StealthStation FlexENT Navigation System Manual rev A

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 3 Contraindications 3 Side effects 3 Material composition 3 Description of the StealthStation FlexENT™ system Use profile 4 Conventions 4 Potential complications 5 Clinical benefits 5 Warnings and precautions 6 Warnings 6 Precautions 8 Content of this manual 8 Related documents 8 Contact information 8 Telephone 9 Mailing address 9 Medtronic E.C. authorized representative 9 Australia 9 World Wide Web 9 E-mail 9

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2.System overview How the system works 11 Dynamic referencing 11 StealthStation FlexENT™ system components Electromagnetic localization system 12 Computer 18 Keyboard and mouse 19 EM instruments 19 System configurations 19 Desktop configuration 20 Cart configuration 20 Detachable equipment/applied parts 22

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3.Operation System components 25 Computer 25 Electromagnetic (EM) instrument interface 28 Cybersecurity 29 StealthStation FlexENT™ system security functionality 29 Best practices for customers to maintain security of the StealthStation FlexENT™ system 30 Security design details 31 Configuring user accounts and changing passwords 36 Configuring anti-virus scan settings 36 What to do if you suspect the StealthStation FlexENT™ system has been compromised 37 Network connection information 38 Connecting to a wired network 38 System setup 39 Attaching the desk stand to the computer 40

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Attaching cables to the computer 41 Connecting a video camera 41 Setting up the side-mount emitter 42 Setting up the flat emitter 50 Setting up the EM instrument interface 51 Draping the emitters 52 Setting up and starting the system 53 Refining emitter position 53 Setting up external video 54 Overview of setting up external video 54 Supported external video display resolutions 54 External video port setup 54 Connecting to the external display device 55 System shutdown 57 Exiting the software 57 Powering down the computer 57 Restarting the system after a power failure 58 Disassembling and storing the floor stand 58 Preparing the cart for transport 59 Transporting the cart 60 Cleaning the system 60

4.System specifications System specifications 61 System classifications 62 System electromagnetic emissions and immunity declarations 63 Electromagnetic emissions and immunity declarations 68 Warnings and precautions 68

5.Troubleshooting and Maintenance Troubleshooting 69 Running the self-test tool 69 Computer 70 EM instrument interface 72 Mouse and keyboard 73 Footswitch (optional) 73 Additional Troubleshooting Information 73 Recommended maintenance 74 Replacing the external power cord 74 Electrical safety tests 75 Performing electrical safety tests 75 System disposal 76

6.Symbols Explanation of symbols on package labeling

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Introduction

Intended use/indications for use The Medtronic StealthStation FlexENT™ computer-assisted surgery system and its associated applications are intended as an aid for precisely locating anatomical structures in either open or percutaneous ENT procedures. Their use 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, can be identified relative to images of the anatomy.

Contraindications None

Side effects The Medtronic computer-assisted surgery system and its associated applications are auxiliary 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 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 FlexENT™ system The StealthStation FlexENT™ system, also known as an Image Guided System (IGS), comprises 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. Localization is also called navigation. 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.

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Introduction Use profile

Use profile The intended user profile for the StealthStation FlexENT™ system is ENT office and 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.

•

Right-click means click with the right mouse button instead of the left button.

•

Double-click means click the left mouse button twice in rapid succession.

Introduction Potential complications

Potential complications The potential complications for StealthStation FlexENT™ Navigation System Cranial Resection and FESS Procedures identified by Medtronic include, but are not limited to: General surgical complications, pain, edema, insufficient treatment, infection, burn, tissue or bone damage, hearing loss, vision impairment, extracranial or intracranial bleeding, electric shock, cerebrospinal fluid leak or fistula, nervous system injury, brain or nerve damage, hydrocephalus, permanent or transient neurological deficit, paralysis, ischemic stroke (cerebral infarction), seizure, death.

Clinical benefits The StealthStation FlexENT™ system comprises a platform, clinical software, surgical instruments, and a referencing system. The system tracks the position of instruments in relation to the surgical anatomy and then identifies this position on preoperative or intraoperative images of a patient. The StealthStation™ ENT software helps guide surgeons during ENT procedures such as Endoscopic Skull Base, Lateral Skull Base, and Functional Endoscopic Sinus Surgery (FESS). Navigated procedures performed using the StealthStation FlexENT™ system with StealthStation™ ENT software potentially confer the following clinical benefits: •

Meta-analyses on commercial image-guided navigation systems suggest a reduction in major complications during endoscopic sinus surgery compared with non-image guided procedures.

•

Image-guided navigation systems used in endoscopic sinus surgery have shown a reduction in the need for revision surgeries.

•

Navigation improves visualization, enabling surgeons to work within complex sinus anatomy and optimize surgical strategies for their patients.

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Introduction Warnings and precautions

Warnings and precautions Warnings Warning: Do not modify the StealthStation FlexENT™ system without prior written consent from Medtronic Navigation, Inc. Prohibited modifications include but are not limited to: altering or repairing 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: The system and its associated applications should be used only by qualified medical professionals who are trained on, and familiar with the proper operation of, Medtronic Navigation computer-assisted surgery systems. Warning: The system and its associated applications should be used only as an adjunct for surgical guidance. They are not a replacement for the surgeon's knowledge, expertise, or judgment. Warning: If system navigation seems inaccurate and recommended steps to restore accuracy are not successful, abort use of the system. Warning: To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth. Warning: To avoid risk of electrical shock, do not touch the StealthStation FlexENT™ system Input/Output (I/O) panel and the patient at the same time. Warning: For electrical safety reasons, disconnect any local area network (LAN) cables from the StealthStation FlexENT™ system before using the system on a patient. Warning: Accessory equipment connected to the analog and digital interfaces of the Medtronic Navigation computer-assisted surgery system must be certified according to the applicable IEC standards (e.g., IEC 60601-1 for medical equipment, UL60601-1, and CSA C22.2 No. 601-1M90). Furthermore all configurations shall comply with the system standard IEC 60601-1 or the system requirements of Clause 16 IEC 60601-1: 3rd Edition. Any person who connects additional equipment to the signal input part or signal output part configures a medical system, and is therefore responsible for ensuring that the system complies with the requirements of the system standard IEC 60601-1 or the system requirements of Clause 16 IEC 60601-1: 3rd Edition. If in doubt, contact technical support or your local Medtronic Navigation™ representative. Warning: The system is not suitable for use in the presence of a flammable, anesthetic mixture with air, oxygen, or nitrous oxide. Position the system at least 25 cm (10 in.) from any source of flammable gas. Warning: The cart’s power strip is intended for medical equipment certified to IEC 60601-1:3rd edition. Plug non-medical equipment into the wall outlet. Warning: Do not connect the StealthStation FlexENT™ cart power cord to a multi-socket power strip or extension cord. Warning: Before surgery, verify that the system cart and other non-sterilizable system components have been cleaned according to the parameters in the StealthStation FlexENT™ cleaning instructions (9736193).

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Introduction Warnings and precautions Warning: Inspect all visible system components before use including the localizers that accompany your system (that is, the EM instrument interface, the side-mount emitter, or the flat emitter). If visibly damaged, do not use the system. Warning: Inspect all platform components of the system before use. If visibly damaged, do not use the system. 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 FlexENT™ 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. Warning: Do not step on the base, legs, or shelves of the system cart because the cart could tip over and cause injury. Warning: Follow system component maintenance and care instructions. Warning: Use of the system may interfere with implantable device communication. Do not use the system while programming or interrogating any implantable device. Warning: Use of the system may interfere with patient monitoring equipment. Position the StealthStation FlexENT™ system, the side-mount emitter, and the flat emitter as far as possible from any such equipment, and use interference filtering if possible. If you continue to experience interference, abort use of the system and call technical support. Warning: Use caution when extending or collapsing the floor stand as possible hand injury may occur. Warning: The side-mount emitter, the flat emitter, the articulating arm, the emitter support bracket, and the floor stand are not intended for sterile patient contact or interaction. If you place these items in the sterile field, bag or drape them. Warning: Position the StealthStation FlexENT™ computer such that the mains outlet plugs are accessible during use. Equipment can be isolated from mains by removing outlet plugs from mains source. Warning: The drawer at the bottom of the StealthStation FlexENT™ cart should be opened only by Medtronic-authorized personnel. Warning: Only Medtronic-authorized personnel should plug equipment into the multi-socket power strip in the drawer at the bottom of the StealthStation FlexENT™ cart. Warning: Avoid draping, covering, or blocking air flow into the computer air inlets. Warning: Discharge static electricity prior to touching StealthStation FlexENT™ equipment.

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Introduction Content of this manual

Precautions Caution: Federal law (U.S.A.) restricts this device to sale by or on the order of a physician. Caution: The system does not contain an uninterruptible power supply (UPS). The system must remain connected to an external source of power. Failure to maintain power may result in damage to computer components and lead to data corruption. Caution: Do not exceed the recommended electrical ratings for the system. Exceeding the ratings could damage the system. Caution: System components, including the side-mount emitter, are fragile. Use care when handling system components. Caution: Do not drop or mishandle the system components in such a manner as to cause physical damage to the components. This may impair device function. Even if the component works immediately after being dropped, operational damage may have occurred that may not be observed until some future time. Caution: The system computer, side-mount emitter, articulating arm, mouse, and keyboard are not designed for sterilization and may be damaged if sterilization is attempted. Caution: Do not leave equipment on the floor stand with its legs partially deployed. It is possible for the floor stand to tip over. Caution: Avoid spilling fluids onto casters because fluid may impair the braking ability and the stability of the cart at rest on inclined surfaces.

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

Related documents For software instructions, refer to the software’s instructions for use. For accessory-specific instructions, refer to the instructions for use provided with the accessory. For instrument cleaning and sterilization instructions, refer to the instructions for use that accompany the instrument. For instructions on cleaning reusable, non-sterilizable items, consult the StealthStation FlexENT™ cleaning instructions (9736193). 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.

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Introduction Contact information

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

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 www.manuals.medtronic.com

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

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Introduction Contact information

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System overview

How the system works The StealthStation FlexENT™ 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 electromagnetically tracks instruments. 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.

Dynamic referencing To maintain accuracy, the StealthStation FlexENT™ 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 electromagnetic localizer, an emitter and instrument interface, locates the patient reference frame and reports the frame’s position to the navigation software. 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. Electromagnetic reference frames include a set of embedded sensors housed within a small module. Consult the software’s instructions for use for more information.

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System overview StealthStation FlexENT™ system components

StealthStation FlexENT™ system components 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.

Electromagnetic instrument interface The patient reference and instruments used in the procedure are connected to the electromagnetic (EM) instrument interface. The electromagnetic instrument interface is mounted to the floor stand or cart during the procedure. Figure 1: EM instrument interface

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System overview StealthStation FlexENT™ system components

Electromagnetic emitters The StealthStation FlexENT™ system supports the use of two emitter designs: the side-mount emitter and the flat emitter. You can use only one emitter with the system at any given time. Connect the emitter to the EM emitter port on the StealthStation FlexENT™ computer. 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, the articulating arm, and the emitter support bracket are not intended for sterile patient contact or interaction. If you place these items in the sterile field, bag or drape them. 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 connected to the surgical table require a surgical table 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 on an articulating arm which is mounted to the floor stand, operating table, or cart. For additional information about setting up the emitter, refer to the “Setting up the side-mount emitter” section on page 42.

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System overview StealthStation FlexENT™ system components Figure 2: Side-mount emitter

Figure 3: 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 4: 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 25.4 cm (10 in) separation between the metal rails and the side-mount emitter.

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System overview StealthStation FlexENT™ system components

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 “Draping the flat emitter” section on page 52.

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System overview StealthStation FlexENT™ system components Figure 5: Flat emitter

Figure 6: 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 Figure 7: 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.

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System overview StealthStation FlexENT™ system components

Applicable standards for EM fields Based on the available standards and international guidelines, the StealthStation FlexENT™ 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 FlexENT™ 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 Non-Ionizing 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. Caution: The field strength directly at the face of the Mobile Emitter, outside of the navigation region, may exceed limits for occupational exposure according to the ICNIRP and for the General Public per ANSI/IEEE. Limit the duration of operator and patient contact with the stronger magnetic fields at the face. Specifically, do not allow the Mobile Emitter to directly contact the patient for the duration of a procedure. Table 1 outlines the operating parameters for the side-mount emitter and the flat emitter. Table 1: Operating parameters for the side-mount emitter and the flat emitter Side-mount emitter

Flat emitter

Transmit frequency

3 kHz to 30 kHz Very Low Frequency (VLF) Band

3 kHz to 30 kHz Very Low Frequency (VLF) Band

Power

<30 W This product operates in the VLF band with an RF output power of less than 0.1 mW e.r.p.

<30 W This product operates in the VLF band with an RF output power of less than 0.1 mW e.r.p.

Field strength

<2.10 x (f / 3350) V/m where f is the <2.10 x (f / 3350) V/m where f is the frequency in Hz from 3 kHz to 5 MHz frequency in Hz from 3 kHz to 5 MHz as as set by IEEE Standard C95.1 – 2005 set by IEEE Standard C95.1 – 2005

Volume

The side-mount emitter produces a low-energy magnetic field volume of approximately 31 cm x 46 cm x 46 cm, in front of the emitter face, and with its near side offset 8.0 cm from the face.

The flat emitter produces a low-energy magnetic field volume of approximately 40.0 cm x 40.0 cm x 37.5 cm, in front of the emitter face, and with its near side offset 5.0 cm from the face.

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System overview StealthStation FlexENT™ system components

Surgical tables and emitter selection Refer to the following table for information about using the flat emitter or side-mount emitter with different types of surgical tables. Before surgery, try the emitter setup with the surgical table to be used, and make sure that the software can track the instrument and the patient reference frame throughout the range of locations required for registration and navigation. Refer to “Refining emitter position” on page 53 for more information.

Type of surgical table

Recommended emitter

1

Fully radiolucent

Flat emitter or side-mount emitter

Fully radiolucent tables do not have any metal around the patient head and torso. Using a fully radiolucent surgical table instead of a fluoroscopically radiolucent table will significantly extend the navigation field above the flat emitter and will slightly extend the navigation field in front of the side-mount emitter.

Flat emitter or side-mount emitter

Fluoroscopically radiolucent tables do not have any metal directly under the patient head and torso. When using the flat emitter, a separation greater than 5 cm (2 in) between the emitter and the metal rails on the table will significantly extend the navigation volume above the flat emitter. When using the side-mount emitter, a separation greater than 25 cm (10 in) between the emitter and the metal rails on the table will slightly extend the navigation volume in front of the side-mount emitter.

2

Fluoroscopically radiolucent

3

Non-radiolucent

Details

Non-radiolucent tables and ENT chairs have variable outcomes with EM navigation. The flat emitter is not Side-mount emitter recommended for use with non-radiolucent tables and ENT (variable outcomes) chairs. Use of the side-mount emitter may be possible. Position the side-mount emitter away from metal in the surgical tables and chairs for best results.

Computer The StealthStation FlexENT™ computer is a high-resolution, flat panel computer display with ports to accommodate connection to other system devices. The computer mounts on a desk stand and sits on a desktop or mounts to the StealthStation FlexENT™ cart and can be adjusted to a variety of positions to accommodate various operating room or office configurations and user needs. The capacitive touchscreen interface can be controlled by a finger, gloved finger, or capacitive stylus. Computer characteristics: 18