Argon CLEANER 15 Bedienungsanleitung Seite 7

INDICATIONS FOR USE:
The CLEANER 15
mechanical declotting of native vessel dialysis fistulae and synthetic dialysis
access grafts.
CONTRAINDICATIONS:
The CLEANER 15
following:
- When in the medical judgment of the physician, such a procedure may
compromise the patient's condition.
- In native vessels smaller than 6mm in diameter
- Existing hemodialysis access site infection.
- Immature native vessel dialysis fistulae (fistulae that have not been used for
at least one hemodialysis treatment).
WARNINGS AND PRECAUTIONS:
- Prior to use, read all package insert warnings, precautions, and instructions.
Failure to do so may result in severe patient injury and death.
- 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.
- Prior to use, carefully examine the CLEANER 15
System to verify that it has not been damaged during shipment. If the
product components show any sign of damage, DO NOT USE.
- 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.
- Practitioners must be aware of potential complications associated with
dialysis fistula and graft thrombolysis including:
 Hemorrhage
 Symptomatic pulmonary embolism  Infection
 Arterial embolization
 Allergic reaction to contrast media  Hematoma
 Pseudoaneurysm
 Pain and/or tenderness
Grafts and Fistulae
™
Rotational Thrombectomy System is indicated for
™
Rotational Thrombectomy System is contraindicated in the
™
Rotational Thrombectomy
 Vessel tear or disruption
 Perforation of the artery or vein
 Death
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