7 D Surgical Spine Module Instructions for Use Rev 0

COPYRIGHT This document and the information contained in it is proprietary and confidential information of 7D Surgical and may not be reproduced, copied in whole or in part, adapted, modified, disclosed to others, or disseminated without the prior written permission of 7D Surgical. This document is intended to be used either by customers and is licensed to them as part of their equipment purchase from 7D Surgical, or to meet regulatory commitments as required by the FDA under 21 CFR 1020.30 (and any amendments to it) and other local regulatory requirements. Use of this document by unauthorized persons is strictly prohibited. Software that may be described in this document is furnished under a license agreement. It is against the law to copy, modify, or distribute the software on any medium, except as specifically allowed in the license agreement. Furthermore, the license agreement may prohibit the software from being disassembled, reverse engineered, or decompiled for any purpose. Warranties are as stated therein. Portions of this document may make reference to other manufacturers and/or their products, which may contain parts whose names are registered as trademarks and/or function as trademarks of their respective owners. Any such use is intended only to designate those manufacturers' products as supplied by 7D Surgical for incorporation into its equipment and does not imply any right and/or license to use or permit others to use such manufacturers' and/or their product names as trademarks. 7D Surgical, Inc. warranties are limited to those express warranties provided at the time of sale or license of its products and are 7D Surgical’s sole and exclusive representations, warranties, and obligations. 7D Surgical makes no other warranty of any kind whatsoever, expressed or implied, including but not limited to, the implied warranties of merchantability or fitness for a particular purpose, whether arising from a statute or otherwise in law or from a course of dealing or usage of trade, all of which are expressly disclaimed, and assumes no responsibility or contingent liability, including indirect or consequential damages, for any use by the purchaser or for any adverse circumstances arising therefrom. 7D Surgical has taken care to ensure the accuracy of this document. However, 7D Surgical, Inc. assumes no liability for errors or omissions and reserves the right to make changes without further notice to any products herein to improve reliability, function, or design. 7D Surgical, Inc. may make improvements or changes in the products or programs described in this document at any time. Unauthorized copying of this document, in addition to infringing copyright, might reduce the ability of 7D Surgical to provide accurate and current information to users. This product may contain remanufactured parts equivalent to new in performance, or parts that have had incidental use. The trademarks mentioned herein are the property of 7D Surgical or their respective owners.

©2021 7D Surgical 7D Surgical, Inc. 60 Scarsdale Road, Unit 118 Toronto, Ontario, Canada, M3B 2R7 INSTRUCTIONS FOR USE: 7D SPINE MODULE 2 of 196

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Contents Copyright ... 2 Software Version Compatibility ... 8 1.

Operational Precautions and Limitations... 9 General Safety Information ... 9 Documentation Symbols and Conventions ... 9 Operational Precautions ... 10 Sterility Precautions ...14 Cleaning and Sterilization Precautions ...15 Electrical Precautions ...15 Ventilation Precautions...17 Environmental Precautions ... 18 Regulatory Compliance ... 20 Environmental Requirements... 21 Operating Requirements ... 21 Transportation and Storage Requirements ... 21

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Hazard Symbols ... 22 Occupational Health and Safety Symbols ... 22 Symbols, Indicators, and Labels – Packaging ... 22 Symbols, Indicators, and Labels - System ... 25

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Product Overview and Use ...28 Indications for Use ...28 Contraindications ...28 Product Description...28 Qualified Personnel ...29 Equipment Use and Modification ...29 Customer Training ...29 Complaint Reporting in the EU ...29 Contact Us ...29

4.

Hardware Overview ... 30 System Head ...31 System Cart ... 32 Locking Castors... 33

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Input/Output Module... 34 Power Input Module ... 35 Foot Pedal ... 36 Computer ... 37 Uninterruptible Power Supply (UPS) ... 37 7D Surgical Light Handle...38 Unpacking 7D Surgical Tracked Navigation Tools ...38 Disposable Reflective Marker Spheres ...38 7D Surgical Tracked Navigation Tools ... 40 7D Surgical Reference Frame ... 42 7D Surgical Flex Array ... 42 7D Surgical Cranial Reference Frame ... 47 7D Surgical Integration Tools ...48 7D Surgical Calibration Device ...48 7D Surgical Universal Arrays ... 49 7D Surgical FlashLock 1 ... 53 Calibrating 7D Surgical Integration Tools ... 57 7D Surgical Drill Guide ... 63 7D Sterilization Trays ... 65 7D Surgical Tracked Navigation Tools ... 65 7D Surgical Reference Frames ... 67 5.

Principles of Operation ... 73 How It Works ... 73 Software Interface ... 73 Launcher Login Screen ... 74 7D Surgical Software Home Screen ... 74 System Manager ... 79 Power Management ...82 Main Window ...83 View Panel ...92 Layouts ... 95 Tool Management Dialog ... 95

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Installation Procedures and Special Requirements ... 97 Visual Inspection ... 97

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Working in a Sterile Environment ...99 Setting Up the System ...99 Workflow for 7D Surgical Cranial Reference Frame ... 103 Positioning the 7D Surgical System at the Surgical Bed ... 110 Positioning the System Head Over the Patient ... 112 Aiming Lasers ... 112 Live Video ... 115 Side of Interest ... 116 7.

Operating Instructions ... 118 Workflow Overview ... 118 Step 1 - Start 7D Spine Module ... 121 Step 2 - Load Data ... 122 Step 3 - Review and Confirm Patient Data ... 123 Step 4 - Set View Thresholds & Clip Image ... 123 Step 5 - Identify Points on 3D Pre-Operative CT Image ... 124 Step 6 - Verify Tracked Navigation Tools ... 125 Step 7 - Attach 7D Surgical Reference Frame ... 127 Using the 7D Surgical Flex Array attached 7D Reference Clamp (Stainless Steel). ... 127 Using the 7D Surgical Flex Rod Connector With the 7D Surgical Flex Array ... 129 Using the 7D Surgical Spine Reference Clamp (Radiolucent) With The 7D Surgical Flex Array ... 132 Using the 7D Surgical Flex Iliac Pin Connector With the 7D Surgical Flex Array ... 134 Using the 7D Surgical Cranial Reference Frame... 137 Step 8 - Position the System Head ... 139 Step 9 - Initiate Flash™ Registration ... 141 Step 10 - Identify Points on Patient ... 142 Step 11 - Verify Registration ... 143 Registration Replayer ... 145 Step 12 - Perform Navigation ... 145 Saved Trajectories ... 149 FLASH™ Fix ... 150 Check Point ... 150 Reslicer ... 152 Fixed Image Navigation Mode ... 153

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Virtual Screw Visualization ... 153 Using the 7D Surgical Drill Guide ... 156 Step 13 - Close Software and Shutdown the System ... 159 8.

Transporting and Storing the System ... 160 Repacking the System for Shipping ... 161 Disposing of the System ... 162

9.

Cleaning and Sterilizing the System ... 163 Cleaning the 7D Surgical System ... 164 Cleaning Solutions... 164 Cleaning and Disinfecting the System Head ... 165 Cleaning and Disinfecting the Monitors ... 166 Cleaning and Disinfecting the Keyboard, Computer Mouse, and Foot Pedal ... 166 Cleaning and Disinfecting the System Cart and Arms ... 166 Cleaning the 7D Surgical Tracked Navigation Tools, Light Handle, and Sterilization Tray167 Cleaning and Sterilization Materials ... 167 Validated Materials ... 168

10. Troubleshooting ... 170 11. Appendix A: Spine Scan Protocol ... 173 12. B: Shipping Components List ... 174 Accessories ... 174 13. Appendix C: System Specifications... 178 7D Surgical System ... 178 7D Surgical Light ... 179 Electromagnetic Compatibility (EMC) ... 180 Electromagnetic Emissions IEC 60601-1-2 – System P/N 10-0001-01, 10-0001-02, 10-000103 ... 180 Electromagnetic Immunity IEC 60601-1-2 – System P/N 10-0001-01, 10-0001-02 ... 181 Electromagnetic Immunity IEC 60601-1-2 – System P/N 10-0001-03 ... 182 Electromagnetic Immunity IEC 60601-1-2 RF – System P/N 10-0001-01, 10-0001-02 ... 183 Electromagnetic Immunity IEC 60601-1-2 RF – System P/N 10-0001-03 ... 184 14. Appendix D: Tracked Drill Guide ... 187 Setup ... 189 Tracking ... 190 Navigation ... 190

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Sterilizing the Medtronic Tracked Drill Guide ... 191 15. Appendix E: Pedicle Access Kit ... 192 Setup ... 193 Tracking ... 193 Navigation ... 194 Sterilizing the IZI Medical Products’ Navigated Pedicle Access Kit... 195 16. Appendix F: Disposable Reflective Marker Sphere Suppliers ... 196

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SOFTWARE VERSION COMPATIBILITY This document is compatible with the following versions of the 7D Spine software:

Version Spine Module 2.0 Spine Toolset 1.11

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1. OPERATIONAL PRECAUTIONS AND LIMITATIONS GENERAL SAFETY INFORMATION

Users are required to thoroughly read this manual before operating the system. If additional training is required, contact 7D Surgical. To prevent personal injury or system damage, read, understand, and obey all safety precautions, warnings in this document, and labels on the 7D Surgical System. Failure to heed these warnings could result in serious injury. This safety information is intended to supplement federal, state, provincial, and local environmental health and safety (EHS) regulations. The information provided covers systemrelated safety with regard to the operation of 7D Surgical System. It does not cover every safety procedure that should be practiced. Ultimately, the user and the organization are responsible for compliance with federal, state, provincial, and local EHS regulations and for maintaining a safe laboratory environment.

DOCUMENTATION SYMBOLS AND CONVENTIONS

DANGER! Danger signifies an action which leads to severe injury or death.

WARNING! Warning signifies an action that could cause personal injury if precautions are not followed.

CAUTION! Caution signifies an operation that could cause damage to the system or corruption or loss of data if precautions are not followed.

Note: Note emphasizes significant information in a procedure or description.

Tip! Tip provides useful information that helps apply the techniques and procedures in the text for a specific need and provides shortcuts, but not essential to the completion of a procedure.

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OPERATIONAL PRECAUTIONS Fire and Explosion Hazard. Do not use the 7D Surgical System in the presence of flammable materials such as solvents, cleaning agents, and endogenous gases. Flammable materials may ignite, causing personal injury or death.

CAUTION! United States federal law restricts the 7D Surgical System to sale by or on the order of a physician. WARNING! Personal Injury Hazard. The 7D Surgical System and its associated applications should be used only by qualified medical professionals who are trained on and familiar with the proper operation of the system. WARNING! Personal Injury Hazard. If the 7D Surgical System stops working and image guided surgery is no longer feasible, revert to standard of care and cycle power to the system.

WARNING! Personal Injury Hazard. The 7D Surgical System and its associated application should be used only as an adjunct for surgical guidance. They are not a replacement for the surgeon’s knowledge, expertise, or judgment. WARNING! Personal Injury Hazard. The 7D Surgical System is not built as a redundant system. Prior to planning a procedure, consider the unlikely event that the system may be unavailable and therefore plan for alternative tools and techniques to be able to finish the surgery successfully without the use of navigation. WARNING! Personal Injury Hazard. In addition to verifying the accuracy of the 7D Surgical System via the 7D Surgical System Software, be sure to verify spinal levels clinically or radiographically (for example, CT, fluoroscopy, etc.). If system navigation seems inaccurate and the recommended steps to restore accuracy are not successful, stop use of the system and revert to standard of care. WARNING! Personal Injury Hazard. Before transporting the 7D Surgical System, ensure that the System Head and monitors are properly secured. Failure to do so could result in the System Head swinging out and hitting someone, causing personal injury or damage to the system. Ensure no loose objects are placed on top of the System Cart during transport.

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WARNING! Personal Injury Hazard. Only one 7D Reference Frame should be attached to the patient at a time.

WARNING! Personal Injury Hazard. To avoid user injury and/or product damage, avoid rolling over cables or other obstacles when transporting the 7D Surgical System. When necessary, use a ramp for crossing obstacles. Always check the castors for damage after crossing obstacles. WARNING! Personal Injury Hazard. Be careful when moving the long Surgical Arm. Failure to do so could result in the System Head swinging out and hitting someone, causing personal injury or damage to the system. WARNING! Pinch Hazard. Be careful when moving the Surgical Arm, taking care to avoid the pinch hazards where the Surgical Arm and extension can come into contact with the user. WARNING! Personal Injury Hazard. Slowly and carefully move the System Head and Surgeon Monitor. Failure to do so could result in personal injury or damage to the 7D Surgical System. WARNING! Personal Injury Hazard. Do not hang anything on the Surgical Arm. Failure to follow this warning may cause unacceptable static force on the system which may cause instability or tipping, resulting in personal injury or damage to the system.

WARNING! Personal Injury Hazard Before transporting the 7D Surgical System, shut down power and safely store all cables.

WARNING! Personal Injury Hazard. Ensure that the 7D Surgical System is positioned on a level surface (<5-degree incline) to minimize the risk of the system tipping and causing personal injury. Ensure that the castors are locked.

WARNING! Trip Hazard. Be careful to place the foot pedal in a location that will not present a tripping hazard.

WARNING! Personal Injury Hazard. Do not protect or shield the view of either the Structured Light Imaging System components (cameras, projector), tracking system, or 7D Surgical Tracked Navigation Tools with methods not approved by 7D Surgical. Non-approved methods will interrupt the optical path and degrade the performance of the 7D Surgical System. Reliance on data provided by the tracking system without an uninterrupted optical path may lead to inaccurate conclusions and the possibility of personal injury.

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WARNING! Personal Injury Hazard. Do not use cables or accessories other than those listed in this guide. The use of other cables or accessories may result in increased emissions and/or decreased immunity of the 7D Surgical System and may result in personal injury. WARNING! Personal Injury Hazard. Only use 7D Surgical tools or specified marker spheres (see Appendix F) with the 7D Surgical System. The accuracy of results produced by applications that incorporate non-7D Surgical components with the system is unknown and may increase the possibility of personal injury. WARNING! Personal Injury Hazard. Do not use the 7D Surgical System without inspecting it for cleanliness and damage both before and during a procedure. Reliance on data provided by an unclean or damaged Optical Tracking System/Structured Light Imaging System may lead to inaccurate conclusions. If your application involves personal safety, inaccurate conclusions increase the possibility of personal injury. WARNING! Personal Injury Hazard. Do not use the 7D Spine Kit components without inspecting them for defects. Do not use bent or damaged 7D Surgical Tracked Navigation Tools. Inspect the 7D Surgical Pedicle Probe(s), and Pointer(s) before use to ensure that the markings are clearly visible. Do not use the 7D Surgical Pedicle Probe(s) or Pointer(s) if the markings are not clear. WARNING! Personal Injury Hazard. Do not use any 7D Surgical Tracked Navigation Tool without first performing the tool verification step of the 7D Surgical System Software workflow. Reliance on data produced by a 7D Surgical Tracked Navigation Tool that has not been verified as accurate may lead to inaccurate conclusions and increase the possibility of personal injury. WARNING! Personal Injury Hazard. Do not use reflective marker spheres without inspecting them for cleanliness and damage both before and during a procedure. Reliance on data produced by unclean or damaged markers may lead to inaccurate conclusions and increase the possibility of personal injury. WARNING! Biohazard. If the 7D Surgical Tracked Navigation Tools, 7D Surgical Tools or the 7D Surgical Light Handle can no longer be used, dispose of them according to hospital procedures for hazardous products. Deposit hazardous materials in appropriately labeled containers. There is a potential risk of personal injury if proper procedures for handling and disposing of hazardous materials are not followed. WARNING! Personal Injury Hazard. Electrical Shock Hazard. Ensure that the power to the 7D Surgical System is off and that the system is disconnected from the AC mains supply before cleaning the system. Wait an additional 5 minutes after powering down the system to Ensure that the UPS has also powered down. Allow the 7D Surgical Light to cool before beginning to clean the system.

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WARNING! Personal Injury Hazard. Do not use the Cart Handle to lift the system over obstacles. Lifting the system at the Cart Handle may result in injury or lead to system malfunction. WARNING! Optical Hazard. Do not look directly into the Aiming Lasers or view with optical instruments. The laser positioning system transmits laser radiation. Use caution when operating the device, and never allow the laser beams to enter someone’s eyes. Looking into the aperture of a laser or viewing with optical instruments may cause eye damage.

WARNING! Optical Hazard. Do not look directly into the 7D Surgical Light. Looking into the light may cause eye damage.

WARNING! Personal Injury Hazard. Do not bump or reposition the 7D Surgical Reference Frame after registration. Such movements may result in inaccurate navigation. If the 7D Surgical Reference Frame moves in relation to the patient anatomy at any time after registration, repeat registration. WARNING! Personal Injury Hazard. Ensure that the 7D Surgical Reference Frame is rigidly attached and locked to the relevant anatomy. Navigational accuracy can degrade on vertebra levels that are not rigidly connected to the 7D Surgical Reference Frame. If the frame moves in relation to the patient anatomy, navigational inaccuracy may result. WARNING! Personal Injury Hazard. Do not lever instruments. Applying leverage to instruments may cause the 7D Surgical Tracked Navigation Tools to deform, resulting in navigational inaccuracy. WARNING! Personal Injury Hazard. Do not bump or reposition the 7D Surgical Cranial Articulating Arm or the 7D Surgical Cranial Reference Frame after registration. Such movements may result in inaccurate navigation. If the 7D Surgical Cranial Articulating Arm or the 7D Surgical Cranial Reference Frame move in relation to the patient anatomy at any time after registration, repeat registration. WARNING! Personal Injury Hazard. Ensure that the 7D Surgical Cranial Reference Frame is rigidly attached and locked to the skull clamp. If the 7D Surgical Cranial Reference Frame moves in relation to the patient anatomy, navigational inaccuracy may result.

WARNING! Personal Injury Hazard. Do not place surgical drill chuck on the 7D Surgical FlashLock 1. Use the appropriate adapter if a power tool is to be used with 7D Surgical FlashLock 1.

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CAUTION! Do not place objects heavier than 10 lbs (4.5 kg) on top of the System Cart during a procedure.

CAUTION! Use care when handling system components of the 7D Surgical System. System components are fragile.

CAUTION! When not in use, ensure that the castors are locked to prevent the System Cart from moving.

CAUTION! Following detachment of the 7D Flex Rod connector, inspect the pedicle screw to ensure there is no movement from its original position.

STERILITY PRECAUTIONS WARNING! Personal Injury Hazard. The non-sterile System Head of the 7D Surgical System should not be moved into the sterile field. Failure to keep the System Head out of the sterile field could result in patient or user infection. WARNING! Personal Injury Hazard. Only properly sterilized surgical tools may come in contact with the patient. When properly sterilized, only the 7D Surgical Tracked Navigation Tools and the 7D Surgical Light Handle are sterile. The surgeon must not operate or touch any other parts of the 7D Surgical System during the procedure (for example, the Surgeon Monitor). Prior to use, clean the 7D Surgical Light Handle and 7D Surgical Tracked Navigation Tools as instructed in Cleaning and Sterilizing the System. Failure to do so could result in patient or user infection. WARNING! Personal Injury Hazard. Do not touch the sterile 7D Surgical Light Handle of the 7D Surgical System with a non-sterile hand. Position the System Head to avoid bumping the 7D Surgical Light Handle with your head. Failure to keep the 7D Surgical Light Handle sterile could result in patient or user infection. If any nonsterile materials or body parts come into contact with the 7D Surgical Light Handle, the contaminated 7D Surgical Light Handle must be replaced with a sterile 7D Surgical Light Handle. WARNING! Personal Injury Hazard. The non-sterile Surgeon Monitor of the 7D Surgical System should not be moved into the sterile field. Failure to keep the Surgeon Monitor out of the sterile field could result in patient or user infection. The keyboard and computer mouse are not intended to be sterilized.

WARNING! Personal Injury Hazard. Failure to sterilize or place a sterile cover over the 7D Surgical Cranial Articulating Arm could result in patient or user infection.

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WARNING! Personal Injury Hazard. Do not place a sterile bag or drape over the 7D Cranial Reference Frame. Covering the 7D Cranial Reference Frame may result in navigational inaccuracy. WARNING! Do not mix Medtronic StealthStation® Universal Drill Guide parts with 7D Surgical Instruments and components.

CAUTION! Do not open sterile-barrier packages or containers until surgical use. At time of use, inspect the barrier package for breach. If the sterile barrier was breached before surgical use, reprocess all devices contained in package.

CAUTION! Do not use reflective marker spheres if the sterile packaging has been damaged.

CAUTION! If the reflective surface of the reflective marker sphere becomes damaged or occluded with foreign matter, replace the sphere before use.

CLEANING AND STERILIZATION PRECAUTIONS CAUTION! Do not re-sterilize reflective marker spheres. Spheres must be discarded after each use. Re-sterilization may not be effective and may affect navigation accuracy of the 7D Surgical System and the 7D Surgical Tracked Navigation Tools. Discard of any 7D Surgical Steinmann Pins which were used in a previous procedure.

CAUTION! Always follow the manufacturer’s recommended dilution, application time, and temperature for surface cleaning detergents.

CAUTION! Do not use fumigation methods to disinfect the 7D Surgical System. Avoid using excessive amounts of cleaning solution or water while cleaning near electrical components.

CAUTION! Do not use solutions containing glutaraldehyde, phenol, iodine, or chloride ions. Do not use solutions containing bleach or alcohol which do not meet the limitations in Cleaning and Sterilizing the System. Using these cleaning solutions may damage the 7D Surgical System, resulting in tracking inaccuracy. Do not use paper products for cleaning optical windows or illuminators. Paper products may cause scratches on windows or the illuminator filters.

ELECTRICAL PRECAUTIONS

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WARNING! Electrical Shock Hazard. Do not bypass the grounding prong on the power cable using a three-prong to two-prong adapter. The 7D Surgical System must be properly grounded to ensure safe operation. Failure to do so presents an electrical shock hazard. WARNING! Electrical Shock Hazard. Do not immerse any part of the 7D Surgical System or allow fluid to enter the equipment. If fluids enter any part of the system, they may damage it and present an electrical shock hazard. WARNING! Electrical Shock Hazard. To reduce the risk of fire, connect only the 7D Surgical System to a circuit provided with 20 amperes maximum branch circuit over-current protection in accordance with the National Electric Code, ANSI/NFPA 70. WARNING! Electrical Shock Hazard. The UPS of the 7D Surgical System has its own internal energy source (battery). The output receptacles of the UPS may be live even when the UPS is not connected to an AC mains supply outlet. WARNING! Chemical Hazard, Environmental Hazard. Do not recharge or disassemble batteries. Some system components in the 7D Surgical System may contain batteries. Do not dispose of batteries in fire. Observe local regulations concerning disposal of batteries. WARNING! Personal Injury Hazard. Do not use the 7D Surgical System on battery power alone. The system is not intended to be operated on battery power during navigation. WARNING! Electrical Shock Hazard. Do not simultaneously touch the patient and the 7D Surgical System Input/Output Module, keyboard, computer mouse, monitors, or batteries to reduce the likelihood of electrical shock. WARNING! Electrical Shock Hazard. Do not connect the 7D Surgical System to a wired network while in the patient vicinity in order to avoid electric coupling to non-medical equipment. WARNING! Electrical Shock Hazard. All maintenance of the 7D Surgical System must be done by appropriately trained personnel. The system does not contain user-serviceable parts. Maintenance by untrained personnel may present an electrical shock hazard.

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VENTILATION PRECAUTIONS WARNING! Personal Injury Hazard. Do not obstruct the normal flow of air around the System Head of the 7D Surgical System (for example, draping or bagging any portion of the System Head). Doing so will affect the operational environment of the optical components, possibly beyond their recommended thresholds. Reliance on data provided by these components that is outside of recommended thresholds may lead to inaccurate conclusions and personal injury.

CAUTION! Do not place the 7D Surgical System near heat sources such as radiators or air ducts. Do not cover the ventilation holes on the System Cart. Overheating the system could result in inaccuracy of internal system components.

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ENVIRONMENTAL PRECAUTIONS WARNING Environmental Hazard. Do not dispose of 7D Surgical System components or subassemblies, including computer parts, as unsorted municipal waste. Follow local municipal waste ordinances for proper disposal provisions to reduce the environmental impact of WEEE (waste, electrical, and electronic equipment). To safely dispose of this equipment, contact 7D Surgical for complimentary equipment pick-up and recycling. WARNING! Personal Injury Hazard. Do not transport or store the 7D Surgical System outside the recommended storage temperature range, as this may cause the system to go out of calibration. Reliance on data provided by out of calibration optical components may lead to inaccurate conclusions and may cause personal injury. Refer to Environmental Requirements. WARNING! Hot Surface Hazard. The ambient temperature of the operating room in which the 7D Surgical System is used must remain between 15°C and 25°C. Failure to keep the ambient temperature within this range could cause the surface of the System Cart and System Head to become very hot. Touching the heated surface of these components could cause user burns. WARNING! Personal Injury Hazard. Do not use the 7D Surgical System in an MRI environment as this may cause damage to the system and may result in personal injury. WARNING! Personal Injury Hazard. Radio frequency communications equipment, including portable and mobile devices, may affect the 7D Surgical System and result in personal injury. WARNING! Personal Injury Hazard. 7D Surgical System is compliant to IEC 60601-12. Failure to meet the electromagnetic interference requirements of 60601-1-2 may corrupt system data. The physician needs to determine if tracking is accurate. Tracking in an untested environment or a location known to cause electromagnetic interference can contribute to inaccurate information and possible personal injury. WARNING! Personal Injury Hazard. Ensure that sources of background infrared (IR) light in the 800 nm to 1100 nm range (for example, sunlight, some operating room lights) are minimized. The Optical Tracking System of the 7D Surgical System is sensitive to IR light. Since the Optical Tracking System functions by detecting IR light reflected from, or emitted by, markers, other sources of IR light can interfere with the system and result in personal injury.

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CAUTION! The ambient temperature of the operating room in which the 7D Surgical System is used must remain between 15°C and 25°C. Failure to keep the ambient temperature within this range could result in inaccuracy of internal system components (for example, camera, projector, tracking system, laser positioning, etc.). If the ambient temperature exceeds the range, the system should not be used. Revert to standard of care.

CAUTION! Ensure that there are no large reflective surfaces within the field of view of the 7D Surgical System. Any reflective surfaces may be draped with non-reflective material to eliminate reflections.

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REGULATORY COMPLIANCE The 7D Surgical System complies with the following regulations. Applicable labels have been affixed to the system where appropriate. •

IEC 60601-1 o

•

•

IEC 60601-1-2 o

Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance

o

Collateral Standard: Electromagnetic disturbances - Requirements and tests

IEC 60601-2-41 o

•

Medical electrical equipment - Part 2-41: Particular requirements for the basic safety and essential performance of surgical luminaires and luminaires for diagnosis

IEC 60825-1:2007 o

•

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

Safety of laser products - Part 1: Equipment classification and requirements

RoHS Directive, 2011/65/EU (RoHS 2)

Note: The 7D Surgical System and the 7D Surgical Tracked Navigation Tools are not made with natural rubber latex. WARNING! Personal Injury Hazard. Be advised that the FDA has issued an alert on latex that should be reviewed and followed prior to using the system. (FDA Medical Alert on Latex: March 29, 1991, Allergic Reactions to Latex-Containing Medical Devices).

CAUTION! Portable and mobile RF communications equipment can affect medical electrical equipment, such as the 7D Surgical System.

CAUTION! The 7D Surgical System has been successfully tested against the requirements of IEC 60601-1-2. However, RF interference could hamper its operation or the operation of other nearby electrical devices. If either of these conditions is suspected, move the conflicting equipment farther apart, separate the equipment with an RF barrier, or discontinue use of the system.

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