Materials Required; Preparing The System - Vascular Restorer CoCr Instructions D'utilisation

therapies for living
- Biliary tract occlusion
- Perforation of biliary tract
- Cholangitis
- Pancreatitis
- Peritonitis
- Sepsis
7. How to use

7.1 Materials required

- Heparinised normal saline solution.
- Contrast medium (use contrast media indicated for intravascular use).
- Medication appropriate to the procedure.
- 0.035" Guidewire, do not use other guidewire sizes.
- Introducer with haemostasis valve in the size indicated on the label. If a long or braided introducer
sheath is used, it is recommended that a larger French-size than the one indicated on the label be
used.
- Haemostasis valve.
- Three-way stopcock.
- Extension line.
- Inflation device (manual pump with manometer fitted).
- Several standard 10-20cc syringes of saline solution for flushing the system.

7.2 Preparing the System

- The stent diameter must match the diameter of the vessel in question and its length must match
that of the lesion. It should preferably be a little longer to ensure full coverage of the lesion.
- Remove the catheter from the protection dispenser. Check that its size is the right one. Remove the
stent's protection sheath.
- Flush or rinse the guide lumen with sterile saline injecting it with a syringe from the connector's
straight port until it comes out the tip. Do not dry with gauze.
DANGER: if the solution does not come out of the delivery catheter, the catheter is not in good condi-
tion and must not be used.
- Inspect the stent to make sure it is located between the radiopaque marks; if you see it has moved,
do not use it.
- The inner lumen of balloon catheter contains air that must be purged before it is introduced in the
blood stream. If the product is not purged correctly, the balloon may be inflated with air and con-
sequently, it may cause the stent to be incorrectly expanded. What's more, in this situation, if the
balloon ruptures, it may cause gaseous embolism in the artery. To proceed purging the balloon,
follow these steps:
• Fill a syringe or the inflation device with an adequate volume of contrast medium/saline. Release
the air just as the product's manufacturer indicates.
• Connect a three-way stopcock to an extension and the extension to the lateral port of the re-
lease system luer connector. Connect the syringe to the three-way stopcock. Alternatively, the
inflation pump may be connected to the three-way stopcock without the extension.
• Place the catheter on an even horizontal surface.
• With the three-way stopcock open allowing the flow from the catheter into the syringe /infla-
tion pump, apply negative pressure in the syringe by pulling the plunger back for at least 30 s
to allow all the air to exit from the inside of the device. It is recommended that the syringe be
kept in a vertical position.
DANGER: if bubbles do not stop passing from the catheter to the syringe after 30 seconds at negative
6
INSTRUCTIONS FOR USE
PERIPHERAL STENT SYSTEM CoCr
restorer