Parcus Tendon Harvester Directions for Use

Tendon Harvester 1. Indications: The Parcus Tendon Harvester is used to remove tendons (e.g. semitendinosus and gracilis) for use in repairing or replacing damaged tendons and ligaments. 2. Warnings: a. This product is intended for use by or on the order a physician. b. No component of this instrument is intended to be left in the body. c. Never use this device if it has been bent or damaged in any way. 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 XRay 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 -6 Parcus Medical to provide a 10 sterility assurance level (SAL):

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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. Identify the tendon to be harvested taking care to select a harvester best matched to the tendon diameter. b. Parcus Tendon Harvesters come in two versions, closed and slotted (open). When using the closed harvester, it is advisable to place sutures through the tendon, at its insertion. Sutures will aid in providing the counter-traction necessary to harvest the tendon. c. The accessory insertion of the semitendinosus tendon should be identified and transected to avoid tendon damage at harvest. Note: Knee flexion may reduce the risk of injury to the saphenous nerve as it crosses the gracilis tendon. d. Once the tendon is released, remove the instrument and tendon from the wound and prepare the graft according to the prescribed surgical technique.