Flex Vessel Prep FSC 4-120 Mode D'emploi page 6

VIII. MATERIALS REQUIRED FOR USE WITH THE FLEX
Vessel Preparation™ Catheter :
WARNING: Use single use items only.
resterilize or reuse.
• Introducer sheath: 6 French
• Sterile heparinized normal saline (referred to
as normal saline throughout IFU)
• 10-cc and 20-cc syringes for flushing
• Guidewire: 0.014" or 0.018" only
• Other equipment, as needed, for
interventional procedures
IX. INSTRUCTIONS FOR USE
Prior to use of the FLEX Vessel Prep™ System,
carefully examine the device for damage and confirm
device integrity. Do not use if the catheter has
bends, kinks, missing components, or other damage.
Do not use if the inner package is open or damaged.
1. Prepare the FLEX Vessel Prep™ System by
irrigating the Guidewire Port with normal
saline. Observe fluid exiting the blue catheter
tip.
2. To irrigate the Flush Port, pull back on the
Sheath Actuates to expose the Treatment
Element. A click verifies the Sheath is fully
retracted. Attach the syringe to the Flush
Port and irrigate with normal saline until fluid
is observed exiting at the distal tip of the
catheter shaft.
3. Un-sheath the Treatment Element by pulling
back on the Sheath Actuator.
4. Pull back the Element Actuator to ensure
Treatment Element expansion occurs.
5. Release Element actuator.
6. Re-sheath the Treatment Element by pushing
Sheath Actuator forward.
7. Premedicate patients with anti-coagulants
and vasodilators according to institutional
protocol for PTA procedures.
100073 Revision R
Do not
Date of Issue: 2022-06
8. Perform peripheral angiogram in the view
best demonstrating the target lesion prior to
device deployment.
9. Utilizing standard fluoroscopic technique, the
femoral arterial segment to be treated is
crossed using standard technique and a
0.014" or 0.018" guidewire is positioned
distally to the segment to be treated.
10. Embolic protection device may be deployed
at the discretion of the operator.
11. The FLEX VP TM catheter is loaded onto the
guidewire and advanced distally past the area
of the vessel to be treated.
12. The Sheath is retracted by pulling back on the
Sheath Actuator, locking the Sheath into
place. A click verifies the Sheath is fully
retracted, exposing the Treatment Element.
Freedom of the Treatment Element can be
visually verified via fluoroscopy by ensuring
the radiopaque marker is positioned proximal
to and free of the Treatment Element.
Note: If the Treatment Element is in a
relatively non-diseased portion of the vessel
with a lumen greater than 2 mm, the
Treatment Element may be seen to have a
degree of expansion under fluoroscopy as the
Treatment Element engages the lesion.
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