Abbott Tendyne TENDV-LP-29S, Инструкция по эксплуатации

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IFU, TENDYNE TM Mitral Valve System Page 22 of 284
c. Maintain tether tension and use the lock
wheel to unpin the tether and remove
the Apical Pad.
CAUTION: Do not lose tether tension.
8. Using fluoroscopic guidance and using the
valve’s tether as a rail, insert the retrieval
sheath and retrieval dilator through the apex of
the heart until the tip is adjacent to the valve’s
stem.
9. Tighten the tuohy valve on the proximal end of
the retrieval tool assembly and activate the pin
to secure the tether.
10. Loosen the retaining ring and slide it to the
proximal end of the stainless steel rod on the
retrieval tool assembly.
11. Under fluoroscopy guidance, slowly compress
the actuator on the retrieval tool assembly to
partially re-sheath the valve into the retrieval
tool.
NOTE: Visualize native leaflets to ensure they
remain free and mobile throughout the re-
sheathing process.
12. Advance the retrieval tool assembly, moving
the partially captured valve into the left atrium
to complete re-sheathing.
13. Lock the bottom thumbscrew on the outer
dilator and unlock the slide bar locking
mechanism on the retrieval sheath assembly.
14. Continue to compress the actuator on the
retrieval tool assembly in a slow controlled
manner until the valve is fully captured. The
double laser mark on retrieval tool assembly
rod indicates that the valve is fully captured.
High forces may be encountered as the cuff
region of the valve is pulled into the retrieval
sheath assembly. Manual assist on the retrieval
tool may be used to fully capture the valve.
15. Remove the entire system.
16. If desired, another valve can be loaded and
deployed.
WARNING: Do not reuse a valve that has been
retrieved.
10.14. Cleaning and Sterilizing the Reusable Stand and
Reusable Weight
CAUTION: Failure to properly clean and/or
re-sterilize the stand and weight prior to use
may result in infections, user injury, or patient
injury.
1. Manually Cleaning the Reusable Stand and
Reusable Weight
a. Immediately after surgery (Point-of-Use),
disassemble the stand by separating the
two (2) posts from the base (Figure 15).
Figure 15. Tendyne
TM
Stand, disassembled.
1. Post Holes
2. Posts
3. Base
b. Using a moistened low-lint wipe, clean all
surfaces and edges of the stand (base, post
holes, and posts [Figure 15]), and weight
(Figure 16).
Figure 16. Tendyne
TM
Weight.