Apple HT208931 User manual

Brand: Apple

Model: HT208931

Type: User manual

Apple HT208931 is designed to analyze pulse rate data and notify you if it identifies an irregular heart rhythm suggestive of atrial fibrillation (AFib). It's important to note that it's not intended to provide a notification for every irregular rhythm and the absence of a notification doesn't mean you're free from any heart condition. To ensure accuracy, make sure your Apple Watch fits snugly on your wrist, as the heart rate sensor needs to stay close to your skin.

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

Apple HT208931 User manual

Apple HT208931 User manual

Apple HT208931 User manual

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