English
User’s Manual
1. Description
The Niti-S & ComVi Biliary Stent consists of the implantable
metallic stent and introducer system.
The stent is made of Nitinol wire. It is a flexible, fine mesh
tubular prosthesis which has radiopaque markers on each end and
at the center.
Model Name
Niti-S Biliary Uncovered Stent
Niti-S Biliary Covered Stent
ComVi Biliary Stent
Figure 1.Stent Model
The Stent is loaded in introducer system and upon deployment the
stent imparts an outward radial force on the luminal surface of the
bile duct to establish patency.
Niti-S Full Covered Biliary Stents used in benign stricture can be
removed; (see Warnings).
Full Covered Biliary Stents can be repositioned after deployment
(see Warnings).
Figure 2.Introducer System
(Percutaneous & Endoscopic)
- The percutaneous introducer system has a usable length of 50cm
- The endoscopic introducer system has a usable length of 180cm
Percutaneous
Type is recommended
-
When approached percutaneously
Endoscopic
Type is recommended
-
When approached endoscopically
2. Principle of Operation
The outer sheath is pulled back by immobilizing the hub in one
hand, grasping the Y-connector with the other hand, and gently
sliding the Y-connector along the pusher towards the hub.
Retraction of the outer sheath releases the stent.
3. Indication for Use
The Niti-S & ComVi Biliary Stent is intended for maintaining
biliary luminal patency in malignant strictures.
The Niti-S Fully Covered Biliary Stent is intended for
maintaining biliary luminal patency in malignant and/or benign
strictures.
The Bumpy Stent [TKxxyyCW or BKxxyyCW] is intended for
use in malignant and/or benign biliary strictures and benign
pancreatic ductal strictures.
WARRANTY
Taewoong Medical Co., LTD. warrants that reasonable care has
been applied within the design and subsequent manufacturing
process of this instrument. This warranty is in lieu of and
excludes all other warranties not expressly set forth herein,
whether expressed or implied by operation of law or otherwise,
including, but not limited to, any implied warranties of
merchantability or fitness for a particular purpose. Handling,
storage, cleaning and sterilization of this instrument as well as
other factors relating to the patient, diagnosis, treatment, surgical
HOLE
(Shortwire
Introducer)