Rev. B 2014-05
IMPORTANT INFORMATION – Please Read Before Use
* For recognized manufacturer and model designation, refer to product label.
56 East Bell Drive
P.O. Box 587
Warsaw, IN 46581
Biomet U.K., LTD.
Waterton Industrial Estate
Bridgend, South Wales
CF31 3XA UK
INSTRUCTIONS FOR USE
SINGLE USE, NON-STERILE INSTRUMENTS
Orthopaedic instruments do not have an indefinite functional life. All instruments are subjected to stresses that impact their effectiveness. This instrument is
designed for single use due to the aspects of the design that would be compromised if used more than once. Instruments are often designed for use with specific
implant(s). Most instrument systems include a delivery system and sterilization cases/trays for sterilization prior to use. It is essential that the surgeon and surgical
staff are fully conversant with the appropriate surgical technique for the instrument and any associated implant.
This instrument is provided NONSTERILE and is for SINGLE USE ONLY. Instrument must be sterilized prior to use. Single Use devices ARE NOT to be
re-sterilized or reused. These single use devices have not been designed to undergo or withstand any form of alteration, such as disassembly, cleaning or
re-sterilization, after a single patient use. Reuse can potentially compromise device performance and patient safety.
Ultrasonically clean instrument for 10 minutes in neutral pH detergent, prepared in accordance with the manufacturer’s instructions. Rinse the instrument
thoroughly with warm tap water. Rinse all lumens, internal areas, sliding mechanisms, and hinged joints. Actuate sliding mechanisms and hinged joints while
rinsing. Dry immediately after final rinse. Dry internal areas with filtered compressed air, if available. Lubricate moving parts with a water-soluble lubricant, if
applicable. Inspect all instruments prior to sterilization or storage to ensure instruments are suitable for use.
Sterilize with steam sterilization. The following steam sterilization cycles are suggested for single use instruments based upon validation of a double wrapped,
multiple insert instrument case, within a properly maintained autoclave. It is critical that process parameters be validated for each facility’s individual type of
sterilization equipment and product load configuration.
• Use a validated, properly maintained and calibrated steam sterilizer.
• Effective steam sterilization can be achieved using the following cycles.
Minimum Exposure Time/Dry Time
4 minutes/30 minute dry time for metal or metal/poly trays and 45 minute dry time for all poly trays.
3 minutes/30 minute dry time for metal or metal/poly trays and 45 minute dry time for all poly trays.
NOTE: The adequacy of any sterilization procedure must be suitably tested. It is critical that appropriate process parameters be validated for each facility’s
sterilization equipment and product/load configuration. Persons who have training and expertise in sterilization processes should substantiate the reliability and
reproducibility of the process. Flash sterilization may be conducted, if applicable, according to the specific health care facility’s policy.
For further information related to the use of this instrument please contact your sales representative or distributor. For further information concerning sterilization,
please consult AAMI Technical Information Report (TIR) 12-1994, EN 285, or EN ISO 17664.
For instruments produced by another manufacturer, reference the manufacturer’s instructions for use.
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01-50-4203 Rev. B 2014-05
INTERPRETATION OF SYMBOLS
CAUTION: FEDERAL (USA) LAW
RESTRICTS THIS DEVICE TO SALE
BY OR ON THE ORDER OF A
DO NOT USE IF PACKAGE IS
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LATEX FREE: A PRODUCT
THAT IS MANUFACTURED
USING SYNTHETIC OR NONLATEXCONTAINING
01-50-4203 Rev. B 2014-05