Abbott Tendyne TENDV-LP-29S, Instructions For Use Manual

Page: 15 / 284

IFU, TENDYNE TM Mitral Valve System Page 15 of 284
Figure 8. Tendyne
TM
Pad Positioning System sterile tray
component layout.
1. Positioning Handle
2. Pressure Transducer
3. 3-way Stopcock
4. 1-way Stopcock
5. Tether Load System (TLS)
4. With the Release Button on the Lead Screw
Knob fully depressed, set the indicator to “15”
relative to the printed scale on the Indicator
Window.
Figure 9. Positioning Handle knobs and actuators.
1. Pad Release Knob
2. Lock Wheel
3. Lock Wheel Release Button
4. Indicator Window
5. Lead Screw Knob
6. Lead Screw Release Button
5. Rotate the Pad Release Knob to open the arms.
6. Attach the Apical Pad with the hole in the outer
ring of the Apical Pad facing up.
7. Rotate the Pad Release Knob in the opposite
direction to close the arms and secure the
Apical Pad onto the Positioning Handle.
8. Advance the pin cam to the opening on the
Apical Pad by activating the Lock Wheel
Release Button and ensuring that the “D”
shaped pin cam engages with the opening.
9. Check pin cam movement by rotating the Lock
Wheel to the full lock position and back to the
full unlocked position.
10. Attach a 20-35mL syringe filled with 10 mL of
sterile saline to the Tether Load System (TLS).
11. With the syringe positioned vertically above
the TLS, pull vacuum to evacuate air, then push
fluid into the System.
12. Repeat this process until minimal bubbles are
observed. Remove syringe from TLS.
13. Align the Pressure Transducer to the holder
without twisting the pressure tube.
Do not clip into the holder.
14. Attach the 1-way stopcock onto the Pressure
Transducer. Re-attach the syringe to the 1-way
stopcock.
15. Hold the System vertically and repeat the air
evacuation procedure.
16. Once air is evacuated, slightly pressurize the
System, lock the 1-way stopcock, and then
remove the syringe.
CAUTION: Do not over pressurize the TLS. Very
little pressure is needed.
17. Clip the Pressure Transducer into the holder
and place the System on a level surface.
Connect Pressure Transducer cable to
interconnect cable.
18. Open the 1-way stopcock to atmosphere and
zero.
19. After the System is zeroed, close the 1-way
stopcock.
20. Verify prep by attaching the weight to the TLS
using the Verification Tether. Insert leader
through the knotted loop on the tether
braided. Place loop of the Verification Tether
around groove in the 2 lb. Weight and tighten.
Insert the leader of the Verification Tether
through the threaded hole on the bottom of
the TLS until the tether braid is clear of the TLS.
Slide tab on the TLS Pin to pin the tether braid.