Additional Information - Medtronic MYOtherm XP Instrucciones De Uso

c. The various components and connections of the system should be checked for leaks during priming and
operation. Leakage of any connections or components may result in air embolism and/or solution loss.
6. After priming the complete system, verify that the pump has been properly occluded and all clamps have
been removed before operation.
8.3. System operating procedure
1. Cold water (2°C to 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 used 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.
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, perform
the following steps:
a. Ensure that the system administration pump is not running.
b. Clamp the asanguineous cardioplegia solution line between the supply bag/bottle and the pump head.
c. Replace the bag/bottle with a full bag/bottle.
d. Remove the tubing clamp from the asanguineous cardioplegia solution supply line.
e. Clear the solution supply line of any entrapped air by forcing it back into the bag/bottle before 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. 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 analyze how the pressure drop generated by the cannula used in
the procedure affects system performance. To prevent device damage and subsequent leakage, do not
exceed a pressure of 750 mmHg in the fluid path.

9. Additional Information

The following information and data are available upon request: test methods used to determine coverage,
leaching, and bioactivity.
10. Important notice—limited warranty (US customers only)
A. This LIMITED WARRANTY provides the following assurance to the patient who receives a MYOtherm XP
system with Cortiva bioactive surface, hereafter referred to as the "Product."
(1) Should the Product fail to function within normal tolerances due to a defect in materials or workmanship
prior to its Use-By Date, Medtronic will, at its option: (a) issue a credit to the purchaser equal to the
Purchase Price, as defined in Subsection A(2), against the purchase of the replacement Product or (b)
provide a functionally comparable replacement Product at no charge.
(2) As used herein, Purchase Price shall mean the lesser of the net invoiced price of the original, or current
functionally comparable, or replacement Product.
B. To qualify for the LIMITED WARRANTY, these conditions must be met:
(1) The Product must be used prior to its Use-by date.
(2) The unused portion of the Product must be returned to Medtronic and shall be the property of
Medtronic.
(3) The Product must not have been altered or subjected to misuse, abuse, or accident.
(4) The Product must be used in accordance with the labeling and instructions for use provided with the
Product.
12 Instructions for Use English