Taewoong Uventa Urethral Stent Manual Del Usuario página 3

English
1. Description
TM
Uventa Urethral Stent consists of the implantable full covered metallic Stent and
introducer system. Uventa
mesh tubular prosthesis which has radiopaque markers on each end and at the center.
The Stent is loaded in the introducer system. Upon deployment, the Stent imparts an
outward radial force on the luminal surface of the spongy urethra to establish patency
(See Figure 1).
2. 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. Purpose of Use
TM
Uventa Urethral Stent is intended for maintaining urethral patency in benign and
malignant urethral obstruction.
Indication for Uventa
Traumatic, inflammatory, iatrogenic urethral strictures or unknown etiology
WARRANTY
Taewoong Medical Co., Ltd. warrants that reasonable care has been applied within the
design and subsequent manufacturing process of this instrument was applied. This
warranty is in lieu of and excludes all other warranties not expressly set forth herein,
whether expressed or implied by the operation of law or otherwise, including, but not
limited to, any implied warranties of merchantability or fitness for a particular purpose.
Handling, storing, cleaning and sterilizing of this instrument as well as other factors
relating to the patient, diagnosis, treatment, surgical 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 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, and any
other or additional liability or responsibility in connection with this instrument.
Taewoong assumes no liability with respect to instruments reused, reprocessed or re-
sterilized, 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 use of Uventa
 Patients who had radical retropubic prostatectomy due to prostate cancer
 Patients with serious neurogenic bladder
 Patients with septicemia due to urinary tract infection
 Patients who showed adverse metallic Stent reaction (Serious urinary tract
infection, repeatable migration of Stent, or foreign body sensation) after installing
Stent
 Patients with urethral perforation or abscess (Exceptionally, metallic Stent can be
installed for treatment of urethral perforation by the doctor's discretion)
 Patients with suspected or impending perforation
 Patients who have been treated due to acute urethral infection
 Recapturing a stent during its deployment is contraindicated.
5. Warnings
 The Stent contains nickel, which may cause allergic reactions in individuals with
nickel sensitivity.
 Do not expose the introducer system to organic solvent (e.g. Alcohol)
 Uventa Urethral Stent can be removed when the doctor's clinical assessment
TM
indicates that the Stent can be safely removed. Caution should be exercised in
deciding to and when removing the Stent.
 Uventa
TM
Urethral Stent cannot be removed when tumor in-growth/over-
growth/occlusion of the Stent lumen is present.
User's Manual
TM
Urethral Stent is made of Nitinol wire. It is a flexible, fine
Model Name
Uventa
Figure 1 Introducer System
TM
Urethral Stent:
TM
Urethral Stent is prohibited for, including but not limited to:
TM
Urethral Stent