2ADXK-3613Dynamic ECG recorder

I VersionDateDescriptionAuthor User's Manual(Dynamic ECGrecorder) ShenzhenViatomTechnology Co.,Ltd. DocumentNumberReversion 41-DO-00281A AuthorReviewApproval ©ViATOMTECHNOLOGY(UNPUBLISHED)ALLRIGHTSRESERVED ThismaterialistheproprietaryinformationofViATOMTechnology.Andany use,reproduction,ordistributionofthematerialcontainedherein,unless specificallyauthorizedbyViATOMTechnology,isexpresslyforbiddenand wouldviolatetherightsandinterestsofViATOMTechnology. II ER1DynamicECGrecorder Contents 1.Thebasics......................................................................................1 2.Introduction...................................................................................3 3.UsingInstructions............................................................................6 4.Maintenance..................................................................................9 5.Accessories....................................................................................11 6.Specifications...............................................................................11 7.Electromagneticcompatibility....................................................11 User’sManual 1 1.Thebasics Thismanualcontainstheinstructionsnecessarytooperatethe productsafelyandinaccordancewithitsfunctionandintended use.Observanceofthismanualisaprerequisiteforproper productperformanceandcorrectoperationandensurespatient andoperatorsafety. 1.1Safety WarningsandCautionaryAdvices Beforeusingthisequipment,pleasereadthismanual carefullyandfullyunderstandthewarningsandrisks. Thisdeviceisnotintendedtoreplacethemedicaldiagnosis ofaprofessionaldoctor. Themeasurementresultsofthisdeviceareforreference onlyandcannotbedirectlyusedasabasisforclinical treatment. Wedonotrecommendtheuseofthisdeviceifyouhavea pacemakerorotherimplantabledeviceinyourbody.Please followthedoctor'sadviceifnecessary. Thisdevicecannotbeusedwithadefibrillator. Thisdevicecannotbeusedduringctornuclearmagnetic resonance(MRI)procedures. Thisequipmentmustnotbeusedinaflammable environment(egoxygen-richenvironment). Thisdeviceisnotintendedforusebyinfantsweighingless than10kg. Donotswimorsubmergethedeviceinthewater.Donot immersethedeviceinwaterorotherliquids. Donotuseacetoneorothervolatilesolutionstocleanthe 2 device. Donotstronglycollideorcrushthedevice.Ifthecasingis broken,stopusingit. Thisdevicecannotbeplacedinapressurevesselorgas sterilizationequipment. Donotdisassemblethedeviceatwill,otherwiseitmay causemachinemalfunctionoraffectthenormaloperation ofthedevice. Keepthisdeviceoutofthereachofchildrenorpets、pests. Thisdeviceshouldnotbeusedonpeoplewithsensitiveskin orallergies. Thisequipmentcannotbeplacedinthefollowing environments:directsunlight,hightemperature,high humidity,closetowaterorfiresources,andhigh electromagneticinfluence. Usersshouldtrytoavoidsweating.Thesweatwillaffectthe contactbetweentheelectrodesandtheskin,affectingthe qualityofthemeasurement. Usersshouldinspectloosenedelectrodes,thatcandegrade performanceorcauseotherproblems Donotparticipateinviolentorextensivephysicalactivityin ordertomakeappropriatemeasurements. Themeasurementresultsofthisdevicecannotdistinguish alldiseases.Ifyourbodyfeelsunwell,youshouldconsult yourdoctorimmediately,inadditiontothemeasurement resultsofthisdevice. Donotself-diagnoseandtakemedicationbasedonthe measurementsofthisdevicewithoutconsultingyour doctor.Inparticular,donottakenewmedicationswithout priorpermission. Thisdeviceisnotasubstituteforprofessionalheartorother organfunctionmeasurementequipment.MedicalECG 3 measurementrequiresmoreprofessionalandcomplete measurements. Thisdevicecannotbeusedtodiagnoseadisease directly.Pleaseconsultyourdoctor. WerecommendthatyourecordyourECGcurveandthe resultsofthemeasurementsandprovidethemtoyour doctorifnecessary. Waste(includingtheequipmentitselfisscrapped)is disposedofinaccordancewithrelevantlawsand regulations. Whentheambienttemperatureis20°C,theminimumand maximumstoragetemperaturefromtheproducttoready foruseis2H（thetimerequired）. Thepatientistheexpecteduser. Donotpileupthelongtubingattheheadofthebed,asit maywraparoundtheheadorneckofthepatientduring sleep. Libatteriescapacitywilldecreaseafterchargedischargefor 300times. Theelectrodes(Appliedparts)shouldnotcontactother conductivepartsincludingearth Theproductshouldnotbemaintainedwhileinuse 2.Introduction 2.1IntendedUse Theproductisintendedtocollecting,recordingandstoringadults’ ECGdataathomeorinhealthcareenvironment,doesnotcontain auto-analysisfunction. 4 TheproductcontinuouslyrecordsandstoresECGandactivitydata forupto3daysatatime. 2.1.1Contraindications: Theproductisnotintendedforuseinpatientswithcardiac pacemakersorotherimplantabledevices. 2.2AboutER1 1.Rightsign Whenwearing,thesidemarked"R"shouldbeontherighthand sideofthewearer. 2.LEDindicator Greenlightflashes(withtherhythmoftheheartbeat):the deviceisinthenormalcollectionstate; Greenlightflashes(5sintervals):thedeviceisinstandby mode; Yellowlightisalwayson:thedeviceischarging,andthegreen lightisalwaysonwhenitisfull YellowlightFlash:insufficientpower; 4 1 3 2 4 5 3.Powerinterfacecontacts Usedtoconnectchargingcables. 4.Electrodebuckle Usedtoconnectcheststraps,disposableECGelectrodes or\chargingcables. 2.3Symbols SymbolSignificance TypeBF-AppliedPart Manufacturer Authorizedrepresentativein theEuropeanCommunity ThisproductcomplieswiththeEuropea CouncilDirective 93/42/EEC(MedicalDeviceDirective) Caution，Incorrectusemaycause personalinjuryanddamagesofgoods. Refertoinstructionmanual. IP22 Protectedagainstsprayingwaterand againstaccesstohazardouspartswitha tool,perIEC60529. FollowInstructionsforUse. Non-ionizingradiation SNSerialnumber Indicateseparatecollectionforelectrical andelectronicequipment(WEEE). 0197 6 2.4Productstructureandcomposition ThisproductismainlycomposedofDynamicECGrecordermain unit,OTGadapter,chargingcableandCheststrap (optional).DisposableECGelectrode(optional). 3.UsingInstructions 3.1Beforeuse WarningsandCautionaryAdvices Beforetakingmeasureme…

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ReportNo.:EED32M00166301Page 49 of 57 PHOTOGRAPHSOFEUTConstructionalDetails TestmodelNo.:ER1 ViewofProduct-1 ViewofProduct-2 ReportNo.:EED32M00166301Page 50 of 57 ViewofProduct-3 ViewofProduct-4 ReportNo.:EED32M00166301Page 51 of 57 ViewofProduct-5 ViewofProduct-6 ReportNo.:EED32M00166301Page 52 of 57 ViewofProduct-7 ViewofProduct-8

ER1-Lower Right Shell-Marked 210-01831-02 DESIGN CHECKED CHECKED APPROVED PROJECTION SCALE: 1:1 SIZE: A4 UNIT:MM SHEET 1 OF 1 NAMEDATE REV.B TITLE: PART NO.: MATERIAL: REV DESCRIPTION DESIGNDATE APPROVED ER1-Lower Right Shell-Marked Dynamic ECG Recorder Internal Power : Li-ion rechargeable 3.7V/90mAh Model:ER1 FCC ID:2ADXK-3613 Input:DC 5V , 1A Production Date:xxxx-xx Shenzhen Viatom Technology Co., Ltd 4E, 3#, Tingwei Industrial Park, Honglang North 2nd Road Baoan District, Shenzhen,China. ER1-Lower Left Shell-Marked 210-01838-03 DESIGN CHECKED CHECKED APPROVED PROJECTION SCALE: 1:1 SIZE: A4 UNIT:MM SHEET 1 OF 1 NAMEDATE REV.A TITLE: PART NO.: MATERIAL: REV DESCRIPTION DESIGNDATE APPROVED ER1-Lower Left Shell Marked SN:2005490001 Not intended for infants weighing less than 10kg Made in China

ReportNo.:EED32M00166301Page 52 of 57 ViewofProduct-7 ViewofProduct-8 ReportNo.:EED32M00166301Page 53 of 57 ViewofProduct-9 ViewofProduct-10 ReportNo.:EED32M00166301Page 54 of 57 ViewofProduct-11 ViewofProduct-12 ReportNo.:EED32M00166301Page 55 of 57 ViewofProduct-13 ViewofProduct-14 ReportNo.:EED32M00166301Page 56 of 57 ViewofProduct-15 ViewofProduct-16 ReportNo.:EED32M00166301Page 57 of 57 ViewofProduct-17 ***EndofReport*** Thetestreportiseffectiveonlywithbothsignatureandspecializedstamp,Theresult(s)showninthis reportreferonlytothesample(s)tested.WithoutwrittenapprovalofCTI,thisreportcan’tbereproduced exceptinfull.

ReportNo.:EED32M00166302Page1of8 1COVERPAGE RFExposureEvaluationReport Product:DynamicECGrecorder Trademark:N/A Model/Typereference:ER1 SerialNumber:N/A ReportNumber:EED32M00166302 FCCID:2ADXK-3613 DateofIssue:Aug.05,2020 TestStandards: 47CFRPart1.1307 47CFRPart2.1093 KDB447498D01GeneralRF ExposureGuidancev06 Testresult:PASS Preparedfor: ShenzhenViatomTechnologyCo.,Ltd. 4E,3#,TingweiIndustrialPark,HonglangNorth2ndRoad, BaoanDistrict,Shenzhen,China Preparedby : CentreTestingInternationalGroupCo.,Ltd. HongweiIndustrialZone,Bao’an70District, Shenzhen,Guangdong,China TEL:+86-755-33683668 FAX:+86-755-33683385 Compiledby:Reviewedby: SunlightSunJokYang Approvedby:Date:Aug.05,2020 SamChuang CheckNo.:3970334567 ReportNo.:EED32M00166302Page2of8 2Version VersionNo.DateDescription 00Aug.05,2020Original ReportNo.:EED32M00166302Page3of8 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.:EED32M00166302Page4of8 4GeneralInformation 4.1ClientInformation Applicant:ShenzhenViatomTechnologyCo.,Ltd. AddressofApplicant:4E,3#,TingweiIndustrialPark,HonglangNorth2ndRoad,BaoanDistrict, Shenzhen,China Manufacturer:ShenzhenViatomTechnologyCo.,Ltd. AddressofManufacturer: 4E,3#,TingweiIndustrialPa「k,HonglangNorth2ndRoad,Baoan District,Shenzhen,China Factory:ShenzhenViatomTechnologyCo.,Ltd. AddressofFactory:4E,3#,TingweiIndustrialPark,HonglangNorth2ndRoad,BaoanDistrict, Shenzhen,China 4.2GeneralDescriptionofEUT ProductName: DynamicECGrecorder ModelNo.(EUT): ER1 TradeMark: N/A EUTSupportsRadios application: 4.0BTSinglemode,2402MHzto2480MHz 4.3 ProductSpecificationsubjectivetothisstandard FrequencyRange:2402MHz~2480MHz ModulationType:GFSK TestPowerGrade: Default TestSoftwareofEUT: NrF AntennaType: ChipAntenna AntennaGain:0dBi PowerSupply:DC5V MaxConductedPeakOutput Power: -8.422dBm TheMaxConductedPeakOutputPowerdatarefertothereport EED32M00166301 SampleReceivedDate: Jun.10,2020 SampletestedDate: Jun.10,2020toJul.30,2020 Thetestedsample(s)andthesampleinformationareprovidedbytheclient. ReportNo.:EED32M00166302Page5of8 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.:EED32M00166302Page6of8 5SAREvaluation 5.1RFExposureComplianceRequirement 5.1.1StandardRequirement AccordingtoKDB447498D01GeneralRFExposureGuidancev06 StandaloneSARtestexclusionconsiderations UnlessspecificallyrequiredbythepublishedRFexposureKDBprocedures,standalone1-gheador bodyand10-gextremitySARevaluationforgeneralpopulationexposureconditions,bymeasurementor numericalsimulation,isnotrequiredwhenthecorrespondingSARExclusionThresholdcondition,listed below,issatisfied. 5.1.2Limits 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 Theresultisroundedtoon…

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ReportNo.:EED32M00166301Page1of57 1 COVERPAGE TESTREPORT Product:DynamicECGrecorder Trademark:N/A Model/Typereference:ER1 SerialNumber:N/A ReportNumber:EED32M00166301 FCCID:2ADXK-3613 DateofIssue:Aug.05,2020 TestStandards: 47CFRPart15SubpartC Testresult:PASS Preparedfor: ShenzhenViatomTechnologyCo.,Ltd. 4E,3#,TingweiIndustrialPark,HonglangNorth2ndRoad, BaoanDistrict,Shenzhen,China Preparedby : CentreTestingInternationalGroupCo.,Ltd. HongweiIndustrialZone,Bao’an70District, Shenzhen,Guangdong,China TEL:+86-755-33683668 FAX:+86-755-33683385 Compiledby:Reviewedby: SunlightSunJokYang Approvedby:Date:Aug.05,2020 SamChuang CheckNo.:3970334567 ReportNo.:EED32M00166301Page 2 of 57 2Version VersionNo.DateDescription 00Aug.05,2020Original ReportNo.:EED32M00166301Page 3 of 57 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. ReportNo.:EED32M00166301Page 4 of 57 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...................................................................................................................15 AppendixB):ConductedPeakOutputPower.......................................................................................................19 AppendixC):Band-edgeforRFConductedEmissions........................................................................................21 AppendixD):RFConduc…

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ReportNo.:EED32M00166301Page 46 of 57 PHOTOGRAPHSOFTESTSETUP TestmodelNo.:ER1 RadiatedspuriousemissionTestSetup-1 (Below30MHz) RadiatedspuriousemissionTestSetup-2 (Below1GHz) ReportNo.:EED32M00166301Page 47 of 57 RadiatedspuriousemissionTestSetup-3( Above1GHz) RadiatedspuriousemissionTestSetup Thereareabsorbingmaterialsundertheground. ReportNo.:EED32M00166301Page 48 of 57 ConductedEmissionsTestSetup