Adverse Effects - Medtronic MYOtherm XP Instrucciones De Uso

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It is the responsibility of the user to dispose of the devices in accordance with local regulations and hospital
procedures.
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This product contains phthalates.

6. Adverse effects

The following known adverse effects are associated with the use of the product: coagulopathy; excessive blood
component activation or thrombogenicity; hemolysis; hemolytic anemia; hypotension; infection; ischemia;
neurological dysfunction; and organ dysfunction.
7. Information for products with Cortiva bioactive surface
The primary blood-contacting surfaces of the product are coated with Cortiva bioactive surface. This coated
surface enhances blood compatibility and provides a blood-contacting surface that is thromboresistant. Cortiva
bioactive surface contains nonleaching heparin derived from porcine intestinal mucosa
Caution: Product coated with Cortiva bioactive surface is intended for single use only. Resterilization may
adversely affect the Cortiva bioactive surface.
Caution: Follow a strict anticoagulation protocol and routinely monitor anticoagulation during all procedures.
8. Instructions for use
8.1. System setup (refer to figure 2 and figure 3)
1. Carefully remove the MYOtherm XP system with Cortiva bioactive surface components from the packaging
to ensure sterile fluid pathway.
Warning: Ensure aseptic technique is used during all stages of setup and use of this system.
Warning: Before removing the MYOtherm XP system with Cortiva bioactive surface from the packaging,
inspect the packaging and product for damage. If the package or product is damaged, do not use as sterility
of the device may have been compromised and/or performance may be affected.
2. Securely mount the MYOtherm XP holder to an appropriate mast near the pump head used. Verify that this
attachment is secure and the mast is capable of safely supporting the system's weight. Orient the mounting
bracket so the outlet chamber is in full view during operation.
Warning: If the holder is mounted to anything other than a vertical mast, care must be taken to ensure the
MYOtherm XP system with Cortiva bioactive surface is at the proper angle (10°) to maintain optimal air
handling capability and avoid air embolism.
3. Slide the heat exchanger into the heat exchanger holder arms. The holder arms will securely seat the heat
exchanger when inserted correctly.
4. Secure the quick coupling connectors from the water source to the inlet and outlet ports of the heat
exchanger as labeled.
5. Perform a water leakage check by circulating water through the heat exchanger while examining the blood
path chamber for evidence of water. This procedure must be performed prior to priming this system. Should
there be any question of system integrity, do not use.
Warning:
a. Do not restrict the water outflow of the heat exchanger.
b. Never exceed water inlet pressure of 275.8 kPa (40 psi).
c. As this 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.
d. Do not exceed blood side pressures of 750 mmHg postprime.
6. Install tubing in the pump head (using the appropriate head inserts) with the asanguineous cardioplegia
solution tubing on top of the blood line within the roller pump. Adjust the pump head occlusion to achieve full
occlusion of both tubing segments.
Warning: 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 cardioplegia solution entering the oxygenator
circuit and inaccurate mixing ratios of blood to cardioplegia solution.
7. Confirm secure connection of the male luer lock fitting of the pressure monitoring line to the pressure
monitoring site at the top of the heat exchanger. Rotate the three-way stopcock to measure pressure from
the heat exchanger.
Note: If the pressure monitoring site on the heat exchanger is not used, place a nonvented cap on this port.
8. Confirm secure connection of the pressure relief line to any available luer port on a vented cardiotomy
reservoir. The line connected to the pressure monitoring port may be connected to a port on a cardiotomy
reservoir for priming/recirculation purposes.
Note: The pressure relief and pressure monitoring lines are preattached to the heat exchanger.
1 Nonleaching is defined as heparin at a level ≤0.1 IU/mL, as measured through clinically relevant extraction conditions.
10 Instructions for Use English
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