HeartMate 3 System Controller Low Flow 2.0 model 106531LF2 - Circulatory assist system, supply unit, external

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 operations.

Functional description

The System Controller Low Flow 2.0 is a small computer that controls and monitors the LVAS operation. It 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.