Parcus Threaded Dilator Instructions for Use

Parcus Threaded Dilator (English) 1. Indications: The Parcus Threaded Dilator is designed to create a starter hole to ease the insertion of Interference Screws in Bone-Tendon/Ligament-Bone ACL Reconstructions. The Threaded Dilator is cannulated and is compatible with 1.5mm or less Guide Wires. 2. Warnings: A. Caution: Federal Law restricts this device to sale by or on the order of a physician. B. Do not use this product if it is bent or there is visible damage to the shaft or drive section. C. This device is only to be used when sufficient bone quality and implant/graft size exists such that fixation is not compromised. D. This device is not intended to be used as an implant. 3. Material: This device is manufactured from a Stainless Steel Alloy and may include an aluminum alloy handle. The materials used in the manufacture of this device 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. 5. 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 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. 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):

1

Cycle Type

Minimum Temperature

Minimum Exposure Time (Wrapped)

Minimum Dry Time

Prevacuum

132°C / 270°F

4 minutes

30 minutes1

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

7. Instructions for use: A. Place the Threaded Dilator over an appropriately placed 1.5mm Guide Wire to guide the dilator into the insertion site. B. Rotate the Threaded Dilator clockwise until the dilator has reached the desired depth. C. Rotate the Threaded Dilator counterclockwise to remove the dilator. D. Place the desired Interference Screw over the Guide Wire and insert per applicable Instructions for Use.