Cannulated Drills and Headed Reamers Instructions for Use

Parcus Cannulated Drills and Headed Reamers Product Information Sheet and Instructions for Use (English) 1. Indications: Parcus Cannulated Drills and Headed Reamers are used to create tunnels and sockets in bone. This product is designed to be used in conjunction with a 2.4mm guide pin. 2. Warnings: A. Caution: Federal Law restricts this device to sale by or on the order of a physician. B. Never place this product over a bent or damaged guide pin. C. Placing off-axis loads on the guide pin by deflecting the drill/reamer may cause damage to both the drill/reamer and the guide pin. D. Never use a dull or damaged drill/reamer. E. This product is not intended to be left in the body. F. Be sure to remove any debris from the cannulation of the drill/reamer during the cleaning process. 3. Material: These products are manufactured from a stainless steel alloy. The material used in the manufacture of the devices 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 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 (Wrapped)

Gravity

132°C / 270°F

15 minutes

Pre-vacuum

132°C / 270°F

4 minutes

Minimum Dry Time 30 minutes1

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

7. Instructions for use: A. Use a purpose designed drill motor or wire driver to place a guide pin in the desired position. B. Securely attach the drill/reamer into a drill chuck. C. Place the drill/reamer over the guide pin. D. Make sure that the drill motor is set to rotate the drill/reamer in a clockwise direction. E. Prudently advance the drill/reamer over the guide pin, ensuring to maintain a coaxial orientation between the pin and the drill/reamer. F. After the desired depth has been reached, reverse the drill motor and remove the drill/reamer from the bone.