Device Dossier

Pty Ltd - HeartSave Y5 - Non-rechargeable semi-automatic external defibrillator

Device Dossier for Pty Ltd - HeartSave Y5 - Non-rechargeable semi-automatic external defibrillator (Non-rechargeable semi-automatic external…

Intended purpose

HeartSave Y5 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 Y5 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 Y5 provides a shock to restore the heart rhythm. The HeartSave Y5 is equipped with a shock button, CPR sensor, display, electrodes and battery.

TGA Public Summary