Healthcare Professionals

Affinity

Venous Reservoir Bag

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.