Apple IRN 2.0 Irregular Rhythm Notification Feature Instruction Manual

Apple IRN 2.0 Irregular Rhythm Notification Feature

Product Information

The IRN 2.0 (Irregular Rhythm Notification) is a feature available on Apple devices that provides notifications for irregular heart rhythms. Below are the important details about the product:

Indications for Use:

The IRN feature is not intended for use in individuals under 22 years of age or those previously diagnosed with AF (Atrial Fibrillation).

Intended Purpose (EU Region):

The IRN feature is not intended for use in individuals under 22 years of age or those previously diagnosed with AF.

Target Population and Intended Users:

The IRN feature is intended for users who are 22 years and older. There are no specific clinical conditions required to use the app. Users interested in learning more about their cardiovascular health may activate the feature after completing an onboarding process.

Russia Country-Specific Information:

The IRN feature is not considered a medical device according to ROSZDRAVNADZOR (Russian Health Authority). It is not intended for use in individuals under 22 years of age or those previously diagnosed with AF.

Safety and Performance:

The performance of the IRN feature was extensively tested in a clinical study involving 573 participants aged 22 and older. The study included individuals with a mix of diagnosed AF and no known history of AF. Demographic characteristics of the study subjects are summarized below:

Black or African American: 57 (9.9%)
Other: 14 (2.4%)

Cautions:

• The IRN feature cannot detect heart attacks. In case of chest pain, pressure, tightness, or suspected heart attack, call emergency services.
• The IRN feature is not a continuous monitor for AF and may not detect all instances of AF. People with AF may not receive a notification.

Product Usage Instructions

Set-Up/On-boarding:

All data collected and analyzed by the IRN feature is saved to the Health app. If desired, you can export your health data from the Health app. Please note that new data cannot be collected if the storage on your Apple Watch is full. To free up space, delete unwanted apps, music, or podcasts. You can check your storage usage by following these steps: 1. Open the Apple Watch app on your iPhone. 2. Tap “My Watch.” 3. Tap “General.” 4. Tap “Storage.”
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Instructions for Use

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 on 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 surface a notification of possible AF when sufficient data are available for analysis. These data are only captured when the user is still. Along with the user’s 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.

INTENDED PURPOSE

(EU REGION)

The Irregular Rhythm Notification Feature is a software-only mobile medical application that is intended to be used with the 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 on 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 surface a notification of possible AF when sufficient data are available for analysis. These data are only captured when the user is still. Along with the user’s 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.

Target Population and Intended Users

The IRNF is intended for users who are 22 years 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.

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 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 on 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 surface a notification of possible AF when sufficient data are available for analysis.

• These data are only captured when the user is still. Along with the user’s 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

Set-Up/On-boarding

• The Irregular Rhythm Notification Feature is compatible with Apple Watch Series 3 or later. 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 on-screen instructions.
• 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 AF and confirmed it on multiple readings.
• If you have not been diagnosed with AF by a medical professional, 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. 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’s 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:

Age Group
<55| 123 (21.5%)

=55 to <65| 140 (24.4%)
=65| 310 (54.1%)
Sex
Male| 286 (49.9%)
Female| 287 (50.1%)
Ethnicity
Hispanic or Latino| 38 (6.6%)
Non-Hispanic or Latino| 535 (93.4%)
Race
White| 502 (87.6%)
Black or African American| 57 (9.9%)
Other| 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 device’s 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 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 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 years.
• 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 iOS-compatible devices and a passcode (personal identification number [PIN]) to your Apple Watch to add a layer of security. It is important to secure the iOS-compatible devices 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 Apple’s 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

099-30417, Revision L, July 2023

References

• Apple Platform Security - Apple Support
• Heart health notifications on your Apple Watch - Apple Support

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