Device Dossier

HeartMate 3 System Controller, Model 106531INT - Circulatory assist system, supply unit, external

Device Dossier for HeartMate 3 System Controller, Model 106531INT - Circulatory assist system, supply unit, external (Circulatory assist system, supply…

Intended purpose

The System Controller is intended for use with the HeartMate 3 LVAS. The System Controller is a small computer that controls and monitors the HeartMate 3 LVAS operation.

Functional description

The System Controller is an extracorporeal interface device that receives power from the Power Module, the Mobile Power Unit or portable Batteries. It appropriately delivers power to the implanted pump via a Driveline that connects the Pump to the System Controller. The System Controller uses lights, sounds, and on-screen messages to communicate with users about operating status and alarm conditions.

TGA Public Summary