Vascular Restorer CoCr Instructions D'utilisation page 4

therapies for living
- Advance the product along the guidewire with a fluoroscopic view. Do not allow the product to ad-
vance without the guidewire inside it.
- Do not superimpose stents of different compositions.
- Do not expose the product to hospital waste material
5. Precautions
General Precautions
- Store in a dry, fresh place, away from direct sunlight.
- Inspect the pack. If it is found to be damaged, do not use the product.
- The minimum size of the introducer with which the system must be used is indicated on the pro-
duct's label. Do not use introducers that are smaller than the size indicated. What's more, in case
of long and/or braided introducer sheaths, a larger French-size than indicated on the label may be
necessary to ensure success of procedure.
- After use, this product may be a biological hazard. Handle and dispose of it in accordance with ac-
cepted medical practice and relevant local, state or federal laws and regulations.
Precautions when preparing the product
- Inspect the product before use to make sure it is in good condition, and throw away any device
which does not inspire confidence.
- Do not prepare or pre-inflate the deployment system before starting the procedure or positioning
the stent in the location of the lesion.
- Do not handle the stent with the fingers, as this could dislodge the stent from the balloon.
- Do not attempt to separate the stent from its deployment system; if you see that the stent is loose
or not properly located, do not use it.
- Adjust the diameter of the stent to the diameter of the artery to be dilated and do not use stents
with a diameter larger than the artery to be treated.
Precautions during advance-positioning-deployment-withdrawal of the product
- In the case of multiple lesions, begin with the most distal lesions, followed by the proximal ones.
- Always advance the device under fluoroscopic visualization. If any resistance is met while advan-
cing, stop and determine the cause before continuing. If the stent can not reach or go through the
lesion, withdraw the whole system as a single unit, including the introducer.
- If any resistance is met while advancing, stop and determine the cause before continuing.
- Before stent deployment tighten the balloon eluting catheter so the stent does not end up in the
wrong place. Do not inflate the balloon until you are not sure that it is in the right place.
- Once expansion of the stent has begun, the system cannot be withdrawn or moved.
- Do not handle, advance or withdraw the catheter or the guidewire while the balloon is inflated.
- Do not exceed the maximum recommended pressure as shown on the label and on the enclosed
compliance curve.
- If resistance of any kind is noted while accessing the lesion, while extracting the deployment sys-
tem or while removing a stent which could not be implanted, the whole system should be with-
drawn as a single unit:
• Do not retract the delivery system inside the introducer since the stent may be released into
the vasculature.
• Position the balloon's proximal marker distally to the introducer's tip.
• Advance the guidewire forward in the anatomy, as far as possible.
• Withdraw and extract the introducer and the balloon catheter with the stent together, as a
single unit.
• Finally, withdraw the guidewire, or in the event that you wish to begin implantation again keep
the guidewire in place and place the rest of the devices.
4
INSTRUCTIONS FOR USE
PERIPHERAL STENT SYSTEM CoCr
restorer