U7I-BP3KX1-1BBlood Pressure Monitor

CVS INSTRUCTION MANUAL Bluetooth"' Blood Pressure Monitor Model # BP3KX1-1B QUESTIONS? 1-800-568-4147 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, 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 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 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 pacemakers 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 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, cuff assembly, batteries and ac adapter (if applicable) may be replaced by the user with Microlife supplied replacements. 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. 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 f…

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ReportNo.:EED32P80883901Page 34 of 42 10PHOTOGRAPHSOFEUTConstructionalDetails ViewofProduct-1 ViewofProduct-2 ReportNo.:EED32P80883901Page 35 of 42 ViewofProduct-3 ViewofProduct-4 ReportNo.:EED32P80883901Page 36 of 42 ViewofProduct-5 ViewofProduct-6 ReportNo.:EED32P80883901Page 37 of 42 ViewofProduct-7 ViewofProduct-8

ReportNo.:EED32P80883902Page1of7 1COVERPAGE RFExposureEvaluationReport Product:BloodPressureMonitor Trademark:Mircrolife Model/Typereference:BP3KX1-1B SerialNumber:N/A ReportNumber:EED32P80883902 FCCID: U7I-BP3KX1-1B DateofIssue:Jul.12,2023 TestStandards: 47CFRPart1.1307 47CFRPart1.1310 47CFRPart2.1093 447498D04InterimGeneralRF ExposureGuidancev01 Testresult:PASS Preparedfor: MicrolifeCorporation 9F,431,RuiGuangRoad,NeiHuTaipei11492,Taiwan,China Preparedby : CentreTestingInternationalGroupCo.,Ltd. HongweiIndustrialZone,Bao’an70District, Shenzhen,Guangdong,China TEL:+86-755-33683668 FAX:+86-755-33683385 Compiledby:Reviewedby: MarkChenTomChen Approvedby:Date:Jul.12,2023 AaronMa CheckNo.:2452140623 ReportNo.:EED32P80883902Page2of7 2Version VersionNo.DateDescription 00Jul.12,2023Original ReportNo.:EED32P80883902Page3of7 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 5.1.1Limits....................................................................................................................................................................6 5.1.2TestProcedure....................................................................................................................................................6 5.1.3EUTRFExposureEvaluation..........................................................................................................................7 ReportNo.:EED32P80883902Page4of7 4GeneralInformation 4.1ClientInformation Applicant: MicrolifeCorporation AddressofApplicant: 9F,431,RuiGuangRoad,NeiHuTaipei11492,Taiwan,China 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:BloodPressureMonitor ModelNo.(EUT): BP3KX1-1B TradeMark: Mircrolife Devicetype: Portable 4.3 ProductSpecificationsubjectivetothisstandard FrequencyRange:2402MHz~2480MHz ModulationType:GFSK TestPowerGrade:Default TestSoftwareofEUT:nRF_DTM AntennaType: Chipantenna AntennaGain: 3dBi PowerSupply: Adapter Model:UES05LU6-060060SPA Input:AC100-240V,50/60Hz,0.3A Output:6.0V  0.6A3.6W Battery6.0V SampleReceivedDate: Jun.15,2023 SampletestedDate: Jun.15,2023toJun.16,2023 Remark: CompanyNameandAddressshownonReport,thesample(s)andsampleInformationwas/wereprovided bytheapplicantwhoshouldberesponsiblefortheauthenticitywhichCTIhasn’tverified. ReportNo.:EED32P80883902Page5of7 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.:EED32P80883902Page6of7 5SAREvaluation 5.1RFExposureComplianceRequirement 5.1.1Limits TheSAR-basedexemptionformulaof§1.1307(b)(3)(i)(B),repeatedhereasFormula(B.2),appliesfor singlefixed,mobile,andportableRFsourceswithavailablemaximumtime-averagedpoweroreffective radiatedpower(ERP),whicheverisgreater,oflessthanorequaltothethresholdPth(mW). Thismethodshallonlybeusedatseparationdistancesfrom0.5cmto40cmandatfrequenciesfrom 0.3GHzto6GHz(inclusive).PthisgivenbyFormula andfisinGHz,distheseparationdistance(cm),andERP20cmisperFormula(B.1). The1mWBlanketExemptionof§1.1307(b)(3)(i)(A)appliesforsinglefixed,mobile,andportableRF sourceswithavailablemaximumtime-averagedpowerofnomorethan1mW,regardlessofseparation distance. 5.1.2TestProcedure SoftwareprovidedbyclientenabledtheEUTtotransmitandreceivedataatlowest,middleandhighest channelindividually. ReportNo.:EED32P80883902Page7of7 5.1.3EUTRFExposureEvaluation ForStandalone: ForBLE Frequency (MHz) Sep…

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ReportNo.:EED32P80883901Page1of24 Appendix:BluetoothLE ReportNo.:EED32P80883901Page2of24 Contents Contents.....................................................................................................................................................................................................2 DutyCycle..................................................................................................................................................................................................3 MaximumPeakConductedOutputPower..................................................................................................................................................6 -6dBBandwidth..........................................................................................................................................................................................9 OccupiedChannelBandwidth..................................................................................................................................................................12 MaximumPowerSpectralDensityLevel..................................................................................................................................................15 BandEdge................................................................................................................................................................................................18 ConductedRFSpuriousEmission............................................................................................................................................................21 ReportNo.:EED32P80883901Page3of24 DutyCycle ConditionModeFrequency(MHz)AntennaDutyCycle(%)CorrectionFactor(dB)1/T(kHz) NVNTBLE1M2402Ant168.961.612.32 NVNTBLE1M2440Ant168.961.612.32 NVNTBLE1M2480Ant168.81.622.33 ReportNo.:EED32P80883901Page4of24 TestGraphs DutyCycleNVNTBLE1M2402MHzAnt1 DutyCycleNVNTBLE1M2440MHzAnt1 ReportNo.:EED32P80883901Page5of24 DutyCycleNVNTBLE1M2480MHzAnt1 ReportNo.:EED32P80883901Page6of24 MaximumPeakConductedOutputPower ConditionModeFrequency (MHz) AntennaConductedPower (dBm) Limit (dBm) Verdict NVNTBLE1M2402Ant11.7330Pass NVNTBLE1M2440Ant10.1930Pass NVNTBLE1M2480Ant1-0.9330Pass ReportNo.:EED32P80883901Page7of24 TestGraphs PeakPowerNVNTBLE1M2402MHzAnt1 PeakPowerNVNTBLE1M2440MHzAnt1 ReportNo.:EED32P80883901Page8of24 PeakPowerNVNTBLE1M2480MHzAnt1 ReportNo.:EED32P80883901Page9of24 -6dBBandwidth ConditionModeFrequency(MHz)Antenna-6dBBandwidth(MHz)Limit-6dBBandwidth(MHz)Verdict NVNTBLE1M2402Ant10.7410.5Pass NVNTBLE1M2440Ant10.7350.5Pass NVNTBLE1M2480Ant10.7130.5Pass ReportNo.:EED32P80883901Page10of24 TestGraphs -6dBBandwidthNVNTBLE1M2402MHzAnt1 -6dBBandwidthNVNTBLE1M2440MHzAnt1 ReportNo.:EED32P80883901Page11of24 -6dBBandwidthNVNTBLE1M2480MHzAnt1 ReportNo.:EED32P80883901Page12of24 OccupiedChannelBandwidth ConditionModeFrequency(MHz)Antenna99%OBW(MHz) NVNTBLE1M2402Ant11.301 NVNTBLE1M2440Ant11.174 NVNTBLE1M2480Ant11.063 ReportNo.:EED32P80883901Page13of24 TestGraphs OBWNVNTBLE1M2402MHzAnt1 OBWNVNTBLE1M2440MHzAnt1 ReportNo.:EED32P80883901Page14of24 OBWNVNTBLE1M2480MHzAnt1 ReportNo.:EED32P80883901Page15of24 MaximumPowerSpectralDensityLevel ConditionModeFrequency (MHz) AntennaConductedPSD (dBm/3kHz) Limit (dBm/3kHz) Verdict NVNTBLE1M2402Ant1-13.368Pass NVNTBLE1M2440Ant1-14.048Pass NVNTBLE1M2480Ant1-15.278Pass ReportNo.:EED32P80883901Page16of24 TestGraphs PSDNVNTBLE1M2402MHzAnt1 PSDNVNTBLE1M2440MHzAnt1 ReportNo.:EED32P80883901Page17of24 PSDNVNTBLE1M2480MHzAnt1 ReportNo.:EED32P80883901Page18of24 BandEdge ConditionModeFrequency(MHz)AntennaMaxValue(dBc)Limit(dBc)Verdict NVNTBLE1M2402Ant1-38.04-20Pass NVNTBLE1M2480Ant1-44.37-20Pass ReportNo.:EED32P80883901Page19of24 TestGraphs BandEdgeNVNTBLE1M2402MHzAnt1Ref BandEdgeNVNTBLE1M2402MHzAnt1Emission ReportNo.:EED32P80883901Page20of24 BandEdgeNVNTBLE1M2480MHzAnt1Ref BandEdgeNVNTBLE1M2480MHzAnt1Emission ReportNo.:EED32P80883901Page21of24 ConductedRFSpuriousEmission ConditionModeFrequency(MHz)AntennaMaxValue(dBc)Limit(dBc)Verdict NVNTBLE1M2402Ant1-49.46-20Pass NVNTBLE1M2440Ant1-48.05-20Pass NVNTBLE1M2480Ant1-47.07-20Pass ReportNo.:EED32P80883901Page22of24 TestGraphs Tx.SpuriousNVNTBLE1M2402MHzAnt1Ref Tx.SpuriousNVNTBLE1M2402MHzAnt1Emission ReportNo.:EED32P80883901Page23of24 Tx.SpuriousNVNTBLE1M2440MHzAnt1Ref Tx.SpuriousNVNTBLE1M2440MHzAnt1Emission ReportNo.:EED32P80883901Page24of24 Tx.SpuriousNVNTBLE1M2480MHzAnt1Ref Tx.SpuriousNVNTBLE1M2480MHzAnt1Emission ***EndofReport***

ReportNo.:EED32P80883901Page1of42 1 COVERPAGE TESTREPORT Product:BloodPressureMonitor Trademark:Mircrolife Model/Typereference:BP3KX1-1B SerialNumber:N/A ReportNumber:EED32P80883901 FCCID: U7I-BP3KX1-1B DateofIssue:Jul.12,2023 TestStandards: 47CFRPart15SubpartC Testresult:PASS Preparedfor: MicrolifeCorporation 9F,431,RuiGuangRoad,NeiHuTaipei11492,Taiwan,China Preparedby : CentreTestingInternationalGroupCo.,Ltd. HongweiIndustrialZone,Bao’an70District, Shenzhen,Guangdong,China TEL:+86-755-33683668 FAX:+86-755-33683385 Compiledby:Reviewedby: MarkChenTomChen Approvedby:Date:Jul.12,2023 AaronMa CheckNo.:2452140623 ReportNo.:EED32P80883901Page 2 of 42 2Content 1COVERPAGE.....................................................................................................................................................................1 2CONTENT............................................................................................................................................................................2 3VERSION.............................................................................................................................................................................3 4TESTSUMMARY...............................................................................................................................................................4 5GENERALINFORMATION...............................................................................................................................................5 5.1C LIENT I NFORMATION ....................................................................................................................................................5 5.2G ENERAL D ESCRIPTIONOF EUT.................................................................................................................................5 5.3T EST C ONFIGURATION ..................................................................................................................................................6 5.4T EST E NVIRONMENT .....................................................................................................................................................7 5.5D ESCRIPTIONOF S UPPORT U NITS ...............................................................................................................................7 5.6T EST L OCATION .............................................................................................................................................................7 5.7M EASUREMENT U NCERTAINTY (95% CONFIDENCELEVELS , K =2).............................................................................8 6EQUIPMENTLIST..............................................................................................................................................................9 7TESTRESULTSANDMEASUREMENTDATA.........................................................................................................12 7.1A NTENNA R EQUIREMENT ............................................................................................................................................12 7.2ACP OWER L INE C ONDUCTED E MISSIONS ................................................................................................................13 7.3M AXIMUM C ONDUCTED O UTPUT P OWER ..................................................................................................................16 7.4DTSB ANDWIDTH ........................................................................................................................................................17 7.5M AXIMUM P OWER S PECTRAL D ENSITY .....................................................................................................................18 7.6B AND E DGEMEASUREMENTSAND C ONDUCTED S PURIOUS E MISSION ...................................................................19 7.7R ADIATED S PURIOUS E MISSION &R ESTRICTEDBANDS ...........................................................................................20 8APPENDIXBLE................................................................................................................................................................31 9PHOTOGRAPHSOFTESTSETUP..............................................................................................................................32 10PHOTOGRAPHSOFEUTCONSTRUCTIONALDETAILS...................................................................................34 ReportNo.:EED32P80883901Page 3 of 42 3Version VersionNo.DateDescription 00Jul.12,2023Original ReportNo.:EED32P80883901Page 4 of 42 4TestSummary 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. ReportNo.:EED32P80883901Page 5 of 42 5GeneralInformation 5.1ClientInformation Applicant:MicrolifeCorporation AddressofApplicant:9F,431,RuiGuangRoad,NeiHuTaipei11492,Taiwan,China 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 5.2GeneralDescriptionofEUT ProductName: BloodPressureMonitor ModelNo.: BP3KX1-1B Trad…

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ReportNo.:EED32P80883901Page 32 of 42 9PHOTOGRAPHSOFTESTSETUP RadiatedspuriousemissionTestSetup-1 (Below1GHz) RadiatedspuriousemissionTestSetup-2( Above1GHz) ReportNo.:EED32P80883901Page 33 of 42 RadiatedspuriousemissionTestSetup-3( Above1GHz) Thereareabsorbingmaterialsundertheground. ConductedEmissionsTestSetup