SECTION 1 SPECIFICATIONS
1.1 OUTLINE........................................................................................ 1
1.2 NAME ............................................................................................. 1
1.3 Configuration and Expansion to the system ................................... 1
1.3.1 Variation ................................................................................... 1
1.3.2 Configuration............................................................................ 1
1.3.3 Reagents.................................................................................. 1
1.3.4 Control Blood ........................................................................... 1
1.3.5 Expansion to the system, and interface ................................... 2
1.4 Performance Characteristics .......................................................... 3
1.4.1 Intended Use............................................................................ 3
1.4.2 Measurement Principle ............................................................ 3
1.4.3 Sample Aspiration Volume and requird volume .......................... 4
1.4.4 Analysis Mode and Throughput ............................................... 4
1.4.5 Measurement, analysis Parameters ........................................ 4
1.4.6 Analysis and Display Range .................................................... 6
1.4.7 Reproducibility ......................................................................... 6
1.4.8 Accuracy .................................................................................. 6
1.4.9 Linearity ...................................................................................... 6
1.4.10 Dilution Linearity ....................................................................... 6
1.4.11 Carryover .................................................................................. 6
1.4.12 Difference between Manual Mode and Sampler Mode............. 7
1.4.13 Stability ..................................................................................... 7
1.4.14 Within-a-Day Stability after Collection of Blood ........................ 7
XS Series S/M
1.4.15 Detection Sensitivity of Immature Cell ...................................... 8
1.4.16 Required Reagent Volume ........................................................ 9
1.5 FUNCTION ................................................................................... 10
1.5.1 Start Up ..................................................................................... 10
1.5.2 Calibration function................................................................. 11
1.5.3 Quality Control Function ......................................................... 12
1.5.4 Online QC Function (optional for SNCS） ............................. 12
1.5.5 Discrete Analysis Function ..................................................... 12
1.5.6 Analysis Order Registration Function (Work Load List Function)
........................................................................................................... 12
1.5.7 Sampler Unit Function（When Sampler Unit OPSU-11 is
installed.）............................................................................. 13
1.5.8 Manual Mode Measurement Function .................................... 15
1.5.9 Capillary Mode Measurement Function.................................. 16
1.5.10 Abnormal Sample Monitoring Function ................................... 16
1.5.11 Abnormal Data Monitoring Function ........................................ 16
1.5.12 Analysis Result Storage Function............................................ 17
1.5.13 Stored Data (Analysis Result) Processing Function................ 17
1.5.14 Stored Data Processing Function by Patient ID ...................... 18
1.5.15 Patient Information Control Function....................................... 19
1.5.16 Function corresponding to XT pro (Standard Function, equal to
XT-1800i)................................................................................. 19
1.5.17 Available Languages ............................................................... 19
1.5.18 Shut Down Function................................................................ 20
December 13, 2007
 1.5.19 Main Unit Status Display Function .......................................... 20 Appendix 1-3 Carryover, Stability .......................................................... 30
1.5.20 Error Monitor Function............................................................ 20
1.5.21 Error Alerting Function............................................................ 20
1.5.22 Maintenance Function (Customer’s operation)....................... 21
1.5.23 Service Function (for Service or Production line) ................... 22
1.5.24 On-Line Support Function (SNCS Option) ............................. 22
1.5.25 Protection Function................................................................. 22
1.5.26 Waste Tank Fluid Level Monitor Function (Optional) .............. 22
1.6 Maintenance Performance ........................................................... 23
1.6.1 Maintenance Performance (for Customer)............................. 23
1.6.2 Maintenance Item .................................................................. 23
1.6.3 Service Items required at the fixed period (by Service Person)
........................................................................................................... 23
1.6.4 Spare Parts ............................................................................ 23
1.7 Acoustic Noise.............................................................................. 24
1.8 Dimension and Weight ................................................................. 24
1.9 Required Conditions ..................................................................... 24
1.9.1 Environmental Requirements................................................. 24
1.9.2 Voltage ................................................................................... 24
1.9.3 Class and Type of Electrical Protection.................................. 24
1.10 Reliability....................................................................................... 25
1.10.1 Designed Lifetime................................................................... 25
1.11 Packing Configuration ................................................................... 25
1.12 Storage Condition ......................................................................... 25
Appendix 1-1 Reproducibility, Accuracy ................................................ 26
Appendix 1-2 Linearity, Dilution Linearity .............................................. 28

XS Series S/M December 13, 2007

 August 5, 2008

SECTION 1 SPECIFICAIONS 1.3 Configuration and Expansion to the system

1.3.1 Variation
1.1 OUTLINE

(1) XS-1000i Close/Open unit Available Auto sampler Handy

• XS-1000i can handle both open and closed mode for analysis. Sample Cap piercer (with built-in Barcode
Tube Barcode Reader) Reader
• The tube with or without cap can be measured. The operator puts
XS-1000i Close
the tube to the sample holder. XS-1000iC Open
Standard Optional Optional
• Optional auto sampler (20 tubes) is available.
XS-800i Open - - Optional
(2) XS-800i
• XS-800i is open mode only.
• XS-800i is designed as the non-pierceable type to minimize the 1.3.2 Configuration
dead volume.
(1) Main Unit (without display)
• The sample tube must be the open type and the operator is required
(2) 20 samples Auto Sampler (Optional)
to set the tube to the sample probe for measurement.
(3) IPU
• 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.
1.3.3 Reagents
• CELLSHEATH (C) is used instead of CELLPACK.
• CELLSHEATH (C) is heated with a reagent heater.
(1) CELLPACK
(2) STROMATOLYSER-4DL
(3) STROMATOLYSER-4DS
1.2 NAME (4) SULOFOLYSER
(5) CELLCLEAN (Detergent)
(1) Name (4 containers (excluding the detergent) are connected.)
Automated Hematology Analyzer

(2) Model 1.3.4 Control Blood

XS-1000i
XS-1000iC (American Market Only) (1) e-CHECK (for XS-1000i/XS-1000iC/XS-800i)
XS-800i (2) Calibrator SCS-1000 (N.American Market: Customer use, other
area: Service Person’s use only)
(3) XS Sampler Unit OPSU-11

XS Series S/M 1-1

1.3.5 Expansion to the system, and interface

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

XS Series S/M 1-2 December 13, 2007

1.4 Performance Characteristics (3) RBC/PLT Measurement
RBC/PLT measurement sample is prepared by aspirating the
1.4.1 Intended Use specified volume and diluted by diluent.
RBC/PLT measurement sample is pushed into the flow cell by
This analyzer analyzes blood-counting parameters of human blood that Volumetric Syringe.
is collected in anticoagulant. Specified volume of sample goes through the aperture of 75um
diameter, and RBC/PLT is counted by Sheath Flow DC Detection
The anticoagulants are EDTA-2K, EDTA-3K, and EDTA-2Na. The Method and Automatic Discrimination Method.
anticoagulant conforms to the NCCLS (National Committee in Clinical
Laboratory Standards) (4) HGB measurement
HGB measurement sample is prepared by aspirating the specified
volume, diluted and hemolyzed using diluent and HGB Lyzing
1.4.2 Measurement Principle reagent.
Transmitted Light value is measured on each sample by calorimetric
(1) WBC/DIFF Measurement (CBC+DIFF Discrete) method, and HGB value is obtained by subtracting the value of
a) WBC/DIFF measurement sample is prepared as below. diluent from the sample value. The measurement method is SLS-Hb
• Aspirate the specified sample volume. method.
• Dilute, hemolyze and dye the aspirated sample using Lyzing
reagent and Dye reagent. Table 1: Dilution ratio, required sample volume, required reagent volume
b) The prepared sample is pushed into the center of Sheath Flow by (Whole Blood Mode)
Measured
Volumetric Syringe. Sample Reagent
Dilution sample
Channel Volume Reagent Volume
c) The sample is measured by Flowcytometry method (same as Ratio
μL μL
volume(W.blood
convert) μL
XE-2100) using semiconductor laser, and counted by 5DIFF STROMATOLYSER-4DL 1000
auto-classification using the side scattered light and side WBC/DIFF 95 11
STROMATOLYSER-4DS 30
1.02
fluorescence light. RBC/PLT 501 2 CELLPACK 1000 0.02
CELLPACK 1000 -
ＨＧＢ 751 2
(2) WBC Measurement (CBC Discrete) SULFOLYSER 500 -

The sample is measured by Flowcytometry method using

semiconductor laser, and counted by auto-classification from the
front scattered light.

XS Series S/M 1-3 December 13, 2007

 August 5, 2008

Table 2: Dilution ratio, required sample volume, required reagent volume 1.4.4 Analysis Mode and Throughput
(Capillary Mode)
Required: The below analysis modes are available.
Whole Blood 20 uL (1) Sample Aspiration Mode (XS-1000i, XS-1000iC)
Dilution 120 uL Manual Mode
Dilution Ratio 7 times Capillary Mode
Total volume of coordinated sample 140 uL
Auto sampler Mode
Sample Reagen Measured
Dilution Volume t sample (2) Sample Aspiration Mode (XS-800i)
Channel μL Reagent
Ratio volume volume(W.bloo Manual Open Mode
(W.Blood） μL d convert) μL
STROMATOLYSER-4DL 1000
Capillary Mode
WBC/DIFF 137 7.9 0.7
STROMATOLYSER-4DS 30
(3) Discrete Mode and Throughput
RBC/PLT 1563 1.29 CELLPACK 1000 0.0066
Model Analysis mode Discrete Throughput
CELLPACK 1000 - XS-1000i Manual CBC Approx. 60
HGB 2340 0.64
SULFOLYSER 500 - XS-1000iC (Open/closed) samples/hour
CBC+DIFF Approx. 60
samples/hour
1.4.3 Sample Aspiration Volume and requird volume Capillary CBC Approx. 49
(Open) samples/hour
Same volme in CBC or CBC+DIFF mode. CBC+DIFF Approx. 49
samples/hour
Model Analysis mode Aspirated volume Required sample Sampler CBC 20 samples
volume /approx.23
XS-1000i Manual/W.Blood 20uL Standard sample minutes
XS-1000iC tube：500uL CBC+DIFF 20 samples
/approx.23
Micro-sample
minutes
tube：90uL
XS-800i Manual CBC Approx. 60
Manual/Capillary 67uL (7 times Micro-sample (Open/ samples/hour
dilution) tube:140uL
CBC+DIFF Approx. 60
Sampler/W.Blood 20uL Standard sample samples/hour
tube : 1mL
Capillary CBC Approx. 55
XS-800i Manual/W.Blood 20uL － (Open) samples/hour
Manual/Capillary 67 uL (7 times － CBC+DIFF Approx. 55
dilution) samples/hour

XS Series S/M 1-4

1.4.5 Measurement, analysis Parameters

(1) Measurement Parameters, Histogram, Scattergram

Table 3: Measurement, Analysis Parameters
Reportable

Research
W.Blood Capillary

N.America

Screen
Parameter Remarks

For
DIFF

DIFF
CBC

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

XS Series S/M 1-4 December 13, 2007

 Reportable

Research
W.Blood Capillary

Screen
N.America
Parameter Remarks

CBC

DIFF

CBC

DIFF

For
Immature Granulocyte Percent (IG%) - v - v v v Option
DIFF Immature Granulocyte Count (IG#) - v - v v v Option
Parameters - - - - - v When DIFF is analyzed.
Other %
Other # - - - - - v When DIFF is analyzed.

White Blood Cell Count (WBC) v - v - v v

Histogram Red Blood Cell Count (RBC) v - - v v
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.

XS Series S/M 1-5 December 13, 2007

 August 5, 2008

1.4.6 Analysis and Display Range 1.4.10 Dilution Linearity

(1) Analysis Range (1) Blood Cell Count (WBC, PLT)

Refer to Appendix 1-1. The high value sample measured data using the method shown
below, is within the range shown in Appendix 1-2 against the
(2) Display Range regression line (any regression equation is available).
Refer to Appendix 1-1. Prepare the high value sample diluted using CELLPACK. Use
the calibrated micro pipette for volumetric measurement.

1.4.7 Reproducibility The dilution examples are shown below.

Table 4： Dilution Example
When fresh normal blood or control blood is analyzed 10 times or No. Sample CELLPACK Volume Diluion Density
more consecutively, the coefficient of variation under 95% confidence Volume
interval should be within the range shown in Appendix 1-1. 1 1.0 mL 0.0 mL 100%
2 0.8 mL 0.2 mL 80%
3 0.6 mL 0.4 mL 60%
1.4.8 Accuracy 4 0.5 mL 0.5 mL 50%
5 0.4 mL 0.6 mL 40%
(1) Blood Cell Count (WBC, RBC, PLT) 6 0.2 mL 0.8 mL 20%
7 0.1 mL 0.9 mL 10%
When fresh normal blood is analyzed 10 times consecutively after
instrument is calibrated, difference between the mean and * Calculate the mean value from the data gained by 3 times of
obtained from the standard instrument should be within the range manual mode measurement of each diluted sample.
shown in Appendix 1-1.
1.4.11 Carryover
(2) Blood Cell Classification (NEUT%, LYMPH%, MONO%, EO%,
BASO%)
(1) Blood Cell Count (WBC, RBC, HGB, HCT, PLT)
a) When 100 or more blood samples (collected on that day) are
When high value sample or control blood (High Abnormal) are
analyzed, the coefficient of variation should be within the range
used, carryover ratio obtained by standard analysis method should
shown in Appendix 1-1.
be within the range shown in Appendix 1-1 (XS-1000iC) and 1-3.
b) The mean difference from the value obtained on the standard
instrument should be within the range shown in Appendix 1-1..
(2) Blood Cell Classification (NEUT#, LYMPH#, MONO#, EO#,
BASO#, DIFF-WBC)
Carryover ratio or background value after high value sample
1.4.9 Linearity
analysis should be within the range shown in Appendix 1-3.
Residual or Residual ratio at specific concentration should be within
the range shown in Appendix 1-2.

XS Series S/M 1-6


1.4.12 Difference between Manual Mode and Sampler Mode
None. (Using the same Aspiration system.)
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 analysis 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.
XS Series S/M
August 5, 2008
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.
1-7
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, conform 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 1-8 December 13, 2007

1.4.16 Required Reagent Volume (3) Required Reagent volume at starting up

(1) Required Reagent volume for sample analysis Table 7: Required Reagent volume at starting up
Background check Background check
Table 5: Required Reagent volume for one sample analysis once twice
CBC
Discrete Mode CBC Total volume Approx.167mL Approx.38.5mL
+DIFF
Total volume Approx.34.5mL Approx.38.5mL CELLPACK Approx.162mL Approx.36mL
STROMATOLYSER-4DL Approx.4mL Approx.2mL
CELLPACK Approx.32mL Approx.32mL
STROMATOLYSER-4DS Approx.0.09mL Approx.0.03mL
STROMATOLYSER-4DL 2mL 2mL
SULFOLYSER Approx.1.0mL Approx.0.5mL
STROMATOLYSER-4DS - 0.03mL
SULFOLYSER Approx.約0.5mL Approx.0.5mL
(4) Required Reagent volume at shutdown
2) Required Reagent volume for auto rinse
Table 8: Required Reagent volume at shutdown
CELLPACK Approx. 95 17 mL
Table 6: Required Reagent volume for auto rinse
Background check Background (5) Required Reagent volume for resume from sleep
once check twice
Total volume Approx. 77mL Approx.38.5mL XS-1000i: 72 mL
CELLPACK Approx. 72mL Approx.36mL XS-800i: 74mL
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.

XS Series S/M 1-9 December 13, 2007

1.5 FUNCTION d) Log-ON to IPU program (can be skipped)
• Log-On window to enter user name and password is
1.5.1 Start Up displayed.
• If Log-On is performed by entering special User name before
Following operations are performed after power is turned ON, and Main Unit checks Log-On condition of IPU, Hot Start is
when condition of instrument is normal, it becomes Ready Mode available as shown below.
within 5 minutes. (except temperature and start up time of the IPU.) .
Temperature of each unit becomes measurable temperature within 20 e) Mode selection of Hot Start
minutes. It's possible to select Hot Start Mode about following contents.
If operator does not Log-ON immediately at IPU program when error (See Section 5 Service Program for detail procedure.)
occurs or background check sequence is extended, above operations
does not work. (i) Error Skip
(ii) Sequence Skip
(1) Power On (iii) Heater ON/OFF
Turn the power ON both main unit and IPU. The power ON order
has no preference. f) Ready
Menu screen of IPU program is displayed.
(2) IPU Start Up
a) Start Up of OS * It is impossible to re-start up only IPU after IPU and Main Unit
OS (Windows XP) is automatically started up. become Ready condition because Main Unit condition cannot
Log-On to OS. (can be skipped.) be specified.

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

XS Series S/M 1-10 December 13, 2007

(3) Main Unit Start Up 1.5.2 Calibration function
a) System Check
b) Program download
If IPU program is started up, program is downloaded from IPU. Customer can calibrate instrument.
c) Start Up Mode Check
• Log On condition of IPU is checked, and if Log On is performed (1) Calibration Method and Parameters
by special user name, it works depending on Hot Start Mode Table 10: Calibration Method and Parameters
setting. WBC RBC HGB HCT PLT
• If Hot Start Setting is not completed, it waits for the setting Auto Calibration (using - - v v -
completion. human blood)
• If start up is performed with the other condition of above, It Manual Calibration - - v v -
works on regular mode. Calibration by Calibrator v v v v v
d) Initialization and check
(i) Initial position of CP Unit/Pipette (2) Auto Calibration
(ii) Initial position of Sample Aspiration Syringe Unit Instrument is calibrated by automatically calculated
(iii) Initial position of Sheath Syringe compensation ratio obtained from analysis results on instrument.
(iv) Initial position of auto sampler Unit
(v) Temperature of Reaction Unit (3) Manual Calibration
(vi) Temperature of Reagent Heater Unit Instrument is calibrated by manually entered compensation
(vii) Pressure/vacuum ratio.
e) Rinse and Background Check
Auto Rinse and Background Check are performed. (4) Calibration by Calibrator (valid/invalid selection is available.)
f) Ready Instrument is calibrated automatically calculated using the
LED shows Ready mode lights. 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 1-11 December 13, 2007

1.5.3 Quality Control Function 1.5.4 Online QC Function (optional for SNCS）

(1) Quality Control Method and Quality Control File Dairy QC data is sent to compile center through communication line,
and customer can refer to the result
Table 11: Quality Control Method and Quality Control File
Point File
Name Analysis Mode level
Number Number 1.5.5 Discrete Analysis Function
Control 300
Control Material 1, 2, 3 Refer to “1.4.3 Analysis Mode and Throughput”.
X Contro Material /Lot
l or 300 20
L-J OTHER1 (Human Blood) -
/Lot 1.5.6 Analysis Order Registration Function (Work Load List
Control
300 Function)
OTHER2 (Human Blood) -
/Lot
XＭ Xbar-M (Human Blood) - 300 1 (1) Registration Number
Control 1,000 samples of analysis information can be registered.

(2) Contents of Registration

(2) Input/Output of Quality Control Data a) Sample Number: (15 characters)
It's possible to store/read all Quality Control Data to CD. b) Rack Number: (6 characters)
c) Rack Position: (2 characters)
(3) Input/Output of Quality Control File d) Analysis Order Information
It's possible to install Quality Control File Storage program e) Comment: (40 characters)
(Sysmex Insight) f) Patient ID (Option): (16 characters)
Character Number indicates number of one byte character.
(4) Output of Quality Control Data
It's possible to output Quality Control Data to following equipment. (3) Input and Edit
• Data Printer (DP) (as for stored data function) a) Manual Input
• Color Graphic Printer (GP/LP) b) Download from Host computer
• Host Computer
(4) Display
a) List Display on the IPU Screen

XS Series S/M 1-12 December 13, 2007

1.5.7 Sampler Unit Function（When Sampler Unit OPSU-11 is
installed.） Table 12: XS-1000i usable Sample Collection Tube
Name Remarks
(1) Applicable Sample Number VENOJECT II (TERUMO)） Re-cap is not acceptable.
• Up to 20 samples Hemoguard (BD)
• Up to 2 racks can be set at once, and 10 samples can be set at VACUETTE (greiner)
each rack. Monovette (SARSTEDT)

(2) Sample Rack

b) Sample
Low profile sample rack is used as the standard. (High profile
Whole blood sample, which has following condition, is
rack cannot be used.)
required.
c) Appropriate Blood Volume and Leave Time
(3) Blood Collection Tube and Sample
Table 13 Sample volume and leave time
a) Blood Collection tube
Appropriate Blood
• Blood Collection Tube with rubber cap is applicable. Diameter Leave Time
Volume
• A standard collection tube is a tube with 12 – 15 mm
Within 4 hours at room
diameter. 15 mm Approx. 1.0-7 mL
temperature
• When collection tubes of which diameter is 12 mm to 14 mm Within 4 hours at room
is used, specified holder should be installed on the rack. 12 mm Approx. 1.0-5mL
temperature
• Overall length of the collection tube including rubber cap is
79mm to 85mm. (4) Throughput (Without Barcorde Reader)
CBC+DIFF：20 samples/approx.23 minitues
Followings table shows the available sample collection tube.
CBC: 20 smples/approx. 23 minutes
Diameter 18 or less
If Barcode Reader is used, the throughput depends on the
Barcode Reader’s specification.
Sample Tube with cap

(5) Monitor Function

a) Blood Volume Monitor
None
60mm or
above
79 - 85mm

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.

12 - 15mm

XS Series S/M 1-13 December 13, 2007

(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
Sample
conforms to the sampler stop setting.
tube

(7) Sampler Stop Condition Setting

Stop/Continue of sampler analysis can be set when following

40mm
error occurs. A
Barcode
a) X M Limit Error
label
b) ID Read Error （Rack ID Read Error function is not employed.）
c) Abnormally Low Value

21mm
d) Abnormal Value (This does not mean Patient Limit but for
Sampler Stop Condition.)
e) Abnormal Sample Aspiration (Barcode should be positoned within the A area.)
f) Expired Control Blood
g) No Registered Control Blood
Barcode label specification should be as below.
(8) Input of Sample ID, Rack ID, and Rack Position
a) Manual Input

b
d
It's possible to input Sample ID, Rack ID, and Rack Position by
keyboard of IPU before analysis is started. 41624269960424
b) Input from Barcode Reader
If built-in type barcode reader is installed, it's possible to set or a c a
cancel reading sample/Rack ID from bar code affixed on the
e
sample collection tube and sample rack.
c) Auto Increment (Barcode label size)
If bar code is not used, sample ID and rack ID are
automatically incremented. <Bardoce label specificaiton>
d) The position of Barcode label appixed Margin （dimensionａ） 5mm and more
In the analysis of sampler mode, the barcode label Bar height （dimensionｂ） 20mm and more
positonshould be as blew. Effective area （dimensionｃ） 40mm and below
width （dimensionｄ） 30mm and more
length （dimensionｅ） 58mm and below
Narrow range ― 0.19mm and more

XS Series S/M 1-14 December 13, 2007

(9) Order Input 1.5.8 Manual Mode Measurement Function
a) Manual Input
Order can be input from IPU. (1) Blood Collection Tube and Sample
b) Host Inquiry a) Blood Collection tube
Host inquiry is possible by sample ID. Overall length of the blood collection tube is less than 80mm.
c) Priority b) Sample
Priority of order shows below. Whole blood mixed enough prior to aspiration.
• Order that registered in Work Load List.
• Order that is inquired to Host. (when Host inquiry is (2) Input of Sample ID
performed) a) Manual Input
It is possible to input sample ID from keyboard of IPU before
• Order input manually.
measurement
b) Input by Handy Barcode Reader (Optional)
(10) Display of Sample ID, Rack ID, Rack Position, and Order It is possible to input sample ID by Handy Barcode Reader before
They are displayed on IPU screen with instrument name. measurement.
(11) Measurement Start Operation (3) Order Input
Measurement starts by pushing Sampler Start Button on Same as “1.5.7 Sampler Unit Function”.
sampler.
(4) Display of Sample ID and Order
(12) Outline of the Sampler Operation They are displayed on IPU screen with instrument name.
a) Positions at the initial position.
b) The first positioned sample tube is gabbed by Catcher. (5) Measurement Start Operation
c) The catcher transfers the sample tube to the mixing position. • Customer sets sample at sample aspiration pipette on Main
d) Sample tube is mixed by the catcher’s tumbling operation. Unit, and push Start Switch.
e) After mixing, the sample tube is transferred and set to the sample • LED turnes on, and that shows sample is being aspirated.
set unit by the catcher. • After sample aspiration is completed, LED status will change to
f) The sample tube is rotated to read the barcode label by sample tube
the condition that shows sample aspiration is completed with
rotating mechanism on the way of the sample set unit moving into
beep sound. Then the sample must be removed from pipette.
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. (6) Output of the measurement results
i) The sample tube is caught by the catcher and returned to its initial Same as “1.5.7 Sampler Unit Function”.
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) Processing Function”.）

XS Series S/M 1-15 December 13, 2007

1.5.9 Capillary Mode Measurement Function 1.5.10 Abnormal Sample Monitoring Function

(1) Blood Collection Tube and Sample Screen and detect the abnormal morphology flags using histogram,
a) Blood Collection tube scattergram and counted data. Positive or Negative is judged by this
Same as “1.5.8 Manual Mode Measurement Function”. function.
b) Sample
Diluted sample which whole blood is diluted 7 times.
1.5.11 Abnormal Data Monitoring Function
(2) Input of Sample ID
Same as “1.5.8 Manual Mode Measurement Function”. (1) Abnormal Data (Patient Limit)
The Normal range of each parameter (Upper and Lower limits) can
(3) Input of Order be set and monitored.
Same as “1.5.7 Sampler Unit Function”. If the patient information program (optional) is installed, normal
range for each condition of age and gender can be set.
(4) Display of Sample ID and Order
Same as “1.5.8 Manual Mode Measurement Function”.
(2) Linearity Error
(5) Measurement Start Operation Analysis data is monitored whether it is within the linearity assured
Same as “1.5.8 Manual Mode Measurement Function”. range.

(6) Output of the measurement results

Same as “1.5.7 Sampler Unit Function”.

XS Series S/M 1-16 December 13, 2007

1.5.12 Analysis Result Storage Function 1.5.13 Stored Data (Analysis Result) Processing Function

Analysis result is stored in IPU. (1) Display

The followings can be displayed on the IPU screen.
(1) Storage Number a) Sample Display
10,000 samples (i) Latest Sample
(ii) Stored Sample
(2) Contents of Storage b) List Display
a) Sample ID (i) Latest Sample
b) Rack ID (Sampler Mode) (ii) Stored Sample
c) Rack Position (Sampler Mode)
d) Analysis Order (2) Validation Function
e) Analysis Mode It's possible to validate analysis result manually or automatically.
f) Analysis Result (Numerical Value, Flag)
g) Scattergram (3) Edit
h) Histogram It's possible to edit following items whose analysis results are not
i) Negative / Positive validated.
j) Error Information • Sample ID
k) Analysis Date • Patient ID
l) Analysis Time • Sample ID Input source
m) Original Information of Sample ID Input • Changing from “Positive” to “Negative” is possible.
n) Validation Status
o) Sequence Number (Analysis Order after Power ON) (4) Delete
and so on Any analysis data can be deleted per sample.

XS Series S/M 1-17 December 13, 2007

(5) Peripheral Output 1.5.14 Stored Data Processing Function by Patient ID
Validated analysis data can be output as follows.
a) Print out (1) Patient ID Registration Function
Stored analysis data can be output as shown below. a) Contents of Registration
Output data can be selected randomly. Patient ID: 16 characters.
b) Input/Edit
Table 14: Stored Data Print Out When inputting the Work Load List from IPU, input or edit is
Auto Print out possible during the stored data (not validated) editing.
Output Device Contents of the latest c) Output
stored data It's output when stored data is displayed or output to the external
Data Printer (DP) Data per one sample v device.
Color Graphic Printer Data per one sample v
(GP/LP) List Print - (2) Previous Data Check Function
Previous analysis data can be checked from the Patient ID.
b) Host Output
(3) Cumulative Display Function
Analysis result can be output to Host Computer.
The Stored Data can be displayed in cumulatively
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 analyzed.)
(This format is the default.)
• XT (XE format is the base format. Zero is applied to the
parameters which cannot be analyzed.)
• 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.

XS Series S/M 1-18 December 13, 2007

1.5.15 Patient Information Control Function 1.5.16 Function corresponding to XT pro (Standard Function,
equal to XT-1800i)
When patient ID function is added, the additional function that can
store and control the Patient Information associated with Patient ID (1) Reagent Check Function
can be added. • Reagent Register Function
• Expire Date Check Function
(1) Registration Number • Reagent Log Function
5,000 patients • Reagent Remaining Amount Display Function

(2) Contents of Registration (2) GP Customize Function

a) Patient Name: 40 Characters
b) Gender: 1 Character (3) QC Data Range Set Function
c) Birthday: 8 Characters
d) Doctor Name: 20 Characters (4) CSV Format Output Function
e) Ward: 20 Characters
f) Comment: 100 Characters
*Character Number indicates 1 byte character. 1.5.17 Available Languages

(3) Input/Edit Japanese, English, German, Italian, French, Spanish, Chinese, Greek,
Input or edit operation is possible from IPU. It is possible to input Russian and Portuguese are available.
the information with the Patient ID by transfering from Host
Computer.

(4) Display
It is possible to display on the IPU screen.

XS Series S/M 1-19 December 13, 2007

1.5.18 Shut Down Function 1.5.21 Error Alerting Function

Rinsing of instrument is performed, and the instrument will become Alarm sounds when the error occurs.
the status that power of Main Unit can be OFF.
(1) Shut Down starts (1) Alarm Sound
a) Selection of Shut down Mode When error occurs on Main Unit, alarm sounds from Main Unit.
After shut down mode is selected, it proceeds in the next step.
(Can be canceled) (2) Stop of Alarm Sound
b) Starting Shut Down Alarm sound from Main Unit can be stopped by operating IPU.
However, if IPU does not communicate with Main Unit (e.g Power
(2) Shut Down Operation of IPU is OFF), power of Main Unit should be turned OFF.
Rinsing of manual whole blood line, CP whole blood line, and
measurement line are performed. (3) Alarm Setting
(3) Output Alarm sound (tone) on the Main Unit can be set (selected).
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.

XS Series S/M 1-20 December 13, 2007

1.5.22 Maintenance Function (Customer’s operation) (3) Maintenance History Registration Function
a) Operation Cycle Number
XS has the following Maintenance Functions which customers can b) Unit Operation Cycle Number
perform. c) Reagent Exchange Log
and so on.
(1) Maintenance Sequence
a) Auto Rinse Sequence (4) Display Parameters
i) Rinse Operation a) HGB Convert Value
Background Check Operation is performed twice. b) FCM Detector Laser Power
ii) Background Check c) FCM Detector PMT (Photo Multiplier Tube) Voltage Setting Value
Background Check is performed, and if background value is d) Pressure
out of range that shows following table, background check is e) Temperature
continued. Continued number of Background Check f) Operation Cycle Count
sequence is up to twice. (Number of Background Check g) Setting Values
Analysis is maximum three times.) If Background value at final and so on.
Background Checkis out of range that shows following table,
Background Error occurs (5) Test Function
a) Sample Aspiration Syringe Operation Test
Table 15: Background Check Level b) Sheath Syringe Operation Test
Parameter Range c) Diaphragm Pump Operation Test
WBC-C 0.3 x 103/uL or less d) Auto sampler Operation Test
WBC-D 0.1 x 103/uL or less e) CP/Pipette Operation Test
RBC 0.02 x 106/uL or less f) Barcode Reader Operation Test
HGB 0.1 g/dL or less and so on.
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)

XS Series S/M 1-21 December 13, 2007

1.5.23 Service Function (for Service or Production line) 1.5.26 Waste Tank Fluid Level Monitor Function (Optional)

The following maintenance functions are available. Alarm sounds when waste tank is full.

(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 Regurator)
• Thermostat (Built in Switching Regurator)
b) Temperature Control Unit
Thermal Protector

(2) IPU
Fuse (depends on the PC specification.)

XS Series S/M 1-22 December 13, 2007

1.6 Maintenance Performance 1.6.3 Service Items required at the fixed period (by Service
Person)
1.6.1 Maintenance Performance (for Customer)
Table 17: Periodical Service item and time to do
All Maintenances operations performed by customer can access form Service Item Time to do
Top or right side. Sheath Syringe Seal Replacement Every three years

1.6.2 Maintenance Item

1.6.4 Spare Parts
Maintenance items and the time to do are shown in the below table.
If the counter is not reset when performing maintenance, the message The following parts are included in XS Supply Parts.
requiring the maintenance will be displayed when the counter reaches
the pre-set cycle number. (1) As Spare

Table16: Maintenance items and time to do Table 18: Spare pars for replacement
Items Time to do Condition Item Included Qty
Shut down Once/day Every 100 analysis Main Unit Fuse 1 set
Piercer Replacement Once/30000 CP Every 30000 CP Tubings Some
analysis analysis
Pump Replacement Once/30000 analysis Every 30000 (2) Tools
(Pneumatic Unit) analysis
Flow Cell Rinse As required Table 19: Tool
RBC Detector Clog As required Item Included Qty Memo
Removal Screwdriver (+) １
Flow Cell Bubble As required Transducer Brush １ RBC Detector Clog Removal
Removal
Reagent As required
Replacement
Waste Container As required
Replacement
Fuse Replacement As required

XS Series S/M 1-23 December 13, 2007

 August 5, 2008
1.7 Acoustic Noise 1.9 Required Conditions

60 dB and below during operation (excluding the accidental noise) 1.9.1 Environmental Requirements
45 db and below (at Ready status)
(1) Ambient Temperature: 15 to 30°C (The reagent temperature
should also be within this range.)
1.8 Dimension and Weight
(2) Relative Humidity: 30 - 85%
Table 20: Dimension and Weight
XS-1000i, Dimensions (W x D x H) (mm) Weight
(3) Atmospheric Pressure: 9kPa – 106kPa
XS-1000iC
Main Unit 320x 413x 403 Approx. 24 kg (4) Installation Condition: Avoid installation in a place where the
Data Processing instrument may be exposed to the direct sunlight, dust, vibration,
Depends on the PC specification. or acid.
Unit

Sampler Unit 450 x 630 x 415 Approx. 14 kg

1.9.2 Voltage
XS-800i Dimensions (W x D x H) (mm) Weight
Main Unit 320x 413 x 503 Approx. 24 kg (1) Rated Voltage
Data Processing 100 – 117 V/220 -240 V +/- 10%
Depends on the PC specification.
Unit
(2) Frequency
50 Hz/60Hz

(3) Power Consumption

As below.

Table 21: Power Consumption

Main Unit + Sampler
100 – 240 V
50 Hz
210 VA and below
60 Hz

1.9.3 Class and Type of Electrical Protection

Class-I electrical apparatus.

XS Series S/M 1-24

1.10 Reliability 1.11 Packing Configuration

1.10.1 Designed Lifetime Packing configuration is as below.

(1) Sample Throughput (1) Main Unit

40 samples/day (2) Sampler Unit
(3) Supply Parts
(2) Designed Lifetime (4) IPU (Japanese Market only)
40 samples/day x 300 days/year x 5 years = 60000 samples (5) Other Optional

1.12 Storage Condition

(1) Storage Condition

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

XS Series S/M 1-25 December 13, 2007

 August 5, 2008
Appendix 1-1 Reproducibility, Accuracy (*: XS-1000iC)
Reproducibility Accuracy
Parameters Analysis Range Display Range W. Blood Mode Capillary Mode Condition
W.Blood Mode Capillary Mode

White Blood (WBC) ±3% or

5.0% and less
Cell 4000x102/μL 0.0-9999.9 ×102/μL 3.0% and less 40x102/μL and more ±2.0x102/μL and ±10% and less
less
Red Blood (RBC) ±2% or ±3×104/μL
Cell 0- 800 ×104/μL 0-9999 ×104/μL 1.5% and less 4.5% and less 400x104/μL and more ± 8% and less
and less
Hemoglobin (HGB) 0.0-25.0 g/dL
0.0-30.0 g/dL 1.5% and less 4.5% and less
Concentrati 0.00-15.52 - - -
0.00-18.62 mmol/L Max-Min < 0.5g/dL Max-Min < 1.5g/dL
on mmol/L
Hematocrit (HCT)
0.0-60.0 HCT% 0.0-100.0 HCT% 1.5% and less 4.5% and less - - -
Mean (MCV)
Corpuscular 1.5% and less
- - 4.5% and less - - -
(erythrocyte) 2.0% and less*
volume
Mean (MCH)
Corpuscular - - 2.0% and less 4.5% and less - - -
Hemoglobin
Mean (MCHC)
Corpuscular
2.0% and less
Hemoglobin - - 6.0% and less - - -
2.5% and less*
Concentrati
on
Platelet (PLT)
Count ±5% or
0-500.0 x 104/μL
0.0-999.9 ×104/μL 4.0% and less 12.0% and less 10×104/μL and more ±1.0×104/μL and ±12% and less
less

RBC (RDW-
Distribution SD) - - 3.0% and less Not measured - - -
Width
RBC (RDW-
Distribution CV) - - 3.0% and less Not measured - - -
Width
Platelet (PDW)
Distribution - - 10.0% and less Not measured - - -
Width
Mean (MPV)
Platelet - - 4.0% and less Not measured - - -
Volume
Platelet (P-LCR
Large Cell ) - - 18.0% and less Not measured - - -
Ratio
Plateletcrit (PCT)
- - 6.0% and less Not measured - - -
Value

XS Series S/M 1-26

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

Reproducibility Accuracy
Parameters Analysis Display Range W. Blood Mode Capillary Mode Condition
W.Blood Mode Capillary Mode
Range
Neutrophil 30.0NEUT% and
1) r=0.90 and more
Percent more， 1) r=0.70 and more
(NEUT%) - - 8.0% and less 16.0% and less 2 2)±3.0 NEUT% and
WBC 40×10 /μL and 2)±3.0 NEUT% and less
less
more
Lymphocyte 15.0LYMPH% and
1) r=0.90 and more 1) r=0.70 and more
Percent more，
(LYMPH%) - - 8.0% and less 16.0% and less 2 2)±3.0 LYMPH% 2)±3.0 LYMPH% and
WBC 40×10 /μL and
and less less
more
Monocyte Percent 5.0MONO% and
1) r=0.75 and more
more， 1) r=0.6 and more
(MONO%) - - 20.0% and less 40.0% and less 2 2)±2.0 MONO%
WBC 40×10 /μL and 2)±2.0 MONO% and less
and less
more
2
Eosinophil - - 25.0% and less， or 40.0% and less WBC 40×10 /μL and 1) r=0.80 and more 1) r=0.60 and more
Percent (EO%) ±1.5EO% and less more 2)±1.0 EO% and 2)±1.0 EO%以内
less
2
Basophil Percent - - 40.0% and less， or 50.0% and less， or WBC 40×10 /μL and 1) r=0.50 and more 1) r=0.50 and more
(BASO%) ±1.0BASO% and ±1.5BASO% and less more 2)±1.0 BASO% and 2)±1.0 BASO% and less
less less
2
Neutrophil Count - - 8.0% and less 16.0% and less 12.0×10 /μL and - -
(NEUT#)
more
2
Lymphocyte - - 8.0% and less 16.0% and less 6.0×10 /μL and - -
(LYMPH#) more
Count
2
Monocyte Count - - 20.0% and less 40.0% and less 2.0×10 /μL and - -
(MONO#)
more
Eosinophil Count - - 25.0% and less， or 40.0% and less， or - - -
2 2
(EO#) ±1.2×10 /μL and ±1.2×10 /μL and less
less
Basophil Count - - 40.0% and less， or 50.0% and less， or - - -
2 2
(BASO#) ±0.6×10 /μL and ±0.6×10 /μL and less
less

XS Series S/M 1-27 December 13, 2007

Appendix 1-2 Linearity, Dilution Linearity
Linearity Dilution Linearity
Parameters Specification
W.Blood Mode Capillary Mode Condition Condition
(W.Blood Mode)
2
1. ±3% or ±3×10 /μL 2
1. 0-1000×10 /μL
±3% or ±5% or 2 and less 2
White Blood Cell (WBC) 2
±3×10 /μL and less
2
±5.0×10 /μL and less
0-1000×10 /μL
2. ±6%
2. 1000.1-3000×10 /μL
2
3. 3000.1-4000×10 /μL
3. ±11%
±3% or ±6% or 4
Red Blood Cell (RBC) 4
±3×10 /μL and less
4
±6×10 /μL and less
0-800×10 /μL -

±2% or ±7% or
Hemoglobin Concentration (HGB)
±0.2g/dL and less ±0.7g/dL and less
0.0-25.0g/dL -

±3% or ±6% or
Hematocrit (HCT)
±1 HCT% and less ±2.0HCT% and less
0.0-60.0HCT% -
Variation of RBC 4
Mean Corpuscular RBC Approx.450×10 /μL,
(MCV) concentration should be - 4 -
(erythrocyte) volume 200<RBC<700×10 /μL
±2fL and less
Mean Corpuscular
(MCH) - - - -
Hemoglobin
Mean Corpuscular
(MCHC) - - - -
Hemoglobin Concentration
4 4
±5% or ±1×10 /μL and 0-100.0×10 /μL, 2
4 1. ±5% or ±1×10 /μL 4
less ±10% or Note, RBC is approx.400×10 /μ, 1. 0-200.0×10 /μL
Platelet Count (PLT)
RBC influence should be
4
±2.0×10 /μL and less 4
and PLT is approx.30.0×10 /μL,
and less 4
2. 200.1-500×10 /μL
4 4 2. ±16%
±2×10 /μL and less 200<RBC<700×10 /μL
RBC Distribution Width (RDW-SD) - - - -
RBC Distribution Width (RDW-CV) - - - -
Platelet Distribution Width (PDW) - - - -
Mean Platelet Volume (MPV) - - - -
Platelet Large Cell Ratio (P-LCR) - - - -
Plateletcrit Value (PCT) - - - -

XS Series S/M 1-28 December 13, 2007

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

Linearity Dilution Linearity

Parameters Specification Condition
W.Blood Mode Capillary Mode Condition
(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 1-29 December 13, 2007

 August 5, 2008
Appendix 1-3 Carryover, Stability (*: XS-1000iC)
Parameters Difference Stability
Carryover between modes After Sample Collection
Manual Mode and Relative With time With Day Related Voltage
Sampler Mode Temperature
1.0% and less 5% or 5.0×102/μL 5% and less 10% and less 5% and less ±10% and less (72 hours
White Blood Cell (WBC) - and less later)
Red Blood Cell (RBC) 1.0% and less - 3% and less 3% and less 5% and less 3% and less -
Hemoglobin 3% and less 3% and less 5% and less 3% and less -
(HGB) 1.0% and less -
Concentration
3% and less 3% and less 5% and less 3% and less +5% and less (8 hours later)
(Control Blood: 5% +8% and less (24 hours
and less) later, kept at cold place)
5% and less* +15% and less (24 hours
later, kept at 18-26°C)
Hematocrit (HCT) 1.0% and less - +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)*
- - - - +5% and less (8 hours later)
+8% and less (24 hours
later, kept at cold place)
+15% and less (24 hours
later, kept at 18-26°C)
Mean Corpuscular
(MCV) - - +8% and less (24 hours later,
(erythrocyte) volume
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 Corpuscular - - - - -
(MCH) - -
Hemoglobin
Mean Corpuscular - - - - -
Hemoglobin (MCHC) - -
Concentration
10% or 10% or 10% or 10% or 2.0×104/μL -
Platelet Count (PLT) 1.0% and less - 2.0×104/μL and less 2.0×104/μL and less 2.0×104/μL and less and less
RBC Distribution Width (RDW-SD) - - - (Reference data) - (Reference data) - (Reference data) - (Reference data) -
RBC Distribution Width (RDW-CV) - - - (Reference data) - (Reference data) - (Reference data) - (Reference data) -
Platelet Distribution - (Reference data) - (Reference data) - (Reference data) -
(PDW) - - - (Reference data)
Width
Mean Platelet Volume (MPV) - - - (Reference data) - (Reference data) - (Reference data) - (Reference data) -
Platelet Large Cell - (Reference data) - (Reference data) - (Reference data) -
(P-LCR) - - - (Reference data)
Ratio
Plateletcrit Value (PCT) - - - (Reference data) - (Reference data) - (Reference data) - (Reference data) -

XS Series S/M 1-30

Appendix 1-3 (2/2)

Difference between Stability

modes After Sample
Parameters Carryover Manual Mode and Collection
Relative Temperature With time With Day Related
Sampler Mode Voltage
±8 NEUT% and less (36
hours later)
Neutrophil Percent (NEUT%) - - 15% and less - - - ±8 NEUT% and less (48
hours later)
±7 LYMPH% and less
Lymphocyte (36 hours later)
(LYMPH%) - - 15% and less - - - ±7 LYMPH% and less
Percent
(48 hours later)
±3 MONO% and less (36
40% or 2.0 MONO% and hours later)
Monocyte Percent (MONO%) - -
less
- - - ±4 MONO% and less (48
hours later)
±3 EO% and less (36
15% or 1.0 EO% and hours later)
Eosinophil Percent (EO%) - -
less
- - -
±3 EO% and less (48
hours later)
Kept in refrigerator:±1
BASO% and less (12
50% or 1.0 BASO% hours later)
Basophil Percent (BASO%) - -
and less
- - - Kept at room
temperature: ±1 BASO%
and less (24 hours later)
2
2.0% or 0.5×10 /μL 15.0% and less 15.0% and 10.0% and -
Neutrophil Count (NEUT#) and less - - less less
2
2.0% or 0.5×10 /μL 15.0% and less 15.0% and 10.0% and -
Lymphocyte Count (LYMPH#) and less - - less less
2
2.0% or 0.3×10 /μL 40.0% or 40.0% or 30.0% or -
2 2
Monocyte Count (MONO#) and less - - 2.0×10 /μL and 2.0×102/μL 1.5×10 /μL
less and less and less
2
2.0% or 0.3×10 /μL 15.0% or 15.0% or 10.0% or -
2 2
Eosinophil Count (EO#) and less - - 1.5×10 /μL and 1.5×102/μL 1.0×10 /μL
less and less and less
2
2.0% or 0.3×10 /μL 50.0% or 50.0% or 40.0% or -
2 2
Basophil Count (BASO#) and less - - 1.0×10 /μL and 1.0×102/μL 0.8×10 /μL
less and less and less

XS Series S/M 1-31 December 13, 2007