PARCUS MEDICAL
Parcus 5.5-6.5 mm Punch / Tap Directions for Use
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Parcus 5.5 – 6.5mm Punch/Tap
1.
Indications: The Parcus 5.5 – 6.5mm Punch/Tap is designed to prepare bone for the implantation of the Parcus 5.5 and 6.5mm V-LoXTM PEEK CF and Twist PEEK 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 V-LoX PEEK CF or Twist PEEK Suture Anchors. C. 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. 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. D. The device should be placed in an ultrasonic cleaning unit and processed according to the unit’s directions E. The device should be rinsed thoroughly with water following the ultrasonic process.
5.
Sterilization:
This device is not provided sterile. The following table provides recommended minimum sterilization parameters -6 that have been validated by Parcus Medical to provide a 10 sterility assurance level (SAL):
1
6.
Cycle Type
Minimum Temperature
Minimum Exposure Time (Wrapped)
Gravity
132°C / 270°F
15 minutes
Prevacuum
132°C / 270°F
4 minutes
Minimum Dry Time
30 minutes1
Drying times vary according to load size and should be increased for larger loads.
Directions for use: A. Connect the Parcus Punch/Tap shaft to the Parcus Ratcheting Handle by pulling the locking collar of the driver towards the proximal end of the driver. (See Ratcheting Handle instructions for use for details on attaching accessory shafts to driver). B. To lock the Punch/Tap into the Ratcheting Handle, align the flats of the shaft to the slots of the Ratcheting Handle. A fully seated shaft should allow the collar on the Ratcheting Handle to slide towards the distal tip of the shaft, locking it in position. C. Identify the site for anchor insertion and gently tap the Parcus Punch/Tap into the bone until the threads of the Punch/Tap can be engaged. Rotate the Punch/Tap clockwise into the bone until the top of the laser line is flush with the bone surface. D. Carefully remove the Punch/Tap by rotating the handle in a counter-clockwise direction until its threaded portion is clear of the bone. E. Insert a Parcus V-LoX PEEK CF or Twist PEEK Suture Anchor into the prepared hole.