The AFFINITY® NT Integrated CVR Membrane Oxygenator with Plasma Resistant Fiber is intended to be used in an extracorporeal perfusion circuit to collect venous and cardiotomy suctioned blood, cool or warm the blood and oxygenate and remove carbon dioxide from the blood during routine cardiopulmonary bypass procedures up to 6 hours in duration.
This device used for any other purposes than for the indicated use is the responsibility of the user.
Gas emboli must be cleared from the extracorporeal circuit before initiating bypass. Gas emboli are hazardous to the patient. If leaks are observed during priming and/or operation, this may result in air embolism to the patient and /or fluid loss. The extracorporeal circuit must be continually monitored. Do not use the device if these conditions are observed.
Federal law (USA) restricts this device to sale by or on the order of a physician. For a complete listing of indications, contraindications, precautions and warnings, please refer to the Instructions For Use which accompany each product.