Samsung Health Monitor Application (ECG App)

1. About these Instructions for Use

1.1 Symbols

Symbols used in these Instructions for Use

Symbols used in the Samsung Health Monitor

The symbols used in the Samsung Health Monitor can be changed.

1.2 Instructions for Use provided in Electronic form

The Instructions for Use of the Samsung Health Monitor are provided in electronic form and are available in the Samsung Health Monitor application and on its web site within samsung.com. If you need Instructions for Use in paper form, you can request it by calling the Official Samsung Support center in your country.

2. Intended Purpose

The Samsung ECG Application is an over-the-counter (OTC) software-only, mobile medical application operating on a compatible Samsung Galaxy Watch and Phone. The app is intended to create, record, store, transfer, and display a single channel electrocardiogram (ECG), similar to a Lead I ECG for adults 22 years and older. Classifiable traces are labeled by the app as either atrial fibrillation (AFib) or sinus rhythm with the intention of aiding heart rhythm identification; it is not intended to replace traditional methods of diagnosis or treatment. The app is not intended for users with other known arrhythmias and users should not interpret or take clinical action based on the device output without consultation of a qualified healthcare professional. The ECG and rhythm classification may be used by users with or without known AFib as data that may be shared with a qualified healthcare professional.

3. Contraindications

• DO NOT use the ECG App if you are younger than 22 years old.
• DO NOT use the ECG App if you have an implanted pacemaker, implanted cardiac defibrillator, or other implanted electronic devices.
• DO NOT use the ECG App if you have known arrhythmia other than Atrial Fibrillation.

4. Cautions

Please follow the Cautions listed below. If you do not follow them, the ECG App may not be able to record accurate measurements.

• The ECG App cannot diagnose cardiac conditions or look for signs of a heart attack.
• The ECG App is not meant to replace traditional methods of diagnosis or treatment by a qualified healthcare professional. If you think you are having a medical emergency, contact your local emergency services immediately.
• DO NOT change your medications or dosage without first consulting your doctor.
• DO NOT interpret or take clinical action based on the ECG App measurements without first consulting with a qualified healthcare professional.
• DO NOT take ECG measurements during any physical activity.
• DO NOT take ECG measurements when the Galaxy Watch is close to strong electromagnetic fields (for example, magnetic resonance imaging (MRI) or X-Ray equipment, electromagnetic anti-theft systems, and metal detectors).
• For security reasons, always pair the Galaxy phone and Galaxy watch via Bluetooth in a private (homebased) setting. It is NOT recommended that pairing be done in a public space.
• DO NOT take ECG measurements during a medical procedure (for example, surgery or external defibrillation procedures).
• DO NOT take ECG measurements when the Galaxy Watch is outside of the following conditions:
  - Temperature: 54°F – 104°F / 12°C – 40°C
  - Humidity: 30% – 90% relative humidity
• Make sure that the finger used to record the ECG is uncovered and free of any bruises, scars, or cuts.
• Certain physiological conditions can prevent some people from having a strong enough signal for the ECG App to detect and analyze.

5. Getting Started

The ECG app consists of Galaxy phone app (ECG-Android) and Galaxy Watch app (ECG-Tizen/Wear OS). The app can be accessed via the Samsung Health Monitor application. The ECG app requires a Galaxy Watch Active2 or Galaxy Watch 3 with Tizen version 4.0.0.8 or later, or Galaxy Watch 4 or later model with Wear OS 3.0 that is paired with a Samsung Galaxy phone running Android 9 Pie or later.

1. Make sure that your Galaxy Watch is paired with your Galaxy phone using Bluetooth.
2. If the ECG App is installed on your Galaxy phone, open the Samsung Health Monitor app and follow the onscreen instructions to set up your profile.

If the ECG App is not installed on your Galaxy phone, install the Samsung Health Monitor App from the Galaxy store and then install the latest update of the Galaxy Wearable software. After installing the update, open the Samsung Health Monitor application and follow the onscreen set-up instructions.

6. Recording an ECG Using Your Galaxy Watch

1. Open the Samsung Health Monitor application on your Galaxy Watch.
2. Make sure the Galaxy Watch is snug on your wrist.
3. Rest your forearms comfortably on a table and then rest a fingertip of the opposite hand lightly on the Galaxy Watch's Home key for 30 seconds. Remain still and do not talk while the Galaxy Watch takes the measurement. When the recording process has finished, the ECG results will appear on your watch. Note: Do not press the Home key during recording; pressing the Home key during recording will stop the recording.
4. Scroll up and down to see your ECG result. If you are experiencing symptoms, tap Add, and on the Symptoms screen, scroll through the list and tap each symptom you are experiencing. Then tap Save to add the symptoms to your ECG report and to return to the Results screen.
5. Tap Done to go back to the Start screen. You can review your ECG report in the ECG app on your phone. (Note that syncing requires that the watch and phone are paired using Bluetooth.)

7. Reviewing Your ECG Reports on Your Galaxy Phone

After you take an ECG, the ECG data is synced to the paired Galaxy phone where a PDF report is created.

1. Open the Samsung Health Monitor app on your Galaxy phone.
2. Tap the thumbnail to see your latest ECG report, or tap View history to see all the available reports.

You may get any of the four following results:

• Sinus Rhythm - This result indicates that during the recording the heart was beating in a regular rhythm with a heart rate of 50–100 beats per minute (BPM).
  Caution: A Sinus Rhythm result does not guarantee that you are not experiencing an arrhythmia or other health condition. If you are not feeling well, contact your doctor.
• Atrial Fibrillation (AFib) - This result indicates that during the recording the heart was beating in an irregular rhythm with a heart rate of 50–120 BPM. If you get this result, contact your doctor for guidance.
• Inconclusive - This result indicates that the ECG recording could not be classified because the heart rate was either too high or too low, or the rhythm was not Atrial Fibrillation or Sinus Rhythm. If you get this result repeatedly, contact your doctor.
  Conditions that lead to an Inconclusive result:
  
  • The heart rate during the recording was less than 50 BPM (low heart rate*), or
  • The heart rate was greater than 100 BPM (high heart rate**) and rhythm was not Atrial Fibrillation, or
  • The heart rhythm was not Sinus or Atrial Fibrillation, or
  • The heart rhythm was Atrial Fibrillation and the heart rate was greater than 120 BPM
  * A low heart rate can be normal, such as in well-trained athletes. It can also be caused by certain medications or conditions associated with abnormal electrical activity within the heart.
  ** A high heart rate can be normal, such as during exercise or emotional stress. It can also be a response to dehydration, fever, infection or other conditions including atrial fibrillation or other arrhythmia.
• Poor Recording - This result means the ECG App was not able to analyze the data. A poor recording usually happens because your body moved during recording or the Galaxy Watch did not have enough skin contact with your wrist or finger. If you get this result repeatedly, refer to "Recording an ECG Using Your Galaxy Watch," above.

8. Safety and Performance

The clinical validation for ECG App tested its accuracy in detecting Sinus Rhythm and Atrial Fibrillation in ECG recordings for 544 subjects. The ECG App rhythm classifications were compared with rhythm classifications performed by a board-certified cardiologists using a 12-lead ECG. The ECG App had a sensitivity of 98.1% in detecting AFib and specificity of 100% in classifying sinus rhythm for all classifiable recordings.

During clinical trials, 16.8% of ECG recordings were either inconclusive or poor recording. If all of these recordings are included, the sensitivity of the ECG App is 87.1% and specificity to detect sinus rhythm is 82.5%. Real-world performance may have more inconclusive and poor recordings.

The ECG PDF report was compared against a standard Lead 1 ECG for key intervals (PR, RR), QRS duration and amplitude. No adverse events were reported during this clinical trial.

* Note: Based on a study conducted at one clinical study facility between September 2019 and April 2020. The clinical site was responsible for determining the accuracy of irregular rhythm measurement. Patient age under 22 was excluded from this study.

9. Troubleshooting

If you have problems using your ECG App, check below table for possible solutions.