3. Attach a syringe of therapeutic agent or heparinized saline to the catheter
flush port and flush the CLEANER 15™ catheter. Be sure that fluid exits from
the most distal catheter hole which is located near the end of the catheter.
Close the stopcock to "lock" the therapeutic agent or heparin in the catheter
and remove the syringe.
Treatment:
The exact treatment procedure is to be determined by the physician. The
following option describes how the procedure may be performed.
4. Complete the procedure under continuous fluoroscopy. Do not initiate
sinuous wire rotation (device activation) unless proper device positioning is
confirmed within the peripheral vasculature.
5. Prepare and drape the puncture site as required.
6. Administer local anesthetic at the puncture site for venous sheath insertion.
7. Select an appropriately sized sheath to accommodate the CLEANER 15™
catheter and other devices/ catheters that may be used during the
procedure. Maximum guidewire size will be dependent upon the introducer
sheath/dilator assembly chosen. If crossing the iliac bifurcation, a long
reinforced sheath should be used.
8. Prepare and place the venous introducer sheath per hospital protocol. The
venous sheath should be placed in the venous limb of the peripheral
vasculature, and directed toward the treatment site. The venous sheath
placement can be optional depending on the clot burden in the vessel.
9. Place the device in the covered position by pushing the sliding lever to the
distal position and rotating the sliding lever to lock in the covered position
(refer to Figure 3). When in the covered position, only the flexible tip of the
sinuous wire should extend from the catheter. Warning: The device
should not be activated in the covered position.
10. Support the flexible tip between the thumb and index finger during insertion
through the sheath valve. Insert the covered device through the venous
sheath and into the venous limb of the peripheral vasculature.
11. Attach a 10cc syringe containing the therapeutic agent intended for infusion
to the stopcock. Open the stopcock to enable flow. Warning: Do not draw
blood back into the catheter.
Note: Follow the manufacturer's instructions regarding reconstitution
and dilution of specified fluids.
Peripheral Vasculature
4