Design considerations for reliability of the Novacor LVAS wearable control system

Novacor has had clinical experience with implantable left ventricular assist systems since 1984. Following the clinical introduction and use of the console-based system, development of a compact, wearable, electronic control system was started. This is a life support device and reliability has always been a primary development concern within Novacor. This paper presents some of the considerations for reliability during the design and qualification of the wearable control system. Results of life testing of the control system and its components are presented.