Taewoong Niti-S Tracheal Uncovered Stent Manual Del Usuario página 3

English
1. Description
The Niti-S Tracheobronchial 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.
Niti-S Tracheal Uncovered Stent
Niti-S Tracheal Covered Stent
Niti-S Bronchial Uncovered Stent
Niti-S Bronchial Covered Stent
Figure1.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
trachea and/or bronchus to establish patency. There are two
introducer systems either Fr sizes. (See Figure 2, 3)
Niti-S Full Covered Tracheobronchial Stents used in benign
stricture can be removed; (see Warnings).
Niti-S Full Covered Tracheobronchial stents can be repositioned
after deployment (see Warnings).
Figure 2. Introducer System (12Fr. or less)
LOCKING SYSTEM(VALVE)
Figure 3. Introducer System (14Fr. or more)
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 (2
towards the hub. Retraction of the outer sheath releases the stent.
3. Indication for Use
The Niti-S Tracheobronchial Stent is intended for maintaining
Tracheal or bronchial luminal patency in tracheobronchial
stricture caused by intrinsic and/or extrinsic malignant and/or
benign stricture.
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
User's Manual
Model Name
nd
inner catheter)