Device Dossier

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

Device Dossier for Automatic-inflation electronic sphygmomanometer, portable, arm/wrist (Automatic-inflation electronic sphygmomanometer, portable,…

Intended purpose

The BPM Core is a digital monitor intended for use in measuring blood pressure, heart rate, to record a single lead ECG in order to detect a risk of atrial fibrillation. The BPM Core also records heart sound to uncover a risk of valvular heart diseases (aortic stenosis, aortic regurgitation, mitral regurgitation). The device is intended to be used on the left arm, in a human adult population with an arm circumference between 9 to 17 inches (22 to 42 cm). The BPM Core is a home use device.

TGA Public Summary