Medtronic Reusable Instruments and Accessories Manual

▪ Immediate-Use Steam Sterilization is only intended for individual instruments and should only be considered under urgent clinical situations and when approved by local policies.

PRECAUTIONS ▪ Excessive force applied by instruments can dislodge implanted devices. ▪ Extreme care should be taken to ensure instruments and accessories remain in good working order. During

the procedure, the proper functioning of instruments and accessories is extremely important. Instruments and accessories should not be bent or damaged. Misuse of instruments and accessories, corrosion, binding, scratching, loosening, bending, or fracture of components of instruments or accessories may inhibit or prevent proper function. ▪ Do not use instruments or accessories for any action for which they are 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 instruments. Proper selection and compliance of the patient greatly affect results. Read and follow all product information supplied by the manufacturer of devices. ▪ Extra care should be taken when using instruments in pediatric patients since these patients can be more susceptible to stresses required in use of instruments. ▪ Ensure instruments or accessories with a measuring function are not worn and any surface markings are clearly visible. ▪ Personnel should wear all appropriate Personal Protective Equipment (PPE) as recommended by the sterilizer manufacturer. When explanting and/or disposing of a device, be sure to avoid exposure to bodily substances such as blood, tissue, etc., as contact could lead to infection or disease. Always wear and use proper equipment, taking special care with sharp objects and needles. Follow your healthcare center’s policy regarding both the disposal of devices and any events of exposure.

POSSIBLE ADVERSE EFFECTS ▪ Nerve damage, paralysis, pain, or damage to soft tissue, visceral organs, or joints. ▪ Infection if instruments or accessories are not properly cleaned and sterilized. ▪ 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 processing personnel. ▪ Bone fracture. ▪ Tissue damage to the patient, physical injury to surgical personnel, and/or increased operating time that may result from accidental disassembly of multi-component instruments occurring during surgery.

▪ 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 results. Physician note: although the physician is the learned intermediary between the company and patient, the important medical information in this document should be conveyed to the patient. These devices should be used only by physicians familiar with the devices, their intended use, and available surgical techniques. In addition, accessories should be used only by operators familiar with the device(s), its intended use, and processing information.

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

EXAMINATION Instruments must always be examined pre/post cleaning and prior to surgery. Examination should be thorough and must include a visual and functional inspection of 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 accessories with obvious signs of excessive wear, damage, or that are incomplete or otherwise non-functional. Accessories must be examined prior to use. Examination should be thorough and must include a visual and functional inspection. Examination must also ensure accessories are complete. Do not process damaged accessories.

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 the device clean in accordance with the instructions in the PROCESSING section.

▪ There is no handle/shaft separation, and the handle-to-shaft connection is secure. ▪ No cuts or gouges in the silicone of the brackets or instrument handles are present. ▪ No cracks or peeling of nylon coating on metal brackets. ▪ There is no damage (cuts, tears, etc.) to insulation. ▪ There is no damage to 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: ▪ 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 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, and lids fit correctly. If the device passes the visual and functional inspection as described in the IFU, the instrument can be expected to perform as intended for the perioperative period.

PROCESSING - 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 processing is contingent upon thoroughness of cleaning. Cleaning is the initial step. Sterilization occurs later in processing and is intended to kill microorganisms to reduce likelihood of transmission and possibility of infection. To ensure acceptable processing, there should be no delay between steps in this document. Instruments may be safely and effectively processed using manual or a combination of manual and automated washer-disinfector (enzymatic or alkaline) cleaning procedures outlined in this document. Accessories 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 these instruments 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: use of neutral detergents, enzymatic cleaning agents (7.0–8.0pH), alkaline cleaning agents (8.0– 11.0pH), soft bristled brushes, and soft pipe cleaners is recommended. High alkaline cleaning agents (>11.0pH) should not be used. Note: alkaline cleaning agents may require neutralization following cleaning. Refer to the manufacturer’s instructions to determine if neutralization is required, and follow the manufacturer’s instructions for neutralization. It is critical alkaline cleaning agents be properly neutralized and rinsed from instruments. Accessories: use of neutral detergents, enzymatic cleaners (7.0–8.0pH) soft bristled brushes, and soft pipe cleaners is recommended. Do not use alkaline cleaning agents as they cause significant damage and render accessories unusable. The following solutions or tools should not be used on instruments or accessories: ▪ 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.

Processing Warnings/Cautions ▪ Do not allow soiled instruments or accessories 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 accessories.

▪ 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 processing instructions before reuse.

▪ Soiled or used instruments should not be loaded into the accessories when cleaned in an automated washerdisinfector. Soiled instruments must be processed separately from accessories.

▪ Accessories can only be cleaned using enzymatic (neutral) cleaning agents. ▪ Universal precautions should be observed by health care facility personnel that work with contaminated or

potentially contaminated instruments or accessories. 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 delicate instruments. ▪ Cool drafts from air ducts or other air currents should be avoided during the cooling phase to avoid poststerilization moisture caused by rapid cooling.

Limitations on Processing ▪ Repeated processing has minimal effect on these instruments or accessories. ▪ End of life is determined by excessive wear and damage from normal use. Although treatment of instruments,

accessories, materials used, and details of cleaning and sterilization have an important effect, there is no limit to the number of times instruments and accessories can be processed. ▪ 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 accessories are included after instructions for instruments) Bringing a new ▪ Instruments are provided non-sterile and must be thoroughly cleaned, then sterilized before instrument into first use and any reuse. service ▪ Remove packaging material prior to cleaning and sterilization. Point of use ▪ Remove visible soil from instruments using non-shedding wipes. ▪ Instruments should be thoroughly cleaned within 30 minutes of use to minimize drying. ▪ If instruments cannot be processed immediately, keep instruments 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 covered instruments to a work area dedicated to transportation further processing. ▪ 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 cleaning specific processing/disassembly/reassembly instructions. For additional details, refer to specific processing/disassembly/reassembly instructions. ▪ Remove occlusions prior to cleaning. Flush cannulated devices with tap or treated water to prevent 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 Tables 1 and 2. Automated 1. Rinse, flush, and scrub instruments under running (cold) tap water at a temperature of cleaning: enzy<43°C (110°F) for 30 seconds to 1 minute. Scrub instruments with appropriately-sized, soft matic or alkaline bristle brushes to remove visible soil. Scrub inside any lumens or cavities and actuate incleaning agent strument (if applicable). 2. Using tap water, prepare an enzymatic cleaning agent1 (described after Table 1) or alkaline cleaning agent2 (described after Table 2) according to the manufacturer’s instructions, dilution recommendations, and temperatures in an appropriately-sized sonicator. 3. Place instruments in enzymatic cleaning agent, submerge completely, and ultrasonicate at 40–50kHz for a minimum of 15 minutes. Multiple ultrasonication cycles totaling a minimum of 15 minutes of ultrasonication time may be used. Ensure surfaces, lumens, and components of the device are in contact with cleaning agent. Note: ultrasonic cleaning is only effective if the surface to be cleaned is immersed in cleaning agent. Air pockets decrease efficacy of ultrasonic cleaning. Minimize air pockets or bub-

INSTRUCTIONS - Instruments Only (Instructions for accessories are included after instructions for instruments) ble formation by flushing lumens, cavities, crevices or springs with cleaning agent while the instrument is immersed in the ultrasonic tank. 4. Transfer instruments to the automated washer-disinfector and program the washer-disinfector with cycle parameters in Tables 1 (enzymatic) or 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 cycle parameters in Tables 1 or 2 are properly programmed. 5. Upon unloading, visually inspect instruments, including lumens and cavities, to ensure visible soil is removed. If soil is still present, repeat the cleaning process or contact Medtronic immediately to arrange for disposal or replacement. Table 1: Enzymatic Cleaning Agent (7.0–8.0pH) Cycle Temperature set Minimum time Concentration points (min:sec) Pre-wash <43°C (110°F) 2:00 N/A Cold tap Pulsed enzymatic Wash Hot tap 10:00 0.2–0.8mL/L wash3 Rinse Hot tap ≥00:15 N/A 4 65°C (149°F) 5:00 0.2–0.8mL/L Detergent wash (Neutral pH) Rinse 71°C (160°F) 15:00 N/A Thermal (disinfection) Rinse (de≥90°C (194°F) 5:00 N/A ionized) Dry 98.8°C (210°F) ≥30:00 N/A Note: cycle validated using Prolystica™ Enzymatic Presoak and Cleaner1 (1-4mL/L) for ultrasonication, Prolystica™ Ultra Concentrate Enzymatic Cleaner3, and Prolystica™ Ultra Concentrate Neutral Detergent4 for washer-disinfector use. Table 2: Alkaline cleaning agent (8.0–11.0pH) Cycle Temperature set Minimum time Concentration points (min:sec) Pre-wash <43°C (110°F) 2:00 N/A Cold tap Pulsed alkaline Wash Hot tap 10:00 2–6 mL/L wash2 Rinse Hot tap ≥00:15 N/A 2 60°C (140°F) 5:00 2–6 mL/L Alkaline detergent wash Rinse 71°C (160°F) 15:00 N/A Thermal (disinfection) Rinse (de≥90°C (194°F) 5:00 N/A ionized) Dry 98.8°C (210°F) ≥30:00 N/A Note: cycle validated using Neodisher® MediClean forte2 (5-10mL/L: ultrasonication; 2-6mL/L: 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. Note: due to many variables involved with washer-disinfectors, health care facilities 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. Cleaning validation was conducted using a full chamber load. Disinfection: ▪ Thermally decontaminate devices by a thermal final rinse within an automated washer-disinthermal fector at ≥90°C (194°F) for 5 to 10 minutes. ▪ Disinfectant solutions and chemicals are not required because the decontamination process includes cleaning followed by sterilization. ▪ Thermal disinfection alone does not render instruments safe for patient use. Drying: automa- ▪ Upon completion of washer-disinfector cycle, perform a visual inspection for dryness. ted washer-disin- ▪ If moisture is observed on instruments after the washer-disinfector cycle, dry using clean, fector absorbent, non-shedding wipes and/or 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 packaged for sterilization.

INSTRUCTIONS - Instruments Only (Instructions for accessories are included after instructions for instruments) Drying: manual ▪ Dry devices using clean, absorbent, non-shedding wipes, 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 packaged for sterilization. Inspection and ▪ If the instrument was disassembled prior to cleaning and sterilization, reassemble if applicareassembly ble. ▪ Carefully inspect the instrument for damage by performing a thorough examination as referred to the EXAMINATION section. ▪ If the instrument is damaged, contact Medtronic immediately to arrange for disposal or replacement. Packaging ▪ A single layer of Spunbond Meltblown Spunbond [SMS] polypropylene non-woven surgical sterilization wrap that is in conformance to ISO 11607-1 or equivalent must be used. ▪ Individual instruments or dedicated sterilization trays must be double wrapped prior to sterilization. Wrap in accordance with local procedures per wrapping techniques listed in guidance document ANSI/AAMI ST79 or ISO/TS 16775. ▪ Only instruments manufactured and/or distributed by Medtronic should be included. ▪ Proceed to the Sterilization section. INSTRUCTIONS - Accessories Only (Instructions for reusable instruments are provided in the previous table) Bringing new ▪ Accessories are provided non-sterile and must be thoroughly cleaned, then sterilized before accessories first use and any reuse. into service ▪ Remove packaging material prior to cleaning and sterilization. Point of use ▪ Remove visible soil from accessories using non-shedding wipes. ▪ Accessories should be thoroughly cleaned immediately after use to minimize drying. Containment ▪ If accessories cannot be processed immediately, keep them moist during transport. and transpor- ▪ Use softened tap water on soiled accessories, if available, or cover with damp towels. tation ▪ Immediately transport accessories to a work area dedicated to further processing. Preparation ▪ Accessories must be cleaned individually and not nested inside one another. Accessory lids for cleaning must be removed and cleaned separately or cleaned in the open position if removal is not applicable. ▪ Accessories may be safely and effectively processed using manual or combination manual and automated washer-disinfector (enzymatic only for accessories) cleaning procedures outlined in this document. Automated 1. Rinse, flush, and scrub accessories under (cold) tap water <43°C (110°F) for a minimum of 30 cleaning: enseconds. zymatic 2. Transfer devices to the automated washer-disinfector and program the washer-disinfector with cycle parameters in Table 3. Ensure accessories are positioned in the washer-disinfector to allow proper drainage. Ensure inner portions of accessories are angled downward toward sprayer arms and cycle parameters in Table 3 are properly programmed. 3. Upon unloading, inspect devices, including any lumens and cavities/mated surfaces, to ensure visible soil is removed. If soil is still present, repeat the cleaning process or contact Medtronic to arrange for disposal or replacement. Table 3: Enzymatic (neutral) cleaner (7.0–8.0pH) Cycle Temperature set Minimum time Concentration points (min:sec) Pre-wash <43°C (110°F) 2:00 N/A Cold tap Pulsed enzymatic Wash 60°C (140°F) Hot 4:00 0.2–0.8mL/L tap wash5 Rinse 60°C (140°F) Hot ≥00:15 N/A tap 60°C (140°F) 5:00 0.2–0.8mL/L Detergent wash6 (Neutral pH) Rinse 71°C (160°F) 5:00 N/A Thermal (disinfection) Rinse (de-ion90°C (194°F) 5:00 N/A ized) Dry 98.8°C (210°F) ≥15:00 N/A 5 Note: cycle validated using Prolystica™ Ultra Concentrate Enzymatic Cleaner and Prolystica™ Ultra Concentrate Neutral Detergent6 for washer-disinfector use. Note: due to many variables involved with washer-disinfectors, health care facilities should properly install, calibrate, and verify the process (e.g. temperatures, times) used for their equip-

INSTRUCTIONS - Accessories Only (Instructions for reusable instruments are provided in the previous table) ment. 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. Cleaning validation was conducted using a full chamber load. Manual clean- 1. Manually clean accessories when an automated washer-disinfector is not available. ing: enzymat- 2. Rinse, flush, and scrub accessories under cold tap water <43°C (110°F) for a minimum of 1 ic minute. 3. Scrub device with appropriately-sized, soft bristle brushes or soft pipe cleaners to remove visible soil. Scrub inside lumens or cavities and actuate devices, if applicable. 4. Scrub until visible soil is removed. 5. Using tap water, prepare an enzymatic cleaning agent7 according to manufacturer’s instructions, dilution recommendations, and temperatures. Place devices in enzymatic cleaning agent, submerge completely, and soak for a minimum of 10 minutes. Ensure surfaces, lumens, and components are in contact with cleaning agent. 6. Remove devices from enzymatic cleaning agent 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 agent according to manufacturer’s instructions, dilution recommendations, and temperatures in an appropriately-sized sonicator. 8. Place devices in enzymatic cleaning agent, submerge completely, and ultrasonicate at 40– 50kHz for a minimum of 20 minutes. Multiple ultrasonication cycles totaling a minimum of 20 minutes of ultrasonication time may be used. Ensure surfaces, lumens, and components are in contact with cleaning agent. Note: ultrasonic cleaning is only effective if the surface to be cleaned is immersed in cleaning agent. Air pockets decrease efficacy of ultrasonic cleaning. Minimize air pockets or bubble formation by flushing lumens, cavities, crevices, or springs with cleaning agent while the device is immersed in the ultrasonic tank. 9. Remove 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. 11. Carefully inspect devices, including any lumens and cavities, to ensure visible soil is removed. If soil is still present, repeat the cleaning process or contact Medtronic immediately to arrange for disposal or replacement. Note: cycle validated using Prolystica™ Enzymatic Presoak and Cleaner7 (1–4mL/L). Drying Automated Washer-Disinfector ▪ Upon completion of washer-disinfector cycle, perform visual inspection for dryness. ▪ If moisture is observed on accessories, dry using clean, absorbent, non-shedding wipes and/or forced (medical grade) air until moisture is no longer present. Manual Dry devices using clean, absorbent, non-shedding wipes and/or forced (medical grade) air. Perform a visual inspection for dryness, and repeat if necessary. Inspection ▪ Inspect accessories for damage by performing a thorough examination as referred to the EXand reloading AMINATION section. ▪ If accessories or modules are damaged, contact Medtronic immediately to arrange for disposal or replacement. ▪ Load accessories with their applicable devices. ▪ Proceed to the Sterilization section. STERILIZATION INSTRUCTIONS for both Instruments and Accessories Sterilization 1. Double wrap individual instruments and/or dedicated accessories containing instruments with non-woven/moisture resistant surgical sterilization wrap. 2. Inspect packaging to ensure no rips, punctures, or seal failures are present in or on packaging prior to loading into the sterilizer. 3. Load instruments and accessories into the sterilizer by following 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.

STERILIZATION INSTRUCTIONS for both Instruments and Accessories Table 4: Sterilization cycle parameters Cycle Temperature set point Dynamic-air-removal 134°C (273°F) Dynamic-air-removal 134°C (273°F)

Minimum exposure time 3 Minutes 18 Minutes

Minimum dry time8 30 Minutes 30 Minutes

8The minimum dry times were validated using sterilizers having vacuum drying capabilities. Dry-

Additional information

ing cycles 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. Sterilization parameters in Table 4 can be achieved in both health care facility and larger, industrial sterilizer models. Because of many variables involved in sterilization, health care facilities 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. Medtronic does not recommend or support Immediate-Use Steam Sterilization of instruments and accessories. Equipment for cleaning, disinfection, sterilization and drying must comply with ISO 17664, ISO 15883, and ISO 17665. Packaging materials must comply with ISO 11607. Instruments and accessories 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 guidelines for processing devices contaminated with high risk tissue at the health care facility. Contact Medtronic for information regarding proper disposal/destruction.

Cleaning and sterilization information provided is in accordance with AAMI TIR12, AAMI TIR30, EN 285, ISO 17664, ISO 17665-1, ISO 15883-2, and ISO 15883-5. Processing instructions provided in this document were validated as being capable of preparing instruments for reuse. Sterilization validation demonstrated a sterility assurance level of 10-6. Sterilization parameters were performed with accessories. Sterilization validation was conducted using an empty chamber load. A double wrapped, “worst case” perforated tray configuration was used in validation activities. It remains the responsibility of the processor to ensure processing is performed using validated equipment and trained personnel in the processing facility to achieve desired results. This normally requires validation and routine monitoring of the process. Deviation by the processor from instructions provided should be properly evaluated for effectiveness and potential adverse consequences. Some devices have specific disassembly/assembly instructions. In this case, refer to instructions provided with the instrument for additional instructions. Users must establish appropriate processing protocols for reusable medical devices using recommendations of the device manufacturer and cleaning agent manufacturer.

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

PRODUCT COMPLAINTS To report product problems, contact Medtronic. Patients in the European Union experiencing a serious incident in relation to the device should contact Medtronic and the competent authority of the Member State in which they are established.

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