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Brainlab Robotics Hardware User's Manual

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ROBOTICS
Version 2.1
Hardware User Guide
Revision 1.0
Date of issue: 2021-07-20 (ISO 8601)
Copyright 2021, Brainlab AG Germany. All rights reserved.

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  • Page 1 ROBOTICS Version 2.1 Hardware User Guide Revision 1.0 Date of issue: 2021-07-20 (ISO 8601) Copyright 2021, Brainlab AG Germany. All rights reserved.

  • Page 3: Table Of Contents

    2.1 Robotics Hardware and Software Components ................17 2.1.1 Robotics Software ..........................19 2.1.2 Robotics Hardware...........................20 2.1.3 Robotics with Imaging Couch Top ....................22 2.1.4 Robotics with iBeam evo Couch Top CA ..................23 2.1.5 Robotics with kVue Pro Couch Top....................24 2.2 Manual Controls ..........................25 2.2.1 Overview ............................25 2.2.2 User Interface...........................27...
  • Page 4 ........63 3.1 STI - Safety Technical Inspection Requirements ...............63 3.2 Damaged Equipment ........................64 3.2.1 Discontinuing Use ..........................64 3.2.2 Returning Damaged Equipment .......................65 3.3 Regulatory Information ........................66 3.4 EMC Notes ............................68 INDEX ..............................75 Hardware User Guide Rev. 1.0 Robotics Ver. 2.1...

  • Page 5: General Information

    Fax: +81 3 3769 6901 Feedback Despite careful review, this user guide may contain errors. Please contact us at user.guides@brainlab.com if you have improvement suggestions. Manufacturer Brainlab AG Olof-Palme-Str. 9 81829 Munich Germany Hardware User Guide Rev. 1.0 Robotics Ver. 2.1...

  • Page 6: Legal Information

    Report Incidents Related to This Product You are required to report any serious incident that may have occurred related to this product to Brainlab, and if within Europe, to your corresponding national competent authority for medical devices. Sales in US US federal law restricts this device to sale by or on the order of a physician.

  • Page 7: Using The System

    Robotics is intended to be operated within the working environment of a medical Electron Accelerator, used to support automated patient positioning procedures in radiotherapeutic or radiosurgery application. Robotics is a device used to compensate rotational patient misalignment (roll and pitch) in a linear accelerator environment for stereotactic radiosurgery or radiotherapy procedures. Intended User The intended user group is trained medical personnel in hospitals, specifically radiographers (MTRA’s) (applies for patient fixation and positioning) as well as physicists (applies for linac...
  • Page 8 This guide provides an introduction and reference for the effective and correct use of Robotics. This guide is written for all members of the clinical team who use or handle the Robotics or parts of it. You should read this guide carefully and acquaint yourself sufficiently with the system before use.

  • Page 9: Symbols

    • SIBA 79200.2,5 / Imprinting: 2.5A - 250VAC T H • Schurter SMD-SPT 2.5 / Imprinting: 2.5A - 250VAC T H 2.5ATH Spare part available with Brainlab Art./No.: RTM2 ELECTRICAL MOUNTING AC- CESSORIES/49775 * Fuse: IEC 60127-2/5 with a nominal fuse rating of 2.5 Amperes [2.5A], time lag [T]...
  • Page 10 Symbols Symbol Explanation Class II medical equipment This medical electrical equipment contains an RF transmitter for operation Refer to instruction manual/booklet Do not step on device Medical Device Unique Device Identifier Hardware User Guide Rev. 1.0 Robotics Ver. 2.1...

  • Page 11: Compatibility With Medical Devices

    Anti-Skid Mat treatment table 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. Warning Only use devices and spare parts specified by Brainlab with Robotics. 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 12: Brainlab Medical Software

    ExacTrac 6.0 Other Brainlab Software If you are running software versions other than those specified above, please 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 13: Non-Brainlab Medical Devices

    Medical Intelligence, Schwabmünchen, Germany iBeam evo Extension 415 Warning To change from an Exact couch to a TrueBeam couch (or vice versa), Robotics must be modified. This change may only be carried out by Brainlab support. Other Non-Brainlab Devices Only combinations with non-Brainlab medical devices authorized by Brainlab may be used together with Robotics.

  • Page 14: Training

    Training Training Brainlab Training Before using the system, Brainlab recommends that all users should participate in a training program held by a Brainlab representative to ensure safe and appropriate use. Responsibility This system solely provides assistance to the physician and does not substitute or replace the physician's experience and/or responsibility during its use.

  • Page 15: Documentation

    User Guide Contents • Patient treatment using the ExacTrac system Clinical User Guide, ExacTrac • Detailed software instructions Hardware User Guide, Imaging Couch • Patient treatment using the Imaging Couch Top and extensions Hardware User Guide Rev. 1.0 Robotics Ver. 2.1...
  • Page 16 Documentation Hardware User Guide Rev. 1.0 Robotics Ver. 2.1...

  • Page 17: Robotics

    For further details regarding use-cases, medical workflows and clinical practice refer to the Clinical User Guide, ExacTrac. As it can be controlled remotely by radio, Robotics can be operated locally as well as remotely from outside the treatment bunker using the ExacTrac patient positioning system.
  • Page 18 On activation of the emergency off (EMO) of the medical electron accelerator, Robotics shuts down its movement immediately. The emergency off system is not part of Robotics but must be provided by the facility operator. Warning 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 movement.

  • Page 19: Robotics Software

    ROBOTICS 2.1.1 Robotics Software Software Overview The Robotics Service Application and Robotics driver software provides you an alternative control terminal for Robotics 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 20: Robotics Hardware

    • 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). (ICT incl. ICT Frameless Extension): Figure 2 Hardware User Guide Rev. 1.0 Robotics Ver. 2.1...
  • Page 21 Robotics and Imaging Couch Top (with Frameless Ext. attached). Couch top at isocenter height; Robotics and couch top in fully extended position;135 kg applied over 2 m length of the Imaging Couch Top, beginning at the cranial end; vertical deflection of couch top measured at isocenter.

  • Page 22: Robotics With Imaging Couch Top

    Robotics with Imaging Couch Top Safety Notes Warning The maximum distributed load permitted on Robotics combined with the Imaging Couch Top for Varian Exact (with extension) is 159 kg. Warning The maximum point load at the cranial end of the Imaging Couch Top for Varian Exact (no extension) is 92.5 kg.

  • Page 23: Robotics With Ibeam Evo Couch Top Ca

    The maximum load on the iBeam evo extension is 70 kg. Warning Do not step on the iBeam evo Couch Top CA. Warning Labels The following warning labels are attached to Robotics or its sub-components when the iBeam evo Couch Top CA is installed: Label Explanation •...

  • Page 24: Robotics With Kvue Pro Couch Top

    Robotics with kVue Pro Couch Top Safety Notes Warning The maximum distributed load permitted on Robotics combined with the kVue Pro Couch Top (independent of insert used) is 144 kg. Warning The maximum point load at the cranial end of the kVue Pro cantilever beams is 95 kg.

  • Page 25: Manual Controls

    ROBOTICS Manual Controls 2.2.1 Overview Left/Right-hand Side of the Device ① ② ③ Figure 3 Component ① Service Lock ② User Interface ③ ON/OFF Switch Hardware User Guide Rev. 1.0 Robotics Ver. 2.1...
  • Page 26 Manual Controls Caudal End ① ③ ④ ② Figure 4 Component ① Access hole for service brake release ② Radio antenna ③ Battery charger jack ④ Fuse Hardware User Guide Rev. 1.0 Robotics Ver. 2.1...

  • Page 27: User Interface

    ① Figure 5 Component Function/Usage Press to lock/unlock the robotics motor brakes. Automatic movement of Robotics is not possible if the brakes are locked: • Button lit: brakes are locked ① LOCK ALL Button • Button unlit: brakes are unlocked The brakes are automatically locked during a self-testing rou- tine at start-up.
  • Page 28 (e.g., using the service application or ExacTrac). In some fault cases, it is necessary to turn Robotics off and then on again before the fault can be cleared. Hardware User Guide Rev. 1.0 Robotics Ver. 2.1...

  • Page 29: Service Lock

    The operating condition of the Service Locks is indicated by the arrow on the rotary knob. Make sure you always turn both knobs fully into their mechanical end-positions, indicated by LOCKED and UNLOCKED. Hardware User Guide Rev. 1.0 Robotics Ver. 2.1...

  • Page 30: On/Off Switch

    The ON/OFF Switch switches Robotics on and off. They are il- luminated to indicate standby operation. It is recommended to switch Robotics off to save battery power if the device is not be- ing used for patient positioning. • The ON/OFF Switches on both sides of the device must be switched on to power up the device.

  • Page 31: Caudal End

    ② ④ ③ Figure 10 Component ① Radio Antenna ② Battery Charger Jack ③ Fuse ④ Charger Cable Warning Do not touch the patient and the fuse holder at the same time. Hardware User Guide Rev. 1.0 Robotics Ver. 2.1...

  • Page 32: Remote Control Using The Radio Transmitter

    ② Movable antenna axis to the shaft points towards Robotics. NOTE: Do not place solid objects between the radio antenna at the foot end of Robotics and the external radio module. EMC Notes This Medical Electrical Equipment needs special precautions regarding EMC and must be installed and put into service accordingly by Brainlab service staff and/or authorized service partners.

  • Page 33: Operating Robotics

    Safety Notes Warning Be aware of risk of injury due to remote controlled operation of Robotics. Make sure that you always have an unobstructed view of the patient when operating Robotics, especially when you perform movements from outside the treatment bunker. Adjust the in-room camera system if necessary.

  • Page 34: Couch Set-Up Verification When Not Using Robotics

    Couch Set-up Verification When not Using Robotics General Information When ExacTrac or Robotics is not used for patient positioning, Robotics shall be aligned in its center position. It is recommended to verify the correct alignment using the supplied water level before patient treatment.

  • Page 35: Maneuvering Robotics During Non-Patient Operation

    You can maneuver Robotics during non-patient operation using the Robotics Service Application. Warning Do not use the Robotics Service Application for the purpose of patient setup before and during radiation treatment. Automatic Cancellation If a maneuver request is not confirmed within three minutes, the request is cancelled automatically.
  • Page 36 • The position is also shown graphically as a single green dot ④. NOTE: Be aware that the position of Robotics as displayed is only a principal orientation guide. The graphical display of the overall operating range (displayed as a diamond shape in this tab) is not to scale.
  • Page 37 ②. When the target position is reached the dot turns green. Select Go to send the maneuver request to Robotics. A dialog displays the set-up movement: Select Acknowledge to confirm your pre-selection or Cancel to cancel the operation.
  • Page 38 To cancel a maneuver, select Stop at the top of the application window. How to Perform a Homing Procedure If a system error occurs, Robotics may perform a homing procedure for QA reasons. Homing means bringing the lifting mechanic into its initial position, to perform an automated internal synchronization of all positioning sensors of the device.
  • Page 39 ROBOTICS Figure 12 Step In the Maneuver tab, select Home to move Robotics to the home position. Enable the movement by pressing both buttons on the confirmation device. How to Shut Down the Robotics Service Application Step Click Off in the upper-right edge of the screen.
  • Page 40 • Click Cancel to confirm that you do not want to reposition Robotics, or • Click Retry to again try to set the final Robotics position to the home or center posi- tions. Hardware User Guide Rev. 1.0 Robotics Ver. 2.1...

  • Page 41: Message Boxes And System Warnings

    Unplug the Battery Charger and click OK for confirmation. Movement is not possible as Robotics is locked manually by LOCK ALL. Press LOCK ALL to un-lock Robotics and click OK for confirmation. Movement is not possible as Robotics is locked manually by the Service Lock.
  • Page 42 Robotics has not been moved to a valid default position. Ensure to reposition Robotics prior to patient treatment. If you decided to skip the final adjustment of Robotics’ po- sition at application shut down, the message box requires you to confirm this a second time by clicking Cancel. To try to position Robotics, click Retry.
  • Page 43 Verify the available clearance before movement. Acknowledge your selection or press Cancel to adjust your movement schedule. Hardware User Guide Rev. 1.0 Robotics Ver. 2.1...

  • Page 44: Using The Anti-Skid Mat

    Using the Anti-Skid Mat 2.4.5 Using the Anti-Skid Mat General Information The Brainlab Anti-Skid Mat can be placed on the couch top beneath the patient for more comfort when performing table tilting. Anti-Skid Mat Figure 13 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 45 ROBOTICS 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 Warning Radiation attenuation will vary depending on beam energy and the beam entry angle through the Anti-Skid Mat.

  • Page 46: Switching Robotics On/Off

    Switching Robotics On/Off 2.4.6 Switching Robotics On/Off General Information If Robotics is not being used for patient positioning, Brainlab recommends switching the device off to save battery power. Hardware User Guide Rev. 1.0 Robotics Ver. 2.1...

  • Page 47: Charging The Battery

    The battery is designed to be used for one day of normal clinical application. Recharging a completely empty battery requires approximately eight hours. Brainlab recommends recharging the battery over night or over the weekend. Battery Type 12 V VRLA, (Model Type: Panasonic R123R4P): Four batteries connected in series produce a nominal voltage of 48 V DC.
  • Page 48 Charger LED lights, indicating an active power input from the Battery Charger to Robot- ics. Robotics starts charging the battery indicated by the blinking of the Battery Status LED. Once the battery is fully charged, the LED is lit continuously, indicating that the device is fully operational.
  • Page 49 ROBOTICS NOTE: Robotics can also be charged even if the device is switched off. Hardware User Guide Rev. 1.0 Robotics Ver. 2.1...

  • Page 50: Battery Charger

    Safety Notes Warning Use only the Battery Charger provided by Brainlab to charge the battery or operate Robotics. Use this Battery Charger only for charging or operation of Robotics. Warning Usage and connection of components other than those as specified by Brainlab for that...

  • Page 51: Cleaning

    ROBOTICS Cleaning General Information Clean Robotics 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. 1.0 Robotics Ver. 2.1...

  • Page 52: Maintaining The System

    To avoid personal injury or system damage due to clamping between moving parts of the device, the cover of Robotics must be mounted properly and show no damage. Do not operate Robotics if a cover is damaged or has been removed.

  • Page 53: Service Brake Release

    Service Brake Release General Information If an internal failure of Robotics 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 54 When in the correct position, release the button to engage the drive brakes. Insert the plastic cap again to cover the hole. NOTE: While the Service Brake Release button is pressed, Robotics does not react to any drive command from ExacTrac.

  • Page 55: Using The Service Locks

    2.7.3 Using the Service Locks General Information Brainlab recommends locking Robotics 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 Step Move the Imaging Couch Top to the home position, (e.g., by using the Robotics Serv-...

  • Page 56: Battery Maintenance

    2.7.4 Battery Maintenance Charging Tab The Charging tab in the Robotics Service Application enables you to track battery voltage and current during the current charging process or to check previous charging cycles. This can help you judge the battery condition.
  • Page 57 Decommissioning the Battery Warning If Robotics is not expected to be used for an extended period of time, the battery should be removed and stored separately. The battery must only be exchanged by Brainlab service staff and/or authorized service partners.
  • Page 58 How to Display a Charging Log Important key parameter values of the last four charging cycles are stored automatically in Robotics. This log file can be uploaded from the device. This functionality is only available when the charger is unplugged.
  • Page 59 You can view, in real-time, the current charging process in the Charging tab. This provides more detailed information about the current battery condition. Step Select the Charging tab. Plug in the battery charger. Recording the charging curve begins immediately when the charger is plugged into Ro- botics. Hardware User Guide Rev. 1.0 Robotics Ver. 2.1...
  • Page 60 Battery Maintenance Step The Charging tab displays the battery voltage in conjunction with the charging current in real-time. A defective battery can be detected by a change in charging characteristics. Hardware User Guide Rev. 1.0 Robotics Ver. 2.1...
  • Page 61 How to Save a Charging Cycle Both charging logs and current charging cycles can be saved to disk for documentation. Step Select Save Record at the bottom of the Charging tab ①. ① Hardware User Guide Rev. 1.0 Robotics Ver. 2.1...

  • Page 62: Retrieving Version Information

    Select the Version tab. This displays the: • Licensee • Firmware checksum In addition, this displays the version numbers of: • The Robotics Service Application • The corresponding DLL • The Robotics Firmware version Hardware User Guide Rev. 1.0 Robotics Ver. 2.1...

  • Page 63: Robotics 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 64: Damaged Equipment

    • Switch off the system and immediately disconnect from the utility power. • Remove the fuse • Contact Brainlab support • Attach a suitable notice such as “DO NOT USE” to the equipment to prevent it from being used inadvertently Hardware User Guide Rev. 1.0 Robotics Ver. 2.1...

  • Page 65: Returning Damaged Equipment

    3.2.2 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 66: Regulatory Information

    MPT N°. 37, 1981), Article 2, Paragraph 1, Item 19, “2.4GHz band wide band low power data communication system” Robotics 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 67 ROBOTICS SAFETY TECHNICAL INSPECTION Warranties do not apply to products that have been modified or replaced without written authorization by Brainlab. Hardware User Guide Rev. 1.0 Robotics Ver. 2.1...

  • Page 68: Emc Notes

    Guidance and Manufacturer's Declaration - Electromagnetic Emissions Robotics is intended for use in the electromagnetic environment specified below. The customer or the user of the Robotics should assure that it is used in such an environment. Emissions test Compliance...
  • Page 69 NOTE: UT is the a.c. mains voltage prior to application of the test level. Guidance and Manufacturer's Declaration - Electromagnetic Immunity Robotics is intended for use in the electromagnetic environment specified below. The customer or the user of Robotics should assure that it is used in such an environment. Immunity Test Compliance...
  • Page 70 RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Robotics is used exceeds the applicable RF compli- ance level above, Robotics should be observed to verify normal operation. If abnormal perform- ance is observed, additional measures may be necessary.
  • Page 71 NOTE: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. Hardware User Guide Rev. 1.0 Robotics Ver. 2.1...
  • Page 72 EMC Notes Hardware User Guide Rev. 1.0 Robotics Ver. 2.1...
  • Page 73 Hardware User Guide Rev. 1.0 Robotics Ver. 2.1...
  • Page 74 Hardware User Guide Rev. 1.0 Robotics Ver. 2.1...

  • Page 75: Index

    68 EMC..................32,68 user guides.................15 fault LED..................28 version information..............62 FCC.................... 66 fuse..................26,31 warning labels, robotics............22-24 Warranty..................66 guides..................15 waste electrical and electronic equipment (WEEE)......6 inspections, robotics..............52 Japan, regulations..............66 labels..................22-24 Hardware User Guide Rev. 1.0 Robotics Ver. 2.1...
  • Page 78 Art-No. 60921-24EN *60921-24EN*...

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