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Argon Medical Devices CLEANER 15 Gebrauchsanleitung Seite 4

Rotations-thrombektomiesystem
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Peripheral Vasculature
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.
Covered Sinuous Wire (Do Not
Activate Device in Covered
Position)
12.
Advance the flexible tip up to the distal most extent of the clot. Uncover the sinuous wire by unlocking, fully retracting the sliding
lever and rotating the sliding lever until an audible "click" is heard (refer to Figure 4). Confirm device positioning within the
treatment site via fluoroscopy. Press the ON/OFF switch to activate rotation.
Sliding Lever Locked in Covered
Position
Figure 3
3

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