Le Maitre 1009-00 Mode D'emploi page 5

If serious medical incidents should arise during use of this medical device, users should notify both LeMaitre Vascular
and the Competent Authority of the country where the user is located.
This product contains no heavy metals or radioisotopes, and is not infectious or pathogenic. Please consult local regulations to verify
proper disposal of sharps.
Cleaning:
1. Devices considered necessary to return should be cleaned using one of the following:
a) Sodium hypochlorite solution (500-600 mg/l), or
b) Peracetic acid solution with subsequent ultrasonic treatment
2. Devices should then be decontaminated with either:
a) 70% solutions of ethanol or isopropanol for a minimum of 3 hours or,
b) Ethylene oxide gas
3. Devices should be completely dried prior to packaging.
Packaging:
1. Cleaned devices 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. For devices capable of penetrating
or cutting skin or packaging material, the primary packaging must be capable of maintaining the product without
puncture of the packaging under normal conditions of transport.
2. The sealed primary container should be placed inside watertight secondary packaging. The secondary packaging
should be labelled with an itemized list of the contents of the primary receptacle. Cleaning methods should be
detailed if possible.
3. Both primary and secondary packaging of cleaned, decontaminated single-use disposable devices should be
labelled with an ISO 7000-0659 Biohazard symbol.
4. Primary and secondary packaging must then be packaged inside an outer package, which must be a rigid,
fi berboard box. The outer shipping container must be provided with suffi cient cushioning material to prevent
movement between the secondary and outer containers.
5. Shipping paper and content marking for the outer shipping container are not required.
6. 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 WARRANTY 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.
These limitations do not apply to consumers in Australia or to the extent they are precluded by local law in any other jurisdiction.
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