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Attaching a Disposable Infl ow Tube Set (REF 7209513) to the Irrigated Illuminator (REF 7210351)
Follow operating room protocol for handling the tube set. Read the assembly instructions included with the
Disposable Infl ow Tube Set (R2593).
Cleaning
1.
Clean the Illuminator thoroughly by washing with a soft brush and non-abrasive enzymatic detergent in hot
water (140° F [60° C]), followed by repeated fl ushing to ensure that all surfaces and movable parts are clean.
2.
The irrigation channel should be cleaned well with hot, soapy water and fl ushed repeatedly with clear
running water.
3.
After hot water washing, instruments should be thoroughly rinsed in warm water, and dried before being
encased and sterilized for the next procedure.
4.
The fi beroptic post and distal tip of the Illuminator must be cleaned and checked routinely to ensure
maximum transmission of light. Both should be cleaned with warm water and mild soap. If stains are present,
a mixture (1:1) of methyl alcohol and acetone may be used. A fi ne woven cloth or lens tissue should be used
for cleaning. Dry with a soft, woven cloth.
Sterilization
WARNING: The only method of sterilization appropriate for the illuminator is autoclave.
•
Pre-Vacuum method at 270–275° F (132–135° C) for 4 minutes; or
•
Gravity method at 270–275° F (132–135° C) for 10 minutes.
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 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.
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.
For Further Information
If further information on this product is needed, please contact LeMaitre Vascular Customer Service at +1-800-628-
9470 in the U.S., or your authorized representative.
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