Edition: 175

SECTION 1 SPECIFICATIONS
1.1 OUTLINE ....................................................................................................................................1

1.2 NAME..........................................................................................................................................1

1.3 Configuration and Expansion to the system ...............................................................................3

1.3.1 Variation .................................................................................................................................3
1.3.2 Configuration..........................................................................................................................3
1.3.3 Reagents................................................................................................................................3
1.3.4 Control Blood .........................................................................................................................4
1.3.5 Expansion to the system, and interface .................................................................................4

1.4 Performance Characteristics.......................................................................................................5

1.4.1 Intended Use..........................................................................................................................5
1.4.2 Measurement Principle ..........................................................................................................5
1.4.2.1 Size of RBC Detector Block aperture/nozzle and FCM Detector Block flow cell/nozzle .....6
1.4.3 Sample Aspiration Volume and required volume ...................................................................6
1.4.4 Analysis Mode and Throughput .............................................................................................7
1.4.5 Measurement, analysis Parameters.......................................................................................8
1.4.6 Analysis and Display Range ..................................................................................................9
1.4.7 Reproducibility........................................................................................................................9
1.4.8 Accuracy ................................................................................................................................9
1.4.9 Linearity................................................................................................................................10
1.4.10 Dilution Linearity...................................................................................................................10
1.4.11 Carryover .............................................................................................................................10
1.4.12 Difference between Manual Mode and Sampler Mode ........................................................10
1.4.13 Stability.................................................................................................................................11
1.4.14 Within-a-Day Stability after Collection of Blood....................................................................11
1.4.15 Detection Sensitivity of Immature Cell .................................................................................12
1.4.16 Required Reagent Volume ...................................................................................................13

1.5 FUNCTION ...............................................................................................................................14

1.5.1 Start Up ................................................................................................................................14
1.5.2 Calibration function ..............................................................................................................15
1.5.3 Quality Control Function.......................................................................................................16
1.5.4 Online QC Function (optional for SNCS) .............................................................................16
1.5.5 Discrete Analysis Function...................................................................................................16
1.5.6 Analysis Order Registration Function (Work Load List Function) ........................................17
1.5.7 Sampler Unit Function (When Sampler Unit OPSU-11 is installed.) ....................................17
1.5.8 Manual Mode Measurement Function..................................................................................21
1.5.9 Capillary Mode Measurement Function ...............................................................................21
1.5.10 Abnormal Sample Monitoring Function ................................................................................21
1.5.11 Abnormal Data Monitoring Function.....................................................................................22
1.5.12 Analysis Result Storage Function ........................................................................................22
1.5.13 Stored Data (Analysis Result) Processing Function.............................................................23
1.5.14 Stored Data Processing Function by Patient ID ...................................................................24
1.5.15 Patient Information Control Function....................................................................................24

XS Series S/M October 2017

 Edition: 175
1.5.16 Function corresponding to XT pro (Standard Function, equal to XT-1800i) .........................25
1.5.17 Available Languages............................................................................................................25
1.5.18 Shut Down Function.............................................................................................................25
1.5.19 Main Unit Status Display Function .......................................................................................25
1.5.20 Error Monitor Function .........................................................................................................25
1.5.21 Error Alerting Function .........................................................................................................25
1.5.22 Maintenance Function (Customer’s operation) ....................................................................26
1.5.23 Service Function (for Service or Production line).................................................................27
1.5.24 On-Line Support Function (SNCS Option) ...........................................................................27
1.5.25 Protection Function ..............................................................................................................27
1.5.26 Waste Tank Fluid Level Monitor Function (Optional)............................................................27

1.6 Maintenance Performance........................................................................................................28

1.6.1 Maintenance Performance (for Customer)...........................................................................28
1.6.2 Maintenance Item.................................................................................................................28
1.6.3 Service Items required at the fixed period (by Service Person) ...........................................28
1.6.4 Spare Parts ..........................................................................................................................28

1.7 Acoustic Noise ..........................................................................................................................29

1.8 Dimension and Weight ..............................................................................................................29

1.9 Required Conditions .................................................................................................................30

1.9.1 Environmental Requirements ...............................................................................................30
1.9.2 Voltage .................................................................................................................................30
1.9.3 Class and Type of Electrical Protection................................................................................30

1.10 Reliability...................................................................................................................................30
1.10.1 Designed Lifetime ................................................................................................................30

1.11 Packing Configuration...............................................................................................................31

1.12 Storage Condition .....................................................................................................................31

Appendix 1-1 Reproducibility, Accuracy (*: XS-1000iC, #:XS-500ix) [AR] ................................32

Appendix 1-2 Linearity, Dilution Linearity ..................................................................................34

Appendix 1-3 Carryover, Stability (*: XS-1000iC)......................................................................36

XS Series S/M October 2017

SECTION 1 SPECIFICAIONS
1.1 OUTLINE
(1) XS-1000i Close/Open unit
• XS-1000i can handle both open and closed mode for analysis.
• The tube with or without cap can be measured. The operator puts the tube to the sample holder.
• Optional auto sampler (20 tubes) is available.
(2) XS-800i
• XS-800i is open mode only.
• XS-800i is designed as the non-pierceable type to minimize the dead volume.
• The sample tube must be the open type and the operator is required to set the tube to the sample
probe for measurement.
• Optional auto sampler (20 tubes) is NOT available
(3) XS-1000iC (in addition to XS-1000i outline above)
• Designed to stabilize the MCV value for 48 hours after collection.
• CELLSHEATH (C) is used instead of CELLPACK.
• CELLSHEATH (C) is heated with a reagent heater.
(4) XS-500i
• XS-500i is open mode only.
• XS-500i is designed as the non-pierceable type to minimize the dead volume.
• The sample tube must be the open type and the operator is required to set the tube to the sample
probe for measurement.
• Optional auto sampler (20 tubes) is NOT available
(5) XS-500ix (Chinese Market Only) [AG]
• XS-500ix is open mode only.
• XS-500ix is designed as the non-pierceable type to minimize the dead volume.
• The sample tube must be the open type and the operator is required to set the tube to the sample
probe for measurement.
• Optional auto sampler (20 tubes) is NOT available
• Optional handy barcode reader is NOT available
(6) XS-900i Close/Open unit (Chinese Market Only)
• XS-900i can handle both open and closed mode for analysis.
• The tube with or without cap can be measured. The operator puts the tube to the sample holder.
• Optional auto sampler (20 tubes) is available.

[AG] 316I058

1.2 NAME
(1) Name
Automated Hematology Analyzer
(2) Model
XS-1000i
XS-1000iC (American Market Only)
XS-900i (Chinese Market Only)

XS Series S/M 1-1 October 2017

 XS-800i
XS-500i
(3) XS Sampler Unit OPSU-11

313D038

XS Series S/M 1-2 October 2017

1.3 Configuration and Expansion to the system

1.3.1 Variation

Available Cap piercer Auto sampler Handy

Sample Tube (with built-in Barcode Barcode
Reader) Reader
XS-1000i Close Standard Optional Optional
XS-1000iC Open
XS-900i
XS-800i Open - - Optional
XS-500i
XS-500ix [AG] Open - - -

1.3.2 Configuration
(1) Main Unit (without display)
(2) 20 samples Auto Sampler (Optional)
(3) IPU Specifications

OS Windows XP Windows Vista Windows 7

Professional Business Professional
CPU 1.5GHz or higher 1.5GHz or higher 2.0GHz or higher
RAM 512MB or more 512MB or more 1.0GB or more
HDD 20GB or more 20GB or more 80GB or more
Monitor XGA(1024x768)
Graphic support - DirectX10 or more DirectX10 or more
Drive CD-R Recorder
I/O LAN
USBx2 (GP/LP Printer, Barcode Reader)
Parallel port (DP Printer)
Serial port (Host)
LAN (additional) (Host)

1.3.3 Reagents
(1) CELLPACK
(2) STROMATOLYSER-4DL
(3) STROMATOLYSER-4DS
(4) SULOFOLYSER
(5) CELLCLEAN (Detergent)
(4 containers (excluding the detergent) are connected.)

TB 201265 313D038 [AG] 316I058

XS Series S/M 1-3 October 2017

1.3.4 Control Blood
(1) e-CHECK (for XS-1000i/XS-1000iC/XS-800i/XS-500i, XS-900i)
(2) e-CHECK(XE)
(3) Calibrator SCS-1000 (N.American Market: Customer use, other area: Service Person’s use only)

1.3.5 Expansion to the system, and interface

*IPU, devices connected to the IPU differ depending on each market.

313D038

XS Series S/M 1-4 October 2017

1.4 Performance Characteristics

1.4.1 Intended Use

This analyzer analyzes blood-counting parameters of human blood that is collected in anticoagulant.

The anticoagulants are EDTA-2K, EDTA-3K, and EDTA-2Na. The anticoagulant conforms to the NCCLS
(National Committee in Clinical Laboratory Standards)

1.4.2 Measurement Principle

(1) WBC/DIFF Measurement (CBC+DIFF Discrete)
a) WBC/DIFF measurement sample is prepared as below.
• Aspirate the specified sample volume.
• Dilute, hemolyze and dye the aspirated sample using Lyzing reagent and Dye reagent.
b) The prepared sample is pushed into the center of Sheath Flow by Volumetric Syringe.
c) The sample is measured by Flowcytometry method (same as XE-2100) using semiconductor
laser, and counted by 5DIFF auto-classification using the side scattered light and side fluores-
cence light.
(2) WBC Measurement (CBC Discrete)
The sample is measured by Flowcytometry method using semiconductor laser, and counted by
auto-classification from the front scattered light.
(3) RBC/PLT Measurement
RBC/PLT measurement sample is prepared by aspirating the specified volume and diluted by dilu-
ent.
RBC/PLT measurement sample is pushed into the flow cell by Volumetric Syringe.
Specified volume of sample goes through the aperture of 75um diameter, and RBC/PLT is counted
by Sheath Flow DC Detection Method and Automatic Discrimination Method.
(4) HGB measurement
HGB measurement sample is prepared by aspirating the specified volume, diluted and hemolyzed
using diluent and HGB Lyzing reagent.
Transmitted Light value is measured on each sample by calorimetric method, and HGB value is
obtained by subtracting the value of diluent from the sample value. The measurement method is
SLS-Hb method.

Table 1: Dilution ratio, required sample volume, required reagent volume

(Whole Blood Mode)

Measured
Sample Reagent
Dilution sample
Channel Volume Reagent Volume
Ratio volume(W.bloo
µL µL
d convert) µL
95 11 STROMATOLYSER-4DL 1000 1.02
WBC/DIFF
STROMATOLYSER-4DS 30
RBC/PLT 501 2 CELLPACK 1000 0.02
751 2 CELLPACK 1000 -
HGB
SULFOLYSER 500 -

XS Series S/M 1-5 October 2017

 Table 2: Dilution ratio, required sample volume, required reagent volume
(Capillary Mode)
Required:
Whole Blood 20 uL
Dilution 120 uL
Dilution Ratio 7 times
Total volume of coordinated sample 140 uL

Sample Measured
Reagent
Dilution Volume sample
Channel Reagent volume
Ratio µL volume(W.bloo
µL
(W.Blood) d convert) µL
WBC/DIFF 137 7.9 STROMATOLYSER-4DL 1000 0.7
STROMATOLYSER-4DS 30
RBC/PLT 1563 1.29 CELLPACK 1000 0.0066
CELLPACK 1000 -
HGB 2340 0.64 SULFOLYSER 500 -

1.4.2.1 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) 0.2 mm (diameter) 0.25mm (squared) 0.2mm (diameter)

1.4.3 Sample Aspiration Volume and required volume

Same volume in CBC or CBC+DIFF mode.
Model Analysis mode Aspirated volume Required sample volume
XS-1000i Manual/W.Blood 20uL Standard sample tube :
XS-1000iC F500uL
XS-900i Micro-sample tube: 90uL
Manual/Capillary 67uL (7 times dilution) Micro-sample tube:140uL
Sampler/W.Blood 20uL Standard sample tube: 1mL
XS-800i Manual/W.Blood 20uL -
XS-500i Manual/Capillary 67 uL (7 times dilution) -
XS-500iX [AG]

313D038 2016012 2016051 [AG] 316I058

XS Series S/M 1-6 October 2017

1.4.4 Analysis Mode and Throughput
The below analysis modes are available.
(1) Sample Aspiration Mode (XS-1000i, XS-1000iC, XS-900i)
Manual Mode
Capillary Mode
Auto sampler Mode
(2) Sample Aspiration Mode (XS-800i, XS-500i, XS-500ix) [AG]
Manual Open Mode
Capillary Mode
(3) Discrete Mode and Throughput

Model Analysis mode Discrete Throughput

XS-1000i Manual CBC Approx. 60 samples/
XS-1000iC (Open/closed) hour
XS-900i CBC+DIFF Approx. 60 samples/
hour
Capillary CBC Approx. 49 samples/
(Open) hour
CBC+DIFF Approx. 49 samples/
hour
Sampler CBC 20 samples /approx.23
minutes
CBC+DIFF 20 samples /approx.23
minutes
XS-800i Manual CBC Approx. 60 samples/
XS-500i (Open/) hour
XS-500ix [AG] CBC+DIFF Approx. 60 samples/
hour
Capillary CBC Approx. 55 samples/
(Open) hour
CBC+DIFF Approx. 55 samples/
hour

313D038 [AG] 316I058

XS Series S/M 1-7 October 2017

1.4.5 Measurement, analysis Parameters
(1) Measurement Parameters, Histogram, Scattergram

Table3: Measurement, Analysis Parameters

Reportable Research
Parameter W.Blood CapillaryFor Screen Remarks
CBC DIFF CBC DIFF N.America
CBC White Blood Cell Count v - v - v v WBC Histogram is
Parameters (WBC) indicated for research.
Red Blood Cell Count v - v - v v
(RBC)
Hemoglobin (HGB) v - v - v v
Hematocrit (HCT) v - v - v v
Mean Corpuscular v - v - v v
Volume (MCV)
Mean Corpuscular v - v - v v
Hemoglobin (MCH)
Mean Corpuscular v - v - v v
Hemoglobin
Concentration (MCHC)
Platelet Count (PLT) v - v - v v
RBC Distribution Width v - - - v v
(RDW-SD, RDW-CV)
Platelet Distribution v - - - - v
Width (PDW)
Mean Platelet Volume v - - - v v
(MPV)
Platelet -Large Cell v - - - - v
Ratio (P-LCR)
Plateletcrit (PCT) v - - - - v
DIFF Neutrophil Percent - v - v v v
Parameters (NEUT%)
Lymphocyte Percent - v - v v v
(LYMPH%)
Monocyte Percent - v - v v v
(MONO%)
Eosinophil Percent - v - v v v
(EO%)
Basophil Percent - v - v v v
(BASO%)
Neutrophil Count - v - v v v
(NEUT#)
Lymphocyte Count - v - v v v
(LYMPH#)
Monocyte Count - v - v v v
(MONO#)
Eosinophil Count (EO#) - v - v v v
Basophil Count - v - v v v
(BASO#)

XS Series S/M 1-8 October 2017

 Reportable Research
Parameter W.Blood Capillary For Screen Remarks
CBC DIFF CBC DIFF N.America
DIFF Immature Granulocyte - v - v v v Option
Parameters Percent (IG%)
Immature Granulocyte - v - v v v Option
Count (IG#)
Other % - - - - - v When DIFF is
analyzed.
Other # - - - - - v When DIFF is
analyzed.

White Blood Cell Count v - v - v v

Histogram (WBC)
Red Blood Cell Count v - - v v
(RBC)
Platelet Count (PLT) v - - - v v
Scattergram 4 DIFF Channel - v - v v v
* In the Research screen, result can be displayed as Non-Reportable, without being masked.

1.4.6 Analysis and Display Range

(1) Analysis Range
Refer to Appendix 1-1.
(2) Display Range
Refer to Appendix 1-1.

1.4.7 Reproducibility
When fresh normal blood or control blood is analyzed 10 times or more consecutively, the coefficient of
variation under 95% confidence interval should be within the range shown in Appendix 1-1.

1.4.8 Accuracy
(1) Blood Cell Count (WBC, RBC, PLT)
When fresh normal blood is analyzed 10 times consecutively after instrument is calibrated, differ-
ence between the mean and obtained from the standard instrument should be within the range
shown in Appendix 1-1.
(2) Blood Cell Classification (NEUT%, LYMPH%, MONO%, EO%, BASO%)
a) When 100 or more blood samples (collected on that day) are analyzed, the coefficient of vari-
ation should be within the range shown in Appendix 1-1.
b) The mean difference from the value obtained on the standard instrument should be within the
range shown in Appendix 1-1.

XS Series S/M 1-9 October 2017

1.4.9 Linearity
Residual or Residual ratio at specific concentration should be within the range shown in Appendix 1-2.

1.4.10 Dilution Linearity

(1) Blood Cell Count (WBC, PLT)
The high value sample measured data using the method shown below, is within the range shown in
Appendix 1-2 against the regression line (any regression equation is available).
Prepare the high value sample diluted using CELLPACK. Use the calibrated micro pipette for volu-
metric measurement.

The dilution examples are shown below.

Table 4: Dilution Example

No. Sample Volume CELLPACK Volume Dilution Density

1 1.0 mL 0.0 mL 100%
2 0.8 mL 0.2 mL 80%
3 0.6 mL 0.4 mL 60%
4 0.5 mL 0.5 mL 50%
5 0.4 mL 0.6 mL 40%
6 0.2 mL 0.8 mL 20%
7 0.1 mL 0.9 mL 10%
* Calculate the mean value from the data gained by 3 times of manual mode measurement of each
diluted sample.

1.4.11 Carryover
(1) Blood Cell Count (WBC, RBC, HGB, HCT, PLT)
When high value sample or control blood (High Abnormal) are used, carryover ratio obtained by
standard analysis method should be within the range shown in Appendix 1-1 (XS-1000iC) and 1-3.
(2) Blood Cell Classification (NEUT#, LYMPH#, MONO#, EO#, BASO#, DIFF-WBC)
Carryover ratio or background value after high value sample analysis should be within the range
shown in Appendix 1-3.

1.4.12 Difference between Manual Mode and Sampler Mode

None. (Using the same Aspiration system.)

XS Series S/M 1-10 October 2017

1.4.13 Stability
The stability obtained by standard analysis method is shown below.
However, aging of sample itself is not considered.

(1) Stability related to Temperature

When fresh normal blood or control blood is used, the data fluctuation obtained by standard analy-
sis method should be within the range shown in Appendix 1-3. Variance range of temperature
should be within from 15 to 30 °C both reagent and instrument.
Fresh normal blood should be used within 12 hours after collection.
Any change in the sample should be subtracted from change ratio.
(2) Within-a-Day Stability
The data fluctuation obtained by standard analysis method using control blood should be within the
range shown in Appendix 1-3.
(3) Day-to-Day Stability
The data fluctuation obtained by standard analysis method using control blood should be within the
range shown in Appendix 1-3.
(4) Stability relative to power Supply voltage
The data fluctuation obtained by standard analysis method using control blood should be within the
range shown in Appendix 1-3.

1.4.14 Within-a-Day Stability after Collection of Blood

Sample should be stored from 18 to 26 °C or cold place (from 2 to 8 °C).

(1) Blood Cell Classification (NEUT%, LYMPH%, MONO%, EO%, BASO%)

Fluctuation ratio of WBC 5 classification values for normal person’s sample passed over from
immediately after collection of blood to 36 and 48 hours should be within the range shown in
Appendix 1-3 at 95% or more of probability till 36 hours, at 90% or more probability till 48hours.
Fluctuation range of WBC count obtained from fresh blood should be within the range shown in
Appendix 1-3 at 95% or more probability.
(2) HCT, MCV
Fluctuation ratio of HCT and MCV for healthy person’s sample passed over from immediately after
collection of blood to 8 and 24 hours (24 hours and 48 hours for XS-1000iC) should be within the
range shown in Appendix 1-3 at 95% or more of probability.
When the sample stored in cool place is used, it’s required to back to room temperature. Analysis
time needs 2 times or more, and it’s needed to adopt average.

XS Series S/M 1-11 October 2017

1.4.15 Detection Sensitivity of Immature Cell
The following condition (1) or (2) should be met.

(1) When estimation is performed under following condition, re-examination ratio by WBC suspect flag,
FP ratio, and FN ratio are shown as follows.
Sample should be within 8 hours after collection, and stored at room temperature or at cool place
Re-examination Ratio: less than 65% (True re-examination ratio is set 50%.)
FP ratio: 15% or lower
FN ratio: 15% or lower
(2) When comparing with XT-1800i (CBC+DIFF) or XT-2000i (CBC+DIFF), the ratio should be within
+3FN% and within +3FP%.

(Condition)
a) Re-examination Ratio = (FP+TP)/(TP+TN+FP+FN)x 100 (%)
b) FP ratio = FP/(TN+FP) x 100 (%)
c) FN ratio = FN/(TP+FN) x 100 (%)

d) Re-examination Ratio, FP ratio, and Estimation method of FN ratio (except erythroblast, con-
form to NCCLSD H-20A)
i) Used Sample
Abnormal sample 100 samples
Normal sample 100 samples
ii) Details of Abnormal sample
• Myelogenetic Immature Cell (Blast, Promyelocyte,
Myelocyte): 100 cells/µL or more, 60 samples or more
• Lymphoid Immature Cell (Blast, Lymphoma Cell,
Adult-T-cell Leukemia): 100 cells/µL or more, 10 samples or more
(Atypical Lymphocyte): 700 cells/µL or more, 5 samples or more
• Erythroblast: 100 cells/µL or more, 5 samples or more
• Left Shift (Stab): 900 cells/µL or more, 10 samples or more
Accorded flag (e.g Blast flag for Blast sample) is not estimated.

XS Series S/M 1-12 October 2017

1.4.16 Required Reagent Volume
(1) Required Reagent volume for sample analysis

Table 5: Required Reagent volume for one sample analysis

CBC
Discrete Mode CBC
+DIFF
Total volume Approx.34.5mL Approx.38.5mL
CELLPACK Approx.32mL Approx.32mL
STROMATOLYSER-4DL 2mL 2mL
STROMATOLYSER-4DS - 0.03mL
SULFOLYSER Approx.約0.5mL Approx.0.5mL

2) Required Reagent volume for auto rinse

Table 6: Required Reagent volume for auto rinse

Background check once Background check twice

Total volume Approx. 77mL Approx.38.5mL
CELLPACK Approx. 72mL Approx.36mL
STROMATOLYSER-4DL Approx. 4mL 2mL
STROMATOLYSER-4DS Approx. 0.06mL 0.03mL
SULFOLYSER Approx. 1.0mL Approx.0.5mL
* If the analysis is not performed more than 12 hours, the auto rinse sequence will be performed
when resuming from sleep mode.
(3) Required Reagent volume at starting up

Table 7: Required Reagent volume at starting up

Background check once Background check twice

Total volume Approx.167mL Approx.38.5mL
CELLPACK Approx.162mL Approx.36mL
STROMATOLYSER-4DL Approx.4mL Approx.2mL
STROMATOLYSER-4DS Approx.0.09mL Approx.0.03mL
SULFOLYSER Approx.1.0mL Approx.0.5mL

(4) Required Reagent volume at shutdown

Table 8: Required Reagent volume at shutdown

CELLPACK Approx. 17 mL

(5) Required Reagent volume for resume from sleep

XS-1000i / XS-900i: 72 mL
XS-800i: 74mL
XS-500i: 74mL
XS-500ix: 74mL [AG]

313D038 [AG] 316I058

XS Series S/M 1-13 October 2017

1.5 FUNCTION

1.5.1 Start Up
Following operations are performed after power is turned ON, and when condition of instrument is
normal, it becomes Ready Mode within 5 minutes. (except temperature and start up time of the IPU.).
Temperature of each unit becomes measurable temperature within 20 minutes.
If operator does not Log-ON immediately at IPU program when error occurs or background check
sequence is extended, above operations does not work.

(1) Power On
Turn the power ON both main unit and IPU. The power ON order has no preference.
(2) IPU Start Up
a) Start Up of OS
OS (Windows XP) is automatically started up.
Log-On to OS. (can be skipped.)
b) IPU program starts Up
IPU program is automatically started up.
c) Program transfer to Main Unit
• After self-diagnostic is completed on Main Unit, program for Main Unit is transferred from
IPU to Main Unit. (Transfer time takes approx. 3 seconds.)
• If self-diagnostic on Main Unit is not completed, IPU program proceeds to next step, and this
program transfer function will be waiting the completion of self-diagnostic on Main Unit
d) Log-ON to IPU program (can be skipped)
• Log-On window to enter user name and password is displayed.
• If Log-On is performed by entering special User name before Main Unit checks Log-On con-
dition of IPU, Hot Start is available as shown below.
e) Mode selection of Hot Start
It’s possible to select Hot Start Mode about following contents.
(See Section 5 Service Program for detail procedure.)
(i) Error Skip
(ii) Sequence Skip
(iii) Heater ON/OFF
f) Ready
Menu screen of IPU program is displayed.

* It is impossible to re-start up only IPU after IPU and Main Unit become Ready condition
because Main Unit condition cannot be specified.
(3) Main Unit Start Up
a) System Check
b) Program download
If IPU program is started up, program is downloaded from IPU.
c) Start Up Mode Check
• Log On condition of IPU is checked, and if Log On is performed by special user name, it
works depending on Hot Start Mode setting.
• If Hot Start Setting is not completed, it waits for the setting completion.

XS Series S/M 1-14 October 2017

 • If start up is performed with the other condition of above, It works on regular mode.
d) Initialization and check
(i) Initial position of CP Unit/Pipette
(ii) Initial position of Sample Aspiration Syringe Unit
(iii) Initial position of Sheath Syringe
(iv) Initial position of auto sampler Unit
(v) Temperature of Reaction Unit
(vi) Temperature of Reagent Heater Unit
(vii) Pressure/vacuum
e) Rinse and Background Check
Auto Rinse and Background Check are performed.
f) Ready
LED shows Ready mode lights.

1.5.2 Calibration function

Customer can calibrate instrument.

(1) Calibration Method and Parameters

Table 10: Calibration Method and Parameters

WBC RBC HGB HCT PLT

Auto Calibration (using human blood) - - v v -
Manual Calibration - - v v -
Calibration by Calibrator v v v v v

(2) Auto Calibration

Instrument is calibrated by automatically calculated compensation ratio obtained from analysis
results on instrument.
(3) Manual Calibration
Instrument is calibrated by manually entered compensation ratio.
(4) Calibration by Calibrator (valid/invalid selection is available.)
Instrument is calibrated automatically calculated using the compensation ratio obtained from SCS-
1000 analysis results.
(5) Precision Check (valid/invalid selection is available.)
Reproducibility of instrument is checked to confirm if calibration by calibrator is possible.
(6) Calibration History Storage Function
10 Calibration Histories can be stored.

XS Series S/M 1-15 October 2017

1.5.3 Quality Control Function
(1) Quality Control Method and Quality Control File

Table 11: Quality Control Method and Quality Control File

Point
Name Analysis Mode level File Number
Number
X Control or Control Control Material 1, 2, 3 300
L-J Control Material /Lot
OTHER1 (Human Blood) - 300
20
/Lot
OTHER2 (Human Blood) - 300
/Lot
X M Control Xbar-M (Human Blood) - 300 1

(2) Input/Output of Quality Control Data

It’s possible to store/read all Quality Control Data to CD.
(3) Input/Output of Quality Control File
It’s possible to install Quality Control File Storage program
(Sysmex Insight)
(4) Output of Quality Control Data
It’s possible to output Quality Control Data to following equipment.
• Data Printer (DP) (as for stored data function)
• Color Graphic Printer (GP/LP)
• Host Computer

1.5.4 Online QC Function (optional for SNCS)

Dairy QC data is sent to compile center through communication line, and customer can refer to the result

1.5.5 Discrete Analysis Function

Refer to “1.4.3 Analysis Mode and Throughput”.

XS Series S/M 1-16 October 2017

1.5.6 Analysis Order Registration Function (Work Load List Function)
(1) Registration Number
1,000 samples of analysis information can be registered.
(2) Contents of Registration
a) Sample Number: (15 characters)
b) Rack Number: (6 characters)
c) Rack Position: (2 characters)
d) Analysis Order Information
e) Comment: (40 characters)
f) Patient ID (Option): (16 characters)
Character Number indicates number of one byte character.
(3) Input and Edit
a) Manual Input
b) Download from Host computer
(4) Display
a) List Display on the IPU Screen

1.5.7 Sampler Unit Function (When Sampler Unit OPSU-11 is installed.)

(1) Applicable Sample Number
• Up to 20 samples
• Up to 2 racks can be set at once, and 10 samples can be set at each rack.
(2) Sample Rack
Low profile sample rack is used as the standard. (High profile rack cannot be used.)
(3) Blood Collection Tube and Sample
a) Blood Collection tube
• Blood Collection Tube with rubber cap is applicable.
• A standard collection tube is a tube with 12 – 15 mm diameter.
• When collection tubes of which diameter is 12 mm to 14 mm is used, specified holder should
be installed on the rack.
• Overall length of the collection tube including rubber cap is 79mm to 85mm.

Followings table shows the available sample collection tube.

XS Series S/M 1-17 October 2017

 Table 12: XS-1000i usable Sample Collection Tube

Name Remarks
VENOJECT II (TERUMO) Re-cap is not acceptable.
Hemoguard (BD)
VACUETTE (greiner)
Monovette (SARSTEDT)

b) Sample
Whole blood sample, which has following condition, is required.
c) Appropriate Blood Volume and Leave Time

Table 13 Sample volume and leave time

Diameter Appropriate Blood Volume Leave Time

15 mm Approx. 1.0-7 mL Within 4 hours at room temperature
12 mm Approx. 1.0-5mL Within 4 hours at room temperature

(4) Throughput (Without Barcorde Reader)

CBC+DIFF: 20 samples/approx.23 minutes
CBC: 20 samples/approx. 23 minutes
If Barcode Reader is used, the throughput depends on the Barcode Reader’s specification.
(5) Monitor Function
a) Blood Volume Monitor
None
b) Blood Collection Tube Monitor
Function to monitor if blood collection tube exits in sample rack.
c) Blood aspiration Monitor
Function to monitor if blood was aspirated. (Blood Aspiration Sensor Function) is available.
(6) Abnormally Low Value Monitor Function
Result is monitored if it is abnormally low value, and if it is abnormal, error history is recorded and
auto sampler operation conforms to the sampler stop setting.
(7) Sampler Stop Condition Setting
Stop/Continue of sampler analysis can be set when following error occurs.
a) Xm Limit Error
b) ID Read Error (Rack ID Read Error function is not employed.)
c) Abnormally Low Value
d) Abnormal Value (This does not mean Patient Limit but for Sampler Stop Condition.)
e) Abnormal Sample Aspiration
f) Expired Control Blood
g) No Registered Control Blood

XS Series S/M 1-18 October 2017

(8) Input of Sample ID, Rack ID, and Rack Position
a) Manual Input
It’s possible to input Sample ID, Rack ID, and Rack Position by keyboard of IPU before analy-
sis is started.
b) Input from Barcode Reader
If built-in type barcode reader is installed, it’s possible to set or cancel reading sample/Rack ID
from bar code affixed on the sample collection tube and sample rack.
c) Auto Increment
If bar code is not used, sample ID and rack ID are automatically incremented.
d) The position of Barcode label affixed
In the analysis of sampler mode, the barcode label positon should be as blew.

(Barcode should be positioned within the A area.)

Barcode label specification should be as below.

(Barcode label size)

<Barcode label specification>

Margin (dimension a) 5mm and more
Bar height (dimension b) 20mm and more
Effective area (dimension c) 40mm and below
width (dimension d) 30mm and more
length (dimension e) 58mm and below
Narrow range - 0.19mm and more

XS Series S/M 1-19 October 2017

(9) Order Input
a) Manual Input
Order can be input from IPU.
b) Host Inquiry
Host inquiry is possible by sample ID.
c) Priority
Priority of order shows below.
• Order that registered in Work Load List.
• Order that is inquired to Host. (when Host inquiry is performed)
• Order input manually.
(10) Display of Sample ID, Rack ID, Rack Position, and Order
They are displayed on IPU screen with instrument name.
(11) Measurement Start Operation
Measurement starts by pushing Sampler Start Button on sampler.
(12) Outline of the Sampler Operation
a) Positions at the initial position.
b) The first positioned sample tube is gabbed by Catcher.
c) The catcher transfers the sample tube to the mixing position.
d) Sample tube is mixed by the catcher’s tumbling operation.
e) After mixing, the sample tube is transferred and set to the sample set unit by the catcher.
f) The sample tube is rotated to read the barcode label by sample tube rotating mechanism on
the way of the sample set unit moving into the main unit.
g) After reading the barcode label, the sample is aspirated.
h) After sample aspiration, the sample set unit returns to the sampler.
i) The sample tube is caught by the catcher and returned to its initial position.
j) The catcher grabs the next sample tube.
(11) Output of Analysis Result
Analysis result is stored as the latest sample. (Refer to “1.5.13 Stored Data (Analysis Result) Pro-
cessing Function”.)

XS Series S/M 1-20 October 2017

1.5.8 Manual Mode Measurement Function
(1) Blood Collection Tube and Sample
a) Blood Collection tube
Overall length of the blood collection tube is less than 80mm.
b) Sample
Whole blood mixed enough prior to aspiration.
(2) Input of Sample ID
a) Manual Input
It is possible to input sample ID from keyboard of IPU before measurement
b) Input by Handy Barcode Reader (Optional)
It is possible to input sample ID by Handy Barcode Reader before measurement.
(3) Order Input
Same as “1.5.7 Sampler Unit Function”.
(4) Display of Sample ID and Order
They are displayed on IPU screen with instrument name.
(5) Measurement Start Operation
• Customer sets sample at sample aspiration pipette on Main Unit, and push Start Switch.
• LED turns on, and that shows sample is being aspirated.
• After sample aspiration is completed, LED status will change to the condition that shows sample
aspiration is completed with beep sound. Then the sample must be removed from pipette.
(6) Output of the measurement results
Same as “1.5.7 Sampler Unit Function”.

1.5.9 Capillary Mode Measurement Function

(1) Blood Collection Tube and Sample
a) Blood Collection tube
Same as “1.5.8 Manual Mode Measurement Function”.
b) Sample
Diluted sample which whole blood is diluted 7 times.
(2) Input of Sample ID
Same as “1.5.8 Manual Mode Measurement Function”.
(3) Input of Order
Same as “1.5.7 Sampler Unit Function”.
(4) Display of Sample ID and Order
Same as “1.5.8 Manual Mode Measurement Function”.
(5) Measurement Start Operation
Same as “1.5.8 Manual Mode Measurement Function”.
(6) Output of the measurement results
Same as “1.5.7 Sampler Unit Function”.

1.5.10 Abnormal Sample Monitoring Function

Screen and detect the abnormal morphology flags using histogram, scattergram and counted data.
Positive or Negative is judged by this function.

XS Series S/M 1-21 October 2017

1.5.11 Abnormal Data Monitoring Function
(1) Abnormal Data (Patient Limit)
The Normal range of each parameter (Upper and Lower limits) can be set and monitored.
If the patient information program (optional) is installed, normal range for each condition of age and
gender can be set.
(2) Linearity Error
Analysis data is monitored whether it is within the linearity assured range.

1.5.12 Analysis Result Storage Function

Analysis result is stored in IPU.
(1) Storage Number
10,000 samples (XS-1000i, XS-1000iC, XS-800i)
8,000 samples (XS-900i, XS-500i)
(2) Contents of Storage
a) Sample ID
b) Rack ID (Sampler Mode)
c) Rack Position (Sampler Mode)
d) Analysis Order
e) Analysis Mode
f) Analysis Result (Numerical Value, Flag)
g) Scattergram
h) Histogram
i) Negative / Positive
j) Error Information
k) Analysis Date
l) Analysis Time
m) Original Information of Sample ID Input
n) Validation Status
o) Sequence Number (Analysis Order after Power ON) and so on

313D038

XS Series S/M 1-22 October 2017

1.5.13 Stored Data (Analysis Result) Processing Function
(1) Display
The followings can be displayed on the IPU screen.
a) Sample Display
(i) Latest Sample
(ii) Stored Sample
b) List Display
(i) Latest Sample
(ii) Stored Sample
(2) Validation Function
It’s possible to validate analysis result manually or automatically.
(3) Edit
It’s possible to edit following items whose analysis results are not validated.
• Sample ID
• Patient ID
• Sample ID Input source
• Changing from “Positive” to “Negative” is possible.
(4) Delete
Any analysis data can be deleted per sample.
(5) Peripheral Output
Validated analysis data can be output as follows.
a) Print out
Stored analysis data can be output as shown below.
Output data can be selected randomly.

Table 14: Stored Data Print Out

Output Device Contents Auto Print out of the

latest stored data
Data Printer (DP) Data per one sample v
Data per one sample v
Color Graphic Printer (GP/LP)
List Print -

b) Host Output
Analysis result can be output to Host Computer.
Output format options are as below.
• K-1000
• K-4500
• SF-3000
• NE Series
• SE-9000
• XT (XE format is the base format. Space is applied to the parameters which cannot be ana-
lyzed.)
(This format is the default.)
• XT (XE format is the base format. Zero is applied to the parameters which cannot be ana-
lyzed.)

XS Series S/M 1-23 October 2017

 • DPS
c) External Storage Device
The analysis data can be stored in the external storage device;
Hard Disk, CD-R and so on.
It is also possible to re-store the stored data form the external device.

1.5.14 Stored Data Processing Function by Patient ID

(1) Patient ID Registration Function
a) Contents of Registration
Patient ID: 16 characters.
b) Input/Edit
When inputting the Work Load List from IPU, input or edit is possible during the stored data
(not validated) editing.
c) Output
It’s output when stored data is displayed or output to the external device.
(2) Previous Data Check Function
Previous analysis data can be checked from the Patient ID.
(3) Cumulative Display Function
The Stored Data can be displayed in cumulatively

1.5.15 Patient Information Control Function

When patient ID function is added, the additional function that can store and control the Patient
Information associated with Patient ID can be added.
(1) Registration Number
5,000 patients
(2) Contents of Registration
a) Patient Name: 40 Characters
b) Gender: 1 Character
c) Birthday: 8 Characters
d) Doctor Name: 20 Characters
e) Ward: 20 Characters
f) Comment: 100 Characters
*Character Number indicates 1 byte character.
(3) Input/Edit
Input or edit operation is possible from IPU. It is possible to input the information with the Patient ID
by transferring from Host Computer.
(4) Display
It is possible to display on the IPU screen.

XS Series S/M 1-24 October 2017

1.5.16 Function corresponding to XT pro (Standard Function, equal to XT-1800i)
(1) Reagent Check Function
• Reagent Register Function
• Expire Date Check Function
• Reagent Log Function
• Reagent Remaining Amount Display Function
(2) GP Customize Function
(3) QC Data Range Set Function
(4) CSV Format Output Function

1.5.17 Available Languages

Japanese, English, German, Italian, French, Spanish, Chinese, Greek, Russian and Portuguese are
available.

1.5.18 Shut Down Function

Rinsing of instrument is performed, and the instrument will become the status that power of Main Unit can
be OFF.
(1) Shut Down starts
a) Selection of Shut down Mode
After shut down mode is selected, it proceeds in the next step.
(Can be canceled)
b) Starting Shut Down
(2) Shut Down Operation
Rinsing of manual whole blood line, CP whole blood line, and measurement line are performed.
(3) Output
Message that shows power of Main Unit can be turned OFF is displayed on the IPU screen. Re-
start of the Main Unit is possible.

1.5.19 Main Unit Status Display Function

Status of Main Unit (Ready, Analysis Mode, Error, and so on) is displayed with instrument name on the
IPU screen.

1.5.20 Error Monitor Function

Status of instrument is monitored, and alarm sounds when error occurs.

1.5.21 Error Alerting Function

Alarm sounds when the error occurs.
(1) Alarm Sound
When error occurs on Main Unit, alarm sounds from Main Unit.
(2) Stop of Alarm Sound
Alarm sound from Main Unit can be stopped by operating IPU.
However, if IPU does not communicate with Main Unit (e.g
Power of IPU is OFF), power of Main Unit should be turned OFF.
(3) Alarm Setting
Alarm sound (tone) on the Main Unit can be set (selected).

XS Series S/M 1-25 October 2017

1.5.22 Maintenance Function (Customer’s operation)
XS has the following Maintenance Functions which customers can perform.

(1) Maintenance Sequence

a) Auto Rinse Sequence
i) Rinse Operation
Background Check Operation is performed twice.
ii) Background Check
Background Check is performed, and if background value is out of range that shows fol-
lowing table, background check is continued. Continued number of Background Check
sequence is up to twice. (Number of Background Check Analysis is maximum three
times.) If Background value at final Background Check is out of range that shows follow-
ing table, Background Error occurs

Table 15: Background Check Level

Parameter Range
WBC-C 0.3 x 103/uL or less
WBC-D 0.1 x 103/uL or less
RBC 0.02 x 106/uL or less
HGB 0.1 g/dL or less
PLT 10 x 103/uL or less

b) Reagent Exchange Sequence

c) Flow Cell Rinse Sequence
d) Flow Cell Bubble Removal Sequence
e) RBC Detector Clog Removal Sequence and so on.
(2) Setting Data Output Function
Various Customer setting data can be output.
a) Display on the IPU Screen
b) Peripheral Output
Color Graphic Printer (GP/LP)
(3) Maintenance History Registration Function
a) Operation Cycle Number
b) Unit Operation Cycle Number
c) Reagent Exchange Log and so on.
(4) Display Parameters
a) HGB Convert Value
b) FCM Detector Laser Power
c) FCM Detector PMT (Photo Multiplier Tube) Voltage Setting Value
d) Pressure
e) Temperature
f) Operation Cycle Count
g) Setting Values and so on.

XS Series S/M 1-26 October 2017

(5) Test Function
a) Sample Aspiration Syringe Operation Test
b) Sheath Syringe Operation Test
c) Diaphragm Pump Operation Test
d) Auto sampler Operation Test
e) CP/Pipette Operation Test
f) Barcode Reader Operation Test and so on.

1.5.23 Service Function (for Service or Production line)

The following maintenance functions are available.
(1) Special Sequence
a) Optical Alignment Sequence
b) Continuous Operation Sequence
c) Depriming Sequence
d) Setting Sequence and so on.
(2) IPU Backup Function (for Service and re-installation)
(3) Raw Data Registration Function (for Service or Data Re-analysis)

1.5.24 On-Line Support Function (SNCS Option)

Service Information such as error log can be transferred through communication line.

1.5.25 Protection Function

(1) Main Unit
a) Power Supply Unit
• Fuse at primary side (Inlet part)
• Over Current Protection Circuit (Built in Switching Regulator)
• Thermostat (Built in Switching Reg ur at or)
b) Temperature Control Unit
Thermal Protector
(2) IPU
Fuse (depends on the PC specification.)

1.5.26 Waste Tank Fluid Level Monitor Function (Optional)

Alarm sounds when waste tank is full.

XS Series S/M 1-27 October 2017

1.6 Maintenance Performance

1.6.1 Maintenance Performance (for Customer)

All Maintenances operations performed by customer can access form Top or right side.

1.6.2 Maintenance Item

Maintenance items and the time to do are shown in the below table.
If the counter is not reset when performing maintenance, the message requiring the maintenance will be
displayed when the counter reaches the pre-set cycle number.

Table16: Maintenance items and time to do

Items Time to do Condition

Shut down Once/day Every 100 analysis
Piercer Replacement Once/30000 CP analysis Every 30000 CP analysis
Pump Replacement (Pneumatic Once/30000 analysis Every 30000 analysis
Unit)
Flow Cell Rinse As required
RBC Detector Clog Removal As required
Flow Cell Bubble Removal As required
Reagent Replacement As required
Waste Container Replacement As required
Fuse Replacement As required

1.6.3 Service Items required at the fixed period (by Service Person)

Table 17: Periodical Service item and time to do

Service Item Time to do

Sheath Syringe Seal Replacement Every three years

1.6.4 Spare Parts

The following parts are included in XS Supply Parts.
(1) As Spare

Table 18: Spare pars for replacement

Item Included Qty

Main Unit Fuse 1 set
Tubings Some

(2) Tools

Table 19: Tool

Item Included Qty Memo

Screwdriver (+) 1
Transducer Brush 1 RBC Detector Clog Removal

XS Series S/M 1-28 October 2017

1.7 Acoustic Noise
60 dB and below during operation (excluding the accidental noise) 45 db and below (at Ready status)

1.8 Dimension and Weight

Table 20: Dimension and Weight

XS-1000i, XS-1000iC, XS-900i Dimensions (W x D x H) (mm) Weight

Main Unit 320x 413x 403 Approx. 24 kg

Data Processing Unit Depends on the PC specification.

Sampler Unit 450 x 630 x 415 Approx. 14 kg

XS-800i, XS-500i, XS-500ix Dimensions (W x D x H) (mm) Weight

[AG]
Main Unit 320x 413 x 503 Approx. 24 kg
Data Processing Unit Depends on the PC specification.

313D038 [AG] 316I058

XS Series S/M 1-29 October 2017

1.9 Required Conditions

1.9.1 Environmental Requirements

(1) Ambient Temperature: 15 to 30 °C (The reagent temperature should also be within this range.)
(2) Relative Humidity: 30 - 85%
(3) Atmospheric Pressure: 70kPa – 106kPa
(4) Installation Condition: Avoid installation in a place where the instrument may be exposed to the
direct sunlight, dust, vibration, or acid.

1.9.2 Voltage
(1) Rated Voltage
100 – 117 V/220 -240 V +/- 10%
(2) Frequency
50 Hz/60Hz
(3) Power Consumption
As below.

Table 21: Power Consumption - Heat Generation

Main Unit + Sampler

100 – 240 V
50 Hz 210 VA and below
60 Hz (714 BTU/h)

1.9.3 Class and Type of Electrical Protection

Class-I electrical apparatus.

1.10 Reliability

1.10.1 Designed Lifetime

At the design phase, the lifetime is estimated as follows.
(1) Designed Lifetime expectancy of analyzer
5 years
(2) Estimated Number of Samples Processed per Day
40 samples/day
(3) Estimated Total Number of Samples Processed
40 samples/day x 300 days/year x 5 years = 60,000 samples
: 201357

XS Series S/M 1-30 October 2017

1.11 Packing Configuration
Packing configuration is as below.
(1) Main Unit
(2) Sampler Unit
(3) Supply Parts
(4) IPU (Japanese Market only)
(5) Other Optional

1.12 Storage Condition

(1) Storage Condition
Ambient Temperature: -10 - 60 °C
Relative Humidity: 10 – 95% (no condensation)
Atmospheric Pressure: 70k – 106 kPa

XS Series S/M 1-31 October 2017

 Appendix 1-1 Reproducibility, Accuracy (*: XS-1000iC, #:XS-500ix) [AR]

Note:
Values listed without any marks are common to all XS models.

Parameters Reproducibility Accuracy

Analysis Display W. Blood Capillary Condition W.Blood Capillary
Range Range Mode Mode Mode Mode

White Blood (WBC) 0-4000 0.0-9999.9 3.0% and 5.0% and 40x102/µL ±3% or ±10% and
Cell x102/µL ×102/µL less less and more ±2.0x102/µL less
and less
Red Blood Cell (RBC) 0- 800 0-9999 ×104/ 1.5% and 4.5% and 400x104/µL ±2% or ± 8% and
×104/µL µL less less and more ±3×104/µL less
350x104/µL and less
and more#
Hemoglobin (HGB) 0.0-25.0 g/ 0.0-30.0 g/dL 1.5% and 4.5% and - - -
Concentration dL 0.00-18.62 less less
0.00-15.52 mmol/L Max-Min < Max-Min <
mmol/L 0.5g/dL 1.5g/dL
Hematocrit (HCT) 0.0-60.0 0.0-100.0 1.5% and 4.5% and - - -
HCT% HCT% less less
Mean (MCV) - - 1.5% and 4.5% and - - -
Corpuscular less less
(erythrocyte) 2.0% and
volume less*
Mean (MCH) - - 2.0% and 4.5% and - - -
Corpuscular less less
Hemoglobin 2.5% and
less*
Mean (MCHC) - - 2.0% and 6.0% and - - -
Corpuscular less less
Hemoglobin 2.5% and
Concentration less*
Platelet Count (PLT) 0-500.0 x 0.0-999.9 4.0% and 12.0% and 10×104/µL ±5% or ±12% and
104/µL ×104/µL less less and more ±1.0×104/µL less
and less
RBC (RDW- - - 3.0% and Not - - -
Distribution SD) less measured
Width
RBC (RDW- - - 3.0% and Not - - -
Distribution CV) less measured
Width
Platelet (PDW) - - 10.0% and Not - - -
Distribution less measured
Width
Mean Platelet (MPV) - - 4.0% and Not - - -
Volume less measured
Platelet Large (P-LCR) - - 18.0% and Not - - -
Cell Ratio less measured
Plateletcrit (PCT) - - 6.0% and Not - - -
Value less measured
(*: XS-1000iC, #:XS-500ix)
[AR] 317G081

XS Series S/M 1-32 October 2017

 Appendix 1-1 (2/2) Reproducibility, Accuracy

Parameters Reproducibility Accuracy

Analysis Display W. Blood Capillary Condition W.Blood Capillary
Range Range Mode Mode Mode Mode
Neutrophil (NEUT%) - - 8.0% and 16.0% and 30.0NEUT% 1) r=0.90 1) r=0.70
Percent less less and more, and more and more
WBC 40x102/ 2) ±3.0 2) ±3.0
µL and more NEUT% NEUT%
and less and less
Lymphocyte (LYMPH%) - - 8.0% and 16.0% and 15.0LYMPH% 1)r=0.90 1) r=0.70
Percent less less and more, and more and more
WBC 40x102/ 2)±3.0 2) ±3.0
µL and more LYMPH% LYMPH%
and less and less
Monocyte (MONO%) - - 20.0% and 40.0% and 5.0MONO% 1)r=0.75 1) r=0.6 and
Percent less less and more, and more more
WBC 40x102/ 2)±2.0 2) ±2.0
µL and more MONO% MONO%
and less and less
Eosinophil (EO%) - - 25.0% and 40.0% and WBC 40x102/ 1)r=0.80 1) r=0.60
Percent less, or less µL and more and more and more
±1.5EO% 2)±1.0 EO% 2) ±1.0 EO%
and less and less 以内
Basophil (BASO%) - - 40.0% and 50.0% and WBC 40x102/ 1)r=0.50 1) r=0.50
Percent less, or less, or µLand more and more and more
±1.0BASO ±1.5BASO 2)±1.0 2) ±1.0
% and less % and less BASO% BASO%
and less and less
Neutrophil (NEUT#) - - 8.0% and 16.0% and 12.0x102/µL - -
Count less less and more
Lymphocyte (LYMPH#) - - 8.0% and 16.0% and 6.0x102/µL - -
Count less less and more
Monocyte (MONO#) - - 20.0% and 40.0% and 2.0x102/µL - -
Count less less and more
Eosinophil (EO#) - - 25.0% and 40.0% and - - -
Count less，or less，or
±1.2Þ102/ ±1.2Þ102/
µL and less µLand less
Basophil (BASO#) - - 40.0% and 50.0% and - - -
Count less，or less，or
±0.6x102/ ±0.6x102/
µL and less µL and less

XS Series S/M 1-33 October 2017

 Appendix 1-2 Linearity, Dilution Linearity

Linearity Dilution Linearity

Specification Condition
Parameters W.Blood Capillary
Condition (W.Blood
Mode Mode
Mode)
White Blood Cell (WBC) ±3% or ±5% or 0-1000×102/µL 1. ±3% or 1. 0-1000×102/
±3×102/µL and ±5.0×102/ ±3×102/µL µL
less µLand less and less 2. 1000.1-
2. ±6% 3000×102/µL
3. ±11% 3. 3000.1-
4000×102/µL
Red Blood Cell (RBC) ±3% or ±6% or 0-800×104/µL -
4 4
±3×10 /µL and ±6×10 /µL and
less less
Hemoglobin (HGB) ±2% or ±7% or 0.0-25.0g/dL -
Concentration ±0.2g/dL and ±0.7g/dL and
less less
Hematocrit (HCT) ±3% or ±6% or 0.0-60.0HCT% -
±1 HCT% and ±2.0HCT% and
less less
Mean Corpuscular (MCV) Variation of - RBC -
(erythrocyte) volume RBC Approx.450×104/
concentration µL,
should be ±2fL 200<RBC<700×1
and less 04/µL
Mean Corpuscular (MCH) - - - -
Hemoglobin
Mean Corpuscular (MCHC) - - - -
Hemoglobin
Concentration
Platelet Count (PLT) ±5% or ±10% or 0-100.0×104/µL, 1. ±5% or 1. 0-200.0×104/
±1×104/µL and ±2.0×104/µL Note, RBC is ±1×102/µL µL
less and less approx.400×10 /4 and less 2. 200.1-
RBC influence µL, and PLT is 2. ±16% 500×104/µL
should be approx.30.0×104/
±2×104/µL and µL,
less 200<RBC<700×1
04/µL
RBC Distribution (RDW-SD) - - - -
Width
RBC Distribution (RDW-CV) - - - -
Width
Platelet Distribution (PDW) - - - -
Width
Mean Platelet (MPV) - - - -
Volume
Platelet Large Cell (P-LCR) - - - -
Ratio
Plateletcrit Value (PCT) - - - -

XS Series S/M 1-34 October 2017

 Appendix 1-2 (2/2) Linearity, Dilution Linearity

Linearity Dilution Linearity

Specificati
Condition
Parameters W.Blood Capillary on
Condition
Mode Mode (W.Blood
Mode)
Eosinophil Percent (EO%) - - - -
Basophil Percent (BASO%) - - - -
Neutrophil Count (NEUT#) - - - -
Lymphocyte Count (LYMPH#) - - - -
Monocyte Count (MONO#) - - - -
Eosinophil Count (EO#) - - - -
Basophil Count (BASO#) - - - -

XS Series S/M 1-35 October 2017

 Appendix 1-3 Carryover, Stability (*: XS-1000iC)

Difference
between Stability
modes
Carryo After Sample
Parameters Manual Relative With time With Day Related
ver Collection
Mode and Temperature Voltage
Sampler
Mode
White Blood (WBC) 1.0% - 5% or 5% and less 10% and 5% and less ±10% and less
Cell and less 5.0×102/µL less (72 hours later)
and less
Red Blood (RBC) 1.0% - 3% and less 3% and less 5% and less 3% and less -
Cell and less
Hemoglobin (HGB) 1.0% - 3% and less 3% and less 5% and less 3% and less -
Concentratio and less
n
Hematocrit (HCT) 1.0% - 3% and less 3% and less 5% and less 3% and less +5% and less
and less (Control Blood: (8 hours later)
5% and less) +8% and less
5% and less* (24 hours later,
kept at cold
place)
+15% and less
(24 hours later,
kept at 18-
26 °C)
+8% and less
(24 hours later,
kept at 18-
26 °C)*
+8% and less
(48 hours later,
kept at cold
place)*
+8% and less
(48 hours later,
kept at 18-
26 °C)*

XS Series S/M 1-36 October 2017

 Difference
between Stability
modes
Carryo After Sample
Parameters Manual Relative With time With Day Related
ver Collection
Mode and Temperature Voltage
Sampler
Mode
Mean (MCV) - - - - - - +5% and less
Corpuscular (8 hours later)
(erythrocyte) +8% and less
volume (24 hours later,
kept at cold
place)
+15% and less
(24 hours later,
kept at 18-
26 °C)
+8% and less
(24 hours later,
kept at 18-
26 °C)*
+8% and less
(48 hours later,
kept at cold
place)*
+8% and less
(48 hours later,
kept at 18-
26 °C)*
Mean (MCH) - - - - - - -
Corpuscular
Hemoglobin
Mean (MCHC) - - - - - - -
Corpuscular
Hemoglobin
Concentratio
n
Platelet (PLT) 1.0% - 10% or 10% or 10% or 10% or -
Count and less 2.0×104/µL 2.0×104/µL 2.0×104/µL 2.0×104/µL
and less and less and less and less
RBC (RDW- - - - (Reference - (Reference - (Reference - (Reference -
Distribution SD) data) data) data) data)
Width
RBC (RDW- - - - (Reference - (Reference - (Reference - (Reference -
Distribution CV) data) data) data) data)
Width
Platelet (PDW) - - - (Reference - (Reference - (Reference - (Reference -
Distribution data) data) data) data)
Width
Mean Platelet (MPV) - - - (Reference - (Reference - (Reference - (Reference -
Volume data) data) data) data)
Platelet Large (P-LCR) - - - (Reference - (Reference - (Reference - (Reference -
Cell Ratio data) data) data) data)
Plateletcrit (PCT) - - - (Reference - (Reference - (Reference - (Reference -
Value data) data) data) data)

XS Series S/M 1-37 October 2017

 Appendix 1-3 (2/2)

Difference
between Stability
modes After
Parameters Carryover Manual Sample
Relative Collection
Mode and With With Related
Temperatur
Sampler time Day Voltage
e
Mode
Neutrophil (NEUT%) - - 15% and less - - - ±8 NEUT%
Percent and less (36
hours later)
±8 NEUT%
and less (48
hours later)
Lymphocyte (LYMPH%) - - 15% and less - - - ±7 LYMPH%
Percent and less (36
hours later)
±7 LYMPH%
and less (48
hours later)
Monocyte (MONO%) - - 40% or 2.0 - - - ±3 MONO%
Percent MONO% and and less (36
less hours later)
±4 MONO%
and less (48
hours later)
Eosinophil (EO%) - - 15% or 1.0 - - - ±3 EO% and
Percent EO% and less less (36 hours
later)
±3 EO% and
less (48 hours
later)
Basophil (BASO%) - - 50% or 1.0 - - - Kept in
Percent BASO% and refrigerator:±1
less BASO% and
less (12 hours
later)
Kept at room
temperature:
±1 BASO%
and less (24
hours later)
Neutrophil (NEUT#) 2.0% or - - 15.0% 15.0% 10.0% -
Count 0.5×102/µL and less and less and less
and less
Lymphocyte (LYMPH#) 2.0% or - - 15.0% 15.0% 10.0% -
Count 0.5×102/µL and less and less and less
and less
Monocyte (MONO#) 2.0% or - - 40.0% or 40.0% or 30.0% or -
Count 0.3×102/µL 2.0×102/ 2.0×102/ 1.5×102/
and less µL and µL and µL and
less less less
Eosinophil (EO#) 2.0% or - - 15.0% or 15.0% or 10.0% or -
Count 0.3×102/µL 1.5×102/ 1.5×102/ 1.0×102/
and less µL and µL and µL and
less less less
Basophil (BASO#) 2.0% or - - 50.0% or 50.0% or 40.0% or -
Count 0.3×102/µL 1.0×102/ 1.0×102/ 0.8×102/
and less µL and µL and µL and
less less less

XS Series S/M 1-38 October 2017