Abbott Tendyne Gebrauchsanweisung Seite 24

CAUTION: Do not damage the pocket fabric or
the leaflets.
23. Align the anterior aspect of the valve cuff
(raised portion) to the Loading Funnel cutout
(Figure 13).
Figure 13. Top down view of valve in Loading Funnel
1. Raised portion of valve
2. Funnel Cutout
24. If a Tendyne Mitral Valve LP is being
loaded, replace the Centering Cone and
attach the Small Inner Centering Cone to the
Centering Rod.
If a standard Tendyne Mitral Valve is being
loaded, do not replace the Centering Cone.
Screw the Centering Cap assembly onto the
Loading Funnel with the Centering Cone fully
retracted, then, while holding the Centering
Rod loosen the thumb screw and gently lower
the Centering Cone in contact with the valve.
10.7. Loading the Valve
1. Rotate the Loading Handle Knob
counterclockwise to compress the valve into
the Loading Tube.
2. Ensure the Centering Cone supports the valve
as it is compressed by gently applying force to
the Centering Rod until the rod reaches its
stop, and then tighten the thumb screw.
3. Continue rotating the Loading Handle Knob
until the stop is reached and the valve is fully
loaded.
TM
IFU, TENDYNE Mitral Valve System
CAUTION: Note time upon completion of this
step. Do not keep the valve loaded in the
Loading Tube longer than 15 minutes. If the
valve is in the Loading Tube longer than
15 minutes, discard the valve and prep a new
valve.
4. Confirm that the tether leader connection is
still visible in the Loading Handle extension
tube.
CAUTION: If the tether leader is not visible in
the Loading Handle extension tube when the
valve is fully loaded, discard the valve and prep
a new valve.
5. Remove Centering Cap assembly. Place Closed
Cap on Loading Funnel.
10.8. Moving the Loading Tube to the Delivery System
Handle
1. Remove the Loading Funnel from the Loading
Tube by unthreading the Loading Funnel collet
connecting the Loading Funnel to the Loading
Tube.
2. Turn the Loading Funnel to the side and keep
the funnel over the Loading Stand Base to
control saline spillage.
3. Ensure the Delivery Sheath side port aligns
with the Loading Tube black mark and attach
the sheath to the Loading Tube by tightening
the collet.
4. Attach saline line to the Hemostasis Adapter on
the Sheath Side Port.
5. Fill the sheath with saline.
NOTE: Do not turn off the saline flush to the
sheath side port.
6. Inflate the collapsible dilator to 4-5 atm to seal
off the end of the sheath, while continuing to
flush through the sheath side port.
7. Close all stopcocks to turn off the flush.
8. Place the sheath and Loading Tube assembly
into the Angled Clip – Clip 3.
9. Remove the tether clip and loosen the Tuohy-
Borst valve.
10. Pull the Loading Handle Knob to disengage
while turning the knob clockwise one complete
rotation. Remove the Knob Retention Thumb
Screw and remove the Loading Handle Knob
from the Loading Handle.
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