Argon CLEANER 15 Bedienungsanleitung Seite 3

- Practitioners must be aware of potential complications associated with
peripheral vasculature thrombolysis including:
 Vessel perforation or rupture
 Vessel spasm
 Hematoma
 Sepsis/Infection
 Intimal disruption
 Vascular thrombosis
 Allergic reaction to contrast medium  Arteriovenous fistula
 Thromboembolic episodes
- Potential fatigue failure of the CLEANER 15™ sinuous wire may occur with
prolonged activation of the CLEANER 15™ device. A withdrawal rate of 1-2
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™ Rotational Thrombectomy System from the
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.
Sinuous Wire
Peripheral Vasculature
Sliding Lever
Figure 2
3
 Distal embolization of blood clots
 Hemorrhage
 Pain and tenderness
 Thrombophlebitis
 Arterial dissection
 Drug reactions
 Amputation
On/Off Switch