LeMaitre LeverEdge Mode D'emploi page 2

LeverEdge® Contrast Injector
Instructions for Use - English
Catalog numbers 4100-00, 4100-01
Description
35 cc syringe with ISO 594 female luer lock.
Indication for Use
The LeverEdge® Contrast Injector is intended to be used to perfuse contrast medias
into the vessels for angiographic procedures.
Contraindication
The LeverEdge Contrast Injector is not designed, sold, or intended for use except
as indicated.
Warnings
Read instructions carefully. The attending clinician is solely responsible for the setup and use of this device. Observe aseptic technique
in all tubing connections. Contents of unopened, undamaged package are sterile and nonpyrogenic. Inspect packaging prior to
opening. If damaged, sterility may be compromised. Inspect for damage before use. If damaged, do not use. Do not over-tighten rigid
connections. This device is designed for single use only. Do not resterilize or reuse. Dispose of this device according to hospital procedure
for contaminated material.
Cautions
Federal (USA) law restricts this device to sale by or on the order of a physician. Observe all additional warnings and cautions contained
in the following directions for use. Proper sterile surgical technique is necessary to use this product. The product is only to be used by a
physician qualifi ed in angiographic procedures. When infusing contrast media, techniques to avoid air or thrombus embolization should
be observed.
Directions for Use
The following procedure is for information purposes only. Proper surgical procedures and techniques are necessarily the responsibility
of the medical professional. Each clinician must determine the appropriate use of this device based upon his or her medical training and
experience and the type of surgical procedure employed.
1. Load LeverEdge Contrast Injector with contrast media using syringe loading technique.
2. Purge the system of all air bubbles by pointing device upward and pressing handle to expel.
3. Attach to the delivery system.
4. Press down on handle while watching angiographic image.
5. If more contrast is needed, push harder until handle reaches bottom of travel.
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.
Notices: 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.