apollo endosurgery X-Tack Gebrauchsanweisung Seite 5

1. Assemble the system
1.1. Remove die card from pouch.
1.2. Remove Bracket from die card.
1.3. Slide the Bracket fitting onto the scope boot
(arrow pointing upwards).
1.4. Fix the Bracket by wrapping the Bracket Strap
(blue) above the scope channel and secure using
the pin on the Bracket.
1.5. Remove device from die card and present distal
end of device to physician.
CAUTION Control the device Handle during
handover to ensure device remains clean.
1.6. Insert device with Scope Liner into the working
channel of the scope.
NOTE: Ensure biopsy valve is OPEN and scope
is not retroflexed. Do not kink the catheter
during insertion as this might compromise
control of the HeliX Tack.
1.7 . Fully seat Scope Liner funnel in scope cap.
1.8. Remove the HeliX Tack Backer Card from the
device catheter.
1.9. Hold the Backer Card (HeliX Tack #2 top/proximal)
and attach to the Bracket fitting by inserting side
tabs.
NOTE: Ensure the Suture is not captured
between the Backer Card and Bracket.
1.10. If required, create suture slack by pulling proximal
end of the Suture and allow to work through HeliX
Tacks. To reduce suture slack, pull Suture tail in
opposing direction.
NOTE: Ensure suture slack between scope
channel funnel and Backer Card is not wrapped
around device catheter prior to attaching to
Scope Bracket.
NOTE: Should the suture become wrapped
around catheter after Backer Card attachment,
it will resolve itself once catheter is removed
for HeliX Tack re-loading.
1.11. Remove and dispose of the Scope Liner Clamp
(red) to release the Scope Liner.
CAUTION: Ensure Handle Slider is in the
'Reset' position labeled 'R' and the Push
Catheter is in the initial locked position.
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1.12. Maneuver scope to target site.
'click'
2. HeliX Tack Placement
2.1. Advance device catheter and push HeliX Tack
against tissue.
CAUTION: Ensure the Handle is in Reset
position prior to driving HeliX Tack.
NOTE: Do not retract device catheter from
the working channel whilst a HeliX Tack is
installed; this could lead to device damage or
inadvertent detachment. 'hold'
2.2. While applying forward pressure on the device
catheter, 'Drive' the HeliX Tack into tissue by
slowly PULLING Handle Slider to 'D' position until
the hard stop is reached.
WARNING: Verify position of HeliX Tack before
driving fully into tissue. Features on the HeliX
Tack, used to resist back-out after surgery, may
catch tissue and complicate repositioning after
the Helix is driven fully into tissue.
2.3. Visually verify if successful placement (location
and depth) was achieved.
NOTE: The HeliX Tack eyelet should be flush
with the mucosal surface as an indication of
correct depth.