Indications for Use
The Affinity Pixie™ Hollow Fiber Oxygenation System is indicated for use for neonate, infant, and small pediatric patients undergoing cardiopulmonary bypass procedures requiring a blood flow rate up to 2.0 L/min.
The Affinity Pixie Hollow Fiber Oxygenator 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 Pixie Cardiotomy/Venous Reservoir 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.
This device used for any purpose other than 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.