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everlife
‘elineDiagnostics
Enabling Better Outoomes
CERTIFICATE OF VALIDATION
CUSTOMER 1 Hi-Precision Diagnostics - Quezon City
‘ADDRESS + Del Monte Avenue, Quezon City
INSTRUMENT + D-10 Analyzer (Dx)
SERIALNUMBER ——: DM22G29001
DATE PERFORMED — : February 09, 2023
NEXT VALIDATION — : August 2023 (07/09/2023 - 09/07/2023)
This isto certify that the
‘B-10 Analyzer (Dx)
‘machine presently installed in this laboratory has passed all validation criteria.
Please see attached report.
VALIDATION DONE BY: REVIEWED/ NOTED BY:
feces weal he
In-House Service Engineer Service Trafning Supervisor
FM-TS-812,Effectvty Date: November 18, 2022, fsue 1, Rev. 3
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LifelineDiagnostics
PERFORMANCE VALIDATION REPORT
instrument: [DIO HEMOGLOBIN ANALYZER
seriatnumeer: [DM 22G 240)
pry.caino: [FL QO[#27 —__]
DATE PERFORMED: Tw.
Machine performance is verified using the manufacturer's recommendation in validating the functionality of
the instrument.
TVPHOCHECK™ DIABETES CONTROL ~ level
Di0Hemog
COMPONENT CRITERIA RESULT REMARKS
[CALIBRATOR 1. 4
[CALIBRATOR 10.3 ic ri
[CALIBRATION SLOPE e
[CALIBRATION INTERCEPT. go — 2. 1
|CONTROL LEVEL 1 ao Re $2 ELS
[conrroc ever 2 Giga. ib. PASSED
[_Perrorwance CRITERIA, I RESULT I REMARKS —__]|
[PUMP PRESSURE asro7sralem’ PSO. lydat Wllyd PASE
[PRESSURE FLUCTUATION < 5% of pressure (A PASSE)
RETENTION TIME Ac 066%01.0(083) [t-. 90 Hr 0.4 PASSED
[RETENTION TIME Ag 1,368 101.54 (146) [L~ |,39 A? Laz Tis
[BASE LINE Flatand around 0.02 [FAT £ AROUND 0,02] PASS
LEAK TEST Should be no leak at pump running at 1.5 ml/min
General Remarks: [THE MACHIME IS OKAY AUD READY 10 JNSTALL
——————
AVERKS, SymoW_ CAREW CE V.
(Signature Over Printed Name)
REVIEWED BY:
Dusten AF Antonio
(Signatufe Over Printed Name)
Immediate Superior
FA-TS-84, effectivity Date: November 18, 2022, sue 1 Rev. 3
