Samsung Health Monitor (Wear OS)

[Application name]
Samsung Health Monitor

[Manufacturer]
Samsung Electronics Co., Ltd.

※ The ECG app is a medical device approved by NMPA. The Blood Pressure App is not a 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]

Samsung Health Monitor- Blood Pressure App is a software-only, mobile health application intended for use with a compatible Samsung Galaxy Watch and Phone to create, record, store and display blood pressure information. The Blood Pressure App determines the systolic and diastolic blood pressure as well as pulse rate and provides values and history charts following calibration with a blood pressure cuff. These data are only captured when the user is at rest. In addition, the user can also view history records through the Samsung Health Monitor on the Galaxy phone.

The Blood Pressure App is intended for over-the-counter (OTC) use in adults 22 years and older. It may not provide accurate results in pregnant women. The BP data displayed by the Blood Pressure App is intended for informational use only. 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 Blood Pressure App is not intended to replace traditional methods for diagnosis or treatment of hypertension.

[Intended Use - ECG]
The ECG App is intended for use with Samsung Galaxy Watch to record, display and store a single-channel electrocardiogram (ECG), similar to a Lead I ECG. It is used for the notification of atrial fibrillation (AFib) or sinus rhythm. The notification is for reference only and cannot be used alone to take clinical action. ECG App is intended for use by adults 22 years and older only, it is not recommended for users with other known arrhythmias.

[Precautions]
※ The Samsung Health Monitor App requires a Galaxy Watch that is paired with a Samsung Galaxy smartphone with the latest Android OS. Check www.samsung.com/apps/samsung-health-monitor/ for watch models and country/region where service is available.
※ 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.