Device Dossier

Model PowerBeat X1 AED System - Non-rechargeable semi-automatic external defibrillator

Device Dossier for Model PowerBeat X1 AED System - Non-rechargeable semi-automatic external defibrillator (Non-rechargeable semi-automatic external…

Intended purpose

Indicated for use on patients with suspected Sudden Cardiac Arrest (SCA) who are unconscious, unresponsive and not breathing or breathing abnormally.

Functional description

A system comprising an AED and defibrillation electrode pads. The AED has LED lights, graphic panel and voice prompt. The device analyses the heart rhythm automatically when the pads are attached to the patient. If the result of the rhythm analysis is 'Shock advised', the device will automatically charge to the pre-set energy and the shock button can be pressed for defibrillation.

TGA Public Summary