Device Dossier

Pty Ltd - HeartSave YA8 - Non-rechargeable public automated external defibrillator

Device Dossier for Pty Ltd - HeartSave YA8 - Non-rechargeable public automated external defibrillator (Non-rechargeable public automated external…

Intended purpose

HeartSave YA8 devices are designed to be used in case of suspected sudden cardiac arrest, to guide the operator to start resuscitation, to analyse victim’s ECG, to deliver defibrillation therapy through self-adhesive electrodes in case of a shockable rhythm and to guide the operator to perform cardiopulmonary resuscitation.

Functional description

The HeartSave YA8 is a fully-automated external defibrillator (AED) with an integrated single channel ECG. The ECG is recorded via the electrodes. When a rhythm requiring defibrillation is detected, the HeartSave YA8 provides a shock to restore the heart rhythm. The HeartSave YA8 is equipped with a CPR sensor, WLAN and LTE configurations, display, electrodes and battery.

TGA Public Summary