Parcus Tap without Handle Instructions for Use

Parcus Tap without Handle (English) 1. Indications: The Parcus Tap without Handle is designed to prepare bone for the implantation of the Parcus Suture Anchors. The shafts are designed to fit into handles/means of insertion that utilize an AO chuck. 2. Warnings: A. Caution: Federal Law restricts this device to sale by or on the order of a physician. B. This product should not be used to implant any device other than the Parcus Suture Anchors. C. This product is not intended for use as an implant. D. Do not use this product if it is bent or there is visible damage to the tip or thread form. 3. Material: This device is manufactured from a Stainless Steel Alloy shaft. 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 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

Minimum Temperature

Minimum Exposure Time (Wrapped)

Minimum Dry Time

Pre-vacuum

132°C / 270°F

4 minutes

30 minutes1

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

7. Instructions for use: A. Connect the shaft of the Parcus Tap to the intended handle/means of insertion, ensuring that it is securely seated. B. Identify the site for anchor insertion and prepare using either a drill or an awl per the technique recommended for the Parcus Suture Anchor to be used. Press the Parcus Tap into the bone until the threads can be engaged. C. Rotate the Tap clockwise into the bone until the top of the laser line is flush with the bone surface. D. Remove the Tap by rotating in a counter-clockwise direction until its threaded portion is clear of the bone. E. Insert a Parcus Suture Anchor into the prepared hole per the technique identified in the Instructions for Use provided with the Suture Anchor.