PARCUS MEDICAL
Parcus 3.5 mm Hex Driver Directions for Use
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Parcus Medical 3.5 mm Hex Driver Important Product Information Produktinformationsblatt Información Importante sobre el Producto Informations Importantes sur le Produit Directions for Use Gebrauchsanleitung Instrucciones de uso Mode d’emploi
Parcus Medical 3.5 mm Hex Driver 1. Indications: The Parcus 3.5mm Hex Driver is designed to insert and remove Parcus Titanium Interference Screws. The shafts feature a 1.5mm cannulation and they are designed to fit into the Parcus Ratcheting Handle and may fit into other handles that utilize a Hudson chuck. 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 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. 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 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. 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
Prevacuum 1
Minimum Dry Time
30 minutes1 132°C / 270°F
4 minutes
Drying times vary according to load size and should be increased for larger loads.
7. Directions for use: A. Connect the Parcus 3.5mm Hex Driver to the Parcus Ratcheting Handle by pulling the locking collar of the driver towards the proximal end of the driver. (See Ratcheting Handle Directions for Use for details on attaching accessory shafts to driver). B. Insert the Parcus 3.5mm Hex Driver until it is fully engaged in the Parcus Ratcheting Handle. It will be necessary to align the flats of the shaft to the slots of the driver to fully lock the shaft into the handle. A fully seated shaft should allow the collar to slide towards the distal tip of the shaft, locking it in position. C. Place a Parcus Titanium Interference Screw onto the drive portion of the driver until it is fully engaged. D. Place the screw and driver over an appropriately placed Parcus 1.5mm Nitinol Guide Wire to guide the screw into the insertion site. E. Rotate the driver clockwise until the screw has reached the desired depth. A counterclockwise rotation of the driver will remove the screw. F. Remove the driver from the screw followed by removal of the guide wire.