Remove Endcap Clip
4.16. While securing Endcap, twist Endcap Clip
counter-clockwise (indicated by arrows) to
remove from Endcap.
4.17 . Discard Endcap Clip.
Trim Excess Endcap Straps
WARNING: Confirm the concealed ends of
both Endcap Straps are fully recessed within
the Endcap.
4.18. Use a surgical blade to trim the excess lengths
of both Endcap Straps flush with the Endcap
surface.
Install Biopsy Valves
4.19. Fit standard biopsy valves to all endoscope and
device working channels.
4.20. The biopsy valve for the Anchor Exchange
(outside) channel should be in the open position.
Load Anchor
4.21. Select appropriate Suture.
4.22. Remove Suture Assembly and Anchor Exchange
from packaging.
4.23. Load the Anchor onto the Anchor Exchange.
4.24. Remove Suture from Suture Cartridge by holding
and pulling the Suture, not the Anchor or Anchor
Exchange.
NOTE: Ensure Suture is not tangled after
removal from the cartridge.
4.25. Insert Anchor Exchange into the open Anchor
Exchange (outside) channel of the device.
CAUTION: Do not use when valve covers are
closed as Suture drag will be increased.
4.26. Using a 'pencil-grip' on the catheter for optimum
control, advance Anchor Exchange until Anchor is
positioned near to the distal end of the device.
CAUTION: If resistance is encountered when
advancing the Anchor Exchange through
the Anchor Exchange Channel, reduce the
endoscope angulation until the device passes
smoothly.
Lubricate Device
4.27 . Fully lubricate the distal 50cm of the installed
device and endoscope, and full length of the
inner walls of the overtube.
WARNING: Use of an appropriate overtube
(with an inner diameter of at least 16.7 mm)
is recommended for transoral procedures.
WARNING: Confirm installed device is of
compatible size with overtube prior to use.
4.28. Insert endoscope into patient.
WARNING: Do not introduce the device with
the Needle Body in its open position.
5. Navigating to target anatomy
5.1. Advance until target anatomy is located.
CAUTION: When intubating or extubating
with the Endoscopic Suturing System, ensure
that the working length of the endoscope and
the external Sheath are advanced or retracted
together and any slack in Actuation Catheter
is removed.
CAUTION: Do not articulate endoscope
without device accessories installed up to
the distal end of the primary channel and
secondary channel (if in use) as this may
result in minor kinking of catheters.
6
5.2. Open Needle Body.
5.3. Advance Anchor Exchange and/or manipulate
endoscope to create Suture slack.
5.4. Once sufficient slack has been created, retract
Anchor Exchange into the device.
5.5. Close Needle Body.
5.6. Use a 'pencil-grip' on the white portion of the
cable to advance Anchor Exchange until Anchor
fully seats onto Needle Body.
5.7 .
A tactile 'click' or firm stop may be felt as the
Anchor seats fully onto Needle Body.
5.8. Check the monitor image to ensure Anchor is
properly installed on Needle Body.
5.9. Ensure that the proximal end of the Suture is
visible beyond the Handle channel valves.