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Follow the recommendations of the manufacturer of the ltered sterilization containers for the proper placement
and use of cases and trays inside the container.
Contraindications
The TRIVEX Sterilization Tray has NOT been validated for use with exible endoscopes, or devices with lumens or
working channels longer than 4 inches (3mm ID). Always refer to instrument manufacturer instructions.
The TRIVEX Sterilization Tray has NOT been validated for ETO sterilization of devices with lumens or working channels
longer than 8 1/2 inches (1.5mm ID). Always refer to instrument manufacturer instructions.
Stacking trays and overloading of the units will adversely a ect sterilization and drying e ectiveness.
DO NOT STACK cases and trays in autoclave chamber.
Notice:
1.
DO NOT load cases into sterilizer on sides or upside down with lid side on the shelf or cart. Load cases on cart
or shelf, so that the lid is always facing upward. This will allow for proper drying. The TRIVEX Sterilization Tray
is designed to drain in this position.
2.
After the autoclave door is opened, all cases must be allowed to cool thoroughly. Place trays on a rack or
shelf with linen cover until cooling is complete. The potential for condensation may increase if the tray is not
allowed to cool properly.
3.
If condensation is observed, check to ensure steps 1 and 2 were followed. In addition, verify that the steam,
which is being used for sterilization processing, has a quality of more than 97%. Also con rm that the
sterilizers have been inspected for routine maintenance in accordance with manufacturer recommendations.
4.
Silicone mat accessories should be placed in alignment with perforations in cases or trays so that sterilant
pathways are not obstructed.
5.
Only use internal baskets, trays, mats, or accessories that have been designed and tested for use in ETO
processes. The TRIVEX Sterilization Tray and mat are made from metal, Radel®-R or silicone and meet this
requirement.
The following table provides guidance on maximum loads. Do not overload delivery systems, and always follow
AAMI, OSHA and hospital standards for maximum loading. Follow instrument manufacturers instructions for use.
Tray Size
Full Size Case (~ 9 x 19 x 4 in.)
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 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.
3
Maximum Total Weight
22 lb. (9 Kg)
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