PEEK CF Interference Screw Driver Directions for Use

Parcus PEEK CF Interference Screw Driver Product Information Sheet and Directions for Use: 1.

Indications:

2.

The Parcus PEEK CF Interference Screw Driver is designed to insert and remove Parcus PEEK CF Interference Screws. The shafts feature a 1.5mm cannulation and are designed to fit into the Parcus Ratcheting Handle and may fit into other handles that utilize a Hudson chuck. Warnings:

3.

A. This product is intended for use by or on the order of a physician. B. This product should not be used to implant any device other than Parcus PEEK CF Interference Screws. C. Do not use this product if it is bent or there is visible damage to the shaft or drive section. Material:

4.

This device is manufactured from a Stainless Steel Alloy. The 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. Inspection:

5.

A. Inspect the device for damage at all stages of handling. B. If damage is detected, consult the manufacturer for guidance. Cleaning: A.

6.

Immediate rinsing and cleaning after use with an enzymatic detergent will effectively remove and prevent drying of adherent blood, tissue, etc. B. Scrub device with a soft brush, paying special attention to the cannulation and other areas where debris might accumulate. Always avoid any harsh materials that can scratch or mar the surface of the device. C. Rinse the device thoroughly with water following the cleaning process. D. The device should be placed in an ultrasonic cleaning unit and processed according to the unit’s directions. E. The device should be rinsed thoroughly with water following the ultrasonic process. Sterilization: This product is a non-sterile item that must be cleaned and sterilized prior to use. The following table provides -6 recommended minimum sterilization parameters that have been validated by Parcus Medical to provide a 10 sterility assurance level (SAL): Cycle Type

Minimum Temperature

Minimum Exposure Time (Wrapped)

Gravity

132°C / 270°F

15 minutes

Pre-vacuum

132°C / 270°F

4 minutes

Minimum Dry Time 30 minutes

1

1

7.

Drying times vary according to load size and should be increased for larger loads Directions for use: A.

B. C. D. E.

Connect the Parcus PEEK CF Interference Screw Driver to the Parcus Ratcheting Handle by pulling the locking collar of the handle towards its proximal end and inserting the Parcus PEEK CF Interference Screw Driver until it is fully seated. It will be necessary to align the flats of the driver with the slots of the handle to allow the locking collar to slide distally, securing the driver to the handle. (See Parcus Ratcheting Handle Directions for Use for details on attaching accessories). Place a Parcus PEEK CF Interference Screw onto the drive portion of the driver until it is fully engaged. Place the screw and driver over an appropriately placed Parcus 1.5mm Nitinol Guide Wire to guide the screw into the insertion site. Rotate the driver clockwise until the screw has reached the desired depth. A counterclockwise rotation of the driver will remove the screw. Remove the driver from the screw followed by removal of the guide wire.