Indications, Safety, and Warnings
Affinity NT Oxygenator, Minimax Plus Oxygenator and Silicone Membrane Oxygenator I2500, I3500, I4500
Indication
The oxygenator is indicated for use in an extracorporeal circulation circuit to oxygenate and remove carbon dioxide from the blood and to cool or warm the blood during cardiopulmonary bypass procedures up to 6 hours in duration.
Contraindication
This device used for any other purposes than for the indicated use is the responsibility of the user.
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.
Silicone Membrane Oxygenator 0600, 0800, 1500
Indication
The ECMO Membrane Oxygenators are intended for use in an extracorporeal perfusion circuit for the oxygenation of and the removal of carbon dioxide from the blood during extended respiratory support applications (ie, ECMO).
Contraindication
Use of this device for any purposes other than for the indicated intended use is the responsibility of the user.
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.