LeMaitre NovaSil Instrucciones De Uso página 3

Complications
In common with other catheterization procedures, complications may oc-
cur. These may include intimal disruption, vessel wall perforation, balloon
rupture with fragmentation, tip separation, local or systemic infection,
arterial thrombosis, local hematomas, air embolus, plaque, arterial dissec-
tion, and hemorrhage.
Storage
Store the catheters in a dry, dark area away from heat and chemicals.
Resterilization/Re-use
This device is single-use only. Do not reuse, reprocess, or re-sterilize. The
cleanliness and sterility of the re-processed device cannot be assured. Reuse
the device may lead to cross contamination, infection, or patient death.
The performance characteristics of the device may be compromised due to
reprocessing or re-sterilization since the device was only designed and tested
for single use. The shelf life of the device is based on single use only.
Warranty Coverage
LeMaitre Vascular, Inc., warrants that reasonable care has been used in
the manufacture of this device. Other than as explicitly provided herein,
LEMAITRE VASCULAR MAKES NO EXPRESS OR IMPLIED WARRANTIES WITH
RESPECT TO THIS DEVICE, WHETHER ARISING BY OPERATION OF LAW OR
OTHERWISE, INCLUDING WITHOUT LIMITATION, ANY IMPLIED WARRANTY OF
MERCHANTABILITY OR FITNESS FOR A PERTICULAR PURPOSE AND HEREBY
DISCALIMS THE SAME. LeMaitre Vascular makes no representation regarding
the suitability for any particular treatment in which the product is used, which
is the sole responsibility of the purchaser.
IN NO EVENT SHALL LEMAITRE VASCULAR (AS USED IN THIS PARAGRAPH,
INCLUDING ITS EMPLOYEES, OFFICERS, DIRECTORS, OR AFFILIATES) BE
LIABLE FOR ANY DIRECT, INDIRECT, CONSEQUENTIAL, SPECIAL, PUNITIVE
OR EXEMPLARY DAMAGES. IN NO EVENT WILL THE LIABILITY OF LEMAITRE
VASCULAR WITH RESPECT TO THIS DEVICE, HOWEVER ARISING, UNDER ANY
THEORY OF LIABILITY, WHETHER IN CONTRACT, TORT, STRICT LIABILITY OR
OTHERWISE, EXCEED ONE THOUSAND DOLLARS ($1,000), REGARDLESS OF
WHETHER LEMAITRE VASCULAR HAS BEEN ADVISED OF THE POSSIBILITY OF
SUCH LOSS, AND NOTWITHSTANDING THE FAILURE OF THE ESSENTIAL PURPOSE
OF ANY REMEDY. THESE LIMITATIONS APPLY TO ANY THIRD-PARTY CLAIMS.
A revision or issue date for these instructions is included on the back page
of these Instructions for Use for the user's information. If twenty-four (24)
months has elapsed between this date and product use, the user should
contact LeMaitre Vascular to see if additional product information is available.