Indications For Use; Contraindications; Warnings And Precautions - Argon CLEANER 15 Bedienungsanleitung

INDICATIONS FOR USE:

The CLEANER 15™ Rotational Thrombectomy System is indicated for
mechanical declotting and controlled and selective infusion of physician-
specified fluids, including thrombolytics, in the peripheral vasculature.

CONTRAINDICATIONS:

The CLEANER 15™ Rotational Thrombectomy System is contraindicated in the
following:
- This system is contraindicated when, in the medical judgment of the
physician, such a procedure may compromise the patient's condition.
- Not designed for peripheral vasculature dilation purposes.
- This system is not intended for the infusion of blood or blood products.
- Refer to the product insert of the therapeutic solution of choice for
indications, contraindications, side effects, and precautions.
- In native vessels smaller than 6mm in diameter
- In patients without a vascular filter such as an inferior vena cava filter.

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™ 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.
- 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.
- Prior to introduction, and anytime the CLEANER 15™ is removed from the
vascular system, the catheter should be flushed.
- If the catheter or guidewire becomes kinked or otherwise damaged during
use, discontinue use and replace.
Peripheral Vasculature
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