Taewoong Niti-S User Manual page 8

CAUTION Do not push forward or pull backward on the
Connector with the stent partially deployed. The Connector must
be securely immobilized. Inadvertent movement of the Connector
may cause misalignment of the stent and possible damage to the
colorectum.
⑤ After Stent Deployment
a) Examine the stent fluoroscopically and/or endoscopically to
confirm expansion.
b) Carefully remove the introducer system, guidewire and
endoscope from the patient. If excessive resistance is felt
during removal, wait 3~5 minutes to allow further stent
expansion (Place the inner sheath back into the outer sheath
as the original state prior to removal.)
c) Balloon dilatation inside the stent can be performed if on
demand.
11. Perform routine post implant procedure
a) Assess the size and stricture of the Stent lumen. A Stent may
require up to 1 to 3 days to expand fully.
b) Doctor's experience and discretion can determine the
appropriate drug regimen for each patient.
c) After implantation, patient should remain on a soft diet until
otherwise determined by the treating doctor.
d) Observe the patient for development of any complications.
12. Instructions for removal of Niti-S Full Covered Stents (see
Warnings)
Visually examine the Stent for any tumor in-growth/over-growth
into the Stent lumen or whether the Stent is occluded. If the Stent
lumen is clear, carefully remove using a forcep and/or snare.
Grasp the retrieval string and/or collapse the proximal end of the
Stent then carefully retrieve the Stent. If the Stent cannot be easily
withdrawn, do not remove the Stent.
Caution: Do not allow excessive force to remove the stent as it
may cause disconnect to the retrieval string.
To reposition a Niti-S & ComVi Full Covered Stent immediately
after deployment, use forceps or a snare to grasp the retrieval
string and gently adjust to the correct placement.
Please note: the stent can only be repositioned and/or removed
proximally.
Reuse Precaution Statement
Contents supplied STERILE (ethylene oxide (EO)). Do not use if
sterile barrier is damaged. In the event of damaged packaging,
call your Taewoong Medical Co., Ltd. representative. For single
patient use only. Do not reuse, reprocess or resterilize. Reuse,
reprocessing or resterilization may compromise the structural
integrity of the device and/or lead to device failure which, in turn,
may result in patient injury, illness or death. Reuse, reprocessing
or resterilization may also create a risk of contamination of the
device and /or cause patient infection or cross infection, including,
but not limited to, the transmission of infectious diseases from
one patient to another. Contamination of the device may lead to
injury, illness or death of the patient.
Storage: Store at room temperature
Disposal Requirements: The Niti-S & ComVi Stent's contained
introducer system. At the end of its used device it must be
properly disposed of in compliance with local or hospital
regulations that it is appropriately packaged and secured.
(10~40℃).