BIOMET Instruments and Cases Instructions for Use

B. Sterilization The health care facility is 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 a particular health care facility. ANSI/AAMI/ISO 17665-1 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices and ANSI/ AAMI ST79 Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities provide guidelines for preparation and assembly, sterilizer loading and unloading, matching the container system to the appropriate sterilization cycle, quality assurance, sterile storage, transport, and aseptic use. USE AND CARE OF SURGICAL INSTRUMENTS/CASES Surgical instruments and instrument cases are susceptible to damage for a variety of reasons, including the following: prolonged use; misuse; rough or improper handling. Care must be taken to avoid compromising the performance of the surgical instruments and instrument cases. To minimize damage and risk of injury and potential adverse effects on users and patients, the following should be reviewed: • See Reusable Instrument Lifespan Manual 1219 for guidance on determining reusable instrument suitability for use, available from your Zimmer Biomet sales representative or at http://labeling.zimmerbiomet.com. • Instruments delivered in a transportation package shall be placed in the specific tray before initial processing in the hospital. • Inspect the instrument case and instruments for damage upon receipt, after each use and cleaning and prior to use. Instruments in need of repair should be set aside for repair service or returned to Zimmer Biomet. Instruments returned to Zimmer Biomet or its distributors should be cleaned and sterilized prior to shipment. ANSI/AAMI ST79 Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities provides guidelines for return, or contact Zimmer Biomet or your distributor for further instructions. • Only use an instrument for its intended purpose. • When handling sharp instruments, use extreme caution to avoid injury. Consult an infection control practitioner to develop and verify safety procedures appropriate for all levels of direct instrument contact and disposal. In the event of an alleged product failure, it is important to have the instrumentation returned to Zimmer Biomet for investigation. • Alkaline detergents with pH ≤ 12 may be used to clean stainless steel and polymer instruments; however, it is critical that alkaline cleaning agents are thoroughly neutralized and rinsed off devices. The use of alkaline cleaning agents might be corrosive to the surface of aluminium and titanium instruments. Drill bits, reamers, rasps and other cutting devices should be carefully inspected after processing with alkaline detergents to ensure that cutting edges are fit for use. • Metal brushes or scouring pads must not be used during manual cleaning procedures. These materials will damage the surface and finish of instruments. Soft-bristled, nylon brushes and pipe cleaners should be used. • Do not stack instruments or place heavy instruments on top of delicate devices. • Saline and cleaning/disinfection agents containing aldehyde, mercury, active chlorine, chloride, bromine, bromide, iodine or iodide are corrosive and should not be used. Instruments must not be placed or soaked in Ringer’s solution. • Descaling agents that include morpholine should not be used in steam sterilizers. These agents leave residues that can damage polymer instruments over time. Steam sterilizers should be descaled in accordance with the manufacturer’s instructions. • Repeated processing according to these instructions has minimal effect on Biomet reusable manual instruments unless otherwise noted. End of life for stainless steel or other metal surgical instruments is normally determined by wear and damage due to the intended surgical use and not to reprocessing. See also the Reusable Instrument Lifespan Manual 1219 for determining end of life by wear and damage due to use. • Polymers used in Biomet instrument sets can be sterilized using steam/ moist heat. Polymer materials have a limited useful life. If polymer surfaces turn “chalky,” show excessive surface damage (e.g. crazing or delamination), or if polymer devices show excessive distortion or are visibly warped, they should be replaced. Notify your Zimmer Biomet representative if polymer devices need to be replaced. • Most currently available polymers will not withstand conditions in washers/sterilizers that operate at temperatures equal to or greater than 141 °C / 285 °F, and use live-steam jets as cleaning features. Severe surface damage to polymer devices may occur under these conditions. • Stainless steel instruments may be treated with rust removal agents approved for surgical instruments if needed. • Titanium and titanium alloy devices are especially susceptible to discoloration from steam impurities and detergent residues which form multi-coloured surface layers of oxide deposits. Upon repeated sterilization, these oxide layers, while not harmful to the patient, may become dark and obscure graduation marks, item and lot numbers, and other stamped or etched information. Acidic, anti-corrosion agents may be used to remove this discoloration as needed.

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Use of hard water should be avoided. Softened tap water may be used for initial rinsing. Purified water should be used for final rinsing to eliminate mineral deposits on instruments.

CLEANING AND DISINFECTION (See also Instrument Assembly and Disassembly Manual 1258 or product-specific Assembly and Disassembly Manual, where applicable, available from your Zimmer Biomet sales representative or at http://labeling.zimmerbiomet.com). Note: for first use, remove and dispose of all packaging material before cleaning and sterilizing instruments. A. Point-of-Use Preparation for Reprocessing Remove excess body fluids and tissue from instruments with a disposable, nonshedding wipe. Place instruments in a basin of distilled water or in a tray covered with damp towels. Do not allow saline, blood, body fluids, tissue, bone fragments or other organic debris to dry on instruments prior to cleaning. Note: Soaking in proteolytic enzyme solutions or other pre-cleaning solutions facilitates cleaning, especially in instruments with complex features and hard-toreach areas (e.g. cannulated and tubular designs, etc.). These enzymatic solutions, as well as enzymatic foam sprays, break down protein matter and prevent blood- and protein-based materials from drying on instruments. Manufacturer’s instructions for preparation and use of these solutions should be explicitly followed. For optimal results, instruments should be cleaned within 30 minutes of use or after removal from solution to minimize the potential for drying prior to cleaning. Used instruments must be transported to the central supply in closed or covered containers to prevent unnecessary contamination risk. Do not place soiled instruments back in the instrument case. B. Preparation before Cleaning Loosen and/or disassemble instruments with removable parts. Care should be exercised to avoid losing small screws and components. If a part is lost, notify your Zimmer Biomet representative when the instrument set is returned. Instruments with removable polymer sleeves must be disassembled for sterilization (e.g. acetabular reamer shaft with sleeve, side cutters, etc.). Symbols or specific instructions etched on instruments or instrument trays and cases should be strictly followed. See also Instrument Assembly and Disassembly Manual 1258 or product-specific Assembly and Disassembly Manual, where applicable, for disassembly instructions prior to cleaning/ sterilization. C. Preparation of Cleaning Agents Neutral pH, enzymatic, and alkaline cleaning agents with low foaming surfactants are recommended. Alkaline agents with pH ≤ 12 may be used in countries where required by law or local ordinance. Alkaline agents should be followed with a neutralizer and/ or thorough rinsing. Only agents with proven efficacy (FDA approved, VAH listed, or CE mark) should be used. As a wide variety of cleaning agents and disinfectants exists globally, Zimmer Biomet does not recommend any specific brand. Agents used during the validation of these processing instructions are as follows: 1. Enzymatic and Neutral Detergents: Steris®, Prolystica® 2X Concentrate Enzymatic Presoak and Cleaner and Prolystica® 2X Concentrate Neutral Detergent. 2. Alkaline Detergent and Neutralizer: neodisher® FA Alkaline Detergent and neodisher® Z Acid Neutralizer. All cleaning agents should be prepared at the use dilution and temperature recommended by the manufacturer. Softened tap water may be used to prepare cleaning agents. Use of recommended temperatures is important for optimal performance of cleaning agents. Dry powder cleaning agents should be completely dissolved prior to use to avoid staining or corrosion of instruments and to ensure correct concentration. Fresh cleaning solutions should be prepared when existing solutions become grossly contaminated (bloody and/ or turbid). Note: It is important to select enzymatic solutions intended for breakdown of blood, body fluids and tissues. Some enzymatic solutions are specifically intended for breaking down faecal matter or other organic contaminants and may not be suitable for use with instruments. D. Combination Manual/Automated Cleaning and Disinfection Instructions 1. Completely submerge the instruments, trays, cases and lids in an enzyme or alkaline (pH ≤12) solution and allow to soak and sonicate for 10 minutes at 40±5 kHz. If using enzymatic cleaning agents, use a soft nylon bristled brush to gently scrub the device until all visible soil has been removed. Particular attention must be given to crevices, lumens, mated surfaces, connectors and other hardto-clean areas. Lumens should be cleaned with a long, narrow, soft nylon bristled brush (i.e. pipe cleaner). Note: Use of a syringe or water jet will improve flushing of difficult-toreach areas and closely mated surfaces. 2. Remove instruments from the cleaning solution and rinse in purified water for a minimum of 1 minute. Thoroughly and aggressively flush lumens, blind holes and other difficult-to-reach areas. 3. Place instruments in a suitable washer/disinfector basket and process through a standard instrument washer/disinfector cleaning cycle. The minimum parameters in Tables 2 and 3 are essential for thorough cleaning and disinfection.

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Note: The washer/disinfector manufacturer’s instructions should be strictly adhered to. Use only cleaning agents recommended for the specific type of automated washer/ disinfector. A washer/disinfector with approved efficacy (e.g. CE mark, FDA clearance, and validation according to ISO 15883) should be used. Table 2. Typical U.S. Automated Washer/Disinfector Cycle for Surgical Instruments Step Description 1 2 minute prewash with cold tap water 2 20 second enzyme spray with hot tap water 3 1 minute enzyme soak 4 15 second cold tap water rinse (X2) 5 2 minute detergent wash with hot tap water (64-66 °C/146-150 °F) 6 15 second hot tap water rinse 7 2 minute thermal rinse (80-93 °C/176-200 °F) 8 10 second purified water rinse with optional lubricant (64‑66 °C/146-150 °F) 9 7 to 30 minute hot air dry (116 °C/240 °F) Table 3. Typical European Automated Washer/Disinfector Cycle for Surgical Instruments Step Description 1 5 min pre-rinse with cold tap water 2 10 min alkaline cleaning agent wash at 55 °C 3 2 min rinse with neutralizer 4 1 min rinse with cold tap water 5 Disinfection at 93 °C with hot purified water until A0 3000 is reached (approx. 10 min) 6 40 min hot air drying at 110 °C 4. Proceed to Inspection, Maintenance, Testing, and Lubrication. INSPECTION, MAINTENANCE, TESTING, AND LUBRICATION (See also Reusable Instrument Lifespan Manual 1219, available from your Zimmer Biomet sales representative or at http://labeling.zimmerbiomet.com) 1. Carefully inspect each device to ensure that all visible contamination or biological residues have been removed. If contamination is noted, repeat the cleaning and disinfection process. 2. Visually inspect for completeness, damage and/or excessive wear. Please see the Reusable Instrument Lifespan Manual 1219 for determining end of life by wear and damage due to use. Note: If damage or wear is noted that may compromise the function of the instrument, do not use the device and contact your Zimmer Biomet representative for a replacement. 3. Check the action of moving parts (e.g. hinges, box-locks, connectors, sliding parts, etc.) to ensure smooth operation throughout the intended range of motion. 4. If necessary, hinged, rotating, or articulating instruments can be lubricated with an instrument product (e.g. instrument milk or equivalent lubricant) specifically designed for compatibility with steam sterilization. Note: These lubrication instructions are not applicable to air-powered or electrical instruments. These devices have different requirements and should be lubricated according to the manufacturer’s instructions. Note: Lubricants not specifically designed for compatibility with steam sterilization should not be used because they: 1) may coat microorganisms; 2) may prevent direct contact of the surface with steam; 3) are difficult to remove. 5. Check instruments with long slender features (particularly rotating instruments) for distortion. 6. Where instruments form part of a larger assembly, check that the devices assemble readily with mating components. REPROCESSABLE INSTRUMENTS STERILE PACKAGING – ONLY APPLICABLE FOR INSTRUMENTS DELIVERED IN NON STERILE CONFIGURATION A. Packaging Individual Instruments • Devices provided non-sterile are indicated by the symbol on the label. • Single devices should be packaged in a medical grade sterilization pouch or wrap which conforms to the recommended specifications for steam sterilization provided in Table 4. Ensure that the pouch or wrap is large enough to contain the device without stressing the seals or tearing the pouch or wrap. • The sterilization wrap used should be FDA cleared and comply with European regulations.

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Standard medical grade, steam sterilization wrap may be used to package individual instruments. The package should be prepared using the AAMI double wrap or equivalent method.

Table 4. Recommended Steam Sterilization Parameters Cycle Type

Temperature

Note: If sterilization wraps are used, they must be free of detergent residues. Reusable wraps are not recommended.

U.S. Prevacuum U.K. Prevacuum Prevacuum1,2

132 °C / 270 °F 134 °C / 273 °F 134 °C / 273 °F

B. Packaging Instrument Sets in Rigid Trays and Cases with Lids • Safety Precaution: The total weight of a wrapped instrument tray or case should not exceed 11.4kg/25lb. Instrument cases may be placed in an approved sterilization container (e.g. Aesculap) with gasketed lids at the user’s discretion. The total weight of the instrument set, case, and sterilization container, must not exceed 11.4kg/25lb (other local limits below 25lb may apply). • Trays and cases with lids may be wrapped in standard medical grade, steam sterilization wrap using the AAMI double wrap method or equivalent. • The sterilization wrap used should be FDA cleared and comply with European regulations. • Trays and cases with lids may also be placed in an approved sterilization container with gasketed lid for sterilization. • Follow the sterilization container manufacturer’s instructions for inserting and replacing sterilization filters in sterilization containers. • Areas designated for specific devices shall contain only devices specifically intended for these areas. • All devices must be arranged to ensure steam penetration to all instrument surfaces. Instruments should not be stacked or placed in close contact. • Any device capable of disassembly must be disassembled prior to placement in the case. C. Instrument trays and cases with defined, preconfigured layouts • Areas designated for specific devices shall contain only devices specifically intended for these areas. • Optional Biomet instruments should not be added to a preconfigured instrument tray or case unless a dedicated universal space or compartment has been included in the design and the guidelines described below for trays and cases without defined layouts or universal spaces can be applied. STERILIZATION • Flash (immediate-use) steam sterilization is not recommended. • Ethylene oxide or gas plasma sterilization methods should not be used unless package inserts for the applicable product specifically provide instructions for sterilization using these methods. • The hospital is responsible for in-house procedures for the reassembly, inspection, and packaging of the instruments after they are thoroughly cleaned in a manner that will ensure steam sterilant penetration and adequate drying. Provisions for protecting any sharp or potentially dangerous areas of the instruments should also be recommended by the hospital. • Steam sterilizer manufacturer recommendations should always be followed. When steam sterilizing multiple instrument sets in one sterilization cycle, ensure that the manufacturer’s maximum load is not exceeded. • Instrument sets should be properly prepared and packaged in trays and/ or cases that will allow steam to penetrate and make direct contract with all surfaces. • See Table 4 for recommended minimum steam sterilization parameters that have been validated to provide a 10-6 sterility assurance level (SAL). Local or national specifications should be followed where steam sterilization requirements are stricter or more conservative than those listed in the table. Note: The sterilizer manufacturer’s instructions for operation and load configuration should be followed explicitly.

Exposure Time 4 minutes 3 minutes 18 minutes

Minimum Dry Time3

Minimum Cool Time4

30 minutes

30 minutes

Disinfection/steam sterilization parameters recommended by the World Health Organization (WHO) for reprocessing instruments where there is concern regarding TSE/CJD contamination. 2 This cycle is not to be used for the inactivation of prions. 3 Drying times vary according to load size and should be increased for larger loads. 4 Cooling times vary according to the type of sterilizer used, device design, temperature and humidity of ambient environment, and type of packaging used. Cooling process should comply with ANSI/AAMI ST79. 1

STORAGE, HANDLING AND SHELF LIFE • Sterile, packaged instruments should be stored in a designated, limited access area that is well ventilated and provides protection from dust, moisture, insects, vermin, sunlight and temperature/humidity extremes. • Care must be exercised when handling wrapped cases or individual instruments to prevent damage to the sterile barrier. • The health care facility should establish a shelf life for sterilized instrumentation based upon the type of sterile wrap or rigid container used and the recommendations of the sterile wrap or rigid container manufacturer. • Sterile instrument packages should be carefully examined prior to opening to ensure that package integrity has not been compromised. Note: Maintenance of sterile package integrity is generally eventrelated. If a sterile wrap is torn, perforated, shows any evidence of tampering or has been exposed to moisture, the instrument set must be cleaned, repackaged and sterilized. Note: If there is any evidence that the lid seal or filters on a sterilization container have been opened or compromised, the sterile filters must be replaced and the instrument set resterilized. •

Non-sterile provided instruments are to be stored in the appropriate packaging that protects the instruments from damage or in an appropriate instrument tray. Instruments must be examined for possible damage before use. Protective caps or other protective elements must be removed before cleaning.

DISPOSAL INFORMATION After use, an instrument is a potential biohazard, since it may be contaminated with blood or other body fluids, bone or other tissue. Handle and dispose of this product in accordance with accepted medical practice and with applicable local, state and national laws and regulations. In the event of an alleged product failure it is important to have the instrumentation returned to Zimmer Biomet for investigation. Any sharp objects should be disposed of immediately after use into a sharps container conforming to EN ISO 23907-1 or equivalent following the requirements in Directive 2010/32/EU or equivalent national laws. The sharp object must not be bent, broken or resheathed prior to disposal. REPORTING PROBLEMS Healthcare professionals, users and patients should report any suspected serious incident related to the device to the manufacturer at www.zimmerbiomet.com and to the competent authority of the member state in which the serious incident has occurred. CAUTION: Federal Law (USA) restricts this device to sale by, or on the order of a physician. All trademarks herein are the property of Zimmer Biomet or its affiliates unless otherwise indicated. Steris® and Prolystica® are registered trademarks of Steris Corporation. Neodisher® is a registered trademark of Chemische Fabrik Dr. Weigert GmbH. CE Mark on the package insert (IFU) is not valid unless there is a CE Mark on the product (description) label.

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