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ECG Smart Watch App

Apple ECG Smart Watch App User manual

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InstructionsforUse
ENGLISH(EN-GB)
ECGapp
InstructionsforUse
AppleInc.
OneAppleParkWay
Cupertino,CA95014,USA
www.apple.com
AppleDistributionInternational
HollyhillIndustrialEstate,
Hollyhill,Cork,
Ireland
Contact:medicalcompliance@group.apple.com
UKRAINECOUNTRY-SPECIFICINFORMATION:
ТОВ«ДЖЕРЕЛО-УКРАЇНА»
01033,Уĸраїна,м.Київ,вулицяШотаРуставелі33-Б,офіс27
email:uarep@jerelo.eu
тел.+38(044)3603011
SWITZERLANDCOUNTRY-SPECIFICINFORMATION:
CH-REP:
QUNIQUEGmbH
Bahnhofweg17
5610Wohlen
Switzerland
AUSTRALIACOUNTRY-SPECIFICINFORMATION:
SponsorDetails:
ApplePtyLtd
Level3,20MartinPlace
Sydney,NSW,2000
Australia
https://www.apple.com/au/
TEL:1-300-321-456
BRAZILCOUNTRY-SPECIFICINFORMATION:
ANVISAN :80117580880
RESPONSÁVELTÉCNICO:LUIZLEVYCRUZMARTINS–CRF-SP:42415
IMPORTADOR:
EmergoBrazilImportImportaçãoeDistribuiçãodeProdutosMédicosHospitalaresLtda.
AvenidaFranciscoMatarazzo,1.752,Salas502/503,ÁguaBranca,SãoPaulo-SP,CEP–05001-200
CNPJ:04.967.408/0001-98
Email:brazilvigilance@ul.com
COLOMBIACOUNTRY-SPECIFICINFORMATION:
PRODUCTO:SoftwaredeElectrografíayaplicacióndeECGparasoftwaredeanálisisde
fotopletismografía
IMPORTADOR:
IMPOMEDS.A.S
Calle1SURNO.77A-21
Interior201MedellinColombia
REGISTROSANITARIONO.:INVIMA2020DM-0021828
ISRAELCOUNTRY-SPECIFICINFORMATION:
AMARREGISTRATIONHOLDER:
MedogarMedicalEquipmentLtd.
HasadnaSt.8P.O.B2586Raʼannana4365104ISRAEL
OfficeTel:+972-9-7401457Fax:+972-9-7401459
מ"בע רפואי מכשור מדוגר
4365104 רעננה 2566ת.ד. 8 הסדנא
09-7401457 : טל
09-7401459 : פקס
اودة اة ور
2566 ص.ب.، 8 درع
4365104 ر
www.medogar.co.ilinfo@medogar.co.il
AMARCertificateNumber:21080016
TURKEYCOUNTRY-SPECIFICINFORMATION:
AppleTeknolojiveSatışLimitedŞirketi
BüyükdereCaddesi
Levent199Kat:22-23
34394Şişli
İstanbul
0
Türkiye
ProductTrackingNumberforECGapp:8682450178021
PERUCOUNTRY-SPECIFICINFORMATION:
RegistroSanitarioN0:DB5982E
IMPORTADOR:
DrogeríaEmergoPeruS.R.L.
CalleLasOrquídeasNro.585,Int.1301,
SanIsidro,Lima,Perú
RUC:20552756534
MALAYSIACOUNTRY-SPECIFICINFORMATION:
AuthorisedRepresentative:
NypraxBusinessSolutions
37JalanTerasekLima,BangsarBaru,
59100Bangsar,KualaLumpur
DeviceLicence:
AppleECGapp
GB7992021-54025
INDIACOUNTRY-SPECIFICINFORMATION:
VoluntaryRegistrationNumber:Apple-USA/I/MD/002975
IMPORTER:
AsiaActualIndia(OPC)Pvt.Ltd.
523A,TowerA,SpazeI-TechPark,Sector49,
Gurgaon,Haryana,India
REPUBLICOFKOREACOUNTRY-SPECIFICINFORMATION:
본앱은“의료기기”임.
수입업자:이머고코리아(유)
06236)서울특별시강남구테헤란로152강남파이낸스센터26층
제조원:AppleInc.
(본사)OneAppleParkWay,Cupertino,CA95014,USA
(공장)20450StevensCreekBlvd.,Cupertino,CA95014,USA
허가번호:수허20-177호
명칭(제품명,품목명,모델명):심전도앱,심전계,ECGApp
소프트웨어버전:2.X
출시연월:2022년01월
포장단위:1ea
사용목적:
모바일플랫폼(AppleWatch)에장착된심전도(ECG)센서를이용하여측정된단일유도(LeadI)유사심전도신호로부터심
방세동또는정상박동존재여부를판정함으로서,심전도신호를생성,기록,저장,전송및표시하는의료용어플리케이션.
INDONESIACOUNTRY-SPECIFICINFORMATION:
ProductLicenceNumber:KEMENKESRIAKL20502121822
REGISTRANT:
PT.ASIAACTUALINDONESIA,DKIJakarta
Gandaria8OfficeTower,Unit6J.Jl.SultanIskandarMuda
JakartaSelatan12240–Indonesia
+62(021)2930-3747
MOLDOVACOUNTRY-SPECIFICINFORMATION:
RegistrationNumber:DM000322299,DM000322300
AUTHORISEDREPRESENTATIVE:
JERELOS.R.L.
MD-2024,str.Pietrăriei,nr19A,of.3.
mun.Chișinău,RepublicaMoldova
+37378538295
INDICATIONSFORUSE
TheECGappisasoftware-onlymobilemedicalapplicationintendedforusewithAppleWatchto
create,record,store,transferanddisplayasinglechannelelectrocardiogram(ECG)similartoaLeadI
ECG.TheECGappdeterminesthepresenceofatrialfibrillation(AF),sinusrhythmandhighheartrate
(noAFdetectedwithheartratebetween100and150bpm)onaclassifiablewaveform.TheECGapp
isnotrecommendedforuserswithotherknownarrhythmias.
TheECGappisintendedforover-the-counter(OTC)use.TheECGdatadisplayedbytheECGappis
intendedforinformationaluseonly.Theuserisnotintendedtointerpretortakeclinicalactionbased
onthedeviceoutputwithoutconsultationwithaqualifiedhealthcareprofessional.TheECGwaveform
ismeanttosupplementrhythmclassificationforthepurposesofdiscriminatingAFfromsinusrhythm
andisnotintendedtoreplacetraditionalmethodsofdiagnosisortreatment.
TheECGappisnotintendedforusebypeopleunder22yearsold.
INTENDEDPURPOSE(EUREGION)
TheECGappisasoftware-onlymobilemedicalapplicationintendedforusewithAppleWatchto
create,record,store,transferanddisplayasinglechannelelectrocardiogram(ECG)similartoaLeadI
ECG.TheECGappdeterminesthepresenceofatrialfibrillation(AF),sinusrhythmandhighheartrate
(noAFdetectedwithheartratebetween100and150bpm)onaclassifiablewaveform.TheECGapp
isnotrecommendedforuserswithotherknownarrhythmias.
TheECGappisintendedforover-the-counter(OTC)use.TheECGdatadisplayedbytheECGappis
intendedforinformationaluseonly.Theuserisnotintendedtointerpretortakeclinicalactionbased
onthedeviceoutputwithoutconsultationwithaqualifiedhealthcareprofessional.TheECGwaveform
ismeanttosupplementrhythmclassificationforthepurposesofdiscriminatingAFfromsinusrhythm
andisnotintendedtoreplacetraditionalmethodsofdiagnosisortreatment.
TheECGappisnotintendedforusebypeopleunder22yearsold.
TargetPopulationandIntendedUsers
TheECGappisintendedforuserswhoare22yearsoldandover.Thereisnospecificclinical
conditionrequiredtousetheapp.Userswhoareinterestedinlearningmoreabouttheir
cardiovascularhealthmaychoosetoactivatethefeatureuponsuccessfulcompletionofan
onboardingprocess.
INTENDEDUSE(NON-EUREGION&REPUBLICOF
KOREA)
TheintendeduseoftheECGappistoallowtheusertotakeasingleleadECGthatisthenclassified
assinusrhythmoratrialfibrillation(AF)onaclassifiablewaveform.TheECGandrhythmclassification
maybeusedbyuserswithorwithoutknownAFasdatathatmaybesharedwithaqualified
healthcareprofessional.TheECGappisintendedtobeusedbylaypeopleaged22yearsandover.
RUSSIACOUNTRY-SPECIFICINFORMATION
TheECGappisnotconsideredamedicaldeviceperROSZDRAVNADZOR(RussianHealthAuthority).
TheECGappisasoftware-onlymobileapplicationintendedforusewithAppleWatchtocreate,
record,store,transferanddisplayasinglechannelelectrocardiogram(ECG)similartoaLeadIECG.
TheECGappdeterminesthepresenceofatrialfibrillation(AF),sinusrhythmandhighheartrate(no
AFdetectedwithheartratebetween100and150bpm)onaclassifiablewaveform.TheECGappis
notrecommendedforuserswithotherknownarrhythmias.
TheECGappisintendedforover-the-counter(OTC)use.TheECGdatadisplayedbytheECGappis
intendedforinformationaluseonly.Theuserisnotintendedtointerpretortakeclinicalactionbased
onthedeviceoutputwithoutconsultationwithaqualifiedhealthcareprofessional.Toreceive
appropriatehealthcareadvice,pleasevisitaqualifiedhealthcareprofessional.TheECGwaveformis
meanttosupplementrhythmclassificationforthepurposesofdiscriminatingAFfromsinusrhythm
andisnotintendedtoreplacetraditionalmethodsofdiagnosisortreatment.
TheECGappisnotintendedforusebypeopleunder22yearsold.
USINGTHEECGAPP
AppSetup/Onboarding
TheECGappiscompatiblewithAppleWatchSeries4orlater(excludingAppleWatchSE).For
regionalavailabilityandadditionaldevicecompatibilityinformation,pleasevisit
https://support.apple.com/HT208955
UpdateAppleWatchandiPhonetolatestOS.
OpentheHealthapponyouriPhoneandselectBrowse.
NavigatetoHeart,thenselectElectrocardiogram(ECG).
Followtheonscreeninstructions.
YoumayexitonboardingatanytimebytappingCancel.
RecordinganECG
MakesureyourAppleWatchissnugonthewristyouselectedinSettings>General>Orientation.
OpentheECGapponyourAppleWatch.
Restyourarmsonatableorinyourlap,andholdyourfingerontheDigitalCrown.Youdonot
needtopressthecrownduringthesession.
Therecordingtakes30seconds.
ECGAnalysis
Afterasuccessfulreading,youwillreceiveoneofthefollowingclassificationsonyourECGapp:
SinusRhythm:Asinusrhythmresultmeanstheheartisbeatinginauniformpatternbetween
50–99BPM.
HighHeartRate-NoAtrialFibrillationDetected:Ahighheartrateresultmeanstheheartis
beatingbetween100and150bpmanddoesnotshowsignsofAtrialFibrillation.
AtrialFibrillation:AnAFresultmeanstheheartisbeatinginanirregularpatternbetween50–99
BPM.
AtrialFibrillation-HighHeartRate:AnAFHighHeartRateresultmeanstheheartisbeatingin
anirregularpatternbetween100and150bpm.
PoorRecording:Apoorrecordingresultmeanstherecordingcouldnotbeclassifiedbecause
oftoomuchartefactornoiseinthewaveform.Thiscanhappenformanyreasonssuchas
excessmovementduringarecording,orwearingyourAppleWatchtooloosely.Certain
physiologicalconditionsmaypreventasmallpercentageofusersfromcreatingenoughsignal
toproduceagoodrecording.
LoworHighHeartRate:theECGappcannotcheckrecordingswithaheartrateunder50bpm
orover150bpm.
AfteranECGrecordingiscomplete,theECGdataisanalysedtodetermineifitisatleast25
secondslong,andifso,ifeitherSinusRhythm,AForhighheartratewithnoAFisdetected,orif
anInconclusiveresultiswarranted.
TheECGrecordingresultontheECGappprovidesadetaileddisplayoftheresult.Adetailed
explanationwillalsobeprovidedintheHealthapponyouriPhone.
PresenceofAFinyourECGresultsmayrepresentonlypotentialfindings.Ifyouareexperiencing
anysymptomsorhaveconcerns,contactyourdoctor.Ifyoubelieveyouareexperiencinga
medicalemergency,contactemergencyservices.
InconclusiveECGresultsmaymeantheremayhavebeentoomuchartefactornoisetoacquirea
goodsignal,oryoumayhaveanarrhythmiaotherthanAFthattheappcannotclassify.Asmall
percentageofpeoplemayhavecertainphysiologicalconditionspreventingthemfromcreating
enoughsignaltoproduceagoodrecording.YoucanlearnmoreaboutInconclusiveECGresults
duringonboarding,byaccessingeducationalinformationintheECGareaoftheHealthappon
youriPhone,orbytappingthe“i”iconontheECGappformoreinformation.
IfyoureceiveanInconclusiveresultduetoapoorrecording,youmighttrytore-recordyourECG.
Asmallpercentageofpeoplemayhavecertainphysiologicalconditionspreventingthemfrom
creatingenoughsignaltoproduceagoodrecording.YoucanreviewhowtotakeanECGduring
onboardingorbytapping“HowtoTakeanECG”intheECGareaoftheHealthapponyour
iPhone.
Aheartratecanbelowbecauseofcertainmedicationsorifelectricalsignalsarenotproperly
conductedthroughtheheart.Trainingtobeaneliteathletecanalsoleadtoalowheartrate.
Aheartratecanbehighbecauseofexercise,stress,nervousness,alcoholdehydration,infection,
AForotherarrhythmia.
AllECGsaresyncedtotheHealthapponyouriPhone.YoumayusetheHealthapptoshareyour
ECGwithaclinician.
DeletingandRestoringECGapponAppleWatch
DeleteECGapponAppleWatch
OnyourAppleWatch,gototheHomeScreen
IfyouareinGridView,touchandholdtheapplightlyuntilitjiggles
Taptheapp,thentapthe“x”icon
IfyouareinListView,swipeleftontheappandtaptheBinicon
TapDelete
PressDigitalCrowntofinish
RestoreECGappontheAppleWatch
GototheAppStoreonyourAppleWatch
SearchforECGapp
Tap torestoretheapp
SAFETYANDPERFORMANCE
TheECGappʼsabilitytoaccuratelyclassifyanECGrecordingasAFandsinusrhythmwasextensively
testedinaclinicaltrialofapproximately546subjects.Rhythmclassificationofa12-leadECGbya
cardiologistwascomparedwiththerhythmclassificationofanECGcollectedsimultaneouslyfromthe
ECG2.0app.TheECGappdemonstrated98.5%sensitivityinclassifyingAF(HR50-150bpm)and
99.3%specificityinclassifyingsinusrhythm(HR50-150bpm)inclassifiablerecordings.
Themorphologyofthewaveformwasalsotestedinthisclinicaltrialbyvisualassessmentofthe
PQRSTwaveandRwaveamplitudeincomparisonwithareference.TheECG2.0appproduceda
visuallyacceptablePQRSTwaveformwithapassratingof100%comparedwiththereference
waveform.Additionally,thetotalpassratingforR-waveamplitudeassessmentwas97.2%compared
withthereference.
TROUBLESHOOTING
IfyouexperiencedifficultiesinoperatingyourECGapp,refertothetroubleshootingguidebelow.
Problem:IcannotgettheECGapptotakeareading.
Solution:
EnsureyouhavecompletedalltheonboardingstepsintheHealthapponyouriPhone.
MakesureyourwristandAppleWatcharecleananddry.Waterandsweatcancauseapoor
recording.
EnsureyourAppleWatch,armsandhandsremainstillduringrecordings.
Problem:Ihavealotofartefact,noiseorinterferenceinmyrecording.
Solution:
Restyourarmsonatableorinyourlapwhileyoutakearecording.Trytorelaxandnotmovetoo
much.
MakesureyourAppleWatchisnʼtlooseonyourwrist.Thestrapshouldbesnugandthebackof
yourAppleWatchneedstobetouchingyourwrist.
Moveawayfromanyelectronicsthatarepluggedintoapowerpointtoavoidelectrical
interference.
Problem:TheECGwaveformsappearupsidedown.
Solution:
Thewatchorientationmaybesettothewrongwrist.OnyouriPhone,gototheWatchapp.Tap
MyWatch>General>WatchOrientation.
AlldatarecordedduringanECGappsessionissavedtotheHealthapponyouriPhone.Ifyouchoose
to,youcansharethatinformationbycreatingaPDF.
NewECGdatacannotberecordedonceyourAppleWatchstorageisfull.Ifyouarenotabletotakea
recordingduetostoragespaceissues,youshouldfreeupspacebydeletingunwantedapps,musicor
podcasts.YoucancheckyourstorageusagebynavigatingtotheAppleWatchapponyouriPhone,
tappingMyWatch,tappingGeneral,thentappingStorage.
CAUTIONS:
TheECGappcannotcheckforsignsofaheartattack.Ifyoubelieveyouʼrehavingamedical
emergency,callemergencyservices.
DONOTtakerecordingswhenAppleWatchisincloseproximitytostrongelectromagneticfields(e.g.
electromagneticanti-theftsystemsormetaldetectors).
DONOTtakerecordingsduringamedicalprocedure(e.g.magneticresonanceimaging,diathermy,
lithotripsy,cauteryandexternaldefibrillationprocedures).
DONOTtakerecordingswhenAppleWatchisoutsidetheoperationaltemperaturerange(0-35 C)
indicatedintheAppleWatchusermanualandhumidityrangeof20-95%relativehumidity.
DONOTusetodiagnoseheart-relatedconditions.
DONOTusewithacardiacpacemaker,ICDsorotherimplantedelectronicdevices.
DONOTtakearecordingduringphysicalactivity.
DONOTchangeyourmedicationwithouttalkingtoyourdoctor.
Notintendedforusebyindividualsundertheageof22.
Youshouldtalktoyourdoctorifyourheartrateisunder50bpmorover150bpmatrestandthisisan
unexpectedresult.
Interpretationsmadebythisapparepotentialfindings,notacompletediagnosisofcardiac
conditions.Theuserisnotintendedtointerpretortakeclinicalactionbasedontheappoutput
withoutconsultationwithaqualifiedhealthcareprofessional.
ThewaveformgeneratedbytheECGappismeanttosupplementrhythmclassificationforthe
purposesofdiscriminatingAFfromnormalsinusrhythmandtachycardia(highheartrate),andisnot
intendedtoreplacetraditionalmethodsofdiagnosisortreatment.
Thisisanoticetotheuserand/orpatientthatanyseriousincidentthathasoccurredinrelationtothe
deviceshouldbereportedtothemanufacturerandthecompetentauthorityoftheMemberStatein
whichtheuserand/orpatientisestablished.
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CAUTION:Appledoesnotguaranteethatyouarenotexperiencinganarrhythmiaorotherhealth
conditionswhentheECGapplabelsanECGasSinusRhythmorTachycardia(highheartrate).You
shouldnotifyyourdoctorifyoudetectpossiblechangesinyourhealth.
SECURITY:Applerecommendsthatyouaddapasscode(personalidentificationnumber[PIN]),Face
IDorTouchID(fingerprint)toyouriPhoneandapasscode(personalidentificationnumber[PIN])to
yourAppleWatchtoaddalayerofsecurity.ItisimportanttosecureyouriPhonesinceyouwillbe
storingpersonalhealthinformationonit.UserswillalsoreceiveadditionaliOSandwatchOSupdate
notificationsonthedevice,andupdatesaredeliveredwirelessly,encouragingrapidadoptionofthe
latestsecurityfixes.See“iOSandwatchOSSecurityGuide”,whichdescribesAppleʼssecurity
practicesandisavailabletoallourusers.FortheiOSandwatchOSSecurityguide,pleasevisit
https://support.apple.com/guide/security/welcome/web.
EquipmentSymbols
Manufacturer
Consultinstructionsforuse
EuropeanAuthorisedRepresentative
MedicalDevice
099-23781RevisionN,March2022
/