SAMSUNG ECG Monitor App with Irregular Heart Rhythm Notification Instructions

SAMSUNG ECG Monitor App with Irregular Heart Rhythm Notification

Product Information

• Specifications
  • Product Name: Samsung ECG Monitor App with Irregular Heart Rhythm Notification
  • Manufacturer: Samsung Electronics Co., Ltd.
  • Address: 129, Samsung-ro, Yeongtong-gu, Suwon-si, Gyeonggi-do 16677, Korea
  • Website: samsung.com.
  • Version: 2023-06 (v 4.0)
• Indications for Use
  • The Samsung ECG Monitor App with Irregular Heart Rhythm Notification is designed to create, record, store, transfer, and display a single channel ECG (similar to a Lead I ECG). The app classifies traces as either AFib (atrial fibrillation) or sinus rhythm to aid in heart rhythm identification.
  • Please note that this app is not intended for users with other known arrhythmias and should not be used as a replacement for traditional methods of diagnosis or treatment. It is important to consult a qualified healthcare professional before interpreting or taking any clinical action based on the device output.
• About these Instructions for Use
  • These Instructions for Use provide important information on how to safely and effectively use the Samsung ECG Monitor App. Please read these instructions carefully before using the app.

The following symbols are used in these instructions:

Monitor safely and effectively and to avoid inaccurate
results.
Manufacturer| | Indicates the name and address of the manufacturer.
Consult Instructions for Use| | Indicates that the user must carefully read the Instructions
for Use before using Samsung Health Monitor.
Medical Device| | Indicates that the ECG Monitor application is a medical
device.

• Accessing these Instructions for Use
  • You can access these Instructions for Use electronically within the Samsung Health Monitor application or on the Samsung Health Monitor page of the Samsung website (www.samsung.com/apps/samsung-healthmonitor/).
  • If you prefer a printed copy, you can download the instructions from the Samsung website and print them. Alternatively, you can contact the official Samsung support center in your country for assistance.
• Cautions
  • Please take note of the following cautions:
  • DO NOT use the ECG Monitor App if you have an implanted pacemaker, implanted cardiac defibrillator, or other implanted electronic device.
  • DO NOT use the ECG Monitor App if you have a known arrhythmia other than atrial fibrillation.
  • DO NOT use the ECG App if you are younger than 22 years old.
  • If you experience shortness of breath, chest pain or pressure, fainting, or symptoms that may indicate a heart attack, contact emergency services immediately.
  • DO NOT change your medications or dosage without first consulting your doctor.
  • DO NOT take ECG measurements during any physical activity.
  • DO NOT take ECG measurements when the Galaxy Watch is close to strong electromagnetic fields (e.g., MRI or X-Ray equipment, electromagnetic anti-theft systems, and metal detectors). Always pair the Galaxy phone and Galaxy watch via Bluetooth in a private (home-based) setting and avoid pairing in public spaces.
  • DO NOT take ECG measurements during a medical procedure (e.g., surgery or external defibrillation procedures).
  • DO NOT take ECG measurements when the Galaxy Watch is outside of specified conditions (not mentioned in the provided text).

Product Usage Instructions

• Step 1: Download and Install the App
  • To use the Samsung ECG Monitor App, follow these steps:
  • Ensure that you have a compatible Samsung Galaxy phone and Galaxy Watch.
  • Open the Samsung Health Monitor application on your Galaxy phone.
  • Search for “Samsung ECG Monitor App” and download it from the app store.
  • Follow the on-screen instructions to install the app on your Galaxy Watch.
• Step 2: Pair Your Galaxy Phone and Galaxy Watch
  • Before using the ECG Monitor App, you need to pair your Galaxy phone and Galaxy Watch via Bluetooth. Follow these steps:
  • Ensure that Bluetooth is enabled on both your Galaxy phone and Galaxy Watch.
  • Open the Samsung Health Monitor application on your Galaxy phone.
  • Select the option to pair a new device.
  • Follow the on-screen instructions to complete the pairing process.
• Step 3: Taking an ECG Measurement
  • Once you have downloaded and installed the app and paired your Galaxy phone and Galaxy Watch, you can take an ECG measurement. Follow these steps:
  • Ensure that your Galaxy Watch is securely fastened to your wrist.
  • Open the Samsung Health Monitor application on your Galaxy phone.
  • Select the option to start an ECG measurement.
  • Follow the on-screen instructions to place your finger on the watch’s sensor and hold still during the measurement process.
  • Wait for the measurement to complete.
• Step 4: Viewing and Sharing ECG Results
  • After taking an ECG measurement, you can view and share the results. Follow these steps:
  • Open the Samsung Health Monitor application on your Galaxy phone.
  • Select the option to view ECG results.
  • The app will display the recorded ECG trace and classify it as either AFib or sinus rhythm.
  • You can share the results with your healthcare professional for further analysis and consultation.
• Step 5: Additional Features and Settings
  • The Samsung ECG Monitor App offers additional features and settings that you can explore. These may include adjusting measurement settings, enabling notifications, and accessing historical ECG data. Refer to the app’s user interface and settings menu for more information.
• FAQ
  • Q: Can I use the ECG Monitor App if I have a pacemaker?
  • A: No, the ECG Monitor App should not be used if you have an implanted pacemaker, implanted cardiac defibrillator, or other implanted electronic device. Consult your healthcare professional for alternative monitoring options.
  • Q: Can I take ECG measurements during physical activity?
  • A: No, it is not recommended to take ECG measurements during any physical activity. Ensure that you are in a stable and relaxed state before initiating an ECG measurement.
  • Q: How can I access the Instructions for Use?
  • A: You can access the Instructions for Use electronically within the Samsung Health Monitor application or on the Samsung website(www.samsung.com/apps/samsung-healthmonitor/). Alternatively, you can download and print a copy from the Samsung website or contact the official Samsung support center in your country for assistance.

Indications for Use

• The Samsung ECG Monitor Application with Irregular Heart Rhythm Notification is an over-the-counter (OTC) software-only, mobile medical application operating on a compatible Samsung Galaxy Watch and Phone for informational use only in adults 22 years and older.
• The app analyzes pulse rate data to identify episodes of irregular heart rhythms suggestive of atrial fibrillation (AFib) and provides a notification suggesting the user record an ECG to analyze the heart rhythm.
• The Irregular Heart Rhythm Notification Feature is not intended to provide a notification on every episode of irregular rhythm suggestive of AFib and the absence of a notification is not intended to indicate no disease process is present; rather the feature is intended to opportunistically acquire pulse rate data when the user is still and analyze the data when determined sufficient toward surfacing a notification.
• Following this prompt, or based on the user’s own initiative, the app is intended to create, record, store, transfer, and display a single channel ECG, similar to a Lead I ECG. Classifiable traces are labeled by the app as either AFib or sinus rhythm with the intention of aiding heart rhythm identification.
• The app is not intended for users with other known arrhythmias, and it is not intended to replace traditional methods of diagnosis or treatment. Users should not interpret or take clinical action based on the device output without consultation of a qualified healthcare professional.

Instructions for Use

About these Instructions for Use

Symbols used

Health Monitor safely and effectively and to avoid inaccurate results.
__| Manufacturer| Indicates the name and address of the manufacturer.
__| Consult Instructions for Use| Indicates that the user must carefully read the Instructions for Use before using Samsung Health Monitor.
__| __

Medical Device

| __

Indicates that the ECG Monitor application is a medical device.

Accessing these Instructions

Accessing these Instructions for Use

• These Instructions for Use are available electronically within the Samsung Health Monitor application and on the Samsung Health Monitor page of the Samsung website (www.samsung.com/apps/samsung-health-monitor/).
• For a printed copy of these Instructions for Use, you can download them from the Samsung website and print them, or contact the official Samsung support center in your country.

Cautions

__| DO NOT use the ECG Monitor App if you have an implanted pacemaker, implanted cardiac defibrillator, or other implanted electronic device.
---|---
__| DO NOT use the ECG Monitor App if you have a known arrhythmia other than atrial fibrillation.
__| DO NOT use the ECG App if you are younger than 22 years old.
__| The ECG Monitor App and Irregular Heart Rhythm Notification feature never look for any forms of arrhythmia other than atrial fibrillation.
__| The ECG Monitor App cannot diagnose cardiac conditions or look for signs of a heart attack. Contact your doctor if you’re not feeling well or are experiencing physical symptoms such as shortness of breath, chest pain or pressure, and fainting.
__| The ECG Monitor App and Irregular Heart Rhythm Notification feature never look for other heart- related conditions, including blood pressure, congestive heart failure, high cholesterol, blood clots, or stroke.
__| The ECG Monitor App is not meant to replace traditional methods of diagnosis or treatment by a qualified healthcare professional. If you think you’re having a medical emergency, contact your local emergency services immediately.
__

| DO NOT use the ECG app if you experience:

1.       Shortness of breath

2.       Chest pain or pressure

3.       Fainting

4.       What you think might be a heart attack

Contact emergency services immediately.

__| DO NOT change your medications or dosage without first consulting your doctor.
__| ECG rhythm-classification results displayed by the ECG Monitor App are for informational purposes only. DO NOT take clinical action based on the ECG App measurements without first consulting with a qualified healthcare professional.
__| The ECG Monitor App is NOT constantly looking for atrial fibrillation when the Irregular Heart Rhythm Notification feature is on. This means that Galaxy Watch may not detect all instances of atrial fibrillation and people with atrial fibrillation may not get a notification.
__| 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 (home-based) 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 oF – 104 oF/12 oC – 40 oC

·         Humidity: 30% – 90% relative humidity

__| Your Galaxy Watch must have a minimum of 10 MB of storage for the Irregular Heart Rhythm Notification feature to monitor your heart rhythm. If the watch has less than 10 MB of storage, the feature will stop monitoring and try again when enough storage is available.
__| Make sure that the finger used to record the ECG is uncovered and free of any bruises, scars, or cuts.
__| Various things can impair the watch’s ability to detect atrial fibrillation. These include a dirty or damaged watch sensor, skin that’s too dry or cold, a dark tattoo on the wrist, a hairy wrist, and user movement while the watch is trying to measure.
__| Certain physiological conditions can prevent some people from having a strong enough signal for the ECG App to detect and analyze.

Using the ECG

Using the ECG Monitor App

Getting started: The ECG App is compatible with following watch models and watch/phone OS versions.

Tizen 4.0.0.8 or higher

| Android 9 or higher
Galaxy Watch4 or higher| WearOS 3.5 or higher
ECG (v1.2)

*ECG App with IHRN feature

| Galaxy Watch4 or higher| WearOS 4.0 or higher

For regional availability, see the Samsung Health Monitor page on the Samsung website (Samsung.com).
To set up the ECG Monitor app:

• Update your Galaxy Watch to the latest version software.
• Install the Samsung Health Monitor app on your phone. The app is available from the Galaxy Store.
• Open Samsung Health Monitor on your phone and follow the on-screen instructions.
• After you’ve set up the app, you can take an ECG using Samsung Health Monitor on your Galaxy Watch.

US Instructions for Use

To turn on the irregular heart rhythm notification feature:

• Set up the ECG Monitor app and record an ECG that isn’t poor quality.
• Tap Get started on the ECG Monitor app launcher screen.
• Follow the on-screen instructions.

Recording an ECG

1. Open Samsung Health Monitor on your Galaxy Watch.
2. Select ECG.
3. Make sure the Galaxy Watch is snug on your wrist.
4. Place your forearm comfortably on a flat surface and then rest a fingertip of the opposite hand lightly on the Galaxy Watch’s home button for 30 seconds. Remain still and don’t talk while the Galaxy Watch takes the measurement. Note: Pressing the home button during recording will stop the recording.

Reviewing your ECG results

• Your ECG reports are saved to the Samsung Health Monitor app on your phone. You may review your reports there and share them with a qualified healthcare professional.

ECG Results you may see
You may get any of the four following results:

• Sinus rhythm—This result means 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’re not experiencing an arrhythmia or other health condition. If you’re not feeling well, contact your doctor.
• Atrial fibrillation (AFib)—This result means 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 means 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. Any of the following conditions can lead to an Inconclusive result:
  • The heart rate during the recording was less than 50 BPM (low heart rate*)
  • The heart rate was greater than 100 BPM (high heart rate**) and rhythm was not Atrial Fibrillation
  • The heart rhythm was not Sinus or Atrial Fibrillation
  • 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 another arrhythmia.
  • Poor recording—This result means the ECG app couldn’t analyze the data. A poor recording usually happens because your body moved during recording or the Galaxy Watch didn’t have enough skin contact with your wrist or finger.
  • If you get this result repeatedly, review the instructions. Go to More options > How to use > ECG> Recording an ECG on your Galaxy Watch.

Receiving an irregular rhythm notification

• When the irregular rhythm notification feature is turned on, the Galaxy Watch uses its optical sensor to periodically check your heart rhythm when you’re still. It’s checking for an irregular rhythm that may indicate atrial fibrillation. If it detects a rhythm that might indicate atrial fibrillation, it will take additional readings to confirm atrial fibrillation. If the watch detects atrial fibrillation for one hour, you’ll receive a notification

Note: If the watch is in bedtime, do not disturb, or theater mode when it detects an irregular heart rhythm, it won’t send an irregular heart rhythm notification until after silent mode is turned off.

• If you receive an irregular heart rhythm notification, take an ECG as soon as possible so you have a more accurate record of your heart rhythm.
• Use the ECG result to decide if you should contact your doctor.

Safety and Performance

• Clinical validations of the ECG Monitor App with the Irregular Heart Rhythm Notification (IHRN) tested the ECG and IHRN features in separate clinical trials.
• The ECG Monitor App’s ECG was validated in a multi-center study comprising 544 subjects (44.3% female, 55.7% male) who were 22 years old or older.
• The ECG Monitor App rhythm classifications were compared with rhythm classifications performed by a board-certified cardiologist using a 12-lead ECG.
• For the classifiable recordings, the ECG Monitor App’s ECG showed a sensitivity of 98.1% by correctly detecting atrial fibrillation in 207 out of 211 subjects, and a specificity of 100% by correctly classifying sinus rhythm in 223 out of 223 subjects.
• The ECG Monitor App’s PDF report was compared against a standard Lead-1 ECG for key intervals (PR, RR), QRS duration and amplitude.
• The IHRN feature was validated in a large, multi-center study comprising 810 subjects (51.6% female, 48.4% male) who were 22 years old or older and who had not been previously diagnosed with permanent AFib.
• Study subjects simultaneously wore a Samsung Galaxy Watch with the IHRN capability and an ECG reference patch for up to 10 days.
• The IHRN feature showed a sensitivity of 68.0% by correctly notifying 102 out of 150 participants who had a continuous AFib episode of 1 hour or longer as shown on the reference ECG patch.
• The IHRN feature also demonstrated a specificity of 98.8% by correctly not notifying 652 out of 660 participants who did not have a concordant AFib episode.
• Based on the clinical trials, the combined, sequential use of receiving an IHRN AFib notification, followed by taking an on-demand ECG, results in an overall sensitivity of 66.7% and an overall specificity of 100%.
• The performance of the ECG Monitor App with the Irregular Heart Rhythm Notification feature is safe and effective in detecting and notifying the user of potential episodes of atrial fibrillation.

Troubleshooting

sure that the ECG app is approved for use in your country.

Make sure you have an active cellular connection when you activate the Samsung Health Monitor app.

I can’t find the ECG Monitor App on my Galaxy Watch.| Check that your Galaxy Watch is compatible with the ECG Monitor app. See the information at: https://[www.samsung.com/us/apps/samsung- health-](http://www.samsung.com/us/apps/samsung-health-)
| monitor/.

Install the Samsung Health Monitor app on the phone and upgrade your Galaxy Wearable software to the latest Maintenance Release (MR).

---|---

I can’t record my ECG.

| Dry or cool skin, not enough skin contact, a dark tattoo or excess hair on the wrist, pressing the Home button, or user movement can cause the ECG Monitor app to shut down, to not start recording, or to stop recording. Go to More options > How to use in Samsung Health Monitor on your phone.

If you still can’t get a successful recording, it might be that the watch can’t detect a strong enough signal to record your ECG.

I got Not enough available storage on my watch.

| Your Galaxy Watch needs at least 10 MB of available storage to monitor for atrial fibrillation and to record an ECG. You’ll need to free up storage on your watch to continue using this feature.

You can clear space by uninstalling apps from your watch in the Galaxy Wearable app on your phone or by deleting files and uninstalling apps directly on your watch.

I don’t see my ECG results in the Samsung Health Monitor phone app.| Make sure your Galaxy Watch is paired via Bluetooth with the Galaxy phone, using the Galaxy Wearable application. If you still don’t see your results, try syncing the data by tapping Sync in the upper right corner.

I’m repeatedly getting a Poor recording result.

| The Galaxy Watch uses an optical sensor to collect signals through the skin. A Poor recording result may be due to “noise” in the signal caused by dirt on the sensors, lack of moisture, a tattoo or other skin pigmentation, a scar, insufficient skin contact, or user movement during the ECG measurement.

·         Clean the back of the watch, the wrist the watch is in contact with, and the fingertip you’re using for the measurement.

·         Make sure the Galaxy Watch is snug on your wrist, rest your forearms comfortably on a table, and then take the ECG.

·         Try wearing the watch on your wrist slightly away from your wrist bone, toward your elbow, to create better skin contact.

Low peripheral blood flow or other condition may prevent the watch from getting a strong enough signal to analyze.

I’m repeatedly getting an Inconclusive result.

| If you think you’re having a medical emergency, contact your local emergency services immediately.

·         An Inconclusive result may be from a potentially high or low heart rate or another heart rhythm that’s not atrial fibrillation or sinus rhythm.

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 another arrhythmia. Stay still for 5–10 minutes, then take an ECG again.

·         An Inconclusive result could be because the heart rate is more than 120 BPM, and the rhythm is atrial fibrillation.

If you get an Inconclusive result repeatedly, contact your doctor.

I keep getting irregular heart rhythm notifications.| Make sure you take an ECG as soon as possible after getting a notification and go by the ECG result. An ECG is a more accurate record of your heart rhythm.

If you get a sinus-rhythm result (no signs of atrial fibrillation), but you’re feeling unwell, contact your doctor.

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My ECG waveform appears upside down.| An inverted waveform could be due to the incorrect wrist selection. If you updated to the WearOS version that introduced support for wrist orientation, the update reset the wrist selection to left. If you normally wear your watch on the right wrist, you’ll need to set the wrist orientation manually. Go to More options > Settings > Accessories > Wrist selection to see which wrist is selected and how to change it, if needed.

CONTACT

• Samsung Electronics Co., Ltd.
• 129, Samsung-ro, Yeongtong-gu, Suwon-si,
• Gyeonggi-do 16677,
• Korea samsung.com.
• 2023-06 ( v 4.0 )

Please read this Instructions for Use carefully to use the product properly ELFU INDICATOR Samsung ECG Monitor App with Irregular Heart Rhythm Notification

References

• Samsung US | Mobile | TV | Home Electronics | Home Appliances | Samsung US

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