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Brainlab ROBOTICS VERO Hardware User's Manual

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ROBOTICS
VERO
Version 2.1
Hardware User Guide
Revision 1.1
Copyright 2015, Brainlab AG Germany. All rights reserved.

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Summary of Contents for Brainlab ROBOTICS VERO

  • Page 1 ROBOTICS VERO Version 2.1 Hardware User Guide Revision 1.1 Copyright 2015, Brainlab AG Germany. All rights reserved.

  • Page 3: Table Of Contents

    Robotics with iBeam evo Couch Top ......................21 Manual Controls ............................22 Operating Robotics Vero ........................25 Couch Set-up Verification When Not Using Robotics Vero .................26 Maneuvering Robotics Vero During Non-Patient Operation................27 Message Boxes And System Warnings......................33 Using the Anti-Skid Mat..........................35 Cleaning ..............................37 Maintaining the System ..........................38...
  • Page 4 TABLE OF CONTENTS REGULATORY INFORMATION ..................49 Regulatory Information ...........................49 EMC Notes ..............................50 APPENDIX ............................53 Third-Party Licensing Information .......................53 INDEX ..............................55 Hardware User Guide Rev. 1.1 Robotics Vero Ver. 2.1...

  • Page 5: General Information

    Worldwide Tel: +49 89 99 15 68 359 service@vero-sbrt.com Feedback Despite careful review, this manual may contain errors. Please contact us at oncology.manuals@brainlab.com if you have suggestions as to how we can improve this manual. Manufacturer Brainlab AG Kapellenstr. 12...

  • Page 6: Legal Information

    • The CE label shows that the Brainlab product complies with the essential re- quirements of Council Directive 93/42/EEC (the "MDD"). • According to the principles set out in the MDD, Robotics Vero is a Class IIb product Disposal Instructions Only dispose of electrical and electronic equipment in accordance with statutory regulations.

  • Page 7: Symbols

    Such problems include device malfunctions, device failure, damage to device or damage to property. Notes NOTE: Notes are formatted in italic type and indicate additional useful hints. Hardware User Guide Rev. 1.1 Robotics Vero Ver. 2.1...

  • Page 8: Intended Use

    Intended Use Intended Use Indications for Use Robotics Vero is a device used to compensate rotational patient misalignment (roll and pitch) in a linear accelerator environment for stereotactic radiosurgery or radiotherapy procedures. Careful Hardware Handling System components and accessory devices comprise precise mechanical parts that must be handled with care.

  • Page 9: About This Guide

    This guide provides an introduction and reference for the effective and correct use of Brainlab’s Robotics Vero. This guide is written for all members of the clinical team who use or handle the Robotics Vero or parts of it. You should read this guide carefully and acquaint yourself sufficiently with the system before use.

  • Page 10: Compatibility With Medical Devices

    Other Brainlab Devices Additional devices may become available after release of this manual. Contact Brainlab support if you have any questions regarding device compatibility with Brainlab software. Only use devices and spare parts specified by Brainlab with Robotics Vero. Using unauthorized devices/spare parts may adversely affect safety and/or effectiveness of the medical device and endanger safety of patient, user and/or environment.

  • Page 11: Brainlab Medical Software

    Robotics Vero. Other Brainlab Software If you are running software versions other than those specified above, contact Brainlab support for clarification regarding compatibility with Brainlab devices. Only Brainlab medical software specified by Brainlab may be installed and used with the system.

  • Page 12: Non-Brainlab Medical Devices

    Other Non-Brainlab Devices Only combinations with non-Brainlab medical devices authorized by Brainlab may be used together with Robotics Vero. Using medical device combinations that have not been authorized by Brainlab may adversely affect the safety and/or the effectiveness of the medical device.

  • Page 13: Training And Documentation

    • A Brainlab representative when held in any country other than Japan. ExacTrac Vero components and accessory devices may only be operated by medical personnel trained in the use of this system by Brainlab, or, in Japan, Mitsubishi Heavy Industries, Ltd.

  • Page 14: Documentation

    • Detailed instructions on using the ExacTrac Vero patient posi- Trac Vero tioning system Hardware User Guide, Imag- • Patient treatment using the Imaging Couch Top and exten- ing Couch Top sions Hardware User Guide Rev. 1.1 Robotics Vero Ver. 2.1...

  • Page 15: Robotics Vero

    Robotics Vero is intended to be operated within the working environment of a medical Electron Accelerator, used to support automated patient positioning procedures in radiotherapeutic application. Robotics Vero is intended to be used for medical appliance solely in combination with- and under control of a computer aided patient positioning system. Patient population The patient population includes any medical condition in which the use of radiation therapy may be appropriate such as cranial, head and neck or spine treatments to detect tumors.
  • Page 16 On activation of the Emergency-Off (EMO) of the Vero, Robotics Vero shuts down its movement immediately. The Emergency-Off system is not part of Robotics Vero but must be provided by the facility operator. The device is connected to the Emergency Off system of the linac. In case of emergency, activate the Emergency Off switch(es) of the linac to STOP Robotics Vero movement.

  • Page 17: Robotics Vero Software

    Robotics Vero Software Software Overview The Robotics Service Application and Robotics driver software provides you an alternative control terminal for Robotics Vero during non-patient operation as well as enhanced diagnostic features for the system. Software Type Robotics service and maintenance application Platform OS Windows XP;...

  • Page 18: Robotics Vero Hardware

    • Lateral tilt /Pitch is defined as rotation of the table top coordinate system (index t) around the Xt axis. • Longitudinal tilt /Roll is defined as rotation of the table top coordinate system (index t) around the Yt axis. (Notifications in accordance with IEC 61217). Figure 2 Hardware User Guide Rev. 1.1 Robotics Vero Ver. 2.1...
  • Page 19 Dimensions of the device w/o Imaging Couch Top in Home Position Height 149 mm Width 589 mm Length 855 mm Tare mass & patient mass Device's mass 61 kg Maximum patient load 135 kg Hardware User Guide Rev. 1.1 Robotics Vero Ver. 2.1...

  • Page 20: Robotics With Imaging Couch Top

    Robotics with Imaging Couch Top Safety Notes The maximum distributed load permitted on Robotics Vero combined with the Imaging Couch Top (with extension) is 135 kg. The maximum point load at the cranial end of the Imaging Couch Top (no extension) is 92,5kg.

  • Page 21: Robotics With Ibeam Evo Couch Top

    The maximum load on the iBeam evo extension is 70kg. Do not step on the iBeam evo couch top. Warning Labels The following warning labels are attached on Robotics Vero or its sub-components: Label Explanation • The maximum point load at the end of the cranial end of thei- Beam evo Couch Top is 100kg.

  • Page 22: Manual Controls

    Unlocked position. NOTE: If either lock is rotated out of the Unlocked position, both LOCK ALL LEDS are lit to indicate that the device is blocked (see page 23). Hardware User Guide Rev. 1.1 Robotics Vero Ver. 2.1...
  • Page 23 Fault LED proceed (e.g. using the Service Application or ExacTrac Vero). In some fault cases it is necessary to turn Robotics Vero off and then on again before the fault can be cleared. Hardware User Guide Rev. 1.1 Robotics Vero Ver. 2.1...
  • Page 24 Manual Controls Caudal End ① ② Figure 6 Component ① Access hole for Service Brake Release (see Page 39) ② Jack for Auxiliary Power Supply (see Page 40) Hardware User Guide Rev. 1.1 Robotics Vero Ver. 2.1...

  • Page 25: Operating Robotics Vero

    • Inside the treatment bunker, the operator standing directly beside the device, or, • Outside the bunker, using the treatment control panel. However, in either case it is necessary to observe and control any movement of Robotics Vero carefully to avoid any danger or hazard for the patient.

  • Page 26: Couch Set-Up Verification When Not Using Robotics Vero

    Couch Set-up Verification When Not Using Robotics Vero General Information When ExacTrac Vero is not used for patient positioning, Robotics Vero shall be aligned in its Center Position (no Robotics tilt). It is recommended to verify the correct alignment using the supplied water level before patient treatment.

  • Page 27: Maneuvering Robotics Vero During Non-Patient Operation

    During non-patient operation any maneuvers of Robotics Vero are solely controlled using the ET Hand Pendant. The ET Hand Pendant must be set up directly beside Robotics Vero in the treatment bunker to have an unobstructed view to Robotics Vero during maneuvering.
  • Page 28 The graphical display of the overall operating range (displayed as a diamond shape in this tab) is not to scale. The values displayed refer to the relative movement of Robotics Vero in accordance with IEC 61217 - 'Table Top System' designation index 't'. The values displayed do not consider any external sources of deflection such as e.g.
  • Page 29 ②. When the target position is reached the dot turns green Click Go to send the maneuver request to Robotics Vero. A dialog displays the set-up movement: Click Acknowledge to confirm your pre-selection or Cancel to cancel the operation.
  • Page 30 Operating Robotics Vero Steps Robotics Vero is now set up to perform the desired maneuver. Enable the movement by pressing both buttons on the confirmation device. Depending on the control position this may be the ExacTrac Vero hand pendant or the ExacTrac Vero control panel. Robotics Vero will continue moving towards the target while both buttons are held pressed.
  • Page 31 How to Perform a Homing Procedure If a system error occurs Robotics Vero may preform a homing procedure for QA reasons. Homing brings the lifting mechanic into its initial position to perform an automated internal balancing of all positioning sensors of the device.
  • Page 32 • Click Cancel to confirm that Robotics Vero is not to be repositioned, or, • Click Retry to once again try to set the final Robotics Vero position to the Home Posi- tion or Center Position as mentioned above.

  • Page 33: Message Boxes And System Warnings

    Movement is not possible as the Auxiliary Power Supply (Battery Charger) is connected to Robotics Vero. Movement is not possible as Robotics Vero is locked man- ually by the Service Lock. Disengage the Service Lock bolts to un-lock the device and click OK for confirmation.
  • Page 34 Operating Robotics Vero Messages Explanation Robotics Vero has not been moved to a valid default posi- tion. Ensure to reposition Robotics prior to patient treat- ment. If you decided to skip the final adjustment of Robotics Vero position at application shut down, the message box requires you to confirm this a second time by clicking Cancel.

  • Page 35: Using The Anti-Skid Mat

    ROBOTICS VERO 2.3.4 Using the Anti-Skid Mat General Information The Brainlab Anti-Skid Mat can be placed on the couch top beneath the patient to enhance comfort when performing table tilting. Anti-Skid Mat Figure 8 Compliances The Brainlab Anti-Skid Mat has been tested for harmful substances and approved for skin contact in accordance with Oeko Tex Standard 100 (product class II).
  • Page 36 Storage Roll the mat up for storage. Dosimetric Properties When irradiating through the Anti-Skid Mat, especially in combination with the Brainlab Imaging Couch Top, verify attenuation and dose build-up experimentally using appropriate measurements. Safety Notes Radiation attenuation will vary depending on beam energy and the beam entry angle through the Anti-Skid Mat.

  • Page 37: Cleaning

    ROBOTICS VERO Cleaning General Information Clean Robotics Vero using a soft and dry cloth. Remove stains with a slightly moistened cloth. Do not use water, sharp objects, rough materials or caustic soaps to remove residue, especially on the bellow. Hardware User Guide Rev. 1.1 Robotics Vero Ver. 2.1...

  • Page 38: Maintaining The System

    To avoid personal injury or system damage due to clamping between moving parts of the device it is mandatory that the cover of Robotics Vero is mounted properly and shows no damage. Do not operate robotics if a cover is damaged or removed.

  • Page 39: Service Brake Release

    Service Brake Release General Information If an internal failure of Robotics Vero occurs that cannot be cleared, it might be necessary to release the electrical brake of the lifting mechanics to move the Imaging Couch Top by hand back to its Home Position.
  • Page 40 • Connect it to supply mains using the appropriate mains power cable (country-specific power cord). • Connect the Auxiliary Power Supply with its power output cable to Robotics Vero. Remove the white plastic cap covering the Service Brake Release. Insert a long thin object (e.g a needle) into the hole, and press the Service Brake Re- lease button behind the cover.
  • Page 41 NOTE: Robotics Vero cannot be maneuvered if the Auxiliary Power Supply is connect- ed. You must unplug the Auxiliary Power Supply before patient treatment. NOTE: While the Service Brake Release button is pressed, Robotics Vero does not react to any drive command from ExacTrac Vero.

  • Page 42: Auxiliary Power Supply For Brake Release

    Safety Notes Use only the Power Supply provided by Brainlab with Robotics Vero. Use this Power Supply only for operation of Robotics Vero. Usage and connection of components other than those as specified by Brainlab for that...

  • Page 43: Using The Service Locks

    Using The Service Locks General Information Brainlab recommends locking Robotics Vero with the Service Locks if the device is not being used for a long period of time or being put out of service. How to Use the Service Locks Steps Move the Imaging Couch Top to the Home Position, e.g.

  • Page 44: Retrieving Version Information

    Select the Version tab in the Robotics Service Application. This displays the: Licensee Firmware checksum In addition displays the version numbers of: • The Robotics Service Application • The corresponding DLL • The Robotics Firmware version Hardware User Guide Rev. 1.1 Robotics Vero Ver. 2.1...

  • Page 45: Robotics Vero Safety Technical Inspection

    If a service contract has been purchased, a Brainlab support specialist will carry out the Safety Technical Inspection as part of the annual PMI. If you do not have a service contract, contact Brainlab support to arrange the inspection for a set fee.

  • Page 46: Damaged Equipment

    • Attach a suitable notice such as “DO NOT USE” to the equipment to prevent it from being used inadvertently If you continue to use equipment that has been found to be defective during an inspection, you risk causing injury to the patient. Hardware User Guide Rev. 1.1 Robotics Vero Ver. 2.1...

  • Page 47: Returning Damaged Equipment

    3.2.1 Returning Damaged Equipment Reporting Damaged Equipment Any damaged equipment should be immediately reported to Brainlab support, together with the following information: • System serial number (located on the system’s type plate) • Serial number of the faulty component (inscribed on the component) •...
  • Page 48 Damaged Equipment Hardware User Guide Rev. 1.1 Robotics Vero Ver. 2.1...

  • Page 49: Regulatory Information

    1 MeV to 50 MeV • R&TTE Directive 1999/5/EC - EN 300 328 Robotics Vero is classified as Type B applied part with internal power source (IEC 60601-1, Medical electrical equipment - General requirements for safety). Connection to mains supply by Class-II power supply.

  • Page 50: Emc Notes

    Guidance and Manufacturer's Declaration - Electromagnetic Emissions Robotics Vero is intended for use in the electromagnetic environment specified below. The customer or the user of the Robotics Vero should assure that it is used in such an environment., Emissions test...
  • Page 51 Guidance and Manufacturer's Declaration - Electromagnetic Immunity Robotics Vero is intended for use in the electromagnetic environment specified below. The customer or the user of Robotics Vero should assure that it is used in such an environment. Immunity Test IEC 60601Test Level...
  • Page 52 Guidance and Manufacturer's Declaration - Electromagnetic Immunity Robotics Vero is intended for use in the electromagnetic environment specified below. The customer or the user of Robotics Vero should assure that it is used in such an environment. Immunity Test Compliance...

  • Page 53: Appendix

    APPENDIX APPENDIX Third-Party Licensing Information General Information Robotics Vero includes proprietary software protected by copyright. In addition, Robotics Vero also includes software licensed under the terms and conditions of the additional license specified below. Lesser General Public License The proprietary software dynamically links with the QT software framework (http://qt.nokia.com) under the terms of the LGPL 2.1 (http://qt.nokia.com/products/licensing) to provide a graphical...
  • Page 54 Third-Party Licensing Information Hardware User Guide Rev. 1.1 Robotics Vero Ver. 2.1...

  • Page 55: Index

    33 operating range, Robotics Vero..........18 QT software framework.............. 53 return address................47 Robotics Service Application............27 Robotics Vero operating range..............18 using..................25 Safety Inspection Record............45 Safety Technical Inspection............45 Hardware User Guide Rev. 1.1 Robotics Vero Ver. 2.1...
  • Page 58 Art-No. 60912-73EN *60912-73EN*...

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