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Parcus Awl/Punch 1. Indications: The Parcus Awl/Punch is designed to gauge patient bone quality and/or to create sockets of specific size in bone. 2. Warnings: A. This product is intended for use 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 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: A. This device is not provided sterile. It should be cleaned and sterilized using validated protocols before each use. B. 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 Gravity PreVacuum 1
Minimum Temperature 132°C / 270°F 132°C / 270°F
Minimum Exposure Time (Wrapped) 15 Minutes 4 Minutes
Minimum Dry Time
30 1 Minutes
Drying times vary according to load size and should be increased for larger loads.
7. Instructions for use: A. Place the tip of the Awl/Punch on the surface of the bone at the point at which the bone quality is to be gauged or the socket is to be created. B. Use a suitable mallet to insert the Awl/Punch into the bone to the desired depth or until the circumferential laser line is flush with the bone. C. Remove the Awl/Punch.