2. Apple
  3. Irregular Rhythm Notification Feature Software

Apple Irregular Rhythm Notification Feature Software Operating instructions

  • Hello, I am a chat assistant and I have read the provided document, which is an 'Instructions for Use' for the Irregular Rhythm Notification Feature on Apple Watch. This document describes how the feature identifies irregular heart rhythms suggestive of atrial fibrillation, provides notifications, and also outlines several important cautions and limitations. I can answer your specific questions about the feature, the watch models it's compatible with, and appropriate usage.
  • Can the Irregular Rhythm Notification Feature detect heart attacks?
    Is the Irregular Rhythm Notification Feature constantly looking for AF?
    What factors can impact the ability of the feature to measure pulse and detect AF?
    What should I do if I receive a notification, but I am not diagnosed with AF by a medical practitioner?
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
/