Device Dossier

HeartMate II System Controller - Circulatory assist system, supply unit, external

Device Dossier for HeartMate II System Controller - Circulatory assist system, supply unit, external (Circulatory assist system, supply unit, external,…

Intended purpose

The HeartMate II System Controller is a small computer that controls and monitors the Left Ventricular Assist System operation and serves as the primary user interface.

Functional description

The System Controller controls and monitors system operation, records device performance and alarm data, and transfers the information to the System Monitor. The System Controller uses lights, sounds, and onscreen messages to communicate with users about operating status and alarm conditions. A driveline, which passes through the patient’s abdomen, connects the implanted pump to the System Controller.

TGA Public Summary