Parcus Tap with Handle Directions for Use

Parcus Tap with Handle 1. Indications: The Parcus Tap with Handle is designed to prepare bone for the implantation of the Parcus Suture Anchors. 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 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 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. 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. 5. Sterilization: This device is not provided sterile. The following table provides recommended minimum sterilization -6 parameters that have been validated by Parcus Medical to provide a 10 sterility assurance level (SAL): Cycle Type

Minimum Temperature

Minimum Exposure Time (Wrapped)

Gravity

132°C / 270°F

15 minutes

Minimum Dry Time

30 minutes Pre-vacuum 1

132°C / 270°F

1

4 minutes

Drying times vary according to load size and should be increased for larger loads. 6. Directions for use: A. Identify the site for anchor insertion and press the Parcus Tap into the bone until the threads can be engaged. Use a suitable mallet if necessary. B. Rotate the Tap clockwise into the bone until the top of the laser line is flush with the bone surface. C. Remove the Tap by rotating the handle in a counter-clockwise direction until its threaded portion is clear of the bone. D. Insert a Parcus Suture Anchor into the prepared hole.