Femoral Offset Guide Directions for Use

Parcus Femoral Offset Guide 1.

Indications:

2.

The Parcus Femoral Offset Guides are used to assist in placing a 2.4mm guide pin for creating the femoral tunnel or socket in ACL reconstructions. Warnings:

3.

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. C. Never use this device if it has been bent or damaged in any way. D. Extending the knee with this instrument in position may result in damage to the instrument. E. Take care to remove all debris from the cannulation of the instrument after use. Material:

4.

This product is manufactured from stainless steel and aluminum alloys. 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. Inspection:

5.

A. Inspect the device for damage at all stages of handling. B. If damage is detected, consult the manufacturer for guidance. Cleaning: A.

6.

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. 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.

Directions for use: A.

B. C. D. E.

Select the proper offset. The Femoral Offset Guides are sized in various millimeter offsets that place a guide pin anterior to the tang of the guide. For example, a 7mm aimer will leave a 2mm wall of bone if a 10mm reamer is used. Insert the aimer into the knee through a tibial tunnel or arthroscopic portal. It may be necessary to flex the knee to place the guide in the desired position. Place the tang of the Femoral Offset Guide at the “over the top” position on the femur. Advance a 2.4mm guide pin trough the cannulation in the guide into or through the bone. Remove the Femoral Offset Guide and use a cannulated drill or reamer over the guide pin to create the tunnel or socket in the targeted bone.