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Arteriovenous Access
1.
It is preferable to allow the prosthesis to heal for a minimum of two weeks prior to commencement of puncturing.
2.
Do NOT puncture the arteriovenous access repeatedly in the same site as this may lead to disruption of the wall of the
prosthesis, haematoma formation or pseudoaneurysm formation. Rotation of the puncture sites along the length of the
prosthesis is necessary.
3.
Do NOT puncture the curve of the prosthesis.
4.
Do NOT puncture within 3 cm of the anastomotic sites.
5.
Strict adherence to aseptic technique is essential to minimise the risk of infection.
6.
Moderate compression of the puncture site will achieve haemostasis.
Vascular Patch
Cut the tubular prosthesis longitudinally to fashion into a vascular patch. Ensure that the blood ow surface is not damaged. When
suturing the patch into place, ensure that the full wall thickness and the mesh are incorporated into each stitch.
Patient Information
The biosynthetic nature of Omni ow II does not change advice given to patients regarding post-operative care of the prosthesis as
compared to other typical vascular prostheses. As such, good practice should include the following:
For bypass patients, avoid any compression of the prosthesis either by overly tight wrapping or clothing or laying on the prosthesis.
Patients should report any abnormal signs immediately to the treating surgeon to reduce the risk of complications.
For AV Access patients:
1.
Check the prosthesis every day. Feel for the pulse (thrill) in the prosthesis.
2.
Inspect daily for signs of infection e.g. swelling, redness and pus.
3.
Inspect daily for bruising or pseudoaneurysm formation.
4.
Keep the skin over the prosthesis clean to help prevent infection.
5.
Do not wear tight clothing or jewelry or drape or carry heavy items over the prosthesis as these may restrict blood ow.
6.
Do not sleep on the arm with the prosthesis as this may occlude the blood ow.
7.
Do not allow blood pressure testing or use of intravenous drips or the taking of blood from the arm with the prosthesis.
8.
Patients should report any abnormal signs immediately to the dialysis unit to reduce the risk of complications.
Storage
The prosthesis must be kept in its original packaging until used. It must be kept in a dust free and dry environment at room
temperature.
Return to Bio Nova International Pty. Ltd.
PATIENT IMPLANT DATA FORM
The implant data form should be completed immediately after surgery by the surgeon and returned in the envelope
provided.
EXPLANTED SPECIMENS OF PROSTHESIS
If the Omni ow II vascular prosthesis is removed from a patient for any reason it may be returned to Bio Nova International
Pty. Ltd. for analysis. Rinse blood and contaminants from the prosthesis using sterile saline. Return the specimen in a
sealed container of 10% formalin. Include the serial number, catalogue number and reason for removal. Contact your local
Omni ow II representative who will make arrangements for the specimen to be returned.
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 of the device may lead to cross contamination, infection, or patient death. The performance characteristics of the
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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. The unused section of the Omni ow II prosthesis or the explanted prosthesis
should be considered as biohazard and be disposed per hospital policy or local regulations.
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.
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