Adverse Effects - Medtronic MYOtherm XP Gebrauchsanweisung

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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 adverse effects are associated with the use of the product:
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Coagulopathy
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Excessive blood component activation or thrombogenicity
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Hemolysis
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Hemolytic anemia
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Hypotension
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Infection
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Ischemia
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Neurological dysfunction
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Organ dysfunction
7. Information for products with Trillium biosurface
The primary blood-contacting surfaces of the product are coated with Trillium biosurface. This coated surface
enhances blood compatibility and provides a blood-contacting surface that is thromboresistant. Trillium
biosurface contains nonleaching heparin derived from porcine intestinal mucosa
Caution: Product coated with Trillium biosurface is intended for single use only. Resterilization may adversely
affect the Trillium biosurface.
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 Trillium biosurface components from the packaging to
ensure sterile fluid pathway.
Warning: Ensure that aseptic technique is used during all stages of setup and use of this system.
Warning: Before removing the MYOtherm XP system with Trillium biosurface 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 MYOtherm XP holder is mounted to anything other than a vertical mast, care must be taken
to ensure the MYOtherm XP system with Trillium biosurface 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 before 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.
2 Nonleaching is defined as heparin at a level ≤0.1 IU/mL, as measured through clinically relevant extraction conditions.
2
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Instructions for Use English 9