PARCUS MEDICAL
Parcus Nitinol Guide Wires with and Without Needle Introducer Instructions for Use
12 Pages
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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. Caution: Federal Law restricts this device to sale 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 10-6 sterility assurance level (SAL): Cycle Type
Minimum Temperature
Minimum Exposure Time (Wrapped)
Minimum Dry Time
Pre-vacuum
132°C / 270°F
4 minutes
30 minutes1
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. Instructions 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. C. Slide the cannulated implant or instrument over the Nitinol Guide Wire into the desired position. D. Remove the Nitinol Guide Wire and discard the Nitinol Guide Wire, Needle and Stylet.