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Brainlab EXACTRAC INFRARED MONITORING Clinical User Manual

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EXACTRAC
INFRARED
MONITORING®
Version 1.0
Clinical User Guide
Revision 1.1
Copyright 2011, Brainlab AG Germany. All rights reserved.

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Summary of Contents for Brainlab EXACTRAC INFRARED MONITORING

  • Page 1 EXACTRAC INFRARED MONITORING® Version 1.0 Clinical User Guide Revision 1.1 Copyright 2011, Brainlab AG Germany. All rights reserved.

  • Page 3: Table Of Contents

    ..............12 Brainlab Medical Instruments .
  • Page 4 TABLE OF CONTENTS ..............23 IR System Components .
  • Page 5 TABLE OF CONTENTS PATIENT MONITORING ............57 .
  • Page 6 TABLE OF CONTENTS ........... . 90 Testing the Earth Leakage Current Breaker .

  • Page 7: General Information

    GENERAL INFORMATION Chapter Overview 1.1.1 Contents Topics Covered Section Contact Data and Legal Information Page 8 Symbols Page 10 Intended Use Page 11 Compatibility with Medical Devices Page 12 Training and Documentation Page 16 Clinical User Guide Rev. 1.1, ExacTrac Infrared Monitoring Ver. 1.0...

  • Page 8: Contact Data And Legal Information

    France and Tel: +33-800-67-60-30 support_fr@brainlab.com French-speaking regions Feedback Despite careful review, this manual may contain errors. Please contact us at igs.manuals@Brainlab.com if you have suggestions as to how we can improve this manual. Manufacturer Brainlab AG Kapellenstr. 12 85622 Feldkirchen Germany Clinical User Guide Rev.

  • Page 9: Legal Information

    (see “LICENSING INFORMATION” on page 103). CE Label • The CE label shows that the Brainlab product complies with the essential re- quirements of Medical Device Directive (MDD). • According to the MDD (Council Directive 93/42/EEC), ExacTrac is a Class IIb product.

  • Page 10: Symbols

    Symbols 1.3.1 Symbols Used in This Guide Warnings Warnings are indicated by triangular warning symbols. They contain safety-critical in- formation regarding possible injury, death or other serious consequences associated with equipment misuse. Cautions Cautions are indicated by circular caution symbols. They contain safety-critical infor- mation regarding possible problems with the device.

  • Page 11: Intended Use

    Intended Use 1.4.1 Using the System Indications for Use This submission describes a system that is intended to be used to place patients at the isocenter of a linear accelerator for stereotactic radiosurgery or radiotherapy procedures. The ExacTrac system uses optical tracking of infrared reflecting markers as the method of locating the position of the pa- tient.

  • Page 12: Compatibility With Medical Devices

    Instruments port if you have any questions regarding instrument compatibility with Brainlab software. Only devices and spare parts specified by Brainlab may be used with ExacTrac Infra- red Monitoring. Using unauthorized devices/spare parts may adversely affect the safe- ty and/or the effectiveness of ExacTrac Infrared Monitoring and endanger the safety of the patient, user and/or environment.

  • Page 13: Brainlab Medical Software

    Only authorized Brainlab employees may install software on the Brainlab system. Do not install or remove any software applications. Other Brainlab If you are running software versions other than those specified above, contact Brainlab support for Software clarification regarding compatibility with Brainlab devices.

  • Page 14: Non-Brainlab Medical Devices

    Only Brainlab support is authorized to modify the hardware configuration of the Exac- Trac workstation. Unauthorized modifications may adversely affect system operation. Clinical User Guide Rev. 1.1, ExacTrac Infrared Monitoring Ver. 1.0...

  • Page 15: Non-Brainlab Software

    Only authorized Brainlab employees may install software on Brainlab systems. The user may not install or remove any software applications. Only Brainlab support is authorized to modify the software configuration of the work- station. Unauthorized modifications may adversely affect system operation. If a virus scanner is installed, it must be configured to not run in the background while Exac- Trac Infrared Monitoring is in operation.

  • Page 16: Training And Documentation

    • Simulate a sufficient number of complete procedures on sawbones and/or cadavers. • Use the system in operations where computer-aided navigation may be desirable but not essential. A Brainlab representative must be present at such operations to provide guidance where necessary.

  • Page 17: Documentation

    Documentation Intended Audience • This guide provides an introduction and reference for the effective and correct use of Brainlab’s ExacTrac system. • This guide is written for all members of the clinical team who use or handle the ExacTrac sys- tem or parts of it.

  • Page 18: Data Protection

    Data Protection 1.7.1 Confidentiality and Protection Against Unauthorized Access Regional In the ExacTrac Infrared Monitoring software, patient data is identified by the patient’s name and Legislation a unique ID. For this reason, it must be handled in accordance with the relevant confidentiality leg- islation and protected against unauthorized access.

  • Page 19: About Exactrac Ir Monitoring

    ABOUT EXACTRAC IR MONITORING Chapter Overview 2.1.1 Contents Topics Covered Section What is ExacTrac IR Monitoring? Page 20 Clinical User Guide Rev. 1.1, ExacTrac Infrared Monitoring Ver. 1.0...

  • Page 20: What Is Exactrac Ir Monitoring

    What is ExacTrac IR Monitoring? 2.2.1 Overview General ExacTrac IR Monitoring enables you to monitor a patient’s position after the patient has been posi- Information tioned for treatment. Features With ExacTrac IR Monitoring you can: • Use a streamlined workflow of infrared monitoring once a patient has been set up to isocenter position by third party IGRT set-up.

  • Page 21: Hardware Overview

    HARDWARE OVERVIEW Chapter Overview 3.1.1 Contents Topics Covered Section ExacTrac Hardware Components Page 22 ExacTrac System Electronics Page 27 Storage and Cleaning Guidelines Page 33 Clinical User Guide Rev. 1.1, ExacTrac Infrared Monitoring Ver. 1.0...

  • Page 22: Exactrac Hardware Components

    ExacTrac Hardware Components 3.2.1 Available Configurations General The ExacTrac system is available in various configurations. The hardware components vary de- Information pending on your chosen hardware and software configuration. For further information, contact Brain- lab support. Clinical User Guide Rev. 1.1, ExacTrac Infrared Monitoring Ver. 1.0...

  • Page 23: Ir System Components

    3.2.2 IR System Components General The standard ExacTrac infrared tracking configuration, includes the following components. Information Workstation and Cabinet Figure 1 Component Function ExacTrac workstation See “ExacTrac Operating Panels” on page 30. Contains the workstation together with power cables, electri- Workstation cabinet cal safety devices, control electronics, etc.
  • Page 24 Monitor Figure 3 Component Function Provides software control in the treatment room. The monitor 17'' touchscreen can either be attached to the wall of the treatment room or to monitor the treatment room ceiling. Clinical User Guide Rev. 1.1, ExacTrac Infrared Monitoring Ver. 1.0...

  • Page 25: Ir Tracking Accessories

    3.2.3 IR Tracking Accessories Body Marker Spheres and Marker Sockets Figure 4 Component Function Enable infrared tracking. They are attached to marker sock- Body marker sphere ets. These are attached to suitable locations on the patient’s skin Marker sockets using adhesive pads, which can be exchanged as required. See “Using Infrared Body Markers”...

  • Page 26: Components For System Calibration And Verification

    3.2.4 Components for System Calibration and Verification ET Isocenter Phantom Figure 6 Component Function Enables isocenter calibration with the linac lasers. See “Iso- ET Isocenter Phantom center Calibration” on page 39. Clinical User Guide Rev. 1.1, ExacTrac Infrared Monitoring Ver. 1.0...

  • Page 27: Exactrac System Electronics

    ExacTrac System Electronics 3.3.1 General Notes on Electrical Safety Regulatory All ExacTrac system components located in the patient vicinity fulfill safety requirements for electri- Background cal medical devices and systems, either as a result of individual certification, or as a result of specific additional installation measures.
  • Page 28 Restrictions Do not connect miscellaneous equipment to the ExacTrac data interfaces or the inte- grated power rail. Only equipment specified by Brainlab may be connected to the sys- tem. Do not connect the ExacTrac system components directly to the mains power supply.

  • Page 29: Exactrac Infrared Monitoring Power Distribution

    3.3.2 ExacTrac Infrared Monitoring Power Distribution General In the ExacTrac system, power is distributed by the workstation cabinet. Information Workstation Cabinet Figure 7 Component Function Provides the overall power for the electronic Workstation Cabinet ExacTrac components. Clinical User Guide Rev. 1.1, ExacTrac Infrared Monitoring Ver. 1.0...

  • Page 30: Exactrac Operating Panels

    3.3.3 ExacTrac Operating Panels General As well as the workstation and power cables, the ExacTrac workstation cabinet also contains vari- Information ous operating and connection panels. Only qualified personnel are permitted to operate or service the system. Transformer Control Panel Figure 8 Component Function...
  • Page 31 ExacTrac System Control Panel Figure 9 Component Function This lights up when building power is available. BUILDING POWER indicator This switches on the system power, providing all system SYSTEM ON button components with electricity (see “Standard ExacTrac Start- up” on page 46). This switches off the system power (see “Closing Down the button SYSTEM OFF...
  • Page 32 Linac Interface If your ExacTrac Infrared Monitoring software configuration includes the automatic beam interlock option (see “Using the Beam Interlock” on page 69), your system will include an electronic interface that connects the ExacTrac system to your Varian linac. Figure 10 Component Function Data connection port for the ExacTrac workstation.

  • Page 33: Storage And Cleaning Guidelines

    Storage and Cleaning Guidelines 3.4.1 Storage Storage Conditions Ambient temperature: -20°C to 60°C Humidity: 10% to 90%, non-condensing Atmospheric pressure: 700 hPa to 1060 hPa Clinical User Guide Rev. 1.1, ExacTrac Infrared Monitoring Ver. 1.0...

  • Page 34: Cleaning

    3.4.2 Cleaning General Cleaning Guidelines Only use non-toxic solvents, as permitted by local regulations. Cleaning should only be performed in well-ventilated areas and solvents disposed of in accordance with lo- cal regulations. Calibration The calibration phantoms should be cleaned using a soft and dry cloth. Do not touch the marker in- Phantoms sets/marker spheres or bring them into contact with moisture.

  • Page 35: System Calibration And Qa

    SYSTEM CALIBRATION AND QA Chapter Overview 4.1.1 Contents Topics Covered Section The Couch/Linac Coordinate System Page 36 Isocenter Calibration Page 39 Verifying the Isocenter Calibration Page 42 Clinical User Guide Rev. 1.1, ExacTrac Infrared Monitoring Ver. 1.0...

  • Page 36: The Couch/Linac Coordinate System

    The Couch/Linac Coordinate System 4.2.1 Overview General To provide the ExacTrac patient positioning system with accurate information on the current patient Information position, a three-dimensional coordinate system consistent with IEC 61217 is used to describe the movement and angle of the couch and linac. ExacTrac with Linac Figure 11...

  • Page 37: Activating Calibration

    ExacTrac IR Monitoring calibration detailed here. A new calibration for ExacTrac 5.5 will there- fore be necessary. Brainlab recommends that you perform calibration with ExacTrac 5.x, and then start ExacTrac IR Monitoring Calibrate the system at least once a week and verify the calibration daily. Regular cal- ibration and verification of the system is necessary to ensure accuracy.
  • Page 38 Do not cover the camera system, e.g. with drapes. Covering the camera system may cause it to overheat. Brainlab strongly recommends that the computer cabinet remains powered up at all times so that the camera remains at operating temperature. To ensure accurate calibration and subsequent infrared tracking, the temperature in the treatment room must remain constant.

  • Page 39: Isocenter Calibration

    Isocenter Calibration 4.3.1 Calibrating the Isocenter Position General Isocenter calibration aligns the couch top with the linac isocenter, directly influencing the accuracy Information of the ExacTrac system. The determination of the linac’s isocenter position is an important and mandatory calibration. This position is the basis for all ExacTrac calculations.
  • Page 40 ET Isocenter Calibrate the isocenter position with an ET Isocenter Phantom. Handle the ET Isocenter Phantom Phantom with care. In case of improper use of the isocentric phantom such as falling down, moving it over a rough surface with the markers facing downwards) you must exchange all the marker spheres. Figure 13 Component Lines for room lasers...
  • Page 41 Performing Isocenter Steps Calibration Select Isocenter Calibration in the Calibration screen (see page 37), and confirm with Next. The Isocenter Calibration screen is shown: Ensure that the phantom is aligned with the room lasers and within the camera field of view (marker spheres are shown in blue).

  • Page 42: Verifying The Isocenter Calibration

    Verifying the Isocenter Calibration 4.4.1 Overview General Use this function to verify whether the phantom was correctly aligned with the lasers during calibra- Information tion. Before starting calibration verification, ensure that the computer cabinet has been running for at least 60 minutes. Activating Isocenter Steps...
  • Page 43 How to Perform Isocenter Steps Verification Place the ET Isocenter Phantom on the couch top, ensuring that all five marker spheres of the phantom are detected and are visible in the Left Camera and Right Camera views. Move the couch manually in accordance with the information provided by the shift indica- tors (see “Positional Indicators”...
  • Page 44 Clinical User Guide Rev. 1.1, ExacTrac Infrared Monitoring Ver. 1.0...

  • Page 45: System Startup

    SYSTEM STARTUP Chapter Overview 5.1.1 Contents Topics Covered Section System Startup Page 46 Starting the ExacTrac Infrared Monitoring Software Page 49 General System Settings Page 53 Clinical User Guide Rev. 1.1, ExacTrac Infrared Monitoring Ver. 1.0...

  • Page 46: System Startup

    System Startup 5.2.1 Standard ExacTrac Startup Mains Input Fuse Switch Figure 16 System On Button Figure 17 Computer On/Off Button Figure 18 Clinical User Guide Rev. 1.1, ExacTrac Infrared Monitoring Ver. 1.0...
  • Page 47 Powering Up the System Steps In the transformer control panel, set the mains input fuse switch to the I position (ON). Ensure that the green BUILDING POWER indicators in the control panels (see “ExacTrac Operating Panels” on page 30) light up, indicating that the building power is available. In the system control panel, press the SYSTEM ON button.

  • Page 48: Exactrac Startup Using The Timer Switch

    Information time of 60 minutes before the system can be calibrated or patients treated. If your system is fitted with a timer switch, Brainlab strongly recommends using this switch to power up the system at least 60 minutes before use.

  • Page 49: Starting The Exactrac Infrared Monitoring Software

    Starting the ExacTrac Infrared Monitoring Software 5.3.1 Software Startup General Once you have booted the ExacTrac system, and accessory components such as the camera and Information workstation are running, you can start the ExacTrac Infrared Monitoring software. Software Startup Icon Figure 20 Starting the Software...
  • Page 50 About ExacTrac In the menu bar, you can access information regarding the current software version and licensed features by pressing About ExacTrac ..in the Info menu. Figure 22 Clinical User Guide Rev. 1.1, ExacTrac Infrared Monitoring Ver. 1.0...

  • Page 51: Software Overview

    5.3.2 Software Overview Navigation Panel Figure 23 Navigation Panel Functions Function Explanation Page Calibrate System calibration Page 35 Start IR Activate IR monitoring for a patient Page 62 Monitoring Exit Software shutdown Page 76 Clinical User Guide Rev. 1.1, ExacTrac Infrared Monitoring Ver. 1.0...
  • Page 52 General Software Functions Component Function • Apply confirms your changes without closing the current dialog. Tab pages • OK confirms your changes and closes the current dialog. • Cancel closes the current dialog. Any changes you have made are discarded. •...

  • Page 53: General System Settings

    General System Settings 5.4.1 View Settings Accessing View Settings Options To access the marker view settings for infrared positioning, select General Settings in the Op- tions menu, and open the View tab in the dialog that is displayed. View Tab Figure 24 Available Settings Options...

  • Page 54: Body Marker Accuracy Settings

    5.4.2 Body Marker Accuracy Settings Accessing Accuracy Settings Options To access the general accuracy settings for body marker positioning, select General Settings in the Options menu, and open the Accuracy tab in the dialog that is displayed. Accuracy Tab Figure 25 Available Settings Component Function...

  • Page 55: Reminder Settings

    5.4.3 Reminder Settings Accessing Reminder Settings Options To access the settings for calibration and for print previews, select General Settings in the Op- tions menu, and open the Reminder tab in the dialog that is displayed. Reminder Tab Figure 26 Calibration Settings Options Never remind of Calibration...
  • Page 56 Clinical User Guide Rev. 1.1, ExacTrac Infrared Monitoring Ver. 1.0...

  • Page 57: Patient Monitoring

    PATIENT MONITORING Chapter Overview 6.1.1 Contents Topics Covered Section Patient Monitoring Workflow Page 58 Using Infrared Body Markers Page 59 Infrared Monitoring Page 62 Using Video Verification Page 71 Generating Treatment Reports Page 74 Clinical User Guide Rev. 1.1, ExacTrac Infrared Monitoring Ver. 1.0...

  • Page 58: Patient Monitoring Workflow

    Patient Monitoring Workflow 6.2.1 Overview Workflow Steps Position the patient on the couch. Attach infrared body markers. See “Using Infrared Body Markers” on page 59. Start the ExacTrac IR Monitoring software. See “Infrared Monitoring” on page 62. Check whether the infrared body markers are visible and whether the number of markers in the left and right camera view match the number of markers on the patient.

  • Page 59: Using Infrared Body Markers

    Do not attach marker sockets to damaged or broken skin. Only Brainlab Infrared Markers should be used for monitoring. If the hospital decides to use 3rd party Infrared Markers, the hospital is responsible for commissioning and quality assurance of this new device combination.
  • Page 60 How to Attach Infrared Body Steps Markers If necessary, shave a small area on the patient’s skin for marker placement. Clean the skin with an alcohol wipe or suitable cleaning solution. Remove the plastic backing from each marker socket, and attach the socket to the pa- tient’s skin.
  • Page 61 If you wish to re-use a marker socket for the same patient, a new adhesive pad should be attached to the marker socket to ensure secure positioning. Brainlab recommends placing infrared body markers in an asymmetrical arrange- ment, as ExacTrac Infrared Monitoring cannot always detect symmetrical marker pat- terns.

  • Page 62: Infrared Monitoring

    Infrared Monitoring 6.4.1 Creating a New Patient File How to Start Before starting IR Monitoring, the patient (wearing infrared body markers) must be positioned at iso- Infrared Monitoring center on the treatment table. Steps Press Start IR Monitoring in the startup screen (see Page 49). In order to perform infrared-based patient monitoring, you will need to create a new pa- tient file.
  • Page 63 How to Store the Patient Position Steps In the patient position screen, the infrared body markers worn by the patient must be clearly visible. Ensure that patient is in right treatment position based on 3rd party IGRT patient position- ing procedure. To record the patient position and marker pattern, press Store IR Reference in the navi- gation panel.

  • Page 64: Performing Infrared Monitoring

    6.4.2 Performing Infrared Monitoring General Infrared monitoring enables you to constantly monitor the patient’s position during treatment. You Information can define tolerances for the patient’s position, so that the system warns you if unacceptable devi- ations occur. You can also enable an automatic treatment beam interlock, so that the beam is automatically cut off if the patient shifts out of position (see “Using the Beam Interlock”...
  • Page 65 Do not adjust the camera position during treatment. Always calibrate the system after an equipment collision occurs. In the case of extreme collisions, contact Brainlab sup- port. Never reposition the patient according to the displayed shift or isocenter cross. The displayed shift information is only intended to support the decision whether a new IGRT setup procedure is required due to patient motion.
  • Page 66 Available Views View Function Two positioning views are provided at the center of the screen: • Top Laser View (this view is always shown) • Left Laser View or Right Laser View Whether the left or right laser view is shown can be configured under Positioning Views General Settings ...
  • Page 67 Adjusting You can adjust thresholds in the left-hand menu bar: Thresholds Figure 29 Component Function Thresholds Adjust the tolerance thresholds in these fields Displays whether the current patient position is within toler- Status indicator ances Clinical User Guide Rev. 1.1, ExacTrac Infrared Monitoring Ver. 1.0...
  • Page 68 Status Indicators Status indicators for aligning the treatment isocenter to the linac isocenter are provided top right of the screen. Indicator Function This icon indicates that the patient is in the correct position that you set when you commenced infrared monitoring as set in the left-hand menu bar.

  • Page 69: Using The Beam Interlock

    6.4.3 Using the Beam Interlock General If you activate the beam interlock, the Linac treatment beam will only be active when the infrared Information monitoring indicates that the patient is within the pre-defined accuracy tolerance (see “Body Marker Accuracy Settings” on page 54). Safety Notes Beam cut off may not be used for respiratory gating.
  • Page 70 How to Use the If the beam is cut off, make sure that the linac is disabled, before entering the treatment room. Beam Interlock Steps Press Enable Beam Interlock. While the patient is within the accuracy tolerances, the status icon displays OK Patient Surveillance Active, and treatment can proceed.

  • Page 71: Using Video Verification

    Using Video Verification 6.5.1 Overview General Video verification provides independent positioning verification based on the patient’s external anat- Information omy. It allows you to compare a live video image with a previously acquired video image. It provides an independent means of patient monitoring in addition to infrared patient monitoring. Video verification can be used in order to verify that the patient’s general posture and arm position are consistent during treatment.

  • Page 72: Storing Video Reference Images

    6.5.2 Storing Video Reference Images General When the patient is in a confirmed and correct treatment position prior to the first treatment, you can Information acquire a reference image. How to Store a Some immobile objects should be included in the reference image, so as to allow subsequent veri- Reference Image fication that the video camera settings have not changed.

  • Page 73: Comparing Reference And Live Images

    6.5.3 Comparing Reference and Live Images General An image saved as reference image can be compared with a live image of a subsequent fraction Information using subtractive video. Subtractive Image Display Figure 30 Changes to the patient position are displayed in the video image. A black screen indicates a perfect match between the live and the reference image.

  • Page 74: Generating Treatment Reports

    Options Set the software to show a print preview automatically on closing the patient in General Settings in the Options menu. Navigate to the folder D:/Brainlab/Export (configurable by Brainlab) with Windows Explor- er and open the PDF. Figure 32 Contents of the...

  • Page 75: System Shutdown

    SYSTEM SHUTDOWN Chapter Overview 7.1.1 Contents Topics Covered Section Closing Down the Software Page 76 Closing Down the Hardware Page 77 Clinical User Guide Rev. 1.1, ExacTrac Infrared Monitoring Ver. 1.0...

  • Page 76: Shutting Down The System

    Shutting Down the System 7.2.1 Closing Down the Software General Once patient treatment has been completed, the software can be shut down. Information How to Close the To close the current patient file, press Close Patient in the navigation panel. Patient File How to Exit the Before shutting down the system, you must exit the ExacTrac Infrared Monitoring software cor-...

  • Page 77: Closing Down The Hardware

    The mains input fuse switch can remain in the I position (ON) and does not need to be reset every Shutdown day. For optimum system performance, Brainlab recommends shutting down the ExacTrac workstation overnight. If the system runs continuously, rebooting the workstation ev- ery morning is recommended. Not rebooting the workstation regularly may result in reduced system performance.
  • Page 78 Emergency Stop If the entire system must be shut down in the event of an emergency, push the EMERGENCY STOP switch in the system control panel. Clinical User Guide Rev. 1.1, ExacTrac Infrared Monitoring Ver. 1.0...

  • Page 79: System Maintenance

    SYSTEM MAINTENANCE Chapter Overview 8.1.1 Contents Topics Covered Section Safety Inspection Overview Page 80 Performing Electrical Inspections Page 84 Handling Damaged Equipment Page 93 Clinical User Guide Rev. 1.1, ExacTrac Infrared Monitoring Ver. 1.0...

  • Page 80: Safety Inspection Overview

    The ExacTrac system should be maintained and inspected on a regular basis to en- sure functionality and safety. Authorized Persons Only Brainlab and/or authorized partners are allowed to repair the system and the equipment. The equipment does not contain user-serviceable parts. To avoid electric shock, do not open equipment or device casing.

  • Page 81: Annual Inspection Requirements

    • If a service contract has been purchased, Brainlab will automatically perform the annual inspec- tion. • If you do not have a service contract, contact Brainlab support (see “Contact Data and Legal Information” on page 8) to arrange the inspection.

  • Page 82: Weekly And Monthly Inspection Requirements

    8.2.3 Weekly and Monthly Inspection Requirements Authorized Persons Only qualified clinical personnel are authorized to perform weekly and monthly inspections. Weekly Inspections Inspect the following components once a week: Component Inspection Cabling Visual control (twists, cracks) Monthly Inspect the following components once a month: Inspections Component Inspection...

  • Page 83: Safety Inspection Requirements

    • Informs Brainlab immediately in writing if the equipment is deemed unsafe. Inspections by • If a suitably qualified person is not available at the customer site, Brainlab’s support specialist Brainlab Personnel will carry out this inspection for a set fee.

  • Page 84: Performing Electrical Inspections

    Performing Electrical Inspections 8.3.1 Overview of Electrical Safety Testing Regulatory Regular electrical safety testing should be conducted by qualified personnel in accordance with DIN Background VDE 0751-1 “Recurrent test and test after repair of medical electrical equipment”. It should include the following items: •...

  • Page 85: Documentation Of Tests

    8.3.2 Documentation of Tests General In accordance with the standard DIN VDE 0751-1, Brainlab recommends logging all measurements Information for the purposes of comparison. In the event of significant deviations compared with previous mea- surements, system failure is likely to occur. In such cases, further detailed investigation should be completed in cooperation with Brainlab support.

  • Page 86: Visual Inspection

    8.3.3 Visual Inspection General Before performing further inspections, a qualitative validation of the connections and wirings of all Information potential equalization conductors within the system should be conducted for safety reasons. Components to be • All connections should be verified in order to ensure that they have not become loose. Reviewed •...

  • Page 87: Protective Earth Resistance Test

    ExacTrac, for example, rises above the specified level, it must be reduced. • The required current for the PE resistance test varies for different countries. As a default value Brainlab recommends using 25 A. • For countries where a different minimum is specified (e.g. DIN VDE 0751-1 for Germany requires only 0.2 A), local regulations apply.

  • Page 88: Leakage Current Test

    8.3.5 Leakage Current Test What is a Leakage A leakage current test is used to verify that components in the patient vicinity that are not connected Current Test? to the protective earth are properly isolated. In the case of the ExacTrac system, this test is partic- ularly important for non-conductive components such as the plastic housing that protects devices.
  • Page 89 Sample Protocol A sample test protocol is shown below: Video Current Feedbac Monitor Camera Flat Panels Type Goggles PE Bar Monitor Camera Clinical User Guide Rev. 1.1, ExacTrac Infrared Monitoring Ver. 1.0...

  • Page 90: Testing The Earth Leakage Current Breaker

    8.3.6 Testing the Earth Leakage Current Breaker Regulatory At this time, there is no international harmonized standard that regulates the requirements and rou- Background tines for repetitive testing and testing before startup of medical electrical devices or systems. However, the German standard DIN VDE 0751-1 “Recurrent test and test after repair of medical electrical equipment”...

  • Page 91: Functionality Tests

    8.3.7 Functionality Tests General A functionality test of all safety-relevant functions must be performed by qualified personnel. Partic- Information ular attention must be paid to the correct functionality of warning signals. Before You Begin Before you begin, power up the ExacTrac system and workstation. ExacTrac Cabinet Functionality Test Steps...

  • Page 92: Troubleshooting The Isolation Transformer

    Should the fault persist, call Brain- former control panel are has tripped. lab support. not illuminated. Internal isolation Call Brainlab support. transformer failure. Release the BUILDING POWER EMERGENCY STOP EMERGENCY STOP dicators in the transformer switch is active (pushed switch by pulling it out.

  • Page 93: Handling Damaged Equipment

    • Switch off the system and immediately disconnect from the utility power. • Contact Brainlab support (see “Contact Data and Legal Information” on page 8). • Attach a suitable notice such as “DO NOT USE” to the equipment to prevent it from being used inadvertently.

  • Page 94: Returning Damaged Equipment

    8.4.2 Returning Damaged Equipment Reporting Any damaged equipment should be immediately reported to Brainlab support. Damaged Brainlab support will ask you for the following information: Equipment • Serial number of the faulty component (inscribed on the component) • A description of the problem...

  • Page 95: Exactrac Infrared Monitoring Troubleshooting

    EXACTRAC INFRARED MONITORING TROUBLESHOOTING Chapter Overview 9.1.1 Contents Topics Covered Section Troubleshooting Detection of Infrared Body Markers Page 96 Clinical User Guide Rev. 1.1, ExacTrac Infrared Monitoring Ver. 1.0...

  • Page 96: Troubleshooting Detection Of Infrared Body Markers

    9.2.1 Overview General Ambiguities can occur with Brainlab’s ExacTrac Patient Positioning System due to inaccurate Information marker placement. This section explains the basis of the algorithm used by ExacTrac Infrared Mon- itoring for detecting the marker positions and the cause of ambiguities. Furthermore, tips are pro- vided to avoid ambiguities in daily use.

  • Page 97: The Principle Of Body Marker Detection

    9.2.2 The Principle of Body Marker Detection General All marker signals (infrared light reflected from the surface of a body marker) are registered electron- Information ically on the camera’s CCD chip. Before the signals are detected, they all intersect at the Focal Point as shown in figure 36.
  • Page 98 Calculating the The second ExacTrac Infrared Monitoring camera determines the remaining degree of freedom at Exact 3D Position the point where the two virtual lines intersect. In this way, the exact 3D position of a marker can be calculated, as shown in figure 38: Figure 38 ExacTrac Infrared Monitoring requires several markers to enhance the accuracy of the patient po- sitioning procedure and to detect additional body movements as contortions or rotations, etc.

  • Page 99: Automatically Solving Ambiguities

    9.2.3 Automatically Solving Ambiguities General ExacTrac Infrared Monitoring compares all possible marker positions detected by the infrared Information camera system, real marker positions, and possible positions due to ambiguities, with an internal reference list in the program, the look-up table (LUT). The look-up table contains the real marker positions generated in one of the following ways: •...
  • Page 100 Reasons for Ambiguities may occur due to symmetrical marker positioning as shown in figure 41: Remaining Ambiguities Figure 41 Description Exact rotation not uniquely defined Avoid symmetrical marker positioning. Ambiguities may occur due to marker shift, caused by any of the following: •...
  • Page 101 Ambiguities due to • Reduced numbers of markers applied. Hidden/Invisible • One marker is damaged or reflects insufficiently. Markers • The patient’s body covers a second marker. • A marker is covered by another marker. • The linac gantry is blocking markers from the camera’s field of view, e.g. prostate patients with markers applied to the thorax.
  • Page 102 Clinical User Guide Rev. 1.1, ExacTrac Infrared Monitoring Ver. 1.0...

  • Page 103: 10 Licensing Information

    10 LICENSING INFORMATION 10.1 Chapter Overview 10.1.1 Contents Topics Covered Section Licensing Page 104 Clinical User Guide Rev. 1.1, ExacTrac Infrared Monitoring Ver. 1.0...

  • Page 104: Licensing

    10.2 Licensing 10.2.1 Overview General ExacTrac Infrared Monitoring is proprietary software. The ExacTrac Infrared Monitoring soft- Information ware is protected by copyright. In addition to the ExacTrac Infrared Monitoring software, other soft- ware applications are also installed on the ExacTrac Infrared Monitoring workstation that are licensed under the GNU General Public License.
  • Page 105 or a portion of it, either verbatim or with modifications and/or translated into another language. (Hereinafter, translation is included without limitation in the term “modification”.) Each licensee is ad- dressed as “you”. Activities other than copying, distribution and modification are not covered by this License; they are outside its scope.
  • Page 106 The source code for a work means the preferred form of the work for making modifications to it. For an executable work, complete source code means all the source code for all modules it contains, plus any associated interface definition files, plus the scripts used to control compilation and instal- lation of the executable.
  • Page 107 10. If you wish to incorporate parts of the Program into other free programs whose distribution con- ditions are different, write to the author to ask for permission. For software which is copyrighted by the Free Software Foundation, write to the Free Software Foundation; we sometimes make excep- tions for this.
  • Page 108 Clinical User Guide Rev. 1.1, ExacTrac Infrared Monitoring Ver. 1.0...

  • Page 109: Status Icons

    11 STATUS ICONS 11.1 Chapter Overview 11.1.1 Contents Topics Covered Section Status Icons Page 109 Clinical User Guide Rev. 1.1, ExacTrac Infrared Monitoring Ver. 1.0...

  • Page 110: Overview

    11.2 Status Icons 11.2.1 Overview When this icon is shown, the patient is in the reference position. OK (Patient The patient is in the reference position, and beam interlock is enabled. Surveillance Active) Warning This icon appears with text in warning messages. Reduced Accuracy This icon indicates reduced positioning accuracy.

  • Page 111: Index

    GNU General Public License ............cleaning ............... guides ............infrared .............. video ..........cleaning guidelines ....... compatible Brainlab medical instruments ...... compatible non-Brainlab medical devices ....... compatible non-Brainlab software hardware ....control panel ExacTrac Infrared Monitoring components ..........ExacTrac system ...........
  • Page 112 ........positioning the phantom ............ required steps reference images ............verification ..........video verification isolation transformer ......... reflective marker spheres ............. control panel ........returning damaged equipment ..........earth leakage current ............ system safety ..........troubleshooting ............safety testing shutdown ............
  • Page 114 Art-No: 60912-15EN *60912-15EN*...

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