COOK Medical Zilver, Инструкция по эксплуатации

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Table 9: Guide to choosing the appropriate Introducer/ Guiding Sheath or
Guiding Catheter
Zilver Delivery System Introducer / Guiding
Sheath French Size
Guiding Catheter
Minimum I.D.
5 Fr 5 Fr 0.072 inch
6 Fr 6 Fr 0.090 inch
7 Fr 7 Fr 0.096 inch
HOW SUPPLIED
Supplied sterilized by ethylene oxide gas in peel-open packages. Intended for one-time use.
Sterile if package is unopened or undamaged. Do not use the product if there is doubt as to
whether the product is sterile. Store in a dark, dry, cool place. Avoid extended exposure to
light. Upon removal from package, inspect the product to ensure no damage has occurred.
INSTRUCTIONS FOR USE
1. Determine the proper stent size after complete diagnostic evaluation. The stent
deployment must be performed under fluoroscopic control. Measure the length of the
target lesion to determine the length of the stent required. Allow for the proximal and
distal aspects of the stent to cover the entire target area.
NOTE:
If multiple stents are required to cover the length of the lesion, please refer
to the Multiple Stent Placement section of these instructions for use for further
recommendations.
The Zilver Vascular Stent is designed not to shorten upon deployment. Bench testing has
shown that the post-deployment unconstrained length varies from the unconstrained length
shown on the package label by -3.7% to +3.0%. Measure the diameter of the reference vessel
(proximal and distal to the lesion) and use the LARGEST reference diameter as your basis for
choosing the appropriate stent size (See Table 10).
Table 10: Stent Size Selection Table
Reference Vessel Diameter Nominal Stent Diameter
5.0 mm
6.0 mm
5.0-6.0 mm 7.0 mm
6.0-7.0 mm 8.0 mm
7.0-8.0 mm 9.0 mm
8.0-9.0 mm 10.0 mm
2. Introduce the extra or ultra stiff wire guide (7.0 and 6.0 French [2.3 and 2.0 mm] systems
accept 0.035 inch [0.89 mm] wire guide; 5.0 French [1.67 mm] system accepts 0.018 inch
[0.46 mm] wire guide) through the access catheter across the distal segment of the target
lesion.
3. Remove the access catheter, leaving the wire guide in place.
4. Predilatation of the lesion was required by protocol during the U.S. clinical study and is
recommended.