CordCutter Instructions for Use

ENGLISH CORDCUTTER Some products may not be licensed in all jurisdictions. Rx Only (USA only) NON-STERILE REUSABLE INDICATIONS The CordCutter is a manual surgical instrument indicated for use during surgical applications. DEVICE DESCRIPTION The CordCutter is a reusable surgical instrument designed to cut suture. PRECAUTIONS Instrument may have sharp cutting edges that will puncture skin. 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 or sharpen. Do not use a DePuy Mitek instrument for any purpose other than its intended use as that may result in damage of the instrument. HOW SUPPLIED: Surgical Instruments are provided NON-STERILE. STORAGE: Store in a cool dry area. CLEANING AND STERILIZATION INSTRUCTONS These cleaning and sterilization instructions have been validated as being capable of preparing CordCutter 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. 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. CAUTIONS • Follow the instructions and warnings issued by the suppliers of any cleaning and disinfection agents and equipment used. • Do not exceed 137°C during sterilization steps. • Highly alkaline conditions can damage products with aluminum parts. • Avoid exposing instruments to hypochlorite solutions, as these will promote corrosion. • Clean delicate instruments separately from other instruments. Limitations on Cleaning and Sterilization • 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). PREPARATION Care at the Point of Use • 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. MANUAL CLEANING Disassembly Instructions 1. Press the button on top of the instrument and pull the inner shaft out of the instrument. 2. While disassembled ensure that the instrument and its removable inner shaft remain together during cleaning. Cleaning 1. Prepare an enzymatic cleaning solution in accordance to the manufacturer’s instructions. 2. Soak soiled instruments for a minimum of 10 minutes. Do not exceed 30°C. 3. 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

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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, 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. 4. Ultrasonically clean the instrument for 20 minutes at 38–49°C in neutral pH detergent, prepared in accordance with the manufacturer’s instructions. Rinsing Rinse the instrument thoroughly with filtered water at 38–49°C, 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 Dry the instrument immediately after final rinse. Use filtered compressed air to dry internal areas. Inspection After Cleaning 1. Inspect all instruments before sterilization or storage to ensure the complete removal of soil from surfaces, tube, holes, and moveable parts. 2. If soil is still present, reclean the instrument. Reassembly Instructions 1. Reassemble the instrument with its original components. 2. Press the button on top of the instrument and insert the shaft into the instrument with the notch pointing down toward the finger holes. 3. After the shaft engages the button should pop up. 4. Pull on the inner shaft to confirm that the shaft is locked into the instrument. INSPECTION AND FUNCTIONAL TESTING 1. Visually inspect the instrument and check for damage and wear. 2. Cutting edges should be free of nicks and have a continuous edge. 3. Moveable parts should have smooth movement without excessive play. 4. Locking mechanisms should fasten securely and close easily. 5. Long, thin instruments should be free of bending and distortion. PACKAGING • 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 • 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

ESPAÑOL CORDCUTTER Es posible que algunos productos no tengan licencia en todas las jurisdicciones. NO ESTÉRIL – REUTILIZABLE INDICACIONES CordCutter es un instrumento quirúrgico manual cuya utilización está indicada durante aplicaciones quirúrgicas. DESCRIPCIÓN DEL DISPOSITIVO CordCutter es un instrumento quirúrgico reutilizable diseñado para cortar suturas. PRECAUCIONES Este instrumento puede tener bordes de corte afilados que pueden perforar la piel.

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