Affinity Fusion

Oxygenation System

Indications, Safety, and Warnings

Affinity Fusion oxygenator with integrated arterial filter

The Affinity Fusion™ Oxygenator with Integrated Arterial Filter and Balance biosurface® is intended to be used in an extracorporeal perfusion circuit to oxygenate and remove carbon dioxide from the blood and to cool or warm the blood during routine cardiopulmonary bypass procedures up to 6 hours in duration. The Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance biosurface is designed to filter from the circuit microemboli larger than the specified micron size for periods up to six hours during cardiopulmonary bypass surgery.

Affinity Fusion Cardiotomy/Venous Reservoir

The Affinity Fusion Cardiotomy/Venous Reservoir with Balance biosurface is intended to be used in an extracorporeal perfusion circuit to collect venous and cardiotomy suctioned blood during routine cardiopulmonary procedures up to 6 hours in duration. The CVR is also intended for use during vacuum assisted venous drainage (VAVD) procedures. The Affinity Fusion Cardiotomy/Venous Reservoir with Balance biosurface is also intended for use after open heart surgery to collect autologous blood from the chest and to aseptically return the blood to the patient for blood volume replacement.


WARNINGS

Read all warnings, precautions, and Instructions for Use carefully prior to use. Failure to read and follow all instructions, or failure to observe all stated warnings, could cause serious injury or death to the patient.  


CONTRAINDICATIONS

Use the device only as indicated. Do not use if air leaks are observed during priming and/or operation; this may result in air embolism to the patient and/or fluid loss.