Apple ECG Smart Watch App Instruction Manual

Instruction Manual for Apple models including: ECG Smart Watch App, Smart Watch App, App

Instructions for Use

Mar 15, 2022 — DO NOT take recordings when Apple Watch is outside the operational temperature range (0-35 C) indicated in the Apple Watch user manual and humidity range of 20- ...11 pages

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Instructions for Use

ENGLISH (EN-GB)
ECG app Instructions for Use
Apple Inc. One Apple Park Way Cupertino, CA 95014, USA www.apple.com
Apple Distribution International Hollyhill Industrial Estate, Hollyhill, Cork, Ireland Contact: medicalcompliance@group.apple.com
UKRAINE COUNTRY-SPECIFIC INFORMATION: «-» 01033, , . , 33-, 27 email: uarep@jerelo.eu . +38 (044) 360 30 11
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Apple Pty Ltd Level 3, 20 Martin Place Sydney, NSW, 2000 Australia https://www.apple.com/au/
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COLOMBIA COUNTRY-SPECIFIC INFORMATION: PRODUCTO: Software de Electrografía y aplicación de ECG para software de análisis de fotopletismografía IMPORTADOR: IMPOMED S.A.S Calle 1 SUR NO. 77A-21 Interior 201 Medellin Colombia
REGISTRO SANITARIO NO.: INVIMA 2020DM-0021828
ISRAEL COUNTRY-SPECIFIC INFORMATION: AMAR REGISTRATION HOLDER: Medogar Medical Equipment Ltd. Hasadna St. 8 P.O.B 2586 Raannana 4365104 ISRAEL Office Tel: +972-9-7401457 Fax:+972-9-7401459 " 4365104 2566 .. 8 09-7401457 : 09-7401459 : 2566 .. 8 4365104 www.medogar.co.il info@medogar.co.il
AMAR Certificate Number: 21080016
TURKEY COUNTRY-SPECIFIC INFORMATION: Apple Teknoloji ve Sati Limited irketi Büyükdere Caddesi Levent 199 Kat:22-23 34394 ili stanbul

Türkiye Product Tracking Number for ECG app: 8682450178021
PERU COUNTRY-SPECIFIC INFORMATION: Registro Sanitario N0 :DB5982E IMPORTADOR: Drogería Emergo Peru S.R.L. Calle Las Orquídeas Nro. 585, Int. 1301, San Isidro, Lima, Perú
RUC: 205 52 75 65 34
MALAYSIA COUNTRY-SPECIFIC INFORMATION: Authorised Representative: Nyprax Business Solutions 37 Jalan Terasek Lima, Bangsar Baru, 59100 Bangsar, Kuala Lumpur Device Licence: Apple ECG app
GB7992021-54025
INDIA COUNTRY-SPECIFIC INFORMATION: Voluntary Registration Number: Apple-USA/I/MD/002975 IMPORTER: Asia Actual India (OPC) Pvt. Ltd. 523A, Tower A, Spaze I-Tech Park, Sector 49,
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REPUBLIC OF KOREA COUNTRY-SPECIFIC INFORMATION: "" . : () 06236) 152 26 : Apple Inc. () One Apple Park Way, Cupertino, CA 95014, USA () 20450 Stevens Creek Blvd., Cupertino, CA 95014, USA : 20-177 (, , ): , , ECG App : 2.X : 2022 01 : 1ea :
(Apple Watch) (ECG) (Lead I) , , , , .
INDONESIA COUNTRY-SPECIFIC INFORMATION: Product Licence Number: KEMENKES RI AKL 20502121822 REGISTRANT:

PT. ASIA ACTUAL INDONESIA, DKI Jakarta Gandaria 8 Office Tower, Unit 6J. Jl. Sultan Iskandar Muda Jakarta Selatan 12240 Indonesia +62 (021) 2930-3747
MOLDOVA COUNTRY-SPECIFIC INFORMATION: Registration Number: DM000322299, DM000322300 AUTHORISED REPRESENTATIVE: JERELO S.R.L. MD-2024, str. Pietrriei, nr 19A, of. 3. mun. Chiinu, Republica Moldova +37378538295
INDICATIONS FOR USE
The ECG app is a software-only mobile medical application intended for use with Apple Watch to create, record, store, transfer and display a single channel electrocardiogram (ECG) similar to a Lead I ECG. The ECG app determines the presence of atrial fibrillation (AF), sinus rhythm and high heart rate (no AF detected with heart rate between 100 and 150 bpm) on a classifiable waveform. The ECG app is not recommended for users with other known arrhythmias.
The ECG app is intended for over-the-counter (OTC) use. The ECG data displayed by the ECG app is intended for informational use only. The user is not intended to interpret or take clinical action based on the device output without consultation with a qualified healthcare professional. The ECG waveform is meant to supplement rhythm classification for the purposes of discriminating AF from sinus rhythm and is not intended to replace traditional methods of diagnosis or treatment.
The ECG app is not intended for use by people under 22 years old.
INTENDED PURPOSE (EU REGION)
The ECG app is a software-only mobile medical application intended for use with Apple Watch to create, record, store, transfer and display a single channel electrocardiogram (ECG) similar to a Lead I ECG. The ECG app determines the presence of atrial fibrillation (AF), sinus rhythm and high heart rate (no AF detected with heart rate between 100 and 150 bpm) on a classifiable waveform. The ECG app is not recommended for users with other known arrhythmias.
The ECG app is intended for over-the-counter (OTC) use. The ECG data displayed by the ECG app is intended for informational use only. The user is not intended to interpret or take clinical action based on the device output without consultation with a qualified healthcare professional. The ECG waveform is meant to supplement rhythm classification for the purposes of discriminating AF from sinus rhythm and is not intended to replace traditional methods of diagnosis or treatment.
The ECG app is not intended for use by people under 22 years old.

Target Population and Intended Users
The ECG app is intended for users who are 22 years old 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.
INTENDED USE (NON-EU REGION & REPUBLIC OF KOREA)
The intended use of the ECG app is to allow the user to take a single lead ECG that is then classified as sinus rhythm or atrial fibrillation (AF) on a classifiable waveform. The ECG and rhythm classification may be used by users with or without known AF as data that may be shared with a qualified healthcare professional. The ECG app is intended to be used by laypeople aged 22 years and over.
RUSSIA COUNTRY-SPECIFIC INFORMATION
The ECG app is not considered a medical device per ROSZDRAVNADZOR (Russian Health Authority).
The ECG app is a software-only mobile application intended for use with Apple Watch to create, record, store, transfer and display a single channel electrocardiogram (ECG) similar to a Lead I ECG. The ECG app determines the presence of atrial fibrillation (AF), sinus rhythm and high heart rate (no AF detected with heart rate between 100 and 150 bpm) on a classifiable waveform. The ECG app is not recommended for users with other known arrhythmias.
The ECG app is intended for over-the-counter (OTC) use. The ECG data displayed by the ECG app is intended for informational use only. The user is not intended to interpret or take clinical action based on the device output without consultation with a qualified healthcare professional. To receive appropriate healthcare advice, please visit a qualified healthcare professional. The ECG waveform is meant to supplement rhythm classification for the purposes of discriminating AF from sinus rhythm and is not intended to replace traditional methods of diagnosis or treatment.
The ECG app is not intended for use by people under 22 years old.
USING THE ECG APP
App Setup/Onboarding
The ECG app is compatible with Apple Watch Series 4 or later (excluding Apple Watch SE). For regional availability and additional device compatibility information, please visit https://support.apple.com/HT208955

Update Apple Watch and iPhone to latest OS.
Open the Health app on your iPhone and select Browse.
Navigate to Heart, then select Electrocardiogram (ECG).
Follow the onscreen instructions.
You may exit onboarding at any time by tapping Cancel.
Recording an ECG
Make sure your Apple Watch is snug on the wrist you selected in Settings > General > Orientation.
Open the ECG app on your Apple Watch.
Rest your arms on a table or in your lap, and hold your finger on the Digital Crown. You do not need to press the crown during the session.
The recording takes 30 seconds.
ECG Analysis
After a successful reading, you will receive one of the following classifications on your ECG app:
Sinus Rhythm: A sinus rhythm result means the heart is beating in a uniform pattern between 5099 BPM.
High Heart Rate - No Atrial Fibrillation Detected: A high heart rate result means the heart is beating between 100 and 150 bpm and does not show signs of Atrial Fibrillation.
Atrial Fibrillation: An AF result means the heart is beating in an irregular pattern between 5099 BPM.
Atrial Fibrillation - High Heart Rate: An AF High Heart Rate result means the heart is beating in an irregular pattern between 100 and 150 bpm.
Poor Recording: A poor recording result means the recording could not be classified because of too much artefact or noise in the waveform. This can happen for many reasons such as excess movement during a recording, or wearing your Apple Watch too loosely. Certain physiological conditions may prevent a small percentage of users from creating enough signal to produce a good recording.
Low or High Heart Rate: the ECG app cannot check recordings with a heart rate under 50 bpm or over 150 bpm.
After an ECG recording is complete, the ECG data is analysed to determine if it is at least 25 seconds long, and if so, if either Sinus Rhythm, AF or high heart rate with no AF is detected, or if an Inconclusive result is warranted.

The ECG recording result on the ECG app provides a detailed display of the result. A detailed explanation will also be provided in the Health app on your iPhone.
Presence of AF in your ECG results may represent only potential findings. If you are experiencing any symptoms or have concerns, contact your doctor. If you believe you are experiencing a medical emergency, contact emergency services.
Inconclusive ECG results may mean there may have been too much artefact or noise to acquire a good signal, or you may have an arrhythmia other than AF that the app cannot classify. A small percentage of people may have certain physiological conditions preventing them from creating enough signal to produce a good recording. You can learn more about Inconclusive ECG results during onboarding, by accessing educational information in the ECG area of the Health app on your iPhone, or by tapping the "i" icon on the ECG app for more information.
If you receive an Inconclusive result due to a poor recording, you might try to re-record your ECG. A small percentage of people may have certain physiological conditions preventing them from creating enough signal to produce a good recording. You can review how to take an ECG during onboarding or by tapping "How to Take an ECG" in the ECG area of the Health app on your iPhone.
A heart rate can be low because of certain medications or if electrical signals are not properly conducted through the heart. Training to be an elite athlete can also lead to a low heart rate.
A heart rate can be high because of exercise, stress, nervousness, alcohol dehydration, infection, AF or other arrhythmia.
All ECGs are synced to the Health app on your iPhone. You may use the Health app to share your ECG with a clinician.
Deleting and Restoring ECG app on Apple Watch
Delete ECG app on Apple Watch
On your Apple Watch, go to the Home Screen
If you are in Grid View, touch and hold the app lightly until it jiggles
Tap the app, then tap the "x" icon
If you are in List View, swipe left on the app and tap the Bin icon
Tap Delete
Press Digital Crown to finish
Restore ECG app on the Apple Watch
Go to the App Store on your Apple Watch
Search for ECG app
Tap to restore the app

SAFETY AND PERFORMANCE
The ECG apps ability to accurately classify an ECG recording as AF and sinus rhythm was extensively tested in a clinical trial of approximately 546 subjects. Rhythm classification of a 12-lead ECG by a cardiologist was compared with the rhythm classification of an ECG collected simultaneously from the ECG 2.0 app. The ECG app demonstrated 98.5% sensitivity in classifying AF (HR 50-150 bpm) and 99.3% specificity in classifying sinus rhythm (HR 50-150 bpm) in classifiable recordings.
The morphology of the waveform was also tested in this clinical trial by visual assessment of the PQRST wave and R wave amplitude in comparison with a reference. The ECG 2.0 app produced a visually acceptable PQRST waveform with a pass rating of 100% compared with the reference waveform. Additionally, the total pass rating for R-wave amplitude assessment was 97.2% compared with the reference.
TROUBLESHOOTING
If you experience difficulties in operating your ECG app, refer to the troubleshooting guide below.
Problem: I cannot get the ECG app to take a reading.
Solution:
Ensure you have completed all the onboarding steps in the Health app on your iPhone.
Make sure your wrist and Apple Watch are clean and dry. Water and sweat can cause a poor recording.
Ensure your Apple Watch, arms and hands remain still during recordings.
Problem: I have a lot of artefact, noise or interference in my recording.
Solution:
Rest your arms on a table or in your lap while you take a recording. Try to relax and not move too much.
Make sure your Apple Watch isnt loose on your wrist. The strap should be snug and the back of your Apple Watch needs to be touching your wrist.
Move away from any electronics that are plugged into a power point to avoid electrical interference.
Problem: The ECG waveforms appear upside down.
Solution:

The watch orientation may be set to the wrong wrist. On your iPhone, go to the Watch app. Tap My Watch > General > Watch Orientation.
All data recorded during an ECG app session is saved to the Health app on your iPhone. If you choose to, you can share that information by creating a PDF.
New ECG data cannot be recorded once your Apple Watch storage is full. If you are not able to take a recording due to storage space issues, 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.
CAUTIONS:
The ECG app cannot check for signs of a heart attack. If you believe youre having a medical emergency, call emergency services.
DO NOT take recordings when Apple Watch is in close proximity to strong electromagnetic fields (e.g. electromagnetic anti-theft systems or metal detectors).
DO NOT take recordings during a medical procedure (e.g. magnetic resonance imaging, diathermy, lithotripsy, cautery and external defibrillation procedures).
DO NOT take recordings when Apple Watch is outside the operational temperature range (0-35 oC) indicated in the Apple Watch user manual and humidity range of 20-95% relative humidity.
DO NOT use to diagnose heart-related conditions.
DO NOT use with a cardiac pacemaker, ICDs or other implanted electronic devices.
DO NOT take a recording during physical activity.
DO NOT change your medication without talking to your doctor.
Not intended for use by individuals under the age of 22.
You should talk to your doctor if your heart rate is under 50 bpm or over 150 bpm at rest and this is an unexpected result.
Interpretations made by this app are potential findings, not a complete diagnosis of cardiac conditions. The user is not intended to interpret or take clinical action based on the app output without consultation with a qualified healthcare professional.
The waveform generated by the ECG app is meant to supplement rhythm classification for the purposes of discriminating AF from normal sinus rhythm and tachycardia (high heart rate), and is not intended to replace traditional methods of diagnosis or treatment.
This is a notice to the user and/or patient that any serious incident that has occurred in relation to the device should be reported to the manufacturer and the competent authority of the Member State in which the user and/or patient is established.

CAUTION: Apple does not guarantee that you are not experiencing an arrhythmia or other health conditions when the ECG app labels an ECG as Sinus Rhythm or Tachycardia (high heart rate). You should notify your doctor if you detect possible changes in your health. 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 the device, and updates are delivered wirelessly, encouraging rapid adoption of the latest security fixes. See "iOS and watchOS Security Guide", which describes Apples 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
099-23781 Revision N, March 2022

References

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