Intended Use

The ECG app allows users to record their single-lead ECGs, which are classified into sinus rhythm, atrial fibrillation (A-fib), and premature beats (ventricular premature beat and atrial premature beat) based on the ECG waveform. It assists in discerning the heart rhythm status, but cannot replace standard diagnostic methods. The ECG app is intended for adults aged 18 and above.

Contraindication

No contraindications have been found.

Installation and Usage Instructions

1. App Authorization and Activation

Open the Huawei Health app, go to the Heart screen, touch the ECG icon, and follow the onscreen instructions to activate the app.

● The operating system on the wearable device must be HarmonyOS or compatibles; the operating system on the mobile phone must be Android 6.0 or compatibles, HarmonyOS 2.0 or compatibles, or iOS 12.0 or compatibles; the Huawei Health app version on the mobile phone must be 11.0 or compatibles. Make sure that your wearable device and phone are running the latest versions before using the app.

● The transmission protocol is Bluetooth 4.2 or compatibles.

● The ECG app can be accessed via the ECG app icon on Huawei wearable devices and in the Huawei Health app on phones.

● The phone Huawei Health app will need to be logged in with a HUAWEI ID, and the Huawei Health app will need to be paired with the wearable device. Go to the Devices screen in the Huawei Health app to connect the phone to your Huawei wearable device via Bluetooth, by following the onscreen instructions.

● Once granted authorization, the ECG app will be able to obtain your name, age, and gender.

● You can modify your basic information in the Huawei Health app, including user name, age, and gender. The modified information will be synced to the ECG app report screen.

2. ECG Recording

● Ensure that the Huawei wearable device fits snugly around the wrist you selected in Settings.

● Open the ECG app on your Huawei wearable device.

● Rest your arm flat on a table or in your lap, and then place your fingers on the digital crown. You do not need to press the crown during the recording.

The recording takes about 30 seconds.

ECG Analysis

After the data is successfully read, you will obtain one of the following classifications on the ECG app:

Sinus rhythm: The heart rate beats regularly at between 50 and 110 beats per minute.

*Note: Sinus rhythm does not guarantee that you are free from arrhythmia or other health problems. If you feel uncomfortable, contact your doctor.

A-fib: The heart rate beats irregularly at between 50 and 110 beats per minute.

Ventricular premature beat: Ventricular premature beat is caused by an ectopic peacemaker in the ventricle. Patients may have no symptoms, or have palpitations, dizziness, or discomfort in the precordium. It is normal for healthy people to have occasional premature beats, but for those with illnesses, it could be an indication of a more serious issue. Ventricular premature beats that happen too frequently can put a heavy burden on the heart and increase the risk of heart failure.

Atrial premature beat: Atrial premature beat is caused by an ectopic peacemaker in the auricle. Patients may have no symptoms, or have palpitations, dizziness, or discomfort in the precordium. It is normal for healthy people to have occasional premature beats, but for those with illnesses, it could be an indication of a more serious issue.

*Note: The result "A-fib", "Ventricular premature beat", or "Atrial premature beat" may only indicate a potential risk. If you have any symptoms or questions, consult your doctor. Contact emergency services in the event of a medical emergency.

-- (inconclusive): Indicates that the ECG cannot be classified because the heart rate is too high or too low, the heart rate cannot be considered as A-fib or sinus rhythm, or the data quality is poor. If you feel uncomfortable, contact your doctor.

• After an ECG recording is complete, the ECG data is analyzed to determine if the duration of the recording is 30 seconds. If so, a result will be selected from sinus rhythm, A-fib, premature beats, and "--".
• You can view details about the result of the ECG recording in the ECG app.
• The result "--" may indicate that there are too many human factors or noises to obtain a good signal, or you may have an arrhythmia that cannot be classified by the app. A small number of people may have some physiological conditions causing them to fail to acquire a good signal to generate good recordings.
• If you receive an inconclusive result due to a poor recording, try to re-record your ECG. A small number of people may have some physiological conditions causing them to fail to acquire a signal to generate good recordings.
• The heart rate may be low because some drugs have been taken or the electrical signals of the heart are not transmitted correctly. Professional training can also lead to a low heart rate.
• The heart rate may be high because of exercise, pressure, stress, alcohol-induced dehydration, infection, A-fib, or other arrhythmias.
• All ECGs will be synced to the Huawei Health app on your phone. You can use the Huawei Health app to share your ECG with a clinician.

Security and Performance

Based on a clinical study in which the irregular rhythms of the 629 participants were classified into sinus rhythm, A-fib, and premature beats, by both this product and 12-lead ECGs (lead I), the sensitivity and specificity of this product are as follows compared with 12-lead ECGs (lead I).

The above data only relates to classification into sinus rhythm, A-fib, and premature beats. Other types of arrhythmia or concurrent arrhythmia scenarios are not considered.

Troubleshooting

If you have trouble using the ECG app, refer to the following troubleshooting guide.

Problem: The Huawei wearable device data measurement fails and the ECG app cannot read the data.

Solution:

• A message is displayed for 5 seconds in various scenarios indicating that a test has failed, and the home screen of the ECG app for the Huawei wearable device is then displayed automatically.
• Ensure that you have completed all the steps as instructed in the Huawei Health app.
• Keep your Huawei wearable device, arms, and hands still during the recording.
• Make sure that your wrist and the Huawei wearable device are dry and clean, since water and sweat stains can affect the recording.
• Touch to measure again if the signal is poor. If your skin is dry, use a small amount of water to moisten your finger and then try again.

  Problem: There are many human factors, noises, or other interferences during the recording.

  Solution:

• Rest your arms flat on the table or in your lap during recording. Try to relax and keep still.
• Ensure that the Huawei wearable device is not loose on your wrist. Ensure that the strap is snug and that the back of the Huawei wearable device touches your wrist.
• To avoid electronic interference, keep the device away from any electronic devices that have been plugged into a socket.

  Problem: The ECG waveform looks upside down.

  Solution:

• The device orientation may be set to the wrong wrist. On your Huawei wearable device, open the ECG app and go to Settings to select the wearing mode (left hand or right hand).

All data recorded will be stored in ECG quick app on your phone. Touch ECG report to view the results or Share to share the data. (In the Huawei Health app, the data is saved to local storage.)

Warnings

• The ECG app is unable to detect signs of a heart attack. Contact emergency services in the event of a medical emergency.
• Do not record an ECG when your device is charging.
• Do not use it while you are undergoing medical treatment (for example, magnetic resonance imaging, diathermy, lithotripsy, burn treatment, and external defibrillation).
• Do not use it with pacemakers, ICDs, or other implanted electronic devices.
• It is not recommended for individuals under the age of 18.
• Do not use it to diagnose heart-related diseases. Do not change your medication without consulting your doctor beforehand.
• Contact your doctor if your resting heart rate is lower than 50 times/min or higher than 110 times/min.
• Do not take a recording when your Huawei wearable device is close to a strong magnetic field (such as from an electromagnetic anti-theft system or a metal detector).
• Do not perform a measurement when the Huawei wearable device is outside of the operating conditions specified in its manual (temperature: between –20°C and +45°C, relative humidity: between 5% and 95%, atmospheric pressure: between 860 hPa and 1060 hPa).

Precautions

• The results from the ECG app only indicate potential risks and are not intended to be a complete diagnosis of your cardiac condition. Do not interpret the results or take clinical measures based on the output of this app without consulting a qualified healthcare professional.
• The ECG app produces waveforms that are designed to provide auxiliary rhythm classifications to help distinguish A-fib from normal sinus rhythm and premature beats. Therefore, it cannot replace a standard diagnosis or treatment methods.
• Users and/or patients should note that any serious incidents that have occurred related to this device should be reported to the manufacturer and to the competent authority of the user and/or patient's country/region.

  Caution: Huawei does not guarantee that you do not have an arrhythmia or other health problems if the ECG app marks an ECG as sinus rhythm or "--". Contact your doctor if there are any changes in your health.

Security

• User privacy: The app data is anonymized. Deleted data cannot be restored.
• Confidential data protection: The app obfuscates and compiles code to prevent third parties from obtaining related data through decompilation.
• Unauthorized access prevention and permission management: The app controls its functions through user accounts. Users who have not logged in cannot use the app. It is important to ensure the security of your phone because it will be used for storing your personal health information.

Product Maintenance

To ensure that the ECG app runs as normal, please update your phone and wearable device to their latest versions. The ECG app will also update automatically with the system version.

For more information on maintenance about system versions, please visit https://consumer.huawei.com/.

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Revised V1.1, 2022.3 HUAWEI All rights reserved.