ECG App Instructions for Use

Intended Use

The ECG app records the user's single-lead ECG, classifies sinus rhythm or atrial fibrillation based on the ECG waveform. Users can share the ECG recordings, rhythm classifications and accompany symptoms with a qualified healthcare professional. The ECG app is intended to be used by people aged 18 years and over.

Contraindications

No contraindications have been found.

Used to Indicate

Atrial fibrillation

Clinical Benefits

Screening of atrial fibrillation for early detection and early treatment.

Installation and Usage Instructions

The ECG app is compatible with the Huawei Watch GT2 Pro Series, and other subsequent watch models.

The ECG app is pre-installed on ECG-compatible Huawei wearables and in the Huawei Health app, so users do not need to install it themselves. As soon as a user has completed the onboarding process, they will be able to use the ECG app.

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.

● Software Environment

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.

● Data Interface

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 Recordings

● 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 30 seconds.

● When an ECG recording is completed, the ECG data is analyzed. The result will be classified as either Sinus rhythm, Atrial fibrillation, or Inconclusive. All ECG results will be synced to the phone app. You can view further information about the result of your ECG recording in the ECG app, and you can also share your ECG recordings with a clinician.

● If you are also experiencing any of the following symptoms, you can add them to the data after completing the ECG recording: Tight chest, Chest pain, Anxiety, Short of breath, Dizziness, Fatigue, Poor sleep, Cold/Fever, Other.

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:

The ECG shows no signs of atrial fibrillation

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

Atrial fibrillation: The heart rate beats irregularly at between 50 and 110 beats per minute.

*Note:

The result "Atrial fibrillation" may only indicate a potential risk. If you feel uncomfortable, please consult your doctor promptly with the printed ECG report.

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 Atrial fibrillation, or sinus rhythm, or the data quality is poor.

*Note:

If you repeatedly get this result and you are not feeling well, please consult your doctor with the printed ECG report.

• The result "Inconclusive" 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.
• Heart rate too low: Resting heart rate is fewer than 50 beats/min. 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.
• Heart rate too high: Resting heart rate is more than 110 beats/min. The heart rate may be high because of exercise, pressure, stress, alcohol-induced dehydration, infection, Atrial fibrillation, or other arrhythmias.

Safety and Performance

Based on a clinical study in which the irregular rhythms of the 629 participants were classified into sinus rhythm and atrial fibrillation, by both wearable devices 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 and atrial fibrillation. 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 classification fails and the ECG app cannot read the data.

Solution:

• Ensure that you have completed all the steps as instructed in the phone app.
• Ensure that your Huawei wearable device, arms, and hands remain still during the recordings.
• Make sure 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.

Warnings

• The ECG app cannot diagnose a heart attack. If you think that you're having a medical emergency, please seek medical attention immediately.
• Do not use it to diagnose heart-related diseases. Do not change your medication without consulting your doctor beforehand.
• 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.
• This app is not recommended for people who suffer from the following conditions:
  • Atrioventricular block or bundle branch block
  • Significant sinus arrhythmia, sinus arrest or sick sinus syndrome
  • Interpolated premature beats, junctional premature beats, or escape rhythms
  • Atrial tachycardia, atrial flutter, ventricular tachycardia, ventricular flutter, or ventricular fibrillation
  • A resting heart rate of fewer than 50 beats/min or more than 110 beats/min (Please seek medical attention if your heart rate is within either of these categories.)
  • Atrial fibrillation which is further complicated by premature beats
  • A critical illness which would make it difficult to accurately assess the effectiveness and safety of the device
  • Tremors or chorea which would make it difficult to complete the examination quietly
  • Bullous disease, or rashes which cover large areas of the skin
  • Prior mental illness or cognitive impairment
  • Upper limb impairments
  • Visual impairment
• 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 take a recording 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 Atrial fibrillation from normal sinus rhythm. 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 " inconclusive ". Contact your doctor if there are any changes in your health.

Security

• User privacy: User data is encrypted when stored in the database. Deleted data cannot be restored.
• Confidential data protection: The app obfuscates and compiles code to prevent third parties from obtaining related data through recompilation.
• 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.
• Adding a passcode to your phone will add a layer of security. This is important when you are storing personal health information on your phone.

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

Device Symbols

Manufacturer

European authorized representative

Medical device

Date of manufacture

Revised V1.4, 2022.9 HUAWEI All rights reserved.