Argon CLEANER 15 Bedienungsanleitung Seite 8

- Caution should be used when dislodging the plug at the arterial anastomosis
to minimize the risk of arterial embolization.
- Due to the lack of excretion associated with hemodialysis patients, use of
contrast should be kept to a minimum throughout this procedure.
- Potential fatigue failure of the CLEANER 15
prolonged activation of the CLEANER 15
cm/second is recommended when sharp radii are encountered (i.e. radius of
a loop graft or fistula, radii < 3 cm).
A SUGGESTED PROCEDURE:
Use sterile technique.
Patient Preparation:
1. Premedicate with appropriate anxiolytic, analgesic and/or antibiotic per
hospital protocol.
Device Performance Testing:
2. Remove the CLEANER 15
package. Press the ON/OFF switch to ensure that the sinuous wire spins
freely (refer to Figure 2). Release the switch to stop the rotator. Precaution:
Do not use the device if it does not activate immediately when the
switch is pressed, and deactivate immediately when the switch is
released.
3. Flush the CLEANER 15
catheter lumen flush port. Return the stopcock to the off position prior to
operation.
Thrombolysis Procedure:
4. Complete the CLEANER 15
fluoroscopy. Do not initiate sinuous wire rotation (device activation) unless
proper device positioning is confirmed within the fistula or graft.
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.
8. Prepare and place the venous introducer sheath per hospital protocol. The
venous sheath should be placed in the venous limb of the graft, and
directed toward the venous anastomosis. In fistulae, the venous sheath
placement can be optional depending on the clot burden in the vessel. If a
venous sheath is used, it should be placed in the venous limb of the fistula
and directed toward the central venous outflow. Note: If no venous sheath
is used in the AV fistula, then go to step 16.
Grafts and Fistulae
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Rotational Thrombectomy System from the
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catheter with heparinized saline through the
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thrombolysis procedure under continuous
8
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sinuous wire may occur with
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device. A withdrawal rate of 1-2
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