apollo endosurgery OverStitch Sx Gebrauchsanweisung Seite 8

8.11. To continue placing stitches with this Anchor,
repeat sections 5-8.
If stitching is complete for this Anchor, proceed
to section 9 to approximate tissue, secure and
cut the Suture.
Multiple Anchors can be utilized with each
Needle Driver and Anchor Exchange.
9. Securing and Cutting Suture
9.1. Ensure Anchor is in Anchor Exchange and open
Needle Body.
9.2. Advance Anchor distal of the device until visible
on monitor.
9.3. Fully depress Anchor Release Button and retract
Anchor Exchange to release Anchor.
CAUTION: Do not release the Anchor inside
the Anchor Exchange channel.
9.4. Remove Anchor Exchange from ESS.
NOTE: The Anchor Exchange can be utilized
for additional sutures.
9.5. Feed proximal end of Suture into removable
Suture Loading Loop.
9.6. After threading, release the proximal end of the
Suture to enable loading.
9.7 . Pull Suture Loading Loop parallel to the device,
to pull Suture into Cinch.
9.8. Holding the proximal end of the Suture, feed the
Cinch down the Anchor Exchange channel until
'Plug and Collar' can be seen on the monitor.
9.9. Pull the Suture and apply counter traction to the
Cinch until the tissue is approximated and the
desired Suture tension is achieved between the
Anchor and the Cinch Collar.
NOTE: It is the Collar that sets the final
position of the Cinch, not the Plug.
WARNING: Excessive tension may damage
tissue.
9.10. While holding suture tension, remove safety
spacer from Cinch handle.
CAUTION: The safety spacer must only be
removed immediately prior to deploying
Cinch.
9.11. Firmly squeeze Cinch Handle to deploy Cinch
and cut Suture.
CAUTION: Suture tension must be
maintained during cinch deployment.
NOTE: Significant force is required to pull
and lock the Plug into the Collar, a 'pop' can
often be felt once the Suture is cut. Do not
over deploy cinch - only squeeze handle until
suture is cut.
9.12. Remove the Cinch.
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9.13. Close Needle Body.
10. Multiple Sutures
10.1. Anchor Exchange and Needle Driver can be
utilized with multiple sutures. Removal of the
endoscope after cinching is not required if
further sutures are to be deployed.
WARNING: If endoscope is removed, ensure
Endcap is secure to endoscope before
next intubation. The Endcap cannot be
repositioned or refitted to the endoscope.
10.2. To use another Suture Assembly, return to
step 4.21 for Anchor loading and follow all
subsequent steps.
If suturing is complete, proceed to section 11
for removal of the device.
11. Removal of Device
11.1. Remove any accessory devices.
11.2. Ensure the Needle Body is closed and retract
endoscope from patient, making sure the
external Sheath is retracted together with the
endoscope.
WARNING: Ensure any Actuation Catheter
slack in device is removed prior to device
removal from patient.
11.3. Insert a surgical blade through the long vertical
slot on side of Endcap and cut each Endcap
Strap.
NOTE: The vertical slot protects the
endoscope from damage during removal of
Endcap.
11.4. While looking down on endoscope face, twist
Endcap clockwise around endoscope to remove
Endcap.
11.5. Unwrap each Sheath Strap and remove Catheter
Sheath from endoscope.
11.6. Undo Handle Strap and slide Handle Bracket off
endoscope.