Merit Medical Endotek ALIMAXX-B Instrucciones De Uso página 4

WARRANTY
The manufacturer warrants that reasonable care has been used in the design
and manufacture of this device. This warranty is exclusive and manufacturer
makes no other representations or warranties of any kind to customers, its end
users, or to any third parties with respect to the device and hereby expressly
disclaims any and all other warranties, express or implied, statutory or
otherwise, including, but not limited to, infringement and the implied warranties
of merchantability and fitness for a particular purpose, even if manufacturer is
aware of such purpose. Handling and storage of this device, as well as other
factors relating to the patient, diagnosis, treatment, implant procedures, and
other matters beyond the control of the manufacturer, directly affect the device
and the results obtained from its use. The manufacturer's obligation under this
warranty is limited to the replacement of the device. Under no circumstances
shall manufacturer be liable to customer or any other person or entity for any
punitive, special, incidental or consequential damages directly or indirectly
arising from the use of this device. The manufacturer neither assumes, nor
authorizes any other person to assume for it, any other or additional liability
or responsibility in connection with this device. This warranty shall not apply,
and manufacturer assumes no liability with respect to, devices that have been (i)
modified, changed, altered, misused, mishandled, repaired, reused, reprocessed,
refurbished or resterilized; (ii) subjected to improper maintenance, testing or
storage, accident, tampering, or inadequate protection against shock, vibration,
excessively high or low temperatures, overpressure, or physical, environmental
or electrical stress; (iii) been used outside the approved "Indications for Use" as
cleared by the relevant competent authority, used contrary to the use outlined
in the device specifications, or in an application or environment for which such
device was not designed or contemplated; or (iv) distributed or used contrary to
applicable federal, state, local or regulatory standards.
figure 1. Radiopaque markers are located at both ends
of the ALIMaXX-B® Uncovered Biliary Stent.
figure 2. There are 5 radiopaque regions present on the
ALIMaXX-B® Uncovered Biliary System.
figure 3. Position the distal end of the endoscope in the
duodenum near the major duodenal Papilla of Vater.
figure 4. Using fluoroscopy, locate the proximal and
distal ends of the stricture.
figure 5. Insert the guide wire through the
endoscope into the bile duct system and through the
stricture.
STENT
RADIOPAPAQUE
figure 6. Flush the delivery system with saline
MARKER
solution through the luer port.
figure 7 . Using radiopaque markers as a guide,
position the stent across the stricture.
figure 8. The delivery system has two deployment triggers
which allow the user to deploy the stent in 2 steps.
figure 9. Hold the handle in the palm of your hand.
Using the index and middle finger, grasp the first
deployment trigger.
figure 10. Slowly retract the outer sheath by pulling
back on the first deployment trigger until it touches
the handle.
figure 11. After confirming the stent position, use
your index and middle finger to grasp the second
deployment trigger.
figure 12. Pull the second deployment trigger until the
trigger touches the handle. The stent is now fully
deployed.
Single Use
MR
MR Conditional
Non-pyrogenic
Sterile if package s unopened or undamaged
The ALIMAXX-B Uncovered Biliary Stent is
contraindicated for: ALL CARDIOVASCULAR
APPLICATIONS
r X onlY
caUtIon: Federal (USA) law restricts this
device to sale by or on the order of a physician.
US and foreign patents issued and pending
ALIMaXX-B® is a trademark of Merit Medical Systems,
Inc. © 2009 Merit Medical Systems, Inc.