Device Dossier

Tubing Set with BIOLINE Coating (HLS Set Advanced) - Tubing set, heart-lung bypass

Device Dossier for Tubing Set with BIOLINE Coating (HLS Set Advanced) - Tubing set, heart-lung bypass (Cardiopulmonary bypass system tubing set, Class…

Intended purpose

Intended for extracorporeal pulmonary support, cardiovascular support or circulatory support. Furthermore, the blood can be cooled or warmed by means of the heat exchanger integrated in the HLS Module Advanced. Partial perfusion of limbs or organs is also possible.

Functional description

The Tubing Set with BIOLINE Coating (HLS Set Advanced) is a preconnected set for extracorporeal circulatory support. The main component is the HLS Module Advanced (oxygenator with heat exchanger, integrated centrifugal pump and sensors) which is driven by CARDIOHELP Device. Further components of the tubing set are tubing, connectors, stop-cocks, a gas filter, a syringe, an emergency priming line and a priming set.

TGA Public Summary