PACKAGING AND LABELING
Inspect the MERIT ENDOTEK™ AL
IMAXX-ES™
Esophageal
Stent, the delivery catheter and the packaging for damage
prior to use. Confirm that the device is consistent with the
package label. Discard and replace any damaged devices.
DO NOT ATTEMPT REPAIR
Contact MERIT ENDOTEK™ Customer Service at 1-800-
356-3748 if the package has been opened or damaged.
STORAGE
Do not expose this device to conditions of extreme heat
and humidity. Store the MERIT ENDOTEK™ AL
IMAXX-ES™
Esophageal Stent System in a normal room temperature
environment.
HOW SUPPLIED
The disposable, single-patient-use self-expanding stents
are available, pre-mounted on the delivery catheter in a
variety of configurations.
All of the esophageal stents are mounted on a delivery
catheter.
WARNING:
The MERIT ENDOTEK™ AL
IMAXX-ES™
Esophageal Stent System is provided non-sterile.
REUSE PRECAUTION STATEMENT
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 disease(s) from one patient
to another. Contamination of the device may lead to
injury, illness or death of the patient.
DO NOT STERILIZE
Each packaged unit is intended for
SINGLE-PATIENT-USE ONLY.
For more information or to arrange for a demonstration,
contact MERIT ENDOTEK™ at 1-800-356-3748.
WARRANTY
The manufacturer warrants that reasonable care has been
used in the design and manufacture of this device. 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. 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 obligation
under this warranty is limited to the replacement of this
device; and the manufacturer shall not be liable for any
incidental or consequential loss, damage, or expense
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.
The manufacturer assumes no liability with respect to
devices that are reused, reprocessed, or resterilized, and
makes no warranties, expressed or implied, including, but
not limited to, merchantability or fitness for intended use,
with respect to such device.
RX only:
CAUTION: Federal (U.S.A.) law restricts this
device to sale by or on the order of a physician.
Single Use
