DePuy Mitek Tibial Guide System Instructions

1. Tibial Guide Arm 2. Tibial Guide Rail 3. Tibial Guide Bullet

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ENGLISH DePuy Mitek Tibial Guide System Rx Only DEVICE DESCRIPTION The DePuy Mitek Tibial Guide System is a non-sterile, reusable, metal guide with three components: 1. Tibial Guide Arm, 2. Tibial Guide Rail, 3. Tibial Guide Bullet INDICATIONS FOR USE The DePuy Mitek Tibial Guide System is intended for use during anterior cruciate ligament reconstruction. CONTRAINDICATIONS None Known WARNINGS • Appropriate personal protective equipment and attire should be worn when cleaning and sterilizing soiled surgical instruments. • Instruments may have sharp cutting edges that will puncture skin. PRECAUTIONS • It is imperative that the surgeon and operating theater staff are fully conversant with the appropriate surgical technique for the surgical instruments. • Inspect for damage prior to use. Replace a damaged, worn or bent instrument. Do not attempt to straighten, sharpen or repair. • Do not use a DePuy Mitek reusable instrument for any purpose other than its intended use as that may result in damage to the instrument. • Follow the instructions and warnings issued by the suppliers of any cleaning and disinfection agents and equipment used. • Do not exceed 137ºC during sterilization. • Complex devices, such as those with tubes, hinges, retractable features, mated surfaces, and textured surface finishes, require special attention during cleaning. Manual pre-cleaning of such device features is required before automated cleaning processing. • Avoid exposing instruments to hypochlorite solutions, as these will promote corrosion. • Repeated processing has minimal effects on instrument life and function. • End of useful instrument life is generally determined by wear or damage from handling or surgical use. Inspect instruments between uses to verify proper functioning. (See “Inspection and Functional Testing” instructions below.) 2

INSTRUCTIONS FOR USE Assemble the Tibial Guide System. Lock the Guide Arm onto the Guide Rail at the desired angle. Position the guide on the tibia. Push the Guide Bullet into place. The Guide Bullet will ratchet into place when the word “Locked” on the Guide Bullet aligns with the arrow on the Guide Rail. To remove the Guide Bullet, rotate the Guide bullet 180 degrees so the word “Locked” faces away from the arrow on the Guide Rail and pull the Guide Bullet out of the Guide Rail. TIBIAL GUIDE ASSEMBLY AND DISASSEMBLY INSTRUCTIONS Assembly and Disassemble per the graphic provided on the IFU. INSTRUMENT CLEANING AND STERILIZATION INSTRUCTIONS CLEANING AND STERILIZATION INSTRUCTIONS These cleaning and sterilization instructions have been validated for preparing reusable Mitek instruments for reuse. It is the responsibility of the end user to ensure that the cleaning and sterilization is actually performed using appropriate equipment, materials, and personnel to achieve the desired result. This normally requires validation and routine monitoring of the process. Any deviation from these instructions should be evaluated for effectiveness and potential adverse consequences. PREPARATION • Clean instruments as soon as possible after use. If cleaning must be delayed, wet the instruments in a compatible liquid solution to prevent drying and encrustation of surgical soil. • Avoid prolonged exposure to saline to minimize the chance of corrosion. • Remove excessive soil with a disposable wipe. Prior to sterilization, instruments should be cleaned by either automated or manual means described below. AUTOMATED CLEANING Instrument types with such complex design features as cannulations, lumens, (i.e. tubes), holes, hinged joints, box locks, spring-loaded retractable features, or flexible shafts; must be manually pre-cleaned prior to automated cleaning to improve the removal of adherent soil. Manual Pre-Cleaning Instructions • Flush internal areas with a warm detergent solution. Pay close attention to lumens, cannulations, holes, threads, crevices, seams, and any hard to reach areas. While flushing, actuate any moveable mechanisms (hinged joints, box locks, or springloaded features) to free trapped blood and debris. If 3

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the components of the instrument can be retracted, retract or open the part while flushing the area. For instruments with flexible shafts, flex the instrument while flushing. For instruments with lumens, brush the internal surfaces of the lumen.

Loading Instructions • Load instruments into washer disinfector so that hinges are open and cannulations and holes can drain. • Place heavier instruments on the bottom of containers. Do not place heavy instruments on top of delicate instruments. • For instruments with concave surfaces, such as curettes, place instrument with the concave surface facing downward to facilitate draining. Automated Cleaning Instructions • Clean in a validated washer disinfector using the “INSTRUMENTS” cycle and a pH neutral cleaning agent intended for use in automated cleaning. Effective automated cleaning can be achieved using the following parameters: two cold water pre-washes (minimum hold of two minutes each); a hot water enzyme wash (minimum hold of 4 minutes); followed by a hot water pH neutral detergent wash (minimum hold 3 minutes at 60ºC); a hot water rinse (minimum time 20 seconds); a thermal rinse (minimum hold of 1 minute at 82.2ºC) and dry (minimum hold 5 minutes at 95ºC). • After automated cleaning, proceed to inspection, instructions below. MANUAL CLEANING Cleaning Instructions • Prepare an enzymatic cleaning solution in accordance to the manufacturer’s instructions. • Soak soiled instruments for a minimum of 10 minutes. Do not exceed 30ºC. • When cleaning, fully immerse the instrument in the cleaning solution to avoid aerosol generation. Use a soft bristle brush to remove all traces of blood and debris; pay close attention to any hard to reach areas, textured surfaces, or crevices. When cleaning Instruments with cannulations or lumens (i.e. tubes), or holes, use a tight-fitting, soft, non-metallic cleaning brush or pipe cleaner to scrub the cannula, lumen, or hole. Push in and out, using a twisting motion to remove debris. Use a syringe filled with enzymatic cleaning solution to flush hard to reach internal areas. When cleaning articulating instruments, (those with moveable parts), brush with a soft non-metallic bristle brush to remove all traces of blood and debris. Pay close attention to threads, crevices, seams, 4

and any hard to reach areas. Actuate any moveable mechanisms, such as hinged joints, box locks, or spring-loaded features, to free trapped blood and debris. If the components of the instrument can be retracted, retract or open the part while cleaning the area. For instruments with flexible shafts, flex the instrument under the cleaning solution. Rinsing Instructions Rinse the instrument thoroughly with filtered water at 38–49ºC, agitate for a minimum of 1 minute; repeat rinse at least two additional times. When rinsing, pay particular attention to flush the cannulations, lumens, or holes with warm tap water. Also pay particular attention to internal areas and moveable parts. Actuate moveable parts while rinsing. If the components of the instrument can be retracted, retract or open the part while rinsing the area. For instruments with flexible shafts, flex the instrument under the rinse solution. Drying Instructions Dry the instrument immediately after final rinse. Use filtered compressed air to dry internal areas. After drying proceed to Inspection instructions. INSPECTION AFTER CLEANING • Inspect all instruments before sterilization or storage to ensure the complete removal of soil from surfaces, tubes and holes, moveable parts. • If areas are difficult to inspect visually, check for blood by immersing or flushing the instrument in a 3% hydrogen peroxide solution. If bubbling is observed, blood is present. Rinse instruments thoroughly after using hydrogen peroxide solution. • If soil is still present, reclean the instrument. MAINTENANCE Between uses, lubricate moving parts with a water-soluble lubricant in accordance with the manufacturer’s instructions. INSPECTION AND FUNCTIONAL TESTING • Visually inspect the instrument and check for damage and wear. • Cutting edges should be free of nicks and have a continuous edge. • Jaws and teeth should align properly. • Moveable parts should have smooth movement without excessive play. • Locking mechanisms should fasten securely and close easily. • Long, thin instruments should be free of bending and distortion.

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PACKAGING • For instruments that are provided in sets, instrument trays may be used for containment during sterilization. • Package trays/instruments with a barrier wrap material in accordance with local procedures, using standardized wrapping techniques such as those described in ANSI/AAMI ST46-1993. STERILIZATION • Place Mitek instrument in the appropriate location within the sterilization tray. If a specific location is not identified for an instrument, it may be placed in the general purpose area (pin-mat) ensuring that the sterilant has adequate access to all surfaces including difficult to reach areas, lumens, etc. • Use a validated, properly maintained and calibrated steam sterilizer. • Effective steam sterilization can be achieved using the following cycles: Cycle Type

Temperature

Minimum Exposure Time

Prevacuum

132–134ºC

4 minutes

Prevacuum

134–137ºC

3 minutes

STORAGE Store sterile packaged instruments in a manner that provides protection from dust, moisture, insects, vermin, and extremes of temperature and humidity.

ESPAÑOL Sistema de guía tibial DePuy Mitek DESCRIPCIÓN DEL DISPOSITIVO El sistema de guía tibial DePuy Mitek es una guía metálica reutilizable no estéril que consta de tres componentes: 1. Brazo de guía tibial, 2. Montante de guía tibial, 3. Cilindro de guía tibial INDICACIONES DE USO El sistema de guía tibial DePuy Mitek está diseñado para ser utilizado durante la reconstrucción del ligamento cruzado anterior. CONTRAINDICACIONES No se conoce ninguna ADVERTENCIAS • Es necesario utilizar una indumentaria y un equipo de protección personal adecuados para llevar a 6