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 portable electrically powered device designed to non-invasively measure a patient’s systolic and diastolic blood pressures and current heart rate. The device provides a visual indication of the risk of hypertension based on 1999 WHO-International Society of Hypertension Guidelines for the management of Hypertension. Increased blood pressure if left untreated can lead to arrhythmias (e.g. atrial fibrillation Afib, premature contraction PC) or non-type -specific arrhythmias providing a warning signal to the user to consult a doctor for potential diagnosis and treatment.

TGA Public Summary