ZIMMER

3.5 mm Hex Head Knob

Surgical Instrument Package Insert

2 Pages

• &  0413  803.006 EN Rev. F (2022-02-04)  Surgical Instrument Package Insert  ENGLISH  Zimmer CAS 75 Queen Street, Suite 3300 Montreal (QC) H3C 2N6, Canada +1 514 396 5422 1 866 3D ORTHO http://www.zimmerbiomet.com  EN  The CE mark is valid only if it is also printed on the product label. Surgical Instrument For detailed information concerning the identification of the product (such as name, reference number, etc.) please refer to the labeling on the package and/or the marking on the device  Important information for the operating surgeon  Before using a product placed on the market by Zimmer CAS, the operating surgeon should study carefully the following recommendations, warnings and instructions, as well as the available product-specific information (e.g., the applicable User Manual, product literature, written Surgical Technique). Zimmer CAS is not liable for complications arising from the use of the device outside of its indicated uses, surgical technique or judgment, product selection, and similar matters outside the control of Zimmer CAS.  INTENDED USE  For information about the intended use, refer to the corresponding system User Manual.  INTENDED USERS  Surgical instruments are intended to be used by: • Physicians/Surgeons trained to perform orthopedic surgical procedures with the device • Nurses trained to prepare the operating room, prepare and handle the instruments, and assist with the surgery procedure • Other Zimmer Biomet authorized representatives  INDICATIONS AND CONTRAINDICATIONS FOR USE  For more information about indications and contraindications, refer to the associated system User Manual and/or Surgical Technique.  CLINICAL BENEFITS, RESIDUAL RISK  PERFORMANCE  AND  For more information about clinical benefits, performance and residual risks, refer to the associated system User Manual and/or Surgical Technique.  WARNINGS  The following are warnings related to the use of the instruments specifically addressed by this insert. Warnings related to the use of Zimmer CAS applications are included in the Surgical Technique or User Manual. • Zimmer CAS applications should not be used to perform surgery in applications other than those specified in the User Manual. • In the case of sterile instruments, the protective packing must be checked for possible damage when opening the package before use as this could impair the sterility. The expiry date for the sterility of the product should also be verified. • Tool calibration, if applicable, must be done as described in the User Manual of the given applications. Before every surgery: • The instruments shall be inspected for excessive bending or other damages such as fatigue or  • • •  deterioration prior to use and verify that they are in good working order. Bends in the instruments may affect system accuracy. If the components are not in good working condition, the system should not be used and technical support should be contacted. If applicable, Tracking Sensors shall be securely assembled to the intended instruments. If applicable, Optical Markers shall be securely assembled and attached to the intended instruments. The instruments must be cleaned and sterilized before every surgery.  PRECAUTIONS  The following are general precautions related to the use of Zimmer CAS applications including the instruments specifically addressed by this insert. Other specific precautions are included in the Surgical Technique or User Manual. • Universal precautions should be observed by all health care professionals working with contaminated or potentially contaminated medical devices. Caution should be exercised when handling devices with sharp points or cutting edges. • If bone references are applicable, if they are contacted during the operation such that they may have potentially moved, the bone registration, or bone digitization steps, should be redone. • Use caution in positioning the CAS Fixation Pins such to avoid injuring veins or arteries, and such to avoid areas which may interfere with other instrumentation or implant components. • Do not clean polyetherimide components with phenol-based detergents. Crazing or cracking may occur. • Polysulfone components may show eventual crazing and/or cracking due to steam boiler chemicals and lubricants. • Sharp-edged instruments (i.e., reamers, bits) should not be reused once they become significantly dulled from general use. It is also recommended that such instruments not be resharpened by the physician or hospital. • Minimize excessive heat buildup due to friction between metallic components and adjacent surfaces, whether it be bone or other metallic surfaces. Excess heat buildup in instruments in contact with bone may cause heat necrosis and lead to early failure of the component. • Disposable pin and screws removed from their original packaging are not resterilizable and must be disposed of after surgery, even if they were not used.  CLEANING AND MAINTENANCE • •  •  •  Instruments must not come into contact with substances containing chlorine or fluorine. Instruments that are made wholly or partly of plastic must not come into contact with strong acids or lyes, organic or ammonia-containing solvents, aromatic and/or halogen hydrocarbons or oxidizing chemicals. Aluminium and materials containing aluminium must never come into contact with substances containing mercury. Even the smallest traces of mercury can lead to considerable corrosion. Instruments made from materials containing aluminium must only be wiped and cleaned with, or placed in, detergents and disinfectants that have a pH value between 4.5 and 8.5. With higher or lower pH values the protective neutral coating of materials containing aluminium dissolves, which leads to corrosion. Reusable instruments must be cleaned and sterilized between patient uses (also see Instructions under section SPECIAL INSTRUCTIONS FOR GENERIC INSTRUMENT CASES) Specific cleaning and maintenance instructions as applicable to each instrument are provided in the Surgical Technique or User Manual  Page 1 of 2  Screws and other mechanisms should be checked and lubricated with a medical grade surgical lubricant after each cleaning or as determined upon inspection.  Manual cleaning method Unless specified otherwise, the following general manual cleaning process shall be used: 1. Disassemble any multi-component instruments. 2. Rinse using tap water for 2 minutes. 3. Prepare the enzymatic cleaning solution (per the manufacturer’s recommendations). 4. Immerse the instrument in the prepared cleaning solution and allow soaking for 20 minutes (refer to applicable surgical technique for soaking time). 5. After the soak, use a soft-bristled, nylon 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 hard-to-clean areas. • Lumens should be cleaned with a long, narrow, soft-bristled brush. • Use a water jet to flush difficult to access areas and closely mated surfaces. • For threaded interfaces, screw/unscrew components while flushing the areas. 6. Rinse using tap water for 3 minutes. Thoroughly and aggressively flush lumens, holes and other difficultto-reach areas. 7. Prepare the enzymatic cleaning solution (per manufacturer’s recommendations) in an ultrasonic cleaner. 8. Immerse the instrument in prepared cleaning solution and sonicate for a minimum of 10 minutes. 9. Rinse the instrument with purified water for a minimum of 3 minutes ensuring all visible evidence of detergent is removed. 10. Repeat the sonication and rinse steps above. 11. Dry article with a clean, lint-free cloth. Automated cleaning method Manual cleaning shall be used prior to Automated cleaning (refer to Manual cleaning method). • Orthopedic instruments with any features such as multiple components, lumens/cannulations, blind holes, mated surfaces, connectors and internal mechanisms should be cleaned following the rigorous manual or combination cleaning procedure. • Thorough visual inspection to ensure effective cleaning is recommended prior to sterilization. Place instruments in a suitable washer-disinfector basket and process through a standard instrument washerdisinfector cleaning cycle as outlined in Table 1 or Table 2 below. Table 1: Typical European Automated WasherDisinfector Cycle for Surgical Instruments Step  Description  1  5 minutes prewash with cold tap water  2  10 minutes alkaline cleaning agent wash at 55°C  3  2 minutes rinse with neutralizer  4  1 minute rinse with cold tap water  5  Disinfection at 93°C with hot purified water until A0 3000 is reached (approx. 10 minutes)  6  40 minutes hot air drying at 110°C  Table 2: Typical US Automated Washer-Disinfector Cycle for Surgical Instruments Step  Description  1  2 minutes prewash with cold tap water  2  20 seconds enzyme spray with hot tap water  3  1 minute enzyme soak  4  15 seconds cold tap water rinse (X2)  5  2 minutes detergent wash with hot tap water (64‑66°C/146‑150°F)  6  15 seconds hot tap water rinse  7  2 minutes thermal rinse (80‑93°C/176‑200°F)  8  10 seconds purified water rinse with optional lubricant (64‑66°C/146‑150°F)  9  7 to 30 minutes hot air drying (116°C/240°F)
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