Parcus 3.5 mm Hex Driver with Handle Directions for Use

Parcus 3.5mm Hex Driver with Handle 1.

Indications: The Parcus 3.5mm Hex Driver with Handle is designed to insert and remove Parcus Titanium Interference Screws. The driver features a 1.5mm cannulation and is compatible with Parcus 1.5mm Guide Wires.

2.

Warnings: 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 Titanium Interference Screws. C. Do not use this product if it is bent or there is visible damage to the shaft or drive section.

3.

Material: This device is comprised of a Stainless Steel Alloy shaft and an Aluminum handle. 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.

4.

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

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6.

Sterilization: This device is not provided sterile. 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)

Gravity

132°C / 270°F

15 minutes

132°C / 270°F

4 minutes

Prevacuum 1

7.

Minimum Dry Time

30 minutes1

Drying times vary according to load size and should be increased for larger loads.

Directions for use: A. Place a Parcus Titanium Interference Screw onto the drive portion of the driver until it is fully engaged. B. Place the screw and driver over an appropriately placed Parcus 1.5mm Guide Wire to guide the screw into the insertion site. C. Rotate the driver clockwise until the screw has reached the desired depth. A counterclockwise rotation of the driver will remove the screw. D. Remove the driver from the screw, followed by removal of the guide wire.