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Peripheral Vasculature
WARNINGS AND PRECAUTIONS:
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Prior to use, read all package insert warnings, precautions, and instructions. Failure to do so may result in severe patient injury
and death.
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These procedures should only be performed by physicians and staff familiar with the equipment and techniques involved. The
device has been sterilized by EtO and is sterile unless the package is opened or damaged. The package should be examined
before use; if damaged, DO NOT USE. The device is intended for single patient use only; DO NOT REUSE OR RE-STERILIZE.
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Prior to use, carefully examine the CLEANER 15™ Rotational Thrombectomy System to verify that it has not been damaged during
shipment. If the product components show any sign of damage, DO NOT USE.
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Due to the risk of exposure to HIV (Human Immunodeficiency Virus) or other blood borne pathogens, health care workers should
routinely use universal blood and body fluid precautions in the care of all patients. Sterile technique must be strictly adhered to
during any handling of the device.
-
Do not advance if resistance is met without first determining the cause of resistance under fluoroscopy and taking any necessary
remedial action. Excessive force against resistance may result in damage to the device or vasculature.
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Prior to introduction, and anytime the CLEANER 15™ is removed from the vascular system, the catheter should be flushed.
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If the catheter or guidewire becomes kinked or otherwise damaged during use, discontinue use and replace.
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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
•
Thromboembolic episodes
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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
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.
•
Distal embolization of blood clots
•
Hemorrhage
•
Pain and tenderness
Thrombophlebitis
•
•
Arterial dissection
•
Drug reactions
•
Arteriovenous fistula
•
Amputation
Sliding Lever
On/Off Switch
Figure 2
2
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