Indications, Safety, and Warnings

Minimax Plus Oxygenator

Indications
The Minimax Plus Hollow Fiber Oxygenator with Plasma Resistant Fiber, with or without Carmeda BioActive Surface, is indicated for use in procedures requiring the extracorporeal oxygenation of and carbon dioxide removal from blood. It is designed to operate at a maximum blood flow rate of 2.3 liters per minute for periods of up to 6 hours.

The Minimax Filtered Hardshell Reservoir is indicated for use in procedures requiring the storage and filtration of blood during extracorporeal circulation at venous blood flow rates of up to 4 liters per minute and cardiotomy filtration rates of up to 2 liters per minute.

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.