PARCUS MEDICAL
Parcus Reusable Knotless PEEK CF Suture Anchor Driver Directions for Use
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Parcus Reusable Knotless PEEK CF Suture Anchor Driver 1. Indications: Parcus Knotless PEEK CF Suture Anchor Drivers are provided unsterile as accessories to Knotless PEEK CF Suture Anchors. They are used to assist in the insertion of Knotless PEEK CF Suture Anchors in bone. 2. Warnings: A. This product is intended for use by or on the order of a physician. B. Never use a bent driver. C. This product is not intended for use as an implant. D. Loading the driver in an off axis manner may result in breakage of the implant or bending of the driver. 3. Material: This device is manufactured from stainless steel and aluminum alloys. The materials used in the manufacture of this device are radiopaque 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 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): 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. Aseptically open the package containing the Knotless PEEK CF Suture Anchor. B. Assemble the suture anchor to the appropriately sized driver by inserting the tip of the driver into the socket of the anchor and pressing until the driver is firmly attached to the anchor. Warning: Off-axis or insufficient seating of the anchor to the driver may result in breakage of the implant. C. Pass sutures and insert implant into bone using the preferred user technique as described in implant DFU. D. Once implant is fully inserted, remove driver by pulling firmly and twisting slightly until the driver is free from the anchor.