NON-STERILE Reusable Instruments Instructions for Use

MATERIALS AND RESTRICTED SUBSTANCES RS Description RS Identifier

1

Residual Risk

Cobalt: This device or one or CAS No. 7440-48-4 more components of EC No. 231-158-0 this device contains the following substance defined as CMR 1B in a concentration above 0.1% weight by weight. Current scientific evidence supports that medical devices manufactured from cobalt alloys or stainless steel alloys do not cause an increased risk of cancer or adverse reproductive effects.

WARNINGS AND CAUTIONS

These instruments must be cleaned, inspected and sterilized prior to use. Do not modify or alter the device unless instructed to do so in the surgical technique guide, the assembly/disassembly instructions, label or processing IFU. These instruments are not intended for use in a MR environment. They have not been tested for safety and compatibility in the MR environment. The instruments have not been tested for heating or migration in the MR environment. Ensure that no instruments or parts of instruments are left in the surgical site prior to closure, as patient injury may result. Instruments may not be detectable using imaging techniques e.g., radiograph, CT scan, fluoroscopy. These instructions are provided for the processing of heatresistant, immersible, critical medical devices, unless otherwise noted on specific product inserts. Information given in product specific IFU 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 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 a biohazard and facilities should ensure that transport and handling procedures comply with local regulations and guidelines. Reusable, non-sterile instruments are required to be cleaned, inspected and sterilized prior to 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 (eg temperature, contact time, and rinse time). Cleaning agents with a used dilution pH of within 7 to 9.5 are recommended. Highly alkaline conditions (pH>10) can limit the lifetime of components / devices, such as aluminum 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. Do not stack trays during sterilization. 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. Automated equipment, including washer-disinfectors and steam sterilizers must be installed, maintained and operated in accordance with manufacturer’s instructions.

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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Do not exceed 140°C (284°F) during processing 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. Part Number 254401005 (Attune Femoral Introducer) must follow Manual Cleaning instructions ONLY.

ADVERSE EVENTS & COMPLICATIONS

SERIOUS INCIDENT REPORTING (EU)

Any serious incident that has occurred in relation to the device should be reported to the manufacturer and the competent authority of the Member State in which the user and/or patient is established. Serious incident means any incident that directly or indirectly led, might have led or might lead to any of the following: (a) the death of a patient, user or other person, (b) the temporary or permanent serious deterioration of a patient’s, user’s or other person’s state of health, (c) a serious public health threat; Adverse events to patient (for more information see implant IFU): • Delay to surgery caused by missing, damaged or worn instruments. • Tissue injury and additional bone removal due to blunt, damaged or incorrectly positioned instruments. • Tissue reactions, osteolysis and/or implant loosening caused by metallic corrosion, allergic reactions, wear or particulate debris. • Infection and toxicity due to improper processing. • Damage to vital organs due to sharp instruments • Neurological damage due to sharp instruments or surgical trauma • Vascular damage due to sharp instruments or damage. • Cardiovascular disorders i.e. venous thrombosis, pulmonary embolism. Adverse events to user: • Cuts, abrasions, contusions or other tissue injury caused by burs, sharp edges, impaction, vibration or jamming of instruments.

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DEVICE PROCESSING

DePuy Synthes 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 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 the product specific instructions for use (IFU). Product specific IFU’s are given priority over these instructions. This can include heat-sensitive devices and certain power (air- or electric-driven) tool designs that are provided with specific cleaning and sterilization instructions. Consult the product specific IFU 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. Manufacturer Contact For local contact information, visit www.depuysynthes.com or contact your local sales representative. Limitations on Processing Repeated processing cycles in compliance with these instructions for use have minimum 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. At the end of the device’s life safely dispose of the device in accordance with local procedures and guidelines. 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 accordance with local procedures and guidelines.

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 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. 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. 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, disassembly instructions, assembly instructions 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 softbristled brushes and twisting action. Brush size should be approximately the same diameter of the lumen to be cleaned.

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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 blowing 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 9.5) 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. 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 to 9.5), 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.

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: 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 reverse osmosis, 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 to 9.5) 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 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. 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.

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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 to 9.5), 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 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 Pre-Wash Enzyme wash Wash

Recirculation Time (minutes) 2 2 5

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

Detergent/Water Type N/A Neutral, Enzymatic Cleaner Neutral pH Detergent

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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Phase Rinse

Recirculation Time (minutes) 2

Rinse

0.25

Water Temp >40°C (104°F) Ambient

Detergent/Water Type 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 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 washerdisinfector 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: Phase

Recirculation Time (minutes)

Water Temp

Thermal Disinfection

1

>90°C (194°F)

Thermal Disinfection

5

>90°C (194°F)

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

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Air Temp

Air Type

115°C (239°F)

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). 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: 6 (a) Lack of moisture. Carefully inspect device lumens and moving parts. If moisture is detected, manually drying should be performed. 6 (b) 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. 6 (c) Damage, including but not limited to, corrosion (rust, pitting), discoloration, excessive scratches, flaking, cracks and wear 6 (d) Proper function, including but not limited to, sharpness of cutting tools, bending or distortion of devices, movement of hinges/joints/box locks and moveable features such as handles, ratcheting and couplings and missing or removed part numbers 6 (e) Improperly functioning devices, devices with unrecognizable markings, missing or removed 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.

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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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 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. The following steam sterilization cycles are examples of validated cycles: Conditioning Sterilization Sterilization Phase Exposure Time Exposure (minutes) Temperature Prevacuum 4 132°C (270°F) Prevacuum 3 134°C (274°F)

Dry Time* 30 minutes 30 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 prevacuum 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 30 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 and should only be performed when approved by local policies. DePuy Synthes does not support immediate-use steam sterilization of instrument sets or cases using this method.

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The following steam sterilization cycle is an example of a validated cycle for individual instruments only: • Unwrapped instrument • A minimum 3 (three) pulse prevacuum 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. Additional Information Cleaning agent information: Examples of detergents that have been used during cleaning validations include ProlysticaTM 2X Concentrate Enzymatic Cleaner, ProlysticaTM 2X Neutral Detergent, EnzolTM, EndozimeTM, Neodisher MedizymTM, Terg-A-ZymeTM, and NpH-KlenzTM. Further information regarding the use of specific cleaning agents, ultrasonic washers, washer-disinfector, packaging materials or sterilizers during validation studies are available on request. The chemical quality of the water used during processing can impact device safety. Facilities should use the recommended water quality requirements for device processing 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. All third party trademarks used herein are trademarks of their respective owners. Where further information is desired, please contact your local DePuy sales representative. For instruments produced by another legal manufacturer, reference the manufacturer’s instructions 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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INTERPRETATION OF SYMBOLS Lift DePUY INC.

Catalogue Number

Right/Left

Made in

Distributed by

Size/ size/ diameter/ inches/ feet/ degrees/ group/ pounds/ outer diameter/ inner diameter

Batch code www.e-IFU.com

/ Canada 800-255-2500 i US Sharps EU: +800 8888 2020

Serial Number

EU: +32 2 4037222

Caution

Consult Instructions for Use

e-IFU website

Manufacturer

Non-sterile

Do not use if package is damaged

Separate collection

Packaging unit

www.e-IFU.com

/ Canada 800-255-2500 i US EU: +800 8888 2020 EU: +32 2 4037222

Contains hazardous substances

CMR

Carcinogenic, mutagenetic or toxic to reproduction

Material(s) of construction

Medical Device

Medical Device

Do not disassemble

Lock

Unlock

Cleaning position Identifier on Instrument

Dismantle for cleaning

FORWARD

Rasps for use with T handle only

APEX

NOT FOR USE WITH IMPLANT

Recyclable

REVERSE

Small/Large

PRELIMINARY ASSEMBLY INSTRUMENT

RESET TO GREEN

MUST USE WITH GUIDE SHAFT

Remove After Reaming

EC

For use with the Tibial Protection Plate

Lubricate Device

MD

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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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DePuy Ireland UC Loughbeg, Ringaskiddy Co. Cork Ireland Tel: +353 214914000 Fax: +353 214914199

Revised 08/2022 © DePuy Synthes 2021-2022. All rights reserved. 2022-09-23 19:14:15

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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