Apple ECG Smart Watch App lets you take an electrocardiogram (ECG) right from your wrist. It can detect atrial fibrillation (AFib), a serious heart condition that can lead to stroke. It can also help you identify if you have a high heart rate without AFib. The app is easy to use and provides clear results that you can share with your doctor.
Apple ECG Smart Watch App lets you take an electrocardiogram (ECG) right from your wrist. It can detect atrial fibrillation (AFib), a serious heart condition that can lead to stroke. It can also help you identify if you have a high heart rate without AFib. The app is easy to use and provides clear results that you can share with your doctor.
InstructionsforUse
ENGLISH(EN-GB)
ECGapp
InstructionsforUse
AppleInc.
OneAppleParkWay
Cupertino,CA95014,USA
www.apple.com
AppleDistributionInternational
HollyhillIndustrialEstate,
Hollyhill,Cork,
Ireland
Contact:medicalcompliance@group.apple.com
UKRAINECOUNTRY-SPECIFICINFORMATION:
ТОВ«ДЖЕРЕЛО-УКРАЇНА»
01033,Уĸраїна,м.Київ,вулицяШотаРуставелі33-Б,офіс27
email:uarep@jerelo.eu
тел.+38(044)3603011
SWITZERLANDCOUNTRY-SPECIFICINFORMATION:
CH-REP:
QUNIQUEGmbH
Bahnhofweg17
5610Wohlen
Switzerland
AUSTRALIACOUNTRY-SPECIFICINFORMATION:
SponsorDetails:
ApplePtyLtd
Level3,20MartinPlace
Sydney,NSW,2000
Australia
https://www.apple.com/au/
TEL:1-300-321-456
BRAZILCOUNTRY-SPECIFICINFORMATION:
ANVISAN :80117580880
RESPONSÁVELTÉCNICO:LUIZLEVYCRUZMARTINS–CRF-SP:42415
IMPORTADOR:
EmergoBrazilImportImportaçãoeDistribuiçãodeProdutosMédicosHospitalaresLtda.
AvenidaFranciscoMatarazzo,1.752,Salas502/503,ÁguaBranca,SãoPaulo-SP,CEP–05001-200
CNPJ:04.967.408/0001-98
Email:brazilvigilance@ul.com
COLOMBIACOUNTRY-SPECIFICINFORMATION:
PRODUCTO:SoftwaredeElectrografíayaplicacióndeECGparasoftwaredeanálisisde
fotopletismografía
IMPORTADOR:
IMPOMEDS.A.S
Calle1SURNO.77A-21
Interior201MedellinColombia
REGISTROSANITARIONO.:INVIMA2020DM-0021828
ISRAELCOUNTRY-SPECIFICINFORMATION:
AMARREGISTRATIONHOLDER:
MedogarMedicalEquipmentLtd.
HasadnaSt.8P.O.B2586Raʼannana4365104ISRAEL
OfficeTel:+972-9-7401457Fax:+972-9-7401459
מ"בע רפואי מכשור מדוגר
4365104 רעננה 2566 ת.ד. 8 הסדנא
09-7401457 : טל
09-7401459 : פקס
اودة ا ة ور
2566 ص.ب.، 8 د رع
4365104 ر
www.medogar.co.ilinfo@medogar.co.il
AMARCertificateNumber:21080016
TURKEYCOUNTRY-SPECIFICINFORMATION:
AppleTeknolojiveSatışLimitedŞirketi
BüyükdereCaddesi
Levent199Kat:22-23
34394Şişli
İstanbul
0
Türkiye
ProductTrackingNumberforECGapp:8682450178021
PERUCOUNTRY-SPECIFICINFORMATION:
RegistroSanitarioN0:DB5982E
IMPORTADOR:
DrogeríaEmergoPeruS.R.L.
CalleLasOrquídeasNro.585,Int.1301,
SanIsidro,Lima,Perú
RUC:20552756534
MALAYSIACOUNTRY-SPECIFICINFORMATION:
AuthorisedRepresentative:
NypraxBusinessSolutions
37JalanTerasekLima,BangsarBaru,
59100Bangsar,KualaLumpur
DeviceLicence:
AppleECGapp
GB7992021-54025
INDIACOUNTRY-SPECIFICINFORMATION:
VoluntaryRegistrationNumber:Apple-USA/I/MD/002975
IMPORTER:
AsiaActualIndia(OPC)Pvt.Ltd.
523A,TowerA,SpazeI-TechPark,Sector49,
Gurgaon,Haryana,India
REPUBLICOFKOREACOUNTRY-SPECIFICINFORMATION:
본앱은“의료기기”임.
수입업자:이머고코리아(유)
06236)서울특별시강남구테헤란로152강남파이낸스센터26층
제조원:AppleInc.
(본사)OneAppleParkWay,Cupertino,CA95014,USA
(공장)20450StevensCreekBlvd.,Cupertino,CA95014,USA
허가번호:수허20-177호
명칭(제품명,품목명,모델명):심전도앱,심전계,ECGApp
소프트웨어버전:2.X
출시연월:2022년01월
포장단위:1ea
사용목적:
모바일플랫폼(AppleWatch)에장착된심전도(ECG)센서를이용하여측정된단일유도(LeadI)유사심전도신호로부터심
방세동또는정상박동존재여부를판정함으로서,심전도신호를생성,기록,저장,전송및표시하는의료용어플리케이션.
INDONESIACOUNTRY-SPECIFICINFORMATION:
ProductLicenceNumber:KEMENKESRIAKL20502121822
REGISTRANT:
PT.ASIAACTUALINDONESIA,DKIJakarta
Gandaria8OfficeTower,Unit6J.Jl.SultanIskandarMuda
JakartaSelatan12240–Indonesia
+62(021)2930-3747
MOLDOVACOUNTRY-SPECIFICINFORMATION:
RegistrationNumber:DM000322299,DM000322300
AUTHORISEDREPRESENTATIVE:
JERELOS.R.L.
MD-2024,str.Pietrăriei,nr19A,of.3.
mun.Chișinău,RepublicaMoldova
+37378538295
INDICATIONSFORUSE
TheECGappisasoftware-onlymobilemedicalapplicationintendedforusewithAppleWatchto
create,record,store,transferanddisplayasinglechannelelectrocardiogram(ECG)similartoaLeadI
ECG.TheECGappdeterminesthepresenceofatrialfibrillation(AF),sinusrhythmandhighheartrate
(noAFdetectedwithheartratebetween100and150bpm)onaclassifiablewaveform.TheECGapp
isnotrecommendedforuserswithotherknownarrhythmias.
TheECGappisintendedforover-the-counter(OTC)use.TheECGdatadisplayedbytheECGappis
intendedforinformationaluseonly.Theuserisnotintendedtointerpretortakeclinicalactionbased
onthedeviceoutputwithoutconsultationwithaqualifiedhealthcareprofessional.TheECGwaveform
ismeanttosupplementrhythmclassificationforthepurposesofdiscriminatingAFfromsinusrhythm
andisnotintendedtoreplacetraditionalmethodsofdiagnosisortreatment.
TheECGappisnotintendedforusebypeopleunder22yearsold.
INTENDEDPURPOSE(EUREGION)
TheECGappisasoftware-onlymobilemedicalapplicationintendedforusewithAppleWatchto
create,record,store,transferanddisplayasinglechannelelectrocardiogram(ECG)similartoaLeadI
ECG.TheECGappdeterminesthepresenceofatrialfibrillation(AF),sinusrhythmandhighheartrate
(noAFdetectedwithheartratebetween100and150bpm)onaclassifiablewaveform.TheECGapp
isnotrecommendedforuserswithotherknownarrhythmias.
TheECGappisintendedforover-the-counter(OTC)use.TheECGdatadisplayedbytheECGappis
intendedforinformationaluseonly.Theuserisnotintendedtointerpretortakeclinicalactionbased
onthedeviceoutputwithoutconsultationwithaqualifiedhealthcareprofessional.TheECGwaveform
ismeanttosupplementrhythmclassificationforthepurposesofdiscriminatingAFfromsinusrhythm
andisnotintendedtoreplacetraditionalmethodsofdiagnosisortreatment.
TheECGappisnotintendedforusebypeopleunder22yearsold.
TargetPopulationandIntendedUsers
TheECGappisintendedforuserswhoare22yearsoldandover.Thereisnospecificclinical
conditionrequiredtousetheapp.Userswhoareinterestedinlearningmoreabouttheir
cardiovascularhealthmaychoosetoactivatethefeatureuponsuccessfulcompletionofan
onboardingprocess.
INTENDEDUSE(NON-EUREGION&REPUBLICOF
KOREA)
TheintendeduseoftheECGappistoallowtheusertotakeasingleleadECGthatisthenclassified
assinusrhythmoratrialfibrillation(AF)onaclassifiablewaveform.TheECGandrhythmclassification
maybeusedbyuserswithorwithoutknownAFasdatathatmaybesharedwithaqualified
healthcareprofessional.TheECGappisintendedtobeusedbylaypeopleaged22yearsandover.
RUSSIACOUNTRY-SPECIFICINFORMATION
TheECGappisnotconsideredamedicaldeviceperROSZDRAVNADZOR(RussianHealthAuthority).
TheECGappisasoftware-onlymobileapplicationintendedforusewithAppleWatchtocreate,
record,store,transferanddisplayasinglechannelelectrocardiogram(ECG)similartoaLeadIECG.
TheECGappdeterminesthepresenceofatrialfibrillation(AF),sinusrhythmandhighheartrate(no
AFdetectedwithheartratebetween100and150bpm)onaclassifiablewaveform.TheECGappis
notrecommendedforuserswithotherknownarrhythmias.
TheECGappisintendedforover-the-counter(OTC)use.TheECGdatadisplayedbytheECGappis
intendedforinformationaluseonly.Theuserisnotintendedtointerpretortakeclinicalactionbased
onthedeviceoutputwithoutconsultationwithaqualifiedhealthcareprofessional.Toreceive
appropriatehealthcareadvice,pleasevisitaqualifiedhealthcareprofessional.TheECGwaveformis
meanttosupplementrhythmclassificationforthepurposesofdiscriminatingAFfromsinusrhythm
andisnotintendedtoreplacetraditionalmethodsofdiagnosisortreatment.
TheECGappisnotintendedforusebypeopleunder22yearsold.
USINGTHEECGAPP
AppSetup/Onboarding
TheECGappiscompatiblewithAppleWatchSeries4orlater(excludingAppleWatchSE).For
regionalavailabilityandadditionaldevicecompatibilityinformation,pleasevisit
https://support.apple.com/HT208955
UpdateAppleWatchandiPhonetolatestOS.
OpentheHealthapponyouriPhoneandselectBrowse.
NavigatetoHeart,thenselectElectrocardiogram(ECG).
Followtheonscreeninstructions.
YoumayexitonboardingatanytimebytappingCancel.
RecordinganECG
MakesureyourAppleWatchissnugonthewristyouselectedinSettings>General>Orientation.
OpentheECGapponyourAppleWatch.
Restyourarmsonatableorinyourlap,andholdyourfingerontheDigitalCrown.Youdonot
needtopressthecrownduringthesession.
Therecordingtakes30seconds.
ECGAnalysis
Afterasuccessfulreading,youwillreceiveoneofthefollowingclassificationsonyourECGapp:
SinusRhythm:Asinusrhythmresultmeanstheheartisbeatinginauniformpatternbetween
50–99BPM.
HighHeartRate-NoAtrialFibrillationDetected:Ahighheartrateresultmeanstheheartis
beatingbetween100and150bpmanddoesnotshowsignsofAtrialFibrillation.
AtrialFibrillation:AnAFresultmeanstheheartisbeatinginanirregularpatternbetween50–99
BPM.
AtrialFibrillation-HighHeartRate:AnAFHighHeartRateresultmeanstheheartisbeatingin
anirregularpatternbetween100and150bpm.
PoorRecording:Apoorrecordingresultmeanstherecordingcouldnotbeclassifiedbecause
oftoomuchartefactornoiseinthewaveform.Thiscanhappenformanyreasonssuchas
excessmovementduringarecording,orwearingyourAppleWatchtooloosely.Certain
physiologicalconditionsmaypreventasmallpercentageofusersfromcreatingenoughsignal
toproduceagoodrecording.
LoworHighHeartRate:theECGappcannotcheckrecordingswithaheartrateunder50bpm
orover150bpm.
AfteranECGrecordingiscomplete,theECGdataisanalysedtodetermineifitisatleast25
secondslong,andifso,ifeitherSinusRhythm,AForhighheartratewithnoAFisdetected,orif
anInconclusiveresultiswarranted.
TheECGrecordingresultontheECGappprovidesadetaileddisplayoftheresult.Adetailed
explanationwillalsobeprovidedintheHealthapponyouriPhone.
PresenceofAFinyourECGresultsmayrepresentonlypotentialfindings.Ifyouareexperiencing
anysymptomsorhaveconcerns,contactyourdoctor.Ifyoubelieveyouareexperiencinga
medicalemergency,contactemergencyservices.
InconclusiveECGresultsmaymeantheremayhavebeentoomuchartefactornoisetoacquirea
goodsignal,oryoumayhaveanarrhythmiaotherthanAFthattheappcannotclassify.Asmall
percentageofpeoplemayhavecertainphysiologicalconditionspreventingthemfromcreating
enoughsignaltoproduceagoodrecording.YoucanlearnmoreaboutInconclusiveECGresults
duringonboarding,byaccessingeducationalinformationintheECGareaoftheHealthappon
youriPhone,orbytappingthe“i”iconontheECGappformoreinformation.
IfyoureceiveanInconclusiveresultduetoapoorrecording,youmighttrytore-recordyourECG.
Asmallpercentageofpeoplemayhavecertainphysiologicalconditionspreventingthemfrom
creatingenoughsignaltoproduceagoodrecording.YoucanreviewhowtotakeanECGduring
onboardingorbytapping“HowtoTakeanECG”intheECGareaoftheHealthapponyour
iPhone.
Aheartratecanbelowbecauseofcertainmedicationsorifelectricalsignalsarenotproperly
conductedthroughtheheart.Trainingtobeaneliteathletecanalsoleadtoalowheartrate.
Aheartratecanbehighbecauseofexercise,stress,nervousness,alcoholdehydration,infection,
AForotherarrhythmia.
AllECGsaresyncedtotheHealthapponyouriPhone.YoumayusetheHealthapptoshareyour
ECGwithaclinician.
DeletingandRestoringECGapponAppleWatch
DeleteECGapponAppleWatch
OnyourAppleWatch,gototheHomeScreen
IfyouareinGridView,touchandholdtheapplightlyuntilitjiggles
Taptheapp,thentapthe“x”icon
IfyouareinListView,swipeleftontheappandtaptheBinicon
TapDelete
PressDigitalCrowntofinish
RestoreECGappontheAppleWatch
GototheAppStoreonyourAppleWatch
SearchforECGapp
Tap torestoretheapp
SAFETYANDPERFORMANCE
TheECGappʼsabilitytoaccuratelyclassifyanECGrecordingasAFandsinusrhythmwasextensively
testedinaclinicaltrialofapproximately546subjects.Rhythmclassificationofa12-leadECGbya
cardiologistwascomparedwiththerhythmclassificationofanECGcollectedsimultaneouslyfromthe
ECG2.0app.TheECGappdemonstrated98.5%sensitivityinclassifyingAF(HR50-150bpm)and
99.3%specificityinclassifyingsinusrhythm(HR50-150bpm)inclassifiablerecordings.
Themorphologyofthewaveformwasalsotestedinthisclinicaltrialbyvisualassessmentofthe
PQRSTwaveandRwaveamplitudeincomparisonwithareference.TheECG2.0appproduceda
visuallyacceptablePQRSTwaveformwithapassratingof100%comparedwiththereference
waveform.Additionally,thetotalpassratingforR-waveamplitudeassessmentwas97.2%compared
withthereference.
TROUBLESHOOTING
IfyouexperiencedifficultiesinoperatingyourECGapp,refertothetroubleshootingguidebelow.
Problem:IcannotgettheECGapptotakeareading.
Solution:
EnsureyouhavecompletedalltheonboardingstepsintheHealthapponyouriPhone.
MakesureyourwristandAppleWatcharecleananddry.Waterandsweatcancauseapoor
recording.
EnsureyourAppleWatch,armsandhandsremainstillduringrecordings.
Problem:Ihavealotofartefact,noiseorinterferenceinmyrecording.
Solution:
Restyourarmsonatableorinyourlapwhileyoutakearecording.Trytorelaxandnotmovetoo
much.
MakesureyourAppleWatchisnʼtlooseonyourwrist.Thestrapshouldbesnugandthebackof
yourAppleWatchneedstobetouchingyourwrist.
Moveawayfromanyelectronicsthatarepluggedintoapowerpointtoavoidelectrical
interference.
Problem:TheECGwaveformsappearupsidedown.
Solution:
Thewatchorientationmaybesettothewrongwrist.OnyouriPhone,gototheWatchapp.Tap
MyWatch>General>WatchOrientation.
AlldatarecordedduringanECGappsessionissavedtotheHealthapponyouriPhone.Ifyouchoose
to,youcansharethatinformationbycreatingaPDF.
NewECGdatacannotberecordedonceyourAppleWatchstorageisfull.Ifyouarenotabletotakea
recordingduetostoragespaceissues,youshouldfreeupspacebydeletingunwantedapps,musicor
podcasts.YoucancheckyourstorageusagebynavigatingtotheAppleWatchapponyouriPhone,
tappingMyWatch,tappingGeneral,thentappingStorage.
CAUTIONS:
TheECGappcannotcheckforsignsofaheartattack.Ifyoubelieveyouʼrehavingamedical
emergency,callemergencyservices.
DONOTtakerecordingswhenAppleWatchisincloseproximitytostrongelectromagneticfields(e.g.
electromagneticanti-theftsystemsormetaldetectors).
DONOTtakerecordingsduringamedicalprocedure(e.g.magneticresonanceimaging,diathermy,
lithotripsy,cauteryandexternaldefibrillationprocedures).
DONOTtakerecordingswhenAppleWatchisoutsidetheoperationaltemperaturerange(0-35 C)
indicatedintheAppleWatchusermanualandhumidityrangeof20-95%relativehumidity.
DONOTusetodiagnoseheart-relatedconditions.
DONOTusewithacardiacpacemaker,ICDsorotherimplantedelectronicdevices.
DONOTtakearecordingduringphysicalactivity.
DONOTchangeyourmedicationwithouttalkingtoyourdoctor.
Notintendedforusebyindividualsundertheageof22.
Youshouldtalktoyourdoctorifyourheartrateisunder50bpmorover150bpmatrestandthisisan
unexpectedresult.
Interpretationsmadebythisapparepotentialfindings,notacompletediagnosisofcardiac
conditions.Theuserisnotintendedtointerpretortakeclinicalactionbasedontheappoutput
withoutconsultationwithaqualifiedhealthcareprofessional.
ThewaveformgeneratedbytheECGappismeanttosupplementrhythmclassificationforthe
purposesofdiscriminatingAFfromnormalsinusrhythmandtachycardia(highheartrate),andisnot
intendedtoreplacetraditionalmethodsofdiagnosisortreatment.
Thisisanoticetotheuserand/orpatientthatanyseriousincidentthathasoccurredinrelationtothe
deviceshouldbereportedtothemanufacturerandthecompetentauthorityoftheMemberStatein
whichtheuserand/orpatientisestablished.
o
CAUTION:Appledoesnotguaranteethatyouarenotexperiencinganarrhythmiaorotherhealth
conditionswhentheECGapplabelsanECGasSinusRhythmorTachycardia(highheartrate).You
shouldnotifyyourdoctorifyoudetectpossiblechangesinyourhealth.
SECURITY:Applerecommendsthatyouaddapasscode(personalidentificationnumber[PIN]),Face
IDorTouchID(fingerprint)toyouriPhoneandapasscode(personalidentificationnumber[PIN])to
yourAppleWatchtoaddalayerofsecurity.ItisimportanttosecureyouriPhonesinceyouwillbe
storingpersonalhealthinformationonit.UserswillalsoreceiveadditionaliOSandwatchOSupdate
notificationsonthedevice,andupdatesaredeliveredwirelessly,encouragingrapidadoptionofthe
latestsecurityfixes.See“iOSandwatchOSSecurityGuide”,whichdescribesAppleʼssecurity
practicesandisavailabletoallourusers.FortheiOSandwatchOSSecurityguide,pleasevisit
https://support.apple.com/guide/security/welcome/web.
EquipmentSymbols
Manufacturer
Consultinstructionsforuse
EuropeanAuthorisedRepresentative
MedicalDevice
099-23781RevisionN,March2022
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Apple ECG Smart Watch App lets you take an electrocardiogram (ECG) right from your wrist. It can detect atrial fibrillation (AFib), a serious heart condition that can lead to stroke. It can also help you identify if you have a high heart rate without AFib. The app is easy to use and provides clear results that you can share with your doctor.
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