[Application name]
Samsung Health Monitor
[Manufacturer]
Samsung Electronics Co., Ltd.
※ The Blood Pressure App and ECG App are a CE-marked medical device.
※ Before use, read ‘Precautions’ and ‘Warnings’ below carefully.
If you need more detailed instructions, please refer to Instructions for Use through the URL below.
www.samsung.com/apps/samsung-health-monitor/
[Intended Use – Blood Pressure]
The Blood Pressure App (BP App) is a software-only, mobile medical application intended for use with a compatible Samsung Galaxy Watch and Phone to create, record, store and display blood pressure information. The BP App determines systolic and diastolic blood pressure, as well as pulse rate, and provides values and history charts following calibration with an upper-arm, cuff-based blood pressure monitor. These data are only captured when the user is at rest.
The BP App is intended for over-the-counter (OTC) use in adults 22 years and older. It may not provide accurate results in pregnant women. This information can be used as an indication for trends in blood pressure between regular checks by a healthcare professional. The user is not intended to interpret or take clinical action based on the device output without consultation with a qualified healthcare professional and validation with a standard measurement method. The BP App is not intended to replace traditional methods for diagnosis or treatment of hypertension.
[Intended 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.
[Precautions]
※ Samsung Galaxy Watch and Galaxy Smartphone with Android N OS or higher are required to use this product.
– Supported watches: Galaxy Watch3, Galaxy Watch Active2, Galaxy Watch4 and later released models(excl. Galaxy Fit)
※ This product has not been tested for and is not intended for use in people under 22 years of age.
※ If Galaxy Watch cannot find the Samsung Health Monitor app, please update Watch SW to the latest version through the Galaxy Wearable App on a smartphone.
※ This product needs to be calibrated with a cuff-type blood pressure meter, not only when it is first used, but every 4 weeks afterwards.
※ Due to country restrictions in obtaining approval/registration as a medical device, the Samsung Health Monitor app only works on watches and smartphones purchased in the countries where the service is currently available. Service may be restricted/unavailable when you travel to non-service countries and do a factory reset of the phone or re-install the Samsung Health Monitor app.