LeMaitre 2107-80 Instrucciones De Uso página 4

placement and inflation.
Caution:
1. Overinflation of the balloon may cause vessel damage.
2. The fluid in the syringe should be checked before each inflation. If the amount exceeds the
stated capacity, remove the syringe and refill to the proper volume. The amount of fluid
remaining in the catheter must be taken into account.
Withdrawing the Catheter
1. To deflate the balloon, open the stop-cock and pull back on the plunger of the
syringe. Withdraw the catheter from the insertion point.
Storage Shelf Life
The shelf life is indicated by the USE BY date on the package label. The Use By date printed on
each label is NOT a sterility date. The Use By date is based on the normal life expectancy of
the natural latex balloon when properly stored. The use of the catheter beyond the expira-
tion date is not recommended because of potential balloon deterioration. LeMaitre Vascular,
Inc. does not make provisions for replacing or reprocessing expired product.
Since natural rubber latex is affected by environmental conditions, proper storage proce-
dures must be practiced to achieve optimum shelf life. The product should be stored in a cool
dark area away from fluorescent lights, sunlight, and chemical fumes to prevent pre-mature
deterioration of the rubber balloon. Proper stock rotation should be practiced.
Re-sterilization/Repackaging
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 of 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.
If for any reason this device must be returned to LeMaitre Vascular, place it in its original
packaging and return it to the address listed on the box.
Limited Product Warranty; Limitation of Remedies
LeMaitre Vascular, Inc. warrants that reasonable care has been used in the manufacture
of this device. Except as explicitly provided herein, LEMAITRE VASCULAR (AS USED IN THIS
SECTION, SUCH TERM INCLUDES LEMAITRE VASCULAR, INC., ITS AFFILIATES, AND THEIR RE-
SPECTIVE EMPLOYEES, OFFICERS, DIRECTORS, MANAGERS, AND AGENTS) 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 MER-
CHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE) AND HEREBY DISCLAIMS THE SAME.
LeMaitre Vascular makes no representation regarding the suitability for any particular
treatment in which this device is used, which determination is the sole responsibility of the
purchaser. This limited warranty does not apply to the extent of any abuse or misuse of, or
failure to properly store, this device by the purchaser or any third party. The sole remedy for
a breach of this limited warranty shall be replacement of, or refund of the purchase price for,
this device (at LeMaitre Vascular's sole option) following the purchaser's return of the device
to LeMaitre Vascular. This warranty shall terminate on the expiration date for this device.
IN NO EVENT SHALL LEMAITRE VASCULAR BE LIABLE FOR ANY DIRECT, INDIRECT, CONSEQUEN-
TIAL, SPECIAL, PUNITIVE, OR EXEMPLARY DAMAGES. IN NO EVENT WILL THE AGGREGATE
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 (US$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 Instruc-
tions 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.