Samsung Health Monitor 1.4.6.001

From version
1.3.2.016
:
- Sleep Apnea Added for supported iso-2 country codes: "US", "KR", "BO", "CL", "AE", "PH", "MU", "ZA", "HK", "RU", "GE", "AZ", "PE"

[Indications for Use – ECG]

The Samsung ECG App 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 labelled 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 with 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.

[Indications for Use – Sleep Apnea]

The Sleep Apnea Feature is an over-the-counter (OTC) software-only, mobile medical application operating on a compatible Samsung Galaxy Watch and Phone.

This feature is intended to detect signs of moderate-to-severe obstructive sleep apnea in the form of significant breathing disruptions over a two-night monitoring period, for adult users 22 years or older. This feature is intended for on-demand use.

This feature is not intended for users who have previously been diagnosed with sleep apnea. Users should not use this feature to replace traditional methods of diagnosis and treatment by a qualified clinician. The data provided by this feature are also not intended to assist clinicians in diagnosing sleep disorders.

※ Attention

1) This product is classified as “Software as Medical Device” and is approved for use by adults (22 years or older) by US FDA.

2) Before using the App, complete the on-boarding process

3) Supported watches

- ECG : Galaxy Watch Active2, Galaxy Watch3 and above

- Sleep apnea : Galaxy watch4 and above with Wear OS 5.0 version or higher

4) This App is available only for Galaxy watch and Galaxy smartphones sold in the US market

5) If you cannot find Samsung Health Monitor app on your Galaxy watch, please update your watch to the latest SW version through Galaxy Wearable Application

6) Please read Instructions for Use at the URL below.

www.samsung.com/apps/samsung-health-monitor/

※ App information

- Manufacturer : Samsung Electronics Co., Ltd.