StealthStation S7 Treatment Guidance System Manual Rev 14 April 2012

Rev.14 04/2012

Explanation Of Symbols On Package Labeling The following symbols may appear on system equipment, system packaging, or in this system manual. The device complies with European Directive MDD 93/42/EEC.

Classified by Underwriters Laboratories Inc. with respect to electric shock, fire, mechanical, and other specified hazards only in accordance with UL60601-1/CAN/CSA C22.2 NO.601.1, and IEC60601-1:1988 + A1:1999 + A2:1995. Control number 87HJ. Federal law (U.S.A.) restricts this device to sale by or on the order of a physician.

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When found in this reference guide, this symbol means: “Warning! Failure to observe could result in injury or death.” When found on equipment, this symbols means: “Attention: consult accompanying documentation.” Caution! Failure to observe could result in damaged equipment, forfeited time or effort, or the need to abort use of the system. For safe use, follow operating instructions.

Consult instructions for use.

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Type BF applied equipment, in compliance with IEC/UL60601-1.

Type B applied equipment, in compliance with IEC/UL60601-1.

F H U

Fragile contents

Keep upright

Keep dry

Power on. Connect to main power.

Power off. Disconnect from main power.

D

Power on for part of the system

Power off for part of the system.

f k _

Use by date specified

r

Sterilized by ethylene oxide

J

Non-sterile

Single use only. Do not reuse.

Quantity

Do not sterilize

Protective Earth (ground)

Equipotentiality: identifies the terminal that when connected together, bring the various parts of the equipment or system to the same potential, not necessarily being earth potential (for local bonding). Do not allow contact with patient. Temperature may exceed limits.

Localizer must not be used in ambient temperatures greater than 33°C (92°F).

Shipping temperature between -29°C and 60°C (-20°F and 140°F) Shipping pressure between 70kPa and 105kPa.

Do not disassemble

USB port

Network connection

Modem port

Serial port

Video In

S-Video In

VGA

L

Radio frequency device. Interference may occur in the vicinity of the device.

Do not transport the carts with monitors in an undocked position. Always dock monitors before moving the carts.

Do not transport the carts with camera in an undocked position. Always dock camera before moving the carts.

Do not transport the carts with drawers in an undocked position. Always dock monitors before moving the carts.

Transport the carts with AXIEM controller docked on its hanger.

No step

Do not push or lean on.

Battery disconnect switch

Remove storage bin to access battery disconnect switch.

Battery disconnect switch location

LASER radiation emitted from aperture. Do not stare into beam. Class 2 LASER product. Maximum output 1mW, wavelength 635nm, IEC60825-1 (2001), ANSIZ136 a (2000). Complies with 21CFR104010 and 104011 except for deviations pursuant to LASER notice no.50 dated July 26, 2001. Do not dispose of this product in the unsorted municipal waste stream. Dispose of this product according to local regulations. See http://recycling.medtronic.com for instructions on proper disposal of this product. China RoHS compliant. Environmental protection use period of 50 years. Environmental protection use period of 5 years.

Table of Contents

Table of Contents 1. Introduction Description of the StealthStation® S7® Treatment Guidance System 1-2 Content of This Manual 1-2 Related Documents 1-3 Conventions 1-3 Intended Use 1-4 Contraindications 1-4 Warnings and Precautions 1-5 Contact Information 1-8 2. System Overview How the System Works 2-2 Dynamic Referencing 2-2 Optical Localization System 2-3 Electromagnetic (AXIEM™) Localization System AXIEM™ System Controller 2-5 AXIEM™ Mobile Emitter 2-7 System Carts 2-8 Staff Cart 2-8 Surgeon Cart 2-12 Keyboard and Mouse 2-13 Optical Instruments 2-13 AXIEM™ System Instruments 2-14 Detachable Equipment/Applied Parts 2-14

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3. Cart Operation System Input/Output Panel 3-2 Network Connection Information 3-5 System Set Up 3-6 Separate the Carts 3-6 Connect and Start the System 3-6 System Shutdown 3-8 Exit the Software 3-8 StealthStation® S7™ System Manual

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Table of Contents Shut Down the System 3-8 Transport Position 3-8 4. System Specifications System Specifications 4-2 System Classifications 4-3 AXIEM™ System Controller Specifications and Classifications 4-4 System Electromagnetic Emissions and Immunity Declarations 4-5 Electromagnetic Emissions and Immunity Declarations 4-11 5. Troubleshooting Cart Separation 5-2 Opening the Staff Cart 5-2 Component Locations 5-4 Component Connections 5-6 System Computer 5-7 Device Connectivity Diagram 5-9 System Power 5-11 Power Switch 5-12 System Camera 5-13 AXIEM™ System Power LED Definitions and Issues Controller Status LED 5-14 Instrument Indicator LEDs 5-14 Surgeon Monitor 5-15 Mouse and Keyboard 5-16 Footswitch 5-16 Optical Instruments 5-16 Recommended Maintenance 5-17

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Introduction

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Description of the StealthStation® S7® Treatment Guidance System 1-2 Content of This Manual Related Documents Conventions

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Intended Use

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Contraindications

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Warnings and Precautions Contact Information

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StealthStation® S7™ System Manual

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Introduction StealthStation® S7® System

Description of the StealthStation® S7® Treatment Guidance System The StealthStation® S7® System is a hardware platform that enables real-time surgical navigation using radiological patient images. The application software reformats patient-specific CT or MR images acquired before surgery, or fluoroscopic images acquired during surgery, and displays them on-screen from a variety of perspectives (axial, sagittal, coronal, oblique). Prior to operating, the surgeon may then create, store, and simulate progression along one or more surgical trajectories. As an aid to visualization, the surgeon may also create and manipulate one or more 3D models of the anatomy. During surgery, the system tracks the position of specialized surgical instruments in or on the patient anatomy and continuously updates the instrument position on these images. If desired, the application software can also show how the actual position and path during surgery relate to the pre-surgical plan, and can help guide the surgeon along the planned trajectory. While the surgeon’s judgement remains the ultimate authority, real-time positional information obtained through the StealthStation® S7® System can serve to validate this judgement as well as guide.

Content of This Manual This system manual is intended as a reference document for biomedical engineers or other qualified personnel who require familiarity with and details about the StealthStation® S7® System. This manual is not a software usage manual. For complete instructions on using a specific software application, refer to the specific application’s instructions for use (procedure pocket guides).

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StealthStation® S7™ System Manual

Introduction Related Documents

Related Documents Consult application-specific pocket guides for software application instructions. Consult instrument-specific package inserts for instrument instructions. Consult the Medtronic Navigation Equipment Cleaning and Sterilization sheet (9730713) for equipment and instrument cleaning and sterilization instructions. Refer to manufacturer’s guides for information on peripheral devices.

Conventions This document employs the following conventions:

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Warnings are indicated by the symbol at left. Failure to observe a warning may result in physical injury to the patient or operator. Pay special attention to these items.

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Cautions are indicated by the symbol at left. Failure to observe a caution could result in damaged equipment, forfeited time or effort, or the need to abort use of the system.

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Procedures are preceded by diamond symbol at left.

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

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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 depress and release the left mouse button. Click, Select, and Highlight are used interchangeably.

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

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Double-click means click twice in rapid succession.

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Introduction StealthStation® S7® System

Intended Use Your Medtronic computer-assisted surgery system and its associated applications are intended as an aid for precisely locating anatomical structures in either open or percutaneous 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, a long bone, or vertebra, can be identified relative to a CT- or MR-based model, fluoroscopic 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.

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Introduction Warnings and Precautions

Warnings and Precautions w

Warnings: ■

Do not modify the StealthStation® S7® System.

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The system and its associated applications should be used only by qualified medical professionals who are thoroughly trained and experienced in performing surgery with Medtronic computer-assisted surgery systems.

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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 judgement.

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If system navigation seems inaccurate and recommended steps to restore accuracy are not successful, abort use of the system.

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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. 601-1-M90). Furthermore all configurations shall comply with the system standard IEC 60601-1-1 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 60601-1-1 or the system requirements of Clause 16 IEC 60601-1: 3rd Edition. If in doubt, contact technical support or your local Medtronic Navigation, Inc. representative.

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The system is not suitable for use in the presence of a flammable, anesthetic mixture with air or oxygen or nitrous oxide.

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Some system components may contain batteries. Do not recharge or disassemble batteries. Do not dispose of batteries in fire. Observe local regulations concerning battery disposal.

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Inspect all instruments before use. If visibly damaged, do not use the instrument.

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Inspect all system components before use. If visibly damaged, do not use the system.

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Discard before use any pre-sterilized component whose sterile packaging appears to be compromised.

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Introduction StealthStation® S7® System

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There is currently no effective sterilization method for components that are tainted with the infectious agent that causes Creutzfeld-Jakob Disease (CJD). Therefore, you must discard immediately after surgery any components that come into contact with biologic material from patients who carry or are suspected to carry this infectious agent. As a precaution, drape all non-disposable components that could otherwise come into contact with such material.

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

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The StealthStation® S7® System is not intended to be operated on battery power alone while instruments are connected to a patient.

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To reduce the potential of electrical shock, the operator should not simultaneously touch the patient and the system input/output panel, mouse, keyboard, or batteries.

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To avoid risk of electrical shock, the StealthStation® S7® System must only be connected to a supply mains with protective earth.

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The StealthStation® S7® System should not be connected to a wired network while in the patient vicinity to avoid electric coupling to non-medical equipment.

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Do not transport the carts in an undocked postion. Carts must be properly placed in the transport position and docked together before moving. To secure the system from unwanted lateral movement (for example, on an incline), lock all the castor wheels of the docked system.

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The StealthStation® S7® System Staff Cart contains a high fidelity 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 warnings prescribed by the user provided player. If these warnings are not available or understood, do not exceed a 50% volume output from the audio player.

StealthStation® S7™ System Manual

Introduction Warnings and Precautions

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Precautions: ■

Federal law (U.S.A.) restricts this device to sale by or on the order of a physician.

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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 technical support representative.

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Verify that all relevant instrumentation has been properly cleaned and sterilized before surgery. Clean and sterilize the components according to the parameters in the Equipment Cleaning and Sterilization sheet (9730713). Clean non-sterilizable equipment according to the parameters in the Non-Sterilizable Equipment Cleaning sheet (9733205).

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The 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 you suspect either of these conditions, move the conflicting equipment farther apart, separate the equipment with an RF barrier, or discontinue use of the system.

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Do not exceed the recommended electrical ratings for the system. Exceeding the ratings could damage the system.

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The system mouse is not designed for sterilization, and may be damaged if sterilization is attempted.

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System components are fragile. Use care when handling system components.

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Before moving the system cart(s), shut down and stow all components, remove any loose items from the top of the cart(s), and dock the carts together.

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Avoid dripping any fluids into any enclosure on the StealthStation® S7® 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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The Staff Cart storage drawer has a maximum load capacity of 3.8kg (8lb).

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Introduction StealthStation® S7® System

Contact Information Telephone (800) 595-9709 (technical support) (720) 890-3200 (general) (720) 890-3500 (fax)

Regular Mail Medtronic Navigation, Inc. 826 Coal Creek Circle Louisville, CO, U.S.A. 80027

Medtronic E.C. Authorized Representative Medtronic B.V. Earl Bakkenstraat 10 6422 PJ Heerlen NETHERLANDS Tel. 31 45 566 80 00

World Wide Web www.medtronicnavigation.com

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

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StealthStation® S7™ System Manual

System Overview

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How the System Works System Carts

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System Overview StealthStation® S7® System

How the System Works The StealthStation® S7® System helps the application software create a translation map between all points in the patient images and the corresponding points on the patient anatomy. After establishing this map, whenever the operator touches a point on the patient using a special tracked instrument or pointing device, the computer uses the map to identify the corresponding point on the images. This identification is called navigation or localization. A localized point is identified on the system display within multiple patient image planes and other anatomical renderings. The system can track instruments either optically or electromagnetically. Some systems may have both or only one of the tracking methods.

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Cautions: ■

The StealthStation® S7® System’s medical electrical equipment needs special precautions regarding electromagnetic classifications (EMC) and needs to be installed and put into service according to the EMC information included in Chapter 4.

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Portable and mobile RF communications equipment can affect medical electrical equipment, such as the StealthStation® S7® System.

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The use of accessories, transducers and cables other than those specified, with the exception of transducers and cables sold by Medtronic as replacement parts for internal components, may result in increased emissions or decreased immunity of the StealthStation® S7® System.

Dynamic Referencing To maintain accuracy, the system must continuously track the position of the anatomy during registration and navigation. This is necessary because you may accidentally or unavoidably move the anatomy or Localizer after patient registration or image acquisition. If the system did not track the position of the anatomy via the patient reference frame, any movement of the patient or localizer after registration or image acquisition would result in inaccurate navigation.

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StealthStation® S7™ System Manual

System Overview How the System Works The device that allows you to register and then track the anatomy is called a patient reference frame. The optical reference frame is a set of optical markers mounted on a metal frame. The AXIEM™ reference frame is a set of embedded sensing coils housed within a small plastic module. Reference frames are rigidly positioned with respect to the patient anatomy. 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 optical markers in the camera’s field of view. This enables the localizer to detect any movement of the anatomy and alert the application software, which updates the registration correlation and thereby maintains accurate navigation. Without dynamic referencing, any movement of the localizer after registration would invalidate the registration, since the positions of the optical markers would change in the navigation field. Dynamic referencing also gives you the flexibility to reposition the localizer at any time. Each application has its own unique reference frame. Consult the application’s instructions for use (procedure pocket guide) for more information.

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Warning: Because the position of the anatomy is defined by the position of the patient Reference Frame, it is important to ensure that the frame does not move with respect to the anatomy from the time of registration until navigation is complete. Slippage or rotation of the Reference Frame with respect to the anatomy after registration will result in inaccurate navigation.

Optical Localization System The optional optical system determines the position of the instrument and patient in the operating room by using a camera to track the positions of optical markers affixed to them. The camera’s field of view defines 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 which you connect to a support mechanism secured to the patient anatomy. There are two types of optical markers. Some components may have LED optical markers, and others may have sterile spheres. LEDs (Light Emitting Diodes) generate and emit infrared light. Sterile spheres reflect infrared light that is emitted by the camera.

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System Overview StealthStation® S7® System The camera (sometimes called the localizer) detects the optical markers, determines their spatial positions using the principle of triangulation, and continuously reports this information to the computer. The system continuously 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.

Camera

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Cautions: ■

Before use, clean the camera lenses using a camera lens cloth and lens cleaner. Do not apply any chemicals to the camera lenses.

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Allow the camera to warm up for two minutes after powering on the system.

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The optical system emits infrared light and can cause, or be susceptible to, infrared interference.

The system camera uses two lenses to geometrically triangulate the spatial coordinates of each optical marker on the instrument and Reference Frame. In the case of cabled devices (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 passive spheres on each device reflect light emitted by infrared illuminators on the camera back into the camera lenses. The camera continuously communicates the location of each LED or passive sphere to the system. In order to effectively “see” the LEDs or passive spheres, the camera must be aimed toward the devices and positioned at the proper distance from them.

Laser aperture

Camera lens

Laser on/off trigger button

Figure 2-1. System camera, aiming laser, and yoke assembly

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StealthStation® S7™ System Manual