SUMMIT SI Occipito-Cervico-Thoracic (OCT) Spinal Fixation System and MOUNTAINEER OCT Spinal System Instructions for Use

and dual diameter rods, are available in various diameters and lengths. Transverse connector and assemblies are available to link the two longitudinal members to provide additional stability in axial rotation. Minipolyaxial and monoaxial screws are used to secure the construct to the upper thoracic spine. These screws are available in various diameters and lengths. Dual wedding band connectors (side-by-side) and axial rod connectors (end-to end) are available in a variety of sizes. For posterior cervical spine internal fixation, hooks or cable connectors can be attached to the longitudinal member with set screws. The construct is positioned over the laminae of the spinal segments to be instrumented. SONGER® Cables are looped around the laminae and passed through the cable connectors and tensioned appropriately.

CLEANING AND STERILIZATION Implants of the SUMMIT SI OCT Spinal System and MOUNTAINEER OCT Spinal System are supplied clean and not sterile. They have been validated according to AAMI TIR 12, Design, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for device manufacturers.

NON-STERILE IMPLANTS For the implants supplied non-sterile, they will be supplied clean. ISO 8828 or AORN recommended practices for in-hospital sterilization should be followed for all components.

RECOMMENDATIONS FOR STEAM STERILIZATION In a properly functioning calibrated steam sterilizer, independent testing has shown that effective sterilization may be achieved using the following parameters: Cycle: Pre-Vacuum Temperature: 270° F (132° C) Exposure Time: 4 minutes Drying Time: 60 minutes Post-sterilization drying of the sterilization load within the steriliza­tion vessel is standard practice in hospitals. ANSI / AAMI ST79:2006, “Comprehensive guide to steam sterilization and sterility assurance in health care facilities” provides guidance to hospitals for selecting appropriate drying parameters based on the sterilization cycle that is being conducted. Sterilizer manufacturers also typically provide recommendations for drying parameters for their specific equipment. Only legally marketed, FDA cleared sterilization wrap, pouches, or DePuy Synthes Reusable Sterilization Containers should be used by the end-user for packaging terminally sterilized devices. The manufacturer’s instructions for use for the sterilization wrap, pouches, or DePuy Synthes Reusable Sterilization Containers are 2017-06-20 11:03:32

to be followed. The use of DePuy Synthes Reusable Sterilization Containers are limited to use in the United States only, and are not approved for use outside of the United States. Inspect visually for damage or the presence of blood or tissue. If blood or tissue is observed on the implant, it must be thoroughly cleaned manually using a soft brush and neutral pH detergent or discarded.

Cleaning instructions ••Enzyme soak ••Rinse ••Ultrasonic cleaning (10-20 minutes) ••Rinse ••Automated cleaning in a washer disinfector with lid on to contain implant components ••Dry Avoid impact, scratching, bending or surface contact with any materials that might affect the implant surface or configuration. Special attention shall be paid to recesses since both chemicals and rinse water may be entrapped in them. Wrap implants in accordance with local procedures using standard wrapping techniques such as those described in ANSI / AAMI ST79:2006. Implants previously implanted should not be re-used.

INDICATIONS AND USAGE CAUTION: U.S.A. Law restricts this device to sale by or on the order of a physician. The surgeon must be thoroughly knowledgeable not only in the medical and surgical aspects of the implant, but must also be aware of the mechanical and metallurgical limitations of metallic surgical implants. Postoperative care is extremely important. The patient must be instructed in the limitations of the metallic implant and be warned regarding weight bearing and body stresses on the appliance prior to firm bone healing. The patient should be warned that noncompliance with postoperative instructions could lead to failure of the implant and possible need thereafter for additional surgery to remove the device. The SUMMIT SI OCT Spinal System and MOUNTAINEER OCT Spinal System are intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3), and are indicated for the following: ••ddd (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies) ••spondylolisthesis ••spinal stenosis

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••fracture/dislocation ••atlanto/axial fracture with instability ••occipitocervical dislocation ••revision of previous cervical spine surgery ••tumors The occipital bone screws are limited to occipital fixation only. The use of the monoaxial and polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine.

significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolis­thesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.

The SONGER wire/cable system to be used with the SUMMIT SI OCT Spinal System and MOUNTAINEER OCT Spinal System allows for wire/cable attachment to the posterior cervical spine.

Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.

The SUMMIT SI OCT System and MOUNTAINEER OCT Spinal System can also be linked to the ISOLA, MONARCH, MOSS MIAMI, VIPER and EXPEDIUM systems using the dual wedding band and axial connectors, and via dual diameter rods.

WARNINGS, PRECAUTIONS AND ADVERSE EFFECTS CONCERNING TEMPORARY METALLIC INTERNAL FIXATION DEVICES.

WARNING: This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic (T4-T12), or lumbar spine.

WARNINGS

POSTOPERATIVE MOBILIZATION Until maturation of the fusion is confirmed by radiographic examination, external immobilization (such as bracing) may be recommended, based on physician judgment.

The following are specific warnings, precautions and adverse effects that should be understood by the surgeon and explained to the patient. These warnings do not include all adverse effects that can occur with surgery in general, but are important considerations particular to metallic internal fixation devices. General surgical risks should be explained to the patient before surgery.

Instructions to the patient to reduce stress on the implants are an equally important part of the attempt to avoid the occurrence of clinical problems that may accompany fixation failure.

Potential risks identified with the use of this device system, which may require additional surgery, include: device component fracture, loss of fixation, non-union, fracture of the vertebra, neurological injury, and vascular or visceral injury.

CONTRAINDICATIONS

In addition, please refer to the Surgical Technique Manual regarding details of safe placement of the occipital screws.

••Active systemic infection or an infection localized to the site of the proposed implantation. ••Severe osteoporosis may prevent adequate fixation of screws and thus preclude the use of this or any other spinal instrumentation system. ••Patients who have been shown to be safely and predictably treated without internal fixation. ••Open wounds.

RELATIVE CONTRAINDICATIONS Relative contraindications include any entity or condition that totally precludes the possibility of fusion (e.g., cancer, kidney dialysis or osteopenia), obesity, certain degenerative diseases, and foreign body sensitivity. Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with

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1. CORRECT SELECTION OF THE IMPLANT IS EXTREMELY IMPORTANT. The potential for satisfactory fixation is increased by the selection of the proper size, shape, and design of the implant. While proper selection can help minimize risks, the size and shape of human bones present limitations on the size, shape and strength of implants. Metallic internal fixation devices cannot withstand activity levels equal to those placed on normal healthy bone. No implant can be expected to withstand indefinitely the unsupported stress of full weight bearing. 2. IMPLANTS CAN BREAK WHEN SUBJECTED TO THE INCREASED LOADING ASSOCIATED WITH DELAYED UNION OR NONUNION. Internal fixation appliances are load sharing devices that are used to obtain alignment until normal healing occurs. If healing is delayed, or does not occur, the implant may eventually break due to metal fatigue. The degree or success

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of union, loads produced by weight bearing, and activity levels will, among other conditions, dictate the longevity of the implant. Notches, scratches or bending of the implant during the course of surgery may also contribute to early failure. Patients should be fully informed of the risks of implant failure. 3. MIXING METALS CAN CAUSE CORROSION. There are many forms of corrosion damage and several of these occur on metals surgically implanted in humans. General or uniform corrosion is present on all implanted metals and alloys. The rate of corrosive attack on metal implant devices is usually very low due to the presence of passive surface films. Dissimilar metals in contact, such as titanium and stainless steel, accel­ erate the corrosion process of stainless steel and more rapid attack occurs. The presence of corrosion often accelerates fatigue fracture of implants. The amount of metal compounds released into the body system will also increase. Internal fixation devices, such as rods, hooks, wires, etc., that come into contact with other metal objects, must be made from like or compatible materials. 4. PATIENT SELECTION. In selecting patients for internal fixation devices, the following factors can be extremely important to the eventual success of the procedure: A. The patient’s occupation or activity. If the patient is involved in an occupation or activity that includes heavy lifting, muscle strain, twisting, repetitive bending, stooping, running, substantial walking, or manual labor, he/she should not return to these activities until the bone is fully healed. Even with full healing, the patient may not be able to return to these activities successfully. B. A condition of senility, mental illness, alcoholism, or drug abuse. These conditions, among others, may cause the patient to ignore certain necessary limitations and precautions in the use of the appliance, leading to implant failure or other complications. C. Certain degenerative diseases. In some cases, the progression of degenerative disease may be so advanced at the time of implantation that it may substantially decrease the expected useful life of the appliance. For such cases, orthopedic devices can only be considered a delaying technique or temporary remedy. D. Foreign body sensitivity. The surgeon is advised that no pre-operative test can completely exclude the possibility of sensitivity or allergic reaction. Patients can develop sensitivity or allergy after implants have been in the body for a period of time. E. Smoking. Patients who smoke have been observed to experience higher rates of pseudarthrosis following surgical procedures where bone graft is used. Additionally, smoking

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has been shown to cause diffuse degeneration of interverte­ bral discs. Progressive degeneration of adjacent segments caused by smoking can lead to late clinical failure (recurring pain) even after successful fusion and initial clinical improvement.

PRECAUTIONS 1. SURGICAL IMPLANTS MUST NEVER BE REUSED. An explanted implant should never be reimplanted. Even though a device appears undamaged, it may have small defects and internal stress patterns that may lead to early breakage. Reuse can compromise device performance and patient safety. Reuse of single use devices can also cause cross-contamination leading to patient infection. 2. CORRECT HANDLING OF THE IMPLANT IS EXTREMELY IMPORTANT. Contouring of metal implants should be done only with proper equipment. The operating surgeon should avoid any notching, scratching or reverse bending of the devices when contouring. Alterations will produce defects in surface finish and internal stresses that may become the focal point for eventual breakage of the implant. 3. BENDING THE CONSTRUCT. Titanium alloy components should never be bent sharply or reverse bent. If a construct is over-contoured it is recommended that a new construct is contoured correctly rather than reverse bending the overcontoured construct. 4. REMOVAL OF THE IMPLANT AFTER HEALING. If the device is not removed after the completion of its intended use, any of the following complications may occur: (1) Corrosion, with localized tissue reaction or pain; (2) Migration of implant position resulting in injury; (3) Risk of additional injury from post-operative trauma; (4) Bending, loosening, and/or breakage, which could make removal impractical or difficult; (5) Pain, discomfort, or abnormal sensations due to the presence of the device; (6) Possible increased risk of infection; and (7) Bone loss due to stress shielding. The surgeon should carefully weigh the risks versus benefits when deciding whether to remove the implant. Implant removal should be followed by adequate postoperative management to avoid refracture or deformity. If the patient is older and has a low activity level, the surgeon may choose not to remove the implant thus eliminating the risks involved in a second surgery. 5. ADEQUATELY INSTRUCT THE PATIENT. Postoperative care and the patient’s ability and willingness to follow instructions are among the most important aspects of successful bone heal­ ing. The patient must be made aware of the limitations of the implant, and instructed to limit and restrict physical activities, especially lifting and twisting motions and participating in any

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type of sports. The patient should understand that a metallic implant is not as strong as normal healthy bone and could loosen, bend and/or break if excessive demands are placed on it, especially in the absence of complete bone healing. Implants displaced or damaged by improper activities may migrate and damage the nerves or blood vessels. An active, debilitated, or demented patient who cannot properly use weight supporting devices may be particularly at risk during postoperative rehabilitation.

POSSIBLE ADVERSE EFFECTS 1. Nonunion, delayed union. 2. Bending or fracture of implant. Loosening of the implant. 3. Metal sensitivity, or allergic reaction to a foreign body. 4. Infection, early or late. 5. Decrease in bone density due to stress shielding. 6. Pain, discomfort, or abnormal sensations due to the presence of the device. 7. Nerve damage due to surgical trauma or presence of the device. Neurological difficulties including radicular pain, tethering of nerves in scar tissue, muscle weakness, and paraesthesia. 8. Vascular damage could result in catastrophic or fatal bleeding. Malpositioned implants adjacent to large arteries or veins could erode these vessels and cause catastrophic bleeding in the late post-operative period. 9. Dural tears experienced during surgery could result in the need for further surgery for dural repair, a chronic CSF leak or fistula, and possible meningitis. 10. Bursitis. 11. Paralysis. 12. Screw back-out, possibly leading to implant loosening, and/or reoperation for device removal. 13. Damage to lymphatic vessels and/or lymphatic fluid exudation. 14. Spinal cord impingement or damage. 15. Fracture of bony structures. 16. Degenerative changes or instability in segments adjacent to fused vertebral levels. 17. Death.

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MAGNETIC RESONANCE (MR) COMPATIBILITY The SUMMIT SI Occipito-Cervico-Thoracic (OCT) System and MOUNTAINEER OCT Spinal System implants have not been evaluated for safety and compatibility in the MR environment. The MOUNTAINEER OCT Spinal System implants have not been tested for heating or migration in the MR environment. SONGER® is a registered trademark of Pioneer Surgical Technology.

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

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/R SS/RADEL® Stainless Steel/RADEL®

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

R/T

S/SI SS/SILICONE POLYOLEFIN RUBBER/Ti SBR 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/ ® RADEL Hydroxyapatite 2017-06-20 11:03:32 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 SS/Ba/RADEL®

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to sale by or on the order of a physician

NONSTERILE NONSTERILE

MSR MEASURING DEVICE

KEEP AWAY FROM SUNLIGHT

USE BY

MATERIAL MATL 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

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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 S SS Stainless Steel S/A SS/Al Stainless Steel/Aluminum SS/Ba/RADEL®

HA Hydroxyapatite

SBR 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

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/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

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

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 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. US REP

EC REP

DePuy Spine, Inc. 325 Paramount Drive Raynham, MA 02767-0350 USA Phone: +1 (800) 451 2006 FAX: +1 (508) 828 3700

DePuy International, Ltd. St. Anthony’s Road Leeds LS11 8DT England Phone: +44 113 270 0461 FAX: +44 113 272 4101

Revised June 2017 © DePuy Synthes 2004-2017. All rights reserved.

2017-06-20 11:03:32

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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