Graft Station Directions for Use

Parcus Graft Station Product Information Sheet and Directions for Use: 1. Indications: The Parcus Graft Station is used to assist in the preparation of graft tissue and material used in the repair of ligaments and tendons. 2. Warnings: A. This product is intended for use by or on the order of a physician. B. No component of this instrument is intended to be left in the body. 3. Material: This product is manufactured from stainless steel and aluminum alloys and autoclavable plastics. 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 the cannulation and other 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):

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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. Assemble the Parcus Graft Station by placing the Graft Grasper and Tensioner into the keyhole slot in the base. Orient the Graft Grasper and Tensioner so that the large tensioning knob is furthest away from the graft post. Select the Fixed Clamp or GFS (Graft Fixation System) Post and place it in one of the two slots opposite the Graft Grasper and Tensioner and lock it to the base by turning the thumb screw at the base of the post. B. Adjust the Graft Grasper and Tensioner so that it can capture the graft by moving it along the slot in the Graft Station Base. Lock the Graft Grasper and Tensioner in position by turning the large knob nearest the base, in a clockwise direction. C. The graft can be secured to the Graft Station by looping it mid-substance around the GFS Post and securing the ends of the graft by using the clamps on the Graft Grasper and Tensioner. D. Once the graft has been prepared, the large knob on the Graft Grasper and Tensioner can be rotated in a clockwise manner to place tension on the graft. The calibration marks on the Graft Grasper and Tensioner can be used to determine the tension placed on the graft. The calibration marks represent the tension in pounds. Conversion to kilograms is as follows: 10 lbs = 4.5 kg 15 lbs = 6.8 kg 20 lbs = 9.1 kg