Device Dossier

BeneHeart L1A - Non-rechargeable public automated external defibrillator

Device Dossier for BeneHeart L1A - Non-rechargeable public automated external defibrillator (Non-rechargeable public automated external defibrillator,…

Intended purpose

The device is intended for semi-automated and fully automated external defibrillation . It also provides CPR feedback and guidance. The device is designed for use on unresponsive patients who are not breathing or not breathing normally. It is intended to treat adults and paediatric patients experiencing sudden cardiac arrest with ventricular fibrillation, pulseless ventricular tachycardia, or ventricular flutter. The AED is suitable for use in public places, healthcare facilities, and emergency response environments by trained laypersons or healthcare professionals.

Functional description

The external defibrillator provides the same therapy in semi-automatic and fully automatic modes. After pads are applied, it analyses the heart rhythm. If shockable, a semi-automatic unit requires the operator to press Shock, while the fully automatic unit delivers it. If non-shockable, the device enters CPR mode and gives audio/visual guidance. Analysis stops during CPR or pad faults.

TGA Public Summary