Medtronic MYOtherm XP Gebrauchsanweisung Seite 8

The fluid pathway is sterile and nonpyrogenic. Inspect each package and device prior to use. Do not use
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if the package is opened or damaged or the protective caps are not in place.
Tubing should be attached in such a manner as to prevent kinks or restrictions that may alter blood or
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water flow.
Do not allow alcohol, alcohol-based fluids; anesthetic fluids (such as isoflurane), or corrosive solvents
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(such as acetone) to come into contact with the device as they may jeopardize the structural integrity.
If air bubbles and/or leaks are observed during priming and/or operation, these conditions may result in
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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.
All gas emboli must be cleared from the extracorporeal circuit before initiating bypass. Gas emboli are
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hazardous to the patient.
This system is intended for use with the MYOtherm XP
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to a vertical pole during operation. Inspection and maintenance of this holder should be performed
routinely.
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
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thermal efficiency.
It is recommended that appropriate clinical laboratory procedures prior to use of this system examine the
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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.
Never exceed water inlet pressure of 40 psi.
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Do not exceed blood side pressures of 750 mmHg post prime.
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The heat exchanger must be in a 10° inclined position as provided by the standard MYOtherm XP
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position at all times to help avoid the introduction of air into the delivery line.
Disinfectants must not be used in the heater/cooler system when the heat exchanger is in use. If
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disinfectants are used in the heater/cooler system prior to use, the system must be thoroughly flushed.
The heat exchanger is extremely efficient. It is recommended that water temperature never be allowed to
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exceed 42°C as thermal blood damage may result.
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
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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.
Do not start cardioplegia pump unless arterial pump is on.
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Do not stop arterial pump unless 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.
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When using with membrane oxygenators the arterial pump must be delivering flow through the oxygenator
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at a flow greater than the flow 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,
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which extends at least 2.5 cm (1 in) above the top of the cardioplegia solution fluid level.
The asanguineous cardioplegia solution should be maintained at an appropriate level within the bag or
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bottle at all times to avoid air entry into the system. Air entry into the system may result in air embolism to
the patient.
The concentrations of additives to the asanguineous cardioplegia solution should be adjusted to achieve
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the desired concentrations in the blood/cardioplegia solution being delivered to the patient.
If a stopcock has been inserted between the patient end of the delivery line and the cardioplegia cannula,
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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.
Possible side effects include, but are not limited to infections, mechanical failure, hemolysis, air embolism,
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blood loss, circulatory compromise and thromboembolic phenomena. These are potential side effects with
all extracorporeal blood systems.
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
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NOTE: Additional warnings and cautions applicable to specific procedures can be found at appropriate places
in these Instructions for Use.
6 Instructions for Use
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Cardioplegia holder to allow for secure mounting
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holder