Indications, Safety, and Warnings

Contraindication

This device used for any other purposes than for the indicated use is the responsibility of the user.

Indication

The Affinity^® Venous Reservoir Bag is intended for use in conjunction with extracorporeal circulation devices to accommodate systemic venous and cardiotomy return blood, during routine cardiopulmonary bypass procedures up to 6 hours in duration.

Warning

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.

Caution: 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.