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The Affinity NT™ oxygenator with 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 (CPB) procedures up to 6 hours in duration. The Affinity NT cardiotomy/venous reservoir (CVR) is intended to be used in an extracorporeal perfusion circuit to collect venous and cardiotomy suctioned blood during routine CPB procedures up to 6 hours in duration.
Use the device only as indicated.
Follow a strict anticoagulation protocol and routinely monitor anticoagulation during all procedures. Maintain adequate anticoagulation per institution CPB protocol. Clear all gas emboli from the extracorporeal circuit before initiating bypass. Gas emboli are hazardous to the patient. Continually monitor the extracorporeal circuit for air bubbles or leaks. Do not use the device if air bubbles or leaks are observed during priming or operation as they may result in air embolism to the patient or fluid loss.
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.