GFS Depth Gauge Directions for Use

Parcus GFS Depth Gauge 1. Indications: The Parcus GFS Depth Gauge is indicated for use with the Parcus Graft Fixation System (GFS) and may be used to measure the overall length of a tunnel as well as for measuring and marking the graft. 2. Warnings: A. This product is intended for use by or on the order of a physician. B. Do not use this product if it is bent or there is visible damage to the shaft or laser markings. 3. Material Specifications: The Parcus GFS Depth Gauge 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. 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 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 Medical to provide a 10-6 sterility assurance level (SAL):

Cycle Type

Minimum Temperature

Minimum Exposure Time (Wrapped)

Gravity

132°C / 270°F

15 minutes

132°C / 270°F

4 minutes

Prevacuum 1

Minimum Dry Time

30 minutes1

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

7. Directions for Use (Soft Tissue Graft): A. To measure the overall length of a tunnel, place GFS Depth Gauge in the tunnel and insert the hooked end of the gauge until it catches on the cortical bone at the distal end of the tunnel. Read the graduations on the GFS Depth Gauge to determine the length of the tunnel. B. To aid in marking the graft, assemble the GFS/Graft construct per GFS Directions for Use and orient it in such a way that the axis of the titanium implant is parallel to the graft. Place the wedge shaped end of the GFS at the zero point on the GFS Depth Gauge and make a mark on the graft with a surgical marker that corresponds to the overall length of the femoral tunnel. This will indicate the point at which the wedge shaped end of the GFS has passed the lateral femoral cortex allowing the implant to flip into position. See Drawing below.