Device Dossier

Pty Ltd - HeartSave Y8 - Non-rechargeable semi-automatic external defibrillator

Device Dossier for Pty Ltd - HeartSave Y8 - Non-rechargeable semi-automatic external defibrillator (Non-rechargeable semi-automatic external…

Intended purpose

HeartSave Y8 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 Y8 is a semi-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 Y8 provides a shock to restore the heart rhythm. The HeartSave Y8 is equipped with a shock button, CPR sensor, WLAN and LTE configurations, display, electrodes and battery.

TGA Public Summary