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HT208931

Apple HT208931 User manual

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InstructionsforUse
ENGLISH(EN)
IrregularRhythmNotificationFeature
InstructionsforUse
AppleInc.
OneAppleParkWay
Cupertino,CA95014
www.apple.com
INDICATIONSFORUSE
TheIrregularRhythmNotificationFeature(IRNF)isasoftware-onlymobilemedicalapplicationthatis
intendedtobeusedwiththeAppleWatch.Thefeatureanalyzespulseratedatatoidentifyepisodes
ofirregularheartrhythmssuggestiveofatrialfibrillation(AFib)andprovidesanotificationtotheuser.
Thefeatureisintendedforover-the-counter(OTC)use.Itisnotintendedtoprovideanotificationon
everyepisodeofirregularrhythmsuggestiveofAFibandtheabsenceofanotificationisnotintended
toindicatenodiseaseprocessispresent;ratherthefeatureisintendedtoopportunisticallysurfacea
notificationofpossibleAFibwhensufficientdataareavailableforanalysis.Thesedataareonly
capturedwhentheuserisstill.Alongwiththeuserʼsriskfactors,thefeaturecanbeusedto
supplementthedecisionforAFibscreening.Thefeatureisnotintendedtoreplacetraditional
methodsofdiagnosisortreatment.
Thefeaturehasnotbeentestedforandisnotintendedforuseinpeopleunder22yearsofage.Itis
alsonotintendedforuseinindividualspreviouslydiagnosedwithAFib.
RUSSIACOUNTRYSPECIFICINFORMATION
TheIrregularRhythmNotificationFeatureisnotconsideredamedicaldeviceperROSZDRAVNADZOR
(RussianHealthAuthority).
TheIrregularRhythmNotificationFeatureisasoftware-onlyapplicationthatisintendedtobeused
withtheAppleWatch.Thefeatureanalyzespulseratedatatoidentifyepisodesofirregularheart
rhythmssuggestiveofatrialfibrillation(AFib)andprovidesanotificationtotheuser.Thefeatureis
intendedforover-the-counter(OTC)use.Itisnotintendedtoprovideanotificationoneveryepisode
ofirregularrhythmsuggestiveofAFibandtheabsenceofanotificationisnotintendedtoindicateno
diseaseprocessispresent;ratherthefeatureisintendedtoopportunisticallysurfaceanotificationof
possibleAFibwhensufficientdataareavailableforanalysis.Thesedataareonlycapturedwhenthe
userisstill.Alongwiththeuserʼsriskfactors,thefeaturecanbeusedtosupplementthedecisionfor
AFibscreening.Thefeatureisnotintendedtoreplacetraditionalmethodsofdiagnosisortreatment.
Thefeaturehasnotbeentestedforandisnotintendedforuseinpeopleunder22yearsofage.Itis
alsonotintendedforuseinindividualspreviouslydiagnosedwithAFib.
USINGTHEIRREGULARRHYTHMNOTIFICATION
FEATURE
Set-Up/On-boarding
TheIrregularRhythmNotificationFeatureiscompatiblewithAppleWatchSeries3,Series4,
Series5,Series6,Series7,andSE.ForregionavailabilityanddevicecompatibilityfortheIRNF,
pleasevisithttps://support.apple.com/HT208931
UpdateAppleWatchandiPhonetolatestOS.
OpentheHealthapponyouriPhoneandselect“Browse”.
Navigateto“Heart”,thenselect“IrregularRhythmNotifications”.
Followtheonscreeninstructionsandcompletetheon-boardingprocedure.
Youmayexiton-boardingatanytimebytapping“Cancel”.
ReceivingaNotification
Oncethefeatureisturnedon,youwillreceiveanotificationifthefeatureidentifiedaheartrhythm
suggestiveofAFibandconfirmeditonmultiplereadings.
IfyouhavenotbeendiagnosedwithAFibbyaphysician,youshoulddiscussthenotificationwith
yourdoctor.
AlldatacollectedandanalyzedbytheIrregularRhythmNotificationFeatureissavedtotheHealth
apponyouriPhone.Ifyouchooseto,youcansharethatinformationbyexportingyourhealthdatain
theHealthapp.
NewdatacannotbecollectedonceyourAppleWatchʼsstorageisfull.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”,andthentapping
“Storage”.
SAFETYANDPERFORMANCE
TheperformanceoftheIrregularRhythmNotificationFeature(IRNF)wasextensivelytestedina
clinicalstudyof573participantsages22andolderwithamixofdiagnosedAFibandnoknown
historyofAFib.Studydemographiccharacteristicsaresummarizedinthetablebelow:
IRNF2.0ClinicalStudySubjectDemographics
N=573
AgeGroup
<55
>=55to<65
>=65
123(21.5%)
140(24.4%)
310(54.1%)
Sex
Male
Female
286(49.9%)
287(50.1%)
Ethnicity
HispanicorLatino
Non-HispanicorLatino
38(6.6%)
535(93.4%)
Race
White
BlackorAfricanAmerican
Other
502(87.6%)
57(9.9%)
14(2.4%)
EnrolledsubjectsworeanAppleWatchandareferenceelectrocardiogram(ECG)patchconcurrently
forupto13days.Forthosesubjectscontributingdatatotheprimaryendpointanalysis,32.4%
(n=140/432)presentedwithAFibasidentifiedonthereferenceECGpatchandwereincludedin
determiningthedevicesensitivity.Ofthose,124receivedanIRNFirregularrhythmnotificationwith
concordantAFibontheECGpatch,andthesensitivitywas88.6%.Ofthe292subjectswhodidnot
presentwithAFibontheECGpatchandcontributeddatatotheanalysisofdevicespecificity,290did
notreceiveanotification.TheAFdetectionspecificitywas99.3%.Theremainingsubjects
(n=141/573)eithercontributeddatatoonlysecondaryendpointanalysesand/ordidnotcompletethe
study.TheseresultssupportthedeviceʼseffectivenessindetectingAFib.
CAUTIONS
TheIrregularRhythmNotificationFeaturecannotdetectheartattacks.Ifyoueverexperience
chestpain,pressure,tightness,orwhatyouthinkisaheartattack,callemergencyservices.
TheIrregularRhythmNotificationFeatureisnotconstantlylookingforAFibandshouldnotbe
reliedonasacontinuousmonitor.ThismeansthefeaturecannotdetectallinstancesofAFib,and
peoplewithAFibmaynotgetanotification.
AppleWatchmaybeunabletocollectdatawhenAppleWatchisinclosevicinitytostrong
electromagneticfields(e.g.electromagneticanti-theftsystems,metaldetectors).
Anumberoffactorscanimpacttheabilityofthefeaturetomeasureyourpulseanddetectan
irregularrhythmsuggestiveofAFib.Theseincludefactorslikemotion,handandfingermovements,
environmentalfactorssuchasambienttemperature,darktattoosonthewrist,andtheamountof
bloodflowtoyourskin(whichcanbereducedbycoldtemperatures).
DONOTwearyourAppleWatchduringamedicalprocedure(e.g.,magneticresonanceimaging,
diathermy,lithotripsy,cauteryandexternaldefibrillationprocedures).
DONOTchangeyourmedicationwithouttalkingtoyourdoctor.
Notintendedforusebyindividualsunderage22.
NotintendedforusebyindividualspreviouslydiagnosedwithAFib.
Notificationsmadebythisfeaturearepotentialfindings,notacompletediagnosisofcardiac
conditions.Allnotificationsshouldbereviewedbyamedicalprofessionalforclinicaldecision-making.
Appledoesnotguaranteethatyouarenotexperiencinganarrhythmiaorotherhealthconditionseven
intheabsenceofanirregularrhythmnotification.Youshouldnotifyyourphysicianifyouexperience
anychangestoyourhealth.
Forbestresults,chargeyourAppleWatchregularlyandmakesureitfitssnuglyontopofyourwrist.
Theheartratesensorshouldstayclosetoyourskin.
Thisisanoticetotheuserand/orpatientthatanyseriousincidentthathasoccurredinrelationto
theIRNFdeviceshouldbereportedtothemanufacturer(Apple)andthecompetentauthorityof
theMemberStateinwhichtheuserand/orpatientisestablished.
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theiPhonesinceyouwillbe
storingpersonalhealthinformation.UserswillalsoreceiveadditionaliOSandwatchOSupdate
notificationsontheiriPhoneandAppleWatch,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of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
MedicalDevice
099-30417,RevisionB,December2021
/