MYOtherm XP

Indications, Safety, and Warnings

MYOtherm XP Cardioplegia Delivery System

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

Indication
The CB MYOtherm XP® is a device intended for the mixing, warming/ cooling and delivery of oxygenated blood/cardioplegia solution in a predetermined ratio.

Warning
The use of certain solvents may compromise the integrity of the device.

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.

Test for the presence of cold agglutinins in the patient’s blood prior to use. The temperature of the blood/cardioplegia solution should never fall below the temperature at which negative cold agglutinins were determined.

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.