XS - Series Calibration Report

Customer : Date :
Model: XS800i
Serial No :

1 BACKGROUND VERIFICATION

1.1 Background check was done by executing the Auto Rinsing. The results are as below :

Parameters Results Acceptable Range Status

WBC ≤1.0 X 10*2/uL PASS
RBC ≤ 2 X 10*4/uL PASS
HGB ≤ 0.2g/dL PASS
PLT ≤ 10 X 10*4/uL PASS

2 OPTICAL ALIGNMENT FOR FORWARD SCATTERING (FSC) - Optical Fine

- Logon servic
- Menu ->Con
2.1 The Dynospheres SS-072-P latex was prepared with 1 drop of SS-072-P to 10mL cellpack. The diluted latex Adjustment (F
was analyzed to determine the Optical Axis of the FSC. The results are as below :

Parameters Results Acceptable Range Status

FSC (X) 60 ± 30 FAIL
FSC (W) Less than 0.35 PASS

3 OPTICAL ALIGNMENT FOR SIDE FLUORESCENCE (SFL) & SIDE SCATTERING (SSC) - Optical Fine - Logon servic
- Menu ->Con
Adjustment (F
3.1 The Fluorescence Latex A-7312 was prepared with 1 drop of A-7312 to 10mL cellpack. The diluted latex was
analyzed to determine the Optical Axis alignment of the SFL & SSC. The results are as below :

Parameters Results Acceptable Range Status

SFL (X) 130 ± 50 FAIL
SFL (W) Less than 0.30 PASS
SSC (X) 50 ± 40 FAIL
SSC (W) Less than 0.35 PASS

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 - Logon servic
4 RBC CLOG LEVEL ADJUSTMENT
- Menu ->Con
4.1 The RBC clog adjustment is monitored after the background check. The result is as below :

Parameter Result Acceptable Range Status

RBC Clog 99 ± 1 FAIL

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5 ASPIRATION ADJUSTMENT
- Menu ->Con
- Menu ->Con
5.1 QC Material : XE e-Check
Lot : 20020811 Note: Target =
Expiry : 25-Mar-2012

Parameter Result Acceptable Range Status

Sample blank 1300 ± 500 FAIL

6 SENSITIVITY ADJUSTMENTS USING e-CHECK NORMAL - Logon servic

- Menu ->Con
- Menu ->Con
6.1 QC Material : e-Check
Lot : 20020811 Notes: After s
Expiry : 25-Mar-2012 material.Som
ran to obtain

Sample Criter

No Suspect
WBC: 4,5 -
HgB: 12 -16
Lymph %: 2
Mono %: 2
Eo %: 0 - 6
Baso %: 0 -
IMI#: < 10
MCV: 82 - 9
MCH: 27,5 -
RETIC: 0,4
PLT: 140 - 4
Asp. Sensor Asp. Sensor
blank blank

6.2 e-check (Normal), was used to perform sensitivity adjustments on certain parameters. The results are as
below :

Parameters Result Assay Value Acceptable Range Status

DIFF-X 165.7 ± 3 ch FAIL
DIFF-Y 56.6 ± 2 ch FAIL
FSC-X 27.4 ± 2 ch FAIL
MCV 82.8 ± 1 fL FAIL
MPV 9.8 ± 1 fL FAIL
HGB blank 2000 2000 ± 500 FAIL
HGB 12.3 ± 1 fL FAIL
ASP. Sensor blank 2000 2000 ± 500 FAIL

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7 SYSMEX CALIBRATION

7.1 Calibrator Used : QC Normal

Lot : 20020811
Expiry : 25-Mar-2012

7.2 QC normal Assay Target Values

Parameter Target Min Max

WBC 7.04 6.6 7.5
RBC 4.4 4.2 4.6
HGB 12.3 11.9 12.7
HCT 36.4 34.6 38.2
MCV 82.8 78.7 86.9
PLT 208.0 177.0 239.0

7.3 Results of QC normal before calibration

Status
Parameter 2nd Run 3rd Run 4th Run 5th Run 6th Run Mean SD CV % Target CV %
WBC 0.0 #DIV/0! #DIV/0! FAIL #DIV/0!
RBC 0.0 #DIV/0! #DIV/0! FAIL #DIV/0!
HGB 0.0 #DIV/0! #DIV/0! FAIL #DIV/0!
HCT 0.0 #DIV/0! #DIV/0! FAIL #DIV/0!
MCV 0.0 #DIV/0! #DIV/0! FAIL #DIV/0!
PLT 0.0 #DIV/0! #DIV/0! FAIL #DIV/0!

7.4 Results of QC normal after calibration

Status
Parameter 2nd Run 3rd Run 4th Run 5th Run 6th Run Mean SD CV % Target CV %
WBC 0.00 #DIV/0! #DIV/0! FAIL #DIV/0!
RBC 0.00 #DIV/0! #DIV/0! FAIL #DIV/0!
HGB 0.00 #DIV/0! #DIV/0! FAIL #DIV/0!
HCT 0.00 #DIV/0! #DIV/0! FAIL #DIV/0!
MCV 0.00 #DIV/0! #DIV/0! FAIL #DIV/0!
PLT 0.00 #DIV/0! #DIV/0! FAIL #DIV/0!

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7.5 Result of QC normal for Capillary mode before calibration

Parameter 2nd Run 3rd Run 4th Run 5th Run 6th Run Mean SD CV% Target CV%
WBC 0.00 #DIV/0! #DIV/0! FAIL #DIV/0!
RBC 0.00 #DIV/0! #DIV/0! FAIL #DIV/0!
HGB 0.00 #DIV/0! #DIV/0! FAIL #DIV/0!
HCT 0.00 #DIV/0! #DIV/0! FAIL #DIV/0!
MCV 0.00 #DIV/0! #DIV/0! FAIL #DIV/0!
PLT 0.00 #DIV/0! #DIV/0! FAIL #DIV/0!

7.6 Result of QC normal for capillary mode after calibration

Parameter 2nd Run 3rd Run 4th Run 5th Run 6th Run Mean SD CV% Target CV%
WBC 0.00 #DIV/0! #DIV/0! FAIL #DIV/0!
RBC 0.00 #DIV/0! #DIV/0! FAIL #DIV/0!
HGB 0.00 #DIV/0! #DIV/0! FAIL #DIV/0!
HCT 0.00 #DIV/0! #DIV/0! FAIL #DIV/0!
MCV 0.00 #DIV/0! #DIV/0! FAIL #DIV/0!
PLT 0.00 #DIV/0! #DIV/0! FAIL #DIV/0!

8 PERFORMANCE VERIFICATION BY USING SYSMEX XS e-CHECK

8.1 Control Used : XE e-Check

Lot No. : 22250810
Expiry date : 4-Nov-2012

8.2 XE e-Check (Low) results :

e-Check Assay Value

Parameter Result Target Limit Min Max Status
WBC 2.93 0.29 2.64 3.22 FAIL
RBC 2.27 0.11 2.16 2.38 FAIL
HGB 5.6 0.2 5.40 5.80 FAIL
HCT 17.3 1 16.30 18.30 FAIL
MCV 76.3 3.8 72.50 80.10 FAIL
MCH 24.7 1.2 23.50 25.90 FAIL
MCHC 32.4 1.9 30.50 34.30 FAIL
PLT 53 21 32.00 74.00 FAIL
RDW-SD 45.7 6.9 38.80 52.60 FAIL
RDW-CV 16.7 2.5 14.20 19.20 FAIL
PDW 10.2 4.1 6.10 14.30 FAIL
MPV 9.2 1.4 7.80 10.60 FAIL
P-LCR 14.9 12.7 2.20 27.60 FAIL
PCT 0.05 0.03 0.02 0.08 FAIL
NEUT# 1.08 0.32 0.76 1.40 FAIL
LYMPH# 1.01 0.4 0.61 1.41 FAIL
MONO# 0.31 0.28 0.03 0.59 FAIL
EO# 0.26 0.13 0.13 0.39 FAIL
BASO# 0.16 0.12 0.04 0.28 FAIL

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8.3 XE e-Check (Normal) results :
Lot no : 22260811
Exp date 4/Nov/12

e-Check Assay Value

Parameter Result Target Limit Min Max Status
WBC 7.04 0.42 6.62 7.46 FAIL
RBC 4.4 0.22 4.18 4.62 FAIL
HGB 12.3 0.4 11.90 12.70 FAIL
HCT 36.4 1.8 34.60 38.20 FAIL
MCV 82.8 4.1 78.70 86.90 FAIL
MCH 28 1.4 26.60 29.40 FAIL
MCHC 33.8 2 31.80 35.80 FAIL
PLT 208 31 177.00 239.00 FAIL
RDW-SD 44.2 6.6 37.60 50.80 FAIL
RDW-CV 15.2 2.3 12.90 17.50 FAIL
PDW 9.4 2.8 6.60 12.20 FAIL
MPV 9.8 1.5 8.30 11.30 FAIL
P-LCR 16 8 8.00 24.00 FAIL
PCT 0.2 0.06 0.14 0.26 FAIL
NEUT# 2.84 0.85 1.99 3.69 FAIL
LYMPH# 2.09 0.63 1.46 2.72 FAIL
MONO# 0.74 0.67 0.07 1.41 FAIL
EO# 0.66 0.33 0.33 0.99 FAIL
BASO# 0.42 0.33 0.09 0.75 FAIL

8.4 XE e-Check (High QC) results :

Lot no : 22240812
Exp date : 4/Nov/12

e-Check Assay Value

Parameter Result Target Limit Min Max Status
WBC 17.42 1.05 16.37 18.47 FAIL
RBC 5.39 0.27 5.12 5.66 FAIL
HGB 17 0.5 16.50 17.50 FAIL
HCT 49.9 2.5 47.40 52.40 FAIL
MCV 92.5 4.6 87.90 97.10 FAIL
MCH 31.5 1.6 29.90 33.10 FAIL
MCHC 34.1 2 32.10 36.10 FAIL
PLT 490 64 426.00 554.00 FAIL
RDW-SD 44.9 6.7 38.20 51.60 FAIL
RDW-CV 14 2.1 11.90 16.10 FAIL
PDW 9.9 2 7.90 11.90 FAIL
MPV 9.9 1.5 8.40 11.40 FAIL
P-LCR 17.1 8.6 8.50 25.70 FAIL
PCT 0.48 0.12 0.36 0.60 FAIL
NEUT# 7.89 2.37 5.52 10.26 FAIL
LYMPH# 4.52 1.36 3.16 5.88 FAIL
MONO# 1.82 1.64 0.18 3.46 FAIL
EO# 1.95 0.98 0.97 2.93 FAIL
BASO# 1.24 0.97 0.27 2.21 FAIL

8.5 If status FAIL, then we need to perform re-calibration!!!

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9 CERTIFICATION

9.1 We certify that the XS -Series Automated Hematology analyzer S/N : 0 has been successfully
calibrated in accordance with the manufacturer's recommendations.

Report and Calibration Performed By : Report Reviewed and Accepted By :

Signature (Engineer 1) Signature (Customer)

Name : Name :

Date : Date :

Signature (Engineer 2)

Name :

Date :

Company Stamp : (Vendor) Company Stamp : (Customer)

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