Medtronic MYOtherm XP Instrucciones De Uso página 11

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Do not allow alcohol, alcohol-based fluids, anesthetic liquids (such as isoflurane), or corrosive solvents
(such as acetone) to come into contact with the device as they may jeopardize the structural integrity.
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If air bubbles and/or leaks are observed during priming and/or operation, these conditions 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.
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Clear all gas emboli from the extracorporeal circuit before initiating bypass. Gas emboli are hazardous to the
patient.
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This system is intended for use with the MYOtherm XP cardioplegia holder to allow for secure mounting to a
vertical pole during operation. Inspection and maintenance of this holder should be performed routinely.
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Never restrict the water outflow of the heat exchanger.
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Direction of water flow through heat exchanger should be countercurrent with blood flow for optimal thermal
efficiency.
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It is recommended that appropriate clinical laboratory procedures prior to use of this system examine the
presence of cold agglutinins in the patient's blood. The temperature of the blood/cardioplegia solution should
not be less than the lowest temperature at which negative cold agglutinins were determined.
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Never exceed water inlet pressure of 275.8 kPa (40 psi).
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Do not exceed blood side pressures of 750 mmHg postprime.
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The heat exchanger must be in a 10° inclined position, as provided by the standard MYOtherm XP holder
position, at all times to help avoid the introduction of air into the delivery line.
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Follow institution CPB protocol when using disinfectants in the heater/cooler during bypass. The integrity of
the water path has been verified with hydrogen peroxide (330 ppm). Contact Medtronic for information
regarding the use of additional disinfectants.
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The heat exchanger is extremely efficient. It is recommended that water temperature never be allowed to
exceed 42°C (107°F) as thermal blood damage may result.
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The luer cap on the monitoring port of this device is vented.
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The cardioplegia pump must be fully occlusive.
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A fully occlusive roller head must be used while operating this system. Failure to fully occlude both tubing
segments within the roller head may result in backflow of cardioplegia solution into the oxygenator and
inaccurate mixing ratios of blood to asanguineous cardioplegia solution.
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Do not start the cardioplegia pump unless the arterial pump is on.
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Do not stop the arterial pump unless the cardioplegia pump is off.
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Arterial flow must always exceed cardioplegia flow.
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Ensure that the system outflow line (patient delivery line) is not clamped while the pump is on.
■ When using with membrane oxygenators the arterial pump must deliver flow through the oxygenator at a
flow greater than that through the cardioplegia circuit. This will help prevent the introduction of air into the
perfusion circuit.
■ Use of a bottle for cardioplegia solution requires the presence of a functional standard air vent in the bottle,
which extends at least 2.5 cm (1 in) above the top of the cardioplegia solution fluid level.
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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 embolization to the
patient.
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The concentrations of additives to the asanguineous cardioplegia solution should be adjusted to achieve the
desired concentrations in the blood/cardioplegia solution being delivered to the patient.
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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. Test the stopcock to ensure that acceptable resistance is
generated at desired flow rate when used with a specific cannula. Monitor system pressure during operation
to determine how the pressure drop generated by the cannula used in the procedure affects system
performance.
Note: Additional warnings and cautions applicable to specific procedures can be found at appropriate places in
these instructions for use.
5. Precautions
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This device was designed for single patient use only. Do not reuse, reprocess, or resterilize any component
of the system. Reuse, reprocessing, or resterilization may compromise the structural integrity of the device
and/or create a risk of contamination of the device, which could result in patient injury, illness, or death.
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Use aseptic technique in all procedures.
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Follow a strict anticoagulation protocol and routinely monitor anticoagulation during all procedures.
Instructions for Use English 9