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Parcus Graft Sizer Product Information Sheet and Instructions for Use 1. Indications: The Parcus Graft Sizers are used to assist in determining the diameter of allograft and autograft tissue used for reconstructing the Anterior and Posterior Cruciate Ligaments. 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 aluminum or a stainless steel alloy. 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 Medical to provide a 10-6 sterility assurance level (SAL): Cycle Type
Minimum Temperature
Minimum Exposure Time Minimum Dry Time (Wrapped)
Gravity
132°C / 270°F
15 minutes
Pre-vacuum
132°C / 270°F
4 minutes
30 minutes1
1 Drying times vary according to load size and should be increased for larger loads
7. Instructions for use: A. Using the sutures attached to a properly prepared graft, draw the graft into the sizing sleeve. The sleeve is used as Go-No Go gauge. B. The diameter of the graft will be determined when it passes snugly through the sleeve.