Johnson & Johnson Medical
Navigation Instruments for EXPEDIUM and VIPER MIS Spine Systems Instructions for Use
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0902-90-111 Rev. F 2797
en
Navigation Instruments for EXPEDIUM® and VIPER® MIS Spine Systems Caution: USA law restricts this device to sale by or on the order of a physician.
DESCRIPTION The navigation instruments for the EXPEDIUM® and VIPER® MIS Spine Systems are reusable spine surgical instruments designed to be tracked using Brainlab and/or Medtronic StealthStation Navigation Systems. The navigated handles, Jamshidi, and trocar are to be navigated with only the Brainlab navigation system. The taps, awls, awl tip taps, probes, and drivers for the Universal Navigation Instruments for EXPEDIUM and VIPER MIS Spine Systems may be navigated using Brainlab or Medtronic StealthStation Navigation Systems. The navigation instruments for EXPEDIUM and VIPER MIS Spine Systems are reusable spine surgical instruments designed to be tracked using Brainlab and/or Medtronic StealthStation Navigation Systems. In the case of the interface with the Brainlab system, some of the instruments will be pre-calibrated within the Brainlab software. For Medtronic StealthStation, the instruments will need to be manually calibrated. All of the Universal Navigation Instruments for EXPEDIUM and VIPER MIS Spine Systems are intended to be used as part of the surgical technique for implantation of already-cleared EXPEDIUM 5.5 Spine System (including EXPEDIUM VERSE™ Spine System), VIPER System (including VIPER®2 and VIPER SAI Systems). The Universal Navigation Instruments have an adaptor and clamp attachment to interface with navigation systems’ arrays. Each of the tracking arrays contains pins for the rigid attachment of reflective marker spheres. The tracking arrays, with reflective marker spheres attached, reflect infrared light generated by the navigation system camera which the camera then receives for detection of the position and orientation of the spheres. In order for an instrument to be tracked the dimensions of the instrument relative to the locatable reflective marker spheres on the tracking array must be either acquired through calibration (manualcalibrated) or loaded and integrated into the Brainlab Navigation
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Software (pre-calibrated). The Universal Navigation Instruments for EXPEDIUM and VIPER MIS Spine Systems can only be pre-calibrated into the Brainlab Navigation System. All other navigation systems require manual calibration. The VIPER and EXPEDIUM navigation handles are manufactured from stainless steel, silicone, and Radel®. The navigation handle containing the pre-calibrated Brainlab tracking array has a titanium nitride coating on the post that supports the array. The navigated instrument shafts are manufactured from stainless steel and aluminum.
INDICATIONS FOR USE Universal Navigation Instruments for EXPEDIUM and VIPER MIS Spine Systems The Universal Navigation Instruments for EXPEDIUM and VIPER MIS Spine Systems are intended to assist the surgeon in precisely locating anatomical structures in either open, minimally invasive, or percutaneous procedures. These are indicated for use in surgical spinal procedures, in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the pelvis or a vertebrae can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy using tracking arrays provided by the navigation manufacturer. These procedures include but are not limited to spinal fusion. These devices can be pre-calibrated and/or manually calibrated with Brainlab Navigation system, where other navigation systems require manual calibration.
VIPER and EXPEDIUM Navigated Instruments The VIPER and EXPEDIUM navigated instruments are image guided surgical instruments for use in the implantation of VIPER and EXPEDIUM pedicle screws in an open or percutaneous approach. The navigated instruments are designed for use only with Brainlab Image Guided Surgery hardware and software. The navigated instruments are indicated for any medical condition
This document is valid only on the date printed. If unsure of the print date, please re-print to ensure use of the latest revision of the IFU (available at www.e-ifu.com). The onus resides with the user to ensure that the most up-to-date IFU is used.
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in which the use of stereotactic surgery may be appropriate, where the use of the VIPER and/or EXPEDIUM Spine Systems is indicated and where reference to a rigid anatomical structure, such as the pelvis or a vertebra can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy.
CONTRAINDICATIONS Medical conditions which contraindicate the use of this instrument include any medical condition which may be contraindicative for the surgical procedure itself. For example, pregnancy would be a contraindication if surgery itself poses risks to the developing fetus. The Universal Navigation Instruments for EXPEDIUM and VIPER MIS Spine Systems are indicated for spinal surgery and therefore are only appropriate for use with spinal navigation software packages. All other navigation software packages are contraindicated. ••DePuy Spine Universal Navigation Instruments for EXPEDIUM and VIPER MIS Spine Systems are NOT compatible with implants from other manufacturers. The Universal Navigation Instruments for EXPEDIUM and VIPER MIS Spine Systems are intended for use with the following DePuy Spine implants: Product VIPER System (including VIPER2 and VIPER SAI Systems) EXPEDIUM 5.5 Spine System (including EXPEDIUM VERSE Spine System)
Brainlab Support: Region United States, Canada, Central and South America Brazil Africa, Asia, Australia, Europe UK Spain France and Frenchspeaking regions Japan
Telephone
Tel: +1 800 597-5911 Fax: +1 708 409-1619
us.support@brainlab.com
Tel: +55 800 892-1217 Tel: +49 89 991568 44 Fax: +49 89 991568 811 support@brainlab.com Tel: +44 1223 755 333 Tel: +34 900 649 115 Tel: +33 800 6760 30 Tel: +81 3 3769 6900 Fax: +81 3 3769 6901
support@brainlab.com
••The VIPER and EXPEDIUM navigation handles are intended for use only with the compatible VIPER and EXPEDIUM navigated instrument shafts.
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WARNINGS AND PRECAUTIONS Caution: DePuy Spine is not a navigation provider. The instruments have been validated for use with the third-party navigation systems of Brainlab and Medtronic StealthStation. Instructions for use and handling of third-party navigation systems are the responsibility of the hospital and navigation company. Refer to the navigation company’s software and user guides for calibration and navigation guidance. Compatible third-party navigation clamps and arrays are listed in the Surgical Technique Guide. Ensure the hospital has the appropriate third-party navigation instruments prior to the case. Note: For information on use of disposable reflective marker spheres, refer to navigation manufacturers’ user guides. Warning: The navigated instrument is a highly accurate and sensitive medical device. Handle it with extreme care. If you drop or otherwise damage it, verify its calibration accuracy. Failure to do so may lead to serious injury to the patient. Warning: Care should be taken to limit bending forces on calibrated instruments as deflection can influence navigation accuracy. Warning: Plan the setup of the OR and instrument array orientation prior to surgery. The navigation camera must have an unobstructed and simultaneous view of the instrument and navigation array. Caution: The navigation system should be set up per the manufacturer’s instructions.
DIRECTIONS FOR USE/DEVICE OPERATIONS • Before clinical use, the physicians/surgeons should thoroughly understand all aspects of the system guide and the limitations of the instrumentation. ••It is recommended that physicians and operators should be thoroughly familiar with, and complete a training program of the navigation software, as well as supervised support sessions with a navigation software representative prior to any surgical procedure using the EXPEDIUM and VIPER navigated instruments. Physicians should be thoroughly familiar with the EXPEDIUM and VIPER Spine Systems prior to using these systems with the Universal Navigation Instruments for EXPEDIUM and VIPER MIS Spine Systems. Physicians and operators of the system should read the user guides carefully before handling the equipment and have access to the user guides at all times. Prior to using the Universal Navigation Instruments for EXPEDIUM and VIPER, the physicians and operators should review the DePuy Spine system guide and navigation systems user guides (provided by navigation systems’ manufacturers) for their indications for use.
This document is valid only on the date printed. If unsure of the print date, please re-print to ensure use of the latest revision of the IFU (available at www.e-ifu.com). The onus resides with the user to ensure that the most up-to-date IFU is used.
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INSTRUCTIONS FOR PROCESSING MEDICAL DEVICES
Non-sterile Implants, and Reusable Instruments, Instrument Trays and Cases Introduction DePuy Synthes non-sterile implants and reusable instruments are critical medical devices. These devices must be cleaned, inspected and sterilized prior to surgical use. These instructions are provided to assist health care personnel in the development of effective procedures for the processing of non-sterile implants and reprocessing of reusable devices. It is the responsibility of the facility to ensure that processing is performed using the equipment, materials and competent personnel at a designated processing area. These instructions are provided for heat-resistant, 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 (airor electric-driven) tool designs that are provided with specific cleaning and sterilization instructions. Consult the product specific instructions for processing in these cases. DePuy Synthes Instruments do not have an indefinite functional life. All reusable instruments are subjected to repeated stresses related to surgical use, routine cleaning, and sterilization processes. 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. DePuy Synthes provides sterile and non-sterile implants. Sterile, single use implants must not be reprocessed or reused. Non-sterile implants must be sterilized prior to use in accordance with these processing instructions. They may be subjected to reprocessing in accordance with these processing instructions, but must be discarded following direct patient contact or use. Manufacturer Contact For local contact information, visit www.depuysynthes.com or contact your local sales representative.
WARNINGS AND CAUTIONS These instructions are provided for the processing of heatresistant, immersible, critical medical devices, unless otherwise noted on specific product inserts. Product specific inserts are given priority over these instructions. This can include heatsensitive devices and certain power (air- or electric-driven) tool designs that are provided with specific cleaning and sterilization
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instructions. Consult the product specific instructions for processing in these cases. 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. Cleaning agents with a used dilution pH of within 7 – 9 are recommended. Highly alkaline conditions (pH>10) can damage components / devices, such as aluminium materials. Do not use saline, environmental disinfection (including chlorine solutions) or surgical antiseptics (such as iodine- or chlorhexidine-containing 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. 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.
This document is valid only on the date printed. If unsure of the print date, please re-print to ensure use of the latest revision of the IFU (available at www.e-ifu.com). The onus resides with the user to ensure that the most up-to-date IFU is used.
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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.
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 chlorhexidinecontaining products. Flush all lumened devices with water (or detergent solution) to prevent the drying of soil and/or debris to the inside. 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.
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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.
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 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 softbristled 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 to 9) in accordance to the detergent manufacturer’s instructions. The temperature of the solution should be ≤40°C (104°F) for manual cleaning.
This document is valid only on the date printed. If unsure of the print date, please re-print to ensure use of the latest revision of the IFU (available at www.e-ifu.com). The onus resides with the user to ensure that the most up-to-date IFU is used.
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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.
10. 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 to 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.
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 a minimum of one minute.
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.
6. Remove the devices and completely submerge 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 with the cleaning solution, articulating areas, and flexible segments 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.
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.
7. 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 mins. 8. 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 and channels. Actuate joints, handles and other moveable device features to rinse thoroughly. 9. 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.
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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. Load the device components in the washer-disinfector in accordance with manufacturer’s instructions, ensuring that the devices and lumens can drain freely. 7. Automated washing shall be conducted in a validated washerdisinfector 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 to manufacturer’s instructions. An example of a validated cycle used for cleaning validation included: Phase
Recirculation Time (mins)
Pre Wash
2
Enzyme wash Wash Rinse
1 5 2
Rinse
0.25
Water Temp Detergent/Water Type Cold Tap N/A Water < 40°C (104°F) Neutral, Enzymatic Cleaner 66°C (151°F) Neutral pH Detergent Tap water > 40°C (104°F) Critical water (RO, Ambient deionized or distilled water)
This document is valid only on the date printed. If unsure of the print date, please re-print to ensure use of the latest revision of the IFU (available at www.e-ifu.com). The onus resides with the user to ensure that the most up-to-date IFU is used.
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Step 4: Thermal Disinfection
Step 6: Maintenance and Inspection
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 min). 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 min, 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. Evenly rinsed surfaces can achieve required heating curve for thermal disinfection. If possible 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.
Instruments should be visually inspected under ambient lighting, to verify that the devices do not have visible soil, damage or moisture.
The following automated cycles are examples of validated cycles: Phase Thermal Disinfection Thermal Disinfection
Recirculation Time (mins) 1 5
Water Temp
Water Type Critical water (RO, > 90°C (194°F) deionized or distilled water) Critical water (RO, > 90°C (194°F) 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 (mins) 7
Air Temp 140 (284)
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 any applicable devices 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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Inspect devices for: ••Lack of moisture. 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, pre-vacuum (forced air removal) cycle. The steam sterilizer should be validated to the requirements of any local standards and guidance such as EN 285 or AAMI/ANSI ST8. The steam sterilizer should be installed and maintained in compliance to 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 to manufacturer’s instructions and does not exceed the criteria for sterilizer load.
This document is valid only on the date printed. If unsure of the print date, please re-print to ensure use of the latest revision of the IFU (available at www.e-ifu.com). The onus resides with the user to ensure that the most up-to-date IFU is used.
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The following steam sterilization cycles are examples of validated cycles: Conditioning Phase Prevacuum Prevacuum
Minimum Sterilization Exposure Time (minutes) 4 3
Minimum Sterilization Exposure Temperature 132°C (270°F) 134°C (274°F)
Dry Time* 30 minutes 30 minutes
Extended steam exposure cycle can be used to meet local requirements such as 134°C (274°F) for 18 minutes. The efficiency of steam sterilizer drying can range considerable depending on the sterilizer design, loading, packaging and steam supply during the sterilization process. The user should employ verifiable methods (e.g. visual inspections) to confirm adequate drying. Extended drying within the sterilizer or in an external drying cabinet in accordance with manufacturer’s instructions may be necessary. Do not exceed 140°C (284°F) during drying. Immediate-Use steam sterilization is only intended for individual instruments 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 using this method. 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
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.
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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™, Terg-A-Zyme™, and NpH-Klenz™. 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. 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 +1-800-365-6633 OR AT +1-508-880-8100.
This document is valid only on the date printed. If unsure of the print date, please re-print to ensure use of the latest revision of the IFU (available at www.e-ifu.com). The onus resides with the user to ensure that the most up-to-date IFU is used.
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SYMBOL TRANSLATION STERILE STERILE
LOT LOT NUMBER REF REF CATALOG NUMBER
SINGLE USE
DO NOT RESTERILIZE
QTY QUANTITY SZ SIZE MADE IN MADE IN NTI NEURAL TISSUE INSTRUMENT IOM NEUROMONITORING INSTRUMENTS
Federal (USA) law restricts this device to sale by or on the order of a physician
T2
ATTENTION. SEE INSTRUCTIONS FOR USE
T1
Lower Limit of temperature = T1 Upper Limit of temperature = T2
PACKAGE CONTAINS FLAMMABLE LIQUID
25°C
STERILE A Sterile medical device processed using aseptic technique STERILE R STERILIZATION BY IRRADIATION STERILE EO STERILIZATION BY ETHYLENE OXIDE LATEX FREE LATEX FREE
STORE AT ROOM TEMPERATURE
KEEP AWAY FROM SUNLIGHT
DO NOT USE IF PACKAGE IS DAMAGED
NON STERILE
MSR MEASURING DEVICE
NONSTERILE NONSTERILE
MANUFACTURER
DATE OF MANUFACTURE US REP US REPRESENTATIVE EC REP AUTHORIZED EUROPEAN REPRESENTATIVE DIST DISTRIBUTED BY XXXX-XX USE BY
MATERIAL MATL
S SS P/F PL/FOAM A/T ACROFLEX®/Ti ACROFLEX®/Titanium Stainless Steel Plastic/Foam A AI Aluminum S/A
PY
SS/Al Polyester A/P Stainless Al/PL Steel / Aluminum PEEK/C
PEEK/CARBON SRSI FIBER COMPOSITE ® B/R Ba/RADEL SS/RADEL®/SILICONE Polyether Ether Ketone/ Barium/RADEL® Carbon Fiber Composite ® / Silicone Stainless Steel / RADEL Aluminum/Plastic
Ba/PEEK Barium Sulfate (BaSO4)/ PEEK Polymer
SRSN Ti/HA SRSI ®/SILICONE ® SS/RADEL Titanium/Hydroxyapatite SS/RADEL / SILICONE/Ti Al Nitride Stainless Steel/RADEL® / ® Stainless Steel / RADELTi/UHMWPE/HA / Silicone / Silicone Titanium Aluminum Nitride Titanium/Ultra-High SRSN Molecular Weight SS/RADEL®/ T Ti Polyethylene/Hydroxyapatite SILICONE/Ti Al Nitride
® / and its alloys Titanium Stainless Steel/RADEL SS/Ti Silicone/Titanium Stainless Aluminum Nitride S/SI SS/SILICONESteel/Titanium
PEEK OPTIMA® Polyether Ether Ketone
®/ SS/Al/SILICONE SS/RADEL Stainless Steel / Silicone SILICONE/Ti Nitride Stainless Steel/ ®/ Stainless Steel/RADEL Aluminum/Silicone P POLYMER Silicone/Titanium Nitride CaP Polymer SS/SILICA GLASS CALCIUM PHOSPHATE SRTA Stainless Steel/Silica Glass P/CM PE/CoCrMo Calcium Phosphate SS/RADEL®/Ti Al Nitride Polyethylene/Cobalt Stainless Steel/RADEL® / SS/SILICA GLASS/ CM CoCrMo Chromium Molybdenum Titanium Aluminum Nitride PL/SILICONE Cobalt Chromium P/C Stainless Steel/Silica Glass/ Molybdenum STA SS/Ti Al Nitride POLYMER/CARBON Plastic /Silicone Stainless Steel/ CMTC FIBER COMPOSITE Titanium Aluminum Nitride CoCrMo/Ti/CALCIUM SS/SILICA GLASS/ Polymer/ PHOSPHATE RADEL® /SILICONE Carbon Fiber Composite S/U SS/ULTEM Cobalt Chromium Stainless Steel/Silica Glass/ Stainless Steel/Ultem Si/NITINOL Molybdenum/Titanium/ RADEL® /Silicone Calcium Phosphate Silicone/Nitinol T Ti SS/SILICA GLASS/ Titanium and its alloys S CoNiCrMo SS SILICONE Cobalt Nickel Stainless Steel S/R SS/RADEL® Stainless Steel/ Chromium Molybdenum Stainless Steel/RADEL® S/A SS/Al Silica Glass/Silicone F FOAM Stainless Steel/Aluminum R/T S/SI SS/SILICONE Foam ® POLYOLEFIN RUBBER/Ti SBR SS/Ba/RADEL Stainless Steel/Silicone HA This document isStainless valid only on the date printed. If unsure of the print date, please Polyolefin Rubber/Titanium Steel/Barium/ ® 2019-10-28 01:37:12 Hydroxyapatite RADEL re-print to ensure use of the latest revision of the IFU (available at www.e-ifu.com). SS/WC/SILICONE T/A Ti/Al The onus resides with the user to ensure that the most up-to-date IFU is used. Stainless Steel/Tungsten S/P SS/PHENOLIC NiTi Ni/Ti Titanium/Aluminum Carbide/Silicone Stainless Steel/Phenolic Nickel/Titanium
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DePuy Spine, Inc. 325 Paramount Drive Raynham, MA 02767-0350 USA
Medos International SÀRL Chemin-Blanc 38 2400 Le Locle, Switzerland
*For recognized manufacturer, refer to product label. EC REP
DePuy International, Ltd. St. Anthony’s Road Leeds LS11 8DT England Phone: +44 113 270 0461 FAX: +44 113 272 4101 Revised November 2019 © DePuy Synthes 2013-2019. All rights reserved.
2019-10-28 01:37:12
This document is valid only on the date printed. If unsure of the print date, please re-print to ensure use of the latest revision of the IFU (available at www.e-ifu.com). The onus resides with the user to ensure that the most up-to-date IFU is used.
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