REUSABLE TRANSPORTATION/STERILIZATION CASSETTES and INSTRUMENTS Instructions for Use

▪ Correct handling of the Medtronic Transportation/Sterilization Cassettes is extremely important. Do not modify Medtronic

Transportation/Sterilization Cassettes. Do not notch or bend Medtronic Transportation/Sterilization Cassettes. Notches, scratches, or other damage and/or wear in Medtronic Transportation/Sterilization Cassettes occurring during surgery may contribute to breakage.

PRECAUTIONS ▪ Excessive force applied by instruments to implants can dislodge devices, particularly hooks. ▪ Instruments should not be exposed to temperatures in excess of 135°C (275°F). This level of heating may modify the

physical characteristics. If uncertain if the instruments were exposed to temperatures in excess of 135°C (275°F), carefully inspect the instruments to ensure they still function as intended. ▪ Extreme care should be taken to ensure instruments remain in good working order. During the procedure, the proper functioning of these instruments is extremely important. Instruments should not be bent or damaged. Misuse of instruments, corrosion, “freezing-up”, scratching, loosening, bending, or fracture of any or all components of the instrument may inhibit or prevent proper function. ▪ Do not use these instruments for any action for which they were not intended. ▪ Regularly review the operational state of all instruments and, if necessary, contact Medtronic or an authorized Medtronic repair representative. To avoid injury, the instrument should be carefully examined for functionality or damage prior to use. A damaged instrument should not be used. Additional back-up instruments should be available. ▪ Preoperative and operating procedures, including knowledge of surgical techniques, are important considerations in the successful use of the instruments by the surgeon. The proper selection and the compliance of the patient will greatly affect the results. ▪ Proper patient selection and operative care are critical to the success of the surgery and avoidance of injury during surgery. Read and follow all other product information supplied by the manufacturer of the implants or the instruments. ▪ Extra care should be taken when using instruments in pediatric patients, since these patients can be more susceptible to the stresses required in the use of the instruments. ▪ Ensure instruments with a measuring function are not worn and any surface engravings are clearly visible. ▪ Exposing Medtronic Transportation/Sterilization Cassettes to temperatures in excess of 135°C (275°F) may modify the physical characteristics. If Medtronic Transportation/Sterilization Cassettes are exposed to temperature exceeding 135°C (275°F), perform an additional inspection to ensure they function as intended. See the EXAMINATION section for more information. ▪ Extreme care should be taken to ensure the Medtronic Transportation/Sterilization Cassettes remain in good working order. During the procedure, proper use of Medtronic Transportation/Sterilization Cassettes is extremely important. Medtronic Transportation/Sterilization Cassettes should not be bent or damaged in any way. Misuse of Medtronic Transportation/ Sterilization Cassettes, resulting in corrosion, scratching, loosening, bending, or fracture of any or all sections may inhibit or prevent proper function. ▪ Medtronic Transportation/Sterilization Cassettes are subjected to repeated stresses related to routine transportation, cleaning, and sterilization processes. Medtronic Transportation/Sterilization Cassettes should be carefully inspected before each use to ensure they are fully functional. ▪ Medtronic Transportation/Sterilization Cassettes are not to exceed a maximum weight and load distribution of 11.4kg/25lbs. ▪ Personnel should wear all appropriate Personal Protective Equipment (PPE) as recommended by sterilizer manufacturer. ▪ Dissimilar metals should be separated from direct contact during sterilization to resist corrosion. Medtronic Transportation/ Sterilization Cassettes are designed with coated brackets or silicone to prevent contact of stainless steel instruments used in the Medtronic Transportation/Sterilization Cassettes.

POSSIBLE ADVERSE EFFECTS ▪ Nerve damage, paralysis, pain, or damage to soft tissue, visceral organs, or joints. ▪ Infection, if instruments or Medtronic Transportation/Sterilization Cassettes are not properly cleaned and sterilized. ▪ Pain, discomfort, or abnormal sensations resulting from the presence of the device. ▪ Nerve damage due to surgical trauma. ▪ Dural leak in cases of excessive load application. ▪ Impingement of close vessels, nerves, and organs by slippage or misplacement of the instrument. ▪ Damage due to spontaneous release of clamping devices or spring mechanisms of certain instruments. ▪ Cutting of skin or gloves of surgical or reprocessing personnel. ▪ Bony fracture in cases of deformed spine or weak bone. ▪ Tissue damage to the patient, physical injury to surgical personnel, and/or increased operating time that may result from the accidental disassembly of multi-component instruments occurring during surgery.

▪ The methods of use are determined by the user’s experience and training in surgical procedures. A successful result is not

always achieved in every surgical case. This fact is especially true in spinal surgery where other patient conditions may compromise the results. Physician note: although the physician is the learned intermediary between the company and patient, the important medical information given in this document should be conveyed to the patient. These devices should be used only by physicians familiar with the devices, their intended use, any additional instrumentation, and any available surgical techniques. In addition, these devices should be used only by operators familiar with the device, its intended use, and reprocessing information.

PACKAGING Instruments may be shipped in stand-alone packaging or in Medtronic Transportation/Sterilization Cassettes. Stand-alone packaging, Medtronic Transportation/Sterilization Cassettes, and the contained medical devices should be intact upon receipt. Medtronic Transportation/Sterilization Cassettes and contained medical devices should be checked for completeness and signs of damage prior to use. Damaged packages, cassettes, or instruments should not be used and should be returned to Medtronic.

EXAMINATION Instruments must always be examined by the user pre/post cleaning and prior to surgery. Examination should be thorough and must include a visual and functional inspection of the working surfaces, pivots, racks, spring or torsional operation, cleanliness of location holes or cannulations, and the presence of any cracks, bending, deformation, or distortion, and that all components are present. Never use instruments or Medtronic Transportation/Sterilization Cassettes with obvious signs of excessive wear, damage, or that are incomplete or otherwise non-functional. Medtronic Transportation/Sterilization Cassettes must be examined by the user prior to use. Examination should be thorough and must include a visual and functional inspection. Examination must also ensure the Medtronic Transportation/Sterilization Cassettes are complete. Do not proceed with reprocessing of a damaged Medtronic Transportation/Sterilization Cassette.

Visual Inspection Ensure the following: ▪ Laser markings, engravings, and other markings are legible. ▪ No cracks, deformation, or distortion are present. ▪ No cracks are present in instrument handles or any part of the instrument. ▪ No discoloration, corrosion, stains, or rust are present. If present, wipe clean in accordance with the instructions in the REPROCESSING section of this document. ▪ There is no handle/shaft separation, and the handle-to-shaft connection is secure. ▪ No cuts or gouges in silicone, silicone brackets, or instrument handles are present. ▪ No cracks or peeling of nylon coating on metal brackets. ▪ There is no damage (cuts, tears, etc.) to the insulation. ▪ There is no damage to the working ends or tips. The working end should be free of cracks, gouges, and other damage. When applicable, the working end should be sharp. ▪ There is no damage to instrument threads. ▪ All parts are present and free of damage and deterioration. Examples of parts that may be missing, loose, or damaged include set screws, springs, curved springs, pins, and prongs. ▪ Mating ends are free of damage (nicks, gouges, bends, etc.) that would interfere with the mating function. ▪ Cannulated instruments with a guide wire or other insertion tool are visually checked.

Functional Inspection As applicable, ensure the following: ▪ Any moving parts move freely, without sticking, binding, or grinding. ▪ Springs return the handle of the instrument to its original position. ▪ Retention tabs hold appropriate mating parts and are not damaged. ▪ The instrument will function as intended with the appropriate mating parts. ▪ Ball detents will hold mating parts and are free from damage. ▪ Sharp edges are sharp to the touch and are not dull, have no nicks, or any other damage. ▪ Tips meet when appropriate. ▪ Ratcheting mechanisms are functional. This includes handles, latches, and other mechanisms. All teeth should be present and functional. ▪ Driver tips are not worn beyond functional use. If necessary, mate the instrument with the appropriate part. ▪ Latches, caddies, modules, or lids, fit correctly.

REPROCESSING - GENERAL CONSIDERATIONS Cleaning is the removal of organic soil. Effective cleaning: ▪ Avoids organic soil transfer from one patient to another. ▪ Allows for successful follow up sterilization. Adequate reprocessing is contingent upon the thoroughness of cleaning. Cleaning is the initial step. Sterilization occurs later in reprocessing and is intended to kill microorganisms to reduce the likelihood of transmission and possibility of infection. To ensure acceptable reprocessing, there should be no delay between the steps in this document. Instruments may be safely and effectively processed using manual or a combination of manual and automated washerdisinfector (enzymatic or alkaline) cleaning procedures outlined in this document. Medtronic Transportation/Sterilization Cassettes may be safely and effectively processed using manual or a combination of manual and automated washer- disinfector (enzymatic) cleaning procedures outlined in this document. The processor should comply with local laws and ordinances in countries where processing requirements are more stringent than those detailed in this document.

Bloodborne Pathogens Universal precautions for handling this instrument after use should be observed by all hospital personnel according to OSHA Standard 29 CFR 1910.1030 regarding occupational exposure to bloodborne pathogens.

Cleaning Agents and Cleaning Tools Instruments: The use of neutral detergents, enzymatic cleaners (7.0 – 8.0 pH), alkaline cleaning agents (8.0 – 11.0 pH), soft bristled brushes, and soft pipe cleaners are recommended. High alkaline cleaning agents (>11.0 pH) should not be used. Note: alkaline cleaning agents may require neutralization following cleaning. Refer to manufacturer’s instructions to determine if neutralization is required, and to follow manufacturer’s instructions for neutralization. It is critical that alkaline cleaning solutions be properly neutralized and rinsed from instruments. Aluminum Transportation/Sterilization Cassettes: the use of neutral detergents, enzymatic cleaners (7.0 – 8.0 pH) soft bristled brushes and soft pipe cleaners are recommended. Do not use alkaline cleaning agents as the alkaline cleaners will cause significant damage and render to the aluminum Transportation/Sterilization Cassettes unusable. The following cleaning agents, solutions, or tools should not be used on the instruments or Medtronic Transportation/ Sterilization Cassettes: ▪ Saline solution. ▪ Solutions containing chlorine (e.g. bleach) or aldehydes (e.g. glutaraldehyde). ▪ Formalin, mercury, chlorides, bromides, iodides, or Ringer's solution. ▪ Metal brushes or scouring pads.

Cleaning and Rinsing Water If available, softened tap water should be used. Critical water should be used for the final rinse step to prevent mineral deposits on surfaces (de-ionized water is recommended). One or more of the following processes may be used to treat water defined as critical water: ultra-filter (UF), reverse osmosis (RO), de-ionized (DI), or equivalent. Use of hard water should be avoided.

Use of Mineral Oil or Silicone-Based Lubricants Mineral Oil- or silicone-based lubricants should not be used as they may not be removed by these cleaning instructions. These types of lubricants may coat microorganisms, prevent direct contact of steam with instrument surfaces, and hinder sterilization.

Reprocessing Warnings/Cautions ▪ Do not allow soiled instruments or Medtronic Transportation/Sterilization Cassettes to dry after use and prior to cleaning.

Cleaning and subsequent sterilization may be hindered when blood or bloody solutions are allowed to dry on instruments or Medtronic Transportation/Sterilization Cassettes. ▪ Medtronic reusable instruments are considered critical devices (i.e. critical contact) and must be thoroughly cleaned, then sterilized prior to initial use, or in adherence to these reprocessing instructions before reuse. ▪ Soiled or used instruments should not be loaded into the Medtronic Transportation/Sterilization Cassettes for cleaning in an automated washer-disinfector. Soiled instruments must be processed separately from Medtronic Transportation/Sterilization Cassettes. ▪ Aluminum Medtronic Transportation/Sterilization Cassettes can only be cleaned utilizing enzymatic (neutral) cleaning solutions. ▪ Certain solutions, (i.e. alkaline based and/or containing bleach, glutaraldehyde or formalin) may significantly damage the Aluminum Transportation/Sterilization Cassettes. These solutions must not be used. ▪ Universal precautions should be observed by all health care facility personnel that work with contaminated or potentially contaminated instruments or Medtronic Transportation/Sterilization Cassettes. Caution should be exercised when handling instruments with sharp points or cutting edges. ▪ Appropriate PPE should be worn when handling or working with contaminated or potentially contaminated materials, devices and equipment. PPE includes gowns, masks, goggles, face shields, gloves, and shoe covers. ▪ Do not place heavy instruments on top of delicate instruments. ▪ Cool drafts from air ducts or other air currents should be avoided during the cooling phase to avoid post-sterilization moisture caused by rapid cooling.

Limitations on Reprocessing ▪ Repeated processing has minimal effect on these instruments or Medtronic Transportation/Sterilization Cassettes. ▪ End of life is determined by excessive wear and damage from normal use. Although the treatment of the instrument or

Medtronic Transportation/Sterilization Cassettes, materials used, and details of cleaning and sterilization have an important effect, for all practical purposes, there is no limit to the number of times instruments and Medtronic Transportation/ Sterilization Cassettes can be reprocessed. ▪ See the EXAMINATION section of this document to determine if the device is at the end of its useful life.

INSTRUCTIONS - Instruments Only (Instructions for the aluminum Transportation/Sterilization Cassettes are included after the instructions for the instruments) Bringing a new ▪ Instruments are provided non-sterile and must be thoroughly cleaned, then sterilized before the first instrument into use and any reuse. service ▪ Remove all packaging material prior to cleaning and sterilization. Point of use ▪ Remove all visible soil from instruments using non-shedding wipes. ▪ Instruments should be thoroughly cleaned within 30 minutes of use to minimize the potential for drying. ▪ If the instruments cannot be reprocessed immediately, keep the devices moist during transport. ▪ Place instruments in a tray of softened tap water, if available, or cover with damp towels. Containment and ▪ Immediately transport the tray containing the covered instruments to a work area dedicated for further transportation reprocessing. ▪ Soiled instruments should be transported separately from non-contaminated instruments to avoid contamination of personnel and surroundings. Preparation for ▪ Instruments that should be disassembled prior to cleaning and sterilization are provided with specific cleaning processing/disassembly/reassembly instructions. For additional details, refer to the specific processing/ disassembly/reassembly instructions for the instrument. ▪ Remove any occlusions prior to cleaning. Flush cannulated devices with tap or treated water to prevent the drying of soil and/or debris on the inside. ▪ Instruments may be safely and effectively processed using manual or a combination manual and automated washer-disinfector (enzymatic or alkaline) cleaning procedures outlined in this document in Table 1 and Table 2. 1. Rinse, flush, and scrub instruments under running (cold) tap water at a temperature of <43°C (<110°F) Automated for 30 seconds to 1 minute. Scrub instruments with appropriately-sized, soft bristle brushes to remove cleaning: visible soil. Scrub inside any lumens or cavities and actuate device (if applicable). enzymatic or alkaline 2. Using tap water, prepare an enzymatic cleaning solution1 (described after Table 1) or alkaline cleaning solution2 (described after Table 2) according to the manufacturer’s instructions, dilution recommendations and temperatures in an appropriately sized sonicator. 3. Place instruments in the enzymatic cleaner, submerge completely, and ultrasonicate at 40 – 50 kHz for a minimum of 15 minutes. Multiple ultrasonication cycles totaling a minimum of 15 minutes of ultrasonication time may be used. Ensure all surfaces, lumens, and components of the device are in contact with the cleaning solution. Note: ultrasonic cleaning is only effective if the surface to be cleaned is immersed in the cleaning solution. Air pockets will decrease the efficacy of the ultrasonic cleaning. Minimize air pockets or bubble formation by flushing lumens, cavities, crevices or springs with cleaning solution while the instrument is immersed in the ultrasonic tank. 4. Transfer the instruments to the automated washer-disinfector and program the washer-disinfector with the cycle parameters listed in Table 1 (enzymatic) or Table 2 (alkaline). Ensure instruments that are cannulated and/or have blind holes are positioned in the washer-disinfector to allow for proper drainage, and pooling of wash water does not occur. Ensure the cycle parameters in Table 1 or Table 2 are properly programmed. 5. Upon unloading, visually inspect instruments, including any lumens and cavities, to ensure all visible soil has been removed. If any soil is still present, repeat the cleaning process or contact Medtronic immediately to arrange for disposal or replacement. Do not proceed with reprocessing of a soiled instrument. Table 1: Enzymatic Cleaner (7.0 – 8.0 pH) Cycle Temperature set Minimum time Concentration (min:s) Pre-wash <43°C (<110°F) 2:00 N/A (Cold tap) Pulsed enzymatic Wash Hot tap 10:00 0.2 – 0.8 mL/liter wash Rinse Hot tap ≥00:15 N/A Detergent wash 65°C (149°F) 5:00 0.2 – 0.8 mL/liter (Neutral pH) Rinse 71°C (160°F) 15:00 N/A Thermal (disinfection) 93°C (200°F) 5:00 N/A Rinse (de-ionized) Dry 98.8°C (210°F) ≥30:00 N/A

INSTRUCTIONS - Instruments Only (Instructions for the aluminum Transportation/Sterilization Cassettes are included after the instructions for the instruments) Table 1: Enzymatic Cleaner (7.0 – 8.0 pH) Cycle Temperature set Minimum time Concentration (min:s) Note: cycle validated using Prolystica Enzymatic Presoak and Cleaner1 (1-4 mL/liter) for ultrasonication and Prolystica Ultra Concentrate Enzymatic Cleaner and Prolystica Neutral Detergent for washerdisinfector use. Table 2: Alkaline cleaning agent (8.0 – 11.0 pH) Cycle Temperature set Pre-wash Pulsed alkaline wash

<43°C (<110°F) (Cold tap) Hot tap Hot tap 60°C (140°F) 71°C (160°F) 93°C (200°F)

Minimum time (min:s) 2:00

Concentration N/A

Wash 10:00 2 – 6 mL/liter Rinse ≥00:15 N/A Alkaline detergent wash 5:00 2 – 6 mL/liter Rinse 15:00 N/A Thermal (disinfection) 5:00 N/A Rinse (de-ionized) Dry 98.8°C (210°F) ≥30:00 N/A 2 Note: cycle validated using neodisher MediClean Forte (5-10mL/liter: ultrasonication; 2-6mL/liter: washer-disinfector). A neutralizing step is not required for neodisher MediClean Forte. However other alkaline cleaning agents may require this step. Refer to manufacturer’s instructions to determine if neutralization is required.

Manual cleaning: enzymatic

Note: due to the many variables involved with washer-disinfectors, each health care facility should properly install, calibrate, and verify the process (e.g. temperatures, times) used for their equipment. Washer-disinfector manufacturer recommendations should always be followed. When cleaning multiple devices in one cleaning cycle, ensure the manufacturer’s maximum load is not exceeded. The cleaning validation was conducted using a full chamber load. 1. Manually clean instruments only when an automated washer-disinfector is not available. 2. Disassemble instruments, if applicable. 3. Rinse, flush, and scrub instruments under running (cold) tap water at a temperature of <43°C (<110°F) for a minimum of 3 minutes. Scrub instruments with appropriately-sized, soft bristle brushes or pipe cleaners to remove visible soil. Scrub inside any lumens or cavities and actuate device (if applicable). 4. Scrub until all visible soil is removed. 5. Using tap water, prepare an enzymatic cleaning solution according to the manufacturer’s instructions, dilution recommendations, and temperatures. 6. Place instruments in the enzymatic cleaner, submerge completely, and soak for 45 - 60 minutes. Ensure all surfaces, lumens, and components of the device are in contact with the cleaning solution. 7. Remove instruments from the enzymatic cleaning solution and flush under running (cold) tap water. Flush any lumens or cavities in the water stream. Rinse with (cold) tap water for a minimum of 3 minutes. 8. Using tap water, prepare a second enzymatic cleaning solution according to the manufacturer’s instructions, dilution recommendations, and temperatures in an appropriately-sized sonicator. 9. Place the instruments in the enzymatic cleaning solution, submerge completely, and ultrasonicate at 40 – 50 kHz for a minimum of 45 minutes. Multiple ultrasonication cycles totaling a minimum of 45 minutes of ultrasonication time may be used. Ensure all surfaces, lumens, and components of the device are in contact with the cleaning solution. Note: ultrasonic cleaning is only effective if the surface to be cleaned is immersed in the cleaning solution. Air pockets will decrease the efficacy of the ultrasonic cleaning. Minimize air pockets or bubble formation by flushing lumens, cavities, crevices, or springs with cleaning solution while the instrument is immersed in the ultrasonic tank. 10. Remove the instruments from the sonicator and rinse using (cold) running tap water. Flush any lumens or cavities in the water stream. Rinse for a minimum of 3 minutes. 11. Repeat rinsing as in step 10, this time with de-ionized water for an additional 3 minutes.

INSTRUCTIONS - Instruments Only (Instructions for the aluminum Transportation/Sterilization Cassettes are included after the instructions for the instruments) 12. Carefully visually inspect instruments, including any lumens and cavities, to ensure all visual soil has been removed. If any soil is still present, repeat the cleaning process or contact Medtronic immediately to arrange for disposal or replacement. Do not proceed with reprocessing of a soiled instrument. Disinfection: ▪ Thermally decontaminate the devices by a thermal final rinse within an automated washer-disinfector at thermal 93°C (200°F) for 5 to 10 minutes. ▪ Disinfection with disinfectant solutions or chemicals is not required because the decontamination process includes cleaning followed by sterilization. ▪ Thermal disinfection alone does not render the instruments safe for patient use. Drying: automated ▪ Upon completion of washer-disinfector cycle perform a visual inspection for dryness. washer-disinfector ▪ If moisture is observed on instruments after the washer-disinfector cycle, dry using clean, absorbent, non-shedding wipes, forced (medical grade) air and/or dry heat oven at ≥118°C (≥245°F) for a minimum of 30 minutes. ▪ For complex instruments (e.g. shaft-in sleeve, cannulation, and blind holes), a dry heat oven at ≥118°C (≥245°F) for a minimum of 30 minutes is required. Perform a visual inspection for dryness. ▪ Instruments should be completely dry before they are packaged for sterilization. Drying: manual ▪ Dry the devices using clean, absorbent, non-shedding wipes and/or forced (medical grade) air and/or a dry heat oven. Perform a visual inspection for dryness, and repeat if necessary. ▪ Instruments should be completely dry before they are packaged for sterilization. Inspection and ▪ If the instrument was disassembled prior to cleaning and sterilization, reassemble, if applicable. reassembly ▪ Carefully inspect the instrument for damage by performing a thorough examination as referred to the EXAMINATION section of this document. ▪ If the instrument is damaged, contact Medtronic immediately to arrange for disposal or replacement. Do not proceed with reprocessing of a damaged device. Packaging ▪ A standard non-woven/moisture resistant surgical sterilization wrap or equivalent must be used. ▪ Individual instruments or dedicated sterilization trays must be double wrapped prior to sterilization. ▪ Only instruments manufactured and/or distributed by Medtronic should be included. ▪ Proceed to the Sterilization section. INSTRUCTIONS - Aluminum Medtronic Transportation/Sterilization Cassettes Only (Instructions for reusable instruments are provided in the previous table) Bringing new ▪ Medtronic Transportation/Sterilization Cassettes are provided non-sterile and must be thoroughly Medtronic cleaned, then sterilized before the first use and any reuse. Transportation/ ▪ Remove all packaging material prior to cleaning and sterilization. Sterilization Cassettes into service Point of use ▪ Remove all visible soil from case and trays using non-shedding wipes. ▪ Medtronic Transportation/Sterilization Cassettes should be thoroughly cleaned immediately after use to minimize the potential for drying. Containment and ▪ If Medtronic Transportation/Sterilization Cassettes cannot be reprocessed immediately, keep the transportation devices moist during transport. ▪ Use softened tap water on soiled Medtronic Transportation/Sterilization Cassettes, if available, or cover with damp towels. ▪ Immediately transport Medtronic Transportation/Sterilization Cassettes to a work area dedicated to further reprocessing. Preparation for ▪ Medtronic Transportation/Sterilization Cassettes must be cleaned individually and not nested inside of cleaning one another. Case and module lids must be removed and cleaned separately or cleaned in the open position if removal is not applicable. ▪ Cases and trays may be safely and effectively processed using manual or combination manual and automated washer-disinfector (enzymatic only for aluminum cases and trays) cleaning procedures outlined in this document. Do not use alkaline solutions on the aluminum Medtronic Transportation/ Sterilization Cassettes as these agents damage the aluminum Transportation/Sterilization Cassettes. Automated 1. Rinse, flush, and scrub cases and trays under (cold) tap water less than <43°C (110°F) for a minimum cleaning: of 30 seconds. enzymatic 2. Transfer the devices to the automated washer-disinfector and program the washer-disinfector with the cycle parameters listed in Table 3. Ensure case and trays are positioned in the washer-disinfector to

INSTRUCTIONS - Aluminum Medtronic Transportation/Sterilization Cassettes Only (Instructions for reusable instruments are provided in the previous table) allow proper drainage. Ensure the inner portions of the cassettes/modules are angled downward toward the sprayer arms and the cycle parameters in Table 3 are properly programmed. 3. Upon unloading, visually inspect devices, including any lumens and cavities/mated surfaces, to ensure all visual soil has been removed. If soil is still present, repeat the cleaning process or contact Medtronic to arrange for disposal or replacement. Do not proceed with reprocessing of a soiled device. Table 3: Enzymatic (neutral) cleaner (7.0 – 8.0 pH) Cycle Temperature set Minimum time Concentration (min:s) Pre-wash <43°C (<110°F) 2:00 N/A (Cold tap) Pulsed enzymatic Wash <60°C (<140°F ) 4:00 0.2 – 0.8 mL/liter wash Hot tap Rinse <60°C (<140°F) ≥00:15 N/A Hot tap Detergent wash 60°C (140°F) 5:00 0.2 – 0.8 mL/liter (Neutral pH) Rinse 71°C (160°F) 5:00 N/A Thermal (disinfection) 90°C (194°F) 5:00 N/A Rinse (de-ionized) Dry 98.8°C (210°F) ≥15:00 N/A Note: cycle validated using Steris Prolystica Ultra Concentrate Enzymatic Cleaner and Prolystica Neutral Detergent for washer-disinfector use.

Manual cleaning: enzymatic

Note: due to the many variables involved with washer-disinfectors, each health care facility should properly install, calibrate, and verify the process (e.g. temperatures, times) used for their equipment. Washer-disinfector manufacturer recommendations should always be followed. When cleaning multiple devices in one cleaning cycle, ensure the manufacturer’s maximum load is not exceeded. The cleaning validation was conducted using a full chamber load. 1. Manually clean Medtronic Transportation/Sterilization Cassettes when an automated washer-disinfector is not available. 2. Rinse, flush, and scrub Medtronic Transportation/Sterilization Cassettes under cold tap water less than <43°C (110°F) for a minimum of 1 minute. 3. Scrub devices with appropriately-sized, soft bristle brushes or pipe cleaners to remove visible soil. Scrub inside any lumens or cavities and actuate device (if applicable). 4. Scrub until all visible soil is removed. 5. Using tap water, prepare an enzymatic cleaning solution according to the manufacturer’s instructions, dilution recommendations, and temperatures. Place devices in the enzymatic cleaner, submerge completely, and soak for a minimum of 10 minutes. Ensure all surfaces, lumens, and components are in contact with the cleaning solution. 6. Remove devices from the enzymatic cleaning solution and flush under running (cold) tap water. Lumens or cavities must be flushed in the water stream. Rinse with cold tap water for a minimum of 1 minute. 7. Using tap water, prepare a second enzymatic cleaning solution according to the manufacturer’s instructions, dilution recommendations and temperatures in an appropriately-sized sonicator. 8. Place the devices in the enzymatic cleaning solution, submerge completely, and ultrasonicate at 40 – 50 kHz for a minimum of 20 minutes. Multiple ultrasonication cycles totaling a minimum of 20 minutes of ultrasonication time may be used. Ensure all surfaces, lumens, and components are in contact with the cleaning solution. Note: ultrasonic cleaning is only effective if the surface to be cleaned is immersed in the cleaning solution. Air pockets will decrease the efficacy of the ultrasonic cleaning. Be sure to minimize air pockets or bubble formation by flushing lumens, cavities, crevices or springs with cleaning solution while the device is immersed in the ultrasonic tank. 9. Remove the devices from the sonicator and rinse using cold running tap water. Lumens or cavities must be flushed in the water stream. Rinse for a minimum of 10 minutes. Multiple cycles totaling a minimum of 10 minutes may be used. 10. Repeat rinsing as in step 9, this time with de-ionized water for an additional 10 minutes. Multiple cycles totaling a minimum of 10 minutes may be used.

INSTRUCTIONS - Aluminum Medtronic Transportation/Sterilization Cassettes Only (Instructions for reusable instruments are provided in the previous table) 11. Carefully visually inspect devices, including any lumens and cavities, to ensure all visible soil has been removed. If any soil is still present, repeat the cleaning process or contact Medtronic immediately to arrange for disposal or replacement. Do not proceed with reprocessing of a soiled device. Drying

Inspection and reloading

Note: cycle validated using Prolystica Enzymatic Presoak and Cleaner1 (1 – 4mL/liter). Automated Washer-Disinfector ▪ Upon completion of washer-disinfector cycle perform visual inspection for dryness. ▪ If moisture is observed on the Medtronic Transportation/Sterilization Cassettes, dry using clean, absorbent, non-shedding wipes, forced (medical grade) air until moisture is no longer present. Manual Dry the devices using clean, absorbent, non-shedding wipes and/or forced (medical grade) air. Perform a visual inspection for dryness, and repeat if necessary. ▪ Inspect the transportation/sterilization cassettes for damage by performing a thorough examination as referred to the EXAMINATION section of this document. ▪ If the Medtronic Transportation/Sterilization Cassettes or modules are damaged, contact Medtronic immediately to arrange for disposal or replacement. ▪ Load the Medtronic Transportation/Sterilization Cassettes or modules with their applicable devices. ▪ Proceed to the Sterilization section.

STERILIZATION INSTRUCTIONS for both Instruments and Medtronic Transportation/Sterilization Cassettes Sterilization 1. Double wrap individual instruments and/or dedicated transportation/sterilization cassettes containing instruments with non-woven/ moisture resistant surgical sterilization wrap. 2. Inspect the packaging to ensure no rips, punctures, or seal failures are present in or on the packaging prior to loading into the sterilizer. 3. Load the instruments into the sterilizer by following the sterilizer manufacturer’s recommended loading procedures and load configurations. 4. Follow the sterilizer manufacturer’s recommended procedures to program the sterilizer with any one of the sets of sterilization cycle parameters in Table 4. Table 4: Sterilization cycle parameters Cycle Temperature Exposure time Minimum dry time3 Dynamic-air-removal 132°C (270°F) 4 Minutes 30 Minutes (4 pre-conditioning pulses) Dynamic-air-removal 135°C (275°F) 3 Minutes 30 Minutes (4 pre-conditioning pulses) Dynamic-air-removal 134°C (273°F) 4 Minutes 30 Minutes (4 pre-conditioning pulses) Dynamic-air-removal 134°C (273°F) 20 Minutes 30 Minutes (4 pre-conditioning pulses) 3The minimum dry times were validated using sterilizers having vacuum drying capabilities. Drying cycles

Additional information

using ambient atmospheric pressure may require longer dry times. Refer to the sterilizer manufacturer’s recommendations. Chamber size and chamber load differences may exist between industrial and health care facility sterilizer models. The sterilization parameters listed in Table 4 can be achieved in both health care facility and larger, industrial sterilizer models. Because of the many variables involved in sterilization, each health care facility should calibrate and verify the sterilization process (e.g. temperatures, times) used for their equipment. Note: steam for sterilization should be generated from water treated to remove total dissolved solids and non-condensable gases, filtered to remove contaminates and water droplets, and supplied via piping without dead legs or other stagnant zones where contamination may collect. Caution: ethylene oxide (EO), gas plasma, gamma irradiation, chemical vapor, or dry heat sterilization methods are not recommended for sterilization of these devices. Steam/moist heat is the recommended method of sterilization. Immediately clean and re-sterilize all instruments used in surgery. Instruments should be thoroughly cleaned, inspected, and sterilized before being returned to Medtronic. Any medical device that has been in contact with a patient known to have or suspected to have a prion or prion-related disease, such as Creutzfeldt - Jakob disease, should not be returned to Medtronic and should be quarantined and processed per the guidelines for processing devices contaminated with high risk tissue at the health care facility. Contact Medtronic for information regarding proper disposal/destruction.

The cleaning and sterilization information provided is in accordance with AAMI TIR12, AAMI TIR30, ANSI/AAMI ST81, ISO 17664, ISO 17665, ISO 15883-2, and ISO 15883-5. The reprocessing instructions provided in this document have been validated as being capable of preparing instruments for reuse. The sterilization validation demonstrated a sterility assurance level of 10-6. The sterilization parameters were performed with Medtronic Transportation/Sterilization Cassettes. The sterilization validation was conducted using an empty chamber load. A double wrapped, “worst case” perforated tray configuration was used in the validation activities. It remains the responsibility of the processor to ensure the processing is performed using validated equipment and trained personnel in the reprocessing facility in order to achieve the desired results. This normally requires validation and routine monitoring of the process. Any deviation by the processor from the instructions provided should be properly evaluated for effectiveness and potential adverse consequences. Some devices have specific disassembly/re-assembly instructions. In this case, refer to the instructions provided with the instrument for additional instructions. Users must establish appropriate reprocessing protocols for reusable medical devices used at their sites using the recommendations of the device manufacturer and cleaning agent manufacturer.

STORAGE AND SHELF LIFE For non-sterile instruments and Medtronic Transportation/Sterilization Cassettes: store in dry, clean conditions at ambient room temperature. Non-sterile instruments and Medtronic Transportation/Sterilization Cassettes are reusable and do not have a specified shelf life. End of life (shelf life) is determined by excessive wear and damage from normal use. Refer to the Limitations of Reprocessing section for more information. For sterilized instruments and Medtronic Transportation/Sterilization Cassettes: ensure the instruments and Medtronic Transportation/Sterilization Cassettes are dry before storing. Store in clean, dry conditions at ambient room temperature. Shelflife of sterilized instruments and Medtronic Transportation/Sterilization Cassettes are dependent upon the legally marketed sterilization wrap. The health care facility should establish a shelf life for sterilized instrumentation based upon the type of sterilization wrap used and the recommendations of the sterile wrap manufacturer.

PRODUCT COMPLAINTS To report product problems, contact Medtronic.

MRI INFORMATION Medtronic instruments are not intended to be used in the magnetic resonance (MR) environment. As such, Medtronic instruments have not been evaluated for safety and compatibility in the MR environment. Therefore, the safety of the Medtronic instruments in the MR environment is unknown.

FURTHER INFORMATION If there is any doubt or uncertainty concerning the proper use of any Medtronic reusable instrument or reprocessing for the instruments or Medtronic Transportation/Sterilization Cassettes, contact Medtronic. In addition, any available surgical techniques will be provided at no charge. ©2016 Medtronic Sofamor Danek USA, Inc. All rights reserved.

AUSTRALIAN SPONSOR: Medtronic Australasia Pty Ltd 5 Alma Road Macquarie Park, NSW 2113 Australia

Medtronic Sofamor Danek USA, Inc. 1800 Pyramid Place Memphis, TN 38132 Telephone: 800 933 2635 (USA) 901 396 3133 (Outside USA) Fax: 901 396 0356

EXPLANATION OF SYMBOLS Authorized representative in the European Community The device complies with European Directive MDD 93/42/EEC The device complies with European Directive MDD 93/42/EEC Catalogue number Batch code Manufacturer Non-sterile Consult instructions for use

Medtronic B.V. Earl Bakkenstraat 10 6422 PJ Heerlen The Netherlands Tel: + 31 45 566 80 00