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Gravity Displacement:
•
270-275°F (132-135°C),
•
10 minutes, 27-30 Psi (2.1 kg/cm2)
EtO-Sterilization:
•
126-136°F (52-57°C)
•
Relative Humidity: 35-70%
•
Gas Concentration: 736 mg/l
•
Exposure Time: 120 minutes
•
Post Vacuum: 24 ±2 Hg - two times
•
Aeration: 11 hours minimum
Disinfectant: Follow manufacturer's recommendations. Disinfection is not a substitute for sterilization.
NOTE: These are suggested parameters only. The chosen sterility method must be validated with chemical or biological
indicators to ensure sterility.
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 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. 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 repair or replacement of 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 date that is three months from the
date of invoice for such 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.
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