2APAPVGM90VivaChek Link Plus Blood Glucose Monitoring System

i UserManual DocumentNumber:1205228801 EffectiveDate:2023--09-19 ii VivaChek TM LinkPlusBloodGlucoseMonitoringSystem DearVivaChek™LinkPlusSystemUser, ThankyouforchoosingtheVivaChek™LinkPlusBloodGlucoseMonitoring System.VivaChek™LinkPlusBloodGlucoseMonitoringSystemisdesignedfor easytestofbloodglucoseandhelpsyoukeepbloodglucoseundercontrol. ReadthisUserManualcarefullybeforeyouuseyourmetersystem.Thismanual willhelpyoutogetcomfortableusingtheVivaChek™LinkPlusBloodGlucose MonitoringSystemandgetreliabletestresults.PleasekeepyourUserManualina safeplace;youmaywanttoreferitinthefuture. IntendedUse VivaChek™LinkPlusBloodGlucoseMonitoringSystemiscomprisedofthe VivaChek™LinkPlusBloodGlucoseMeterandtheVivaChek™InoBlood GlucoseTestStrips.VivaChek™LinkPlusBloodGlucoseMonitoringSystemis intendedtoquantitativelymeasuretheglucoseconcentrationinfreshcapillary wholebloodsamplesdrawnfromthefingertips.Itisintendedforusebypersons withdiabetesathomeasanaidtomonitortheeffectivenessofdiabetescontrol.It isnotintendedforneonataluseorforthediagnosisoforscreeningfordiabetes. Thissystemisintendedforself-testingoutsidethebody(invitrodiagnosticuse), andshouldonlybeusedbyasinglepersonandshouldnotbeshared. PrincipleofOperation VivaChek™LinkPlusBloodGlucoseMonitoringSystemisdesignedto quantitativelymeasuretheglucoseconcentrationinfreshcapillarywholeblood. Theglucosemeasurementisachievedbyusingtheamperometricdetection method.Thetestisbasedonmeasurementofelectricalcurrentcausedbythe reactionoftheglucosewiththereagentsontheelectrodeoftheteststrip.The bloodsampleispulledintothetipoftheteststripthroughcapillaryaction.Glucose inthesamplereactswithglucoseoxidaseandthemediator.Electronsare generated,producingacurrentthatispositivecorrelationtotheglucose concentrationinthesample.Afterthereactiontime,theglucoseconcentrationin thesampleisdisplayed. iii TABLEOFCONTENTS 1.UnderstandingYourTestingTools........................................... 1 YourSystemOverview................................................................1 YourMeterDisplay...................................................................2 MeterUseandPrecautions.......................................................3 ImportantSafetyInformation......................................................4 Limitations..............................................................................5 2.SettingYourSystem............................................................. 6 SettheDateandTime...............................................................6 SettheAudioFeature..............................................................8 SettheMealMarker..................................................................8 SettheHypoglycemia(Hypo)Warning.........................................8 SettheKetoneWarning...........................................................9 3.PerformingaTest................................................................... 10 PreparingtheTestStrip.............................................................10 PreparingtheLancingDevice....................................................11 GettingaBloodDropforTesting.................................................12 DiscardingtheUsedTestStrip....................................................14 RemovingtheUsedLancet...........................................................14 ExpectedDiabetesControlGoal...........................................................15 QuestionableorInconsistentResults....................................................16 SymptomsofHighorLowBloodGlucose.............................................16 PrecisionandAccuracy.........................................................................17 ComparingMeterandLaboratoryResults.....................................19 TestingwithControlSolution.......................................................19 UnderstandControlTestResult...................................................22 UsingtheMeterMemory............................................................23 ViewingYourTestResults.........................................................23 4.MaintenanceandTroubleshooting............................................. 25 ChargingtheBattery................................................................25 CaringforYourGlucoseMonitoringSystem..................................26 CleaningandDisinfection..........................................................26 TroubleshootingGuide.............................................................29 5.TechnicalInformation............................................................. 31 SystemSpecifications...............................................................31 4GSpecifications.....................................................................32 iv Warranty...............................................................................32 EMCGuidance........................................................................33 FCCRequirement...................................................................36 1 CHAPTER1:UNDERSTANDINGYOURTESTINGTOOLS YourSystemOverview SNProprietaryNameCommonNameIncludedintheMeterBox? 1VivaChek™LinkPlus BloodGlucoseMeter BloodGlucoseMeterYes 2VivaChek™InoBlood GlucoseTestStrip BloodGlucoseTest Strip Noandshouldbe purchasedseparately 3VivaChek™Ino ControlSolution GlucoseSolutionNoandshouldbe purchasedseparately 4VivaChek™Lancing Device LancingDeviceNoandshouldbe purchasedseparately 5VivaChek™LancetsLancetforsingle patientuseonly Noandshouldbe purchasedseparately 2 Note: TheVivaChek™InoBloodGlucoseTestStrips,VivaChek™InoControl Solution,VivaChek™LancingDeviceandVivaChek™Lancetsarenecessary forusebutnotincludedinthemeterboxandshouldbepurchasedseparately, pleasecontact24/7VivaChekCustomerSupportat888-969-6928for purchasing. 3 YourMeterDisplay Thepicturebelowshowsallthesymbolsthatappearonyourmeterdisplay. Pleasemakesurethedisplayisworkingproperlybeforetesting.Whenthemeteris off,pressandholdMainButtontoseethecompletedisplay.Alldisplaysegments wi…

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EUT Appearance Report No.: R2306A0646 TA Technology (Shanghai) Co., Ltd. TA-MB-01-032E Page 1 of 3 This report shall not be reproduced except in full, without the written approval of TA Technology (Shanghai) Co., Ltd. EUT Appearance EUT Appearance Report No.: R2306A0646 TA Technology (Shanghai) Co., Ltd. TA-MB-01-032E Page 2 of 3 This report shall not be reproduced except in full, without the written approval of TA Technology (Shanghai) Co., Ltd. EUT Appearance Report No.: R2306A0646 TA Technology (Shanghai) Co., Ltd. TA-MB-01-032E Page 3 of 3 This report shall not be reproduced except in full, without the written approval of TA Technology (Shanghai) Co., Ltd. Picture 1: Constituents of EUT

X X X X X X X X X X X (01)X X X X X X X X X X X (21)X X X X X X X X X X X 3.7V 800mAh FCC ID: 2APAPVGM90 MODEL: VGM90 For in vitro diagnostic use. Manufactured by: 24/7 Customer Support Tel: Blood Glucose Meter PN: Effective date:

Internal photo FCC ID: 2APAPVGM90 TA Technology (Shanghai) Co., Ltd. TA-MB-01-033E Page 1 of 8 This report shall not be reproduced except in full, without the written approval of TA Technology (Shanghai) Co., Ltd. Internal photo Internal photo FCC ID: 2APAPVGM90 TA Technology (Shanghai) Co., Ltd. TA-MB-01-033E Page 2 of 8 This report shall not be reproduced except in full, without the written approval of TA Technology (Shanghai) Co., Ltd. Internal photo FCC ID: 2APAPVGM90 TA Technology (Shanghai) Co., Ltd. TA-MB-01-033E Page 3 of 8 This report shall not be reproduced except in full, without the written approval of TA Technology (Shanghai) Co., Ltd. Internal photo FCC ID: 2APAPVGM90 TA Technology (Shanghai) Co., Ltd. TA-MB-01-033E Page 4 of 8 This report shall not be reproduced except in full, without the written approval of TA Technology (Shanghai) Co., Ltd. Internal photo FCC ID: 2APAPVGM90 TA Technology (Shanghai) Co., Ltd. TA-MB-01-033E Page 5 of 8 This report shall not be reproduced except in full, without the written approval of TA Technology (Shanghai) Co., Ltd. Internal photo FCC ID: 2APAPVGM90 TA Technology (Shanghai) Co., Ltd. TA-MB-01-033E Page 6 of 8 This report shall not be reproduced except in full, without the written approval of TA Technology (Shanghai) Co., Ltd. Internal photo FCC ID: 2APAPVGM90 TA Technology (Shanghai) Co., Ltd. TA-MB-01-033E Page 7 of 8 This report shall not be reproduced except in full, without the written approval of TA Technology (Shanghai) Co., Ltd. Internal photo FCC ID: 2APAPVGM90 TA Technology (Shanghai) Co., Ltd. TA-MB-01-033E Page 8 of 8 This report shall not be reproduced except in full, without the written approval of TA Technology (Shanghai) Co., Ltd.

Antenna Locations Report No.: R2306A0646 TA Technology (Shanghai) Co., Ltd. TA-MB-01-031S Page 1 of 1 This report shall not be reproduced except in full, without the written approval of TA Technology (Shanghai) Co., Ltd. Antenna Locations Note: The location of the test is detailed in Section 10.1.

Prepared by: Wei Fangying Approved by: Fan Guangchang TA Technology (Shanghai) Co., Ltd. Building 3, No.145, Jintang Rd, Pudong Shanghai, P.R.China TEL: +86-021-50791141/2/3 FAX: +86-021-50791141/2/3-8000 SAR TEST REPORT Applicant VivaChek Biotech (Hangzhou) Co., Ltd FCC ID 2APAPVGM90 Product VivaChek Link Plus Blood Glucose Monitoring System Brand VivaChek Model VGM90 Report No. R2306A0646-S1 Issue Date August 28, 2023 TA Technology (Shanghai) Co., Ltd. tested the above equipment in accordance with the requirements in FCC 47 CFR § 2.1093, IEEE 1528-2013, ANSI C95.1: 1992, IEEE C95.1: 1991. The test results show that the equipment tested is capable of demonstrating compliance with the requirements as documented in this report. SAR Test Report Report No.: R2306A0646-S1 TA Technology (Shanghai) Co., Ltd. TA-MB-06-003S Page 2 of 79 This report shall not be reproduced except in full, without the written approval of TA Technology (Shanghai) Co., Ltd. Table of Contents 1 Test Laboratory ............................................................................................................................... 3 1.1 Notes of the Test Report ......................................................................................................... 3 1.2 Test Facility ............................................................................................................................. 3 1.3 Testing Location ...................................................................................................................... 3 1.4 Laboratory Environment .......................................................................................................... 3 2 Statement of Compliance ............................................................................................................... 4 3 Description of Equipment Under Test ............................................................................................. 5 4 Test Specification, Methods and Procedures ................................................................................. 7 5 Operational Conditions during Test ................................................................................................ 8 5.1 Test Positions .......................................................................................................................... 8 5.1.1 Body Worn Configuration .................................................................................................. 8 5.2 Measurement Variability .......................................................................................................... 9 5.3 Test Configuration ................................................................................................................. 10 5.3.1 eMTC Test Configuration ................................................................................................ 10 6 SAR Measurements System Configuration .................................................................................. 12 6.1 SAR Measurement Set-up .................................................................................................... 12 6.2 DASY5 E-fiel d Probe System ................................................................................................ 13 6.3 SAR Measurement Procedure .............................................................................................. 14 7 Main Test Equipment .................................................................................................................... 16 8 Tissue Dielectric Parameter Measurements & System Check ..................................................... 17 8.1 Tissue Verification ................................................................................................................. 17 8.2 System Check ....................................................................................................................... 19 8.3 SAR System Validation ......................................................................................................... 22 9 Normal and Maximum Output Power ........................................................................................... 23 9.1 eMTC Mode .......................................................................................................................... 23 10 Measured and Reported (Scaled) SAR Results ........................................................................... 27 10.1 EUT Antenna Locations ........................................................................................................ 27 10.2 Measured SAR Results ......................................................................................................... 28 11 Measurement Uncertainty ............................................................................................................ 30 ANNEX A: Test Layout ......................................................................................................................... 31 ANNEX B: System Check Results ....................................................................................................... 33 ANNEX C: Highest Graph Results....................................................................................................... 36 ANNEX D: Probe Calibrat ion Certificate (SN: 7543)............................................................................ 44 ANNEX E: D750V3 Dipole Calibration Certificate................................................................................ 53 ANNEX F: D1750V2 Dipole Calibration Certificate .............................................................................. 61 ANNEX G: D1900V2 Dipole Calibration Certificate ............................................................................. 67 ANNEX H: DAE4 Calibration Certificate (SN: 1692) ............................................................................ 75 ANNEX I: The EUT Appearance ...…

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SAR Test Report Report No.: R2306A0646-S1 TA Technology (Shanghai) Co., Ltd. TA-MB-06-003S Page 61 of 79 This report shall not be reproduced except in full, without the written approval of TA Technology (Shanghai) Co., Ltd. ANNEX F: D1750V2 Dipole Calibration Certificate SAR Test Report Report No.: R2306A0646-S1 TA Technology (Shanghai) Co., Ltd. TA-MB-06-003S Page 62 of 79 This report shall not be reproduced except in full, without the written approval of TA Technology (Shanghai) Co., Ltd. SAR Test Report Report No.: R2306A0646-S1 TA Technology (Shanghai) Co., Ltd. TA-MB-06-003S Page 63 of 79 This report shall not be reproduced except in full, without the written approval of TA Technology (Shanghai) Co., Ltd. SAR Test Report Report No.: R2306A0646-S1 TA Technology (Shanghai) Co., Ltd. TA-MB-06-003S Page 64 of 79 This report shall not be reproduced except in full, without the written approval of TA Technology (Shanghai) Co., Ltd. SAR Test Report Report No.: R2306A0646-S1 TA Technology (Shanghai) Co., Ltd. TA-MB-06-003S Page 65 of 79 This report shall not be reproduced except in full, without the written approval of TA Technology (Shanghai) Co., Ltd. SAR Test Report Report No.: R2306A0646-S1 TA Technology (Shanghai) Co., Ltd. TA-MB-06-003S Page 66 of 79 This report shall not be reproduced except in full, without the written approval of TA Technology (Shanghai) Co., Ltd. SAR Test Report Report No.: R2306A0646-S1 TA Technology (Shanghai) Co., Ltd. TA-MB-06-003S Page 67 of 79 This report shall not be reproduced except in full, without the written approval of TA Technology (Shanghai) Co., Ltd. ANNEX G: D1900V2 Dipole Calibration Certificate SAR Test Report Report No.: R2306A0646-S1 TA Technology (Shanghai) Co., Ltd. TA-MB-06-003S Page 68 of 79 This report shall not be reproduced except in full, without the written approval of TA Technology (Shanghai) Co., Ltd. SAR Test Report Report No.: R2306A0646-S1 TA Technology (Shanghai) Co., Ltd. TA-MB-06-003S Page 69 of 79 This report shall not be reproduced except in full, without the written approval of TA Technology (Shanghai) Co., Ltd. SAR Test Report Report No.: R2306A0646-S1 TA Technology (Shanghai) Co., Ltd. TA-MB-06-003S Page 70 of 79 This report shall not be reproduced except in full, without the written approval of TA Technology (Shanghai) Co., Ltd. SAR Test Report Report No.: R2306A0646-S1 TA Technology (Shanghai) Co., Ltd. TA-MB-06-003S Page 71 of 79 This report shall not be reproduced except in full, without the written approval of TA Technology (Shanghai) Co., Ltd. SAR Test Report Report No.: R2306A0646-S1 TA Technology (Shanghai) Co., Ltd. TA-MB-06-003S Page 72 of 79 This report shall not be reproduced except in full, without the written approval of TA Technology (Shanghai) Co., Ltd. SAR Test Report Report No.: R2306A0646-S1 TA Technology (Shanghai) Co., Ltd. TA-MB-06-003S Page 73 of 79 This report shall not be reproduced except in full, without the written approval of TA Technology (Shanghai) Co., Ltd. SAR Test Report Report No.: R2306A0646-S1 TA Technology (Shanghai) Co., Ltd. TA-MB-06-003S Page 74 of 79 This report shall not be reproduced except in full, without the written approval of TA Technology (Shanghai) Co., Ltd. SAR Test Report Report No.: R2306A0646-S1 TA Technology (Shanghai) Co., Ltd. TA-MB-06-003S Page 75 of 79 This report shall not be reproduced except in full, without the written approval of TA Technology (Shanghai) Co., Ltd. ANNEX H: DAE4 Calibration Certificate (SN: 1692) SAR Test Report Report No.: R2306A0646-S1 TA Technology (Shanghai) Co., Ltd. TA-MB-06-003S Page 76 of 79 This report shall not be reproduced except in full, without the written approval of TA Technology (Shanghai) Co., Ltd. SAR Test Report Report No.: R2306A0646-S1 TA Technology (Shanghai) Co., Ltd. TA-MB-06-003S Page 77 of 79 This report shall not be reproduced except in full, without the written approval of TA Technology (Shanghai) Co., Ltd. SAR Test Report Report No.: R2306A0646-S1 TA Technology (Shanghai) Co., Ltd. TA-MB-06-003S Page 78 of 79 This report shall not be reproduced except in full, without the written approval of TA Technology (Shanghai) Co., Ltd. ANNEX I: The EUT Appearance The EUT Appearance are submitted separately. SAR Test Report Report No.: R2306A0646-S1 TA Technology (Shanghai) Co., Ltd. TA-MB-06-003S Page 79 of 79 This report shall not be reproduced except in full, without the written approval of TA Technology (Shanghai) Co., Ltd. ANNEX J: Test Setup Photos The Test Setup Photos are submitted separately. ******END OF REPORT ******

Prepared by: Xu Ying Approved by: Xu Kai TA Technology (Shanghai) Co., Ltd. Building 3, No.145, Jintang Rd, Pudong Shanghai, P.R.China TEL: +86-021-50791141/2/3 FAX: +86-021-50791141/2/3-8000 RF TEST REPORT Applicant VivaChek Biotech (Hangzhou) Co., Ltd FCC ID 2APAPVGM90 Product VivaChek Link Plus Blood Glucose Monitoring System Brand VivaChek Model VGM90 Report No. R2306A0646-R1 Issue Date August 28, 2023 TA Technology (Shanghai) Co., Ltd. tested the above equipment in accordance with the requirements in FCC CFR47 Part 2 (2022)/ FCC CFR 47 Part 24E (2022). The test results show that the equipment tested is capable of demonstrating compliance with the requirements as documented in this report. RF Test Report Report No.: R2306A0646-R1 TA Technology (Shanghai) Co., Ltd. TA-MB-05-002R Page 2 of 41 This report shall not be reproduced except in full, without the written approval of TA Technology (Shanghai) Co., Ltd. TABLE OF CONTENT 1. Test Laboratory ............................................................................................................................ 4 1.1. Notes of the test report ......................................................................................................... 4 1.2. Test facility ........................................................................................................................... 4 1.3. Testing Location ................................................................................................................... 4 2. General Description of Equipment under Test .............................................................................. 5 2.1. Applicant and Manufacturer Information ............................................................................... 5 2.2. General information .............................................................................................................. 5 3. Applied Standards ........................................................................................................................ 6 4. Test Configuration ........................................................................................................................ 7 5. Test Case ..................................................................................................................................... 8 5.1. RF Power Output and Effective Isotropic Radiated Power ................................................... 8 5.2. Occupied Bandwidth ............................................................................................................ 9 5.3. Band Edge Compliance...................................................................................................... 10 5.4. Peak-to-Average Power Ratio (PAPR) ............................................................................... 11 5.5. Frequency Stability ............................................................................................................. 12 5.6. Spurious Emissions at Antenna Terminals ......................................................................... 14 5.7. Radiated Spurious Emission .............................................................................................. 15 6. Test Results ............................................................................................................................... 18 6.1. RF Power Output and Effective Isotropic Radiated Power ................................................. 18 6.2. Occupied Bandwidth .......................................................................................................... 19 6.3. Band Edge Compliance...................................................................................................... 22 6.4. Peak-to-Average Power Ratio (PAPR) ............................................................................... 30 6.5. Frequency Stability ............................................................................................................. 31 6.6. Spurious Emissions at Antenna Terminals ......................................................................... 34 6.7. Radiated Spurious Emission .............................................................................................. 37 7. Main Test Instruments ................................................................................................................ 39 ANNEX A: The EUT Appearance ...................................................................................................... 40 ANNEX B: Test Setup Photos ........................................................................................................... 41 RF Test Report Report No.: R2306A0646-R1 TA Technology (Shanghai) Co., Ltd. TA-MB-05-002R Page 3 of 41 This report shall not be reproduced except in full, without the written approval of TA Technology (Shanghai) Co., Ltd. Summary of measurement results LTE-M Band 2 Number Test Case Clause in FCC rules Verdict 1 RF Power Output and Effective Isotropic Radiated Power 2.1046 24.232(c) PASS 2 Occupied Bandwidth 2.1049 PASS 3 Band Edge Compliance 2.1051 /24.238(a) PASS 4 Peak-to-Average Power Ratio 24.232/KDB 971168 D01(5.7) PASS 5 Frequency Stability 2.1055 / 24.235 PASS 6 Spurious Emissions at Antenna Terminals 2.1051 / 24.238(a) PASS 7 Radiated Spurious Emission 2.1053 / 24.238(a) PASS Date of Testing: June 19, 2023 ~ August 4, 2023 and August 22, 2023 Date of Sample Received: June 14, 2023 Note: PASS: The EUT complies with the essential requirements in the standard. FAIL: The EUT does not comply with the essential requirements in the standard. All indications of Pass/Fail in this report are opinions expressed by TA Technology (Shanghai) Co., Ltd. based on interpretations and/or observations of test results. Measurement Uncertainties were not taken into account and are published for informational purposes only. RF Test Report Report No.: R2306A0646-R1 TA Technology (Shanghai) Co., Ltd. TA-MB-05-0…

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Prepared by: Xu Ying Approved by: Xu Kai TA Technology (Shanghai) Co., Ltd. Building 3, No.145, Jintang Rd, Pudong Shanghai, P.R.China TEL: +86-021-50791141/2/3 FAX: +86-021-50791141/2/3-8000 RF TEST REPORT Applicant VivaChek Biotech (Hangzhou) Co., Ltd FCC ID 2APAPVGM90 Product VivaChek Link Plus Blood Glucose Monitoring System Brand VivaChek Model VGM90 Report No. R2306A0646-R2 Issue Date August 28, 2023 TA Technology (Shanghai) Co., Ltd. tested the above equipment in accordance with the requirements in FCC CFR47 Part 2 (2022)/ FCC CFR47 Part 27C (2022). The test results show that the equipment tested is capable of demonstrating compliance with the requirements as documented in this report. RF Test Report Report No.: R2306A0646-R2 TA Technology (Shanghai) Co., Ltd. TA-MB-05-003R Page 2 of 66 This report shall not be reproduced except in full, without the written approval of TA Technology (Shanghai) Co., Ltd. TABLE OF CONTENT 1 Test Laboratory ............................................................................................................................... 6 1.1 Notes of the Test Report ......................................................................................................... 6 1.2. Test facility .............................................................................................................................. 6 1.3 Testing Location ...................................................................................................................... 6 2 General Description of Equipment under Test ................................................................................ 7 2.1 Applicant and Manufacturer Information.................................................................................. 7 2.2 General information ................................................................................................................. 7 3 Applied Standards .......................................................................................................................... 9 4 Test Configuration ........................................................................................................................ 10 5 Test Case ...................................................................................................................................... 11 5.1 RF Power Output and Effective Isotropic Radiated Power ..................................................... 11 5.2 Occupied Bandwidth ............................................................................................................. 13 5.3 Band Edge Compliance ........................................................................................................ 14 5.4 Peak-to-Average Power Ratio (PAPR) .................................................................................. 16 5.5 Frequency Stability ................................................................................................................ 17 5.6 Spurious Emissions a t Antenna Term inals ............................................................................ 18 5.7 Radiated Spurious Emission ................................................................................................. 20 6 Test Results .................................................................................................................................. 23 6.1 RF Power Output and Effective Isotropic Radiated Power .................................................... 23 6.2 Occupied Bandwidth ............................................................................................................. 25 6.3 Band Edge Compliance ........................................................................................................ 31 6.4 Peak-to-Average Power Ratio (PAPR) .................................................................................. 47 6.5 Frequency Stability ................................................................................................................ 48 6.6 Spurious Emissions at Antenna Terminals ............................................................................ 54 6.7 Radiated Spurious Emission ................................................................................................. 60 7 Main Test Instruments .................................................................................................................. 64 ANNEX A: The EUT…

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