PT.
SABA INDOMEDIKA
XP-Series Calibration Report
Customer : RSUD. Anshari Saleh Banjarmasin Date : 29 Maret 2019
Model : XP-100 Serial No : B1554
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 0.000 ≤ 0.3 X 10 *3/uL PASS
RBC 0 ≤ 0.02 X 10*6/uL PASS
HGB 0.000 ≤ 0.1g/dL PASS
PLT 0 ≤ 10 X 10*3/uL PASS
2 SENSITIVITY ADJUSTMENT FOR WBC AND RBC
2.1 Material Used : Cellcheck-400 (P/N 814-0022-6)
Lot No. : A8005
Expiry date : 15 Mei 2019
2.2 Cellcheck-400 Assay Values
Parameter Assay Values Target Min Max
WBC 133.0 180.1 178.1 182.1
RBC 113.0 142.4 140.4 144.4
2.3 Cellcheck-400 latex was measured. The results are as below :
Parameters Results Target Status
WBC 180.4 180.1 PASS
RBC 143.1 142.4 PASS
3 SENSITIVITY ADJUSTMENT FOR PLT
3.1 Material Used : Latex Calibrator PLT (P/N 951-0222-1)
Lot No. : NA
Expiry date : NA
3.2 Latex Calibrator PLT was measured. The result are as below :
Parameters Results Target Acceptable Range Status
PLT NA NA ± 0.1 fL #VALUE!
4 BLANK ADJUSTMENT HGB
4.1 HGB blank result is as below :
Parameters Results Assay Value Status
HGB Blank 2066 2000 ± 200 PASS
5 SENSITIVITY ADJUSTMENT FOR HGB
5.1 QC Material : Eightcheck-3WP (Normal)
Lot No. : 90050822
Expiry date : 13-Apr-2019
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PT. SABA INDOMEDIKA
5.2 Eightcheck-3WP Normal
Parameter Assay Value Min Max
HGB 12.3 11.8 12.8
5.3 Eightcheck-3WP Normal was measured. The result is as below :
Parameters Results Assay Value Status
HGB 12.4 12.3 PASS
6 CLOG LEVEL ADJUSTMENT FOR WBC AND RBC
6.1 Clog results are as below :
Parameters Results Assay Value Status
WBC Clog 99 100 ± 1.0 PASS
RBC Clog 99 100 ± 1.0 PASS
7 SYSMEX SCS-1000 CALIBRATION
7.1 Calibrator Used : SCS-1000
Lot : 90570525
Expiry : 31 Maret 2019
7.2 SCS-1000 Assay Target Values
Parameter Target Min Max
WBC 7.07 6.77 7.37
RBC 4.375 4.287 4.463
HGB 12.06 11.94 12.18
HCT 34.10 33.35 34.85
MCV 77.94 77.08 78.80
PLT 255.4 242.6 268.2
7.3 Results of SCS-1000 before calibration
Status
Parameter 2nd Run 3rd Run 4th Run 5th Run 6th Run Mean SD CV % Target CV %
WBC 7.10 7.20 7.30 7.20 7.20 7.200 0.071 0.98 PASS PASS
RBC 4.36 4.31 4.37 4.38 4.29 4.342 0.040 0.91 PASS PASS
HGB 12.30 12.3 12.3 12.4 12.3 12.32 0.045 0.36 FAIL PASS
HCT 33.90 33.6 34.0 33.9 33.4 33.76 0.251 0.74 PASS PASS
MCV 77.75 77.96 77.80 77.40 77.9 77.75 0.213 0.27 PASS PASS
PLT 259.00 268 249 256 262 258.8 7.050 2.72 PASS PASS
7.4 Results of SCS-1000 after calibration
Status
Parameter 2nd Run 3rd Run 4th Run 5th Run 6th Run Mean SD CV % Target CV %
WBC 7.30 7.40 7.30 7.20 7.10 7.260 0.114 1.57 PASS PASS
RBC 4.29 4.32 4.36 4.37 4.32 4.332 0.033 0.76 PASS PASS
HGB 12.00 12.1 12.1 12.1 12.1 12.08 0.045 0.37 PASS PASS
HCT 33.40 33.6 33.9 33.9 33.5 33.66 0.230 0.68 PASS PASS
MCV 77.86 77.78 77.75 77.57 77.5 77.70 0.134 0.17 PASS PASS
PLT 260.00 252 255 269 268 260.8 7.596 2.91 PASS PASS
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PT. SABA INDOMEDIKA
8 PERFORMANCE VERIFICATION BY USING SYSMEX EIGHTCHECK-3WP
8.1 QC Material : Eightcheck-3WP Low
Eightcheck-3WP Normal
Eightcheck-3WP High
Lot No. : 900508xx
Expiry date : 13-Apr-2019
8.2 Eightcheck-3WP (Low) results :
Eightcheck Assay Value
Parameter Result Target Limit Min Max Status
WBC 3.2 3.2 0.4 2.8 3.6 PASS
RBC 2.37 2.35 0.12 2.2 2.5 PASS
HGB 5.9 5.9 0.3 5.6 6.2 PASS
HCT 17.0 16.7 1.4 15.3 18.1 PASS
MCV 71.7 71.1 4.3 66.8 75.4 PASS
MCH 24.9 25.1 1.5 23.6 26.6 PASS
MCHC 34.7 35.3 2.8 32.5 38.1 PASS
PLT 64 60 18 42.0 78.0 PASS
8.3 Eightcheck-3WP (Normal) results :
Eightcheck Assay Value
Parameter Result Target Limit Min Max Status
WBC 7.5 7.3 0.5 6.8 7.8 PASS
RBC 4.30 4.35 0.17 4.2 4.5 PASS
HGB 12.1 12.3 0.4 11.9 12.7 PASS
HCT 34.0 33.8 2.5 31.3 36.3 PASS
MCV 79.1 77.7 3.9 73.8 81.6 PASS
MCH 28.1 28.3 1.6 26.7 29.9 PASS
MCHC 35.6 36.4 2.5 33.9 38.9 PASS
PLT 208 230 35 195.0 265.0 PASS
8.4 Eightcheck-3WP (High) results :
Eightcheck Assay Value
Parameter Result Target Limit Min Max Status
WBC 18.7 18.2 1.3 16.9 19.5 PASS
RBC 5.28 5.29 0.21 5.1 5.5 PASS
HGB 16.2 16.6 0.6 16.0 17.2 PASS
HCT 45.3 44.6 3.3 41.3 47.9 PASS
MCV 85.8 84.3 4.2 80.1 88.5 PASS
MCH 30.7 31.4 1.7 29.7 33.1 PASS
MCHC 35.8 37.2 2.6 34.6 39.8 PASS
PLT 504 549 71 478.0 620.0 PASS
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9 CERTIFICATION
9.1 We certify that the XP-Series Automated Haematology analyzer S/N : B1554 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 : Khalid Rizal A Name :
Date : 29 Maret 2019 Date : 29 Maret 2019
Signature (Engineer 2)
Name :
Date :
Company Stamp : (Vendor) Company Stamp : (Customer)
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