DJO Surgical Instruments and Instrument Cases Product description

handling and storage. The inserts may consist of trays, holders, and silicone mats. The instrument cases will allow sterilization of the contents to occur in a steam autoclave utilizing the cleaning, sterilization, and drying cycle that has been validated and detailed below. Instrument cases do not provide a sterile barrier and must be used in conjunction with sterilization wrap to maintain sterility. Instruments are provided non-sterile and should be stored in their original packaging until cleaned and sterilized according to the recommended guidelines listed below. WARNINGS

Automated cleaning may not be thorough enough. Carefully inspect each instrument to ensure that all visible blood residue and other contaminants have been removed.

CAUTION

Federal Law (USA) restricts this device to sale by or on the order of a physician.

REPROCESSING LIMITATIONS

DJO Surgical instruments can be steam sterilized and repeat sterilization will not adversely affect them. If problems related to instrument sets are identified when using our instruments or instrument cases, please bring it to the attention of DJO Surgical for investigation. The lifetime of an instrument is typically limited by normal wear and damage due to use.

DISCLAIMER

DJO Surgical instrument cases are intended to protect instrumentation and facilitate the sterilization process by allowing steam penetration and drying. DJO Surgical has verified through laboratory testing that our instrument cases are suitable for the sterilization cycles listed in the sterilization section of the IFU. Health care personnel are ultimately responsible for ensuring that any packaging method or material, including a reusable rigid container system, is suitable for use in sterilization processing and sterility maintenance in their particular health care facility. Testing should be conducted in a health care facility to assure that conditions essential to sterilization can be achieved.

1 For modified case Revision “J” or greater.

2 For cleaning and sterilization of instrumentation distributed by DJO Surgical, please refer to the manufacturer’s Instructions for Use provided in the Instrument Tray.

INSTRUCTIONS FOR USE POINT OF USE PREPARATION

Keep instruments moist and do not allow blood and/or bodily fluids to dry on the instruments. The decontamination process should begin immediately after the completion of the surgical procedure. If cleaning must be delayed, place instruments in a covered container with appropriate enzymatic detergent to delay drying. Instruments should be cleaned within 30 minutes of use to minimize the potential for drying prior to cleaning. Wash all instruments whether or not they were used or were inadvertently contacted with blood. Disassemble instruments with removable parts; loosen instruments with movable parts, as applicable.

DECONTAMINATION

Saturate the surface completely with full strength disinfectant/cleaner* (e.g. CaviCide) and allow to remain in contact with devices for 5 minutes.

AUTOMATED CLEANING

DJO Surgical rigid instrument cases may be washed and/or disinfected by using an automated washer-disinfection unit utilizing thermal disinfection. Temperatures, cycles, and disinfectant type used should be as instructed by manufacturer of the washer-disinfection unit. For ultrasonic cleaning follow the manufacturer’s specifications for suggested water level and concentration. When using mechanical washers, make sure the instruments are secured in place, and do not touch or overlap. Automated washer/disinfector systems are not recommended as the sole cleaning method for complex, surgical instruments. Complex instrumentation, such as tubes, hinges, retractable features, mated surfaces, sliding components, turning knobs, spring-loaded features, and textured surfaces, should be cleaned in accordance with the procedure described in the manual cleaning section.

A. MANUAL CLEANING: ALL INSTRUMENTS

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Pre-Cleaning: Remove gross contaminants by immersing the devices in room temperature neutral pH enzymatic cleaner* (e.g. MetriZyme) and disassemble/loosen instruments, if suitable. The majority of the surgical instruments and trial devices are simply constructed and will not require disassembly. However, some of the more complex instruments are made of several components and these should be disassembled into their individual parts prior to decontamination. Scrub with the appropriate soft bristle brush until visibly clean. Washing: Immerse devices in the ultrasonic washer/cleaner with room temperature neutral pH enzymatic cleaner* (e.g. MetriZyme) and sonicate for 10 minutes. Ultrasonic cleaners can be used with hot water per the manufacturers’ recommended temperature; however, room temperature was qualified. Be aware that loading patterns, water temperature, and other external factors may change the effectiveness of the equipment. Rinsing: Thoroughly rinse the devices with deionized or distilled water. For example, a minimum of 2 minutes three (3) times.

* Do not use high acidic (pH <4) or high alkaline (pH >10) products for disinfection or cleaning, since these can corrode metal, cause discoloration or stress fractures. DJO Surgical has qualified the above cleaning method with the provided solution examples, for a 3 Spore Log Reduction (SLR). Other cleaning/disinfection methods may also be suitable, however individuals or hospitals not using the recommended method are advised to validate any alternate method using appropriate laboratory techniques. B. MANUAL CLEANING: INSTRUMENTS WITH CANNULAS, LUMENS, OR HOLES

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C. MANUAL CLEANING: ARTICULATING INSTRUMENTS

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Pre-Cleaning: Follow the “Pre-Cleaning” and “Washing” steps in Section A. Manual Cleaning – ALL INSTRUMENTS. Washing: After ultrasonic cleaning, in a fresh enzymatic cleaning bath use a tight-fitting, soft, non-metallic cleaning brush or pipe cleaner to scrub any cannula, lumen, or hole(s). Push in and out, using a twisting motion to remove debris. Use a syringe filled with enzymatic neutral pH cleaning solution to flush hard to reach internal areas. Rinsing: Flush the instrument paying special attention to the cannulations, lumens, and/or holes with deionized or distilled water. For example, a minimum of 2 minutes three (3) times. Pre-Cleaning: Follow the “Pre-Cleaning” and “Washing” steps in Section A. Manual Cleaning – ALL INSTRUMENTS. Washing: After ultrasonic cleaning, immerse the instrument in fresh neutral pH enzymatic cleaning solution to avoid aerosol generation. Actuate moveable mechanisms, such as knobs, hinges, box locks, or spring-loaded/retractable features. For instruments with flexible shafts, bend or flex the instrument under the neutral pH cleaning solution while brushing the flexible areas. For instruments with internal cavities, after actuating components in the neutral PH cleaning solution, fully open components and use a tight-fitting, soft, non-metallic cleaning brush or pipe cleaner to scrub the internal cavities. Use a syringe filled with enzymatic neutral pH cleaning solution to flush hard to reach internal areas Rinsing: Actuate and/or retract moveable parts while rinsing with deionized or distilled water. For example, a minimum of 2 minutes three (3) times. For instruments with flexible shafts, flex the instrument while rinsing.

DRYING

Allow devices to air dry a minimum of 20 minutes prior to inspection and sterilization preparation. Instruments must be thoroughly dried to remove residual moisture before they are stored. Filtered compressed air may be used prior to air drying if available.

MAINTENANCE INSPECTION AND TESTING

After cleaning/disinfection, the disassembled instruments should be visually inspected. Check for misalignment, burrs, bent, or fractured tips. Mechanically test the working parts (e.g. hinges) to verify that each instrument functions throughout its intended range of motion. Place instruments into appropriate configuration within instrument case and wrap with protective sterilization wrap according to AAMI / AORN guidelines. Surgical instruments and instrument cases are susceptible to damage from prolonged use, and through misuse or rough handling. Care must be taken to avoid compromising their performance. To minimize damage, conduct the following: 1. Inspect instrument cases and instruments for damage when received and after each use and cleaning. Incompletely cleaned instruments should be re-cleaned, and those that need repair returned for servicing. 2. Only use an instrument for its intended purpose. 3. When handling sharp instruments use extreme caution to avoid injury. Consult with an infection control practitioner to develop safety procedures appropriate for all levels of direct instrument contact. 4. If instruments appear to be damaged in such a way that may compromise the performance of the instrument, contact your DJO Surgical representative for a replacement. 5. Visually inspect the instrument and check for damage and wear, moveable parts should have smooth movement, locking mechanisms should fasten securely

PACKAGING

Health care personnel are ultimately responsible for ensuring that any packaging method or material is suitable for use in sterilization processing and sterility maintenance in their particular health care facility.

TRANSPORT

Compliance with the general precautionary measures for handling contaminated/biologically hazardous materials is required.

STERILIZATION

Instruments supplied by DJO Surgical have been thoroughly cleaned, inspected and tested for proper function prior to shipment. Unless otherwise indicated, these instruments are NOT STERILE and must be sterilized prior to use. Instruments provided outside of instrument sets should be fully loosened/disassembled and wrapped per AAMI ST:79/AORN Guidelines. NOTE: DJO Surgical does not recommend Flash Sterilization or Chemical Sterilization. The following are minimum cycles required for steam sterilization that has been validated by DJO Surgical under laboratory conditions to achieve a SAL of 10-6 with components loosened. DJO Surgical has data on file. Other sterilization cycles may also be suitable; however individuals or hospitals not using the recommended method are advised to validate any alternate method using appropriate laboratory techniques. Proper validation of the autoclave is essential to ensure proper sterilization temperatures and cycle times. Sterilization with a Pre-Vacuum Sterilizer (HI-VAC): 270° F (132° C), 4-minute exposure time, with 4 pulses and a 30-minute dry time. Sterilization with a Gravity Displacement Sterilizer: 270° F (132° C), 15-minute exposure time, with a 30-minute dry time.

STORAGE

Instruments must be thoroughly dried to remove residual moisture before they are stored. Instruments or instrument cases that have been processed and wrapped to maintain sterility should be stored in a manner to avoid extremes in temperature and moisture. Care must be taken in handling wrapped instruments or instrument cases to prevent damage to the barrier. The health care facility should establish a shelf life for wrapped or pouched instruments or instrument cases, based upon the type of sterile wrap or pouch used and the recommendations of the sterile wrap/pouch manufacturer. The user must be aware that maintenance of sterility is event-related and that the probability of occurrence of a contaminating event increases over time and with handling.

CONTACT INFORMATION

DJO Surgical ATTN: Customer Service 9800 Metric Boulevard Austin TX, 78758 USA 1-800-456-8696

The instructions provided above have been validated by DJO Surgical as being capable of preparing a medical device for re-use. It remains the responsibility of the user to ensure that the reprocessing is performed using appropriate equipment and materials, and that personnel in the reprocessing facility have been adequately trained to achieve the desired result. This normally requires validation and routine monitoring of the process. An electronic version of this IFU can be located at:

http://djoglobal.com/our-brands/djo-surgical Some DJO Surgical products use SurgiBit® technology. The SurgiBit® technology is protected by the following patents: Drill Point protected under U.S. Design Patents D523313 & D523398. U.S. Utility Patents Pending.