U7I-TWIN200VSRDigital Blood Pressure Monitor

EN WatchBP Professional Ofice Blood Pressure and cardiovascular screening monitor Instruction Manual TWIN200 VSR Office Vascular MODE 2 The Microlife Upper Arm Automatic Digital Blood Pressure and Cardiovascular Screening Monitor Model WatchBP Ofice Vascular (TWIN200 VSR) is a non-invasive digital blood pressure device using oscillometric technique and an upper-arm blood pressure cuff to measure systolic and diastolic blood pressures, pulse rate, mean arterial pressure (MAP) for or use in adults and pediatrics (but not neonates) with arm cuff circumference sizes ranging from 14 -52 cm. The device screens for the presence of atrial ibrillation during measurement. The device can accurately measure blood pressure in pregnant patients including those with known or suspected pre-eclampsia. A recommended test for diagnosing Peripheral Artery Disease (PAD) is performing ankle- arm measurements to assess the ankle brachial index (ABI). The device has proven to be a fast, easy, and reliable alternative for Peripheral Arterial Disease (PAD) screening as has been clinically validated with a Doppler device [1]. The device also provides a user-friendly and more reproducible cuff-based brachial- ankle PWV measurement method to evaluate arterial stiffness in clinical practice. The device provides aortic blood pressure parameters, includes central systolic blood pressure (cSBP), central pulse pressure (cPP) and central diastolic blood pressure (cDBP), non-invasively through the use of a brachial cuff. This was validated against invasive blood pressure measurement and showed that the device determines central blood pressure measurement with high accuracy [2]. The memory data can be transferred to the PC (personal computer) running the WatchBP Analyzer software by connecting the monitor via USB cable or Bluetooth. The device is meant for useing by healthcare professionals in clinical practice. Contra-indications The device is not intended for measuring blood pressure in patients of age less than 3 years old ( infant or neonates). The device measures brachial blood pressure using pressured cuff over upper arm. If the measurementing arm or leg suffers from injuries (e.g. open wounds) or conditions (e.g. intravenous drip) or has stents implanted making it unsuitable for surface contact or pressurization of the arm, do not use the device. The device is not intended to measure pulse rate to check the frequency of pacemaker. Indications for Use WatchBP product support: https://www.microlife.com/professional-products WatchBP Software support: https://www.microlife.com/support/software-professional-products Developers support: https://www.microlife.com/developers1 EN 3 WatchBP Office Product description ・Contents ............................................................................................................................... 4 ・Model Type ............................................................................................................................ 4 ・Upgrading the version of the device ......................................................................................... 4 ・Product Overview .................................................................................................................. 5 ・Display .................................................................................................................................. 5 Initial set up ・Attaching the power plug to the power adapter ........................................................................6 ・Power ON/OFF ......................................................................................................................6 ・Set the date, time and the safeguard pressure ......................................................................6-7 Before using the device ・Selecting the correct cuff ........................................................................................................8 ・Fitting the cuff properly ............................................................................................................9 Taking measurements in MANUAL and AUTO mode ・Turn on the power ................................................................................................................. 10 ・Connect the cuff to the device ............................................................................................... 10 ・Select an operation mode ..................................................................................................... 10 ・Settings of AUTO mode .......................................................................................................8-9 ・Taking measurement in Single or Both Arm(s) Mode .............................................................. 12 ・Viewing stored values ........................................................................................................... 12 ・Settings of the measurement ................................................................................................ 12 ・Taking measurement simultaneously in one Arm & one ankle .................................................. 13 Using WatchBP Analyzer ・Installing the Software Program ............................................................................................. 14 ・Connecting the Device to a Computer ................................................................................... 14 ・Start the Software Program ................................................................................................... 14 ・Transferring and deleting measurement data ......................................................................... 14 ・Bluetooth connectivity .......................................................................................................... 15 Rechargeable battery and power adapter ・Rechargeable Battery ........................................................................................................... 15 ・Usi…

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Report No. : EED32M00235001Page 49 of 61 PHOTOGRAPHS OF EUT Constructional Details Test model No.: WatchBP Office Vascular View of Product-1 View of Product-2 Report No. : EED32M00235001Page 50 of 61 View of Product-3 View of Product-4 Report No. : EED32M00235001Page 51 of 61 View of Product-5 View of Product-6 Report No. : EED32M00235001Page 52 of 61 View of Product-7 View of Product-8 Report No. : EED32M00235001Page 53 of 61 View of Product-9 View of Product-10

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Report No. : EED32M00235001Page 53 of 61 View of Product-9 View of Product-10 Report No. : EED32M00235001Page 54 of 61 View of Product-11 View of Product-12 Report No. : EED32M00235001Page 55 of 61 View of Product-13 View of Product-14 Report No. : EED32M00235001Page 56 of 61 View of Product-15 View of Product-16 Report No. : EED32M00235001Page 57 of 61 View of Product-17 View of Product-18 Report No. : EED32M00235001Page 58 of 61 View of Product-19 View of Product-20 Report No. : EED32M00235001Page 59 of 61 View of Product-21 View of Product-22 Report No. : EED32M00235001Page 60 of 61 View of Product-23 View of Product-24 Report No. : EED32M00235001Page 61 of 61 View of Product-25 View of Product-26 The test report is effective only with both signature and specialized stamp, The result(s) shown in this report refer only to the sample(s) tested. Without written approval of CTI, this report can’t be reproduced except in full. *** End of Report ***

ReportNo.:EED32M00235002Page1of8 1COVERPAGE RFExposureEvaluationReport Product:DigitalBloodPressureMonitor Trademark: Model/Typereference: WatchBPOfficeVascular,TWIN200VSR SerialNumber:N/A ReportNumber:EED32M00235002 FCCID:U7I-TWIN200VSR DateofIssue:Aug.31,2020 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: SunlightSunJokYang Approvedby:Date:Aug.31,2020 SamChuang CheckNo.3970340721 ReportNo.:EED32M00235002Page2of8 2Version VersionNo.DateDescription 00Aug.31,2020Original ReportNo.:EED32M00235002Page3of8 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 5.1.2Limits....................................................................................................................................................................6 5.1.3EUTRFExposure..............................................................................................................................................7 PHOTOGRAPHSOFEUTCONSTRUCTIONALDETAILS..........................................................................................8 ReportNo.:EED32M00235002Page4of8 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 ModelNo.(EUT): WatchBPOfficeVascular,TWIN200VSR TestModelNo.: WatchBPOfficeVascular TradeMark: EUTSupportsRadios application: BT4.2Singlemode,2402MHzto2480MHz 4.3 ProductSpecificationsubjectivetothisstandard FrequencyRange:2402MHz~2480MHz ModulationType:GFSK TestPowerGrade:Default TestSoftwareofEUT:NRF AntennaType:CeramicAntenna AntennaGain:0dBi PowerSupply: Adapter MODELNo:UE15WCP1-075150SPA PARTNo:UE140425DGHD03-R INPUT:100-240V~50/60Hz,500mA OUTPUT:7.5V  1.5A Battery GPRHC252C236 GP250AAHC4BMXZ 4.8V2400mAh MaxConductedPeak OutputPower: -2.58dBm TheMaxConductedPeakOutputPowerdatarefertothereport EED32M00235001 SampleReceivedDate:Aug.04,2020 SampletestedDate:Aug.04,2020toAug.10,2020 Thetestedsample(s)andthesampleinformationareprovidedbytheclient. ModelNo.:WatchBPOfficeVascular,TWIN200VSR OnlythemodelWatchBPOfficeVascularwastested,Theirelectricalcircuitdesign,layout,components used,internalwiring,softwareandouterdecorationareidentical.Onlythemodelnamesaredifferent.The testedproducthastwomodelnames,WatchBPOfficeVascularisthemarketmodelname;TWIN200VSRis thefactoryinternalmodelname. ReportNo.:EED32M00235002Page5of8 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.:EED32M00235002Page6of8 5SAREvaluation 5.1RFExposureComplianceRequirement 5.1.1StandardRequirement AccordingtoKDB447498D01GeneralRFExposureGuidancev06 StandaloneSARtestexclusionconsiderations UnlessspecificallyrequiredbythepublishedRFexposureKDBprocedures,standalone1-gheador bodyand10-gextremitySARevaluationforgeneralpopulationexposureconditions,b…

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ReportNo.:EED32M00235001Page1of61 1 COVERPAGE TESTREPORT Product:DigitalBloodPressureMonitor Trademark: Model/Typereference: WatchBPOfficeVascular,TWIN200VSR SerialNumber: N/A ReportNumber:EED32M00235001 FCCID: U7I-TWIN200VSR DateofIssue: Aug.31,2020 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: SunlightSunJokYang Approvedby:Date:Aug.31,2020 SamChuang CheckNo.3970340721 ReportNo.:EED32M00235001Page 2 of 61 2Version VersionNo.DateDescription 00Aug.31,2020Original ReportNo.:EED32M00235001Page 3 of 61 3TestSummary TestItemTestRequirementTestmethodResult AntennaRequirement 47CFRPart15SubpartCSection 15.203/15.247(c) ANSIC63.10-2013PASS ACPowerLineConducted Emission 47CFRPart15SubpartCSection 15.207 ANSIC63.10-2013PASS 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. Thetestedsample(s)andthesampleinformationareprovidedbytheclient. ModelNo.:WatchBPOfficeVascular,TWIN200VSR OnlythemodelWatchBPOfficeVascularwastested,Theirelectricalcircuitdesign,layout,componentsused, internalwiring,softwareandouterdecorationareidentical.Onlythemodelnamesaredifferent.Thetested producthastwomodelnames,WatchBPOfficeVascularisthemarketmodelname;TWIN200VSRisthe factoryinternalmodelname. ReportNo.:EED32M00235001Page 4 of 61 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 6.3P RODUCT S PECIFICATIONSUBJECTIVETOTHISSTANDARD ........................................................................................7 6.4D ESCRIPTIONOF S UPPORT U NITS ...............................................................................................................................9 6.5T EST L OCATION .............................................................................................................................................................9 6.6D EVIATIONFROM S TANDARDS ......................................................................................................................................9 6.7A BNORMALITIESFROM S TANDARD C ONDITIONS ..........................................................................................................9 6.8O THER I NFORMATION R EQUESTEDBYTHE C USTOMER ..............................................................................................9 6.9M EASUREMENT U NCERTAINTY (95% CONFIDENCELEVELS , K =2)..............................................................................9 7EQUIPMENTLIST............................................................................................................................................................10 8RADIOTECHNICALREQUIREMENTSSPECIFICATION........................................................................................13 AppendixA):6dBOccupiedBandwidth.....................................................................…

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ReportNo.:EED32M00235001Page 47 of 61 PHOTOGRAPHSOFTESTSETUP TestmodelNo.:WatchBPOfficeVascular RadiatedspuriousemissionTestSetup-1 (Below1GHz) RadiatedspuriousemissionTestSetup-2( Above1GHz) ReportNo.:EED32M00235001Page 48 of 61 RadiatedspuriousemissionTestSetup Thereareabsorbingmaterialsundertheground. ConductedEmissionsTestSetup