Instructions for Use and Reprocessing Instructions

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Instructions for Use and Reprocessing Instructions Some products may not be licensed in all jurisdictions. CAUTION: USA law restricts these devices to sale by or on the order of a physician. Section 1 outlines information for sterile devices. Section 2 outlines information for cleaning and sterilization of single use devices. Section 3 outlines information for cleaning and sterilization of reusable surgical instruments. Most instrument systems include inserts/trays and a container(s). Many instruments are intended for use with a specific implant. It is essential that the surgeon and operating room staff is fully conversant with the appropriate surgical technique for the instruments and associated implant, if any. DePuy Synthes Instruments do not have an indefinite functional life. All reusable instruments are subjected to repeated stresses related to bone contact, impaction, routine cleaning, and sterilization processes. Instruments should be carefully inspected before each use to ensure that they are fully functional. Scratches or dents can result in instrument breakage or soft tissue injury. Care should be taken to remove any debris, tissue or bone fragments that may collect on the instrument. For further information on end of life refer to End of Life indicators at www.e-ifu.com/referenced-documents. Metal instrument or its fragments can be located by means of an external imaging device (e.g., X-ray, CT scanner). The limits of accuracy for instruments with a measuring function will vary between instruments from different product systems; the greatest limit of accuracy for an instrument with a measuring function is ± 15%. Power instrumentation of the EXPEDIUM® and EXPEDIUM Verse System consisting of drill bits, taps and screwdrivers are compatible for use with the Colibri II (532.101) and Small Battery Drive II (532.110) Power Tool Systems for orthopedic and general surgery procedures. Expedium® Verse power instrumentation consisting of power facilitator (299704205P), power X25 inserter (299704230P), and power correction key inserter (299704220P) attachments are compatible with the MatrixPro Driver (05.000.020) distributed by DePuy Synthes CMF for the insertion of Expedium® Verse set screws. Users should consult the technique guide or the Instructions for Use of the concerned system for specific instructions in the use of powered instruments. Precaution: DePuy Synthes Neural Tissue Instruments are intended for use in the Peripheral Nervous System only. Neural Tissue Instruments are tools used by surgeons during spinal surgery to facilitate visualization of the neuroanatomy and disc space and to retract and reposition, probe and provide suction around the dural sac and nerve roots allowing safe passage of other spinal instrumentation and implants. During spinal surgery revision procedures, the surgeon may utilize the nerve root instruments to dissect or separate scar tissue and adhesions, such that these tissues may be safely mobilized or repositioned during disc space access and decompression.

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SECTION 1. F OR STERILE DEVICES, THE FOLLOWING INSTRUCTIONS APPLY: For the devices (implants and instruments) supplied sterile, the contents are sterile unless the package is damaged, opened, or the expiration date on the device label has passed. The integrity of the packaging should be checked to ensure that the sterility of the contents is not compromised. Remove devices from packaging, using aseptic technique, only after the correct size has been determined. PRECAUTION: Do not use devices if the condition of the package and/or labeling indicates a chance that the devices may not be sterile. Devices supplied sterilized from the manufacturer must not be resterilized.

SECTION 2. F OR SINGLE USE NONSTERILE DEVICES, THE FOLLOWING INSTRUCTIONS APPLY: SINGLE USE DEVICES SHOULD NOT BE REUSED. Reuse can compromise device performance and patient safety. Reprocessing or resterilization may lead to changes in material characteristics, which may impact the device performance and patient safety. Reuse of single-use devices can also cause cross-contamination leading to patient infection.

SECTION 3. FOR REUSABLE INSTRUMENTS, THE FOLLOWING INSTRUCTIONS APPLY: These reprocessing instructions apply to: • Reusable surgical instruments supplied by DePuy Synthes • Instruments intended for reprocessing in a health care facility setting These reprocessing instructions have been validated as being capable of preparing reusable DePuy Synthes instruments for reuse. It is the responsibility of the reprocessor to ensure that the reprocessing is actually performed using appropriate equipment, materials, and personnel to achieve the desired result. This normally requires validation and routine monitoring of the process. Any deviation by the reprocessor from these instructions should be evaluated for effectiveness and potential adverse consequences. Please telephone DePuy Synthes Customer Service at (800) 365-6633 or (508) 880-8100 if you need additional assistance.

WARNINGS AND PRECAUTIONS These instructions are provided for the processing of heat-resistant, immersible, critical medical devices, unless otherwise noted on specific product inserts. Product specific inserts are given priority over these instructions. This can include heat-sensitive devices and certain power (air- or electricdriven) tool designs that are provided with specific cleaning and sterilization instructions. Consult the product specific instructions for processing in these cases.

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The instructions provided are given as guidance for medical device processing and have been validated by the manufacturer. It is the responsibility of the healthcare facility to ensure that processing is performed using the required equipment, materials and personnel at a defined processing area. This will include the handling of devices during transportation, processing and storage prior to surgical use. Those using these instructions should be qualified personnel with documented training and competency in accordance with local procedures, guidelines, and standards. Surgically used instruments can be considered biohazard and facilities should ensure that transport and handling procedures comply with local regulations and guidelines. Sterile, single use implants must not be reprocessed or reused. Sterile implants are labelled as single use and have not been validated for reprocessing. Non-sterile implants must be processed prior to use in accordance with these processing instructions. They may be subjected to reprocessing in accordance with these processing instructions, but they must be discarded following direct patient contact or use. Reusable, non-sterile surgical instruments are required to be cleaned, inspected and sterilized prior to surgical use. Care should be taken in the handling and cleaning of sharp devices. All devices must be thoroughly cleaned and inspected prior to sterilization. Long, narrow lumens, blind holes, moving and intricate parts require particular attention during cleaning and inspection. During cleaning, only use detergents that are labelled for use on medical devices and in accordance with the manufacturer’s instructions (e.g., temperature, contact time, and rinse time). Cleaning agents with a used dilution pH of within 7-9 are recommended. Highly alkaline conditions (pH>10) can damage components/devices, such as aluminum materials. Do not use saline, environmental disinfection (including chlorine solutions) or surgical antiseptics (such as iodine- or chlorhexidinecontaining products). Do not use a cleaning aid that can damage the surface of instruments such as steel wool, abrasive cleaners or wire brushes. Instruments should be carefully inspected before each use to ensure that they are functional. Scratches, dents or other damage can result in instrument breakage or tissue injury. In the event of instrument breakage during use, ensure that all device fragments that may have entered the surgical site are removed prior to completion of the procedure as patient injury may result. Instruments must be cleaned separately from instrument trays and cases. Instrument trays and cases are designed as an organizational tool in preparation for sterilization, storage and surgical use. Non-sterile implant sets may be processed in their trays provided. Automated equipment, including washer-disinfectors and steam sterilizers must be installed, maintained and operated in accordance with manufacturer’s instructions. Do not exceed 140°C (284°F) during reprocessing steps. For patients with, or suspected with, Creutzfeldt-Jakob disease (CJD), variant CJD or other transmissible spongiform encephalopathy (TSE) and related infections, it is recommended to treat the patient using single-use instruments. Safely dispose of all devices used in accordance with local procedures and guidelines.

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ADVERSE EFFECTS The following list of adverse effects may be associated with the use of these devices: • Patient Infection • Adverse Local Tissue Reaction • Soft Tissue Damage • Reusable devices must be cleaned and sterilized before each use or it could lead to patient infection. For additional adverse effects, please refer to related product specific IFUs (System/Implant IFUs).

LIMITATIONS ON PROCESSING Repeated processing cycles in compliance with these instructions for use have minimal effects on device life and function. Instruments do not have an indefinite functional life. End of life of devices is determined by wear and damage due to surgical use and handling. Evidence of damage and wear on a device may include but is not limited to corrosion (i.e., rust, pitting), discoloration, excessive scratches, flaking, wear and cracks. Improperly functioning devices, devices with unrecognizable markings, missing or removed (buffed off) part numbers, damaged and excessively worn devices should not be used. Non-sterile implants must be discarded following patient use. Any implant with evidence of damage, such as due to handling or processing must be discarded.

Step 1: Point of Use Care Ensure that no instruments or parts are left in the surgical site prior to closure as patient injury may result. All single use devices and materials should be removed and discarded in compliance to local policies. The drying of gross soil (blood, tissue and/or debris) on devices following surgical use should be avoided. It is preferred that gross soil is removed from devices following use and in preparation for transportation to a processing area. Gross soil can be removed using sponges, cloths, or soft brushes. Water and/or cleaning detergents (labelled for use on medical devices) may be used. Do not use saline, environmental disinfection (including chlorine solutions) or surgical antiseptics (such as iodine- or chlorhexidine-containing products. Flush all lumens, blind holes, small clearances, and moving and intricate parts with water (or detergent solution) to prevent the drying of soil and/or debris. If gross-soil cannot be removed at the point of use, the devices should be transported to prevent drying (e.g., covered with a towel dampened with purified water) and cleaned as soon as possible at a designated processing area. Surgical cement should be removed from devices during surgical use and prior to setting. When cement hardens it will typically require physical methods to remove. Chemical solvents should not be used. Hardened cement may be removed with an approved stylus or removing tool, but these may damage devices.

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Step 2: Containment and Transportation Surgically used devices may be considered bio-hazardous and should be safely transported to a designated processing area in accordance with local policies.

Step 3: Cleaning Preparation before Cleaning It is recommended that devices should be reprocessed as soon as is reasonably practical following surgical use. Instruments must be cleaned separately from instrument trays and cases. Non-sterile implants may be cleaned and disinfected in the provided implant trays. Care should be taken in the handling and cleaning of sharp devices. These are recommended to be cleaned separately to reduce risks of injury. Multi-part or complex instruments may require disassembly for cleaning. Refer to any technique guides or other supplemental information for specific device disassembly and/or reassembly instructions. Any devices with moving parts (e.g., ratchets, box locks, hinges or actuated parts) need to be actuated during manual cleaning and rinsing to ensure access of the cleaning process. All devices with lumens need to be manually flushed to remove debris and brushed thoroughly using appropriately sized soft-bristled brushes and twisting action. Brush size should be approximately the same diameter of the lumen to be cleaned. Using a brush that is too big or too small for the diameter of the lumen/cannulation may not effectively clean the lumen. Refer to any technique guides or other supplemental information for specific device lumen diameters. After brushing, rinse with water by flushing and blow clean compressed air through all lumens. NOTE: Two cleaning methods are provided, a Manual and an Automated Method, and at least one shall be performed.

Cleaning: Manual 1. Prepare a neutral or mild alkaline cleaning solution (pH 7-9) in accordance to the detergent manufacturer’s instructions. The temperature of the solution should be ≤40°C (104°F) for manual cleaning. NOTE: The cleaning solution may contain enzymes. Aluminum-safe alkaline cleaners can be used but can vary in material compatibility overtime based on their formulation. Material compatibility should be confirmed with the detergent manufacturer. 2. Immerse devices and parts in the detergent solution, and soak for a minimum of 5 minutes. 3. While immersed, use a soft non-metallic bristle brush (plastic bristles, like nylon) or sponge to thoroughly clean all traces of blood and debris from all device surfaces for a minimum of one minute. 4. Ensure all lumens are thoroughly brushed. Push the brush through the entire length of the lumen using a twisting motion to remove debris from both ends for a minimum of one minute.

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5. During cleaning, actuate joints, handles and other movable device features to expose all areas to the detergent solution, if applicable. Ensure all lumens, blind holes, small clearances, and moving and intricate parts are flushed for a minimum of one minute. 6. Rinse all devices by immersion in ambient, < 40°C (104°F), tap water for a minimum of one minute and until evidence of debris, soil, and cleaning solution are visually removed. Use a large syringe (e.g., 50ml or greater) filled to capacity with tap water to thoroughly flush lumens, blind holes, small clearances, and moving and intricate parts. Actuate joints, handles and other moveable device features to rinse thoroughly. 7. Completely submerge the devices in an ultrasonic bath prepared with a neutral or mild alkaline pH detergent (pH 7-9), prepared in accordance with the manufacturer’s instructions. Use a large syringe (50ml or greater) flush all lumens, blind holes, small clearances, and moving and intricate parts with the detergent solution to minimize the formation of air pockets or bubbles. 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 ultrasonic cleaning. 8. Ultrasonically clean the device components for a minimum of 10 minutes in accordance with manufacturer’s instructions. An example of a validated cycle used for cleaning validation included 40kHz at 25°C for 10 minutes). 9. Rinse all devices by immersion in ambient, < 40°C (104°F), tap water for a minimum of one minute and until evidence of debris, soil, and cleaning solution are visually removed. Use a large syringe (e.g., 50ml or greater) filled to capacity with tap water to thoroughly flush lumens, blind holes, small clearances, and moving and intricate parts. Actuate joints, handles and other moveable device features to rinse thoroughly. 10. Remove the devices and repeat the rinsing using in ambient, < 40°C (104°F) critical water (high purity water generated by processes such as RO, deionization or distillation) for at least 15 seconds. 11. Remove and dry device using a clean, soft, lint-free cloth or clean compressed air. Ensure that all lumens and articulated areas are dried using compressed air.

Cleaning: Automated 1. Prepare a neutral or mild alkaline cleaning solution (pH 7-9) in accordance with the detergent manufacturer’s instructions. The temperature of the solution should be ≤40°C (104°F) for manual cleaning. NOTE: The cleaning solution may contain enzymes. Aluminum-safe alkaline cleaners can be used but can vary in material compatibility overtime based on their formulation. Material compatibility should be confirmed with the detergent manufacturer. 2. Immerse devices and parts in the detergent solution, and soak for a minimum of 5 minutes. 3. While immersed, use a soft non-metallic bristle brush (plastic bristles, like nylon) or sponge to thoroughly scrub all traces of blood and debris from all device surfaces for at least one minute. 4. Ensure all lumens are thoroughly brushed. Push the brush through the entire length of the lumen using a twisting motion to remove debris from both ends for at least one minute.

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5. During cleaning, actuate joints, handles and other movable device features to expose all areas to the detergent solution, if applicable. Ensure all lumens are flushed for at least one minute. 6. Rinse all devices by immersion in ambient, < 40°C (104°F), tap water for a minimum of one minute and until evidence of debris, soil, and cleaning solution are visually removed. Use a large syringe (e.g., 50ml or greater) filled to capacity with tap water to thoroughly flush lumens, blind holes, small clearances, and moving and intricate parts. Actuate joints, handles and other moveable device features to rinse thoroughly. 7. Completely submerge the devices in an ultrasonic bath prepared with a neutral or mild alkaline pH detergent (pH 7-9), prepared in accordance with the manufacturer’s instructions. Use a large syringe (50ml or greater) flush all lumens, blind holes, small clearances, and moving and intricate parts with the detergent solution to minimize the formation of air pockets or bubbles. 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 ultrasonic cleaning. 8. Ultrasonically clean the device components for a minimum of 10 minutes in accordance with manufacturer’s instructions. An example of a validated cycle used for cleaning validation included 40kHz at 25°C for 10 minutes). 9. Rinse all devices by immersion in ambient, < 40°C (104°F), tap water for a minimum of one minute and until evidence of debris, soil, and cleaning solution are visually removed. Use a large syringe (e.g., 50ml or greater) filled to capacity with tap water to thoroughly flush lumens, blind holes, small clearances, and moving and intricate parts. Actuate joints, handles and other moveable device features to rinse thoroughly. 10. Load the device components in the washer-disinfector in accordance with manufacturer’s instructions, ensuring that the devices and lumens have maximum exposure to detergents and rinse water and can drain freely. 11. Automated washing shall be conducted in a validated washer-disinfector in compliance to ISO 15883-1 and -2, or to an equivalent standard. Automated washing can be included as part of a validated washing, disinfection, and/or drying cycle in accordance with manufacturer’s instructions. An example of a validated cycle used for cleaning validation included: Phase Pre Wash Enzyme wash Wash Rinse Rinse

Recirculation Time (minutes) 2 2 5 2

Water Temp Cold Tap Water < 40°C (104°F) 66°C (151°F) > 40°C (104°F)

0.25

Ambient

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Detergent/Water Type N/A Neutral, Enzymatic Cleaner Neutral pH Detergent Tap water Critical water (RO, deionized or distilled water)

Step 4: Thermal Disinfection Thermal disinfection is recommended to render devices safe for handling prior to steam sterilization. Thermal disinfection should be conducted in a washer-disinfector compliant to ISO 15883-1 and -2, or to an equivalent standard. Thermal disinfection in the washer-disinfector shall be validated to provide an A0 of at least 600 (e.g., 90°C/194°F for 1 minute). Higher levels of A0 can be achieved by increasing the exposure time and temperature (e.g., A0 of 3000 at >90°C/194°F for 5 minutes, in accordance with local requirements). Load the device components in the washer-disinfector in accordance with manufacturer’s instructions, ensuring that the devices and lumens can drain freely. Lumened devices should be placed in a vertical position. If this is not possible due to space limitations within the washer-disinfector, use an irrigating rack/load carrier with connections designed to ensure an adequate flow of process fluids to the lumen or cannulation of the device if provided. The following automated cycles are examples of validated cycles: Recirculation Time (minutes)

Water Temp

Thermal Disinfection

1

> 90°C (194°F)

Thermal Disinfection

5

> 90°C (194°F)

Phase

Water Type Critical water (RO, deionized or distilled water) Critical water (RO, deionized or distilled water)

Step 5: Drying It is recommended that drying is conducted in a washer-disinfector compliant to ISO 15883-1 and -2, or to an equivalent standard. Drying efficiency in washer-disinfectors can range considerably based on the automated system design and load configuration. The following automated cycle is an example of a validated cycle: Phase Dry

Recirculation Time (minutes) 7

Air Temp 115°C (239°F)

Air Type Medical grade

Following automated drying, inspect the device for residual moisture. Any residual moisture identified should be dried manually (as described below).

For manual drying: • Ensure each device is dried and inspected thoroughly. • For external surfaces, use a clean, soft, lint-free cloth to avoid damage to the surface. • Open and close or actuate any applicable devices with moving parts during drying. Pay special attention to any device threads, ratchets and hinges or areas where fluid can accumulate. Clean, compressed air (e.g., medical grade) may be used to facilitate surface drying. • Dry all lumen/cannulated parts using clean compressed air (e.g., medical grade).

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Step 6: Maintenance and Inspection Instruments should be visually inspected under ambient lighting, to verify that the devices do not have visible soil, damage or moisture.

Inspect devices for: • Lack of moisture. Carefully inspect device lumens and moving parts. If moisture is detected, manually drying should be performed. • Cleanliness. If any residual soil is discovered during inspection, repeat the cleaning steps on those devices until all visible soil is removed from the device. • Damage, including but not limited to, corrosion (rust, pitting), discoloration, excessive scratches, flaking, cracks and wear • Proper function, including but not limited to, sharpness of cutting tools, bending of flexible devices, movement of hinges/joints/box locks and moveable features such as handles, ratcheting and couplings and missing or removed part numbers Improperly functioning devices, devices with unrecognizable markings, missing or removed (buffed off) part numbers, damaged and worn devices should be discarded. Disassembled devices should be reassembled prior to sterilization when specified. Lubricate any moving parts with a water-soluble surgical instrument lubricant. The lubricant should be approved for use on medical devices and provided with data to ensure biocompatibility and compatibility with steam sterilization.

Step 7: Packaging Place cleaned, dry devices into the specified locations within the cases provided, if applicable. Only legally marketed, and locally approved sterilization barriers (e.g., wraps, pouches or containers) should be used for packaging terminally sterilized devices, in compliance to the manufacturer’s instructions.

Step 8. Sterilization Steam (moist heat) sterilization shall be performed in a locally approved/cleared, pre-vacuum (forced air removal) cycle. The steam sterilizer should be validated to the requirements of any local standards and guidance including EN 285, AAMI/ANSI ST8 and ISO 17665. The steam sterilizer should be installed and maintained in compliance with equipment manufacturer’s instructions and local requirements. Ensure that the steam sterilizer cycle is chosen that is designed to remove air from porous or lumened device loads in accordance with equipment manufacturer’s instructions and does not exceed the criteria for sterilizer load. The following steam sterilization cycles are examples of validated cycles: Conditioning Phase Pre-vacuum Pre-vacuum

Sterilization Exposure Time (minutes) 4 3

Sterilization Exposure Temperature 132°C (270°F) 134°C (274°F)

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Dry Time* 30-60 minutes 30-60 minutes

Extended steam exposure cycle can be used to meet local requirements (outside US) such as 134°C (274°F) for 18 minutes. * When applying dry times to DePuy Synthes cases and their accessories, dry times outside the standard healthcare pre-vacuum parameters may be required. This is especially important for polymer-based (plastic) cases/trays used in conjunction with heavy duty nonwoven sterilization wraps. The current recommended dry times for DePuy Synthes cases can range from a standard 20 minutes to an extended time of 60 minutes. The dry time is most often influenced by the presence of polymer based (plastic) materials; therefore, changes such as elimination of silicone mats and/or change in sterile barrier system (e.g., heavy grade to light grade wrap or the use of rigid sterilization containers) can reduce the necessary dry time. Dry times may be highly variable due to differences in packaging materials (e.g., nonwoven wraps), environmental conditions, steam quality, device materials, total mass, sterilizer performance and varying cool down time. The user should employ verifiable methods (e.g., visual inspections) to confirm adequate drying. Do not exceed 140°C (284°F) during drying. Immediate-use steam sterilization is only intended for individual instruments in emergency situations and should only be performed when approved by local policies. DePuy Synthes does not support immediate-use steam sterilization of instrument sets, cases or implants. The following steam sterilization cycle is an example of a validated cycle for individual instruments only: • Unwrapped instrument • A minimum 3 (three) pulse pre-vacuum cycle • 132°C (270°F) for 4 minutes For product sold sterile, refer to device specific insert for limitations regarding resterilization.

Step 9: Storage Sterilized products should be stored in a dry, clean environment, protected from direct sunlight, pests, and extremes of temperature and humidity. Refer to sterilization wrap or rigid container manufacturers IFU for limits on sterile product storage time and storage requirements for temperature and humidity.

ADDITIONAL INFORMATION Cleaning agent information: Examples of detergents that have been used during cleaning validations include Prolystica™ 2X Concentrate Enzymatic Cleaner, Prolystica™ 2X Neutral Detergent, Enzol™, Endozime™, Neodisher Medizym™, Tergazyme™, and NpH-Klenz™. Further information regarding the use of specific cleaning agents, ultrasonic washers, washerdisinfector, packaging materials or sterilizers during validation studies are available on request. The chemical quality of the water used during reprocessing can impact device safety. Facilities should use the recommended water quality requirements for device reprocessing in accordance with local guidance (such as AAMI TIR 34, Water for the reprocessing of medical devices) and these instructions for use.

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These instructions for use have been validated in accordance with ISO 17664. It remains the responsibility of the facility to ensure that the processing is performed using equipment, materials and personnel at a designated area, and achieves the desired requirements. This includes validation and routine monitoring of the process. Likewise, any deviation by the processor from these recommendations should be evaluated for effectiveness and any potential adverse consequences. All personnel using these instructions should be qualified with documented expertise, competency and training. Users should be trained on healthcare facility policies and procedures along with current applicable guidelines and standards.

LIMITED WARRANTY AND DISCLAIMER PRODUCTS FROM DEPUY SYNTHES PRODUCTS, INC. ARE SOLD WITH A LIMITED WARRANTY TO THE ORIGINAL PURCHASER AGAINST DEFECTS IN WORKMANSHIP AND MATERIALS. ANY OTHER EXPRESS OR IMPLIED WARRANTIES, INCLUDING WARRANTIES OF MERCHANTABILITY OR FITNESS, ARE HEREBY DISCLAIMED. IF MORE THAN TWO YEARS HAVE ELAPSED BETWEEN THE DATE OF ISSUE/REVISION OF THIS INSERT AND THE DATE OF CONSULTATION, CONTACT DEPUY SYNTHES SPINE FOR CURRENT INFORMATION AT +1-508-880-8100.

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SYMBOL TRANSLATION

MR Safe PACKAGING UNIT

DO NOT USE IF PACKAGE IS DAMAGED

DO NOT RESTERILIZE

MATERIAL MATERIAL

T2

CAUTION MR Unsafe SINGLE USE

T1

MEDICAL DEVICE

CONSULT INSTRUCTIONS FOR USE

Lower Limit of temperature = T1 Upper Limit of temperature = T2

LOT LOT NUMBER SN SERIAL NUMBER

25°C

REF REF CATALOG NUMBER

SZ SIZE

STERILE R STERILIZATION BY IRRADIATION

MADE IN MADE IN

KEEP AWAY FROM SUNLIGHT

NTI NEURAL TISSUE INSTRUMENT IOM NEUROMONITORING INSTRUMENTS

ATTENTION. SEE INSTRUCTIONS FOR USE

Contains EU Regulated Chemical Substance

STERILE EO STERILIZATION BY ETHYLENE OXIDE STERILE GP STERILE GAS PLASMA

Contains Human Blood product

PACKAGE CONTAINS FLAMMABLE LIQUID

NON STERILE

LATEX FREE LATEX FREE

NONSTERILE NONSTERILE

DATE OF MANUFACTURE

MANUFACTURE AND DATE OF MANUFACTURE EC REP AUTHORIZED EUROPEAN REPRESENTATIVE DIST DISTRIBUTED BY

STERILE Sterilized using steam or dry heat

MSR MEASURING DEVICE Federal (USA) law restricts this device to sale by or on the order of a physician

MANUFACTURER

STERILE A Contains EU Regulated Sterile medical device Medicinal Substance processed using aseptic technique

STORE AT ROOM TEMPERATURE

QTY QUANTITY

MR Conditional

STERILE STERILE

Contains Human Origin Substance

Contains Animal Origin Substance

UDI UNIQUE DEVICE IDENTIFICATION XXXX-XX USE BY

STERILE BARRIER SYSTEM

MATERIAL A/T ACROFLEX®/Ti ACROFLEX®/Titanium

P/F PL/FOAM Plastic/Foam

A AI Aluminum

PY Polyester

A/P Al/PL Aluminum/Plastic B/R Ba/RADEL® Barium/RADEL®

PEEK/C PEEK/CARBON FIBER COMPOSITE Polyether Ether Ketone/ Carbon Fiber Composite

SRSN SS/RADEL®/ SILICONE/Ti Al Nitride Stainless Steel/RADEL® / Silicone/Titanium Aluminum Nitride

Ba/PEEK Barium Sulfate (BaSO4)/

PEEK OPTIMA® Polyether Ether Ketone

SS/RADEL®/ SILICONE/Ti Nitride

SRSI SS/RADEL®/SILICONE Stainless Steel/RADEL® / Silicone

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Ti/HA Titanium/Hydroxyapatite Ti/UHMWPE/HA Titanium/Ultra-High Molecular Weight Polyethylene/Hydroxyapatite SS/Ti Stainless Steel/Titanium SS/Al/SILICONE Stainless Steel/

MATERIAL A/T ACROFLEX®/Ti ACROFLEX®/Titanium

P/F PL/FOAM Plastic/Foam

A AI Aluminum

PY Polyester

A/P Al/PL Aluminum/Plastic

PEEK/C PEEK/CARBON FIBER COMPOSITE Polyether Ether Ketone/ Carbon Fiber Composite

B/R Ba/RADEL® Barium/RADEL® Ba/PEEK Barium Sulfate (BaSO4)/ PEEK Polymer CaP CALCIUM PHOSPHATE Calcium Phosphate CM CoCrMo Cobalt Chromium Molybdenum CMTC CoCrMo/Ti/CALCIUM PHOSPHATE Cobalt Chromium Molybdenum/Titanium/ Calcium Phosphate CoNiCrMo Cobalt Nickel Chromium Molybdenum F

FOAM Foam

PEEK OPTIMA® Polyether Ether Ketone P

POLYMER Polymer

P/CM PE/CoCrMo Polyethylene/Cobalt Chromium Molybdenum P/C POLYMER/CARBON FIBER COMPOSITE Polymer/ Carbon Fiber Composite Si/NITINOL Silicone/Nitinol

SRSI SS/RADEL®/SILICONE Stainless Steel/RADEL® / Silicone SRSN SS/RADEL®/ SILICONE/Ti Al Nitride Stainless Steel/RADEL® / Silicone/Titanium Aluminum Nitride SS/RADEL®/ SILICONE/Ti Nitride Stainless Steel/RADEL®/ Silicone/Titanium Nitride SRTA SS/RADEL®/Ti Al Nitride Stainless Steel/RADEL® / Titanium Aluminum Nitride STA SS/Ti Al Nitride Stainless Steel/ Titanium Aluminum Nitride S/U SS/ULTEM Stainless Steel/Ultem T Ti Titanium and its alloys

S SS Stainless Steel S/A SS/Al Stainless Steel/Aluminum

HA Hydroxyapatite

SBR SS/Ba/RADEL® Stainless Steel/Barium/ RADEL®

NiTi Ni/Ti Nickel/Titanium

S/P SS/PHENOLIC Stainless Steel/Phenolic

PL Plastic

S/PL SS/PL Stainless Steel/Plastic

S/R SS/RADEL® Stainless Steel/RADEL® R/T POLYOLEFIN RUBBER/Ti Polyolefin Rubber/Titanium T/A Ti/Al Titanium/Aluminum Ti/CoCrMo Titanium/Cobalt Chromium Molybdenum

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Ti/HA Titanium/Hydroxyapatite Ti/UHMWPE/HA Titanium/Ultra-High Molecular Weight Polyethylene/Hydroxyapatite SS/Ti Stainless Steel/Titanium SS/Al/SILICONE Stainless Steel/ Aluminum/Silicone SS / SILICA GLASS Stainless Steel/Silica Glass SS / SILICA GLASS/ PL / SILICONE Stainless Steel/Silica Glass/ Plastic /Silicone SS / SILICA GLASS/ RADEL® / SILICONE Stainless Steel/Silica Glass/ RADEL® /Silicone SS / SILICA GLASS/ SILICONE Stainless Steel/ Silica Glass/Silicone S/SI SS/SILICONE Stainless Steel/Silicone SS/WC/SILICONE Stainless Steel/Tungsten Carbide/Silicone W/C Tungsten Carbide

MATERIAAL A/T ACROFLEX®/Ti ACROFLEX®/titanium

P/F PL/FOAM Plastic/schuim

S/PL SS/PL Roestvrij staal/plastic

A AI Aluminium

PY Polyester

A/P Al/PL Aluminium/plastic

PEEK/C PEEK/CARBON FIBER COMPOSITE Polyetheretherketon/ koolstofvezelcomposiet

SRSI SS/RADEL®/SILICONE Roestvrij staal/ RADEL® /silicone

B/R Ba/RADEL® Barium/RADEL® Ba/PEEK Bariumsulfaat (BaSO4)/ PEEK-polymeer CaP CALCIUM PHOSPHATE Calciumfosfaat CM CoCrMo Kobaltchroommolybdeen CMTC CoCrMo/Ti/CALCIUM PHOSPHATE Kobaltchroommolybdeen/ titanium/calciumfosfaat

PEEK OPTIMA® Polyetheretherketon P

POLYMER Polymeer

P/CM PE/CoCrMo Polyethyleen/ kobaltchroommolybdeen P/C POLYMER/CARBON FIBER COMPOSITE Polymeer/ koolstofvezelcomposiet

SRSN SS/RADEL®/ SILICONE/Ti Al Nitride Roestvrij staal/ RADEL®/silicone/ titanium-aluminiumnitride SS/RADEL®/

SILICONE/Ti Nitride Roestvrij staal/RADEL®/ silicone/titaniumnitride SRTA SS/RADEL®/Ti Al Nitride Roestvrij staal/RADEL® / titanium-aluminiumnitride STA SS/Ti Al Nitride Roestvrij staal/ titanium-aluminiumnitride

Ti/CoCrMo Titanium/ kobaltchroommolybdeen Ti/HA Titanium/hydroxyapatiet Ti/UHMWPE/HA Titanium/polyethyleen met ultrahoog molecuulgewicht/ hydroxyapatiet SS/Ti Roestvrij staal/titanium SS/Al/SILICONE Roestvrij staal/ aluminium/silicone SS / SILICA GLASS Roestvrij staal/silicaglas SS / SILICA GLASS/ PL / SILICONE Roestvrij staal /silicaglas/ plastic/silicone SS / SILICA GLASS/ RADEL® / SILICONE Roestvrij staal/silicaglas/ RADEL®/silicone

Si/NITINOL Silicone/nitinol

S/U SS/ULTEM Roestvrij staal/Ultem

S SS Roestvrij staal

T Ti Titanium en zijn legeringen

S/A SS/Al Roestvrij staal/aluminium

SS / SILICA GLASS/ SILICONE Roestvrij staal/silicaglas/ silicone

S/R SS/RADEL® Roestvrij staal/RADEL®

S/SI SS/SILICONE Roestvrij staal/silicone

NiTi Ni/Ti Nikkel/titanium

SBR SS/Ba/RADEL® Roestvrij staal/barium/ RADEL®

R/T POLYOLEFIN RUBBER/Ti Polyolefinerubber/titanium

SS/WC/SILICONE Roestvrij staal/ wolfraamcarbide/silicone

PL Plastic

S/P SS/PHENOLIC Roestvrij staal/fenol

T/A Ti/Al Titanium/aluminium

W/C Wolfraamcarbide

CoNiCrMo Kobaltnikkelchroommolybdeen F

FOAM Schuim

HA Hydroxyapatiet

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MATÉRIAU A/T ACROFLEX®/Ti ACROFLEX®/titane

P/F PL/FOAM Plastique/mousse

S/PL SS/PL Acier inoxydable/plastique

A AI Aluminium

PY Polyester

A/P Al/PL Aluminium/plastique

PEEK/C PEEK/CARBON FIBER COMPOSITE Composite polyétheréthercétone/fibre de carbone

SRSI SS/RADEL®/SILICONE Acier inoxydable/ RADEL®/silicone

B/R Ba/RADEL® Baryum/RADEL® Ba/PEEK Sulfate de baryum (BaSO4)/ polymère PEEK CaP CALCIUM PHOSPHATE Phosphate de calcium CM CoCrMo Cobalt-chrome-molybdène CMTC CoCrMo/Ti/CALCIUM PHOSPHATE Cobalt-chrome-molybdène/ titane/phosphate de calcium CoNiCrMo Cobalt-nickelchrome-molybdène F FOAM Mousse HA Hydroxyapatite NiTi Ni/Ti Nickel/titane PL Plastique

PEEK OPTIMA® Polyétheréthercétone P

POLYMER Polymère

P/CM PE/CoCrMo Polyéthylène/ cobalt-chrome-molybdène P/C POLYMER/CARBON FIBER COMPOSITE Matériau composite en fibre de carbone/polymère Si/NITINOL Silicone/nitinol S SS Acier inoxydable

SRSN SS/RADEL®/ SILICONE/Ti Al Nitride Acier inoxydable/RADEL®/ silicone/nitrure d’aluminium et de titane SS/RADEL®/ SILICONE/Ti Nitride Acier inoxydable/RADEL®/ silicone/nitrure de titane SRTA SS/RADEL®/Ti Al Nitride Acier inoxydable/RADEL®/ nitrure d’aluminium et de titane STA SS/Ti Al Nitride Acier inoxydable/nitrure d’aluminium et de titane S/U SS/ULTEM Acier inoxydable/ultem T Ti Titane et ses alliages

S/A SS/Al Acier inoxydable/aluminium

S/R SS/RADEL® Acier inoxydable/RADEL®

SBR SS/Ba/RADEL® Acier inoxydable/ baryum/RADEL®

R/T POLYOLEFIN RUBBER/Ti Caoutchouc polyoléfinique/ titane

S/P SS/PHENOLIC Acier inoxydable/ résine phénolique

T/A Ti/Al Titane/aluminium

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Ti/CoCrMo Titane/ cobalt-chrome-molybdène Ti/HA Titane/hydroxyapatite Ti/UHMWPE/HA Titane/polyéthylène à poids moléculaire très élevé/ hydroxyapatite SS/Ti Acier inoxydable/titane SS/Al/SILICONE Acier inoxydable/ aluminium/silicone SS / SILICA GLASS Acier inoxydable/ verre de silice SS / SILICA GLASS/ PL / SILICONE Acier inoxydable/verre de silice/plastique/silicone SS / SILICA GLASS/ RADEL® / SILICONE Acier inoxydable/verre de silice/RADEL®/silicone SS / SILICA GLASS/ SILICONE Acier inoxydable/ verre de silice/silicone S/SI SS/SILICONE Acier inoxydable/silicone SS/WC/SILICONE Acier inoxydable/carbure de tungstène/silicone W/C Carbure de tungstène

Alt personell som bruker disse instruksjonene, må være kvalifisert med dokumentert ekspertise, kompetanse og opplæring. Brukerne må være opplært i institusjonens retningslinjer og rutiner sammen med gjeldende retningslinjer og standarder.

BEGRENSET GARANTI OG ANSVARSFRASKRIVELSE PRODUKTER FRA DEPUY SYNTHES PRODUCTS, INC. SELGES MED EN BEGRENSET GARANTI TIL DEN OPPRINNELIG KJØPEREN MOT DEFEKTER I PRODUKSJON OG MATERIALER. ENHVER ANNEN UTTRYKT ELLER UNDERFORSTÅTT GARANTI, INKLUDERT GARANTIER OM SALGBARHET ELLER EGNETHET, FRASKRIVES HERVED. HVIS MER ENN TO ÅR HAR GÅTT MELLOM DATOEN FOR UTSTEDELSE/REVISJON AV DETTE INNLEGGET OG KONSULTASJONSDATOEN, MÅ DU KONTAKTE DEPUY SYNTHES SPINE FOR OPPDATERT INFORMASJON PÅ +1-508-880-8100.

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MATERIAL A/T ACROFLEX®/Ti ACROFLEX® / titan

P/F PL/FOAM Plast/skumplast

A AI Aluminium

PY Polyester

A/P Al/PL Aluminium/plast

PEEK/C PEEK/CARBON FIBER COMPOSITE Polyeter-eterketon/ kolfiberkomposit

B/R Ba/RADEL® Barium/RADEL® Ba/PEEK Bariumsulfat (BaSO4)/ PEEK-polymer CaP CALCIUM PHOSPHATE Kalciumfosfat CM CoCrMo Kobolt-krom-molybden CMTC CoCrMo/Ti/CALCIUM PHOSPHATE Kobolt-krom-molybden/ titan/kalciumfosfat CoNiCrMo Kobolt-nickelkrom-molybden F FOAM Skumplast HA Hydroxiapatit

PEEK OPTIMA® Polyeter-eterketon P

POLYMER Polymer

P/CM PE/CoCrMo Polyetylen/ kobolt-krom-molybden P/C POLYMER/CARBON FIBER COMPOSITE Polymer/kolfiberkomposit Si/NITINOL Silikon/nitinol

SRSI SS/RADEL®/SILICONE Rostfritt stål/RADEL® /silikon SRSN SS/RADEL®/ SILICONE/Ti Al Nitride Rostfritt stål/RADEL® / silikon/titan-aluminium-nitrid SS/RADEL®/ SILICONE/Ti Nitride Rostfritt stål/RADEL® / silikon/titan-nitrid SRTA SS/RADEL®/Ti Al Nitride Rostfritt stål/RADEL® / titan-aluminium-nitrid STA

SS/Ti Al Nitride Rostfritt stål/ titan-aluminium-nitrid S/U SS/ULTEM Rostfritt stål/ultem

T Ti Titan och titanlegeringar

S SS Rostfritt stål S/A SS/Al Rostfritt stål/aluminium SBR

SS/Ba/RADEL® Rostfritt stål/ barium/RADEL®

NiTi Ni/Ti Nickel/titan

S/P SS/PHENOLIC Rostfritt stål/fenol

PL Plast

S/PL SS/PL Rostfritt stål/plast

S/R SS/RADEL® Rostfritt stål/RADEL® R/T POLYOLEFIN RUBBER/Ti Polyolefingummi/titan T/A Ti/Al Titan/aluminium Ti/CoCrMo Titan/ kobolt-krom-molybden

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Ti/HA Titan/hydroxiapatit Ti/UHMWPE/HA Titan/polyetylen med ultrahög molekylvikt/ hydroxiapatit SS/Ti Rostfritt stål/titan SS/Al/SILICONE Rostfritt stål/ aluminium/silikon SS / SILICA GLASS Rostfritt stål/kiseldioxidglas SS / SILICA GLASS/ PL / SILICONE Rostfritt stål/kiseldioxidglas/ plast/silikon SS / SILICA GLASS/ RADEL® / SILICONE Rostfritt stål/kiseldioxidglas/ RADEL® /silikon SS / SILICA GLASS/ SILICONE Rostfritt stål/ kixeldioxidglas/silikon S/SI SS/SILICONE Rostfritt stål/silikon SS/WC/SILICONE Rostfritt stål/ wolframkarbid/silikon W/C Wolframkarbid