Taewoong Niti-S User Manual page 6

· Check the expiration date "Use by". Do not use the device
beyond the use by date.
· The Niti-S & ComVi Stent is supplied sterile. Do not use if the
packaging is opened or damaged.
· The Niti-S & ComVi Stent is intended for single use only. Do
not resterilize and/or reuse the device.
9. Instructions in the event of Damage
WARNING: Visually inspect the system for any sign of damage.
DO NOT USE if the system has any visible signs of damage.
Failure to observe this precaution may result in patient injury.
10. Procedure
① Examine stricture endoscopically and fluoroscopically
a) Carefully examine both the proximal and distal segment of
stricture endoscopically and/or fluoroscopically.
b) The Internal luminal diameter should be measured exactly
with endoscope and/or fluoroscope.
② Stent Size Determination
a) Measure the length of the target stricture.
b) Select a stent size that is 20 to 40mm longer than the
measured length of the stricture in order to cover fully both
ends of the lesion.
c) Measure the diameter of the reference stricture - it is
necessary to select a stent which has an unconstrained
diameter about 1 to 4mm larger than the largest reference
target diameter, to achieve secure placement.
③ Stent Deployment Preparation
- The Niti-S & ComVi Stent can be placed with the aid of
fluoroscopy, and/or endoscopy.
- Pass a 0.035" (0.89 mm) guidewire to the level of the
stricture. (TTS)
- Pass a 0.038" (0.97 mm) guidewire to the level of the
stricture. (OTW)
A. TTS procedure
a) Under the endoscopic guidance, insert an endoscope to the
level of the obstruction, then introduce the guide wire
through the working channel of the endoscopy. Advance until
the guide wire across the target stricture to where the stent
introducer system will be placed over the guide wire.
b) Remove the stylet from the distal end of the introducer.
c) Ensure that the valve of Y-connector connecting the inner
sheath and outer sheath is locked by rotation proximal valve
end in a clockwise direction to prevent premature stent
deployment.
d) Flush the inner lumen of introducer system.
B. OTW procedure
a) Remove the stylet from the distal end of the introducer.
b) Under the fluoroscopy guidance, insert a guide wire across
the stricture to where the stent introducer system will be
placed over the guide wire.
c) Ensure that the valve of Y-connector connecting the inner
sheath and outer sheath is locked by rotation proximal valve
end in a clockwise direction to prevent premature stent
deployment.