Contraindications - LeMaitre AnastoClip GC Instructions D'utilisation

4. Place the clips in such a fashion that they are not "rocking" on their axis ("tips").
5. Inspect the anastomotic site to ensure proper application and that hemostasis has been achieved. If bleeding
is observed after application, additional clips or placement of manual sutures may be necessary to complete
hemostasis.
6. If tissue cannot be properly everted due to the presence of arteriosclerotic or calcified material, do not use the
AnastoClip GC applier.
7. Do not evert the tissue by grasping one tissue edge with one pair of forceps and the other tissue edge with another
pair of forceps and pulling them together to evert and apply the clips. This may result in asymmetrical eversion of
tissue, which could result in possible bleeding or leakage.
8. Inspect the vessel wall to ensure that the forceps do not damage vessel during manipulation.
9. Do not use the tissue everting forceps if the tips scissor when they are closed.
10. When using the AnastoClip GC applier with tissue or prosthetic graft material (e.g., Meadox, knitted polyester),
ensure that the total thickness of the everted tissue to be anastomosed does not exceed the total width of the clip
being used (see tables A, B, and C).
11. The tissue everting forceps are packaged NONSTERILE and must be cleaned and sterilized prior to use.
12. The AnastoClip GC applier is provided STERILE and is intended for use in a SINGLE procedure only.
13. The AnastoClip Remover is provided STERILE and is intended for use in a SINGLE procedure only.

Contraindications

1. Do not use the AnastoClip GC applier if tissue can not be properly everted due to the presence of arteriosclerotic or
calcified material, or where the vessel has been severely compromised due to endarterectomy (e.g., carotid or any
other artery in this condition).
2. The clips should not be more than 0.5 mm between one another. If this cannot be achieved, use of the AnastoClip GC
applier is contraindicated.
3. Do not use the AnastoClip GC applier if all the tissue layers cannot be completely symmetrically everted prior to
application of the clip.
4. Do not use the AnastoClip GC applier on tissue that is too friable for use of sutures.
5. The tissue must comfortably fit within the confines of the jaws, or use of the instrument is contraindicated.
6. The AnastoClip GC applier is not intended for use except as indicated. DISCARD AFTER USE. DO NOT RESTERILIZE.
7. Do not use the tissue everting forceps if the tips scissor when they are closed.
NOTE: The tissue everting forceps are packaged with instrument guards to protect the tip of the forceps during shipment.
Remove the protective guard prior to cleaning, sterilization and use.
Cleaning And Sterilization Method: Tissue Everting Forceps
Caution: The tissue everting forceps are packaged NONSTERILE and must be cleaned and sterilized prior to use.
Cleaning
Using a clean towel, wipe all visible soil from the forceps. Prepare an enzymatic detergent per the manufacturer's recom-
mendations. Allow the forceps to soak in the enzymatic detergent for a minimum of one minute. Using a soft bristled
brush remove any remaining soil paying particular attention to the inside of the forceps hinge, serration grips and pin.
Thoroughly rinse in fresh running water and/or distilled water to remove all traces of detergents and soil. Forceps should
be inspected for cleanliness and damage, ensure they function correctly and are clean prior to sterilization.
Sterilization
The tissue everting forceps may be steam sterilized in a gravity displacement or prevacuum autoclave). It is recom-
mended that the tissue everting forceps be sterilized in accordance with one of the following sterilization times and
temperatures:
Gravity-Displacement Steam Sterilization
Wrapped Forceps
Temperature: 270-275°F (132-135°C)
Exposure Time: 10 minutes
Gravity-Displacement Flash Cycle
Unwrapped Forceps
Temperature 270-275°F (132-135°C)
Exposure Time: 10 minutes
Pre-Vacuum Steam Sterilization
Wrapped Forceps
Temperature: 270-275°F (132-135°C)
Exposure Time: 4 minutes
Pre-Vacuum Flash Cycle
Unwrapped Forceps
Temperature 270-275°F (132-135°C)
Exposure Time: 4 minutes
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 perfor-
mance 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 explic-