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

Page: 16 / 284

IFU, TENDYNE TM Mitral Valve System Page 16 of 284
Holding the TLS from the bottom surface, lift
until the weight is clear of the table.
If weight does not verify an acceptable signal,
repeat steps 7 to 12 once. If weight does not
verify an acceptable signal after a second
evacuation, discard unit start with a new
System.
2 lb. weight – pressure monitor 120 mmHg
(+/ - 15 mmHg)
21. Remove the Verification Tether by retracting
the slide tab to release the TLS Pin and pull the
Verification Tether through the TLS, and attach
the TLS to the Positioning Handle.
CAUTION: Ensure the TLS Pin is not engaged
after the TLS has been attached to the
Positioning Handle. If the TLS Pin is engaged it
may interfere with the nitinol leader joint and
could result in damage to the Pin.
10.5. Preparing the Delivery System Handle and
Collapsible Dilator
1. Remove sterile tray from Delivery System
packaging. Inspect and remove contents to
sterile table.
Figure 10. Tendyne Delivery sterile tray component
layout.
1. Delivery Sheath
2. Introducer Needle
3. Collapsible Dilator
4. Delivery Handle
5. Hemostasis Valve Adapter
6. Tuohy-Borst with extension
7. 1-way Stopcock
8. 3-way Stopcock
2. Attach the Hemostasis Valve to the Delivery
Sheath side port.
3. Attach a 3-way stopcock to the Collapsible
Dilator hub.
4. Carefully remove the protector from the
Collapsible Dilator.
5. Prepare diluted contrast solution
(30/70 contrast/saline).
6. Fill a balloon inflation device with at least
5-10 ml of the contrast solution.
7. Attach the balloon inflation device to the 3-way
stopcock.
8. Using standard balloon preparation
techniques, prepare the Collapsible Dilator to
remove air and close the 3-way stopcock.
9. Refill the inflation device with 20 ml of contrast
solution.
10. Insert the Collapsible Dilator into the
Hemostasis Valve on the Delivery Sheath until
the strain relief on the Collapsible Dilator hub
abuts the Hemostasis Valve housing.
10.6. Preparing the Loading System
1. Remove sterile tray from Loading System
Package. Inspect components and remove
from tray.
Figure 11. Tendyne Loading System sterile tray component
layout.
1. Centering Cap Assembly
2. Tether Clip
3. Loading Tube
4. Loading Funnel