LeMaitre Pruitt F3-S Mode D'emploi page 6

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 Shunt when properly stored. The use of the Shunt beyond the expiration
date is not recommended because of potential bond deterioration. LeMaitre Vascular, Inc. does not make provisions for replacing or
reprocessing expired product.
Proper storage procedures must be practiced to achieve optimum shelf life. The product should be stored in a cool dark area. Proper
stock rotation should be practiced.
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.
Safe Handling and Disposal
This device is single-use and disposable device. Do not implant. Please return the used device only at the time that the device has not performed
as intended or the device is related to an adverse event. In other situations, the device should not be returned but disposed according to local
regulations.
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 sharps, heavy metals or radioisotopes, and is not infectious or pathogenic. No special requirements for disposal are
evident. Please consult local regulations to verify proper disposal.
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:
LeMaitre Vascular
Attn: Complaint Lab
63 Second Avenue
Burlington, MA 01803
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 specifi ed 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
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