PARCUS MEDICAL Nitinol Guide Wires Mode D'emploi page 2

Parcus Nitinol Guide Wires with and without Needle Introducer (English)
1. Indications:
Parcus Nitinol Guide Wires with and without Needle Introducer are used to aid in the placement of
cannulated implants and instruments.
2. Warnings:
A. This product is intended for use by or on the order of a physician.
B. This product is designed for Single Use Only
C. Inspect for damage prior to use. Do not use if damaged.
D. Devices that are reused can fatigue and break.
E. Do not use if the packaging has been opened or compromised.
F. This product is not intended for use as an implant.
G. This device is sold as Non-sterile or Sterile. Non-sterile devices must be sterilized prior to use.
(See Sterilization)
3. Material:
Guide Wires are manufactured from Nitinol per ASTM 2063.
Needles and Stylets are made from stainless steel alloy, nickel-plated brass and plastic.
Materials used in the manufacture of this device that are intended to be placed inside the body are
radio-opaque and can, therefore, be detected with conventional X-Ray or fluoroscopy.
4. Sterilization:
A. Nitinol Guide Wires with and without Needle Introducer may be supplied as Non-sterile and
Sterile.
B. Non-sterile devices
The following table provides recommended minimum sterilization parameters that have been
validated by Parcus Medical to provide a 10
Cycle Type
Gravity
Pre-vacuum
1
Drying times vary according to load size and should be increased for larger loads.
C. Sterile Devices
The device is supplied in sterile packaging. The contents are sterilized by EO gas. These
products must never be re-sterilized.
5. Packaging and Labeling:
A. Do not use this product if the packaging or labeling has been damaged, shows signs of exposure
to moisture or extreme temperature or has been altered in any way.
B. Please contact Parcus Medical Customer Service to report any package damage or alterations.
6. Storage:
Products must be stored in the original, unopened package in a dry place and must not be used
beyond the expiration date indicated on the package.
7. Directions for use:
For Percutaneous Procedures:
A. Introduce the Needle with Stylet through the skin and underlying tissue into the desired position.
B. Remove the Stylet, insert the Nitinol Guide Wire and remove the Needle while leaving the Nitinol
Guide Wire in position.
:
Minimum
Temperature
132°C / 270°F
132°C / 270°F
:
.
-6
sterility assurance level (SAL):
Minimum Exposure
Time (Wrapped)
15 minutes
4 minutes
Minimum Dry
Time
1
30 minutes