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 Lime meinenon mueuEe. bn,everlife 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