Oxygenator, extracorporeal membrane

Intended purpose

The medical device is intended for use in extracorporeal perfusion circuit during cardiopulmonary bypass in cardiac surgery to oxygenate and remove carbon dioxide from the blood and regulate the blood temperature. The medical device may be integrated with arterial filter, that enables filtration of arterial blood with removal of microemboli and microaggregates larger than 38 μm. The medical device is equipped of a hard-shell cardiotomy/venous reservoir intended to collect, store and filter venous and cardiotomy suctioned blood during cardiopulmonary bypass procedure up to 6 hours in surgery. The hard-shell cardiotomy/venous reservoir is also intended for use during vacuum-assisted venous drainage (VAVD) procedures. The medical device is furthermore intended to reduce the content of lipidic particles and leukocytes in the portion of extracavitary blood coming from the surgical field and gradually collected in the pericardial sac. The blood to be treated should contain anticoagulant. The medical device is indicated for use on adult patients undergoing extracorporeal circulation during cardiopulmonary bypass procedures. The medical device should not be used for more than 6 hours. Contact with blood for longer periods is not advised.