LeMaitre XenoSure 0.6BV8 Mode D'emploi page 5

Explantation:
1. Explanted XenoSure patches should be directly transferred to a sealable container filled with a solution of alkaline buffered 2% glutaraldehyde or
4% formaldehyde prior to shipment.
2. Cleaning of explanted patches should be minimal if necessary. Proteolytic digestion should not be used in any circumstances.
3. XenoSure explants should not be decontaminated under any circumstances. DO NOT autoclave the sample or use ethylene oxide gas to
decontaminate.
Packaging:
1. Explants should be sealed and packed in a manner that minimizes potential for breakage, contamination of the environment or exposure to those
handling such packages during transit. Material that is absorbent and is cushioning should be selected for isolating the sealable container inside the
secondary packaging. Primary and secondary packaging must then be packaged inside an outer package.
2. Explants in sealed primary containers should be labeled with an ISO 7000-0659 Biohazard symbol. The same symbol should be attached to the
secondary packaging and to the outer packaging. Outer packaging should also be labelled with Name, Address and Telephone Number of Sender,
and the statement, "Upon discovery of damage or leakage, the package should be isolated and sender notified".
3. Packages prepared in the above manner may be shipped to:
Limited Product Warranty; Limitation of Remedies
LeMaitre Vascular, Inc. warrants that reasonable care has been used in the manufacture of this device and that this device is suitable for the indication(s)
expressly specified in these instructions for use. Except as explicitly provided herein, LEMAITRE VASCULAR (AS USED IN THIS SECTION, SUCH TERM INCLUDES
LEMAITRE VASCULAR, INC., ITS AFFILIATES, AND THEIR RESPECTIVE 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 WAR-
RANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE) AND HEREBY DISCLAIMS THE SAME. 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, CONSEQUENTIAL, 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 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.
LeMaitre Vascular
Attn: Complaint Lab
63 Second Avenue
Burlington, MA 01803
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