U7I-BP3GT1-6FDigital Blood Pressure Monitor

1 Important Product and Safety Information Follow Instructions for Use. This document provides important product operation and safety information regard- ing this Blood Pressure Monitor. Please read this document thoroughly before using the device and keep for future reference. This blood pressure monitor is an automatic digital blood pressure measuring device for use by adults, including those with Diabetes mellitus, on the upper arm at home or in the doctor’s office. It enables a very fast and reliable measurement of the systolic and diastolic blood pressure, as well as the pulse rate, by way of the oscillometric method. This device detects the appearance of irregular heartbeats during measurement and provides a warning signal when the irregular heartbeat is detected. The device can be connected via Bluetooth ® to a smart mobile device running the Microlife Connected Health App. This blood pressure monitor IS intended to be used: •For self-measurement/monitoring of blood pressure and pulse in adults, including those with Diabetes mellitus; whereas the person being measured may be the user/operator of the device. •Within a home healthcare environment. •With a cuff located upon the user’s upper arm; ½ inch above the elbow over the artery as indicated on the cuff. This blood pressure monitor IS NOT intended for use with: •Pregnancy •Preeclampsia •Children under 12 •Neonatal patients WARNING – Potentially hazardous situation that if not avoided may result in serious injury or death. •Self-measuring means monitoring, not diagnosis or treatment. Unusual values must always be discussed with your doctor. Under no circum- stances should you independently alter the dosages of any drugs prescribed by your physician. •Consult your physician before using this device if any of the following or similar conditions are present: arrhythmias such as atrial or ventric- ular premature beats or atrial fibrillation, arterial sclerosis, poor 2 perfusion, diabetes, age, pregnancy, preeclampsia, renal diseases. Motion during measurement, including trembling or shivering may affect the measurement. •Though not for use with children under 12, ensure that any children around this device are supervised; some parts are small enough to be swallowed and any present tubes or cables may provide a risk of strangulation. •Ensure the cuff tubing is not kinked during use as harmful injury may occur due to the effect of blood flow interference caused by high pressure in the cuff not releasing. DO NOT: Use this device if you think it is damaged or anything appears unusual (e.g. sporadic operation, open packaging upon purchase). Use the displayed pulse for checking the frequency of heart pacemak- ers as this device is not suitable for this action. Open/modify this device; inaccuracy and/or harmful injury may result. Conduct many frequent measurements as this may result in harmful injury due to blood flow interference. Place the Cuff over a wound as this may cause further injury. Place and pressurize the Cuff over/near any present intravascular access or therapy, or arteriovenous shunt, as this may cause blood flow interference and result in harmful injury. Place and pressurize the Cuff over a limb near the side of a mastecto- my as this may cause harmful injury. Use the Blood Pressure Monitor on a limb simultaneously with other medical equipment on the same limb due to possible interference with such medical equipment. Maintain pressure in the Cuff applied to the limb for a prolonged amount of time. Ensure that circulation in the limb is not impaired by checking circulation if prolonged/repeated exposure to pressure occurs. Service the device when being used or when power is supplied. When the device is not in use and power is removed, cuff assembly, batter- ies and ac adapter (if applicable) may be replaced by the user with Microlife supplied replacements. No other parts/components are accessible. 3 CAUTION – Potentially hazardous situation that if not avoided may result in minor/moderate injury, property damage, and/or damage to the device •This device contains sensitive electronics components. Avoid strong electrical or electromagnetic fields in the direct vicinity of the device (e.g., mobile telephones, microwave ovens). These can lead to temporary impairment of the measuring accuracy. Move the device to another location if interference is determined. •When not using the Blood Pressure Monitor for extended lengths of time, remove the batteries to avoid potential battery leakage and damage to the monitor. •When replacing the batteries, ensure all the batteries are replaced simultaneously to avoid battery damage and potential damage to the monitor. Microlife USA does not recommend using rechargeable batteries. •To avoid inaccurate measurements and to lessen any discomfort from Cuff pressure, ensure the Cuff is placed correctly on the limb and fits correctly when snug (not tight), as indicated by markings with the Cuff. •Consult your physician in cases of frequent irregular heartbeat detections. •This Risk Indicator feature is provided in order to help you understand your potential blood pressure risk. However, this feature is neither a diagnosis nor a substitute for a medical examination. It is important to consult with your physician to determine your risk. DO NOT: Drop this device or expose it to strong vibrations; sensitive components may be affected resulting in inaccuracies and/or operational issues. Use the Blood Pressure Monitor outside of its specified operation temper- ature and humidity rating, or if stored outside of its specified storage temperature and humidity rating. Avoid storage in direct sunlight. Use this device in a moving vehicle; inaccurate measurements may result. Use third party accessories. Only use Microlife authorized accessories, such as cuffs or AC adapters, as those not approved for use with the device may provide inaccurate measurements, injury, and/or damage the device. 4 STANDAR…

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ReportNo.:EED32N00021901Page 33 of 41 PHOTOGRAPHSOFEUTConstructionalDetails TestmodelNo.:BP3GT1-6F ViewofProduct-1 ViewofProduct-2 ReportNo.:EED32N00021901Page 34 of 41 ViewofProduct-3 ViewofProduct-4 ReportNo.:EED32N00021901Page 35 of 41 ViewofProduct-5 ViewofProduct-6 ReportNo.:EED32N00021901Page 36 of 41 ViewofProduct-7 ViewofProduct-8

BP3GT1-6FFCClabelandsize

ReportNo.:EED32N00021901Page 37 of 41 ViewofProduct-9 ViewofProduct-10 ReportNo.:EED32N00021901Page 38 of 41 ViewofProduct-11 ViewofProduct-12 ReportNo.:EED32N00021901Page 39 of 41 ViewofProduct-13 ViewofProduct-14 ReportNo.:EED32N00021901Page 40 of 41 ViewofProduct-15 ViewofProduct-16 ReportNo.:EED32N00021901Page 41 of 41 ViewofProduct-17 Thetestreportiseffectiveonlywithbothsignatureandspecializedstamp,Theresult(s)showninthis reportreferonlytothesample(s)tested.WithoutwrittenapprovalofCTI,thisreportcan’tbereproduced exceptinfull. ***EndofReport***

ReportNo.:EED32N00021902Page1of8 1COVERPAGE RFExposureEvaluationReport Product:DigitalBloodPressureMonitor Trademark: Model/Typereference: BP3GT1-6F SerialNumber: N/A ReportNumber: EED32N00021902 FCCID:U7I-BP3GT1-6F DateofIssue:Apr.19,2021 TestStandards: 47CFRPart1.1307 47CFRPart2.1093 KDB447498D01GeneralRFExposureGuidancev06 Testresult:PASS Preparedfor: MicrolifeCorporation 9F,431,RuiGuangRoad,NeiHuTaipei11492,Taiwan Preparedby : CentreTestingInternationalGroupCo.,Ltd. HongweiIndustrialZone,Bao’an70District, Shenzhen,Guangdong,China TEL:+86-755-33683668 FAX:+86-755-33683385 Compiledby:Reviewedby: MartinLeeAaronMa Approvedby:Date:Apr.19,2021 DavidWang CheckNo.:4538028527 ReportNo.:EED32N00021902Page2of8 2Version VersionNo.DateDescription 00 Apr.19,2021 Original ReportNo.:EED32N00021902Page3of8 3Contents Page 1COVERPAGE......................................................................................................................................................................1 2VERSION..............................................................................................................................................................................2 3CONTENTS..........................................................................................................................................................................3 4GENERALINFORMATION...............................................................................................................................................4 4.1C LIENT I NFORMATION ....................................................................................................................................................4 4.2G ENERAL D ESCRIPTIONOF EUT..................................................................................................................................4 4.3T EST L OCATION .............................................................................................................................................................5 4.4D EVIATIONFROM S TANDARDS ......................................................................................................................................5 4.5A BNORMALITIESFROM S TANDARD C ONDITIONS ..........................................................................................................5 4.6O THER I NFORMATION R EQUESTEDBYTHE C USTOMER ..............................................................................................5 5SAREVALUATION.............................................................................................................................................................6 5.1RFE XPOSURE C OMPLIANCE R EQUIREMENT ...............................................................................................................6 5.1.1StandardRequirement........................................................................................................................................6 5.1.2EUTRFExposure...............................................................................................................................................7 PHOTOGRAPHSOFEUTCONSTRUCTIONALDETAILS............................................................................................8 ReportNo.:EED32N00021902Page4of8 4GeneralInformation 4.1ClientInformation Applicant: MicrolifeCorporation AddressofApplicant: 9F,431,RuiGuangRoad,NeiHuTaipei11492,Taiwan Manufacturer: ONBOElectronic(Shenzhen)Co.,Ltd. AddressofManufacturer: No.138,HuashengRoad,LangkouCommunity,DalangStreet,LonghuaDistrict, Shenzhen,China Factory: ONBOElectronic(Shenzhen)Co.,Ltd. AddressofFactory: No.138,HuashengRoad,LangkouCommunity,DalangStreet,LonghuaDistrict, Shenzhen,China 4.2GeneralDescriptionofEUT ProductName:DigitalBloodPressureMonitor ModeNo.:BP3GT1-6F TradeMark: ProductType: MobilePortableFixLocation BluetoothVersion:V4.0 OperationFrequency: 2402MHz~2480MHz ModulationType: GFSK TransferRate:1Mbps2Mbps NumberofChannel:40 AntennaType:PCBantenna AntennaGain:0dBi PowerSupply:4*AAABatteryor SwitchingAdapter MODEL:DSA-6E-05US INPUT:100-240V~50/60Hz0.3A Output:6V0.6A SampleReceivedDate: Apr.8,2021 SampletestedDate: Apr.8,2021toApr.13,2021 CompanyNameandAddressshownonReport,thesample(s)andsampleInformationwas/wereprovided bytheapplicantwhoshouldberesponsiblefortheauthenticitywhichCTIhasn’tverified. ReportNo.:EED32N00021902Page5of8 4.3TestLocation Alltestswereperformedat: CentreTestingInternationalGroupCo.,Ltd BuildingC,HongweiIndustrialParkBlock70,Bao'anDistrict,Shenzhen,China Telephone:+86(0)75533683668Fax:+86(0)75533683385 Notestsweresub-contracted. FCCDesignationNo.:CN1164 4.4DeviationfromStandards None. 4.5AbnormalitiesfromStandardConditions None. 4.6OtherInformationRequestedbytheCustomer None. ReportNo.:EED32N00021902Page6of8 5SAREvaluation 5.1RFExposureComplianceRequirement 5.1.1StandardRequirement AccordingtoKDB447498D01GeneralRFExposureGuidancev06 StandaloneSARtestexclusionconsiderations UnlessspecificallyrequiredbythepublishedRFexposureKDBprocedures,standalone1-gheadorbody and10-gextremitySARevaluationforgeneralpopulationexposureconditions,bymeasurementor numericalsimulation,isnotrequiredwhenthecorrespondingSARExclusionThresholdcondition,listed below,issatisfied. Limits The1-gand10-gSARtestexclusionthresholdsfor100MHzto6GHzattestseparationdistances ≤50mmaredeterminedby: [(max.powerofchannel,includingtune-uptolerance,mW)/(min.testseparationdistance,mm)]· [√f(GHz)]≤3.0for1-gSARand≤7.5for10-gextremitySAR,where f(GHz)istheRFchanneltransmitfrequencyinGHz PoweranddistanceareroundedtothenearestmWandmmbeforecalculation 17 Theresultisroundedtoonedecimalplaceforcomparison Thetestexclusionsareapplicableonlywhentheminimumtestseparationdistanceis≤50mmand fortransmissionfrequenciesbetween100MHzand6GHz.Whentheminimumtestseparation distanceis<5mm,adistanceof5mmisappliedtodetermineSARtestexclusion ReportNo.:EED32N00021902Page7of8 5.1.2EUTRFExposure MeasurementData GFSKmode TestchannelPeak…

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Report No. EED32N00021901Page 1 of 25 Appendix: Bluetooth LE Report No. EED32N00021901Page 2 of 25 Contents AppendixA:DTSBandwidth ....................................................................................................... 3 Test Result ................................................................................................................................................... 3 Test Graphs ................................................................................................................................................. 4 AppendixB:OccupiedChannelBandwidth ................................................................................ 6 Test Result ................................................................................................................................................... 6 Test Graphs ................................................................................................................................................. 7 AppendixC:Maximumconductedoutputpower ...................................................................... 9 Test Result ................................................................................................................................................... 9 Test Graphs ............................................................................................................................................... 10 AppendixD:Maximumpowerspectraldensity ....................................................................... 12 Test Result ................................................................................................................................................. 12 Test Graphs ............................................................................................................................................... 13 AppendixE:Bandedgemeasurements .................................................................................... 15 Test Result ................................................................................................................................................. 15 Test Graphs ............................................................................................................................................... 16 AppendixF:ConductedSpuriousEmission .............................................................................. 17 Test Result ................................................................................................................................................. 17 Test Graphs ............................................................................................................................................... 18 AppendixG:DutyCycle ............................................................................................................. 23 Test Result ................................................................................................................................................. 23 Test Graphs ............................................................................................................................................... 24 Report No. EED32N00021901Page 3 of 25 AppendixA:DTSBandwidth TestResult Test Mode AntennaChannel DTSBW [MHz] FL[MHz]FH[MHz]Limit[MHz]Verdict BLE_1M Ant1 24020.6882401.648 2402.3360.5PASS 24400.7002439.644 2440.3440.5PASS 24800.6962479.648 2480.3440.5PASS Report No. EED32N00021901Page 4 of 25 TestGraphs Date: 11.APR.2021 09:38:22 BLE_1M_Ant1_2402 Date: 11.APR.2021 09:43:02 BLE_1M_Ant1_2440 Report No. EED32N00021901Page 5 of 25 Date: 11.APR.2021 09:45:01 BLE_1M_Ant1_2480 Report No. EED32N00021901Page 6 of 25 AppendixB:OccupiedChannelBandwidth TestResult Test Mode AntennaChannel OCB [MHz] FL[MHz]FH[MHz]Limit[MHz]Verdict BLE_1M Ant1 24021.0752401.461 2402.535---PASS 24401.0832439.457 2440.539---PASS 24801.0872479.453 2480.539---PASS Report No. EED32N00021901Page 7 of 25 TestGraphs Date: 11.APR.2021 09:38:34 BLE_1M_Ant1_2402 Date: 11.APR.2021 09:43:14 BLE_1M_Ant1_2440 Report No. EED32N00021901Page 8 of 25 Date: 11.APR.2021 09:45:13 BLE_1M_Ant1_2480 Report No. EED32N00021901Page 9 of 25 AppendixC:Maximumconductedoutputpower TestResult Test ModeAntennaChannelResult[dBm]Limit[dBm]Verdict BLE_1MAnt1 2402-0.25<=30PASS 2440-1.95<=30PASS 2480-3.65<=30PASS Report No. EED32N00021901Page 10 of 25 TestGraphs Date: 11.APR.2021 09:38:43 BLE_1M_Ant1_2402 Date: 11.APR.2021 09:43:23 BLE_1M_Ant1_2440 Report No. EED32N00021901Page 11 of 25 Date: 11.APR.2021 09:45:21 BLE_1M_Ant1_2480 Report No. EED32N00021901Page 12 of 25 AppendixD:Maximumpowerspectraldensity TestResult Test ModeAntennaChannelResult[dBm/3-100kHz]Limit[dBm/3kHz]Verdict BLE_1MAnt1 2402-4.8<=8PASS 2440-5.82<=8PASS 2480-7.25<=8PASS Report No. EED32N00021901Page 13 of 25 TestGraphs Date: 11.APR.2021 09:38:51 BLE_1M_Ant1_2402 Date: 11.APR.2021 09:43:31 BLE_1M_Ant1_2440 Report No. EED32N00021901Page 14 of 25 Date: 11.APR.2021 09:45:29 BLE_1M_Ant1_2480 Report No. EED32N00021901Page 15 of 25 AppendixE:Bandedgemeasurements TestResult Test Mode Antenna Ch Name Channel Ref Level[dBm] Result[dBm]Limit[dBm]Verdict BLE_1M Ant1 Low2402-0.47-47.99<=-20.47 PASS High2480-3.68-52.94<=-23.68 PASS Report No. EED32N00021901Page 16 of 25 TestGraphs Date: 11.APR.2021 09:39:02 BLE_1M_Ant1_Low_2402 Date: 11.APR.2021 09:45:40 BLE_1M_Ant1_High_2480 Report No. EED32N00021901Page 17 of 25 AppendixF:ConductedSpuriousEmission TestResult Test Mode AntennaChannel Freq Range [MHz] Ref Level [dBm] Result[dBm] Limit[dBm ] Verdict BLE_1M Ant1 2402 Reference-0.48-0.48---PASS 30~1000-0.48-51.61<=-20.48 PASS 1000~26500-0.48-52.21<=-20.48 PASS 2440 Reference-2.10-2.10---PASS 30~1000-2.10-51.68<=-22.1 PASS 1000~26500-2.10-50.63<=-22.1 PASS 2480 Reference-3.74-3.74---PASS 30~1000-3.74-52.03<=-23.74 PASS 1000~26500-3.74-49.64<=-23.74 PASS Report No. EED32N00021901Page 18 of 25 TestGraphs Date: 11.APR.2021 09:39:10 BLE_1M_Ant1_2402_0~Reference Date: 11.APR.20…

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ReportNo.:EED32N00021901Page1of41 TESTREPORT Product:DigitalBloodPressureMonitor Trademark: Model/Typereference: BP3GT1-6F SerialNumber:N/A ReportNumber: EED32N00021901 FCCID:U7I-BP3GT1-6F DateofIssue:Apr.19,2021 TestStandards: 47CFRPart15SubpartC Testresult:PASS Preparedfor: MicrolifeCorporation 9F,431,RuiGuangRoad,NeiHuTaipei11492,Taiwan Preparedby : CentreTestingInternationalGroupCo.,Ltd. HongweiIndustrialZone,Bao’an70District, Shenzhen,Guangdong,China TEL:+86-755-33683668 FAX:+86-755-33683385 Compiledby:Reviewedby: MartinLeeAaronMa Approvedby:Date:Apr.19,2021 DavidWang CheckNo.:4538028527 ReportNo.:EED32N00021901Page 2 of 41 1Content 1CONTENT.............................................................................................................................................................................2 2VERSION..............................................................................................................................................................................3 3TESTSUMMARY................................................................................................................................................................4 4GENERALINFORMATION...............................................................................................................................................5 4.1C LIENT I NFORMATION ....................................................................................................................................................5 4.2G ENERAL D ESCRIPTIONOF EUT..................................................................................................................................5 4.3T EST C ONFIGURATION ...................................................................................................................................................7 4.4T EST E NVIRONMENT ......................................................................................................................................................7 4.5D ESCRIPTIONOF S UPPORT U NITS ...............................................................................................................................7 4.6T EST L OCATION .............................................................................................................................................................8 4.7M EASUREMENT U NCERTAINTY (95% CONFIDENCELEVELS , K =2)..............................................................................8 5EQUIPMENTLIST..............................................................................................................................................................9 6TESTRESULTSANDMEASUREMENTDATA..........................................................................................................11 6.1A NTENNA R EQUIREMENT .............................................................................................................................................11 6.2C ONDUCTED E MISSIONS .............................................................................................................................................12 6.3M AXIMUM C ONDUCTED O UTPUT P OWER ...................................................................................................................15 6.4DTSB ANDWIDTH .........................................................................................................................................................16 6.5M AXIMUM P OWER S PECTRAL D ENSITY ......................................................................................................................17 6.6B AND E DGEMEASUREMENTSAND C ONDUCTED S PURIOUS E MISSION ....................................................................18 6.7R ADIATED S PURIOUS E MISSION &R ESTRICTEDBANDS ...........................................................................................19 7APPENDIXA......................................................................................................................................................................30 PHOTOGRAPHSOFTESTSETUP..................................................................................................................................31 PHOTOGRAPHSOFEUTCONSTRUCTIONALDETAILS.........................................................................................33 ReportNo.:EED32N00021901Page 3 of 41 2Version VersionNo.DateDescription 00 Apr.19,2021 Original ReportNo.:EED32N00021901Page 4 of 41 3TestSummary TestItemTestRequirementResult AntennaRequirement 47CFRPart15SubpartCSection 15.203/15.247(c) PASS ACPowerLineConducted Emission 47CFRPart15SubpartCSection 15.207 PASS DTSBandwidth 47CFRPart15SubpartCSection 15.247(a)(2) PASS MaximumConductedOutput Power 47CFRPart15SubpartCSection 15.247(b)(3) PASS MaximumPowerSpectral Density 47CFRPart15SubpartCSection15.247(e)PASS BandEdgeMeasurements 47CFRPart15SubpartCSection 15.247(d) PASS ConductedSpurious Emissions 47CFRPart15SubpartCSection 15.247(d) PASS RadiatedSpuriousEmission& Restrictedbands 47CFRPart15SubpartCSection 15.205/15.209 PASS Remark: CompanyNameandAddressshownonReport,thesample(s)andsampleInformationwereprovidedbythe applicantwhoshouldberesponsiblefortheauthenticitywhichCTIhasn’tverified. N/A:Inthiswholereportnotapplication. ReportNo.:EED32N00021901Page 5 of 41 4GeneralInformation 4.1ClientInformation Applicant: MicrolifeCorporation AddressofApplicant: 9F,431,RuiGuangRoad,NeiHuTaipei11492,Taiwan Manufacturer: ONBOElectronic(Shenzhen)Co.,Ltd. AddressofManufacturer: No.138,HuashengRoad,LangkouCommunity,DalangStreet,Longhua District,Shenzhen,China Factory: ONBOElectronic(Shenzhen)Co.,Ltd. AddressofFactory: No.138,HuashengRoad,LangkouCommunity,DalangStreet,Longhua District,Shenzhen,China 4.2GeneralDescriptionofEUT ProductName: DigitalBloodPressureMonitor ModeNo.:BP3GT1-6F Trademark: ProductType: MobilePortableFixLocation BluetoothVersion:V4.0 OperationFrequency: 2402MHz~2480MHz Modulati…

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ReportNo.:EED32N00021901Page 31 of 41 PHOTOGRAPHSOFTESTSETUP TestmodelNo.:BP3GT1-6F RadiatedspuriousemissionTestSetup-1 (Below1GHz) RadiatedspuriousemissionTestSetup-2( Above1GHz) ReportNo.:EED32N00021901Page 32 of 41 ConductedEmissionsTestSetup