PARCUS MEDICAL
PEEK CF Interference Screw Driver with handle
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Parcus PEEK CF Interference Screw Driver with Handle
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 PEEK CF Interference Screw Driver with Handle Product Information Sheet and Directions for Use: 1. Indications: The Parcus PEEK CF Interference Screw Driver with Handle is designed to insert and remove Parcus PEEK CF 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 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. 3. Material: This device is manufactured from 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. 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. 6. Sterilization: This product is a non-sterile item that must be cleaned and sterilized prior to use. The following table provides recommended minimum sterilization parameters that have been validated by Parcus -6 Medical to provide a 10 sterility assurance level (SAL):
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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
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Drying times vary according to load size and should be increased for larger loads 7. Directions for use: A. Place a Parcus PEEK CF 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.