sequence ..............................................................................................................................23

1.27 Designed Life Time..........................................................................................................................23

1.28 Periodical Replacement...................................................................................................................23

1.28.1 Maintenance Items.........................................................................................................23
1.28.2 Periodical Maintenance Items........................................................................................24

XN-1000/2000 S/M 2 July 2015

1.29 Conditions of Storing .......................................................................................................................24

1.30 System Extendability .......................................................................................................................25

1.31 XN-10/XN-20/XN-11/XN-21 Special Analysis Mode ........................................................................30

1.31.1 Special Analysis Mode ...................................................................................................30
1.31.2 Definitions ......................................................................................................................30
1.31.3 Special Analysis Mode Configurations...........................................................................31
1.31.4 Body Fluid (BF) Mode ....................................................................................................31
1.31.5 HPC Mode .....................................................................................................................35
1.31.6 hsA Mode.......................................................................................................................38

XN-1000/2000 S/M 3 July 2015

Chapter 1 Specifications

1.1 Name & Model

1.1.1 Common Name
XN series

1.1.2 Brand Name

Automated Hematology Analyzer XN series

1.1.3 Model
XN-10 / XN-20
XN-11 / XN-21 (North America only)

2013135

1.2 Definitions
Analyzers (XN-10/XN-20, XN-11/XN-21) Module for analyzing samples.
IPU The computer for controlling each analyzers and managing data.
Samplers Sampler for moving racks to each analyzer.
Single Model Sampler (SA-10) A sampler with reanalysis functions which can connect 1 analyzer.
A sampler with reanalysis functions which can connect 2
Twin Model Sampler (SA-20)
analyzers.
Simplified Sampler (SA-01) A sampler withoug reanalysis functions.
Single Model (XN-1000) 1 analyzer with a sampler.
Twin Model (XN-2000) 2 analyzers with a sampler.

2013111 2013135

1.3 Configurations and System Extendability

1.3.1 Analyzer Configurations
1. There are 2 types of analyzers by hardware difference. A combination for each type of analyzers
and parameters are shown in the following table. Some part of analysis parameters can be
selected by parameters license.
XN-20 XN-10
XN-20[A1] XN-20[A2] XN-10[B1] XN-10[B2] XN-10[B3] XN-10[B4]
WNR      
RBC/PLT      
HGB      
Parameters

WDF      
WPC  
RET   ON OFF ON OFF
PLT-O △  △ OFF  OFF
PLT-F ON OFF ON ON OFF OFF

XN-1000/2000 S/M 1-1 April 2016

 WB, PD, Low
     
Analysis Mode
WBC Mode
BF Select Select Select Select Select Select
HPC Select Select

hsA Select Select Select Select

XN-21 XN-11
XN-21A1] XN-21[A2] XN-11[B1] XN-11[B2] XN-11[B3] XN-11[B4]
WNR      
RBC/PLT      
HGB      
Parameters

WDF      
WPC  
RET   ON OFF ON OFF
PLT-O △  △ OFF  OFF
PLT-F ON OFF ON ON OFF OFF
WB, PD, Low
     
Analysis Mode

WBC Mode
BF Select Select Select Select Select Select
HPC Select Select

hsA Select Select Select Select

2013135

: Equipped △ : Output as a research

ON: “Selected” by software OFF: “Not Selected” by software Select: Selective method by software
*Abbreviation words are as shown in the following table.
WB Whole Blood

PD Pre diluted

BF Body Fluid

HPC Hematopoietic Progenitor Cell

WNR WBC, NRBC

WDF WBC, DIFF

WPC WBC, Precuror Cell

DFL Diluent Florescence

PLT-F PLT Florescence

hsA High Sensitivity Analysis

2. Configuration examples with options

a. Twin Model (XN-2000)
(Analyzers x 2 + Twin sampler + IPU + Pneumatic Unit)
b. Single Model (XN-1000)
(Analyzer x 1 + Single Sampler + IPU + Pneumatic Unit)
c. Simplified Model (XN-1000)

XN-1000/2000 S/M 1-2 April 2016

 (Analyzer x 1 + Simplified Sampler + IPU + Pneumatic Unit)

313A006 2013111

1.3.2 Reagent Configurations

1. CELL PACK DCL
2. SULFOLYSER
3. LYSERCELL WNR
4. FLUOROCELL WNR
5. LYSERCELL WDF
6. FLUOROCELL WDF
7. LYSERCELL WPC
8. FLUOROCELL WPC
9. CELLPACK DFL
10. FLUOROCELL RET
11. FLUOROCELL PLT
12. CELLPACK DST (Concentrated)
13. CELLCLEAN (Sample tube type)
14. CELLSHEATH (C) (for XN-21/XN-11 only)
2013135

CELLSHEATH (C) cannot be shared with other instruments. CELLSHEATH (C) configurations
are as follows. 314A034

XN-2000 with RU-20 XN-2000 without RU-20

PU

PU
RU WPC DFL
WPC DFL

DST
CSC
SLS
TANK SLS

CSC DCL WDF

WDF

CSC CSC WNR

WNR

XN-1000/2000 S/M 1-3 April 2016

 [Reference]

XN-9000 (XN X 3, IPU) with RU-20 (No reagent share)

PU

WPC DFL

RU DST WPC DFL PU WPC DFL

IPU‐PC
SLS TANK
SLS SLS CT‐PC

WDF WDF WDF

CSC
CSC CSC
WNR WNR WNR

XN-9000 (XN X 3, IPU X 1) with RU-20 (Reagent share)

PU

RU
PU
DST

WPC DFL
IPU‐PC
TANK

SLS CT‐PC

WDF

CSC CSC
CSC
WNR

XN-9000 (XN X 3, IPU) without RU-20 (No reagent share)

PU PU

WPC DFL WPC DFL WPC DFL

IPU‐PC
CSC
CSC CSC
SLS SLS SLS CT‐PC

WDF WDF WDF

DCL DCL
WNR WNR DCL WNR

XN-1000/2000 S/M 1-4 April 2016

 XN-9000 (XN X 3, IPU) without RU-20 (Reagent share)

PU
PU

CSC WPC DFL

IPU‐PC

SLS CT‐PC

WDF

DCL CSC
CSC
WNR

XN-9000 (XN X 4, IPU X 2) with RU-20 (Reagent share)

PU PU

RU RU
DST DST

IPU‐PC
WPC DFL WPC DFL

TANK IPU‐PC
TANK
SLS SLS CT‐PC

WDF WDF

CSC CSC WNR CSC CSC WNR

Reagent Share Reagent Share

XN-9000 (XN X 4, IPU X 2) with RU-20 (Reagent share)

PU PU

DST
DST
RU WPC DFL RU WPC DFL IPU‐PC
WPC DFL WPC DFL
TANK TANK IPU‐PC

SLS SLS SLS SLS CT‐PC

WDF WDF WDF WDF

CSC WNR CSC WNR CSC WNR CSC WNR

XN-1000/2000 S/M 1-5 April 2016

 XN-9000 (XN X 4, IPU X 2) without RU-20 (No reagent share)

PU PU

CSC CSC
CSC CSC
WPC DFL IPU‐PC
WPC DFL WPC DFL WPC DFL

IPU‐PC

SLS SLS SLS SLS CT‐PC

WDF WDF WDF WDF

DCL
DCL
DCL
WNR DCL
WNR WNR WNR

XN-9000 (XN X 4, IPU X 2) without RU-20 (Reagent share)

PU CSC PU CSC
IPU‐PC
WPC DFL WPC DFL

IPU‐PC

SLS SLS CT‐PC

WDF WDF

CSC CSC
DCL DCL
WNR WNR

Reagent Share Reagent Share

XN-1000/2000 S/M 1-6 April 2016

1.3.3 Control Blood and Calibrator
1. Control Blood: XN CHECK
2. Control Blood for Body Fluid: XN CHECK BF (Level 1)
Control Blood for Body Fluid: XN CHECK BF (Level 2)
3. Calibrator: XN CAL (Including sensitivity calibration)
4. Calibrator for PLT-F: XN CAL PF

1.3.4 Others
1. Linearity Check Samples

1.4 Interface with Other Instruments

Figure 1

XN-1000/2000 S/M 1-7 April 2016

1.4.1 Analyzers
1. USB Controller for IPU Connection x 1
2. Pneumatic Unit Control Port x 1
3. AC Power Inlet Port x 1
4. Waste Tank with Filled-Water Sensor Port x 1
5. Reagent Chamber Port x 1
6. Indication Light Port x 1

1.4.2 Pneumatic Unit

1. Control Port x 1
2. AC Power Inlet Port x 1
3. IPU

1.4.3 IPU
The IPU specifications are as follows:
Operating System (OS) Windows 7 professional (32bit) English version

CPU 2.0GHz or higher. Must be a Dual Core.

Memory 4 GB

Hard Disk 160GB or higher

A Chassis supports 2 bays for RAID.

Chip Set High Precision Evet Timer (HPET) function is needed.

Software RAID

ACPI2.0 for supporting WOL (Supporting suspend power control S1 state

and S3 state)

BIOS USB power supply should be stopped by PC shut down, or having its setting.

Display 1920 x 1080 Wide Display with a speaker.

Touch Panel Option

Key Board / Mouse USB type or PS2 type can be used.

2 controllers are needed for connecting an analyzer and other equipment

USB Controller
(handheld barcode reader, printer, keyboard and mouse).

4 ports or moreneeded.

USB hub can be used. However, USB hub should operate by bus power on
PC for connecting an analyzer. (do not use self-power) It's necessary for
starting an analyzer from PC.

Parallel Port Use only for a data printer.

Serial Port Use only for connection between LIS and RS-232C.

Network Card (NIC) 2 ports are necessary for 100/1000baseT.

For direct connections to LIS, SNCS, remote access and others, or for
hospital management terminals service connections.

For LAS (HST-NEXT, WAM, Reagent supply instrument) connections. This

NIC should have “Wake On Lan” function.

XN-1000/2000 S/M 1-8 April 2016

1.5 System Extendability (Peripherals)
1.5.1 Options
1. Sampler (Including dock space)
2. Wagon for XN series without a reagent chamber
3. Wagon for XN series with a reagent chamber
4. Concentration reagent dilution unit (RU-20)
5. Touch panel, Monitor arm
6. Handheld barcode reader
7. DP Printer
8. GP /LP Printer
9. Waste tank with Filled-water detection sensor
10. Indication light

1.6 System Extendability (Software)

1.6.1 System Variations
Refer to”System Extendability (software)”

1.6.2 Security soft (Option)

Solid core

1.7 Intended Use

1.7.1 Intended Use
XN series analyze CBC item, DIFF item, RET related items and NRBC item in anticoagulant
for human blood. Anti-coagulant are EDTA-2K, EDTA-3K EDTA-2Na. Volume of anti-
coagulant conform to CLSI. This instrument also analyzes few cells in peripheral blood, or
samples excluding peripheral blood (body fluid, cord blood, Harvest) by special mode.

1.7.2 Average Number of Analysis

200 times a day (per 1 analyzer)

1.7.3 Special Mode Specifications

Refer to “1.32 XN-10/XN-20 Special Analysis Mode”

XN-1000/2000 S/M 1-9 April 2016

1.8 Analysis Principle
1.8.1 Blood Volumetric Method
Pipetting method using a syringe.

1.8.2 WBC/NRBC/BASO Measurement

The diluted samples for measuring WBC/NRBC/BASO are forced to the center of the
sheath reagent (CELLPACK) flowing in the flowcell by pushing with the volumetric
syringe. The specified volume of samples are measured in automatic discrimination to
analyze the forward scatter (FSC) and the side fluorescent light (SFL) by the Flow
Cytometry Method with using the semiconductor laser.

1.8.3 DIFF Measurement

The diluted sample for measuring DIFF is forced to the center of the sheath reagent
(CELLPACK) flowing in the flowcell by pushing with the volumetric syringe. The
specified volume of samples are measured in automatic discrimination to analyze the
side scatter (SSC) and the side fluorescent light (SFL) by the Flow Cytometry Method
with using the semiconductor laser.

1.8.4 WPC/HPC Detection

The diluted samples for measuring WPC/HPC detection are forced to the center of the sheath
reagent (CELLPACK) flowing in the flowcell by pushing with the volumetric syringe. The
specified volume of samples are measured in automatic discrimination to analyze the forward
scatter (FSC), side scatter (SSC) and the side fluorescent light (SFL) by the Flow Cytometry
Method with using the semiconductor laser.

1.8.5 RET/PLT-O Measurement

The diluted samples for measuring RET/PLT-O are forced to the center of the sheath reagent
(CELLPACK) flowing in the flowcell by pushing with the volumetric syringe. The specified
volume of samples are measured in automatic discrimination to analyze the forward scatter
(FSC) , the side scatter (SSC) and the side fluorescent light (SFL) by the Flow Cytometry
Method with using the semiconductor laser.

1.8.6 RBC/ PLT-I Measurement

The diluted samples for measuring RBC/PLT-I are forced to the center of the sheath reagent
(CELLPACK) flowing in the flowcell by pushing with the volumetric syringe. The specified
volume of sample particles pass through the 75 micrometer diameter pore, and are measured
by automatic discrimination by the sheath flow DC method.

1.8.7 HGB Measurement

The abosoption value of the transmitted light in the diluted sample is measured in every
analysis. The Hgb value is obtained by subtracting diluent converted value from the Hgb
diluted sample converted value. (Colorimetric method)
*Measurement Method: SLS-Hb method.

1.8.8 PLT-F Measurement

The diluted sample for measuring PLT-F detection is forced to the center of the sheath reagent
(CELLPACK) flowing in the flowcell by pushing with the volumetric syringe. The specified
volume of samples are measured in automatic discrimination to analyze the forward scatter
(FSC), side scatter (SSC) and the side fluorescent light (SFL) by the Flow Cytometry Method
with using the semiconductor laser.

XN-1000/2000 S/M 1-10 April 2016

 1.9 Measurement Parameters
1.9.1 Measurement Mode and Required Sample Volume

Each measurement mode is shown in the following table.

Asp. Required Blood

Outline Support
Volume Volume

Sampler Analysis*1  88μL 1mL

Basic measurement
mode for analyzing
human peripheral blood.
Manual Analysis  88μL 1mL
WB Mode Low
Low WBC mode needs
WBC Mode Micro Analysis*2  88μL 0.3 mL
3-times longer counting
time in basic
measurement mode Micro Analysis*3
 88μL 160μL
(Micro tube Measurement)

Sampler Analysis*1 - - -

Measurement Mode for Manual Analysis - - -

Dilution (PD) analyzing the prediluted
Mode blood sample by 7-times Micro Analysis*2  70μL 0.7mL
with CELLPACK (B1)
Micro Analysis*3 140μL
 70μL
(Micro tube Measurement) (After dilution)

Sampler Analysis*1 - - -

Measurement mode for

Manual Analysis  88μL 1mL
Body Fluid
analyzing WBC and
Mode Micro Analysis*2  88μL 0.7mL
RBC in the body fluid

Micro Analysis*3
 88μL 160μL
(Micro tube Measurement)
Measurement mode for
analyzing rare cells in
the peripheral blood, or
Special
samples besides the Refer to 1.32 XN-10/XN-20 Special Analysis Mode
Analysis Mode
peripheral blood (body
fluid, cord blood,
hervest)

: Supported -: Not Supported

*1: Sampler Measurement: Measurement with automatic sample tube transportation by the
sampler
*2: Micro analysis: Manual measurement with the cap-opened sample tube for reducing the
dead volume
*3: Micro analysis (Micro tube measurement): Measurement with a cap-opened micro tube.

XN-1000/2000 S/M 1-11 April 2016

1.9.2 Measurement Discret0 Mode and Measurement Channels
1. Whole Blood (WB) Mode
XN-20[A1], XN-21[A1]
Measurement Channels

RBC/PLT HGB WNR WDF WPC RET PLT-F

1    - - - -

2     - - -

3      - -

4       -

5    - -  -

6     -  -

7    - - - 

8     - - 

9      - 

10       

11    - -  

12     -  

XN-20[A2], XN-21[A2]
Measurement Channels

RBC/PLT HGB WNR WDF WPC RET PLT-F

1    - - - N/A

2     - - N/A

3      - N/A

4       N/A

5    - -  N/A

6     -  N/A

2013135

XN-1000/2000 S/M 1-12 April 2016

 XN-10[B3], XN-11[B3]
Measurement Channels

RBC/PLT HGB WNR WDF WPC RET PLT-F

1    - N/A - N/A

2     N/A - N/A

3    - N/A  N/A

4     N/A  N/A

XN-10[B4], XN-11[B4]
Measurement Channels

RBC/PLT HGB WNR WDF WPC RET PLT-F

1    - N/A N/A N/A

2     N/A N/A N/A

2. Low WBC Mode

(WDFch of WB mode needs 3-times longer of counting time. WBC is calculated from WDFch)
XN-20[A1], XN-21[A1]
Measurement Channles

RBC/PLT HGB WNR WDF WPC RET PLT-F

1     - - -

2      - -

3       -

4     -  -

5     - - 

6      - 

7       

8     -  

XN-20[A2], XN-21[A2]
Measurement Channels

RBC/PLT HGB WNR WDF WPC RET PLT-F

1     - - N/A

2      - N/A

3       N/A

4     -  N/A

2013135

XN-1000/2000 S/M 1-13 April 2016

 XN-10[B1], XN-11[B1]
Measurement Channels

RBC/PLT HGB WNR WDF WPC RET PLT-F

1     N/A - -

2     N/A  -

3     N/A - 

4     N/A  

XN-10[B2], XN-11[B2]
Measurement Channles

RBC/PLT HGB WNR WDF WPC RET PLT-F

1     N/A N/A -

2     N/A N/A 

XN-10[B3], XN-11[B3]
Measurement Channles

RBC/PLT HGB WNR WDF WPC RET PLT-F

1     N/A - N/A

2     N/A  N/A

XN-10[B4], XN-11[B4]
Measurement Channels

RBC/PLT HGB WNR WDF WPC RET PLT-F

1 P P P P N/A N/A N/A

3. PD Mode
XN-20[A1], XN-21[A1]
Measurement Channels

RBC/PLT HGB WNR WDF WPC RET PLT-F

1    - - - -

2     - - -

3     -  

2013135

XN-1000/2000 S/M 1-14 April 2016

 XN-20[A2], XN-21[A2]
Measurement Channles

RBC/PLT HGB WNR WDF WPC RET PLT-F

1    - - - N/A

2     - - N/A

3     -  N/A

XN-10[A2], XN-11[A2]
Measurement Channels

RBC/PLT HGB WNR WDF WPC RET PLT-F

1    - N/A - -

2     N/A - -

3     N/A  

XN-10[B2], XN-11[B2]
Measurement Channels

RBC/PLT HGB WNR WDF WPC RET PLT-F

1    - N/A N/A -

2     N/A N/A -

3     N/A N/A 

XN-10[B3], XN-11[B3]
Measurement Channels

RBC/PLT HGB WNR WDF WPC RET PLT-F

1    - N/A - N/A

2     N/A - N/A

3     N/A  N/A

XN-10[B4], XN-10[B4]
Measurement Channels

RBC/PLT HGB WNR WDF WPC RET PLT-F

1    - N/A N/A N/A

2     N/A N/A N/A

2013135
4. Body Fluid (BF) Mode
All Analyzers (Common)
Measurement Channels

RBC/PLT HGB WNR WDF WPC RET PLT-F

1  - -  - - -

XN-1000/2000 S/M 1-15 April 2016

1.9.3 Measurement Discrete Mode & Measurement Channels
Refer to Appendix 1

1.9.4 Size of RBC Detector Block aperture/nozzle and FCM Detector Block flow
cell/nozzle
RBC Detector Block RBC Detector Block FCM Detector Block FCM Detector Block
aperture nozzle flow cell nozzle

75 um (diameter) 0.2mm (diameter) 0.2mm (squared) 0.2mm (diameter)

2016051

1.10 Measurement & Display Ranges

Refer to Appendix 1

1.11 Reproducibility
Reproducibility is shown in Appendix A when the coefficient of variation is 95% confidence by mea-
suring fresh whole blood (NRBC = Nucleated Red Blood Cell, IG = Immature Granulocyte, RET-He
= more than RET# 2.0 x 104/μl), or control blood continuously measured more than 10 times. The
following parameters and measurement mode are shown in the table below.

Parameter /
Method
Measurement Mode

PLT-F
Diluted fresh blood or control blood used as samples
Low WBC Mode

Measuring abnormal samples of the fresh blood including NRBC and IG cells
NRBC% NRBC#
more than 5 times continuously. (Because volume of abnormal samples is
IG% IG#
limited)

1.12 Accuracy
1.12.1 Blood Cell Count (WBC, RBC)
When more than 100 fresh blood samples are measured after calibrating the instrument, the
average of these samples comparing to the same samples which run on the standard
instrument should be in range of Appendix 1.

1.12.2 Hemoglobin (HGB)

When more than 100 fresh blood samples are measured after calibrating the instrument, the
average of these samples comparing to the same samples which run on the standard
instrument or “*International Council for Standardization in Hematology” should be in range of
Appendix 1.
*ICSH (International Council for Standardization in Hematology) = Hemoglobin measurement
method by Cyanmethemoglobin method (HiCN).

1.12.3 Hematocrit (HCT)

When more than 100 fresh blood samples are measured after calibrating the instrument, the
average of these samples comparing to the same samples which run on the standard
instrument or “*International Council for Standardization in Hematology” should be in range of
Appendix 1.

XN-1000/2000 S/M 1-16 April 2016

1.12.4 Blood Cell Classifications (NEUT%, LYMPH%, MONO%, EO%, BASO%,
IG%, NRBC)
When more than 100 fresh blood samples or more than 20 NRBC, IG are measured, the
correlation coefficient comparing to the same samples run on the standard instrument should
be in range of Appendix A. Also, the average comparing to the same samples run on the
standard instrument should be in range of Appendix 1.

1.12.5 Reticulocyte Parameters (RET#, RET%, LFR, MFR, HFR, IRF, RET-He)
When more than 100 fresh blood samples, the correlation coefficient comparing to the same
samples run on the standard instrument or using a visual method (CLSI H44-A2) should be in
range of Appendix A. Also, the average comparing to the same samples run on the standard
instrument should be in range of Appendix 1.

1.12.6 Platelet Parameters (PLT, IPF%)

When more than 100 fresh blood samples including more than 20 of 50000/µL or less
platelets samples, or more than 10 of over 10% IPF samples are measured, the correlation
coefficient of PLT comparing to samples run on the FCM measurement method by ICSH, the
correlation coefficient of the IPF comparing to samples run on the XE-5000 should be in range
of Appendix 1.

*The reference method for platelet counting would be tested using FCM in the ICSH (International Council for
Standardization in Haematology) protocol. Am J Clin Pathol. 2001;1:115: 460-464.

1.13 Linearity
Residual (ratio) should be in range of Appendix 1 in specified concentration.

1.14 Carryover
Refer to Appendix 1

XN-1000/2000 S/M 1-17 April 2016

1.15 Stability
1.15.1 Temperature Stability
Using fresh blood samples or control blood, the fluctuation by the standard measurement
method should be in range of Appendix A. The ranges of temperature change should be 15°C
through 30°C in both of reagents and instruments.
Fresh blood samples should be collected within 12 hours.
The variation of samples should be subtracted from the variation ratio for the RET related
parameter.

1.15.2 Within Day Stability

Using control blood, the fluctuation by the standard measurement method should be in range
of Appendix 1.

1.15.3 Day to Day Stability

Using control blood, the fluctuation by the standard measurement method should be in range
of Appendix 1.

1.15.4 Voltage Stability

Using control blood, the fluctuation by the standard measurement method should be in range
of Appendix 1.

1.15.5 Within Day Stability after Collecting Blood

The variation after collecting *health human fresh blood should be in range of Appendix 1.
*In NRBC and IG, the blood samples which are detected each cell are targeted.

1.16 Throughput
1.16.1 Whole Blood (WB) Mode
(Sampler Analysis, Manual Analysis, Micro Determination Analysis)
CBC: 100 samples/1hour (95 samples/hour with simplified sampler)
CBC+DIFF: 100 samples / 1 hour [88 samples/ 1 hour]
CBC+DIFF+WPC: 88 samples / 1 hour [68 samples/ 1hour]
CBC+DIFF+ WPC +RET: 71 samples/1 hour [57 samples / 1 hour]
CBC+RET: 83 samples / 1 hour
CBC+DIFF+RET: 83 samples/ 1 hour [65 samples/1 hour]
CBC+PLT-F: 68 samples /1 hour
CBC+DIFF+PLT-F: 68 samples /1 hour [55 samples/1 hour]
CBC+DIFF+ WPC +PLT-F: 53 samples / 1 hour [45 samples/ 1 hour]
CBC+DIFF+ WPC +RET+PLT-F: 47 samples / 1 hour [41 samples / 1 hour]
CBC+RET+PLT-F: 47 samples / 1 hour
CBC+DIFF+RET+PLT-F: 47 samples/1 hour [41 samples/ 1 hour]
*[] = Low WBC counting mode

2013111

XN-1000/2000 S/M 1-18 April 2016

1.16.2 Dilution Mode
CBC: 90 samples/1 hour [All types]
CBC+DIFF: 90 samples/ 1 hour [All types]
CBC+DIFF+RET: 53 samples/ 1 hour [A2, B3]
CBC+DIFF+PLT-F: 52 samples / 1 hour [B2]
CBC+DIFF+RET+PLT-F: 39 samples/1 hour [A1, B1]

BF mode: 40 samples / 1 hour

XN-1000/2000 S/M 1-19 April 2016

1.17 Reagent Consumption
Reagent Consumption for WB analysis (Continuous analysis)
SLS WNR WDF WPC RET PLT-F CELLPACK
Total
Discrete Mode Lyse Dye Lyse Dye Lyse Dye Lyse Dye Dye DCL

CBC 0.5 1.5 0.02 0.0 0.00 0.0 0.00 0.0 0.00 0.00 27.9 29.92

CBC+DIFF 0.5 1.5 0.02 1.5 0.02 0.0 0.00 0.0 0.00 0.00 32.8 36.34

CBC+DIFF+WPC 0.5 1.5 0.02 1.5 0.02 1.5 0.02 0.0 0.00 0.00 38.9 43.96
CBC+DIFF+WPC
0.5 2.5 0.02 1.5 0.02 1.5 0.02 1.5 0.02 0.00 45.6 53.18
+RET
CBC+RET 0.5 2.5 0.02 0.0 0.00 0.0 0.00 1.5 0.02 0.00 37.5 42.04

CBC+DIFF+RET 0.5 2.5 0.02 1.5 0.02 0.0 0.00 1.5 0.02 0.00 40.1 46.16

CBC+ PLT-F 0.5 1.5 0.02 0.0 0.00 0.0 0.00 1.5 0.00 0.02 39.0 42.54
CBC+DIFF+PLT-
0.5 1.5 0.02 1.5 0.02 0.0 0.00 1.5 0.00 0.02 41.0 46.06
F
CBC+DIFF+WPC
0.5 1.5 0.02 1.5 0.02 1.5 0.02 1.5 0.00 0.02 47.5 54.08
+PLT-F
CBC+DIFF+WPC
0.5 2.5 0.02 1.5 0.02 1.5 0.02 3.0 0.02 0.02 53.7 62.80
+RET+PLT-F
CBC+RET+PLT-F 0.5 2.5 0.02 0.0 0.00 0.0 0.00 3.0 0.02 0.02 47.6 53.66
CBC+DIFF+RET
0.5 2.5 0.02 1.5 0.02 0.0 0.00 3.0 0.02 0.02 50.2 57.78
+PLT-F

*CBC includes WNRch counting

312K089

1.18 Traceability
Refer to the Appendix 1

1.19 Noise
60 dB or lower (with sampler)
Following noises are not included. It should be under 50dB in ready status (pneumatic unit stops
operation)
• Drainage sound of rinse cup
• Feed-in sound or Ejection sound of sample racks
• sound of clamping sample tubes or sound of releasing sample tubes
• Alarm sound

XN-1000/2000 S/M 1-20 April 2016

1.20 Dimension and Weight
Dimension and Weight
Dimension (W×D×H (mm)) Weight

Analyzer 300 x 640 x 790 49kg

IPU (data operation unit) depends on the PC spec depends on the PC spec

Pneumatic Unit 280 x 355x 400 17kg

Single Model 645 x 755 x 855 78kg

Twin Model 960 x 880 x 855 143 kg

Simplified Sampler 520 X 210 X 200 7kg

WG-10 652 X 934.2 X 706 85kg

WG-15 400.4 X 934.2 X 706 25kg

WG-15 (including RU-20) 400.4 X 979.2 X 706 25kg

WG-20 1052.4 X 934.2 X 706 110kg

WG-20 (including RU-20) 1052.4 X 934.2 X 706 110kg

2013111 201435

1.21 Environmental Requirements

• Ambient and reagent temperatures: 15°C - 30°C

• Relative humidity: 30% - 85% 20% - 85%

• Relative pressures: 70kPa - 106 kPa
• Installation location: Avoid from direct sunshine, dust, vibration and acid

315K066

1.22 Power Supply

• Voltage: AC 100V - 240 V
• Frequency: 50Hz / 60Hz
• Power consumption: see the following table.

Power consumption
Analyzers Pneumatic Unit

100V - 240V 100V - 120V 220V - 240V

50Hz 230 VA or lower 220 VA or lower

270VA or lower
60Hz 280 VA or lower 250 VA or lower

1.23 Safety Protection

Class I Instrument

XN-1000/2000 S/M 1-21 April 2016

1.24 Containers for Sample
1.24.1 Sample Tube (normal)
Height: 70mm - 85mm including caps, diameters:1 - 15mm not including caps.
The validated sample tubes are as follows:
Name Remarks

Venoject II (TERUMO) Recap cannot be used.

Hemoguard (BD)

VACUETTE (greiner)

Monovette (SARSTEDT)

1.24.2 Micro Tube

The validated sample tubes are as follows:
Name Remarks
Capiject (TERUMO)
Microtainer 365973 (BD)

1.25 Analysis
Modes and Analysis Procedure
Sampler Mode
Manual Mode
with Barcode Reader

WB Mode WB Mode Dilution Mode BF Mode

Sample tube
Sample tube Sample tube
Sample tube (normal) (normal)
Sample Tube (normal) (normal)
with cap Micro Tube
Micro Tube Micro Tube

Materials WB WB x7 diluted samples Body Fluid

<Analysis Procedure>

1. Switching Analysis Select the analysis mode (normal mode, diluent mode, BF
-
Mode mode) after switching to manual mode.
Input sample number, discrete and other.
2. Input sample
- (This procedure can be skipped when sample numbers and
number
discrete are read with analyzer internal barcode reader.)
Set the rack to the
3. Start analyzing Place the samples to the rack and press the start switch.
sampler

XN-1000/2000 S/M 1-22 April 2016

1.26 Rinse Sequence
Auto rinse (Background Check)
Measuring a background check will be extended when values are not in the range of the
following table. Extended cycle is up to 2 times (Maximum cycles for the background check is
3 times). If the value of the background check check of last cycle is not in the range of the
following table, background check error occurs.

Background Check Level

Parameter Range

WBC-N 1.0 x 102/µL or lower

WBC-D 1.0 x 102/µL or lower

WBC-P 1.0 x 102/µL or lower

RBC-I 2 x104 /µL or lower

HGB 0.1g /dL or lower

PLT-I 1.0 x104 /µL or lower

PLT-F 0.3 x104 /µL or lower

PLT-O 1.0 x104 /µL or lower

1.27 Designed Life Time

Useful Life 5 years

Number of standard 200 samples / 1 day (per 1 analyzer)

sample processing 100 samples / 1 day (for simplefied sampler)

200 samples per 1 day x 300 days per 1 year

x 5 years = 300,000 samples
Designed Life Time
100 samples per 1 day X 300 days per 1
year X 5 years = 150, 000 samples

2013111

1.28 Periodical Replacement

1.28.1 Maintenance Items
Description Period Method Operator
Piercer Once per 2 years (120,000 times) Replace User
FCM Sheath Syringe Seal Once per 2 years (260,000 times) Replace FSR
WB Syringe Seal Once per 2 years (120,000 times) Replace FSR
RBC Sheath Syringe Seal Once per 2 years (120,000 times) Replace FSR

XN-1000/2000 S/M 1-23 April 2016

1.28.2 Periodical Maintenance Items
Description Period Method Operator Required Time
Approximately 10
Operating automatically when minutes
Start up Once a day User
startup (When ambient
temperature = 23°C)
Place CELLCLEAN (sample tube
type) to the sampler.(By a setting, Approximately 15
Shut down Once a day User
a rinse sequence is executed and minutes
shut down automatically.)
Place CELLCLEAN (sample tube
type) to the sampler. (By a setting,
Once per 1000 Approximately 20
Rinse Sequence a rinse sequence is executed and User
analysis minutes
returns in ready state
automatically.)

1.29 Conditions of Storing

• Ambient temperature:-10°C - 60°C
• Relative Humidity: 20% - 95%
• Pressure: 70 kPa - 106kPa

2015089

XN-1000/2000 S/M 1-24 April 2016

1.30 System Extendability
The system variations supported by XN series are shown in table 1. Each system is connected to 1
IPU.
Table 1: System Variations

System Variations Descriptions

Twin Model
XE-2100 stand-alone system
equivalent
1 Analysis Equipment
(3 modules configuration)

Single Model
XT-2000i stand-alone system
equivalent
1 Analysis Equipment
(2 Modules configuration)

Conveyer Model
Conveyer system support
model

Configurable combinations with the Twin Model, Single Model and Conveyer Model
are shown in Table 2. These configurations are shown from one IPU, in whole
conveyer systems, each configuration, shown in “conveyer model” in table below,
might combine multiple systems. Refer to the “1.3.1 Analysis Configurations” about
analysis of A1, A2, B1, B2, B3, B4.

XN-1000/2000 S/M 1-25 April 2016

 Table 2: Analyzer Combination List (All patterns)
Model Combination Remarks

Twin Model CBC+DIFF+WPC+RET+PLT-F

CBC+DIFF+WPC+RET

CBC+DIFF+RET+PLT-F

CBC+DIFF+PLT-F

CBC+DIFF+RET

CBC+DIFF

CBC+DIFF+WPC+RET+PLT-F
Place A1 on the left side of the analyzer.

XN-1000/2000 S/M 1-26 April 2016

 Model Combination Remarks

CBC+DIFF+WPC+RET
Place A2 on the left side of the analyzer.

CBC+DIFF+RET+PLT-F
Place B1 on the left side of the analyzer.

CBC+DIFF+PLT-F
Place B2 on the left side of the analyzer.

CBC+DIFF+RET
Place B3 on the left side of the analyzer.

Single Model CBC+DIFF+WPC+RET+PLT-F

CBC+DIFF+WPC+RET

CBC+DIFF+RET+PLT-F

CBC+DIFF+PLT-F

XN-1000/2000 S/M 1-27 April 2016

 Model Combination Remarks

CBC+DIFF+RET

CBC+DIFF

Analyzer [B4, B4] (use for 1st check

Conveyer
only) + Analyzer [A1] (for 1st check &
Model reexamination)

Analyzer [B4, B4] (use for 1st check

only) + Analyzer [A2] (for 1st check &
reexamination)

Use for 1st check only

For 1st check & reexamination

Use for 1st check only

For 1st check & reexamination

Use for 1st check only

For 1st check & reexamination

XN-1000/2000 S/M 1-28 April 2016

 Model Combination Remarks

Use for 1st check only

For 1st check & reexamination

Use for 1st check only

For 1st check & reexamination

Use for 1st check only

For 1st check & reexamination

Use for 1st check only

For 1st check & reexamination

Use for 1st check only

For 1st check & reexamination

Use for 1st check only

For 1st check & reexamination

Use for 1st check only

For 1st check & reexamination

XN-1000/2000 S/M 1-29 April 2016

1.31 XN-10/XN-20/XN-11/XN-21 Special Analysis Mode
1.31.1 Special Analysis Mode
• The special analysis mode is an analysis mode for analyzing samples besides peripheral
blood (body fluid, marrow fluid, cord blood, harvest, blood products) or for analyzing
neonatal blood.
• Analysis channels and reagents used on this mode use same channels and reagents as
the normal analysis. However, analysis conditions (dilution rate, counting time) and
analyzing data method change according to each sample.
• When analyzing in the special analysis mode, a discrete of the analysis channels is fixed.

1.31.2 Definitions
Body Fluid: The fluid flowing in the biological body
In an expanded sense, blood, lymph fluid, and urine are parts of the body fluid,
however, body fluid means coelomic fluid in sample tests. The body fluid includes
Cerebrospinal fluid (CSF), pleural effusion (PE), abdominal dropsy, fluid of the
joint and others.
Total Nucleated Cell Number (TNC): Nucleated cell numbers included in the body fluid
sample, White blood cells, mesothelial cells, blood plasma cells, histiocyte,
neoplastic cells and other nucleated cells are included in the body fluid.

2013135

XN-1000/2000 S/M 1-30 April 2016

1.31.3 Special Analysis Mode Configurations
1. Configurations
• Body Fluid Mode
• HPC Mode
• hsA Mode

2. Descriptions of each mode

Configuration Description

WBC/TNC are counted and categorized by

WDF channel. Nucleated cells other than
WBC (mesothelial cell) are detected by
enlarging the fluorescence range of WDF
channel. The volume of body fluid analysis in
WDF channel is about 10µL. (Its volume is
10 times bigger than the XN series
Body Fluid Mode
WB mode or 4.4 times bigger than the
XE-500 BF mode.) RBC are counted
by the DC method transducer same as
the WB mode. The analyzed volume
of RBC in the BF mode is about 3.3
times bigger than the XN series
standard mode.

HPC Mode Calculating HPC# by WPC channel.

WBC/Neclear cells are counted or classified

on WDF channel. Counting volume is twice
as big as BF mode. RBC is computed with
hsA Mode DC transducer (counting volume is 3.3 times
bigger of XN series normal mode) and RET
channel (counting volume is 170.7 times
bigger of RET channel on XN series.)

313A006

1.31.4 Body Fluid (BF) Mode

a. Background
The blood cells in the body fluid (cerebrospinal fluid, hydrothorax, abdominal dropsy, synovia) have
been counted and categorized manually in the current situation. However, there are some issues
such as speed of analysis, difference of laboratory technicians, reliability of analysis results and
standardization of calculated data.
In the body fluid mode, XN-10/XN-20, has realized to get an enough analysis volume in the instru-
ment with a small amont of aspirated body fluid, and achieve a reliability of analysis data.

b. Sample Cells
• Cerebrospinal fluid: (CSF)
• Pleural fluid
• Ascites fluid
• Synovial fluid

XN-1000/2000 S/M 1-31 April 2016

 c. Analysis Purpose
• Cerebrospinal fluid:Conducting diagnosis of inflammatory affection of central nervous system
(cerebral meningitis, encephalitis, myelitis), and subarachnoid bleeding.
• Pleural fluid: Discriminating the exudate, the transudate, the acute inflammation and the
systemic disease
• Ascites fluid: Discriminating the exudate, the transudate, the acute inflammation and the
systemic disease
• Synovial fluid: Discriminating the inflammatory diseases (rheumatoid arthritis, gout, sep-
tic arthritis), and the non-inflammatory diseases (osteoarthritis, traumatic
arthritis).

d. Analysis Channels
RBC/PLT HGB WNR WDF WPC RET PLT-F

 - -  - - -

: Analysis channel

e. Scattergram
Scattergram: WDF Channel (including a fluorescent range sized area)
Histogram: RBC

f. Analysis Parameters, Display Range

Refer to Appendix 1

g. Reproducibility
Body fluid samples are not used for reproducibility test because body fluid deteriorate by time
advance and/or mixing. Checking the reproducibility by simulated samples created with
diluted human blood or diluted control blood.

i. WBC-BF and TC-BF#

(1) 0.05 - 0.15 x 102/µL : 30.0% or below
(2) 0.16 - 0.30 x 102/µL: 15.0% or below
(3) 0.31 - 0.50 x 102/µL: 10.0% or below

ii. RBC-BF
0.3 - 5.0 x 104/µL: 40.0% or below, or Max - Min ≤ 0.7 x 104/µL

h. Accuracy
In correlation tests using 50 or more body fluid samples, correlation coefficients (r) and slope
of regression lines should be as follows against the correlation (visual method)
• WBC - BFr ≥ 0.9 and slope of regression line: within 1± 0.3
• TC - BF#r ≥ 0.9 and slope of regression line: within 1± 0.3
• RBC - BFr ≥ 0.8 and slope of regression line: within 1 ± 0.3

XN-1000/2000 S/M 1-32 April 2016

 MN%, PMN%, MN#, PMN#
In correlation test using more than 50 body fluid samples, coefficient of correlation and slope
of regression line are as follows against correlation (categorized with visual method the slide
created by cytospin method).
• MN%r ≥ 0.7 and slope of regression line: within 1± 0.5
• PMN%r ≥ 0.7 and slope of regression line: within 1± 0.5
• MN#r ≥ 0.9 and slope of regression line: within 1± 0.5
• PMN#r ≥ 0.9 and slope of regression line: within 1± 0.5

i. Linearity
In specific concentration (analysis range), residual rate or residual errors or standard values
should be within a specific range. The linearity specification is based on the evaluation using
control blood.
(a). Analysis Range
• WBC-BF 0.00 - 100.00 x 102/µL when RBC are less than 100 x 104/µL
• TC-BF# 0.00 - 100.00 x 102/µL when RBC are less than 100 x 104/µL
• RBC-BF 0.0 - 500.0 x 104/µL

(b). Residual Error, Residual Rate

The residual error and the residual rate should be as follows against the diluent theoretical
value.
• WBC-BF: within(0 - 0.50 x 102/µL) ± 0.1 x 102/µL
within (0.50 - 100.00 x 102/µL) ± 20.0%
• TC-BF#: within (0 - 0.50 x 102/µL) ± 0.1 x 102/µL
within (0.50 - 100.00 x 102/µL) ± 20.0%
• RBC-BF: ± 2.0% or ±1.0 x 104/µL

j. Carryover
The carryover rate using artificial samples is as follows. (Adjusting WBC-BF and TC-BF to
100.00 x 102/µL, adjusting RBC-BF to 500.0 x 104/µL)
• WBC-BF: 0.3% or 0.01 x 102/µL or lower
• TC-BF#: 0.3% or 0.01 x 102/µL or lower
• RBC-BF: 0.3% or 0.3 x 104/µL or lower

*The background check is required if analysis results are as follows:

1. WBC-BR and TC-BF# > 100.00 x 102/uL
2. RBC-BF > 100.0 x 104/uL
3. When next analysis sample is low sample (such as CSF)

XN-1000/2000 S/M 1-33 April 2016

 k. Stability after collecting samples
Stability after collection is not specified due to changing the samples themselves over time
after collected.

l. Stability
(1) Time to Time Stability(Instrument Stability)
Variations are as follows:
• WBC-BF within 5.0%
• TC-BF# within 5.0%
• RBC-BF within 3.0%
(2) Day to Day Stability (Instrument Stability)
Variations are as follows:
• WBC-BF within 10.0%
• TC-BF# within 10.0%
• RBC-BF within 5.0%

m. Auto rinse (Background Check)

Repeating measurements until the value becomes within the following acceptable background
value. (up to 3 times)
If the value does not become under the acceptable background value in 3 times
measurements, the background error occurs.
• WBC-BF 0.01 x 102/µL or lower
• RBC-BF 0.3 x 104/µL or lower

n. Thoughput
40 samples / 1 hour

o. Required Sample Volume

Aspiration amount of samples 88mL
Necessary amount of samples 1mL

p. Requied Reagent Volume

CELLPACK DCL 52mL
LYSERCELL WDF 1.5mL
FLUOROCELL WDF 0.02mL

XN-1000/2000 S/M 1-34 April 2016

1.31.5 HPC Mode
a. background
Previously, stem cell source (bone marrow liquid, peripheral blood stem cell, cord blood) in
stem cell transfusion was measured or classified in FCM method. There was issues of cost,
speed, differences between technician or facility. In order to improve performance of
measuring stem cells with XN-10/XN-20 HPC Mode.

Following applications are expected.

- Providing information of collecting timing for stem cells.
- Providing information of apheresis production.
- Providing information of harvest stem cells.
- Test for coil blood

b. Sample
- peripheral blood (EDTA-2K)

c. Parameters
NO. Item Parameter Channel
Peripheral blood cells
1 HPC# WPC
number

Parameters obtained from other than WPC channel are same as whole blood mode.

Handling for reportable/research

China: Research
North America: Reportable
Europe and AP: Reportable

d. Method
Manual analysis (not available in sampler mode)
Micro analysis (blood test tube)
Micro analysis (micro tube)

e. Analysis channel and exclusive channel

On HPC mode, an exclusive channel is used. HPC# is measured on WPC channel. Other
parameters than HPC# are also provided.

Exclusive measurement sequence

On exclusive measurement sequence, sample is aspirated twice per one measurement.
First sample aspiration is used for whole blood analyasis and second aspiration is used for
HPC mode with WPC channel.

313A006

XN-1000/2000 S/M 1-35 April 2016

 Table 1: Channel
RBC
Channel WPC HGB WNR WDF RET PLT-F*
PLT
First sample      
aspiration (for Not Measured
other than HPC#) same measurement process as whole blood mode.


Second sample
aspiration (for WPC channel Not Measured
HPC#) sequence for
exclusive HPC mode

:Measurement channel
*: depends of instrument configuration

Table 2: Outline of WPC channel sequence for HPC mode (differences with whole blood mode)
Whole Blood
HPC mode Remarks
Mode
WPC Channel approx. 18
approx. 12 sec Proper time for HPC analysis
Reaction time sec
For improving reproducibility. 4 times
WPC Channel measurements for WPC channel.
4 times 1 times
measurement cycles A scattegram is produced from the result
of 4 times measurements.

Quality Control
HPC# is added to Whole blood mode QC.

WPC Scattergram
WPC scattergram is shown below. This is displayed in HPC screen.

Side Scattered(SSC)XFront Scattered (FSC)

XN-1000/2000 S/M 1-36 April 2016

 f. Performance
Reproducibility
The coefficient of variation by measuring 5 times with HPC existed sample should be in the
ranged as follows. Or, mean value should be in the range as follows.
Within 30% or within +/-15X102/µL

Accuracy
Average value of peripheral blood with more than 20 samples compared with reference
method (CD34) should be in the range as follows.
HPC#: Within 30% or within +/-10X102/µL

Carryover
Carryover ratio after measuring WBC high value sample (300.0X102/uL) should be in the
range as follows.
WBC-P: Within 0.5%

g Throughput
Processing Capability
3 min 41 seconds /sample (16 samples/ hour) [A1]
3 min 10 seconds /sample (18 samples/ hour) [A2]

Sample aspiration volume

190uL

Required sample volume

Sampler Mode: -
Manual Mode Measurement : 1mL
Micro analysis: 0.4mL
Micro analysis (micro tube) : 260uL

Required Reagent Volume

CELLPACK DCL: 93.5mL [A1]
82.9mL [A2]
CELLPACK DST: -
CELLPACK DFL: 3.0mL [A1]
1.5mL [A2]
SULFOLYSER: 0.5mL
LYSERCELL WNR: 2.5mL
LYSERCELL WDF: 1.5mL
LYSERCELL WPC: 4.5mL
FLUOROCELL WNR: 20uL
FLUOROCELL WDF: 20uL
FLUOROCELL RET: 20uL
FLUOROCELL PLT: 20uL [only A1]
FLUOROCELL WPC: 80uL

XN-1000/2000 S/M 1-37 April 2016

1.31.6 hsA Mode
a. Background
Placed as research parameter for WBC and RBC low value sample to improve reliability by
increasing measurement volume.

b. Supposed Sample
Cerebrospinal fluid CSF)
blood derivatives
platelet derivatives
concentrated RBC derivatives
plasma derivatives

c. Supposed purpose
Research purpose for low concentration blood sample (improvement for classification of
cerebrospinal fluid or blood derivatives QC management)

d. Channel
* depends of instrument configuration
RBC/PLT HGB WNR WDF WPC RET PLT-F

 - -  -  -

e.Displayed Scattergram
Scattergram: WDF channel (including fluorescence range)
Scattergram: RET channel
Histogram: RBC
f. Measurement parameter and display range
Following parameters are research parameters.

Parameters Display range Remarks

WBC: 0.000 - 9999.999X102/uL displayed to one decimal place for WBC-BF
RBC: 0.0000 - 9999.999X104/uL displayed to three decimal places for RBC-BF
RBC-O RBC-O is used when lower than 20.0000X104/uL
RBC-O: RBC-I is used when bigger than 20.0000X104/uL
RBC-I: 0.00 - 9999.999X104/uL displayed to one decimal place for RBC-BF
RBC-O0.0000 - 9999.999X104/uL displayed to three decimal places for RBC-BF
TC#: 0.000 - 9999.999X102/uL displayed to one decimal place for TC-BF#
MN#: 0.000 - 9999.999X102/uL displayed to one decimal place for BF mode
PMN#: 0.000 - 9999.999X102/uL displayed to one decimal place for BF mode
MN%: 0.0 - 100.0%
PMN%: 0.0 - 100.0%
HF#: 0.000 - 9999.999X102/uL displayed to one decimal place for HF-BF#
HF#: 0.0 - 9999.999X102/uL displayed to one decimal place for HF-BF#
LYMPH#: 0.000 - 9999.999X102/uL
LYMPH %: 0.0 - 100.0%
MONO#: 0.000 - 9999.999X102/uL
MONO%: 0.0 - 100.0%

313A009

XN-1000/2000 S/M 1-38 April 2016

 NEUT#: 0.000 - 9999.999X102/uL
NEUT%: 0.0 - 100.0%
EO#: 0.000 - 9999.999X102/uL
EO%: 0.0 - 100.0%

g. Reproducibility
Verify that the reproducibility using human-blood or control blood.

i) WBC and TC#

a. when 0.050 - 0.150X102/uL, within 20.0%
b. when 0.151 - 0.301X102/uL, within 10.0%
c. when 0.301 - 0.500X102/uL, within 7.0%

ii) RBC-I
When 0.3 - 5.0X104/uL, within 40.0% or Max-Min<=0.7X104/uL

iii)RBC-O
When 0.3000 - 40.0000X104/uL, within 3.0%

h. Accuracy
Not specify the accuracy as this is research parameter.

i. Linearity
i) Measurement range
WBC: 0.000 - 100.000X102/µL (when RBC is below 100.0X104/µL
TC#: 0.000 - 100.000X102/µL (when RBC is below 100.0X104/µL
RBC-I: 0.00 - 500.00X104/µL
RBC-O: 0.0000 - 50.0000X104/µL

ii) Residual ratio

Residual ratio to reference (residual value) should be as follows.
WBC: within ( 0.000 - 0.500X102/µL)±0.1X102/µL
Within ( 0.501 - 100.000X102/µL) ±20%
TC#: within ( 0.000 - 0.500X102/µL)±0.1X102/µL
Within ( 0.501 - 100.000X102/µL) ±20%
RBC-I: Within (0.00 ? 50.00X104/µL) ±1.0X104/µL
RBC-I: 50.01 - 500.00X104/µL ±2%
RBC-O: Within (0.0000 ? 40.0000X104/µL) ±1.0X104/µL

j. Carryover
WBC: within 0.01%
TC#: within 0.01%
RBC-I: 0.3% or within 0.3X104/µL
WBC-O: Within 0.01%

l. Stability
Stability relative to temperature
Not specify the Stability as this is research parameter.

Within-a-Day Stability
Not specify the Stability as this is research parameter.

XN-1000/2000 S/M 1-39 April 2016

 Within-a-Day Stability
Not specify the Stability as this is research parameter.

Stability relative to Power Supply Voltage

Not specify the Stability as this is research parameter.

m. Rinse and Blank Check

Measurement operation continues until background values fall within specified range up to 3
cycles.
Background error is displayed when background value does not fall within the specified range
after perofming maximum cycles.
WBC: within0.010X102/µL
RBC-I: within0.30X104/µL
RBC-O: within0.0100X104/µL

h. Processing Capability
3 min 238 seconds (17 samples/hour)

o. Required sample volume

Sample aspiration volume: 200µL
Required sample volume
Manual Mode Measurement: 1mL
Micro analysis: 0.4mL
Micro analysis (micro tube): 260uL

p. Required Reagent Volume

CELLPACK DCL: 71.6mL [A1]
CELLPACK DFL: 1.5mL
FLUOROCELL RET: 20uL
LYSERCELL WDF: 2.5mL
FLUOROCELL WDF: 40uL
LYSERCELL WNR: 2.0mL

XN-1000/2000 S/M 1-40 April 2016