The Scan Monitor is a wearable, Bluetooth-connected wrist-worn watch that records two medical measurements: heart activity (electrocardiogram (ECG)) and oxygen saturation (SpO2). It is intended for use by healthcare professionals, patients with known or suspected heart conditions, and health-conscious individuals. The device classifies ECG signals as Normal Sinus Rhythm, Atrial Fibrillation, Inconclusive, or Noisy, and provides SpO2 measurements with a range of 70% to 100%.
Indications for Use
The Scan Monitor is intended for use in recording, storing, and transferring single-channel ECG rhythms, as well as detecting the presence of atrial fibrillation. It is also indicated for use in measuring and displaying SpO2, and is intended for spot-checking of adult patients in hospitals, clinics, long-term care facilities, and homes.
Device Description
The Scan Monitor has two stainless steel electrodes integrated on the back case of the watch and is available in two sizes, 38 mm and 42 mm. It has a companion mobile application called Health Mate, and provides measurements such as step count, sleep cycles, running, biking, and walking.
Manual:
Download: Scan Monitor Regulation Number: 21 CFR 870.2340
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