BIOtherm

Indications, Safety, and Warnings

ECMOtherm^® II Heat Exchanger
BIOtherm™ Heat Exchanger

ECMOtherm II Heat Exchanger

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

Indication: ECMOtherm-II™ Heat Exchanger are intended for use in the cardiopulmonary support procedures to cool and warm the blood. Typical applications include: total body perfusion, coronary perfusion, rapid infusion, and cardioplegia.

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

Blood inlet and outlet connections should be banded for added protection against high fluid pressures. Water inlet and outlet connections should be banded if Hansen type fittings are not used.

Do not exceed 65 psi water phase pressure.

Caution: Swedish law restricts this device to be ordered by, and sold to, a physician or medical institution only. For a complete listing of indications, contraindications, precautions and warnings, please refer to the Instructions For Use which accompany each product.

BIOtherm Heat Exchanger

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

Indication: BIOtherm™ Heat Exchangers are intended for use in the cardiopulmonary support procedures to cool and warm the blood. Typical applications include: total body perfusion, coronary perfusion, rapid infusion, and cardioplegia.

Warnings: 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.

Blood inlet and outlet connections should be banded for added protection against high fluid pressures. Water inlet and outlet connections should be banded if Hansen type fittings are not used.

Do not exceed 45 psi water phase pressure.

Caution: Swedish law restricts this device to be ordered by, and sold to, a physician or medical institution only. For a complete listing of indications, contraindications, precautions and warnings, please refer to the Instructions For Use which accompany each product.