5.10. Fully depress Anchor Release Button to release
Anchor.
5.11. With Anchor Release Button still fully depressed,
slightly retract Anchor Exchange.
6. Tissue and Suture Management
6.1. Open Needle Body.
CAUTION: If the Needle Body does not open,
ensure that the Anchor has been released
from the Anchor Exchange.
WARNING: Ensure appropriate Suture slack
has been created for desired Suture path and
pattern. Advance Anchor Exchange and/or
manipulate endoscope to create Suture slack.
6.2. Position tissue in appropriate location for
suturing, using Apollo Helix or other 2.8mm
compatible accessory if required.
7. Use of Tissue Helix (Optional)
7 .1.
Advance Helix into Helix Channel of ESS in the
retracted position, until distal tip is visible on the
monitor.
CAUTION: If resistance is encountered
when advancing the Helix through the Helix
Channel of the ESS, reduce the endoscope
angulation until the device passes smoothly,
and ensure that the device's secondary
working channel is not obstructed.
7 .2.
Fully depress Helix Handle button to expose
Helix Tip.
CAUTION: Do not depress Helix Handle
button while advancing Helix through the
device.
7 .3.
Acquire tissue by rotating Helix Handle
clockwise until correct tissue depth is achieved.
7 .4.
Maintain gentle forward pressure during tissue
acquisition.
7 .5.
Advance / retract Helix to position tissue into
desired location.
8. Suturing
8.1. Drive Needle through tissue by closing the
Needle Body.
8.2. Ensure that the Needle Arm does not
inadvertently close on any foreign object or
device.
Retrieve Anchor
8.3. Use a 'pencil-grip' to advance the Anchor
Exchange until the Anchor is engaged and
resistance is felt.
NOTE: Resistance may vary due to the
position of the endoscope.
7
8.4. Retract Anchor Exchange to acquire Anchor.
8.5. Use a 'pencil-grip' on the white section of the
cable and place the remaining fingers of the
same hand on the device handle to prevent
damage to Suture or tissue once the Anchor
'pops' off the Needle Body.
CAUTION: Do not press the Anchor Release
Button, as this may cause inadvertant drop of
the Anchor.
WARNING: If sufficient slack has not been
created prior to driving the Anchor through
tissue, retraction of the Anchor Exchange may
be difficult and the Anchor may not release
correctly from the Needle Body.
Release Tissue
8.6. Rotate Helix handle counter-clockwise until the
device is free from tissue.
8.7 .
Return the Helix handle button.
8.8. Check monitor to ensure tip is fully retracted into
shaft before withdrawing into Helix Channel.
8.9. Withdraw Helix a short distance into Helix
Channel.
8.10. Open Needle Body.
CAUTION: Do not tension the Suture with the
Anchor in the Needle Body.