Apple Irregular Rhythm Notification Feature Software Operating instructions

Apple
Brand
Apple
Model
Irregular Rhythm Notification Feature Software
Type
Operating instructions

Apple Irregular Rhythm Notification Feature Software helps identify irregular heart rhythms suggestive of atrial fibrillation (AF). It analyzes pulse rate data from your Apple Watch to opportunistically notify you of possible AF when sufficient data is available. The feature is not intended to replace traditional methods of diagnosis or treatment. It cannot detect heart attacks or constantly monitor for AF and may not detect all instances of AF. Factors like motion, tattoos, or cold temperatures can impact its accuracy. Notifications should be reviewed by a medical professional.

Apple Irregular Rhythm Notification Feature Software helps identify irregular heart rhythms suggestive of atrial fibrillation (AF). It analyzes pulse rate data from your Apple Watch to opportunistically notify you of possible AF when sufficient data is available. The feature is not intended to replace traditional methods of diagnosis or treatment. It cannot detect heart attacks or constantly monitor for AF and may not detect all instances of AF. Factors like motion, tattoos, or cold temperatures can impact its accuracy. Notifications should be reviewed by a medical professional.

InstructionsforUse
ENGLISH(EN-GB)
IrregularRhythmNotificationFeature
InstructionsforUse
AppleInc.
OneAppleParkWay
Cupertino,CA95014,USA
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AppleWatch.Thefeatureanalysespulseratedatatoidentifyepisodesof
irregularheartrhythmssuggestiveofatrialfibrillation(AF)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of
everyepisodeofirregularrhythmsuggestiveofAFandtheabsenceofanotificationisnotintended
toindicatenodiseaseprocessispresent;rather,thefeatureisintendedtoopportunisticallydisplaya
notificationofpossibleAFwhensufficientdataisavailableforanalysis.Thisdataisonlycaptured
whentheuserisstill.Alongwiththeuserʼsriskfactors,thefeaturecanbeusedtosupplementthe
decisionforAF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AF.
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AppleWatch.Thefeatureanalysespulseratedatatoidentifyepisodesofirregularheartrhythms
suggestiveofatrialfibrillation(AF)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ofeveryepisodeofirregular
rhythmsuggestiveofAFandtheabsenceofanotificationisnotintendedtoindicatenodisease
processispresent;rather,thefeatureisintendedtoopportunisticallydisplayanotificationof
possibleAFwhensufficientdataisavailableforanalysis.Thisdataisonlycapturedwhentheuseris
still.Alongwiththeuserʼsriskfactors,thefeaturecanbeusedtosupplementthedecisionforAF
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AF.
USINGTHEIRREGULARRHYTHMNOTIFICATION
FEATURE
Setup/Onboarding
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onboardingprocedure.
Youmayexitonboarding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AFandconfirmeditonmultiplereadings.
IfyouhavenotbeendiagnosedwithAFbyamedicalpractitioner,youshoulddiscussthe
notificationwithyourdoctor.
Alldatacollectedandanalysed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Watch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,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aged22andolderwithamixofdiagnosedAFandnoknownhistory
ofAF.Studydemographiccharacteristicsaresummarised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AF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AFontheECGpatch,andthesensitivitywas88.6%.Ofthe292subjectswhodidnot
presentwithAF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AF.
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AFandshouldnotbe
reliedonasacontinuousmonitor.ThismeansthefeaturecannotdetectallinstancesofAF,and
peoplewithAFmaynotgetanotification.
AppleWatchmaybeunabletocollectdatawhenitisincloseproximitytostrongelectromagnetic
fields(e.g.electromagneticanti-theftsystemsormetaldetectors).
Anumberoffactorscanimpacttheabilityofthefeaturetomeasureyourpulseanddetectan
irregularrhythmsuggestiveofAF.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theageof22.
NotintendedforusebyindividualspreviouslydiagnosedwithAF.
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doctor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youriPhonesinceyouwillbe
storingpersonalhealthinformationonit.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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
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Apple Irregular Rhythm Notification Feature Software Operating instructions

Apple
Brand
Apple
Model
Irregular Rhythm Notification Feature Software
Type
Operating instructions

Apple Irregular Rhythm Notification Feature Software helps identify irregular heart rhythms suggestive of atrial fibrillation (AF). It analyzes pulse rate data from your Apple Watch to opportunistically notify you of possible AF when sufficient data is available. The feature is not intended to replace traditional methods of diagnosis or treatment. It cannot detect heart attacks or constantly monitor for AF and may not detect all instances of AF. Factors like motion, tattoos, or cold temperatures can impact its accuracy. Notifications should be reviewed by a medical professional.

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