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

A battery-powered device designed to noninvasively measure systolic and diastolic blood pressure, pulse rate, detection of pulse arrhythmia, atrial fibrillation (AFib), Atrial and/or Ventricular Premature Contractions (PC) using a self-contained software program that regulates automatic arm cuff inflation and measurement cycles. It is intended to be used by adult/patient consumers and not to be used on infants or neonates. This device is designed to be portable and is often used for emergency services or home blood pressure monitoring.

TGA Public Summary