Taewoong Niti-S Tracheal Uncovered Stent Manual Del Usuario página 4

procedures, and other matters beyond Taewoong's control directly
affect the instrument and the results obtained from its use.
Taewoong's obligation under this warranty is limited to the repair
or replacement of this instrument and Taewoong shall not be
liable for any incidental or consequential loss, damage, or expense
directly or indirectly arising from the use of this instrument.
Taewoong neither assumes, nor authorizes any other person to
assume for it, any other or additional liability or responsibility in
connection with this instrument. Taewoong assumes no liability
with respect to instruments reused, reprocessed or resterilized and
makes no warranties, expressed or implied, including but not
limited to merchantability or fitness for a particular purpose, with
respect to such instruments.
4. Contraindication
The Niti-S Tracheobronchial Stent is contraindicated for, but is not
limited to;
· Placement in polypoid lesions.
· Patient with bleeding disorder.
· Intra-abdominal abscess/perforation.
· Patients with coagulopathy
· Strictures that do not allow passage of a guidewire.
· Any use other than those specifically outlined under indications
for use.
· Removal or repositioning of fully deployed uncovered Stents is
contraindicated. (See Warnings).
· Suspected or impending perforation.
· Recapturing a stent during its deployment is contraindicated.
5. Warnings
· The device should be used with caution and only after careful
consideration in patients with elevated bleeding times,
coagulopathies, or in patients with radiation colitis or proctitis.
· Chemoradiation therapy or radiotherapy alone may lead to
tumor shrinkage and subsequent stent migration.
· The stent containes nickel, which may cause an allergic reaction
in individuals with nickel sensitivity.
· Do not expose the introducer system to organic solvent (e.g.
Alcohol)
· Do not use with Ethiodol or Lipiodol contrast media.
· Niti-S Full Covered Stents can be removed where the treating
doctor's clinical assessment of the stented stricture indicates the
Stent can be safely removed. Caution should be exercised in
deciding to and when removing the Stent.
· Niti-S Full Covered Stent cannot be removed when there is
tumor in-growth/over-growth/occlusion of the Stent lumen.
· Niti-S Full Covered Stent can be repositioned immediately after
deployment.
· Uncovered/bare Stents should not be removed once fully
deployed, (See Contraindications).
· Do not attempt to recapture/reload a stent once its deployment is
advanced.
6. Potential complications
Potential complications associated with the use of Niti-S Stent
may include, but are not limited to:
Procedural Complications
· Bleeding
· Stent misplacement
· Pain
· Death (other than that due to normal disease progression)
· Perforation
· Deployment failure