Taewoong Niti-S Manual Del Usuario página 6

A thorough understanding of the techniques, principles, clinical
applications and risks associated with this procedure is necessary
before using the device.
 Care should be taken when removing the introducer system and
guidewire immediately after stent deployment since this may
result in stent dislodgement if the stent has not been adequately
deployed.
 Care should be taken when performing dilation after the Stent
has been deployed as this may result in perforation, bleeding,
Stent dislodgement or Stent migration.
 The packaging and the device should be inspected prior to use.
 Use of fluoroscopy is recommended to ensure correct placement
of the device.
 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
Examine stricture fluoroscopically and/or endoscopically.
a) Carefully examine both the proximal and distal segment of
stricture fluoroscopically.
b) The Internal luminal diameter should be measured exactly
with fluoroscope.
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 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.
Stent Deployment Preparation
- The Niti-S & ComVi Stent can be placed with the aid of
fluoroscopy and/or endoscopy.
- Pass a 0.038" (0.97mm) guidewire to the level of the stricture.
- Pass a 0.035" (0.89 mm) guidewire to the level of the
stricture.
a) Under the fluoroscopy guidance, insert a guide wire across
the 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.