U7I-BP3GK1-4BDigital Blood Pressure Monitor

BP3GK1-4B 1 IB BP3GK1-4B EN EN Microlife BP3GK1-4B Instruction Manual English BP3GK1-4B 2 IB BP3GK1-4B EN EN Important Product and Safety Information Follow Instructions for Use. This document provides important product operation and safety information regarding 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 on the wrist 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. This blood pressure monitor IS intended to be used: • For self-measurement/monitoring of blood pressure and pulse in adults; 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 wrist; ½ inch from the hand. 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 circumstances 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 ventricular premature beats or atrial fibrillation, arterial sclerosis, poor 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. 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 pacemakers as this device is not suitable for this action.  Open/modify this device; inaccuracy and/or harmful injury may result. BP3GK1-4B 3 IB BP3GK1-4B EN EN  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 mastectomy 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, batteries may be replaced by the user. No other parts/components are accessible. 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. BP3GK1-4B 4 IB BP3GK1-4B EN EN 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 temperature 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. STANDARDS This medical device is compliant with:  Medical device and non-invasive blood pressure monitor standards IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, and AAMI/ANSI/IEC 80601-2-30, and  Electromagnetic standards IEC 60601-1-2, along with FCC Part 15, and  Clinical Testing per standard ISO 81060-2:2013 was conducted on blood pressure device using the same measurement technology. Please…

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ReportNo.:EED32M00340301Page 50 of 56 PHOTOGRAPHSOFEUTConstructionalDetails TestmodelNo.:BP3GK1-4B ViewofProduct-1 ViewofProduct-2 ReportNo.:EED32M00340301Page 51 of 56 ViewofProduct-3 ViewofProduct-4 ReportNo.:EED32M00340301Page 52 of 56 ViewofProduct-5 ViewofProduct-6 ReportNo.:EED32M00340301Page 53 of 56 ViewofProduct-7 ViewofProduct-8

BP3GK1-4BFCClabelandsize

ReportNo.:EED32M00340301Page 53 of 56 ViewofProduct-7 ViewofProduct-8 ReportNo.:EED32M00340301Page 54 of 56 ViewofProduct-9 ViewofProduct-10 ReportNo.:EED32M00340301Page 55 of 56 ViewofProduct-11 ViewofProduct-12 ReportNo.:EED32M00340301Page 56 of 56 ViewofProduct-13 ViewofProduct-14 Thetestreportiseffectiveonlywithbothsignatureandspecializedstamp,Theresult(s)showninthis reportreferonlytothesample(s)tested.WithoutwrittenapprovalofCTI,thisreportcan’tbereproduced exceptinfull. ***EndofReport*** Antenna

ReportNo.:EED32M00340302Page1of8 1COVERPAGE RFExposureEvaluationReport Product:DigitalBloodPressureMonitor Trademark:microlife Model/Typereference:BP3GK1-4B SerialNumber:N/A ReportNumber:EED32M00340302 FCCID: U7I-BP3GK1-4B DateofIssue:Dec.22,2020 TestStandards: 47CFRPart1.1307 47CFRPart1.1310 KDB447498D01GeneralRFExposure Guidancev06 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: billLu AaronMa Approvedby:Date:Dec.22,2020 DavidWang CheckNo.:4538065840 ReportNo.:EED32M00340302Page2of8 2Version VersionNo.DateDescription 00Dec.22,2020Original ReportNo.:EED32M00340302Page3of8 3Contents Page 1COVERPAGE......................................................................................................................................................................1 2VERSION..............................................................................................................................................................................2 3CONTENTS..........................................................................................................................................................................3 4GENERALINFORMATION...............................................................................................................................................4 4.1C LIENT I NFORMATION ....................................................................................................................................................4 4.2G ENERAL D ESCRIPTIONOF EUT..................................................................................................................................4 4.3P RODUCT S PECIFICATIONSUBJECTIVETOTHISSTANDARD ........................................................................................4 4.4T EST L OCATION .............................................................................................................................................................5 4.5D EVIATIONFROM S TANDARDS ......................................................................................................................................5 4.6A BNORMALITIESFROM S TANDARD C ONDITIONS ..........................................................................................................5 4.7O 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.:EED32M00340302Page4of8 4GeneralInformation 4.1ClientInformation Applicant: MicrolifeCorporation AddressofApplicant: 9F,431,RuiGuangRoad,NeiHu,Taipei11492,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 ModelNo.(EUT): BP3GK1-4B TradeMark: microlife EUTSupportsRadios application: 4.2(BLE) 4.3 ProductSpecificationsubjectivetothisstandard FrequencyRange:2402MHz~2480MHz ModulationType:GFSK TestPowerGrade: Default TestSoftwareofEUT: Nrfgo AntennaType:ChipAntenna AntennaGain:0dBi PowerSupply:DC3.0V MaxConductedPeak OutputPower: BT4.0:-0.65dBm TheMaxConductedPeakOutputPowerdatarefertothereport EED32M00340301 SampleReceivedDate: Dec.07,2020 SampletestedDate: Dec.07,2020toDec.18,2020 CompanyNameandAddressshownonReport,thesample(s)andsampleInformationwas/were providedbytheapplicantwhoshouldberesponsiblefortheauthenticitywhichCTIhasn’tverified. ReportNo.:EED32M00340302Page5of8 4.4TestLocation Alltestswereperformedat: CentreTestingInternationalGroupCo.,Ltd BuildingC,HongweiIndustrialParkBlock70,Bao'anDistrict,Shenzhen,China Telephone:+86(0)75533683668Fax:+86(0)75533683385 Notestsweresub-contracted. FCCDesignationNo.:CN1164 4.5DeviationfromStandards None. 4.6AbnormalitiesfromStandardConditions None. 4.7OtherInformationRequestedbytheCustomer None. ReportNo.:EED32M00340302Page6of8 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 fortransmissi…

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ReportNo.:EED32M00340301Page1of56 1 COVERPAGE TESTREPORT Product:DigitalBloodPressureMonitor Trademark:microlife Model/Typereference:BP3GK1-4B SerialNumber:N/A ReportNumber:EED32M00340301 FCCID: U7I-BP3GK1-4B DateofIssue:Dec.22,2020 TestStandards: 47CFRPart15SubpartC Testresult:PASS Preparedfor: MicrolifeCorporation 9F,431,RuiGuangRoad,NeiHu,Taipei11492,Taiwan Preparedby : CentreTestingInternationalGroupCo.,Ltd. HongweiIndustrialZone,Bao’an70District, Shenzhen,Guangdong,China TEL:+86-755-33683668 FAX:+86-755-33683385 Compiledby:Reviewedby: billLu AaronMa Approvedby:Date:Dec.22,2020 DavidWang CheckNo.:4538065840 ReportNo.:EED32M00340301Page 2 of 56 2Version VersionNo.DateDescription 00Dec.22,2020Original ReportNo.:EED32M00340301Page 3 of 56 3TestSummary TestItemTestRequirementTestmethodResult AntennaRequirement 47CFRPart15SubpartCSection 15.203/15.247(c) ANSIC63.10-2013PASS ACPowerLineConducted Emission 47CFRPart15SubpartCSection 15.207 ANSIC63.10-2013N/A ConductedPeakOutput Power 47CFRPart15SubpartCSection 15.247(b)(3) ANSIC63.10-2013PASS 6dBOccupiedBandwidth 47CFRPart15SubpartCSection 15.247(a)(2) ANSIC63.10-2013PASS PowerSpectralDensity 47CFRPart15SubpartCSection 15.247(e) ANSIC63.10-2013PASS Band-edgeforRF ConductedEmissions 47CFRPart15SubpartCSection 15.247(d) ANSIC63.10-2013PASS RFConductedSpurious Emissions 47CFRPart15SubpartCSection 15.247(d) ANSIC63.10-2013PASS RadiatedSpurious Emissions 47CFRPart15SubpartCSection 15.205/15.209 ANSIC63.10-2013PASS Restrictedbandsaround fundamentalfrequency (RadiatedEmission) 47CFRPart15SubpartCSection 15.205/15.209 ANSIC63.10-2013PASS Remark: TestaccordingtoANSIC63.4-2014&ANSIC63.10-2013. CompanyNameandAddressshownonReport,thesample(s)andsampleInformationwas/wereprovided bytheapplicantwhoshouldberesponsiblefortheauthenticitywhichCTIhasn’tverified. ReportNo.:EED32M00340301Page 4 of 56 4Content 1COVERPAGE.....................................................................................................................................................................1 2VERSION..............................................................................................................................................................................2 3TESTSUMMARY................................................................................................................................................................3 4CONTENT.............................................................................................................................................................................4 5TESTREQUIREMENT.......................................................................................................................................................5 5.1T ESTSETUP ................................................................................................................................................................... 5 5.1.1ForConductedtestsetup ................................................................................................................................... 5 5.1.2ForRadiatedEmissionstestsetup ................................................................................................................... 5 5.1.3ForConductedEmissionstestsetup ............................................................................................................... 6 5.2T EST E NVIRONMENT ...................................................................................................................................................... 6 5.3T EST C ONDITION ........................................................................................................................................................... 6 6GENERALINFORMATION...............................................................................................................................................7 6.1C LIENT I NFORMATION ....................................................................................................................................................7 6.2G ENERAL D ESCRIPTIONOF EUT..................................................................................................................................7 6.3D ESCRIPTIONOF S UPPORT U NITS ...............................................................................................................................9 6.4T EST L OCATION .............................................................................................................................................................9 6.5A BNORMALITIESFROM S TANDARD C ONDITIONS ..........................................................................................................9 6.6O THER I NFORMATION R EQUESTEDBYTHE C USTOMER ..............................................................................................9 6.7M EASUREMENT U NCERTAINTY (95% CONFIDENCELEVELS , K =2)..............................................................................9 7EQUIPMENTLIST............................................................................................................................................................10 8RADIOTECHNICALREQUIREMENTSSPECIFICATION........................................................................................12 AppendixA):6dBOccupiedBandwidth .................................................................................................................. 15 AppendixB):ConductedPeakOutputPower ........................................................................................................ 20 AppendixC):Band-edgeforRFConductedEmissions ....................................................................................... 23 AppendixD):RFConductedSpuriousEmissions ................................................................................................. 26 AppendixE):PowerSpectralDensity ....................................................................…

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ReportNo.:EED32M00340301Page 48 of 56 PHOTOGRAPHSOFTESTSETUP TestmodelNo.:BP3GK1-4B RadiatedspuriousemissionTestSetup-1(Below30MHz) RadiatedspuriousemissionTestSetup-2(Below1GHz) ReportNo.:EED32M00340301Page 49 of 56 RadiatedspuriousemissionTestSetup-3( Above1GHz) RadiatedspuriousemissionTestSetup-3( Above1GHz) Thereareabsorbingmaterialsundertheground.