Manual Surgical Orthopedic Instruments Cleaning and Sterilization Instructions

INSTRUCTIONS FOR USE 2. WARNINGS AND PRECAUTIONS a. Universal precautions should be observed by all hospital personnel that work with contaminated or potentially contaminated medical devices. b. Caution should be exercised when handling devices with sharp points or cutting edges. c. Personal Protective Equipment (PPE) should be worn when handling or working with contaminated or potentially contaminated materials, devices and equipment. PPE includes gown, mask, goggles or face shield, gloves and shoe covers. d. Metal brushes or scouring pads must not be used during manual cleaning procedures. These materials will damage the surface and finish of instruments. e. Soft-bristled, nylon brushes and pipe cleaners should be used. f. Do not place heavy instruments on top of delicate devices. g. Do not allow contaminated devices to dry prior to reprocessing. All subsequent cleaning and sterilization steps are facilitated by not allowing blood, body fluid, bone and tissue debris, saline, or disinfectants to dry on used instruments. h. Remove excess body fluids and tissues with a disposable, non-shedding wipe and cover with a damp cloth. i. Automated cleaning alone may not be effective. A thorough manual cleaning process is recommended. j. Instruments should be removed from trays and cleaned separately. k. Cleaning agents with chlorine or chloride as the active ingredient are corrosive to stainless steel and must not be used. Enzymatic and cleaning agents with neutral pH are recommended.

3. POINT OF USE PREPARATION, CONTAINMENT AND TRANSPORTATION a. Remove excess body fluids and tissue from instruments with a disposable, non-shedding wipe. b. 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. Instruments should be cleaned within 30 minutes of use to minimize the potential for drying prior to cleaning. c. Used instruments must be transported to the central supply in closed or covered containers to prevent unnecessary contamination risk.

4. PREPARATION OF CLEANING AGENTS a. Neutral pH enzymatic and low foaming cleaning agents are preferred and recommended by Shukla Medical. b. All cleaning agents should be prepared at the use-dilution and temperature recommended by the manufacturer. c. Softened tap water may be used to prepare cleaning agents. Use of recommended temperatures is important for optimal performance of cleaning agents. d. Fresh cleaning solutions should be prepared when existing solutions become grossly contaminated (bloody and/or turbid).

5. MANUAL CLEANING PROCESS a. Use the neutral pH enzyme soaking solution that has been prepared. b. Completely submerge the instrument(s) in enzyme solution and allow it to soak for 20 minutes. c. Use a soft-bristled brush to gently clean the device (particular attention shall be given to crevices, lumens, mated surfaces and other hard-to-clean areas) until all visible soil has been removed. d. Lumens should be cleaned with a long, narrow, soft-bristled brush (i.e. pipe cleaner brush). e. The enzyme solution should be changed when it becomes grossly contaminated (bloody and/or turbid). f. Remove the device(s) and instrument(s) from the enzyme solution and rinse in purified water (from one or any combination of the following processes: ultra-filter, RO, DI and/or distilled) for a minimum of 3 minutes. g. Unless otherwise specified, disassemble all modular components for cleaning. Reassemble for sterilization. h. Thoroughly flush lumens, holes and other difficult to reach areas Rinse instrument in purified water (from one or any combination of the following processes: ultra-filter, RO, DI and/or distilled) thoroughly for at least 3 minutes or until there is no sign of blood or soil in the rinse stream. i. Dry the instrument with a clean, disposable, absorbent, non-shedding wipe. Instructions for Use Universal Orthopedic Extraction Solutions from SHUKLA Medical

INSTRUCTIONS FOR USE 6. AUTOMATED CLEANING PROCESS a. Automated washer/disinfector systems are not recommended as the sole cleaning method for surgical instruments. Orthopedic instruments should be cleaned following the manual cleaning procedure outlined in paragraph 5 above. An automated washer/disinfector may be used as follow-up to the manual cleaning procedure above but is not necessary. 7. INSPECTION, MAINTENANCE AND LUBRICATION a. Carefully inspect each device to ensure that all visible contamination has been removed. If contamination is noted repeat the cleaning/disinfection process. b. Visually inspect per Reusable Instrument Inspection Manual (FCD-17089) for device integrity, damage and/or excessive wear NOTE: If damage or wear is noted that may compromise the function of the instrument, contact Shukla Medical for a replacement. c. Check the action of moving parts (e.g. hinges, sliding parts, etc.) to ensure smooth operation throughout the intended range of motion. Hinged, rotating, sliding or articulating instruments should be lubricated with a water soluble product (e.g. Instrument Milk or equivalent lubricant) intended for surgical instruments that must be sterilized. d. To remain effective, the expiration date specified by the manufacturer should be adhered to for both stock and usedilution concentrations NOTE: Mineral oil or silicone lubricants should not be used because they 1) coat microorganisms; 2) prevent direct contact of the surface with steam; and 3) are difficult to remove. 8. STERILIZATION INSTRUCTIONS a. Steam sterilize using a pre-vacuum cycle for 4 minutes at a minimum temperature of 132°C (270°F). b. When sterilizing multiple instruments in one steam sterilization cycle, ensure that the sterilizer manufacturer’s maximum load is not exceeded. c. Drying times will vary according to load size and should be increased for larger loads. d. “Flash” sterilization is not recommended for SHUKLA Medical instruments and systems. e. Following Table 1 summarizes the minimum exposure times and temperatures that have been validated for SHUKLA Medical systems. f. The times in Table 1 below in relationship to temperature indicate the holding time after the specified temperature has been reached and do not include heating or drying times. g. There are two options for wrapping the system for sterilization. If double blue wrapping, refer to table 1A. If placing in a rigid sterile container, refer to table 1B.

1) STERILIZATION INSTRUCTIONS FOR ALL SHUKLA SYSTEMS SHUKLA Part Numbers:

Min. Temp.

Min. Exposure Time Wrapped

Min Dry Time

Min Open Door Time

Min Cool Down Time

1A) Wrapped in 2 Layers of Single-Ply Polypropylene Wrap Using Sequential Envelope Folding Techniques MKS1031, S9SPINE, S9COPTER

132°C/ 270°F

4 min.

30 min.

-

-

MKS1022, S9BLADE, S9MAXI, S9MINI

132°C/ 270°F

4 min.

45 min.

-

-

S9KNE/S9KNEE, 120-00/S9HIP-MOD, S9NAIL/ S9WINQ, S9NAIL-BR, S9LAG

132°C/ 270°F

4 min.

45 min.

-

104-00/S9HIP, MKS1017, S9SCRW/S9SCREW

132°C/ 270°F

4 min.

60 min.

30 min. 15 min.

30 min.

1B) Placed in Aesculap Sterile Container System (JK444) w/ Lid (JK486) + Single-Use Filters US751 or Equivalent All Systems

132°C/ 270°F

4 min.

30 min.

-

-

h. For the above table, please note items i to l below: i. The temperature listed is the minimum validated steam sterilization temperature required to achieve a 10-6 sterility assurance level (SAL). j. Local or national specifications should be followed where steam sterilization requirements are stricter or more conservative than those listed in this table. k. AAMI/AORN steam sterilization cycles with longer times than those listed are also acceptable. l. Drying times vary according to load size and should be increased for larger loads. Instructions for Use Universal Orthopedic Extraction Solutions from SHUKLA Medical

INSTRUCTIONS FOR USE 9. STORAGE INSTRUCTIONS a. Sterile, packaged instruments should be stored in a designated, limited access area that is well ventilated and provides protection from dust, moisture, insects, and temperature/humidity extremes Sterile instrument packages should be carefully examined prior to opening to ensure that package integrity has not been compromised.

10. FOR LOANER/RENTAL SETS a. Loaner/rental sets should undergo all steps of decontamination, cleaning, disinfection, inspection, and sterilization before being returned to Shukla Medical. b. All rental sets are sent out with a Decontamination Certificate that is to be filled out and returned with the set along with any supplementary evidence of decontamination. Missing or damaged instruments from loaner sets should be brought to the attention of the operating room supervisor, to the director of the central supply department, and to Shukla Medical to ensure that the missing/damaged instrument(s) are backfilled.

11. CUSTOMER SERVICE INFORMATION: a. Address: SHUKLA MEDICAL 8300 Sheen Dr. St. Petersburg. FL 33709 b. Phone: +1 (888)-4SHUKLA c. E-mail: [email protected] d. Website: www.ShuklaMedical.com

Revolutionizing the Art of Revision Surgery

In 1998, aerospace component manufacturer S.S. White Technologies, Inc. acquired the Medical Products Division of Snap-On. S.S. White rebranded the medical division in 2007 to create Shukla Medical. Today, Shukla Medical is the industry leader in orthopedic implant extraction tools. We are the only company to offer a comprehensive, truly universal orthopedic revision line for removing IM nails, hip and knee implants, spine hardware, and broken or stripped screws. Surgeons and industry leaders know: If Shukla can’t get it out, no one can.

SHUKLA Surgical Tech Support 24 hours a day, 7 days a week 727-626-2771 When you have tried all known techniques to extract an implant or remove a screw but determine you need suggestions for alternate techniques, help is only a phone call away. We will quickly put you in touch with our Technical Experts who will suggest other solutions to use our tools.

Contact us to learn more Shukla Medical 8300 Sheen Drive St. Petersburg, FL 33709 www.ShuklaMedical.com T: 888-4-SHUKLA T: 888-474-8552 F: 727-626-2770 [email protected]

SHUKLA Medical offers the best warranty in the industry. Every component in a SHUKLA extraction system is designed and manufactured by us. Every component in our extraction systems that is not a single-use* or a wear* component is warranted against manufacturing defects for the life* of the system. All other parts are covered for as long as the purchased version of the system is actively Instructions for Use marketed by SHUKLA Medical. Universal Orthopedic Extraction Solutions from SHUKLA Medical *Please see our website for the complete explanation of these terms and full details on our warranty.

L3-IFU-INS-REVISED: OCTOBER-06-20

Shukla Medical designs and manufactures instrumentation for orthopedic implant extraction at our headquarters in St. Petersburg, Florida, USA. We are proud to be an ISO 13485:2016 Certified company.