Stealth-Midas MR8 System Manual Rev B March 2022

No part of this documentation may be reproduced in any form or by any means or used to make any derivative work (such as translation, transformation, or adaptation) without written permission from Medtronic Navigation, Inc. The information contained in this document is accurate at time of publication. Medtronic reserves the right to make changes to the product described in this manual without notice and without incorporating those changes to products already sold.

1.Introduction Intended use/indications for use 5 Contraindications 5 Side effects 5 Material composition 5 Description of the StealthStation™ system 5 System installation 6 Use profile 6 Conventions 6 Potential complications 7 Clinical benefits 7 Warnings and precautions 7 Warnings 7 Precautions 8 Content of this manual 9 Related documents 9 Contact information 9 Telephone 9 Mailing address 9 Medtronic E.C. authorized representative 10 Australia 10 World Wide Web 10 E-mail 10

2.System overview How the system works 11 Precautions 11 Dynamic referencing 11 Optical localization system 12 Camera 12 Electromagnetic localization system 14 Electromagnetic instrument interface 15 Electromagnetic emitters 16 System carts 21 Main cart 21 Camera cart 26 System configurations 28

3.Cart Operation System Input/Output panels 29 Main cart I/O panel connections 29 Camera cart I/O panel connections 33 System security 34 StealthStation™ S8 system security functionality 34 Best practices to maintain security of the StealthStation™ S8 system 34 What to do if you suspect the StealthStation™ S8 system has been compromised 34 Security for wireless communication 35 Network connection information 35 Wireless networks 35 Wired networks 36 Configuring user accounts and changing passwords 37

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System set up 39 Separating the carts 40 Positioning the main cart monitor 40 Connecting and starting the system 40 Connect either the optical or the EM hardware to the main cart 41 Launching the software 42 Setting up external video 42 System shutdown 45 Exiting the software 45 Shutting down the system 45 Cleaning the system 46 Transport position 46 Cord wrapping locations 47 Wrapping cords and closing all storage compartments 48 Docking the camera (optical system) 49 Docking the main cart monitor 50 Docking the camera cart monitor 50 Docking the carts 50 Transporting the carts 51 Storing the carts 52

4.System specifications System specifications 53 System classifications 54 System electromagnetic emissions and immunity declarations 55 Electromagnetic emissions and immunity declarations 59 Warnings and precautions 60

5.Troubleshooting Cart Separation 61 Difficulty docking or separating the main cart and the camera cart 61 Component connections 61 Running the self-test tool 61 System power 63 No power to system 63 Power switch 64 System camera 64 Camera motion is too tight or too loose 65 EM system LED definitions and issues 66 EM instrument interface status indicator LEDs 66 Instrument indicator LEDs 67 Main cart monitor 67 The monitor screen is blank 67 The display on the monitor is distorted 67 Main cart monitor motion is too tight or too loose 68 Camera cart monitor 69 Camera cart monitor motion is too tight or too loose 69 Mouse and keyboard 69 Footswitch 69 The system does not recognize the footswitch 69 Optical Instruments 70

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The system does not recognize the optical instruments 70 Recommended maintenance 70 Replacing the power cord 71 Removing and reattaching the back storage bin on the main cart 71 System disposal 71

6.Symbols Explanation of symbols on package labeling 73

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Introduction

Intended use/indications for use The StealthStation™ System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation™ System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, a long bone, or vertebra, can be identified relative to a CT or MR based model, or fluoroscopy images, or digitized landmarks of the anatomy.

Contraindications Medical conditions which contraindicate the use of a Medtronic computer-assisted surgery system and its associated applications include any medical conditions which may contraindicate the medical procedure itself.

Side effects The Medtronic computer-assisted surgery system and its associated applications are adjuvant surgical tools and do not independently produce any side effects. When used in conjunction with navigated instruments for surgical procedures, the associated side effects are the same as those for the procedure itself.

Material composition Material contained in product that can cause an allergic reaction: Nickel For additional materials of concern information such as REACH, CA Prop 65, or other product stewardship programs, go to www.medtronic.com/productstewardship.

Description of the StealthStation™ system The StealthStation™ System, also known as an Image Guided System (IGS), is comprised of a platform, clinical software, surgical instruments, and a referencing system (which includes patient and instrument trackers). The IGS tracks the position of instruments in relation to the surgical anatomy, known as localization, and then identifies this position on preoperative or intraoperative images of a patient. The StealthStation™ platform supports both optical and electromagnetic (EM) localization. Localization is also called navigation.

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Introduction System installation Localization is achieved when the system (hardware and software) creates a map between all points in the patient images and the corresponding points on the patient anatomy. After this map has been established, whenever the operator touches a point on the patient with a tracked instrument or pointing device, the computer uses the map to identify the corresponding point on the patient images. A localized point is identified on the system display with multiple patient image planes and possibly other anatomical renderings. The StealthStation™ platform is made up of one or more carts which contain the key navigation components including the localizers and the computer with the operating system.

System installation The StealthStation™ S8 system is installed by qualified Medtronic personnel only. If you have any questions about your system installation, contact Medtronic Navigation.

Use profile The intended user profile for the StealthStation™ system is operating room staff, including surgeons, nurses, surgical technologists, and hospital biomedical engineers. The intended patient population for the system is patients for whom stereotactic image guided surgery is appropriate.

Conventions This document employs the following conventions: •

Warnings are preceded by the word Warning. Failure to observe a warning may result in physical injury to the patient or operator. Pay special attention to these items.

•

Precautions are preceded by the word Caution. Failure to observe a precaution could result in damaged equipment, forfeited time or effort, or the need to abort use of the system.

•

References to buttons that appear on the system display are enclosed in square brackets. For example: Click [Edit...].

•

References to menu options that appear on the system display are printed in bold letters. For example: Choose Clear from the list.

•

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Instructions to click an object on the screen means to place the pointer over the object using the system mouse, and press and release the left mouse button. Instructions to tap an object on the screen means to tap the screen with a finger, a gloved finger, or a capacitive stylus. Click and tap are used interchangeably.

Introduction Potential complications

Potential complications Potential complications related to the use of a Medtronic computer-assisted surgery system and its associated applications are the same as the potential complications for the procedures in which the system is used. See the pocket guides for detailed lists of the potential complications associated with these procedures.

Clinical benefits Clinical benefits related to the use of a Medtronic computer-assisted surgery system and its associated applications are the same as the clinical benefits for the procedures in which the system is used. See the pocket guides for detailed lists of the clinical benefits associated with these procedures.

Warnings and precautions Warnings Warning: The system hardware and software should be used only by qualified medical professionals who are trained in performing surgery and familiar with image-guided surgery systems. Warning: If system navigation seems inaccurate and recommended steps to restore accuracy are not successful, abort use of the system. Warning: Inspect all visible system components before use including the localizers that accompany your system (that is, the camera, the EM instrument interface, the side-mount emitter, or the flat emitter). If visibly damaged, do not use the system. Warning: To avoid the risk of electrical shock, do not simultaneously touch the patient and the system input/output panel, mouse, keyboard, or batteries. Warning: To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth. Warning: Metallic and conductive objects in or near the electromagnetic navigation field can degrade navigational accuracy and the navigation volume. If metallic distortion causes excessive error, navigation may be disabled. To restore navigation, move metallic and conductive objects away from the navigation field. Warning: Electrical noise in or near the electromagnetic navigation field can degrade navigational accuracy. If electrical noise introduces excessive error, the system may automatically disable navigation. To restore navigation, move devices that produce electrical noise (such as electrocautery equipment and electric drills) away from the navigation field. Warning: Prevent fluid from entering any part of the StealthStation™ S8 system. Shut down the system, disconnect the power, and allow the system to dry if you suspect fluids may have entered any part of the system.

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Introduction Warnings and precautions Warning: Do not step on the base or legs of the system carts because the carts could tip over and cause injury. Warning: The system is not suitable for use in the presence of a flammable, anesthetic mixture with air, oxygen, or nitrous oxide. Warning: Do not modify the StealthStation™ S8 system without prior written consent from Medtronic Navigation, Inc. Prohibited modifications include but are not limited to: altering, repairing, or replacing system components; altering software provided by Medtronic; updating the operating system or drivers; and installing any software that is not provided by Medtronic, including antivirus software. Secure the system to prevent unauthorized modifications. Unauthorized modifications could render the system unsafe or ineffective for its intended use. Warning: Follow system component maintenance and care instructions. Warning: The StealthStation™ S8 system camera cart contains a stereo system for music playback from a user provided audio player. This system may be capable of sound levels which can lead to permanent hearing loss at high volume. The volume is controlled at the user-provided audio player. For hearing safety, follow all instructions and warnings prescribed by the manufacturer of the user-provided player.

Precautions Caution: Federal law (U.S.A.) restricts this device to sale by or on the order of a physician. Caution: The system and its associated applications contain no user-repairable parts. For repair or replacement of any part of the system or application, contact a Medtronic Navigation™ technical support representative. Caution: To avoid interrupting navigation, do not use the StealthStation™ S8 system on battery power alone while the system is in use with a patient. Caution: Periodically plug in the system to recharge the backup batteries. The backup batteries on the main cart and the camera cart are intended to keep the system operating for a short time if power is lost or disconnected. If the backup batteries are not charged, the system will shut down immediately when power is lost. The backup battery in the camera cart will recharge only when the two carts are connected with the cart-to-cart cable. Caution: Before surgery, clean the system carts and other non-sterilizable system components according to the parameters in the StealthStation™ S8 cleaning instructions (9735727). Caution: The system mouse and keyboard are not designed for sterilization and may be damaged if sterilization is attempted. Caution: System components are fragile. Use care when handling system components. Caution: Keep the rear storage bin clear of extraneous materials which could block air flow through the perforated panel. Blocking air flow could result in excessive internal cart temperatures, which could degrade the system’s performance and longevity. Caution: Avoid spilling fluids onto casters because fluid may impair the braking ability and the stability of the cart at rest on inclined surfaces.

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Introduction Content of this manual

Content of this manual This system manual is intended as a reference document for biomedical engineers or other qualified personnel who require familiarity with the StealthStation™ S8 system. This manual is not a software usage manual. For instructions on using specific software, refer to the instructions for use provided with the software.

Related documents For software instructions, refer to the specific software’s instructions for use. For components that interface with the StealthStation™ S8 system, such as instruments, patient reference frames, or intraoperative imaging systems, refer to the component’s instructions for use. For instrument cleaning and sterilization instructions, refer to the Medtronic Navigation™ Equipment Cleaning and Sterilization sheet (9730713) or refer to the instructions for use that accompany the instrument. For instructions on cleaning non-sterilizable items, consult the StealthStation™ S8 cleaning instructions (9735727). Refer to manufacturer’s guides for information on peripheral devices.

Contact information If a serious incident occurs in relation to the use of this Medtronic computer-assisted surgery system, report it to Medtronic Navigation. If a serious incident occurs in the European Union, also report it to the competent authority in the Member State where the incident occurred.

Telephone Technical support worldwide

+1 720 890 3160

Technical support in the USA

+1 800 595 9709

General

+1 720 890 3200

Fax

+1 720 890 3500

Mailing address Medtronic Navigation, Inc. 826 Coal Creek Circle Louisville, Colorado 80027 USA

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Introduction Contact information

Medtronic E.C. authorized representative Medtronic B.V. Earl Bakkenstraat 10 6422 PJ Heerlen The Netherlands Tel. +31 45 566 80 00

Australia Medtronic Australasia Pty Ltd 2 Alma Road Macquarie Park, NSW 2113 Australia Tel. 1800 668 670 (within Australia)

World Wide Web www.medtronic.com

E-mail E-mail product enhancement requests to: [email protected]

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System overview

How the system works The StealthStation™ S8 system, which is a combination of hardware and software, works in conjunction with special trackable instruments to help guide surgeons during surgical procedures. To achieve this guidance, the system tracks the position of a specialized instrument in relation to the surgical anatomy and transmits that information to the software. The software then displays the instrument’s position on diagnostic or intraoperative images of the patient. The system can track instruments either optically or electromagnetically. Some systems may have one or both of the tracking methods. With optical tracking, a camera (also called a localizer) detects infrared light from optical markers (either reflective spheres or LEDs) on the specialized instrument. The infrared light is either emitted by the camera and reflected off spheres on the instrument or emitted directly by LEDs on the instrument. The camera transmits the instrument’s location to the navigation software. Similarly, with electromagnetic tracking, an emitter and an instrument interface work together as a localizer. The emitter emits a low-energy magnetic field with unique characteristics at every point. The electromagnetic instruments contain sensors which allow the navigation software to identify the instrument’s location within the electromagnetic field. For the software to display the instrument’s location in relation to images of the patient, you must assist the software by creating a map between points on the patient and points in the images. This process is called registration. After registration is complete, whenever the operator touches a point on the patient using a special tracked instrument, the computer uses the map to identify the corresponding point on the images. This identification is called navigation. A navigated point is identified on the system display within multiple patient image planes and other anatomical renderings.

Precautions Caution: Portable and mobile RF (radio frequency) communications equipment can affect the StealthStation™ S8 system.

Dynamic referencing To maintain accuracy, the StealthStation™ S8 system uses dynamic referencing to constantly track the position of the anatomy during registration and navigation. Two devices are necessary for dynamic referencing: a patient reference frame and a localizer. The patient reference frame is rigidly positioned with respect to the anatomy. The localizer, which is either a camera for optical tracking or an emitter and instrument interface for electromagnetic tracking, locates the patient reference frame and reports the frame’s position to the navigation software.

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System overview How the system works Because the reference frame sits in a rigid, fixed position with respect to the anatomy, any movement of the anatomy or the localizer results in corresponding movement of the reference frame in the localizer’s field of view. This enables the localizer to detect any movement of the anatomy by detecting the position of the reference frame, which moves concurrently with anatomy. Then, the system can display the instrument or implant location relative to the patient reference frame, thereby maintaining accurate navigation. Without dynamic referencing, any movement of the localizer after registration would invalidate the registration because the position of the reference frame would change in the navigation field. Dynamic referencing allows the flexibility to reposition the localizer at any time. Each tracking method has its own unique reference frames. Optical reference frames feature a set of markers (reflective spheres or infrared LEDs) mounted on a frame. Electromagnetic reference frames include a set of embedded sensors housed within a small module. Consult the software’s instructions for use for more information.

Optical localization system The optical localization system determines the position of the instrument and patient in the operating room by using a camera (a type of localizer) to track the positions of optical markers. The camera’s field of view and the software determine the optical navigation field. In the case of instruments, the markers are attached directly to the instrument body. In the case of the patient, the markers are attached to a patient reference frame. The system user connects the patient reference frame to a support mechanism and secures that mechanism in a fixed position in relation to the patient anatomy. There are two types of optical markers. Some components may have infrared LED optical markers, and others may have reflective spheres. LEDs generate and emit infrared light. Reflective spheres reflect infrared light that is emitted by the camera. The camera detects the optical markers, determines their spatial positions using the principle of triangulation, and constantly reports this information to the computer. The system constantly recomputes the relative spatial positions and orientations of the patient reference frame and instrument in the navigation field, and relates this information to the patient registration data in order to identify the location of the instrument on the operative images and on optional 3D renderings.

Camera Warning: The optical system emits (and receives) infrared light and can cause, or be susceptible to, infrared interference. Caution: Before use, clean the camera lenses according to the StealthStation™ S8 cleaning instructions (9735727). Dirty camera lenses could impair optimal performance of the camera. Caution: Allow the camera to warm up for 3 minutes after powering on the system because the camera will not track instruments or the patient reference frame until it has warmed up.

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System overview How the system works The standard infrared camera uses two lenses to geometrically triangulate the spatial coordinates of each optical marker on the instrument and the reference frame. In the case of devices with LEDs (such as the active registration probe), the camera lenses receive infrared light signals directly from the LEDs on each device. In the case of passive (wireless) devices, the reflective spheres on each device reflect light emitted by infrared illuminators on the camera back into the camera lenses. The camera constantly communicates the location of each LED or reflective sphere to the system. In order to effectively localize the LEDs or reflective spheres, the camera must be aimed toward the devices (see Figure 2) and positioned at the proper distance from them, which varies between 1.0 m and 2.4 m (3.3 ft and 7.9 ft) and 1.0 m and 3.0 m (3.3 ft and 9.8 ft) depending on the software application. Figure 1: Camera, lift arm assembly, and camera handle

1 2 status indicator LEDs

3 Laser aperture

2 Camera lenses

4 Laser on/off trigger button

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System overview How the system works Figure 2: Camera volume

1 Standard volume

2 Extended volume, which is available with some software applications

Laser aiming system Warning: The laser aiming system is a Class 2 laser that transmits laser radiation. Use caution when operating the device, and never allow the laser beam to enter someone’s eye. Laser radiation, even at low levels, can damage the eyes. The laser aiming system (located between the camera lenses, see Figure 1) helps to aim the camera by projecting a low-power laser beam approximately in the center of the camera’s field of view. The laser is activated by a trigger button in the handle. Press the on/off trigger button to activate the laser and release the button to deactivate the laser.

Electromagnetic localization system The electromagnetic (EM) localization system tracks instruments and anatomy simultaneously. An EM emitter is placed near the surgical field, and it generates a low-energy magnetic field, called the navigation field, that encompasses the anatomy of interest. Because every location in the navigation field has unique characteristics, the system can determine the position of a tracked device by measuring the field characteristics at that location. Sensors embedded in the patient reference frame, which is attached to the patient’s fixed anatomy, enable the system to identify the location of the anatomy of interest in the EM field. Similarly, sensors embedded in the pointer probe or other instrument enable the system to identify the instrument’s position and, for some instruments, the trajectory in the field. The system constantly re-computes the relative spatial positions of the patient reference frame and instrument in the navigation field, and relates this information to the patient registration data in order to identify the location of the instrument on the operative images.

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System overview How the system works

Electromagnetic instrument interface The main cart houses the electromagnetic localization system components including the EM instrument interface and the emitter. These EM components connect directly to the main cart. The main cart includes a computer, monitor, and all related peripheral devices. The main cart is a platform from which the surgeon or qualified assistant can control the navigation software. Figure 3: EM instrument interface

1 EM instrument interface status indicator LEDs 2 Instrument indicator LED (6 total) 3 Instrument port (6 total) Connect the patient reference and EM instruments to the instrument ports on the EM instrument interface. The instrument indicator’s LED glows green when the instrument is properly connected and functioning normally. For more information about the status indicator colors, see “EM instrument interface status indicator LEDs” on page 66 or “Instrument indicator LEDs” on page 67.

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System overview How the system works

Electromagnetic emitters The StealthStation™ S8 system supports the use of 2 emitter designs: the side-mount emitter and the flat emitter. You can use only 1 emitter with the system at any given time. Connect the emitter to the EM emitter port on the main cart localization I/O panel (see “Main cart I/O panel connections” on page 29). Warning: Do not use the side-mount emitter or the flat emitter in ambient (room) temperatures greater than 30°C (86°F). Exceeding this temperature limit could result in navigational inaccuracy or patient or user harm from excessive temperatures. Warning: Do not place the side-mount emitter in contact with the patient because the emitter temperature may reach 48°C (118°F). Warning: Do not exceed the maximum weight load of 6.5 kg (14 lbs) on the flat emitter. Warning: The side-mount emitter, the flat emitter, and the arm assembly that supports the sidemount emitter are not intended for sterile patient contact or interaction. If you place these items in the sterile field, bag or drape them. Warning: If the flat emitter is left in the storage bin during system use, it can reach 56°C (133°F). In this condition, allow the flat emitter to cool for five minutes outside of the storage bin before patient contact. Caution: For procedures performed with the flat emitter, a surgical table with a radiolucent table top is recommended. If the surgical table has a metal frame or metal side rails, position the flat emitter at least 5 cm (2 in) away from the metal. Positioning the emitter closer may result in reduced navigational accuracy and volume. Caution: If the surgical table to be used with the side-mount emitter has a metal frame or metal side rails, position the side-mount emitter at least 25 cm (10 in) away from the metal. Positioning the emitter closer may result in reduced navigational accuracy and volume. Caution: Procedures performed with the side-mount emitter require a surgical bed featuring side rails because the arm assembly that supports the emitter connects to the side rails.

Side-mount emitter navigation field The side-mount emitter produces a low-energy magnetic field that encompasses the emitter. Minimize the amount of metal placed in this field. The navigation field, the portion of the magnetic field that is appropriate for navigation, begins 8 cm (3 in) from the emitter face and has a cubical volume of approximately 31.0 cm x 46.0 cm x 46.0 cm (12.2 in x 18.1 in x 18.1 in) (length x width x height). For best results, place the patient in the center of the navigation field. The side-mount emitter may be placed in a holder which is mounted to the operating table or to the main cart. For additional information about setting up the emitter, refer to the emitter setup quick reference guide (9735730).

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System overview How the system works Figure 4: Side-mount emitter

Figure 5: Side-mount emitter magnetic and navigation fields

Low-energy magnetic field: Minimize the amount of metal in this field. Metal objects

1 such as instrument stands, equipment carts, surgical lights, and viewing screens in this area will reduce the navigation field size.

2 Side-mount emitter 3 Navigation field Figure 6: Side-mount emitter navigation field

Note: This navigation field size is based on testing with a fluoroscopically radiolucent surgical table with non-magnetic metal rails 3 cm to 6 cm tall by 1 cm to 3 cm wide (1.2 in to 2.4 in tall by 0.4 in to 1.2 in wide) and a 25 cm (10 in) separation between the metal rails and the side-mount emitter.

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System overview How the system works

Flat emitter navigation field The flat emitter produces a low-energy magnetic field that encompasses the emitter. Minimize the amount of metal placed in this field. The navigation field, the portion of the magnetic field that is appropriate for navigation, begins 5 cm (2 in) from the emitter face and extends approximately 40.0 cm x 40.0 cm x 37.5 cm (15.7 in x 15.7 in x 14.8 in) (length x width x height). The flat emitter is intended to be placed on the operating table under the patient’s head. For best results, place the patient in the bottom center of the navigation field. Before use, drape the flat emitter. For additional information about setting up and draping the flat emitter, refer to the emitter setup quick reference guide (9735730). Figure 7: Flat emitter

Figure 8: Flat emitter magnetic and navigation fields

Low-energy magnetic field: Minimize the amount of metal in this field. Metal objects such as

1 instrument stands, equipment carts, surgical lights, and viewing screens in this area will reduce the navigation field size.

2 Flat emitter 3 Navigation field

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System overview How the system works Figure 9: Flat emitter navigation field

Note: This navigation field size is based on testing with a fluoroscopically radiolucent surgical table with non-magnetic metal rails 3 cm to 6 cm tall by 1 cm to 3 cm wide (1.2 in to 2.4 in tall by 0.4 in to 1.2 in wide) and a 5 cm (2 in) separation between the metal rails and the flat emitter.

Applicable standards for EM fields Based on the available standards and international guidelines, the StealthStation™ electromagnetic system is considered safe for use in surgical environments. The electromagnetic system has been successfully tested against the requirements of IEC 60601-1 General Requirements for Basic Safety and Essential Performance, and the associated Part 2 Collateral Standard, Electromagnetic Compatibility. Guidelines for exposure to electromagnetic fields are not addressed as part of the above certifications, and no single definitive source exists for demonstration of safety. The StealthStation™ electromagnetic system is in compliance with the recommended guidelines for EMF exposure as outlined by a number of U.S. and international bodies. The system complies with occupational exposure basic restrictions recommended by the Institute of Electrical and Electronics Engineers (IEEE), as formally recognized by the American National Standards Institute (ANSI) in the Standard for Safety Levels with Respect to Human Exposure to Radio Frequency Electromagnetic Fields, 3 kHz to 300 GHz. This system also complies with occupational exposure basic restrictions recommended by the International Commission on NonIonizing Radiation Protection (ICNIRP), as formally recognized by the World Health Organization (WHO), in the Guidelines for Limiting Exposure to Time-Varying Electric and Magnetic Fields (1 Hz –100 kHz). For occupational exposure, electromagnetic field exposures outside the surface of the side-mount emitter and the flat emitter are below the basic restrictions. Table 1 outlines the radio frequency wireless operating parameters for the side-mount emitter and the flat emitter.

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