Medtronic MYOtherm XP Gebrauchsanweisung Seite 13

System Operating Procedure
1. Cold water (2-4°C) recirculation through the heat exchanger should be initiated 1 to 2 minutes before the
delivery of cold blood/cardioplegia solution to the patient.
WARNING: If cold agglutinins have been demonstrated in the patient's blood, the blood temperature
MUST be maintained at a level greater than that at which agglutination was demonstrated.
WARNING: When using with membrane oxygenators, the arterial pump must be delivering flow through
the oxygenator at a flow greater than the flow through the cardioplegia circuit. This will help prevent the
introduction of air into the perfusion circuit.
2. To initiate blood/cardioplegia solution delivery to the patient, remove any tubing clamps from the delivery
line, start the system pump and adjust to the desired rate of infusion.
3. Stop the system pump to terminate the infusion of solution after achieving desired volume administration.
NOTE: A clamp should always be placed on the delivery line distal to the outlet chamber at the conclusion
of each cardioplegia administration.
4. Cold water recirculation through the heat exchanger should be discontinued when the system pump has
been stopped to avoid excessive cooling of the residual contents of the heat exchanger.
5. If additional blood/cardioplegia solution delivery is required, repeat Steps 1 through 4.
WARNING: The asanguineous cardioplegia solution should be maintained at an appropriate level within
the bag or bottle at all times to avoid air entry into the system. Air entry into the system may result in air
embolism to the patient.
6. Should replacement of the asanguineous cardioplegia solution bag (or bottle) become necessary:
6a. Ensure that the system administration pump IS NOT RUNNING.
6b. Clamp the asanguineous cardioplegia solution line between the supply bag/bottle and the pump
head.
6c. Replace the bag/bottle with a full bag/bottle.
6d. Remove the tubing clamp from the asanguineous cardioplegia solution supply line.
6e. Clear the solution supply line of any entrapped air by forcing it back into the bag/bottle PRIOR TO
restarting system pump flow.
WARNING: If a stopcock has been inserted between the patient end of the delivery line and the
cardioplegia cannula, care should be taken to ensure that the stopcock is correctly oriented. If the
stopcock becomes closed during delivery of cardioplegia solution, back pressure could build-up resulting
in bursting of the heat exchanger housing or tubing connections. The stopcock should be tested to ensure
that acceptable resistance is generated at desired flow rate when used with a specific cannula. Pressure
monitoring of the system during operation should be maintained to determine system performance and
pressure drop generated with the cannula used for the procedure. To prevent device damage and
subsequent leakage, DO NOT EXCEED a pressure of 750 mmHg in the fluid path.
Instructions for Use 11