PWAP app Instructions for Use_EN-US
Pulse Wave A-fib Prompt App
Instructions for Use
Huawei Device Co., Ltd.
No.2 of Xincheng Road, Songshan Lake Zone, Dongguan, 523808 Guangdong, P.R. China
Website: https://consumer.huawei.com/en/
Lotus NL B.V.
Koningin Julianaplein 10, 1e Verd, 2595AA, The Hague, Netherlands
Tel: +31644168999 Email: info@lotusnl.com
The PWAP app was manufactured and released on the date shown on the About screen.
Product Name: Pulse Wave A-fib Prompt App
Model: PPG-1
Release Versions: V1 on the phone; V1 on the wearable device
Structure: Consists of a wearable app and a phone app.
Intended Purpose
The Pulse Wave A-fib Prompt (PWAP) app is an independent app that works with Huawei wearable devices. It analyzes pulse data to identify irregular heart rhythms and notifies users of suspected atrial fibrillation (A-fib). Users can actively collect data or enable automatic data collection in the background. When users choose to enable automatic data collection in the background, the app does not send a notification every time it detects suspected A-fib, so no notification does not mean that there is no irregularity. Data is only collected when the user is still. The app can be used to supplement the decision for A-fib screening. The app is not intended to diagnose atrial fibrillation.
The app should not be used by anyone under the age of 18.
Contraindications
No contraindications have been found.
Indication
Atrial fibrillation
Clinical Benefit
Supplement the decision for A-fib screening.
Installing and Using the App
1. Software
− The operating system on the wearable device must be HarmonyOS 5.0 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.
2. Data interface
The transmission protocol is Bluetooth 4.2 or compatibles.
3. Installing the app
− The PWAP app is compatible with the HUAWEI WATCH GT 4 Series and other subsequent wearable models.
− The PWAP app is pre-installed on PWAP-compatible Huawei wearable devices and in the Huawei Health app, so users do not need to install it themselves. They only need to complete the registration process in order to be able to use the PWAP app.
4. Authorizing and activating the app
− To access the PWAP app, touch the PWAP icon on your Huawei wearable device or go to the Huawei Health app on your phone.
− Log in to the Huawei Health app with your HUAWEI ID, and go to the Devices screen in the Huawei Health app to connect your Huawei wearable device to your phone via Bluetooth, by following the onscreen instructions.
− Once you have granted the necessary permissions, the PWAP app will be able to obtain information such as your name, age, and gender.
− In the Huawei Health app, go to Health, select Heart, touch the PWAP icon, and follow the onscreen instructions to activate the PWAP app.
5. Using the PWAP app
− Ensure that your Huawei wearable device fits snugly around your wrist.
− Open the PWAP app on your Huawei wearable device.
− Keep your arms level and still.
− It takes 45–50 seconds to complete a measurement.
− Once the measurement is complete, the PWAP app will analyze the data. The result will either be "Suspected A-fib" or "No abnormalities". All results from the wearable app will be synced to the phone app via Bluetooth. You can view your results on your phone app.
− If automatic collection is enabled in the phone app, the wearable app will automatically take measurements while you are resting. If the app suspects A-fib, the screen will turn on or vibrate. When you are sleeping, the app will not provide a vibration reminder; instead, a silent pop-up reminder will appear. When you are awake, you will receive a reminder every hour.
− You can view the results from the past week on your wearable device, and you can view more historical data on your phone.
PWAP Analysis
Once the data has been read successfully, you will obtain one of the following results on the PWAP app:
l No abnormalities: There were no signs of A-fib.
*Note:
If the result is "No abnormalities", this does not guarantee that you do not have arrhythmia or other health problems. If you feel uncomfortable, please contact your physician.
l Suspected A-fib: An irregular cardiac rhythm has been detected, and it may be A-fib.
*Note:
If the result is "Suspected A-fib", you may have an underlying health issue. If you feel uncomfortable, please contact your physician immediately.
Safety and Performance
A clinical study of a total of 183 subjects with medium skin tones was conducted to calculate the sensitivity and specificity of the PWAP app for identifying A-fib, using the investigator's interpretation of the ECG (lead II) as the gold standard. The sensitivity for identifying A-fib was 98.36% (91.28%, 100.00%), and the specificity was 97.54% (93.02%, 100.00%). In terms of the analysis of safety data set, no device defects, software failures, adverse events, or serious adverse events occurred during the investigation.
A study was conducted to evaluate the effectiveness of the PWAP app in screening for sinus rhythm and A-fib in patients with light skin and dark skin tones. A total of 58 subjects were enrolled in the study, including 31 with light skin and 27 with dark skin. The sensitivity for the overall population was 89%. In the A-fib group the sensitivity was 96%. For the group of subjects with light skin tones in the A-fib group, the sensitivity was 92%; for the group with dark skin tones, the sensitivity was 100%. The sensitivity for the entire sinus rhythm group was 84%. For the light and dark skin tone groups, the respective sensitivities were 91% and 79%. There have been no adverse events during the clinical investigation.
Troubleshooting
If you have trouble using the PWAP app, see the following common issues and follow the steps to troubleshoot:
Problem: The Huawei wearable device fails to classify data and the PWAP app cannot read the data.
Solution:
l Ensure that you have completed all the steps as instructed in the phone app.
l Ensure that your Huawei wearable device, arms, and hands are still during a measurement.
Problem: There is a lot of interference when using the app, for example from human factors and noise.
Solution:
l Rest your arms flat on a table or on your lap during a measurement.
l Ensure that your Huawei wearable device fits snugly around your wrist.
Warnings
l The PWAP app cannot diagnose a heart attack. If you think that you are experiencing a medical emergency, please seek immediate medical attention.
l Do not use the app to diagnose heart-related diseases. Do not make any changes to your medication without consulting your physician beforehand.
l The PWAP app performs measurements at intervals and cannot be used as a continuous monitoring device. This means that it cannot detect all A-fibs, and patients with A-fib may not receive notifications about every occurrence.
l A number of factors may affect the app's ability to measure your pulse rate and detect A-fib, including motion, hand and finger movements, environmental factors such as ambient temperature, a dark-colored tattoo on the wrist, and the level of blood flow to the skin (which may be lower in low temperatures).
l A Huawei wearable device may not be able to collect data when it is close to a strong electromagnetic field (such as an electromagnetic anti-theft system or a metal detector).
l Do not wear the Huawei wearable device when undergoing medical treatment (such as magnetic resonance imaging, diathermy, lithotripsy, burn treatments, or external defibrillation).
l The app is not intended for use by individuals who have previously been diagnosed with A-fib.
l The app is not recommended for use by:
− Users using pacemakers or implantable cardioverter defibrillators (ICDs), or users with atrioventricular block or bundle branch block;
− Users with sinus tachycardia, significant sinus bradycardia, significant sinus arrhythmia, sinus arrest, or sick sinus syndrome;
− Users with interpositional premature beats, dual-law premature beats, triple-law premature beats, border premature beats, or escape beat heart rhythms;
− Users with atrial tachycardia, atrial flutter, ventricular tachycardia, ventricular flutter, or ventricular fibrillation;
− Users with a resting heart rate of less than 50 beats/minute or more than 110 beats/minute;
− Users with tremor or chorea diseases who struggle to remain still for the duration of a measurement;
− Users with bullous disease or a generalized rash;
− Users with a history of mental illness or cognitive impairment;
− Users with upper limb impairments;
− Users with visual impairments;
− Users with skin diseases on their wrists, including but not limited to large-scale herpes and ulcers;
− Users under the age of 18.
Precautions
l The results from the PWAP app only indicate potential risks and are not intended to be a complete diagnosis of your heart condition. Do not interpret the results or take clinical measures based on readings or results shown by this app without consulting a qualified healthcare professional.
l Users and/or patients should report any serious incidents related to the app to the manufacturer and to the relevant authority in their country/region.
Caution: Even when the PWAP app shows that you have "No abnormalities" or you do not receive a "Suspected A-fib" notification, Huawei cannot guarantee that you have no arrhythmia or other health problems. If you notice any changes in your health, please contact your physician.
Security
l User privacy: User data is encrypted when stored in the database. Deleted data cannot be restored.
l Protecting your confidential data: The app obfuscates and compiles code to prevent third parties from obtaining related data through recompilation.
l Preventing unauthorized access and managing permissions: Users need an account to access and use the app. Users who have not logged in cannot use the app. It is important to keep your phone secure when you are using it to store personal health information.
l Setting a passcode on your phone will add an extra layer of security. This is important when you are storing personal health information on your phone.
Product Maintenance
To ensure that the PWAP app works correctly, please update your phone and wearable device systems to their latest versions. The PWAP app will update automatically when the system is updated.
For more information about maintenance and system versions, please visit https://consumer.huawei.com/
Device Symbols
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Manufacturer |
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Authorized representative in the European Union |
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Medical device |
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Date of manufacture |
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CE mark. Indicates that the device complies with REGULATION (EU) 2017/745. |
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Revised V1.1, 2025.7 HUAWEI All rights reserved |
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