Fitbit ECG App Instructions for Use

1 FitbitECGAppInstructionsforUseVersionAD1 29-0517-01 November15,2021 TableofContentsGlossary4 IndicationsforUse5 ProductDescription6 Cautions6 Expectations7 HowtheFitbitECGappworks7 Resultsyoumightsee7 NormalSinusRhythm7 AtrialFibrillation7 Inconclusive7 GeneralWarningsandPrecautions8 OperatingInstructions9 InstalltheFitbitECGapp9 Taketheassessment10 Canceltheassessment10 Seeyourresults10 Deleteyourresults11 DeleteandRestoretheFitbitECGapp11 Troubleshooting12 Inconclusive:Highheartrate12 Inconclusive:Lowheartrate12 Inconclusive:Didn tgetagoodreading13 ClinicalStudy14 DiseaseandSelf-careInformation15 Whatisatrialfibrillation?15 Signsthatyoumayhaveatrialfibrillation15 Lifestyleandotherfactors152 Potentialtreatmentoptions16 InformationforPhysicians16 TermsofService16 UserAssistanceInformation173 GlossaryAAtrialfibrillation(AFib)Atrialf ibrillation(AFib)isatypeofirregularheart rhythm, (ECG)Anelectrocardiogram(ECG) (beats) softenexpressedasbeatsperminute(bpm).

2 *:TheFitbitECGappisasoftware-onlymobilem edicalapplicationintendedforusewithFitbi twrist-wearableproductstocreate,record,s tore,transfer,anddisplayasingle-channele lectrocardiogram(ECG) (AFib) (OTC) **(EU/EEA/UK):TheFitbitECGappisintendedt oallowtheusertorecordawaveformsimilartoa single-leadECGthatisthenclassifiedassinu srhythmoratrialfibrillation(AFib) *USIndicationsforUseappliestotheUnitedSt ates,India,andthefollowingUSterritories: AmericanSamoa,PuertoRico,Guam,USVirginIs lands**Non-USIndicationsforUseappliestot hefollowingcountries:EUcountrieswherethe FitbitECGappisavailable:Germany,Ireland, Spain,France,Netherlands,Sweden,Italy,Be lgium,Poland,Austria,CzechRepublic,Portu gal,Romania, :Switzerland,Canada,NewZealand,SouthAfri ca,Norway,Chile,Singapore, :HongKongProductDescriptionTheFitbitECGs oftware-onlymedicalapplicationisusedtocr eateandrecordanECG,similartoasingle-lead ECG,whenyouopentheFitbitECGapp,followthe Instructions .

3 You ,displayingpastresults,exportingareport, ,orthosewhohaveapacemaker,internaldefibr illator, , , ,theheart' ,theupperchamberscontractirregularly,inc reasingtheriskofheartattack,bloodclots,s troke, ,theheartmaynotalwaysbeatirregularly, tdiagnoseAFib, tshowsignsofAFib, , ,theFitbitECGappcan ,butcommoncausesaremovingtoomuchduringth eassessment,notrestingyourhandsonatable, ,see"Troubleshooting"onpage ,butsomepeopledon ,sotheearlieryoudetectit, , ,see"ClinicalStudy"onpage , ,bloodclots,stroke, ,yourheartmaynotalwaysbeatirregularly,ma kingitchallengingtodetecteveninthedoctor , ,it , , , , talreadyinstalledonyourFitbitwrist-wornp roduct, , ( +)andFitbitCharge5( +).Formoreinformation, , ,andlogintoyourFitbitaccountifyouhaven ,tapHealthAssessments&ReportsHeartRhythm Assessment(ECG) , , , , , ,aresultwon ,youseeoneofthefollowingresults: , :Yourheartratewastoolow,toohigh,ortheFit bitECGappcouldn , ,see"Troubleshooting" ,yourresultstransferfromyourFitbitwrist- wornproducttotheFitbitapp, , ,tapHealthAssessments& , ,tapHealthAssessments& , , ,install,andmanageapps, :Inconclusive:HighheartrateIfyourheartra teisover120bpm,theFitbitECGappcan ,suchas:lRecentexerciselStresslNervousne sslAlcohollDehydrationlInfectionlAFib,or otherarrhythmiaLearnmorefromtheAmericanH eartAssociationorbyvisitingthewebsiteoft heEuropeanSocietyofCardiology[ ].

4 Inconclusive:LowheartrateIfyourheartrate isunder50bpm,theFitbitECGappcan ,suchas:lTakingcertainmedicationssuchasb eta-blockersorcalciumchannelblockerslHav ingexcellentaerobicfitnesslOtherarrhythm iaLearnmorefromtheAmericanHeartAssociati onorbyvisitingthewebsiteoftheEuropeanSoc ietyofCardiology[ ].Inconclusive:Didn tgetagoodreadingTherearemanypossiblereas onsforgettinganinconclusiveresult,butcom moncausesare:lMovingtoomuchduringtheasse ssmentlNotrestingyourhandsonatablelOther arrhythmiaIftheFitbitECGappcouldn tgetagoodreading,trythefollowingtroubles hootingtips:lMakesureyou , , ,wentswimming,showered,orperspired, ,oryou renotfeelingwell, , , sabilitytoclassifycardiacrhythmsasatrial fibrillation(AFib)andsinusrhythm(SR)from awaveformsimilartoaLeadIECG,andconfirmth esoftware ,withandwithoutaknowndiagnosisofAFib, , , ,theFitbitECGApp , , (AFib) , ,theheartcontractsirregularly, , thaveanysymptoms,butothersmayexperience.

5 LIrregularheartbeatlHeartpalpitationslLi ghtheadednesslExtremefatiguelShortnessof breathlChestpainLearnmorefromtheCDCorbyv isitingthewebsiteoftheEuropeanSocietyofC ardiology[ ].LifestyleandotherfactorsRiskfactorsfor AFibinclude:lAdvancedagelHighbloodpressu relObesitylEuropeanancestrylDiabeteslHea rtfailurelIschemicheartdiseaselHyperthyr oidismlChronickidneydiseaselHeavyalcohol uselEnlargementofthechambersontheleftsid eoftheheartLearnmorefromtheCDCorbyvisiti ngthewebsiteoftheEuropeanSocietyofCardio logy[ ]. :lMedicationlSurgerylLifestylechangesLea rnmorefromtheCDCorbyvisitingthewebsiteof theEuropeanSocietyofCardiology[ ].InformationforPhysiciansAphysician (877) , ( Terms ) FitbitService includesourdevicesincludingassociatedfir mware,applications,software,websites,API s,products, ,theUnitedKingdomorSwitzerland,theseTerm sareanagreementbetweenyouandFitbitIntern ationalLimited,anIrishcompanywithitsregi steredofficeat76 LowerBaggotStreet,Dublin2, ,theseTermsareanagreementbetweenyouandFi tbitLLC,199 FremontStreet,14thFloor,SanFrancisco, Fitbit , we, us, or our, , ,donotcreateanaccount, :FB603, (Austria,Belgium,CzechRepublic,France,Ge rmany,Ireland,Italy,Luxembourg,Netherlan ds,Poland,Portugal,Romania,Spain,Sweden, andSwitzerland) Fitbit ,Inc.

6 (UK,US,HongKong,AmericanSamoa,PuertoRico ,Guam, ,Canada,NewZealand,India,SouthAfrica,Chi le,Singapore,andAustralia) , :156023504 ABN:84156023504 Localityofregisteredoffice:Unit308,469-4 81 HighSt,Northcote,VIC3070,AustraliaEquipm entSymbolsCEMarkReadInstructionsforUseMa nufacturerEuropeanAuthorisedRepresentati veForcustomersupport.