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HexaPOD evo RT System

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1. Figure 30 System Overview window Subsystems On the right hand side there are several control buttons which are explained in the control buttons following table Table 9 The Subsystems control buttons C Connects all subsystems _ Connect to all subsystems Performs all safety checks one after the other Run checks HexaPOD evo RT System 09 001 1068_EN User Manual Rev 1 1 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Page 53 Performing Initialization and Safety Checks The System Overview Window Table 9 The Subsystems control buttons Logs out of the iGUIDE software Usually this button is not visible It is visible only at the iGUIDE software start for a very short time and in the case of connection problems to substitute the key Moves the robotic couchtop to its lowest position Use this position for patients to get on and off the robotic couchtop Moves the robotic couchtop to its START position This is the position with optimum movement range The iGUIDE software will prompt the user to enable the robotic couchtop to move This should be done prior to patient set up Subsystem On the left hand side the several subsystem symbols are displayed They are symbols explained in the following table Table 10 Subsystem symbols Measuring System s Chap 7 Displays the status of the external imaging system S Signal Interface Chap 7 Displays the status of the devices o
2. Figure 19 HexaPOD OFF Button The robotic couchtop shuts down the HexaPOD ON LED goes off 09 001 1068_EN Rev 1 1 Page 40 HexaPOD evo RT System User Manual 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Operating the HexaPOD evo RT System Operating the iGUIDE Software 3 2 Operating the iGUIDE Software 3 2 1 Starting and Shutting Down the iGUIDE Software Using the iGUIDE Key With the iGUIDE key you can activate and deactivate the iGUIDE software Table 7 Function of the iGUIDE Key Sse iGUIDE ON 12 o clock The iGUIDE software is active o _isupe Before you start the GUIDE workstation the key has to be switched to this position iGUIDE OFF 3 o clock The GUIDE software is inactive The HexaPOD evo system will not be used for patient ee positioning and monitoring _iguwe In this position the HexaPOD evo system cannot set the EXTERNAL INHIBIT signal Move the iGUIDE key to this position to shut down the iGUIDE software Figure 20 Location of the iGUIDE Key on the EnableSwitch Board Note For a description of the EXTERNAL INHIBIT signal please refer to Section 1 7 2 Safety Features on page 21 HexaPOD evo RT System 09 001 1068_EN User Manual Rev 1 1 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Page 41 Operating the HexaPOD evo RT System Operating the iGUIDE Software Note Note 09
3. 0 000 ee eee 153 HexaPOD evo RT System 09 001 1068_EN User Manual Rev 1 1 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Page 7 Table of Contents Blank page 09 001 1068_EN HexaPOD evo RT System Rev 1 1 User Manual Page 8 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Section 1 1 1 2 1 3 1 4 1 5 1 6 1 7 1 8 1 9 Before You Begin Before You Begin Title Page About this User Manual T a a R Intended Use of the HexaPOD evo RT System sessessessessessossossossessossessessess ID Requirements on the User OTE TE AIAI OIEA POETE OI AE TEEN L Required Environment E EA EESE Ee TEETE ee Tee ee EEE ES PEE EAAS ee eT eT Z Labelling TTT 2 one Compatibility and Compliance sss ss sss sss sss s scs s sss css cease neeaaea aaeeea aeaaeae ID Safety Te REEE TT EIEEE Le eT eT S ANA EPEE E EET TT ETE T IEC 62353 Test TETHER Z T E HexaPOD evo RT System 09 001 1 User Manual 2012 Medical Intelligence Medizintechnik GmbH All rights reserved 068_EN Rev 1 1 Page 9 Before You Begin Blank page 09 001 1068_EN HexaPOD evo RT System Rev 1 1 User Manual Page 10 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Before You Begin About this User Manual 1 1 About this User Manual The intention of this User Manual is to assist you in the safe and effective operation and maintenance o
4. Managing the iGUIDE Software Getting Support Note 7 7 09 001 1068_EN Rev 1 1 Page 118 Misc DefaultSlot Defines the slot in which the reference frame is assumed to be located for treatments It has no effect on the Correlation Check RTMStep Defines whether the HexaPOD evo system is responsible for performing Relative Table Movements RTMs When you deactivate RTMs RTMs for any treatment sites that are opened in the iGUIDE software will be deleted They will not be restored when RTMs are reactivated Specification RTMCoordinateSystem Defines the coordinate system used for RTMs Getting Support If you are not able to resolve the problem yourself you can contact the manufacturer for support You can help the manufacturer support you as follows Take screen dumps and provide descriptive comments by pressing the PRINT button see Section 7 3 Getting Information from Users on page 108 Get the most recent log files from the GUIDE software See Section 7 6 4 Getting iGUIDE Log Files on page 116 When requested by the manufacturer start a remote service session so that the manufacturer representatives have direct access to the iGUIDE workstation See Section 7 6 5 Starting an IntelliMax Remote Session on page 116 HexaPOD evo RT System User Manual 2012 Medical Intelligence Medizintechnik GmbH All rights reserved 7 8 Note Managing the iGUIDE Software HexaPOD evo RT System Property Scr
5. OFF Translational movements are activated MOVEMENT PENDING LED ON A movement has been requested Press the OPERATE button and the ENABLE buttons to allow the movement to be executed OFF No movements pending The MOVEMENT PENDING LED should light up when you press a movement button Not in use Movement Buttons The label on each button shows the corresponding movement Press and hold the ENABLE buttons and one of the movement buttons to move the robotic couchtop The ROT TRANS LED shows if rotations or translations are active ROT TRANS button Pressing this button toggles between rotations and translations The ROT TRANS LED shows if rotations or translations are active 09 001 1068_EN HexaPOD evo RT System Rev 1 1 User Manual Page 134 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Description of the System Components Handheld Controller Table 31 Buttons and LEDs on the HHC OPERATE Button The OPERATE button must be pressed with the ENABLE buttons to allow pending movements indicated by the MOVEMENT PENDING LED to be execute ENABLE Buttons 2 These buttons must be pressed and held together with either the OPERATE button or a movement button to enable movements of the robotic couchtop Note If you fix the HHC at one of the side rails of the robotic couchtop be careful that you safely position it between two faste
6. e the calibration tolerance of the treatment room lasers is lt 0 5 mm Figure 35 iGUIDE Reference Frame aligned to the room lasers 1 The Alignment Check is started in the check series when you click the Run checks button You can start the Alignment Check separately by clicking Alignment Check in the Isocenter Manager status dialog box Then follow the instructions on the screen to do the Alignment Check 2 The GUIDE software displays the following dialog E Alignment Check Figure 36 Mount the reference frame for Alignment Check Mount the reference frame in the required slot and click OK 3 The GUIDE software sends movement commands to the robotic couchtop It may be necessary to first move the Precise Table You have to enable the movements of the robotic couchtop using the HHC or ESB HexaPOD evo RT System 09 001 1068_EN User Manual Rev 1 1 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Page 59 Performing Initialization and Safety Checks Performing the Safety Checks WARNING Troubleshooting 09 001 1068_EN Rev 1 1 Page 60 4 When the reference frame has reached the registered location the iGUIDE software prompts you as to whether the reference frame is aligned with the lasers Alignment Check Check carefully the incorrect answer can lead to incorrect positioning Is the reference frame exactly aligned with the lasers Figure 37 Verifying the alignment of the iGU
7. 1 7 1 WARNING Before You Begin Safety Safety Medical Intelligence took every reasonable precaution during manufacture to safeguard the health and safety of the users that operate this equipment You must obey the precautions listed in this section at all times In the case of injury to persons or damage to material the manufacturer s responsibility according to the certificates will no longer apply if e you did not obey the safety directions in this section and or e if you used the equipment improperly i e not in accordance with the intended use see Section 2 1 Introduction to the HexaPOD evo RT System on page 29 Important Safety Directions Medical Intelligence designs all products in order to meet stringent safety standards All medical electrical equipment requires proper installation operation and maintenance particularly with regard to safety e The HexaPOD evo RT System must be operated only by qualified trained and authorized personnel The personnel must read and obey all warnings instructions and other information in this User Manual e Never use the HexaPOD evo RT System if you know or if you have any reason to think that any part of the equipment is defective or adjusted incorrectly Only trained and authorized service personnel is allowed to repair the equipment e Before you use the HexaPOD evo RT System always make sure that the daily safety checks were satisfactorily completed and tha
8. A _8 c D O E DF 5 G E Relative RF pos TX 2 87 cm TY 25 58 cm TZ 0 67 cm RX 0 18 deg RY 0 01 deg RZ 0 73 deg 4 Figure 75 Relative reference frame position HexaPOD evo RT System User Manual 2012 Medical Intelligence Medizintechnik GmbH All rights reserved 6 7 Note Positioning the Patient Monitoring the Patient during Irradiation Monitoring the Patient during Irradiation During irradiation the iGUIDE software does not monitor the robotic couchtop position The GUIDE software waits for the TREATMENT BEAM signal to arrive from the Linac When the TREATMENT BEAM signal is on the following dialog box appears Figure 76 Treatment in progress When the TREATMENT BEAM signal is on the Position Guard is not active also refer to Position Guard indicator on page 82 and movements of the robotic couchtop are blocked When the TREATMENT BEAM signal is off the Position Guard is active also refer to Position Guard indicator on page 82 Always monitor the patient while irradiation is in progress Immediately stop irradiation if the patient moves WARNING Note Watch the TREATMENT BEAM LED on the EnableSwitch Board If the LED stays OFF during irradiation put the system out of service and call the technician HexaPOD evo RT System 09 001 1068_EN User Manual Rev 1 1 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Page 97 Positioning the Patient H
9. Principal Workflow 2 3 Principal Workflow Starting the HexaPOD evo RT Start Operations System see 3 1 Logging in the iGUIDE Software see 3 2 1 Performing Movements see 3 3 Mounting the iGUIDE Reference Frame see 3 4 Initialization Procedure see 4 2 Performing the Safety Checks see 4 3 Working on the Patient Record Patient Management see 5 2 Managing the Patient Treatment Sites see 5 3 Opening a new Fraction see 6 2 Initialization and Checks Patient Positioning Registering the Patient see 6 3 Performing the Relative Table Movements see 6 4 Handling the Correcting the Positional Error Alert see 6 8 see 6 5 Verifying the Patient Position Position Guard see 6 6 Monitoring the Patient during Radiation see 6 7 Closing the Fraction see 6 9 Figure 9 Principal workflow HexaPOD evo RT System 09 001 1068_EN User Manual Rev 1 1 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Page 31 Overview of the HexaPOD evo RT System Coordinate Systems Used by the iGUIDE Software 2 4 GUIDE software coordinate systems for RTM 09 001 1068_EN Rev 1 1 Page 32 Coordinate Systems Used by the iGUIDE Software Different coordinate systems are used by the iGUIDE software to match to the coordinate system of the Linac and the treatment
10. Rot deg IEC61217 Coordinate System Cancel l Figure 23 Manual Precise Table rotations and moves requested When the robotic couchtop has reached the target position the dialog box will close HexaPOD evo RT System 09 001 1068_EN User Manual Rev 1 1 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Page 45 Operating the HexaPOD evo RT System Performing Movements 3 3 2 WARNING 09 001 1068_EN Rev 1 1 Page 46 Enabling HexaPOD evo RT Couchtop Movements Never enable movements of the robotic couchtop while imaging is in progress Movements of the robotic couchtop must be enabled with either the ESB or HHC before they can be carried out The following dialog box appears when a movement of the robotic couchtop is required E Move HexaPOD to START Ay Move HexaPOD to START Press m ws Enable the movement until the HexaPOD reaches its destination Press EnableSwitch Board Press the OPERATE buttons Handheld Controller Press the OPERATE button and ENABLE buttons registration Cancel this move only if you have already scanned the patient but have not yet This move brings the HexaPOD to the START position This move is mandatory after registered the patient lt O aS Figure 24 Dialog when movements required The MOVEMENT PENDING LEDs on the ESB and HHC also indicate when a movement of the robotic c
11. This allows you to get quick assistance for problems with the GUIDE workstation 09 001 1068_EN HexaPOD evo RT System Rev 1 1 User Manual Page 116 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Managing the iGUIDE Software Diagnostic Tools The IntelliMax remote session stays active until e You click End session in the IntelliMax Connect box e You log off e The remote personnel ends the session Note As long as the Session status is active remote personnel have access to the iGUIDE workstation When you end the active IntelliMax session no remote access to the iGUIDE workstation is possible Configuring the HexaPOD evo RT System When you click the iGUIDE Configurator symbol the iGUIDE Configurator appears CameraLog CommunicationLag HesapodLog Interlock Log Figure 96 iGUIDE Configurator Logger The iGUIDE Configurator is used for making some basic hardware settings and for defining the log level Logger Normally the log level for all logs should be Off If you run into problems with the system you may be requested to activate logging Setup You have the following possibilities for setting up the HexaPOD evo system DefaultStat A ATM Step Yes El Specification ATMCoordinateSyster IEC61217 Figure 97 iGUIDE Configurator Setup HexaPOD evo RT System 09 001 1068_EN User Manual Rev 1 1 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Page 117
12. set Note Make sure no other system is setting the EI Figure 90 Verifying that the EXTERNAL INHIBIT Signal is set The signal interface now releases the interlock The GUIDE software prompts you again as to whether the EXTERNAL INHIBIT signal is visible on the Linac If the EXTERNAL INHIBIT signal is no longer visible which should be the case click El not set Interlock Check Is the External Inhibit EI set Note Make sure no other system is setting the EI EEDS Figure 91 Verifying that the EXTERNAL INHIBIT Signal is released If the EXTERNAL INHIBIT is still visible check if it may be coming from other equipment Running the Alignment Check The Alignment Check moves the robotic couchtop so that the reference frame is aligned to the room lasers This allows you to verify that there the calibration has not been changed which occurs for example if the camera is moved To run the Alignment Check 1 HexaPOD evo RT System User Manual Click the Isocenter Manager symbol with the left mouse button The Isocenter Manager status box opens Click Alignment Check Isocenter Perform Checks Alignment Cre System Calibration Figure 92 Starting the Alignment Check 09 001 1068_EN Rev 1 1 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Page 113 Managing the iGUIDE Software Diagnostic Tools 3 When prompted mount the reference frame to the robotic couchtop
13. 1 1 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Page 101 Positioning the Patient Closing the Fraction Blank page 09 001 1068_EN HexaPOD evo RT System Rev 1 1 User Manual Page 102 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Managing the iGUIDE Software 7 Managing the iGUIDE Software Section Title Page 7 1 iGUIDE Software Management Tasks sss sss ss sss sss sa caaeaae aeaaea eanas sas 105 7 2 Managing iGUIDE Users ee eT ee ee eT ne TNT eee Re eT Meee T 7 3 Getting Information from Users sss ss ss sss css ss cs asse sacs esaeen eaae eana aeaaeae 108 7 4 Identifying Startup Problems LAA a a a a a a a a a a a a a a a a a a a a a a a a a a a a a a a a a d a a a a a a a a a a a aa a a a a a a a a a a a a a OH 1 08 7 5 Running the Daily Safety Checks A a N N 7 6 Diagnostic Tools LA a a a a a a a a a a a a a a a a a a a a a a a a a a a a a a a a a a a a a a a a a a a a a a a a a a a a a a a a a a a a a a AAA a a a a a a a a a AA 114 7 7 Getting SUOT auido ee oes 118 7 8 HexaPOD evo RT System Property Screens sss ecce ea a a aa as asas ss ennenen aana aaas 119 HexaPOD evo RT System 09 001 1068_EN User Manual Rev 1 1 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Page 103 Managing the iGUIDE Software Blank page 09 001 1068_EN HexaPOD evo RT System Rev 1 1 User Manual Page 104 2012 Medical Intelligence
14. 1 1 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Page 121 Managing the iGUIDE Software HexaPOD evo RT System Property Screens The following properties are available for the Camera Table 23 Camera properties en O i Shows or hides the display of the volume being tracked All markers of the reference frame or calibration tool must be within this volume to be tracked Camera volume button Show Show grid button button Shows or hides the grid 1x1 kea 2x2 Switches between a 1 x 1 display one perspective or 2 x 2 button display 4 perspectives Shows the current tracked positions of the reference frame and Current positions calibration tool Display Shows different perspectives of the treatment area Measuring System s Properties System Overview Subsystems Measuring System s Figure 101 Measuring System s properties The following properties are available for the Measuring System s Table 24 aa T System s properties p Description S a n ilaina Disables enables the data transfer function button Disconnect Disconnects connects the communication to the measuring Connect button system l l Shows the connection and data transfer events for the current Imaging history seca 09 001 1068_EN HexaPOD evo RT System Rev 1 1 User Manual Page 122 2012 Medical Intelligence Medizintechnik GmbH All rights reser
15. 3 Editing a Treatment Site 1 Select the treatment site that you intend to edit in the Patients list 2 Click the Edit Treatment Site button The Edit Treatment Site dialog box is opened 3 Edit the necessary information Edit Treatment Site 9 I Edit Treatment Site Treatment Site newR Relative Table Movement TX L_ ijem TY cm TEL cm IEC61217 Coordinate System Figure 53 Click on a field in order to allow the modification of its content 09 001 1068_EN HexaPOD evo RT System Rev 1 1 User Manual Page 76 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Managing Patient Data Managing the Patient Treatment Sites 4 Once you have finished all modifications click Save The modified values are displayed in the Patients window Patients i S gt Test Patient 1 12345678901 Patient ID 05432 gt Test Patient 2 12345678902 s ar T Susan 4 Miller Susan 05432 Last Name Susan Pelvis Date of birth 1 1 1990 Sex newRTM notes Comment Relative Table Movement TK L 00 enm TY __2 00Jem TZ __4 00 em IEC61217 Coordinate System Fraction Event History Logged in as Christine Operator Figure 54 The newly defined RTM values Note The used coordinate system is shown under the Relative Table Movement values in the example above it is 1EC61217 Coordinate System This will be displayed if selected For additional information refer to Section 2 4 Coordinate Systems Used
16. 65 Separation distances 155 Show Ethernet Config 116 Signal Interface 54 136 properties 120 Slot reference frame 85 Start IntelliMax Remote Session 116 START position HexaPOD evo Couchtop 54 moving the robotic couchtop 85 Starting errors 108 Status Position Guard 82 Subsystem connecting 55 control buttons 53 symbol 54 55 Switching on HexaPOD evo RT Couchtop 40 HexaPOD evo RT System 39 Symbol subsystem 54 Synergy CS coordinate system 33 System Overview window 353 09 001 1068_EN Rev 1 1 Page 160 T Tabletop HexaPOD evo RT Couchtop 131 Technical data 149 Test IEC 62353 23 Tools properties 123 Tracking System 138 Training requirements 13 TREATMENT BEAM signal 35 97 Treatment site 63 adding 75 deleting 78 displaying information 72 editing 76 managing 71 Troubleshooting close fraction 100 PE correction 94 screenshot 44 startup problems 108 U User managing 106 requirements 13 rights 107 V Verifying patient position 95 reference frame position 95 reference frame slot 85 W Warning 12 Workstation logging in 105 X XVI coordinate system 33 pinging 115 XVI system automatic PE transfer 89 manual PE correction 92 positional error transfer 87 HexaPOD evo RT System User Manual 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Blank page HexaPOD evo RT System 09 001 1068_EN User Manual Rev 1 1 2012 Medical Intelligence Medizintechnik GmbH
17. 92 65 5 lt TroubleshOotne lt lt 0445 50 8 nea een OF ey oe eee Oe A Ok 3 HER ARS 94 66 Veniyine the Patient Position 2 oot e bie taa e ete A we kad we a a 95 6 7 Monitoring the Patient during Irradiation 1 essas ennnen useen reenen eerren 97 68 Elandling the Posion Guard Alert 134 i o aioe ga EA Abas aid We Bane A 98 6 9 Glositie the Facon ennaa 52s as kash be Beh ees ticle ee Ele A cles tae Bs hha a Se Be A Bln Broce Be 100 7 Managing the GUIDE Software 0 cc cece eee eee eee eens 103 7 1 aGUIDE Software Management T asksscs 345d vow d dh ae ea eee Oe ee Ee 105 fea Manaemei1GuUlpe Users 2 lt 1 4606 05etncurceces duos tetas ioetd Sou psceseeecne ed 106 To Getting Informatio froni Users v5 4 histga 4c euee Adio RA ahaa ok ari eae Ox 108 7A Identifying Startup Problems 042k tie ws ood Ae RASA RCSA R OER EBA SERRE TA 108 Ta ATRE the Daily Safety Cnecks s o a esn bedi dow GOs toes dears ene ee a RO Ree 111 70s K Te e T K ee araara gen sia hae As de he Ae a TTT 114 7 6 1 Pinging the HexaPOD Powerbox XVI Workstation or Network Security Solution 115 7 6 2 Viewing the Network Configuration 0 ccc eee cnc ee eee eee eens 116 Zoo Tansan ROM Piles 44 4 4 0 440dae Medea sais sae da ed Daa ek ene CSAS oe 116 OA Getinge IGUIDE Log Files cds cashay gacisoe Guha a ate seb aan ae sa aoe ee Ber a 116 7 6 5 Starting an IntelliMax Remote Session 00 cece cee cee eee ees 116 7 6 6 Configuring t
18. Close Fraction accidently then click Cancel to return The fraction is now complete The iGUIDE software will no longer set the EXTERNAL INHIBIT signal To treat another patient click the Patients button and follow the instructions from Section 6 2 Starting the Patient Positioning on page 84 onwards If you will treat the next patient without the iGUIDE software move the robotic couchtop to the LOAD position If the patient was not treated before Close Fraction there will be an Abort Fraction button instead of Close Fraction You will receive a confirmation message by the GUIDE software Figure 80 Aborting Fraction confirmation 09 001 1068_EN Rev 1 1 Page 100 HexaPOD evo RT System User Manual 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Positioning the Patient Closing the Fraction If you click Yes the following dialog box will appear description see above Do not move HexaPOD Move to LOAD Figure 81 Aborting Fraction dialog Note After closing or aborting a fraction the Position Guard gets deactivated Deactivating the iGUIDE Software during a fraction If a fraction is open and you turn the iGUIDE key to iGUIDE OFF the following dialog box appears Do not move HexaPOD Move to LOAD Figure 82 Closing the fraction using the iGUIDE key The fraction will be closed and the login window is opened HexaPOD evo RT System 09 001 1068_EN User Manual Rev
19. First Name type it in e g Susan e Last Name type it in e g Miller e Date of birth modify the displayed date e g 01 01 1980 Enter the new value manually or click on the arrows on the right side to decrement or increment the value displayed e Sex click the corresponding check box e g Female e Comment type in a comment if needed e g treatment description It is not mandatory to enter a comment All fields are required except the Comment field S Add Patient Add Patient Patient ID First Name Last Name Date of birth 101011990 Sex Male Female Comment Cancel Figure 41 Add Patient dialog box HexaPOD evo RT System User Manual 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Managing Patient Data Working on the Patient Record 3 Click Save The iGUIDE software creates a new patient record The patient data is displayed in the Patients window Patients o p gt Test Patient 1 12343678901 Patient ID gt Test Patient 2 12345678902 s gt Test Patient 4 12345678904 a llr Susan a Last Name me Date of birth 17371990 cx notes Comment Treatment Site Overview Treatment Site Last Opened Fractions 1 25 2011 0 Logged in as Christine Operator Figure 42 New patient The Add Treatment Site dialog box is opened 4 If desired you can enter the RTM values for the new patient for a description of RTMs refer to Section 2
20. ISM bands Radiated RF 3 V m IEC 61000 4 3 80 MHz to 2 5 GHz for 80 MHz to 800 MHz d VP for 800 MHz to 2 5 GHz where P is the nominal output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol NOTE 1 At 80 MHz and 800 MHz the limits for the higher frequency range apply NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcasts and TV broadcast cannot be predicted theoretically with accuracy To access the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the HexaPOD evo RT System is used exceeds the applicable RF compliance level above the HexaPOD evo RT System should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re
21. Logging off the iGUIDE Software 41 M Main windows of the iGUIDE Software 43 Managing patient treatment site 71 Manual correction positional error 92 Measuring System 54 Measuring System s properties 122 Mobile phone safety 22 Monitoring patient during radiation 97 Move back 98 Movement of HexaPOD evo RT Couchtop 47 Moving the Linac Precise Table 45 HexaPOD evo RT System User Manual 2012 Medical Intelligence Medizintechnik GmbH All rights reserved N Note 12 NSS pinging 115 O Opening new fraction 84 Operating environment required 14 P Patient 63 adding 66 assist on the robotic couchtop 84 data 65 66 ID 66 management buttons 64 monitoring during radiation 97 registering 8S searching and selecting 65 verifying the position 95 Patient record 65 archiving 69 deleting 70 editing 68 restoring 69 Patient treatment site adding 75 deleting 78 displaying information 72 editing 76 managing 71 Patients window 63 Pause Position Guard 99 PE correction troubleshooting 94 PE positional error 34 87 Performing Alignment Check 59 Correlation Check 57 HexaPOD Enable Check 57 Interlock Check 58 RTM 86 safety checks 56 Ping NSS 115 Ping Powerbox 115 Ping XVI 115 Position reference frame 95 Position Guard 22 35 alert 98 status 82 Positional Error 34 HexaPOD evo RT System User Manual Index Positional error 34 automatic transfer 89 correction values 87 manual correction 92 Positiona
22. Movement l jis Actual Set Stop Field ID View Restrictions d Description E SS S 260 External system has inhibited Radiation Type treatment Energy Energy lies Segment MU 2 Set Segment MU 2 Set Technique Leaves Not Ready X1 Wedge Leaves Not Ready X2 Diaphragm Position Y2 Diaphragm Position Y1 Diaphragm Position X1 Diaphragm Position X2 Prescribed MU Check external system Backup MU 12 Inhibits Dose Hate egmen A p arr OTT Hag Exit Copy to Service A Beam Timer Total MU Figure 34 External Inhibit display on the Elekta Desktop software Troubleshooting If the check fails the Interlock Check is marked with a red x in the Safety Check dialog box Call the system administrator or a service engineer to do a check of the system 09 001 1068_EN HexaPOD evo RT System Rev 1 1 User Manual Page 58 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Performing Initialization and Safety Checks Performing the Safety Checks 4 3 4 Performing the Alignment Check The Alignment Check moves the robotic couchtop so that the reference frame is aligned to the room lasers This verifies that the calibration has not been changed which occurs for example if the camera is moved This check requires that e the treatment room lasers are calibrated e the treatment room lasers were not changed since the last GUIDE software set to work procedure and
23. Patient Registering the Patient When you open a new fraction the HexaPOD system automatically raises the EXTERNAL INHIBIT signal refer to Section 6 1 The Positioning Window on page 81 Moving the robotic couchtop to its START position When opening a fraction the iGUIDE software prompts you automatically to move the robotic couchtop into its START position This movement should only be enabled once the patient is safely on the robotic couchtop The START position allows the robotic couchtop the maximum range of movement possible for PE corrections You must ensure that the robotic couchtop has reached this position before using the Precise table to align to the patients external surface markings e g tattoos marks on shells or to cover sheets to the treatment rooms lasers Verifying the reference frame slot Once the patient is aligned to the room lasers you can mount the reference frame After you have mounted the reference frame you must check that the assumed position as displayed in the Positioning window corresponds to the actual position Assumed RF slot A B c D E G ES Figure 58 Assumed slot for reference frame indication If the reference frame is mounted in another slot click the corresponding radio button The new selection is shown as follows Selected RF slot e A B C D DE G ES Figure 59 Selected slot for reference frame indication After you register the patient you can no longer change the slot for
24. RT Couchtop 40 128 Coordinate system iGUIDE Software 32 of XVI 33 Correlation Check 111 Performing 57 starting 54 HexaPOD evo RT System User Manual Index Index D Daily QA procedure 53 56 Deleting a patient record 70 patient treatment site 78 Desktop showing 105 symbols 105 Diagnostic Tools overview 114 Disclaimer 11 Disinfecting 144 Displaying patient treatment site 72 Disposal 145 Documentation for HexaPOD evo RT System 12 Dosimetric properties HexaPOD evo RT Couchtop tabletop 132 E Editing a patient record 68 patient treatment site 76 Electromagnetic compatibility 22 Electromagnetic environment EME requirements 152 EMI requirements 153 separation distances 155 EMC electromagnetic compatibility 22 EME requirements 152 Emergency procedures 22 EMI requirements 153 EN 60601 coordinate system 32 EN 61217 coordinate system 32 Entering RTM values 67 75 Environment anaesthetic 14 required 14 Errors starting 108 ESB EnableSwitch Board 136 Ethernet configuration 116 Extensions HexaPOD evo RT Couchtop tabletop 131 EXTERNAL INHIBIT signal 22 58 09 001 1068_EN Rev 1 1 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Page 157 Index F Final disposal 145 Fraction 63 closing 100 opening 84 Fraction Event History 72 details 74 H HexaPOD Enable Check 111 performing 57 starting 54 HexaPOD evo RT Couchtop 128 control panel 40 128 dosimetric properties 132 m
25. Rev 1 1 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Page 91 Positioning the Patient Correcting the Positional Error 6 5 2 Manual Positional Error Transfer You may correct the Positional Error manually if you have a version before XVI R4 5 if your system is configured for manual PE correction or if problems occur at the automatic transfer from XVI see Section 6 5 1 Automatic Positional Error Transfer from XVI on page 89 If the automatic transfer from XVI fails then please refer to Enabling manual Positional Error transfer on page 91 and then continue with step 3 below Else do all steps listed below Ensure that the position of the patient does not change between the XVI scan and entering of the PE values from the XVI system WARNING Follow the XVI instructions to get the PE values 2 Inthe Positioning window of the GUIDE software click Imaging completed The Positional Error dialog box is displayed Step through all six entry fields for the correctional position values and enter the values as displayed on the XVI screen For safety reasons you have to enter the values twice Y A a Positional Error Positional Error Transfer Re enter the PE values to confirm Translation Rotation Figure 67 Manual Positional Error Transfer The GUIDE software will not allow you to enter rotations above 2 9 If rota tions of this magnitude occur the user should check the
26. Use of the HexaPOD evo RT System 00000 1 3 Requirements onm the User sich aiwe va Mode Ds ee ORO SSS TA Required Environment 32 4 s0ds25 04a x oa Se sUA Sawa ea ae Sa R58 ky Abe Me 4 44 4 ew ore edd ote Genk es et Geet Oe Sao es eh 1 5 1 Labelling on the Packaging 4 344 ds0 nahh redledwi nennen 1 5 2 Labelling on the HexaPOD evo RT Couchtop 1 6 Compatibility and Compliance 0 0 ccc ee eens LE 5 eirag ae erea ease ts a A Rad We ed cea tence debated Ferel Important Safety Directions 44 4 6 pacnd0s eee Ro oan bees L72 Sale ty Fears 42s cg nated Reet 88 Sige bw hile Re ae a Ld Emergency Procedures 3 44 RRR T KR enei E Rd 1 7 4 Electromagnetic Compatibility EMC and Mobile Phones ko SEC62553 Test estes cure seuss Laedeteaot eee ee eee es bee eee LS AGIOGS ay oc 4 5s oti eat ou omens Sy ae ee eres Bonen reek wie ay aceon 2 Overview of the HexaPOD evo RT System 000000 e eee 2 1 Introduction to the HexaPOD evo RT System nnnnann nennen 2 2 Components of the HexaPOD evo RT System nnn 233 Principal WOrkKMOws Z E be wd acne Aa ew ae aera EE 2 4 Coordinate Systems Used by the GUIDE Software 2 5 How the HexaPOD evo RT System Positions Patients 3 Operating the HexaPOD evo RT System 0 00 00 cee eee 3 1 Starting the HexaPOD evo RT System 0 0 cee ee 3 1 1 Switching on the HexaPOD Powerbox 00 3 1 2 Checking the Status of th
27. and click OK The GUIDE software sends movement commands to the robotic couchtop It may be necessary to first move the Precise Table You have to enable the movements of the robotic couchtop using the HHC or ESB 4 When the reference frame has reached the registered location the GUIDE software prompts you as to whether the reference frame is in the lasers Alignment Check Is the reference frame exactly aligned with the lasers Figure 93 Verifying the alignment of the iGUIDE Reference Frame to the lasers 5 Respond to the prompt as follows Click Yes if the reference frame is aligned to the lasers Click No if the reference frame is not aligned to the lasers Click Cancel to cancel the Alignment Check Note that it will not be possible to treat patients using the HexaPOD evo system until the Alignment Check has been passed The Alignment Check will fail for example if e The room lasers were adjusted e The camera was moved Diagnostic Tools When you click the Diagnostic Tools symbol on the desktop a folder opens with the following advanced troubleshooting tools Diagnostic Table 20 Diagnostic Tools Tools gt Displays the current versions of software components used by the iGUIDE software The manufacturer may request you to provide List I ee Vasa image versions in case of problems a Checks the network communication with the powerbox L See Pinging the HexaPOD Powerbox XVI Wor
28. box safety Checks E Z T i J l A Safety Checks Status HexaPOD Enable Check X Correlation Check yf Interlock Check v Alignment Check e Figure 32 Safety Checks Status dialog The checks are marked as follows e A green tick behind the check means that the check was successfully completed e A red x behind a text means that the check had failed e A check displayed in blue and bold means that the check is being performed at the moment e A check displayed in blue and not bold means that the check is waiting to be started When all checks are completed successfully the Cancel button changes to Close Click it to continue working with the iGUIDE software If a check fails the checks that follow are not started automatically Try and repeat the checks and if they do not pass call the system administrator or a service engineer to do a check of the system HexaPOD evo RT System User Manual 2012 Medical Intelligence Medizintechnik GmbH All rights reserved 4 3 1 Troubleshooting 4 3 2 Note Troubleshooting Performing Initialization and Safety Checks Performing the Safety Checks Performing the HexaPOD Enable Check The HexaPOD Enable Check checks if the OPERATE buttons on the ESB and the OPERATE and ENABLE buttons on the HHC are stucked in the ON position If these buttons were stuck any movement requests sent to the robotic couchtop would be carried out immediately whic
29. cm Translation cm Rotation deg Set Value Actual Value Set Value Actual Value Set Value Actual Value 0 30 0 30 1 30 1 30 0 12 0 13 359 10 359 10 0 02 0 02 0 60 0 60 Synergy Coordinate System Logged in as Christine Operator Figure 68 Positioning window Modifying the PE You have two possibilities for modifying the PE values Please regard the different Values results e Click the Edit PE values button available after step 4 to correct the entered PE values The values will be overwritten e Click the Imaging completed button see step 2 to define the treatment position in relation to the current position after a new scan has been performed Using the Imaging completed button will add the new values to the previous corrections These moves will not be taken from the previous scan position WARNING HexaPOD evo RT System 09 001 1068_ EN User Manual Rev 1 1 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Page 93 Positioning the Patient Correcting the Positional Error 6 5 3 Troubleshooting Values too high If the transferred or entered values are too high the iGUIDE software displays the or wrong 09 001 1068_EN Rev 1 1 Page 94 following dialog box E Positional Error Translation Rotation Maximum limit 3 0 YL 359 1 deg Z deg OOO Figure 69 Too high position values If the values of the first and second ent
30. desired slot slots A G are available and secure it for details refer to Section 8 8 iGUIDE Reference Frame on page 140 Place the reference frame as close to the isocentre as possible without obstructing the treatment fields obscuring the view of the camera on the reference frame or causing a collision with any part of the machine Note The reference frame can only be secured onto the robotic couchtop in the correct direction due to slightly different circumferences of the indexing hole If you try and force the frame on the robotic couchtop in the wrong direction then this can damage the reference frame or the tabletop To gantry Figure 29 IGUIDE Reference Frame e Always make sure that the reference frame is mounted correctly and the mounting system is firmly locked e Do not touch drop or otherwise damage the optical markers WARNING e Do not mount the reference frame so that it is more than 50 cm from isocenter during positioning HexaPOD evo RT System 09 001 1068_EN User Manual Rev 1 1 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Page 49 Operating the HexaPOD evo RT System Mounting the iGUIDE Reference Frame Blank page 09 001 1068_EN HexaPOD evo RT System Rev 1 1 User Manual Page 50 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Performing Initialization and Safety Checks Performing Initialization and Safety Checks Section Title Page 4 1
31. evo Module 48V 800VA l _ P C d US A N X Intertek 3099857 Conforms to UL STD 60601 1 Certified to CAN CSA STD C22 2 NO 601 1 Medical Intelligence Medizintechnik GmbH Robert Bosch StraBe 8 yyyy mm dd 86830 Schwabm nchen Made in Germany Germany Caution Federal law restricts this device to sale by or on order of a physician L10603 100_01_Rev xxx Figure 6 Device plate of the robotic couchtop The appearance of the label and availability of the symbols may vary The symbols on the device plate have the following meaning Table 4 Symbols on the device plate Specific warning if displayed in conjunction with a warning text If displayed without a warning text the user has to refer to the product documentation Manufacturer and the related contact details yyyy mm dd Date of manufacturing Type B applied parts Z Product not to be disposed of in the domestic waste stream HexaPOD evo RT System User Manual 2012 Medical Intelligence Medizintechnik GmbH All rights reserved 1 6 Before You Begin Compatibility and Compliance Table 4 Symbols on the device plate CE marking see CE marking on page 19 ETL marking see ETL marking on page 19 Compatibility and Compliance Compatibility You may only use the HexaPOD evo RT System in combination with other equipment or components if these are expressly recognized by Medical Intelligence as compatible Consult Medical Intelligence
32. open the window For a detailed description of the Patients window and its functions refer to Section 5 1 The Patients Window on page 63 Positioning In the Positioning window you can move and control the robotic couchtop to the final intended position for treatment You open the Positioning window by clicking the Open Fraction for Positioning button after you have selected a treatment site in the Patients window Positioni Note The button is not clickable For a detailed description of the Positioning window and its functions refer to Section 6 1 The Positioning Window on page 81 HexaPOD evo RT System 09 001 1068_EN User Manual Rev 1 1 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Page 43 Operating the HexaPOD evo RT System Operating the iGUIDE Software 3 2 3 Capturing a Screenshot for Error Reporting In the case of troubles you can create a screenshot by pressing the Print Screen key on the keyboard A dialog box will be opened where you can see the screenshot and should enter your comments Pesitioneeg Tes Patient 4 17 456 re90e Optionally enter a comment Figure 22 Screenshot for troubleshooting After clicking OK the screenshot is saved Notify the iGUIDE administrator 09 001 1068_EN HexaPOD evo RT System Rev 1 1 User Manual Page 44 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Operating the HexaPOD evo RT System
33. patient position Note Multiple significant rotation correction values can be an indication that the patient was not set up correctly 09 001 1068_EN HexaPOD evo RT System Rev 1 1 User Manual Page 92 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Positioning the Patient Correcting the Positional Error 4 Confirm the PE correction by clicking the Move button Note The Edit PE values button is activated when you click the Move button You can use Edit PE values button to modify the PE values See below for details 5 If necessary move the Precise Table as shown in the movement hints refer to Section 3 3 1 Moving the Linac Precise Table on page 45 6 Enable the movement of the robotic couchtop by pressing the ENABLE buttons on the ESB refer to Section 3 3 2 Enabling HexaPOD evo RT Couchtop Movements on page 46 The robotic couchtop will now move to the final treatment position 7 Before starting treatment continue with Section 6 6 Verifying the Patient Position on page 95 The Position Guard constantly monitors the position of the robotic couchtop see Section 6 8 Handling the Position Guard Alert on page 98 Positioning Miller Susan 05432 Se Assumed RF slot A F G IS Absolute RF position TX 1 981 cm TY 2 79cm TZ 10 68 cm RX 2 38 deg RY 0 39 deg RZ 2 32 deg 4 Treatment Site newRTM Relative Table Movement Positional Error Translation
34. planning system In order to avoid misunderstandings and possible clinical mistreatment it is vital that the treatment planning system the iGUIDE software and the Linac use the same coordinate system The iGUIDE software can be configured in either the EN 61217 coordinate system or the EN 60601 coordinate system refer to Section 7 6 6 Configuring the HexaPOD evo RT System on page 117 The configuration setting cannot be changed by an operator The coordinate system currently being used by the iGUIDE software is displayed context sensitively on the GUI In the following example the IEC61217 Coordinate System is used for the RTMs and is displayed below its values Relative Table Movement TX 0 cm T L 0 cm TZ 0 cm Figure 10 Coordinate system button below the RTM values If you click on it you will get a 3D view of the respective coordinate system Figure 11 Display of the coordinate system according to EN 61217 Figure 12 Display of the coordinate system according to EN 60601 HexaPOD evo RT System User Manual 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Overview of the HexaPOD evo RT System Coordinate Systems Used by the iGUIDE Software XVI coordinate system for PEC The XVI coordinate system that is used for PE correction is different to both the EN 60601 and the EN 61217 coordinate system see Section 6 5 Correcting the Positional Error on page 87 For PE correction
35. relevant patient marking have been aligned to treatment room lasers Displays the status of the Relative Table Movements Displays the status of the Positional Error Correction Edits the PE values entered manually Only enabled when you have manually entered the PE values Aborts the fraction before treatment has been started or close the fraction after treatment If enabled it indicates that the 6 5 iGUIDE software is ready to receive the PE data from the external measurer Click to enter the PE values manually 09 001 1068_EN Rev 1 1 Page 83 Positioning the Patient Starting the Patient Positioning 6 2 WARNING Note WARNING 09 001 1068_EN Rev 1 1 Page 84 Starting the Patient Positioning The first steps to start with the patient positioning are e setting up and immobilize the patient correctly e mounting the reference frame Assisting patients onto the robotic couchtop It is recommended that you move the robotic couchtop to the LOAD position lowest position when helping patients onto or off the robotic couchtop also refer to Section 3 3 2 Enabling HexaPOD evo RT Couchtop Movements on page 46 1 Hold the ENABLE buttons on the HHC and press the LOAD button on the control panel JJS E Le YAWN SAZ PIS Figure 57 Moving the HexaPOD evo RT Couchtop to the LOAD position 2 Press the OPERATE and ENABLE buttons on the HHC to enable the movement The robotic
36. subsystems affected by the safety check will be shown as yellow You can restart a single safety check by clicking the symbol with the left mouse button and clicking the failed safety check Running the HexaPOD Enable Check The HexaPOD Enable Check checks if the OPERATE buttons on the ESB and the OPERATE button and ENABLE buttons on the HHC are locked in the ON position In this condition any movement requests sent to the robotic couchtop would be carried out immediately which would pose a safety risk To run the HexaPOD Enable Check 1 Click the HexaPOD symbol with the left mouse button The HexaPOD status box opens 2 Click HexaPOD Enable Check Perform Checks HexaPOD Enable Check Correlation Check Figure 86 Starting the HexaPOD Enable Check No additional user interaction is required during the HexaPOD Enable Check Running the Correlation Check During the Correlation Check the iGUIDE workstation sends movement commands to the robotic couchtop The camera verifies that the robotic couchtop moves as expected To run the Correlation Check 1 Mount the reference frame in slot Figure 87 IGUIDE Reference Frame in slot HexaPOD evo RT System 09 001 1068_EN User Manual Rev 1 1 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Page 111 Managing the iGUIDE Software Running the Daily Safety Checks Note 09 001 1068_EN Rev 1 1 Page 112 4 Click the HexaPOD
37. table position The high precision camera tracks the markers on the reference frame in real time making it possible to calculate the position of the robotic couchtop and patient HexaPOD evo RT System 09 001 1068_EN User Manual Rev 1 1 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Page 29 Overview of the HexaPOD evo RT System Components of the HexaPOD evo RT System ZZ Components of the HexaPOD evo RT System The following figure shows all components of a HexaPOD evo system The components are divided into the rooms where they are located Treatment Room re Equipment puel Isolation Room al Transformer Elekta Linear i E Accelerator L 2 GUIDE Tracking System GUIDE Terminal Power Interlocks HexaPOD evo RT Couchtop KVM A Extender Handheld Controller Powerbox TCP IP KVM Extender GUIDE Workstation GUIDE Software TCP IP EnableSwitch Board AC Wall Outlet RA Isolation Elekta Network Security SS Transformer Solution XVI Workstation Figure 8 The components of the HexaPOD evo system For additional information on the components please refer to Chapter 8 Description of the System Components on page 125 09 001 1068_EN HexaPOD evo RT System Rev 1 1 User Manual Page 30 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Overview of the HexaPOD evo RT System
38. the EC Directive 93 42 EEC i e MDD and bears the CE marking Other medical products which are used together with the HexaPOD evo RT System must also bear the CE marking and must be tested according to the corresponding directives ETL marking Where applicable the components of the HexaPOD evo RT System are ETL listed and bear the ETL mark HexaPOD evo RT System 09 001 1068_EN User Manual Rev 1 1 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Page 19 Before You Begin Compatibility and Compliance IEC standards The HexaPOD evo RT System complies with the following IEC standards e IEC 60601 1 Medical electrical equipment Part 1 General requirements for safety e IEC 60601 1 1 Medical electrical equipment Part 1 General requirements for safety Collateral standard Safety requirements for medical electric systems e TEC 60601 1 2 Medical electrical equipment Part 1 General requirements for safety Collateral standard Electromagnetic compatibility Requirements and tests e IEC 60601 2 1 Medical electrical equipment Part 2 1 Particular requirements for the safety of electron accelerators in the range of 1 MeV to 50 MeV e TEC 62304 Medical device software Software life cycle processes The GUIDE Workstation is a non medical electrical device and complies to e IEC 60950 1 Informaton technology equipment Safety Part 1 General requirements e EN 55022 IEC CISPR 22 Information technology equipme
39. the iGUIDE Software on page 103 Note During the initialization procedure you may be requested to move the robotic couchtop refer to Section 3 3 Performing Movements on page 45 HexaPOD evo RT System 09 001 1068_EN User Manual Rev 1 1 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Page 55 Performing Initialization and Safety Checks Performing the Safety Checks 4 3 Note 09 001 1068_EN gt Rev 1 1 Page 56 Performing the Safety Checks At the beginning of each working day when the iGUIDE software is initially started the safety checks have to be performed and successfully completed You can start the safety checks manually as described below Medical Intelligence recommends that you do the Daily QA procedure with the gantry at 180 in order to clear the area for the camera To start the safety checks click Run checks The checks are performed one after the other and cannot be skipped These checks can also be run separately between treatments if required The following checks must be performed e HexaPOD Enable Check see Section 4 3 1 Performing the HexaPOD Enable Check on page 57 e Correlation Check see Section 4 3 2 Performing the Correlation Check on page 57 e Interlock Check see Section 4 3 3 Performing the Interlock Check on page 58 s Alignment Check see Section 4 3 4 Performing the Alignment Check on page 59 The check results are displayed in the following dialog
40. x H 2 042 x 530 x 199 mm Power supply 48 VDC Safe workload 200 kg Tabletop material carbon fibre reinforced plastics A 1 2 HexaPOD Powerbox Table 35 Technical data of the HexaPOD Powerbox 100 240 V AC 15 10 A 1 3 iGUIDE Tracking System Table 36 Technical data of the camera A 1 4 iGUIDE Workstation iGUIDE Workstation Computer Table 37 Technical data of the iGUIDE Workstation computer Midi tower personal computer Input voltage 115 or 230 V AC 10 IEC 60038 50 60 Hz iGUIDE Workstation Monitor Table 38 Technical data of the iGUIDE workstation monitor Standard 17 TFT VGA monitor Input voltage 100 230 V AC 10 IEC 60038 50 60 Hz HexaPOD evo RT System 09 001 1068_EN User Manual Rev 1 1 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Page 149 Technical Data A 1 5 A 1 6 09 001 1068_EN Rev 1 1 Page 150 iGUIDE Terminal Monitor Table 39 Technical data of the iGUIDE terminal monitor Standard 19 TFI VGA monitor Input voltage 100 230 V AC 10 IEC 60038 50 60 Hz KVM Extenders The local KVM Extender is located in the control room the remote KVM Extender is located in the treatment room The following table lists the common technical data of both KVM Extenders Table 40 General technical data of the KVM Extenders Component connectors VGA USB Connection cable between the CAT S KVM Extenders Local K
41. 001 1068_EN Rev 1 1 Page 42 Logging into the iGUIDE Software When you switch on the iGUIDE workstation the iGUIDE software starts automatically and the login window appears Enter your user name and password Version 7 0 19694 1 EN1 2 GUIDES 2 0 user name iy Password OK Exit Medical Intelligence Medizintechnik GmbH m 200 2 Basics pa gana MRT RENN Sree bed Robert Bosch Str S hla el ss BEJ Schwabm nchen Germany 2 i F LEKITA support elekta com were elekta com Figure 21 The login window of the iGUIDE software The first time that the iGUIDE software is started daily the System Overview window will be displayed see Section 4 1 The System Overview Window on page 53 From this window the daily safety checks can be run Subsequent logins will take you directly to the Patients window see Section 5 1 The Patients Window on page 63 If for any reason the iGUIDE software does not start then you will see the login window of the operating system Log in as user iGUIDE Do not enter any password If you have to contact your service representative they will require the version of iGuide that you are running You can find this in the login window see above Using the iGUIDE Key to perform treatment without the HexaPOD evo RT System If the HexaPOD evo system will not be used during a treatment it is strongly recommended to disable the iGUIDE software At any time it is possible to log off the iGUIDE s
42. 12 PM Started PEC 0 00 0 00 1 00 0 0 0 0 7 12 PM Target reached PEC 7 12 PM High Tension signal changed to On 7 12 PM High Tension signal changed to Off 7 12 PM Treatment fraction closed Details Logged in as Christine Operator Figure 49 The Fraction Event History 3 If you want to get detailed information about a fraction click on Details underneath the Fraction Event History box Note The detailed information is needed only for analysis or diagnostic HexaPOD evo RT System 09 001 1068_EN User Manual Rev 1 1 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Page 73 Managing Patient Data Managing the Patient Treatment Sites 09 001 1068_EN Rev 1 1 Page 74 The iGUIDE software displays the detailed history of the selected fraction as properties tree For single information on one property you can click the corre sponding arrow 10 _ Property 4 7 Value 34 PM Fraction opened Event Type FEOO1 Event payload Timestamp 1 25 2011 7 10 34 PM gt Execution context 1 G 14 PM Patient position registered Event Type FE002 Event payload Timestamp 1 25 2011 7 11 14 PM gt Execution context A i L 14 PM RTM initiated Event Type FE003 Event payload RTM T 10 20 30 RC 0 0 O deg RO XyzStatic CS lt IEC6 Timestamp 1 25 2011 7 11 14 PM Execution context 4 Patient Positioner Current pose T 46 644 0 054 11 309 R 0 7
43. 33 1 064 0 449 deg RO XyzStati Tool pose T 145 895 177 88 1553 131 R 0 918 35 081 0 865 deg RO Xy Is missing False RMS 0 263239055871964 Current slot SlotA gt Calibration Phantom gt Interlock gt Tracker gt Hexapod gt Base Table gt Spatial Measurer gt Position Guard Z K gt k 12 Z K K 2 2 2 Z K 02 PM Target reached 06 PM Received imaging permissio 06 PM Imaging complete 21 PM PEC initiated 34 PM Target reached 39 PM HT signal has changed 42 PM HT signal has changed 45 PM Fraction closed Event Type FEO14 gt Event payload Timestamp 1 25 2011 7 12 45 PM Figure 50 gt Execution context The detailed fraction history HexaPOD evo RT System User Manual 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Managing Patient Data Managing the Patient Treatment Sites 5 3 2 Adding a Treatment Site 1 Click the Add Treatment Site button d The Add Treatment Site dialog box is opened where you can enter the treatment ae site values 2 Define the name of the treatment site and the RTM values if desired refer to Section 2 5 How the HexaPOD evo RT System Positions Patients on page 34 Add Treatment Site Add Treatment Site Treatment Site Relative Table Movement TX L fem TR em Tz _ ojcem IEC61217 Coordinate System Figure 51 Add a treatment site Always verify that you have entered the RTM values correctly and th
44. 5 How the HexaPOD evo RT System Positions Patients on page 34 Add Treatment Site 9 Add Treatment Site Treatment Site description Relative Table Movement TX L ijem TY cm TZ cm IEC61217 Coordinate System Figure 43 Add Treatment Site dialog box HexaPOD evo RT System 09 001 1068_EN User Manual Rev 1 1 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Page 67 Managing Patient Data Working on the Patient Record Always verify that you have entered the RTM values correctly and that the correct coordinate system is selected WARNING 5 Ifyou want to add the treatment site later click Cancel As a result of this the patient data will contain no treatment site Note If RTM is not necessary enter zero in the three RTM fields 5 2 3 Editing a Patient Record 1 Inthe Patients list select the patient record you want to edit 2 Click the Edit Patient button The Edit Patient dialog box is opened Here you can modify the patient data ST Edit Patient TN ES T Boi Edit Patient Patient ID 05432 First Name Miller Last Name Susan Date of birth Sex B Male Female Comment Cancel Figure 44 Edit Patient dialog box 3 Edit the data as required and then click Save The Edit Patient dialog is closed and the iGUIDE software displays the modified data 09 001 1068_EN HexaPOD evo RT System Rev 1 1 User Manual Page 68 2012 Medical Intelligence Medizintechnik GmbH All ri
45. All rights reserved Human Care Makes the Future Possible www elekta com Corporate Head Office Regional Sales Marketing and Service Elekta AB publ North America Europe Latin America Africa Box 7593 SE 103 93 Stockholm Sweden Atlanta USA Middle East amp India Tel 46 8 587 254 00 Tel 1 770 300 9725 Tel 44 1293 544 422 Fax 46 8 587 255 00 Fax 1 770 448 6338 Fax 44 1293 654 321 info elekta com Info america elekta com info europe elekta com Asia Pacific Hong Kong China Tel 852 2891 2208 Fax 852 2891 7133 info asia elekta com ELEKTA
46. ESB The following buttons and LEDs are available on the ESB iGUIDE 300 68 Dv GO Figure 110 EnableSwitch Board Table 32 Buttons and LEDs on the ESB EXTERNAL INHIBIT LED ON The HexaPOD evo system has set the EXTERNAL INHIBIT signal which prevents treatments on the Linac OFF No interlock treatment possible Move the iGUIDE key to iGUIDE OFF to bypass this inhibit LINAC READY LED ON The robotic couchtop can move if the TREATMENT BEAM LED is off OFF No robotic couchtop movements are possible The LINAC READY LED includes all safety equipment for preventing movements for example the touchguard TREATMENT BEAM LED ON Linac radiating no movements of the robotic couchtop possible OFF No radiation the robotic couchtop can be moved if the LINAC READY LED is on Note Watch the TREATMENT BEAM LED on the ESB If the LED stays OFF during treatment put the system out of service and call the technician MOVEMENT PENDING LED ON A movement has been requested and can be enabled OFF No movements pending This LED corresponds to the MOVEMENT PENDING LED on the HHC HexaPOD ON LED ON The robotic couchtop is on OFF The robotic couchtop is off This LED corresponds to the HexaPOD ON LED on the control panel of the robotic couchtop 09 001 1068_EN HexaPOD evo RT System Rev 1 1 User Manual Page 136 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Description of the Sy
47. GUIDE 2 0 Planning Guide e 009 001 1081 HexaPOD evo RT System iGUIDE 2 0 Installation Manual e 009 001 1078 HexaPOD evo RT System iGUIDE 2 0 Set to Work Manual e 009 001 1079 HexaPOD evo RT System iGUIDE 2 0 Customer Acceptance Test e 009 001 1068 HexaPOD evo RT System iGUIDE 2 0 User Manual e 009 001 1074 HexaPOD evo RT System HexaPOD RT System IEC 62353 Test Documentation e 009 001 1080 HexaPOD evo RT System iGUIDE 2 0 Maintenance Manual e P10105 152 iBEAM evo Couchtop User Manual e System Guide for the GUIDE Tracking System i e Passive Polaris Spectra User Guide Northern Digital Inc Waterloo Canada www ndigital com Note that not all features described in this manual apply to the HexaPOD evo system For warnings cautions notes and directives regarding the iGUIDE Tracking System refer to the System Guide for the iGUIDE Tracking System In the case of differences the specifications in the present manual are valid HexaPOD evo RT System User Manual 2012 Medical Intelligence Medizintechnik GmbH All rights reserved 1 2 Intended Use Use of the equipment Note 1 3 Before You Begin Intended Use of the HexaPOD evo RT System Intended Use of the HexaPOD evo RT System The HexaPOD evo system is intended to be used for accurate patient positioning within a radiation therapy treatment environment It comprises of e the HexaPOD evo RT Couchtop to support and aid in positioning a patient e the iGUIDE Sof
48. GUIDE Reference Frame cccesescscscscssesescscvcnsnsesesescnenes 49 HexaPOD evo RT System 09 001 1068_EN User Manual Rev 1 1 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Page 37 Operating the HexaPOD evo RT System Blank page 09 001 1068_EN HexaPOD evo RT System Rev 1 1 User Manual Page 38 2012 Medical Intelligence Medizintechnik GmbH All rights reserved 3 1 WARNING 3 1 1 Note 3 1 Operating the HexaPOD evo RT System Starting the HexaPOD evo RT System Starting the HexaPOD evo RT System Do not touch the patient while touching one of the connectors on the robotic couchtop Switching on the HexaPOD Powerbox The robotic couchtop and camera are powered from the powerbox in the equipment room To switch on the powerbox push its mains switch for details refer to Section 8 2 HexaPOD Powerbox on page 127 The green check back light will come on If the green check back light does not come on call a service engineer The powerbox is only powered if the Linac power is ON Checking the Status of the iGUIDE Tracking System The camera will automatically start when you switch on the powerbox The LEDs on the camera show you its status POWER LED Ee Error LED Figure 15 iGUIDE Tracking System Polaris Spectra The POWER LED and the Status LED must be lit up Note that after switching on the POWER LED will flash You have to wait 30 minutes to
49. IDE Reference Frame to the lasers 5 Respond to the prompt as follows Click Yes if the reference frame is aligned to the lasers Click No if the reference frame is not aligned to the lasers Note that it will not be possible to treat patients using the HexaPOD evo system until the Alignment Check has been passed Click Cancel to cancel the Alignment Check Note that the Alignment Check must be successfully completed before patients can be treated Check the correct alignment of the treatment room lasers with the engravings on the reference frame If they do not exactly match inform the administrator Do not use the HexaPOD evo RT System for treatments If the check fails the Alignment Check is marked with a red x in the Safety Checks Status dialog box The reason may be for example e The room lasers were adjusted e The camera was moved When the iGUIDE software displays the following dialog the robotic couchtop may be in LOAD position or the camera was moved in a specific direction 57 Alignment Check i Isocenter is not reachable OK l Figure 38 Isocenter not reachable at Alignment Check When the robotic couchtop is in LOAD position move it to START position and repeat the Alignment Check If the robotic couchtop is already in START position or if the check still fails the camera was moved Then you have to call the system administrator or a service engineer to move it to its correct position and to
50. IDE software Overview of the HexaPOD evo RT System Introduction to the HexaPOD evo RT System Introduction to the HexaPOD evo RT System The HexaPOD evo RT System is a unique fully robotic patient positioning system It allows the clinical user to remotely correct for misalignments of the patient not only along the traditional translational axes but also for roll pitch and yaw rotational X Y Z The 6 degrees of freedom given by the robotic couchtop allow the user to reposition the patient in any direction within sub millimeter accuracy Figure 7 HexaPOD evo RT System iGUIDE Tracking System HexaPOD evo RT Couchtop G iGUIDE Reference Frame The robotic couchtop is a 6 axis radiotherapy treatment table that accurately positions the patient for treatment delivery in all translational and rotational axes It is designed to replace the couch tops of RT systems like e Elekta Precise Treatment System with Precise Table e Elekta Synergy Platform with Precise Table e Elekta Synergy S and Elekta Axesse with Precise Table The robotic couchtop features a robotic patient positioning platform with six degrees of freedom It enables accurate and remote correction of any misalignments detected by state of the art image guidance systems thereby closing the gap in the 6DOF chain of IGRT localisation and tumour isocentre targeting The GUIDE Tracking System along with the GUIDE software controls the robotic couchtop and validates the
51. Medizintechnik GmbH All rights reserved Managing the iGUIDE Software GUIDE Software Management Tasks 7 1 Note iGUIDE Software Management Tasks The iGUIDE Administrator in the clinic is responsible for performing the following tasks in the iGUIDE software e Managing users e Supporting users e Performing some basic troubleshooting e Performing basic system configuration e Starting remote service sessions This chapter contains the information the iGUIDE Administrator requires for these tasks Standard users do not have access to the functions shown in this chapter Opening the Desktop When the iGUIDE workstation starts the iGUIDE user will automatically be logged in see the following section for details and the iGUIDE login will appear To log in onto the Windows desktop click Exit Version 2 0 19694 1 EN1 0 iGUIDE user name I Password M OK Exit Ag Figure 83 iGUIDE login The iGUIDE software will shut down and the Windows login will appear Click the iGUIDE Administrator account and enter your password The Windows desktop will appear You have access to the iGUIDE software management tools from the desktop Table 16 Symbols on the desktop F Opens the iGUIDE user manager You can use the user manager to add or delete iGUIDE users or reset an iGUIDE user s password See Section 7 2 Managing iGUIDE Users on page 106 Opens a folder that contains screen dumps The screen dumps m
52. ON LED The HexaPOD ON button is used to switch on the robotic couchtop The HexaPOD ON LED lights up when the robotic couchtop is booting or on LOAD Button Press this button with the ENABLE buttons on the HHC to move the robotic couchtop to the LOAD position HexaPOD OFF Button Press and hold this button until the robotic couchtop shuts down 4 seconds Operating the For a description of how to operate the robotic couchtop please refer to Section 3 1 3 robotic couchtop Switching on and off the HexaPOD evo RT Couchtop on page 40 and to Section 3 3 2 Enabling HexaPOD evo RT Couchtop Movements on page 46 09 001 1068_EN HexaPOD evo RT System Rev 1 1 User Manual Page 128 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Description of the System Components HexaPOD evo RT Couchtop Positioning Range of the HexaPOD evo RT Couchtop The robotic couchtop has six independently operating lifting units that give it six degrees of freedom The lifting units allow the robotic couchtop to be precisely positioned translationally along all three axes and rotationally around all three axes within the specified movement limits The robotic couchtop has two primary operating positions the LOAD position and the START position The LOAD position is the lowest position and is used to help patients onto and off of the robotic couchtop The START position is the position used to start positioning It is the position
53. Performing Movements 3 3 Performing Movements During a normal workflow or in the warm up procedures for iGUIDE software corrections to the table position may require a combination of movements both of the robotic couchtop and the Linac Precise table If the movement is within the range of the robotic couchtop the user will be immediately asked to enable the movement see Section 3 3 2 Enabling HexaPOD evo RT Couchtop Movements on page 46 If the move required is outside this range then the user will be prompted to initially move the Linac Precise table see below and then enable the robotic couchtop Always pay attention to the robotic couchtop when performing movements to e avoid collisions e immediately stop unintended movements or e immediately stop movements that can be of danger to the patient or treatment personnel Note Release the enable buttons to stop the robotic couchtop immediately Always monitor the robotic couchtop anytime you move it regardless of whether you do so locally from the HHC or remotely from the control room Ensure that neither patient nor robotic couchtop touch any surrounding WARNING equipment 3 3 1 Moving the Linac Precise Table If the robotic couchtop cannot reach a target position from the current position a dialog box will appear informing you how the Precise Table must be moved l amp Move the Precise Table Vertical 3 0cm Lateral 1 0 cm Long 2 1 cm Iso
54. Powrerbox a Ping xv ES EaR Sa Pinging 192 168 30 4 with 32 bytes of data Reply from 192 168 30 4 bytes 32 time lt ims TTL 128 Reply from 192 168 30 4 bytes 32 time lt ims TTL 128 Reply from 192 168 30 4 bytes 32 time lt ims TTL 128 Reply from 192 168 30 4 bytes 32 time lt ims TTL 128 me Ping statistics for 192 168 30 4 Packets Sent 4 Received 4 Lost z loss Approximate round trip times in milli seconds _ Minimum ms Maximum ms Average ms i Press any key to continue Ping NSS Figure 94 Pinging XVI HexaPOD evo RT System 09 001 1068_EN User Manual Rev 1 1 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Page 115 Managing the iGUIDE Software Diagnostic Tools 7 6 2 Viewing the Network Configuration J When you double click the Show Ethernet Config symbol a Windows console opens with the current ehternet configuration Show Ethernet EN Ethernet Config Fs om x Contig a Mindows IP Configuration Ethernet adapter Ethernet adapter PowerBOX Connection specific DNS Suffix IPuv4 Address gt 192 168 127 1 Subnet Mask gt 255 255 255 0 Default Gateway S Ethernet adapter LAN Connection specific DNS Suffix gt 192 168 30 7 gt 255 255 255 0 re Default Gateway Press any key to continue Figure 95 IGUIDE Workstation ethernet configuration The iGUIDE workstation was delivered with two netw
55. RADIATION THERAPY PRECISION HexaPOD evo RT System GUIDES 2 0 User Manual Document number 009 001 1068 EN Language English Revision 1 1 Date 2012 03 08 Valid for P10603 911 iGUIDE 2 0 W t M bhi niji 70060001 HR R F 09 001 1068_EN Rev 1 1 Page 2 Copyright Statement 2012 Medical Intelligence Medizintechnik GmbH All rights reserved No part of this document may be reproduced in any form without written permission from the copyright holder Use of the information contained herein is strictly reserved for Medical Intelligence Medizintechnik GmbH its parent company and its Licensees Other use in any form and or by any means whatsoever is prohibited Trademarks and Trade Names Statement Medical Intelligence 3 D Arm BlueBAG BodyFIX HeadFIX Fraxion HexaPOD iBEAM iGUIDE are registered trademarks and trade names of Medical Intelligence Medizintechnik GmbH its parent company or third parties who have licensed their trademarks and trade names to Medical Intelligence Medizintechnik GmbH or its parent company Do not reproduce display or otherwise use any of these trademarks or trade names without first obtaining written permission from Medical Intelligence Medizintechnik GmbH Acknowledgement of other Trademarks Registered trademarks and trade names of other manufacturers which appear in this document are hereby acknowledged Referenced Documents Not all
56. The System Overview Window sessessessssseesossessessossossessossossosseesossessossees 53 4 2 manea O oii ae ae 55 4 3 Performing the Safety Checks eeseseesessesosseseesesessesssseseesossesessessrsessesesseso 56 HexaPOD evo RT System 09 001 1068_EN User Manual Rev 1 1 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Page 51 Performing Initialization and Safety Checks Blank page 09 001 1068_EN HexaPOD evo RT System Rev 1 1 User Manual Page 52 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Performing Initialization and Safety Checks The System Overview Window 4 1 The System Overview Window Note The tasks described in this chapter cover all items of the Daily QA procedure These procedures are mandatory before using the iGUIDE software on a daily basis The System Overview window contains all the functions that you need in order to make the system ready for treatment From this window you have direct access to the safety checks that you must perform daily before any treatment The System Overview window is opened when the HexaPOD evo system starts for the first time in the day see Section 3 2 1 Starting and Shutting Down the iGUIDE Software on page 41 or after one of the subsystems has been offline You can also open the System Overview window by clicking the Subsystems button System Overview Subsystems Logged in as Christine Operator
57. U for 5 s gt 95 dip in U IEC 61000 4 11 of the HexaPOD evo RT System requires continued operation during power mains interruptions it is recommended that the HexaPOD evo RT System be powered from an uninterruptible power supply or a battery Power frequency magnetic fields should be at levels characteristic of a typical location in a commercial or hospital environment Power frequency 50 60 Hz magnetic field IEC 61000 4 8 Dips Interruptions lt 5 U for 0 5 cycles Mains power quality should be Variations on power gt 95 dip in U that of a typical commercial or supply input hospital environment If the user NOTE U means the rated AC mains voltage prior to the application of the test level HexaPOD evo RT System 09 001 1068_EN User Manual Rev 1 1 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Page 153 Electromagnetic Compatibility Requirements for non life supporting equipment Table 49 Requirements for non life supporting equipment Immunity test IEC 60601 test level Electromagnetic environment guidance level Portable and mobile RF communications equipment should be used no closer to any part of the HexaPOD evo RT System including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended Separation Distance Conducted RF a ae IEC 61000 4 6 150 kHz to 80 MHz d 53 VP outside
58. VM Extender Control Room Table 41 Technical data of the local KVM Extender Dimensions L x W x H 120 x 110 x 29 mm Remote KVM Extender Treatment Room Table 42 Technical data of the remote KVM extender Dimensions L x W x H 138 x 98 x 29 mm Supply voltage 9 V DC PSU input voltage 100 230 V AC 10 IEC 60038 50 60 Hz Isolation Transformers isolation Transformer Treatment Room Table 43 Technical data of the isolation transformer treatment room Dimensions L x W x H 240 x 150 x 85 mm Supply voltage 100 115 or 230 V AC nominal 50 60 Hz Capacity rating 300 VA HexaPOD evo RT System User Manual 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Technical Data Isolation Transformer Control Room Table 44 Technical data of the isolation transformer control room Dimensions L x W x H 270 x 170 x 9S mm Supply voltage 100 115 or 230 V AC nominal 50 60 Hz Capacity rating 600 VA A 1 7 iGUIDE Reference Frame iGUIDE Calibration Tool Table 45 Technical data of the reference frame and calibration tool Reference frame material carbon fibre reinforced plastics CFRP PVC Calibration tool material Perspex Plexiglas GS PMMA HexaPOD evo RT System 09 001 1068_EN User Manual Rev 1 1 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Page 151 Electromagnetic Compatibility A 2 A 2 1 A 2 2 09 001 1068_EN Rev 1 1 Pa
59. ain positions 54 switching on 40 tabletop 131 tabletop extensions 131 technical data 149 HexaPOD evo RT System switching on 39 HexaPOD Handheld Controller 134 HexaPOD OFF button 128 HexaPOD ON button 128 HexaPOD ON LED 128 HexaPOD powerbox 39 127 technical data 149 HexaPOD properties 119 HHC HexaPOD Handheld Controller 134 I IEC 62353 test 23 IEC standards 20 iGUIDE configuring 117 coordinate system 32 initialization 55 log files 116 status boxes 109 iGUIDE Calibration Tool 142 iGUIDE Configurator 117 GUIDE Log Files 116 iGUIDE reference frame 140 iGUIDE Software 29 logging in 42 logging off 41 main windows 43 iGUIDE Terminal 143 GUIDE Tracking System 29 54 138 safety 12 technical data 149 1GUIDE User Manager 107 iGUIDE Workstation 143 technical data 149 Indications of the HexaPOD evo RT System 13 09 001 1068_EN Rev 1 1 Page 158 Initializing the iGUIDE system 55 Install new rom file 116 IntelliMax 116 Intended use of the HexaPOD evo RT System 13 Intention of the manual 11 Interlock Check 112 performing 58 starting 54 IP address 116 Isocenter Manager 54 Isocenter Manager properties 124 Isolation transformer technical data 150 K KVM Extender 143 technical data 150 L Labelling 15 LED HexaPOD ON 128 Linac desktop External Inhibit 58 Linac Precise Table moving 45 LOAD button 128 LOAD position HexaPOD evo Couchtop 54 Log files GUIDE 116 Logging in the GUIDE Software 42
60. an be seen e On the right the values for the rotation can be seen Positional Error Translation cm Rotation deg Set Value Actual Value Set Value Actual Value A Y Z Figure 62 The Positional Error table The Set Value columns show the values calculated by the XVI system The Actual Value columns show the current position of the robotic couchtop The colors of the values indicate the position status of the related axis see following table Table 15 Indication of the PE value colors Value color Meaning White The kV imaging is not yet complete and PE data not available or transferred Red The position of the robotic couchtop is out of tolerance treatments are not possible patient can be treated Green The position of the robotic couchtop is within tolerance the patient can be treated To correct the PE you have two possibilities Yellow The position of the robotic couchtop has been changed but the user has confirmed that the patient is in the correct position for treatment The automatic transfer refer to Section 6 5 1 Automatic Positional Error Transfer from XVI on page 89 e manual correction refer to Section 6 5 2 Manual Positional Error Transfer on page 92 09 001 1068_EN HexaPOD evo RT System Rev 1 1 User Manual Page 88 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Positioning the Patient Correcting the Positional Error 6 5 1 Automatic Positional Error Transfer f
61. andling the Position Guard Alert 6 8 Note Return to Imaging Position Note Handling the Position Guard Alert When a fraction is open the Position Guard monitors the position of the robotic couchtop by means of the reference frame If the reference frame moves the following dialog box appears K 1 Position Guard Alert Unexpected Movement Return to Imaging Position Accept Current Position Restart Positioning i Abort Fraction J Return to Imaging Treatment Position Select this option if the movement was unintentional The HexaPOD will be returned to the previous position Do not select this option if you put the reference frame in another slot F I confirm that the patient will be correctly positioned with the selected option Beware that a wrong decision will lead to wrong patient positioning y Lad Figure 77 Position Guard Alert If the reference frame is no longer visible the dialog box has the following title Cannot see Reference Frame In this case only Pause Position Guard and Abort Fraction are enabled You can manually undo the movement or can select one of the buttons for more information and then click Confirm The descriptions of the buttons appear below Select this option if the position of the HexaPOD or Precise Table was unintentionally moved The HexaPOD will be moved back to the imaging or treatment position Do not select this option if y
62. as to be considered during planning of treatment compared to other solutions commercially obtainable Requirements on the User This User Manual is written for users and iGUIDE administrators of the HexaPOD evo RT System as defined above Before you attempt to work with the HexaPOD evo RT System you must have received adequate training on its safe and effective use Training requirements may vary from country to country Make sure that you receive such training in accordance with local laws or regulations that have the force of law Information on training is available from your local Medical Intelligence representative HexaPOD evo RT System 09 001 1068_EN User Manual Rev 1 1 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Page 13 Before You Begin Required Environment 1 4 CAUTION Transport and storage Normal use 09 001 1068_EN Rev 1 1 Page 14 Required Environment Anaesthetic environment Do not operate the HexaPOD evo RT System in environments with flammable anaesthetic mixtures Environmental conditions Make sure that the environmental conditions at site comply with the requested conditions as stated in the following tables Risk of damage to the equipment Never exceed the environmental conditions required by the HexaPOD evo RT System Environmental conditions for transport and storage Table 1 Conditions for transport and storage Relative humidity 10 to 90 Atm
63. at the correct coordinate system is selected WARNING Note The coordinate system which is used for RTM is shown under the Relative Table Movement values in the example above it is 1EC61217 Coordinate System This will be displayed if selected For additional information refer to Section 2 4 Coordinate Systems Used by the iGUIDE Software on page 32 Note When you use other systems that also support relative patient positioning then Medical Intelligence strongly recommends not to use the RTM feature of the iGUIDE software patient management See Section 2 5 How the HexaPOD evo RT System Positions Patients on page 34 for details HexaPOD evo RT System 09 001 1068_EN User Manual Rev 1 1 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Page 75 Managing Patient Data Managing the Patient Treatment Sites 3 Click Save The iGUIDE software displays the newly created treatment site in the Treatment Site Overview Patients oC BD Test Patent 7 12345675501 Patient ID gt Test Patient 2 12345678902 Test Patient 3 12345678903 First Name yy ney 4 Miller Susan 05432 Last Name Sean Pelvis Date of birth 1 1 1990 Sex no RTM notes Comment Relative Table Movement TX __ooo cem TY _ ooo cem TZ L__0 00 cm IEC61217 Coordinate System Fraction Event History Logged in as Christine Operator Figure 52 The newly created treatment site in the Treatment Site Overview 5 3
64. ated it is not necessary to define RTMs when setting up treatments e The coordinate system used for RTMs can be defined This must match the coordinate system of the treatment planning system See Section 7 6 6 Configuring the HexaPOD evo RT System on page 117 for further information HexaPOD evo RT System User Manual 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Overview of the HexaPOD evo RT System How the HexaPOD evo RT System Positions Patients What are PE Values When a patient is positioned the position and orientation of the treatment target can only be approximated To get the exact position an imaging system such as XVI is required The imaging system scans the volume around the isocenter and then reconstructs it The positional offsets between the reconstructed volume and the volume used for planning are calculated These are the Positional Error PE values The PE values are transferred to the iGUIDE software automatically or manually depending on the system configuration The iGUIDE software translates the PE values into movement commands for the robotic couchtop The operator then performs an automatic remote table move so that the treatment target is oriented as required at the isocenter What is the Position Guard The Position Guard is a major security feature of the HexaPOD evo system It monitors the position of the reference frame and generates an alert the Position Guard Al
65. ay have been taken by a user upon encountering problems See Section 7 3 Getting Information from Users on page 108 HexaPOD evo RT System 09 001 1068_EN User Manual 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Page 105 Rev 1 1 Managing the iGUIDE Software Managing iGUIDE Users Table 16 Symbols on the desktop A Opens a folder with various tools for troubleshooting Diagnostic See Section 7 6 Diagnostic Tools on page 114 Tools Starts the iGUIDE software L I Opens a folder with log files from the HexaPOD evo system The manufacturer may request these files for assistance during debugging Beles Opens a tool for basic configuration of the HexaPOD evo system See Section 7 6 6 Configuring the HexaPOD evo RT System on page 117 Initiates a remote session with the IntelliMax software You should only start remote sessions if requested by remote support personnel See Starting an IntelliMax Remote Session on page 116 7 2 Managing iGUIDE Users There are two levels of user management on the iGUIDE workstation e Windows user management The Windows user management controls the access to the Windows desktop The GUIDE workstation is delivered with the following Windows user accounts iGUIDE When the iGUIDE workstation starts this user account is automatically logged in no password The iGUIDE software then opens This user account can only be used for runn
66. bH All rights reserved Positioning the Patient Correcting the Positional Error Troubleshooting Enabling manual Tn case of problems see step 3 above you may have to transfer the PE corrections Positional Error from the XVI system to the iGUIDE software manually transfer You enable the manual PE transfer by clicking the Imaging completed symbol The iGUIDE software will prompt for your confirmation Figure 65 Switch to manual mode For additional information refer to Section 6 5 2 Manual Positional Error Transfer on page 92 Turn the iGUIDE The Imaging in progress message will close when the PE correction data has been key successfully transferred If it remains opened when the XVI scan is finished turn the iGUIDE key to iGUIDE OFF The fraction will be closed and the GUIDE software displays the following dialog Aborting Fraction S Aborting Fraction iGuide was overriden Do not move HexaPOD j Mowe to LOAD Figure 66 The Aborting Fraction dialog Before you click the desired option you have two possibilities to turn the iGUIDE key e Ifyou turn the iGUIDE key back to the iGUIDE ON position before clicking an option the Patients window will be opened e If you leave the iGUIDE key at the iGUIDE OFF position before clicking an option the login window will be opened Now enter a comment and click the desired option in the Aborting Fraction dialog HexaPOD evo RT System 09 001 1068_EN User Manual
67. be Performed A RTM to be Performed Enable the movement until the HexaPOD reaches its destination EnableSwitch Board Press the OPERATE buttons Handheld Controller Press the OPERATE button and ENABLE buttons Treatment Site descri This move is required to bring the treatment target into the isocenter Relative Table Movement Translation cm Set Value Actual Value n 2 00 1 46 3 00 2 46 Z IEC61217 Coordinate System Logged in as Christine Operator Figure 60 Performing RTMs e In the Set Value column the GUIDE software displays the RTM values from the patient record e In the Actual Value column the system displays the current position of the robotic couchtop in relation to the position where you registered the patient For further details and directions refer to What are RTMs on page 34 Make sure that RTMs are only performed once guided either by the HexaPOD evo system or by another system such as the Desktop or Mosaiq HexaPOD evo RT System User Manual 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Positioning the Patient Correcting the Positional Error When the RTM is zero or if it is successfully performed the RTM to be performed dialog box is closed the new values are displayed green and the Relative Table Movement button is indicated with a green tick Positioning Miller Susan 05432 T
68. by the iGUIDE Software on page 32 HexaPOD evo RT System 09 001 1068_EN User Manual Rev 1 1 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Page 77 Managing Patient Data Managing the Patient Treatment Sites 5 3 4 Note 09 001 1068_EN Rev 1 1 Page 78 Deleting a Treatment Site 1 Select the treatment site that you intend to remove permanently from the database in the Patients list The treatment site management buttons that are available are displayed on the right side 2 Click the Delete Treatment Site button The iGUIDE software prompts you for confirmation E Delete Treatment Site Do you want to delete Treatment Site newRIM Figure 55 Delete Treatment Site confirmation dialog 3 Click Yes to delete the treatment site The iGUIDE software removes the treatment site from the database With Delete Treatment Site the Fraction Event History will also be deleted HexaPOD evo RT System User Manual 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Positioning the Patient 6 Positioning the Patient Section Title Page 6 1 The Positioning Wna a paata aE ERA E 49 ETHAEE AER 4 aT r Ear raant sre 6 2 Starting the Patient Positioning cccccccscssescecescececescecesescnsesceceseecscese OF 6 3 R gistering the Palini eos nines 6 4 Performing the Relative Table Movements RTMs sesesesesosesesesesoseesesesesesese OO 6 5 Correcting the Posit
69. c is radiating TREATMENT BEAM Signal The Linac sets this signal to high during radiation The HexaPOD evo RT System locks the HexaPOD evo RT Couchtop from moving when this signal is active HexaPOD evo RT System 09 001 1068_EN User Manual Rev 1 1 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Page 25 Before You Begin Glossary Blank page 09 001 1068_EN HexaPOD evo RT System Rev 1 1 User Manual Page 26 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Overview of the HexaPOD evo RT System Overview of the HexaPOD evo RT System Section Title Page 2 1 Introduction to the HexaPOD evo RT System ssessossessossessossessessessessossess 29 2 2 Components of the HexaPOD evo RT System sesseseesseseessossessossessossessessesse DO 2 3 Princ WOO uci nunca 2 4 Coordinate Systems Used by the iGUIDE Software css ss ss sss css cs ccs caaeaae aaeeea DL 2 5 How the HexaPOD evo RT System Positions Patients cccccccccscscscscscsceeee D4 HexaPOD evo RT System 09 001 1068_EN User Manual Rev 1 1 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Page 27 Overview of the HexaPOD evo RT System Blank page 09 001 1068_EN HexaPOD evo RT System Rev 1 1 User Manual Page 28 2012 Medical Intelligence Medizintechnik GmbH All rights reserved 2 1 Short description HexaPOD evo RT Couchtop GUIDE Tracking System and iGU
70. cc ee ee ee ee ee ee ee eee 143 8 11 iGUIDE Terminal in the Treatment Room 0 0 ce ee ce eee eee ee eae 143 Cold User Repairable PACs na pea 4m ace LG Sk men ae Sie ey WRN le BAS eke be SU ete nca Rad arg Boe 143 8 amp 1 Cleaning and Disintectinie lt 0 4 444 i8 Aad Go ak ES RONEN SE OS HR A 144 SA Tipa Di Sag raana ssn ard cated oes pass ua tes Ge aes Pia Ae aegis eed es Gee eee eee hae 145 LST Tee T 154 2 5 8 os nck oh oe Sk ou oooh 84 Be be hee Se eae a oe eas sae 147 Ak Techne Al DAA esrar ne ban Bie ee oa ee ore a tn Bit ele ne ens Sl So DS wSeeene Th eoees 149 ALl HexaPOD cvo RT Couchtop 4 idsa lt tiste tcvad haba e ee aa wees oh ehw Rewee ea 149 ALA FlexaPQ DiPOWer DO sired aeiae Woe Bebe Wt oe Bae Be Shine ee Sey See 149 Ales GUIDE Tracking SySteni ereer sa Goa 4 edhe Guay BAe Ew on 8 Bee 149 A 1 4 GUIDE Workstation 644 05 een eb eric aes doa Sao howdy ako 2 ee eS oe ee ee 149 Pols 6 16 5 e c L chap tey aa ae kd etd ord bet he hae ed dea wees ee 150 ALG Isolation TranSoOrmers vide ide oes BS oe ee cr eee oa oa ee OW Reale BS 150 A 1 7 iGUIDE Reference Frame iGUIDE Calibration Tool 0 0 0000 151 A2 El ctromacnetic Compatibilty x t e 6tss ein oe ee ew ks Gla ea A de eA 152 A 2 1 Cables and Accessories that Maintain Compliance 0 0 0c e senner nnee 152 A 2 2 Guidance and Manufacturer s Declaration for EME 0 00 ee eee 152 A 2 3 Guidance and Manufacturer s Declaration for EMT
71. couchtop then moves to the lowest position You can now assist the patient onto or off the robotic couchtop The HexaPOD evo RT System postions and monitors the robotic couchtop not the patient directly The patient must be adequately immobilized and the user must watch the patient at all times during positioning and treatment Confirming settings on XVI before the iGUIDE software is ready to begin imaging will break the iGuide workflow As a result of this the gantry needs to be manually moved to the acquisition start angle Opening an new fraction To position a patient for treatment you have to select the patient and the treatment site for details refer to Chapter 5 Managing Patient Data on page 61 and then open a new fraction 1 To do this click Open Fraction for Positioning on the right side of the Patients window The Positioning window is opened and the iGUIDE software generates a new data set for the treatment fraction You can view this data set later in the Fraction history see Section 5 3 1 Displaying Information on a Treatment Site on page 72 In this data set the GUIDE software saves all relevant actions during the fraction Ensure that the correct patient is selected in the iGUIDE software You can do this for example by asking for name and date of birth HexaPOD evo RT System User Manual 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Note Note Note 6 3 Positioning the
72. ctions position values Make sure that you entered all six correctional position values correctly on the corresponding fields Only then click OK When all values are displayed correctly in the Positional Error dialog box click Move Verifying the Patient Position The HexaPOD evo system monitors the position of the reference frame and not the patient s position Once you have finished positioning the patient you have to verify that the patient is in the correct position One possibility for doing this is to compare the position of the reference frame with the position during previous fractions Note that it only makes sense to verify the reference frame position this way if the patient is identically positioned and immobilized on the robotic couchtop for example with the BodyFIX system e Before you apply radiation make sure that the patient is at the correct position e Before irradiation for stereotactic or radio surgery treatments it is highly recommended to perform a control XVI scan to verify the patient position Verification of the patient position is especially important when any of the applied positional error correction values is greater than 1 mm or 1 Verifying the reference frame position When the patient is identically positioned and immobilized on the robotic couchtop and the reference frame is installed in the same slot as in a previous treatment the position of the reference frame should be almost identical to t
73. dizintechnik GmbH All rights reserved Page 125 Description of the System Components Blank page 09 001 1068_EN HexaPOD evo RT System Rev 1 1 User Manual Page 126 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Description of the System Components Overview of the Components 8 1 Overview of the Components You will find a figure which shows the components of a HexaPOD evo system in Section 2 2 Components of the HexaPOD evo RT System on page 30 8 2 HexaPOD Powerbox The powerbox is located in the equipment room and supplies the robotic couchtop and the camera with power The main power switch is on the front side of the powerbox Figure 104 HexaPOD Powerbox Push the mains switch to switch on or off the powerbox Note The powerbox is only powered if the Linac power is ON HexaPOD evo RT System 09 001 1068_EN User Manual Rev 1 1 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Page 127 Description of the System Components HexaPOD evo RT Couchtop 8 3 HexaPOD evo RT Couchtop The following figure shows the robotic couchtop with the control panel which is drawn to a larger scale on the right side Figure 105 HexaPOD evo RT Couchtop with control panel Table 27 Buttons on the robotic couchtop control panel POWER LED ON The robotic couchtop is getting power from the powerbox OFF No power to robotic couchtop HexaPOD ON Button HexaPOD
74. documents referred to in this document are part of the scope of delivery for the equipment Medical Intelligence reserves the right to determine which documents are delivered with a product Manufacturer s Address and Contact Information TECHNICAL SUPPORT HELPDESK ALL Medical Intelligence PRODUCTS TEL 49 82 32 96 92 0 FAX 49 82 32 96 92 800 mail to schwabmuenchen elekta com WORLDWIDE PRODUCT MANUFACTURING and SUPPORT CENTER Manufacturer s Address Medical Intelligence Medizintechnik GmbH Robert Bosch StraBe 8 86830 Schwabm nchen GERMANY www elekta com medint HexaPOD evo RT System User Manual 2012 Medical Intelligence Medizintechnik GmbH All rights reserved User Notices and Important Notices The manufacturer can issue user notices and important notices for this User Manual It is your responsibility e to make sure that the notice is attached to this User Manual Attach any notices after this page e to record the update When you include a notice in this User Manual document it in the following table Amendment Number Date Signature HexaPOD evo RT System 09 001 1068_EN User Manual Rev 1 1 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Page 3 Blank page 09 001 1068_EN HexaPOD evo RT System Rev 1 1 User Manual Page 4 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Table of Contents T eTel R it Abourthis User E IT 1 2 Intended
75. e GUIDE Tracking System 3 1 3 Switching on and off the HexaPOD evo RT Couchtop 3 2 Operating the GUIDE Software dad ica sie since sedan es 3 2 1 Starting and Shutting Down the GUIDE Software 3 2 2 GUIDE Software Main Windows 0 0 0 cee eee eens 3 2 3 Capturing a Screenshot for Error Reporting do Perhormine Movements orrasa kh ao aes ew Se ae i RES Be we 3 3 1 Moving the Linac Precise Table 0 0 cece eee 3 3 2 Enabling HexaPOD evo RT Couchtop Movements 3 4 Mounting the GUIDE Reference Frame 2 0 cee eee 4 Performing Initialization and Safety Checks 4 1 The System Overview Window 0 ccc eee cence ee eee eens A TE 2 O is tee aa w ss eo aa ee eR ee a ioe ae ee ee 4 3 Performing the Safety Checks 0 0 ccc eee eee 4 3 1 Performing the HexaPOD Enable Check 4 3 2 Performing the Correlation Check 0 0 0 0 eee 4 3 3 Performing the Interlock Check 0 0 0 cee eee HexaPOD evo RT System User Manual 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Table of Contents 09 001 1068_EN Rev 1 1 Page 5 Table of Contents 434 Perornine theAlgnment Check o 4 a0 sa eee os as ee A ie eee eas ee 59 5 Mahaeine Patient Dalase soso aero eu nietd eae beh aa wes Patan eee ease eas 61 SAD The Patients Window soru 2cv5e Solr ees eee ee eee eee etched tees eee 63 oe Working
76. e entity accountable for the use and maintenance of the medical equipment The entity accountable can be for example a hospital or an individual clinician If specific national regulations do not exist it is recommended to use the standard IEC 62353 as the basis for the electrical testing 1 9 Glossary Alignment Check Verifies that the HexaPOD evo RT System can position the iGUIDE Reference Frame in the room lasers ENABLE Buttons Buttons on the Handheld Controller for enabling movements EnableSwitch Board ESB The control unit in the treatment room the LEDs provide an overview of the status of the HexaPOD evo RT System The OPERATE buttons allow you to enable HexaPOD evo RT Couchtop movements from the treatment room EXTERNAL INHIBIT LED LED on the EnableSwitch Board that indicates that the HexaPOD evo RT System is preventing the Linac from releasing radiation HexaPOD evo RT System 09 001 1068_EN User Manual Rev 1 1 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Page 23 Before You Begin Glossary Used by the HexaPOD evo RT System Identify IO System and other equipment to EXTERNAL INHIBIT Signal prevent the Linac from releasing radiation Handheld Controller HHC The control unit mounted to the HexaPOD evo RT Couchtop HexaPOD evo RT Couchtop robotic couchtop The HexaPOD evo RT Couchtop can position the patient under the treatment beam with six degrees of freedom HexaPOD e
77. e START position the rotational range is reduced accordingly e Make sure that the camera is powered for at least 30 minutes before you perform the daily safety checks e Never make changes additions or maintenance to the equipment if you do not have appropriate qualifications and training Never use spare parts that are not supplied or explicitly approved by the manufacturer This relation is shown in the following figure deg Available rotational range 0 10 20 30 40 Offset from START position mm Figure 107 Translational and rotational dependency The available rotational range is the maximum value for all three axes If the robotic couchtop is only to be rotated around one axis the available rotational range will be higher HexaPOD evo RT System User Manual 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Description of the System Components Tabletop of the HexaPOD evo RT Couchtop 8 4 Tabletop of the HexaPOD evo RT Couchtop The tabletop of the robotic couchtop is a carbon fibre tabletop solution based on the Medical Intelligence iBEAM evo Couchtop There are several adaptable extensions available for the tabletop in order to make it suitable for clinical requirements Note A damaged carbon fibre tabletop cannot be repaired Handle the tabletop with care Integrated Indexing systems add position references to couch tops and thus minimise both setup indexing system time and positioning e
78. ed and the image registration has been performed the XVI system sends the PE correction values to the iGUIDE software The Waiting for Data message will close and the Positional Error dialog box will appear with the received data F Lod Positional Error E Translation Rotation 0 23 cm m XxX Y 0 86 em z oa Cancel j Move l Figure 64 Positional Error values transferred If the Positional Error dialog box does not appear abort the fraction by turning the GUIDE key see Turn the iGUIDE key below Confirm the PE correction by clicking the Move button If the movement is too large for the robotic couchtop to complete the iGUIDE software will prompt you to move the Precise table refer to Section 3 3 Perform ing Movements on page 45 Once this has been done or if this is not needed the robotic couchtop movement can be enabled and the values are displayed in green in the Positioning window Once the robotic couchtop reaches its intended final position the iGUIDE soft ware releases the EXTERNAL INHIBIT signal Now the robotic couchtop is at its final position for treatment Before starting treatment you may continue with Section 6 6 Verifying the Patient Position on page 95 The Position Guard constantly monitors the position of the robotic couchtop see Section 6 8 Handling the Position Guard Alert on page 98 HexaPOD evo RT System User Manual 2012 Medical Intelligence Medizintechnik Gm
79. eens HexaPOD evo RT System Property Screens You can view the properties of one of the subsystems by clicking the corresponding symbols with the right mouse button Only users with Administrator rights have access to the property screens HexaPOD Properties System Overview Subsystems HexaPOD HexaPOD Coordinate System Hexapod CS Show operating range Show flexibility range X Y Tx F50 00 mm 7 0 00 mm 0 00 mm 0 00 deg 0 00 deg Figure 98 HexaPOD properties The following properties are available for the HexaPOD Table 21 HexaPOD properties ma ena Disconnect Disconnects connects the communication to the robotic Connect button couchtop Use this button for testing the communication for example if the robotic couchtop does not react to commands Go to top button Sends a movement request to the robotic couchtop to move to the uppermost position The movement must be enabled using the HHC or ESB Go to middle Sends a movement request to the robotic couchtop to move to a button position 50 mm above the LOAD position The movement must be enabled using the HHC or ESB Go to bottom Sends a movement request to the robotic couchtop to move to button the LOAD position lowest position The movement must be enabled using the HHC or ESB Get position Requests the current position of the robotic couchtop and puts it button in the position fields Go to position Send
80. ensure that the camera is warmed up completely e When you work with the HexaPOD evo RT System make sure that there no other optical markers for example a second reference frame are within the field of view of the camera e Make sure that the camera is powered for at least 30 minutes before you perform the daily safety checks e The camera uses IR light for tracking Ensure that all other light sources WARNING and objects that point or reflect light at the camera are removed or disabled while you work with the iGUIDE software Other optical tracking systems must also be disabled HexaPOD evo RT System 09 001 1068_EN User Manual Rev 1 1 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Page 39 Operating the HexaPOD evo RT System Starting the HexaPOD evo RT System 3 1 3 Switching on and off the HexaPOD evo RT Couchtop Figure 16 The HexaPOD evo RT Couchtop with control panel Starting up the HexaPOD evo RT Couchtop When you switch on the powerbox the POWER LED will light up Figure 17 POWER LED lights up Press the HexaPOD ON button for 3 seconds to start the robotic couchtop OC Figure 18 Switching on the HexaPOD evo RT Couchtop The HexaPOD ON LED will light up After 20 seconds you will hear a click from the robotic couchtop This indicates that it has finished booting Shutting down the HexaPOD evo RT Couchtop Press and hold the HexaPOD OFF button for 4 seconds
81. er Manual 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Description of the System Components GUIDE Workstation in the Control Room 8 10 iGUIDE Workstation in the Control Room The GUIDE workstation is installed in the control room It provides the PC with the GUIDE software In order to use the iGUIDE software you must start the PC by pressing the Power ON button To start and operate the iGUIDE software refer to Section 3 2 Operating the iGUIDE Software on page 41ff The PC provides also a backup system which is activated when the iGUIDE workstation is shut down Note In order to provide regular backups the PC of the iGUIDE workstation must be shut down at the end of the day 8 11 iGUIDE Terminal in the Treatment Room The GUIDE terminal is installed in the treatment room It is connected through a KVM Extender bridge to the iGUIDE workstation in the control room The iGUIDE workstation can be operated from the iGUIDE terminal Only one person may control the HexaPOD evo RT System and its components at one time Treatment personnel in the treatment room must have priority Do not perform movements of the robotic couchtop from the WARNING control room until all treatment personnel has left the treatment room 8 12 User Repairable Parts The HexaPOD evo RT System does not contain any parts that users can repair Therefore always leave the corrective maintenance tasks to qualified and service eng
82. ert if the position of the reference frame has been changed or if the reference frame can no longer be tracked which can occur if a marker is not in view of the camera When you register a patient in the iGUIDE software the iGUIDE software uses the current position of the reference frame as the registered position If the reference frame moves unexpectedly the Position Guard Alert is shown During During irradiation the Linac generates the TREATMENT BEAM signal When this signal irradiation is active the iGUIDE software including Position Guard is inactive Changes in the position of the reference frame will be first noticed when irradiation stops and the TREATMENT BEAM signal is no longer active HexaPOD evo RT System 09 001 1068_EN User Manual Rev 1 1 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Page 35 Overview of the HexaPOD evo RT System How the HexaPOD evo RT System Positions Patients Blank page 09 001 1068_EN HexaPOD evo RT System Rev 1 1 User Manual Page 36 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Operating the HexaPOD evo RT System 3 Operating the HexaPOD evo RT System Section Title Page 3 1 Starting the HexaPOD evo RT System ccccscscesescecvcvcnsescscecnensesesescvenenees 39 3 2 Operating the IGUIDE Softwar e ccccccsescscscesssescvcvcnsesesescscnsnsesesceonenees 41 3 3 Perlormine Movements canis hens 45 3 4 Mounting the i
83. f the HexaPOD evo RT System Note The contents of the former iGUIDE System User Manual was integrated into this manual Where the term user appears in this document it denotes both the body that has the authority over the equipment and those persons who actually handle the equipment e The term user means a qualified person who uses any part of the equipment and its accessories for the purpose of treating patients and who has been specifically trained in the safe clinical use of the equipment Such treatment is restricted to being therapeutic in nature e The term iGUIDE administrator means a qualified person who performs administration tasks in the clinic as e g managing the iGUIDE software and performing the system calibration Always keep this User Manual with the HexaPOD evo RT System for easy reference Before you attempt to use the product always make sure that you read understand note and strictly obey all e warnings e safety labels and markings e cautions e notes e important notices user notices Disclaimer Medical Intelligence assumes no liability for the use of this document if there are any unauthorised changes to the content or format Medical Intelligence applied every care to make sure that the information in this document is accurate However Medical Intelligence assumes no responsibility or liability for errors inaccuracies or omissions that appear in this document In order to improve reliabilit
84. f the transmitter W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply to all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people HexaPOD evo RT System 09 001 1068_EN User Manual Rev 1 1 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Page 155 Electromagnetic Compatibility Blank page 09 001 1068_EN HexaPOD evo RT System Rev 1 1 User Manual Page 156 2012 Medical Intelligence Medizintechnik GmbH All rights reserved A Abort fraction 99 Absolute reference frame position 96 Accept current position 99 Accompanying documentation 12 Add Treatment Site 67 Adding a patient 66 patient treatment site 75 Alignment Check 113 performing 59 starting 57 Anaesthetic environment 14 Archiving a patient record 69 Assisting patient on the robotic couchtop 84 Automatic transfer positional error 89 C Calibration tool 142 properties 123 ROM file 116 technical data 151 Camera 54 138 technical data 149 Camera properties 121 Caution 12 CE marking 19 Classification 20 Cleaning 144 Closing fraction 100 Compatibility 19 Compliance 19 Components of the HexaPOD evo RT System 30 127 Configurator 117 Connecting subsystem 55 Contraindications of the HexaPOD evo RT System 13 Control button subsystem 53 Control panel HexaPOD evo
85. for advice on compatibility with the HexaPOD evo RT System before you use any equipment or components not supplied by Medical Intelligence The use of accessories including cables other than explicitly approved by the manufacturer may negatively affect the electromagnetic compatibility increasing emissions or decreasing immunity of the HexaPOD evo system or may damage the robotic couchtop Only perform changes and or additions to the equipment if you are expressly authorized to do so by Medical Intelligence Such changes must comply with the safety precautions of Section 1 7 Safety on page 21 best engineering practice all applicable laws and all regulations that have the force of law within the jurisdiction e Never make changes additions or maintenance to the equipment if you do not have appropriate qualifications and training Never use spare parts that are not supplied or explicitly approved by the manufacturer Never install any software on the iGUIDE workstation other than WARNING software provided by the manufacturer Compliance The HexaPOD evo system is designed to comply with internationally recognised standards for safety and performance These standards are listed below Note The HexaPOD evo system complies with standards only if it is used in accordance with the intended use see Section 2 1 Introduction to the HexaPOD evo RT System on page 29 CE marking The HexaPOD evo RT System complies with the Essential Requirements of
86. ge 152 Electromagnetic Compatibility Cables and Accessories that Maintain Compliance The following table shows the cables that must be used together with the HexaPOD evo RT System in order to make sure that it is compliant with the emissions and immunity requirements of IEC 60601 1 2 Table 46 Cables allowed MI MI part number number Type Shielded cable XS 5 Mains Mains power cable Mains power cable 03 011 0011 Olflex 191CY K 6 HexaPOD 03 011 0012 Unitronic LiYCY communication cable HexaPOD power 03 011 0013 Olflex 191CY cable Ground earth cable 03 011 0015 Lapp Multistandard no 1 x 4 0 mm M03 Interlock T cable 03 011 0014 011 0014 12 x 0 24 mm2 HX Doors 3 interlock K 2 x 0 75 mm2 connection cable HX 11 EnableSwitch Board 03 011 0022 Unitronic LiYCY yes connection cable HX 12 Tracking System 03 011 0023 Unitronic LiYCY yes communication cable Guidance and Manufacturer s Declaration for EME The HexaPOD evo RT System is intended for use in an electromagnetic environment as listed below Make sure it is only used within such an environment Table 47 Required electromagnetic environment Emissions test Compliance Electromagnetic environment guidance RF emissions The HexaPOD evo RT System uses RF CISPR 11 energy only for its internal functions Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF e
87. ghts reserved Managing Patient Data Working on the Patient Record 5 2 4 Archiving a Patient Record Once the course of treatment for a patient is complete you can move the patient record to the archive The patient records in the archive remain within the database but the iGUIDE software does not display them on the Patients list You can restore patient records from the archive Restored patient records will be displayed again on the Patients list refer to Section 5 2 5 Restoring an Archived Patient Record on page 69 1 In the Patients list select the patient record you want to archive 2 Click the Archive patient button w 3 The GUIDE software prompts you for confirmation LY 57 Archive patient Figure 45 Archive confirmation dialog Click Yes to archive the patient record The patient data is moved to the archive and is no longer available in the Patients list 5 2 5 Restoring an Archived Patient Record To restore a patient from the archive you have to display the archived patients list first 1 Inthe Patients window click the Open Close Archive button The GUIDE software displays all patients contained in the archive The frame around the Open Close Archive button becomes green The Delete patient button and the Restore Patient button become accessible 2 In the Archived Patients list select the patient record you want to restore Click the Restore Patient button The patient record is restored and no l
88. h would pose a safety risk The HexaPOD Enable Check is started in the check series when you click the Run checks button You can start the HexaPOD Enable Check separately by clicking HexaPOD Enable Check in the HexaPOD status dialog box No additional user interaction is required for the HexaPOD Enable Check If the check fails the HexaPOD Enable Check is marked with a red x in the Safety Check dialog box Call the system administrator or a service engineer to do a check of the system Performing the Correlation Check During the Correlation Check the iGUIDE workstation sends movement commands to the robotic couchtop The camera verifies that the actual movements correlate to the expected movements To avoid collisions and to avoid the gantry obscurring the reference frame please move the gantry to 180 before starting the Correlation Check Before starting the Correlation Check the iGUIDE software requires that the reference frame is mounted in slot A of the table The Correlation Check is started in the check series when you click the Run checks button You can start the Correlation Check separately by clicking Correlation Check in the HexaPOD status dialog box or in the Camera status dialog box You have to enable the movements with the HHC or ESB For details see Section 3 3 Performing Movements on page 45 If the check fails the Correlation Check is marked with a red x in the Safety Check dialog box Call the system adm
89. he HexaPOD evo RT System 0 ce ee ene 117 dol Cetine SUPPORT 24 an E tre tiara oie dale Seo eek Aka E Meee 6 eee in a Ge hd Set ae 118 AS HexaPOD eyo RI Systemi Property Screens sce ee cs gle oie ask pee Se ee ee OE ae ee hae A 119 09 001 1068_EN HexaPOD evo RT System Rev 1 1 User Manual Page 6 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Table of Contents 8 Description of the System Components cc ccc ccc ccc cee eee eens 125 8 1 Overview Or the Components sessen Wha a ed Oa ee dee os 4 MEER ee E 127 62 HexaPOD Powerbox errana ae a bE ois Hee eee Gace Moka ee Aes ke 127 So HexaPOD evo RT COUMO rers riro aw Ane Gey arse wee Na eA eho ae hed eee 128 8 4 Tabletop of the HexaPOD evo RT Couchtop lt 131 8 4 1 Extensions to the HexaPOD evo RT Couchtop 0 0 0c cece eee 131 See Domene Properties 4 0 c sHdout Pedue asin eid dekh Souecduseestaendeees 132 S9 Handheld Controlle ang ave cdetae amp ce Senet deardie dark aoa wtaicad a a a aa canta ede dee a a 134 T gt bnableSwitcibOard lt ss oee aed oe eee hee Ree ete th eae ee Sea eee es 136 Bo IG WDE Irackie Sy Steril 9 here saa Ge encase ae de tr dear San ew ge aR de ee ee 138 8 8 IGUIDE Reference Fame 2015 tities Bee thd seh bales ass Beach e alee cab adtea Atle rn elo ieee 140 69 lt JjGUIDE Calibration lool ires 6 026448 weaned Baek chee ce ed ek Rees Oho RS Rohe Ee 142 8 10 iGUIDE Workstation in the Control Room 0 0
90. he carbon fibre tabletop and of the extensions there are sections of solid carbon fibre When the radiation beam passes through these areas before entering the patient unacceptable distortions of the intended dose distribution within the patient can occur The treatment planning system does not account for these distorted distributions Therefore make sure that the imaging and or the treatment radiation does not involve these areas The areas are indicated in the following figure by doted red lines All dimensions in the figure are in millimetres m O O S O o o 0 1 2 P On j 0 yw l l L lt i JS ef OP ee eee TE ee a 1 iv Sl ES Ss SS So cee i _ 80 Figure 108 Areas of solid carbon fibre inlays HexaPOD evo RT System 09 001 1068_EN Rev 1 1 User Manual 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Page 133 Description of the System Components Handheld Controller 8 5 Handheld Controller Use the Handheld Controller HHC to position the robotic couchtop manually For a description of how to enable robotic couchtop movements with the HHC please refer to Section 3 3 2 Enabling HexaPOD evo RT Couchtop Movements on page 46 menee Figure 109 Handheld Controller The following buttons and LEDs are available on the HHC Table 31 Buttons and LEDs on the HHC ROT TRANS LED ON Rotational movements are activated
91. he position during the last fraction The iGUIDE software allows you to view the absolute position of the reference frame Proceed as follows 1 Click the arrow on the right side of the slot indicator Selected RF slot A B D E F G Figure 72 Selected reference frame slot indication HexaPOD evo RT System 09 001 1068_EN User Manual Rev 1 1 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Page 95 Positioning the Patient Verifying the Patient Position 09 001 1068_EN Rev 1 1 Page 96 The absolute position of the reference frame in the room is displayed Click the arrow on the right side of the absolute reference frame position indicator Selected RF slot G A _B c D O E DF D G S RZ gt a Absolute RF pos TX 3 36cm TY 2 61 cm TZ 0 27 cm RX 0 91 deg RY 0 27 deg Figure 73 Absolute reference frame position The Reference fraction dialog box which shows the reference frame positions of former fractions is displayed Reference fraction 9 E Reference fraction 1 26 2011 2 33 13 PM gt Transl 57 25 918 34 134 03 Rot 2 37 0 41 1 26 2011 2 38 28 PM gt Transl 64 52 917 26 133 96 Rot 2 38 0 41 1 53 Figure 74 Reference fraction dialog box If you want a reference frame position of a previous fraction select the desired position and click Select The new relative reference frame position is shown as follows Selected RF slot
92. in order to maintain the integrity of the reference frame and the arrangement of the optical markers Do not touch the optical markers on the reference frame The arrangement of the markers can be disturbed and their reflective quality can be lost For additional information on the optical markers refer to the e System Guide for the iGUIDE Tracking System i e Passive Polaris Spectra User Guide Northern Digital Inc Waterloo Canada www ndigital com Do not touch drop or otherwise damage the optical markers WARNING 09 001 1068_EN HexaPOD evo RT System Rev 1 1 User Manual Page 140 2012 Medical Intelligence Medizintechnik GmbH All rights reserved How to mount 1 the reference frame 2 3 4 WARNING HexaPOD evo RT System User Manual Description of the System Components GUIDE Reference Frame Lift up the levers on both sides of the reference frame Figure 113 Lifting the securing levers Position the reference frame over the desired slot slots are available use the slot which will be as closest to isocenter as possible Figure 114 Positioning the reference frame Lower the reference frame completely into the mounting holes It will only fit if it is correctly oriented Note that the nose of the reference frame must be pointed to the gantry see Figure 112 on page 140 Push down the securing levers on the reference frame Do not force them into place The securing leve
93. in which the robotic couchtop has the largest range of movement for positioning The following figure provides an overview of the positioning range Note The following figure gives an approximation of the movement range of the robotic couchtop a 30mm 20 mm 10 mm 3 0mm Z 10 mm l 20 mm 30 mm 40 mm 50 mm 60 mm 70 mm 80 mm X START position LOAD position Positioning limits _ Path between LOAD position RI and START position Figure 106 Movement range of the robotic couchtop HexaPOD evo RT System 09 001 1068_EN User Manual Rev 1 1 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Page 129 Description of the System Components HexaPOD evo RT Couchtop WARNING Note 09 001 1068_EN Rev 1 1 Page 130 As indicated in this figure the following movement range for positioning is available from the START position Table 28 Positioning range Y axis left right Positioning outside of this range is not possible As indicated in the previous figure the full rotational range 3 around all three axes is only available when the robotic couchtop is within 12 mm from the START position When the robotic couchtop is further than 12 mm from th
94. ineers HexaPOD evo RT System 09 001 1068_EN User Manual Rev 1 1 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Page 143 Description of the System Components Cleaning and Disinfecting 8 13 WARNING CAUTION 09 001 1068_EN Rev 1 1 Page 144 Cleaning and Disinfecting Always clean the components of the HexaPOD evo system according to the hygiene regulations of the treatment environment and at specified time intervals Cleaning and disinfection techniques for the equipment and the rooms must comply with all applicable local laws and regulations which have the force of law in the jurisdiction where the equipment is being used Disinfect the robotic couchtop according to clinical standards before and after each treatment especially after direct contact with body fluids Pay extra attention to the extension mounting area Permitted cleaning agents e hand applied water based detergents with the addition of a non corrosive biocide Never use corrosive or chlorine bleach based cleaning agents solvents or abrasive detergents Do not use sprays for disinfection because the vapours may penetrate and damage the equipment If you are not sure about the properties of a cleaning agent do not use it Immediately dry all surfaces after cleaning How to clean and disinfect the surfaces that come into contact with patients e Moisten a soft clean and lint free cloth with a permitted cleaning agent e With
95. ing the iGUIDE software iGUIDE Administrator This user account is for the person in the clinic responsible for managing the iGUIDE workstation Elekta Service User This user account is for service Administrator For use by the manufacturer only e GUIDE user management When the iGUIDE software is running it controls permissions to perform functions and access data depending on the users rights It is recommended that every user has his her own individual user account 09 001 1068_EN HexaPOD evo RT System Rev 1 1 User Manual Page 106 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Managing the iGUIDE Software Managing GUIDE Users iGUIDE User Manager The Elekta Service User and the iGUIDE Administrator have access to the iGUIDE User Manager They can add edit and delete users User name Description Add User Edit User Delete User Figure 84 IGUIDE User Manager iGUIDE User Rights As can be seen in this dialog box iGUIDE users can have the following sets of rights e Operator Users with Operator rights can perform treatments and set up new patients and edit patient data e Administrator Users with Administrator rights can perform the system calibration and have access to the Windows desktop and some diagnostic tools Inform the customer representative that only users that have been trained for the system calibration are allowed to have Administrator rights The follo
96. inistrator or a service engineer to do a check of the system Note The Correlation Check will also fail when the reference frame is not in the slot A HexaPOD evo RT System 09 001 1068_EN User Manual Rev 1 1 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Page 57 Performing Initialization and Safety Checks Performing the Safety Checks 4 3 3 Performing the Interlock Check The Interlock Check ensures that the HexaPOD evo system can prevent the Linac from radiating when the patient is not in the treatment position It sets the Linac s EXTERNAL INHIBIT signal Note Make sure that the EXTERNAL INHIBIT signal is not active 1 The Interlock Check is started in the check series when you click the Run checks button You can start the Interlock Check separately by clicking Interlock Check in the Signal Interface status dialog box Then follow the instructions on the screen to do the Interlock Check 2 The iGUIDE software displays the following dialog box two times Interlock Check Is the External Inhibit EI set on the Treatment Control System Note Make sure no other system is setting the EI Figure 33 Verify the External Inhibit state Check the status twice in the View Restrictions dialog box at the Linac desktop and click the corresponding button in the Interlock Check dialog box each time 5002 Receive External Prescription 5 18 2011 3 10 15 PM Gantry Angle deg Patient Name aa Si Gantry
97. ional Error seesessesossessesesossesoesossessesessesosseseesessesesse B7 6 6 Verifying the Patient Position ccccccscscscscscessscecncnsesescscscnsesesescecscseeseso JD 6 7 Monitoring the Patient during Irradiation sesessesoesossessssesoesossesessessesessese DT 6 8 Handling the Position Guard Alert sesesesessesesesosossesesossesosesssseseseseesesese DO 6 9 Closing the Fraction kak ada ah aa a d d d a d a a a a aa aa TT TT TT a TT TT TT TTT TT TT TT TT TT a TT TTT TTT TT 100 HexaPOD evo RT System 09 001 1068_EN User Manual Rev 1 1 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Page 79 Positioning the Patient Blank page 09 001 1068_EN HexaPOD evo RT System Rev 1 1 User Manual Page 80 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Positioning the Patient The Positioning Window 6 1 The Positioning Window From the Positioning window you can move and control the robotic couchtop allowing you to position it in the isocenter for radiation treatment To open the window click Open Fraction for Positioning on the right side of the Patients window after you have selected a treatment site refer to Section 5 3 Managing the Patient Treatment Sites on page 71 Positioning Miller Susan 05432 Positioning Assumed RF slot ae Treatment Site noRTM Relative Table Movement Positional Error Translation c
98. is far off the focus of these objects In case of uncertainty do not hesitate to contact the physician on duty or the administrator of the iGUIDE software e When you work with the HexaPOD evo RT System make sure that there no other optical markers for example a second reference frame are within the field of view of the camera e Make sure that the camera is powered for at least 30 minutes before you perform the daily safety checks WARNING e The camera uses IR light for tracking Ensure that all other light sources and objects that point or reflect light at the camera are removed or disabled while you work with the iGUIDE software Other optical tracking systems must also be disabled HexaPOD evo RT System 09 001 1068_EN User Manual Rev 1 1 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Page 139 Description of the System Components GUIDE Reference Frame 8 8 iGUIDE Reference Frame The reference frame is installed on the robotic couchtop The camera finds the accurate patient position tracking the six optical markers on the top side of the reference frame The optical markers are arranged in a specified geometric pattern see in Figure 112 Figure 112 The iGUIDE Reference Frame Optical marker total of six Nose points always towards the gantry 37 Locking lever red Bottom Plate for storing the reference frame safely Note Always handle and store the reference frame carefully
99. ition Guard indicator Description The Position Guard is active The position of the robotic couchtop is within the tolerance limits of the GUIDE software The Position Guard is inactive during treatment imaging or movements requested by GUIDE The position of the robotic couchtop is out of tolerance The GUIDE software raises the EXTERNAL INHIBIT signal refer to Section 1 7 2 Safety Features on page 21 HexaPOD evo RT System User Manual 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Positioning buttons and status symbols Positioning the Patient The Positioning Window On the right side of the screen there are several buttons status symbols which are explained in the following table The buttons represent the steps involved in the iGUIDE software workflow Once they have been completed by the users a green tick appears over the button Each step must be completed before the next button step can be selected started Table 14 The positioning buttons and status symbols a EE Restart Positioning Register Patient Relative Table Movement Imaging completed Positional Error Correction Edit PE values lt Abort Fraction or Close Fraction HexaPOD evo RT System User Manual 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Goes back to the beginning of the positioning procedure Registers a patient Click this button once the
100. kstation or Network Powerbox Security Solution on page 115 Checks the network communication with the XVI workstation See Pinging the HexaPOD Powerbox XVI Workstation or Network Security Solution on page 115 Checks the network communication with the NSS rl See Pinging the HexaPOD Powerbox XVI Workstation or Network sos Security Solution on page 115 09 001 1068_EN HexaPOD evo RT System Rev 1 1 User Manual Page 114 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Managing the iGUIDE Software Diagnostic Tools Table 20 Diagnostic Tools Symbol Bet J CRE Shows the network configuration of the iGUIDE workstation ane See Viewing the Network Configuration on page 116 Contig x Starts the ROM file installer which is used to copy the ROM file of a LETA reference frame or calibration tool from the CD Install new rom file See Installing ROM Files on page 116 Opens the iGUIDE Configurator for performing basic configuration of the HexaPOD evo system See Section 7 6 6 Configuring the HexaPOD evo RT System on page 117 For use by remote service personnel only during IntelliMax sessions 7 6 1 Pinging the HexaPOD Powerbox XVI Workstation or Network Security Solution If you suspect network communication problems with the powerbox or the XVI workstation you can try pinging the powerbox the XVI workstation or the NSS by Ping double clicking the corresponding symbol
101. l Error table 88 Positioning buttons 83 Positioning window 81 Positions of HexaPOD evo RT Couchtop 54 POWER LED 128 Powerbox HexaPOD 39 127 pinging 115 technical data 149 Print Screen 44 Properties 123 calibration tool 123 camera 121 couchtop 119 Isocenter Manager 124 signal interface 120 XVI 122 Q QA procedure 53 R Radiation monitoring the patient 97 Reference frame 54 123 140 absolute position 96 moves 98 properties 123 relative position 96 ROM file 116 technical data 151 verifying slot 85 verifying the position 95 Registering patient 85 Relative reference frame position 96 Relative Table Movements 34 Releasing the patient 22 Requirements environment 14 on the user 13 training 13 Restart positioning 99 Restoring a patient record 69 Results safety checks 56 ROM files installing 116 09 001 1068_EN Rev 1 1 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Page 159 Index RTM 34 Performing 86 RTM values entering 67 75 S Safety concept 21 directions 21 electromagnetic compatibility 22 GUIDE Tracking System 12 Safety checks 53 Alignment Check 113 Correlation Check 111 HexaPOD Enable Check 111 Interlock Check 112 performing 56 results 56 Screen Camera 121 HexaPOD 119 Isocenter Manager 124 Measuring System s 122 Signal Interface 120 Tools 123 Screendump 108 Screenshot for troubleshooting 44 Searching a patient 65 Selecting a patient
102. ller that indicates when a movement command has been sent to the HexaPOD evo RT Couchtop 09 001 1068_EN HexaPOD evo RT System Rev 1 1 User Manual Page 24 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Before You Begin Glossary OPERATE Button Button on the Handheld Controller for enabling a pending movement OPERATE Buttons Buttons on the EnableSwitch Board for enabling movements Positional Error Used to position the treatment site exactly into isocenter The PE values are provided by the imaging system POWER LED Indicates that the HexaPOD evo RT Couchtop is getting power Relative Table Movements Used to position the treatment site roughly into isocenter from a known position for example markers on the skin ROT TRANS Button Switches between rotational and translational modes ROT TRANS LED i Indicates if rotational mode is active Signal Interface Contains in combination with the interlock PCB the switching logic for enabling movements of the HexaPOD evo RT Couchtop Also sets the EXTERNAL INHIBIT signal which prevents the Linac from releasing radiation START Position The position in which the HexaPOD evo RT Couchtop has the largest range of movement System Calibration The procedure for aligning the isocenter of the HexaPOD evo RT System to the XVI isocenter also known as set to work TREATMENT BEAM LED LED on the EnableSwitch Board that indicates when the Lina
103. m Translation cm Rotation deg Set Value Actual Value Set Value Actual Value Set Value Actual Value Logged in as Christine Operator Figure 56 Positioning window HexaPOD evo RT System 09 001 1068_EN User Manual Rev 1 1 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Page 81 Positioning the Patient The Positioning Window System symbols and positioning data Position Guard indicator 09 001 1068_EN Rev 1 1 Page 82 On the left hand side of the Positioning window you see a treatment room illustration and the positioning data of the selected patient At the left side of the treatment room illustration several symbols may appear their meanings are described below Table 12 The system symbols Status of the Position Guard Table 13 EXTERNAL INHIBIT signal is set no radiation possible The Linac is sending a blocking signal Possible reasons Touchguard or the terminate key may have been activated Indicates that the reference frame cannot be tracked out of 6 8 volume At the bottom of the figure the slot used for the reference frame is shown also refer to section Verifying the reference frame slot on page 85 Below the figure two tables display the values for the Relative Table Movement and the Positional Error correction Depending on the status of the Position Guard refer to Section 1 7 2 Safety Features on page 21 it may have the following colors Table 13 The Pos
104. missions The HexaPOD evo RT System is suitable for CISPR 11 use in all facilities including residential buildings and those facilities that are directly connected to the public mains network that supplies residential buildings Harmonic emissions Class A EN 61000 3 2 Flicker EN Compliant 61000 a 3 Al HexaPOD evo RT System User Manual 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Electromagnetic Compatibility A 2 3 Guidance and Manufacturer s Declaration for EMI The HexaPOD evo RT System is intended for use in an electromagnetic environment that meets the requirements listed in the following tables General EMI requirements Table 48 General EMI requirements Immunity test IEC 60601 test level Compliance Electromagnetic environment level guidance Electrostatic discharge 6 kV contact Floors should be wood concrete ESD IEC 61000 4 2 8 kV air or ceramic If floors are covere with synthetic material relative humidity should be at least 30 Mains power quality should be that of a typical commercial or hospital environment Electrical fast transient 2 kV for power supply burst IEC 61000 4 4 lines 1 kV for I O lines Surge 1 kV differential mode IEC 61000 4 5 2 kV common mode Mains power quality should be that of a typical commercial or hospital environment lt 40 U for 5 cycles 60 dip in Ut lt 70 U for 25 cycles 30 dip in U lt 5
105. n the signal interfaces The Interlock Check may be started 4 3 3 Camera Chap 7 Displays the camera status The Correlation Check may be started 4 3 2 Isocenter Manager Chap 7 Displays the isocenter status The Alignment Check may be started 4 3 4 The system may be calibrated by the administrator Tools Chap a Displays the serial number of the reference frame HexaPOD a Displays the robotic couchtop status The HexaPOD Enable Check and the Correlation Check may be started 09 001 1068_EN HexaPOD evo RT System Rev 1 1 User Manual Page 54 2012 Medical Intelligence Medizintechnik GmbH All rights reserved 4 2 Performing Initialization and Safety Checks Initialization Initialization When the iGUIDE software starts it automatically establishes a connection to all subsystems The symbol shows the status of the connection e Blue movement in the frame Subsystem connecting is in progress e Green Subsystem is ready e Yellow Safety checks have not yet been performed for the subsystem e Red Subsystem is not functional Note that treatments cannot be performed if any of the symbols are red Click a symbol to get more information about the subsystem and a list of appropriate tasks Example Camera No connection mnn Figure 31 Subsystem without connection Right clicking for GUIDE administrator only on a symbol opens a pane with details on the subsystem refer to Chapter 7 Managing
106. ng properties are available for the Signal Interface Table 22 i Interface properties p Description Disconnect a Disconnects connects the communication to the ee interface Connect button in the powerbox Signal states Shows the states of the Shows the states of the following signals 0 signals Internal Contact K manufacturer if this state error occurs oa This signal indicates the status of the iGUIDE oa key No iGUIDE OFF Yes iGUIDE ON This signal indicates that no equipment is inhibiting robotic couchtop movements LINAC READY This signal is No if the touchguard is pressed or the STOP MOTORS button has been activated TREATMENT This signal should normally be No It is BEAM active when the Linac is radiating Indicates if the iGUIDE workstation is oe setting the EXTERNAL INHIBIT signal which INHIBIT Pat bd prohibits the Linac from radiating pete ener Activates the EXTERNAL INHIBIT signal for testing purposes button LEDs The LEDs at the bottom of the screen correspond to the input signals in the signal interface in the powerbox Camera Properties System Overview Subsystems Camera a M E RB010 01 m 1427 02 mm 0 05 mm 101 44 mm 0 00 deg 0 02 deg 0 01 deg 7 0 RB009 01 m 1427 05 mm 0 00 mm 101 49 mm 0 01 deg 0 01 deg 0 00 deg 0 076 Patients A Figure 100 Camera properties HexaPOD evo RT System 09 001 1068_EN User Manual Rev
107. ning bolts of the rail Movement modes Continuous When you push one of the Movement buttons simultaneously with one of the Enable buttons then the robotic couchtop moves until it reaches the limit stop of the related axis or until the movement is complete Once the movement is complete the Movement Pending LED will go off Stepwise When you briefly push any one of the Movement buttons simultaneously with one of the Enable buttons then the robotic couchtop moves by 0 5 mm into the related direction Note If any Movement button gets stuck while you push it immediately release all Enable buttons If any Enable button gets stuck after release immediately push the OFF button on the Control panel for approximately five seconds see Section 8 3 HexaPOD evo RT Couchtop on page 128 HexaPOD evo RT System 09 001 1068_EN User Manual Rev 1 1 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Page 135 Description of the System Components EnableSwitch Board 8 6 EnableSwitch Board The GUIDE software sends positioning commands to the robotic couchtop However the robotic couchtop will not move unless you enable the movement To enable the movement simultaneously push the two hard wired OPERATE buttons on the ESB which is located in the contol room As soon as you release one or both of them the robotic couchtop immediately stops any movement For ease of operation put the keyboard of the iGUIDE Workstation on the
108. nslation 0 0 1427 0 101 5 Rotation 0 01 0 02 0 01 3 18 2011 2 08 04 PM service 1 1 4 4 0 7 0 0 0 10 Yes Registered by Isocentre calibration procedure 3 11 2011 2 37 06 PM admin 1 2 4 6 0 9 i S 0 12 Yes Registered by Isocentre calibration procedure 3 11 2011 2 01 36 PM service 1 2 4 5 0 9 0 0 0 09 Yes Registered by Isocentre calibration procedure 3 4 2011 12 17 05 PM service 849 5 8 1 556 9 1 27 0 60 Yes Registered by Isocentre calibration procedure 12 10 2010 1 57 00 PM admin 2567 7 911 4 1240 6 39 12 22 59 16 23 Yes Registered by Isocentre calibration procedure 11 19 2010 9 58 00 AM admin 53 7 38 7 16 4 0 83 0 01 0 06 Yes Registered by Isocentre calibration procedure 11 8 2010 12 19 28 PM service 174 5 132 1 1554 4 35 12 0 26 0 32 Yes Registered by Isocentre calibration procedure Logged in as service Administrator Figure 103 Isocenter Manager properties The following properties are available for the Isocenter Manager Table 26 Isocenter Manager properties emn OOO oi Shows the date user and coordinates of the currently valid Current isocenter 1socenter Shows the isocenter history The entries show the position of the Isocenter list currently registered isocenter in relation to the previously registered isocenter 09 001 1068_EN HexaPOD evo RT System Rev 1 1 User Manual Page 124 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Desc
109. nt Radio disturbance characteristics Limits ad methods of measurement e EN 55024 IEC CISPR 24 Information technology equipment Immunity characteristics Limits ad methods of measurement The GUIDE software is medical software and complies to e TEC 62304 Medical device software Software life cycle processes Classification According to the IEC standards the HexaPOD evo RT System is classified as follows Table 5 IEC classification of the HexaPOD evo RT System Type of protection against electric shock Class I equipment Degree of protection against electric Type B applied parts shock Degree of protection against the ingress IPXO as defined in IEC 60529 Ordinary of liquids equipment enclosed equipment without protection against the ingress of liquids Methods of disinfection recommended For guidelines on how to clean and by the manufacturer disinfect the equipment see Section 8 13 Cleaning and Disinfecting on page 144 Not suitable for sterilization Degree of safety of application in the This equipment is not suitable for the use presence of flammable anesthetic mixture in the presence of a flammable anesthetic with air or with oxygen or with nitrous mixture with air or with oxygen or with oxide nitrous oxide Mode of operation Suitable for continuous operation 09 001 1068_EN HexaPOD evo RT System Rev 1 1 User Manual Page 20 2012 Medical Intelligence Medizintechnik GmbH All rights reserved 1 7
110. oftware manually To do so turn the iGUIDE key into its 3 o clock position Shutting down the iGUIDE Software At the end of the day or if the iGUIDE software has hung turn the iGUIDE key to iGUIDE OFF The login window appears Click Exit to leave the iGUIDE software Then you will see the login window of the Operating system where you can shut down the system HexaPOD evo RT System User Manual 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Operating the HexaPOD evo RT System Operating the iGUIDE Software 3 2 2 iGUIDE Software Main Windows The graphical user interface of the iGUIDE software has a given structure On the left side the different windows are displayed on the right side the window buttons and several main functions are displayed and may be selected The windows are dedicated to specific tasks are provided by the iGUIDE software Table 8 The main windows of the iGUIDE software E Baar System Overview In the System Overview window you can view the status of the HexaPOD evo system components and prepare the HexaPOD evo system for operation This includes the safety checks that you must perform daily before you do any treatment Click to open the window For a detailed description of the System Overview window and its functions refer to Section 4 1 The System Overview Window on page 53 In the Patients window you can manage patient and treatment data Patient Click to
111. onger displayed in the Archived Patients list Click the Open Close Archive button to show the Patients list with the active patient records HexaPOD evo RT System 09 001 1068_EN User Manual Rev 1 1 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Page 69 Managing Patient Data Working on the Patient Record 5 2 6 09 001 1068_EN Rev 1 1 Page 70 Deleting an Archived Patient Record Deleting a patient record means that it will be removed permanently from the database and that it cannot be restored You can only delete patient records that have been archived This can only be done from the archive list 1 Inthe Patients window click the Open Close Archive button The iGUIDE software displays all patients contained in the archive The frame around the Open Close Archive button becomes green The Delete patient button and the Restore Patient button become accessible 2 In the Archived Patients list select the patient record you want to delete Click the Delete Archived Patient button The GUIDE software prompts you for confirmation S Delete patient Do you want to delete patient Miller Susan Figure 46 Delete confirmation dialog 4 Click Yes to delete the patient record The GUIDE software removes the patient from the database HexaPOD evo RT System User Manual 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Managing Patient Data Managing the Patient Treatmen
112. onthe Patient Records 2 4 i44 lt 4245 538iG 66h oS RIA ERERS DOS DEAE EA LAD OS 65 Sak sSearchineand Selecting ayPaticnt 22 5 0caesce takin oe aus SER Ee ee Ree Se eA 65 NAD Addie a New Patient erai i ecbch BH hh ea ORS eee R a E ack ek 66 S223 JEdiinea Patient RE ON eas tists diene ee eae ead tad we ae ee 68 S24 Archivine o Patient Recorde 254 624aved 046 H5 ak bits 4 LEED oe GRIa RCRA EOE 69 523 Restoring an Archived Patient Records cisse RSE S as a dos ee ak Se eS we eS 69 5 2 6 Deleting an Archived Patient Record i044 R RRR K KR at tet an WRB REAR Hed 70 5 3 Managing the Patient Treatment Sites ee eee eee eens 71 5 3 1 Displaying Information on a Treatment Site 0 ee ee ene 72 S52 Addie Vreatment olee TTT 75 Deon Edine a Neate nt S TTT 76 JDA Deleting a Treatment Site 05 5 0 ss a A bse Sane Be a are 78 6 Positonine the Patient lt 2 6 R 4 sae T Soe ata ETA ten a ee hae Oe 79 6 ThePositionine Window gt sucks sie N iit err ne eS Se R ee eS 81 62 State dhe Paent POsiiOnin se o 5 cne rine tease yada oa bebe odnw sw ia aes 84 6 ARESISTELING he PALICING TTT ii wake a Ghats sae acy ats Sh at wa a ete te ae 85 6 4 Performing the Relative Table Movements RTMs 00 c eee ee ee eens 86 6 Cotrecting the ostona ENO rire a2 aceasta wos beatae Gu ee ee Dae 87 6 5 1 Automatic Positional Error Transfer from XVL ccc eee ene 89 6 0 2 Manual Positional Error lrausiets 34 000 ceakehad ee EO dann on Gees
113. or is warming up The POWER LED will stop flashing and light steady when the position sensor is ready for tracking Solid fSolid Off The position sensor is ready for use no faults The position sensor is The position sensor is ready for use no faults for use no faults Any state Any state Flashing An error has been detected The error can only or solid be corrected by a service technician If the POWER LED is not on call a hospital technician to examine the power supply in the treatment room If there is no error with the power supply in the treatment room you must call your service representative HexaPOD evo RT System User Manual 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Description of the System Components GUIDE Tracking System Infrared sources The camera uses infrared light to detect the position of the markers on the reference frame Because of that e light sources that point directly at the camera and or e objects that reflect towards or even focus light at the camera can confuse the camera This can lead to inaccurate patient positioning with the consequence of clinical mistreatment Therefore e remove all light sources that point at the camera e remove all objects that focus or reflect light at the camera from the treatment room as long you work with the GUIDE software If it is not possible to remove these light emitting objects then make sure that the camera
114. orienting or relocating the HexaPOD evo RT System or the transmitting device from which it is receiving signals Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m 09 001 1068_EN HexaPOD evo RT System Rev 1 1 User Manual Page 154 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Electromagnetic Compatibility Recommended Separation Distances Table 50 Recommended separation distances Transmitter RF output Recommended separation distance d m for the frequency ranges power W The HexaPOD evo RT System is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the equipment can help to prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the components of the HexaPOD evo RT System as recommended in the table below The recommended separation distance depends on both the rated maximum transmitter RF output power and the transmitter frequency of the communications equipment 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz d 2 4P TATE PENECAR 3 E 3 For transmitters rated at a maximum output power not listed above you can estimate the recommended separation distance d m To do so use the applicable formula dependent on the transmitter frequency In this formula P is the maximum output power rating o
115. ork cards with the following IP configurations e NPort Connection to powerbox IP Address 192 168 127 1 Subnet Mask 255 255 255 0 Default Gateway None e Local Area Connection to NSS IP Address 192 168 30 7 Subnet Mask 255 255 255 0 Default Gateway None 7 6 3 Installing ROM Files The ROM files contain the geometric data of the reference frame and calibration tool Only one ROM file for each tool type is required If the reference frame or calibration L Ba Install new tool is switched the ROM file must be loaded from the corresponding CD rom file To install a ROM file place the CD in the CD drive of the iGUIDE workstation and click the Install new rom file symbol Getting iGUIDE Log Files The GUIDE software writes log files to the iGUIDE Log Files folder on the desktop The manufacturer may ask you to send the most recent log files for assistance in debugging The manufacturer may also ask you to change the log level This defines the level of information written to the log file See Section 7 6 6 Configuring the HexaPOD evo RT System on page 117 for information on how to change the log level Starting an IntelliMax Remote Session When you click Start IntelliMax Remote Session the IntelliMax software on the iGUIDE workstation opens a connection to an IntelliMax server Remote support personnel can log into the IntelliMax server and set up a remote desktop to the GUIDE workstation
116. ospheric pressure 50 kPa to 106 kPa Standard environmental conditions for normal use Table 2 Conditions for normal use Relative humidity 30 to 75 non condensing Atmospheric pressure 70 kPa to 106 kPa HexaPOD evo RT System User Manual 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Before You Begin Labelling 1 5 Labelling Note Not all labels shown here may be applicable for your installation 1 5 1 Labelling on the Packaging You will find the following labels on the packaging Table 3 Labelling on the packaging The labelled equipment must be protected against rain and other forms of splash water Permitted temperature range of the labelled equipment during transportation and storage Correct orientation of the labelled equipment The arrows always point upwards 1 5 2 Labelling on the HexaPOD evo RT Couchtop The symbols and labels described in this section can be found on the robotic couchtop Labels regarding Load Conditions Labels indicating allowable load conditions are located at the T end of the robotic couchtop Figure 1 Location of load condition labels HexaPOD evo RT System 09 001 1068_EN User Manual Rev 1 1 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Page 15 Before You Begin Labelling Point Load This label indicates the safe working load at the G end of the robotic couchtop if applied as a point load T T xxx kg x
117. ou moved the reference frame Click Return to Imaging Position and acknowledge the information at the bottom of the message 09 001 1068_EN Rev 1 1 Page 98 HexaPOD evo RT System User Manual 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Accept Current Position Note Restart Positioning Pause Position Guard Note Abort Fraction Positioning the Patient Handling the Position Guard Alert The GUIDE software will register the current position as the new guarded position This option is the manual override of the Position Guard By overriding the Position Guard the user is acknowledging that the change in the position of the robotic couchtop is correct for the subsequent treatment If you accept the current position the former position cannot be restored Restart patient positioning from the beginning The GUIDE software is overridden allowing treatments The position guard will be reactivated when the reference frame becomes visible This option is only available if the position of the reference frame cannot be determined This would be occur if the reference frame was removed or if any of the markers are blocked for example by the touchguard or gantry If markers are blocked remove any obstacles for example rotate the gantry 90 Otherwise click Pause Position Guard and acknowledge the information at the bottom of the message The iGUIDE software switches off the Po
118. ouchtop is required NE YIN Se ye Figure 25 MOVEMENT PENDING LEDs You can enable movements from the control room by pressing and holding the OPERATE buttons on the ESB until the movement is complete and the MOVEMENT PENDING LED goes out OIG Figure 26 Enabling movements HexaPOD evo RT System User Manual 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Operating the HexaPOD evo RT System Performing Movements In the treatment room press and hold the ENABLE buttons and the OPERATE button on the HHC until the movement is complete and the MOVEMENT PENDING LED goes out O oC OPO Figure 27 Enabling movements Never move the robotic couchtop 1 simultaneously with the Linac table base 2 while any other equipment in the treatment room moves e g the gantry 3 while any other action takes place in the treatment room e g the exchange of accessories 4 when an electron applicator or a shadow tray is mounted to the gantry head The electron applicator or shadow tray considerably extend from the gantry head and thus put the Touchguard out of action 5 ifthe projected movement path of the robotic couchtop is blocked e g by the gantry or by gantry attachments Only one person may control the HexaPOD evo RT System and its components at one time Treatment personnel in the
119. p_YYYY MM DD_hhmmss png Comments Screen_dump_YYYY MM DD_hhmmss txt Identifying Startup Problems When the iGUIDE software starts it sets up communication with its communication partners Once communication has been established the safety checks have to be passed The symbols in the System Overview window show the status of the communication partners e Green Communication OK all safety checks have been passed e Red Error safety checks not possible e Yellow Communication OK at least one safety check not passed Table 18 Identifying startup problems HexaPOD Make sure that the powerbox and robotic couchtop have been switched on Ping the powerbox If the powerbox does not respond to the ping contact service Camera Make sure that the powerbox has been switched on Ping the powerbox If the powerbox does not respond to the ping contact service HexaPOD evo RT System User Manual 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Managing the iGUIDE Software Identifying Startup Problems Table 18 Identifying startup problems Signal Interface Make sure that the powerbox has been switched on Ping the powerbox If the powerbox does not respond to the ping contact service Measuring System s Make sure that the XVI system has been switched on Restart the XVI system while the iGUIDE software is running Ping the XVI system If the XVI system does not respond to the ping contact ser
120. perform a system calibration HexaPOD evo RT System User Manual 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Managing Patient Data 5 Managing Patient Data Section Title Page 5 1 The TATE dice ceteris 5 2 Working on the Patient Record sessesessessesesoesesoesossesessesesseseesessesessesseses OD 5 3 Managing the Patient Treatment Sites ccccccesescscccssescscecscscesesescscocscese 7 1 09 001 1068_EN Rev 1 1 Page 61 HexaPOD evo RT System User Manual 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Managing Patient Data Blank page 09 001 1068_EN HexaPOD evo RT System Rev 1 1 User Manual Page 62 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Managing Patient Data The Patients Window 5 1 The Patients Window Patient data The iGUIDE software uses three terms for the definition of patient data terms e Patient For every patient a patient record is defined with a unique patient ID The patient record contains all data of one patient which are relevant for treatment e Treatment site A treatment site specifies the area which shall be treated Several treatment sites may be defined for a patient e Fraction A fraction is the whole session in which a specific treatment site of a patient is positioned and irradiated For a treatment site several fractions may be performed Patients window You manage patient and t
121. perties The central baseline attenuations perpendicular incidence of the carbon fibre tabletop of the robotic couchtop and the related extensions were measured in a clinical environment on an Elekta Synergy system in W rzburg Germany The following table lists the measurements results Phantom PMMA Field size 96 x 104 mm SSD 952 mm d 48 mm PTW Multidose Table 30 Dosimetric properties Attenuation at 6 MV Attenuation at 10 MV For details on the dosimetric properties of the extensions refer to the P10105 152 iBEAM evo Couchtop User Manual Treatment through the carbon fibre tabletop can increase the skin dose The skin dose also depends on the beam energy and the treatment plan prescriptions For further details of the dosimetric properties of the carbon fibre tabletop refer to the P10105 152 iBEAM evo Couchtop User Manual e The radiation attenuation will vary depending on beam energy and beam entry angle through the carbon fiber tabletop e Always make sure that the skin dose levels are within safe limits before you radiate through the carbon fiber tabletop e Take the dose attenuation into account when radiating through the carbon fiber tabletop HexaPOD evo RT System User Manual 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Description of the System Components Tabletop of the HexaPOD evo RT Couchtop Areas of solid carbon fibre inlays In the areas of the mechanical joints both of t
122. plied standards see Section IEC standards on page 20 The data of the EMC test report can be found in the Appendix of this User Manual see Appendix A The HexaPOD evo system requires special precautions regarding EMC and must be installed and put into service in accordance with the information provided in the relevant product documentation Other electronic devices exceeding the limits defined in such EMC standards such as mobile phones or diathermy units may possibly lead to malfunctions and can influence the safe operation of the HexaPOD evo system It is your responsibility to make sure that mobile phones and other devices that transmit radio frequency are not allowed and not used in the vicinity of the HexaPOD evo system The Appendix of this User Manual informs you about the minimum separation distances between the components of the HexaPOD evo system and such transmitting devices see Appendix A Do not allow any radio transmitting devices exceeding the limits defined in the EMC standard such as mobile phones diathermy units etc in the vicinity of the HexaPOD evo RT System If other devices are present in the vicinity of the HexaPOD evo RT System the user should check that its intended use is not affected HexaPOD evo RT System User Manual 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Before You Begin IEC 62353 Test 1 8 IEC 62353 Test The standard IEC 62353 Medical Electrical Equipment rec
123. position of the reference frame and notifies you in case of changes The Position Guard prevents the Linac from radiating if the reference frame has moved What are RTMs In some cases the desired treatment isocenter as calculated by the treatment planning system will not match the external markings on the patient s skin or stabilization devices such as a thermoplastic shell To reach the treatment isocenter from these markings shifts as calculated by the treatment planning system are required These shifts are referred to in the iGUIDE software as Relative Table Movements RTMs When you set up a treatment site for a patient in the iGUIDE software you define the RTMs as provided by the treatment planning system When you prepare a patient for a treatment fraction e You first fixate the patient on the robotic couchtop e You then move the robotic couchtop so that the markings are aligned with the lasers e You register the current position in the iGUIDE software e The GUIDE software moves the robotic couchtop according to the RTMs for the treatment site The treatment target will now approximately be at the isocenter An XVI scan can be performed to calculate how the robotic couchtop must be moved to bring the treatment target to the position and orientation defined by the treatment planning system The GUIDE administrator has the following choices for configuring RTMs e RTMs can be activated or deactivated When deactiv
124. reatment Site description Relative Table Movement Positional Error Translation cm Translation cm Rotation deg Set Value Actual Value Set Value Actual Value Set Value Actual Value 1 00 1 00 2 00 1 99 3 00 3 01 IEC61217 Coordinate System Logged in as Christine Operator Figure 61 RTM succesfully performed 6 5 Correcting the Positional Error Overview Once the RTMs are complete the further general workflow for Linacs that are equipped with an XVI system is that e you acquire a volumetric kV image of the patient e the XVI system reconstructs the volumetric image and registers it against the planning CT data set of the patient e the XVI system calculates a set of PE values e the XVI system transfers the PE values to the GUIDE software when automatic Positional Error transfer is available e the iGUIDE software transforms the PE values into correction values and sends the movement commands to the robotic couchtop e you enable the movements to bring the patient into the final treatment position Note For detailed information on XVI please refer to the XVI user documentation HexaPOD evo RT System 09 001 1068_EN User Manual Rev 1 1 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Page 87 Positioning the Patient Correcting the Positional Error Positional Error The Positional Error table provides two sets of six display fields each table e On the left the values for the translation c
125. reatment data from the Patients window When you have logged in succesfully to the iGUIDE software see Section 3 2 1 Starting and Shutting Down the iGUIDE Software on page 41 and the daily QA has been performed the Patients window is shown automatically You can also open the Patients window by clicking the Patients button Patients oo 8 Test Patient 3 12345678903 Patient ID gt Test Patient 4 12345678904 man Last Name Date of birth 51 01 1990 7 a notes Comment Relative Table Movement TX _ ooo cem TY __o 00Jem TZ __0 00 em IEC61217 Coordinate System Fraction Event History Logged in as Christine Operator Figure 39 The Patients window On the left hand side of the Patients window you see the Patients list with columns for the Name of the patient and the Patient ID HexaPOD evo RT System 09 001 1068_EN User Manual Rev 1 1 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Page 63 Managing Patient Data The Patients Window Patient management buttons 09 001 1068_EN Rev 1 1 Page 64 The buttons displayed on the right of the patient window are explained in the following table Table 11 The patient management buttons ator Testor Tre Opens a fraction for patient positioning A treatment site must be selected Open Fraction for Positioning The Positioning window is Add Patient A cA G Edit Patient displayed Adds a patien
126. reference frame and sets the Linac s EXTERNAL INHIBIT signal thus preventing the Linac from radiating if the reference frame moves unexpectedly The Position Guard is active as soon as a fraction is opened It raises the EXTERNAL INHIBIT signal upon opening of a fraction and releases it when the robotic couchtop has reached the treatment position The Position Guard will then raise the EXTERNAL INHIBIT signal if e The table moves out of tolerance The EXTERNAL INHIBIT signal is released when the robotic couchtop moves back to the treatment position e The reference frame cannot be seen by the camera The EXTERNAL INHIBIT signal is released when the reference frame is visible again Emergency Procedures You must be thoroughly familiar with all the local emergency procedures and the locations of all emergency buttons and switches for example e The STOP Motors button on the Linac table base e Any locally installed Emergency OFF switches mounted in the treatment room the control room and or anywhere else in the vicinity of the Linac How to release the patient In case of a power failure or when you push any Emergency OFF button the robotic couchtop is de energized and cannot be moved In order to release the patient lower the Linac Precise Table Electromagnetic Compatibility EMC and Mobile Phones The HexaPOD evo system is compliant with the requirements of the applicable EMC standards as described in the list of the ap
127. ries differs the iGUIDE software displays the following dialog box oor E Positional Error Re enter the PE values to confirm Rotation Translation Y 358 1 deg Entered values do not match Figure 70 Wrong position values Correct the wrong entries which are commented in red accordingly HexaPOD evo RT System User Manual 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Only three values displayed at XVI Too many zeros 6 6 WARNING Positioning the Patient Verifying the Patient Position If the XVI system only displays three PE values then the incorrect correction preset has been selected in XVI Precise table instead of Hexapod For additional information refer to the User Manual of the XVI system You must always enter all six values as calculated by the XVI system If you only enter the values for translation or rotation then the robotic couchtop will not be able to perform the PE correction When you enter three values of 0 on the entry fields of any column then the iGUIDE software displays the following dialog as a reminder that you must enter all six correctional position values as calculated by the XVI system E Manual Entry Check Warning You entered 0 for all rotation or translation fields All six PE values must be entered exactly Click OK to continue or Cancel to correct the values Figure 71 Zeros entered as corre
128. ription of the System Components 8 Description of the System Components Section Title Page 8 1 Overview of the Components SPHHSSHSSHSSHSSHSSHHSHSHSHHSHHSHSHHHHHHHHHSHHHHHHHHHHHHHHHHHHHHHHEHHHHHHHHEHHHHCH HOH 127 8 2 HexaPOD Powerbox PHS SHHSHSHSHSHSSHSHSHHSHHSHHSHHSHHHSHSHHSHSHHHSHHSHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHCHHOHOODH 127 8 3 HexaPOD evo RT Couchtop SHHSSHSHSHSHSHSHSHSHHSHHSHHSHHSHHSHHHHSHHHHSHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHCHHHOOD 128 8 4 Tabletop of the HexaPOD evo RT Couchtop ccccccccscccscccscceseseseceseseses 131 8 5 Handheld Controller SHHSSHSHSHSHSHSHSHSHSHHSHSHSHHSHHSHHSHHHHHHSHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHCHHHHHHHHHH OD 1 34 8 6 EnableSwitch Board EEPE TEE PETI PESEE IIE VO ENEE T ENOAT E AE ERLEA NANS E 7 8 7 iGUIDE Tracking AK nicotene 138 8 8 IiGUIDE Reference Frame TTT HET T 71 8 9 iGUIDE Calibration ars is nani a es cd 142 8 10 iGUIDE Workstation in the Control Room SPHHHSHSHSHHSHSHSHSHHSHHSHSHSHSHSHSHHHHHHHHHHHHHHHHHHHHHHHHHHOHHOHHD 143 8 11 iGUIDE Terminal in the Treatment Room SPOHSOSSHSHSHSHSHSHSHSHSHSHHSHHSHHSHHSHHHHHHHHHHHHHHHHHHHOHHHHOHHHHOH 143 8 12 User Repairable Parts SPHSHSHSHSHSHSHSHSHSHSHSHSHSHSHSHSHSHSHHSHHSHHSHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHOHOHOHD 143 8 13 Cleaning and TT a T EE 144 8 14 Final Piono THE 145 HexaPOD evo RT System 09 001 1068_EN User Manual Rev 1 1 2012 Medical Intelligence Me
129. rom XVI To correct the PE using automatic transfer from XVI to the iGUIDE software available in XVI R4 5 and higher 1 Before scanning the patient ensure that the correction method chosen at XVI is HexaPOD Never enable movements of the robotic couchtop while imaging is in progress WARNING 2 When the iGUIDE software is ready to receive the PE data from XVI the Imaging completed button is enabled in the Positioning window 3 When the settings are confirmed at XVI the scan may be started by the user XVI sends a message to the iGUIDE software notifying that the scan is starting This message includes the patient ID The following message will appear on the iGUIDE software Waiting for data To cancel turn the iGUIDE key to iGUIDE OFF Figure 63 Waiting for Positional Error data from XVI If this message does not appear you will have to transfer the PE correction values manually from the XVI software to the iGUIDE software See Enabling manual Positional Error transfer below Note If the user clicks Dismiss at XVI the iGUIDE software will remain in this state Abort the fraction by turning the iGUIDE key see Turn the iGUIDE key below HexaPOD evo RT System 09 001 1068_EN User Manual Rev 1 1 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Page 89 Positioning the Patient Correcting the Positional Error 09 001 1068_EN Rev 1 1 Page 90 When the scan has been reconstruct
130. rrors They aid the precise localisation and re positioning of patients on the treatment couch Furthermore the patient position is always aligned with the table s X and Y axes Refer to the P10105 152 iBEAM evo Couchtop User Manual for further information Accessory rails The robotic couchtop has fixed rails on both sides of the tabletop in Figure 108 which can be used to fix accessories Do not attach heavy accessories with long attachments Do not exceed the maximum load of the accessory rails 40 kg 88 Ib CAUTION 8 4 1 Extensions to the HexaPOD evo RT Couchtop You can expand the tabletop of your robotic couchtop with extensions see the following table Contact Medical Intelligence for a complete list For directions on how to use the extensions refer to the P10105 152 iBEAM evo Couchtop User Manual Table 29 Standard extensions to the HexaPOD evo RT Couchtop Extension name Part number Extra View Radiation length target iBEAM evo P10105 423 650 mm E Prostate Extension 650 e area BEAM evo P10105 413 400 mm Supra Extension HAN clavicular area Do not radiate through the extension mounting area WARNING HexaPOD evo RT System 09 001 1068_EN User Manual Rev 1 1 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Page 131 Description of the System Components Tabletop of the HexaPOD evo RT Couchtop 8 4 2 WARNING 09 001 1068_EN Rev 1 1 Page 132 Dosimetric Pro
131. rs should be flush with the reference frame Figure 115 Securing the reference frame Always make sure that the reference frame is mounted correctly and the mounting system is firmly locked 09 001 1068_EN Rev 1 1 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Page 141 Description of the System Components GUIDE Calibration Tool How to remove the reference frame 8 9 WARNING Note 1 Grab the red locking lever through the cutouts in the base of the reference frame and lift it up fully see the following figure Repeat this on the opposite side of the reference frame died D Figure 116 How to disengage the locking levers of the reference frame Carefully remove the reference frame from the robotic couchtop 3 Put the reference frame on the Bottom Plate and store it in a safe place IGUIDE Calibration Tool The calibration tool see in the figure below is used to perform the system calibration procedure which is given in detail in the 09 001 1078 HexaPOD evo RT System iGUIDE 2 0 Set to Work Manual The following figure shows the calibration tool with the Indexing Bar fixed at slot B Figure 117 The iGUIDE Calibration Tool Do not touch drop or otherwise damage the optical markers The calibration tool is not used within the clinical workflow of the HexaPOD evo RT System 09 001 1068_EN Rev 1 1 Page 142 HexaPOD evo RT System Us
132. s a movement request to the robotic couchtop to move to button the position defined in the position fields The movement must be enabled using the HHC or ESB HexaPOD evo RT System 09 001 1068_EN User Manual Rev 1 1 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Page 119 Managing the iGUIDE Software HexaPOD evo RT System Property Screens Table 21 HexaPOD properties Description Position fields Shows the current position of the robotic couchtop or the position to be moved to HexaPOD Selects the coordinate system used to show the position data Coordinate This selection has no effect on the operation of the HexaPOD System list evo system Show operating Switches on and off the display of the movement ranges range option Show flexibility This option can only be selected if Show operating range is range option selected It switches on and off the display of the limits Signal Interface Properties System Overview Subsystems Signal Interface Inhibit override No LINAC READY Yes TREATMENT BEAM Off EXTERNAL INHIBIT No 0 1 2 3 4 5 6 7 Set EXTERNAL INHIBIT _ Inputs Version string Figure 99 Signal Interface properties 09 001 1068_EN HexaPOD evo RT System Rev 1 1 User Manual Page 120 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Managing the iGUIDE Software HexaPOD evo RT System Property Screens The followi
133. s with all local and international regulations and laws You must separately remove all materials that can be hazardous to human health and or to the environment Dispose these materials of through competent licensed facilities The remaining material may be recycled where facilities and local regulations permit this Never dispose of Medical Intelligence products in the domestic waste stream HexaPOD evo RT System 09 001 1068_EN User Manual Rev 1 1 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Page 145 Description of the System Components Final Disposal Blank page 09 001 1068_EN HexaPOD evo RT System Rev 1 1 User Manual Page 146 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Appendix A Section Title Page A 1 Technical Data SHHSSHSHSHSHSHSHSHSHSHSHSHHSHSHSHSHHHSHHHHSHHHHHHHSHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHH OH 149 A 2 Electromagnetic Compatibility cccccccccscsscecescececcscecescecesescecescecesees 152 HexaPOD evo RT System 09 001 1068_EN User Manual Rev 1 1 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Page 147 Blank page 09 001 1068_EN HexaPOD evo RT System Rev 1 1 User Manual Page 148 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Technical Data A 1 Technical Data A 1 1 HexaPOD evo RT Couchtop Table 34 Technical data of the HexaPOD evo RT Couchtop Dimensions L x W
134. sition Guard and the Position Guard indicator turns red When the reference frame reappears the dialog box and the indicator disappear automatically Do not disable the Position Guard unless absolutely necessary The Position Guard is a vital safety feature of the iGUIDE software Only disable the Position Guard if you are absolutely sure that the modified position is correct Avoid all further movements of the Precise Table or robotic couchtop The fraction will be ended The Patients window will open The iGUIDE software displays the following dialog Figure 78 The Aborting Fraction dialog Enter a comment and click the desired option HexaPOD evo RT System 09 001 1068_EN User Manual Rev 1 1 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Page 99 Positioning the Patient Closing the Fraction Note Troubleshooting Closing the Fraction Once the treatment is complete click Close Fraction Then the iGUIDE software displays a dialog where you can enter notes regarding the treatment These notes are displayed with the Fraction history see Section 5 3 1 Displaying Information on a Treatment Site on page 72 K Closing Fraction Do not move HexaPOD Move to LOAD Figure 79 The Fraction notes dialog Enter your notes if desired and click the desired movement button to save the Fraction notes to perform the movement and to finally close the treatment fraction If you clicked
135. stem Components EnableSwitch Board Table 32 Buttons and LEDs on the ESB iGUIDE Key iGUIDE ON 12 o clock The HexaPOD evo system prevents radiation if the patient iGUIDE is not in the final treatment position g GUIDE iGUIDE OFF 3 o clock The HexaPOD evo system cannot raise an inhibit Additionally the iGUIDE software is shut down In the iGUIDE OFF position treatments can be performed without using the HexaPOD evo system OPERATE Buttons 2 Both of these buttons must be pressed and held to enable movements of the robotic couchtop from the control room HexaPOD evo RT System 09 001 1068_EN User Manual Rev 1 1 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Page 137 Description of the Syste GUIDE Tracking System 8 7 Power delivery Note Troubleshooting 09 001 1068_EN Rev 1 1 Page 138 m Components iGUIDE Tracking System The camera is connected via the powerbox When it is delivered with power the POWER LED will be on As soon as the camera is at operating temperature the status LED will be on For positioning with the camera a warm up period of 30 Minutes must be respected POLAR is ae ay z P Figure 111 Indicator LEDs of position sensor O POWER LED D Status LED G Error LED The indicator LEDs have the following meanings Table 33 LEDs on the camera W M land iGUIDE Tracking System Status Jo Any state Any state The position sens
136. symbol with the left mouse button The HexaPOD status box opens Click Correlation Check Perform Checks HexaPOD Enable Check Correlation Check oe Figure 88 Starting the Correlation Check Enable the movements with the HHC or ESB No additional user interaction is required during the Correlation Check Running the Interlock Check The Interlock Check ensures that the HexaPOD evo RT System can prevent the Linac from radiating when the patient is not in the treatment position It sets the Linac s EXTERNAL INHIBIT signal may be called DOOR 3 in older systems Other equipment connected to the Linac may set the EXTERNAL INHIBIT To run the Interlock Check Ensure that there is currently no EXTERNAL INHIBIT signal on the Linac Click the Signal Interface symbol with the left mouse button The Signal Interface status box opens Click Interlock Check Signal Interface Perform Checks Interlock a 2 Figure 89 Starting the Interlock Check The signal interface sets the EXTERNAL INHIBIT signal and prompts you as to whether the EXTERNAL INHIBIT signal is visible on the Linac HexaPOD evo RT System User Manual 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Note 4 Managing the iGUIDE Software Running the Daily Safety Checks If the EXTERNAL INHIBIT signal is indicated on the Linac which should be the case click El set Interlock Check Is the External Inhibit EI
137. t Test Patient 1 12345678901 Patient ID 05432 gt Test Patient 2 12345678902 Test Patient 3 12345678903 First Name gt Test Patient 4 12345678904 4 Miller Susan 05432 Last Name Kes Date of birth 1 1 1990 e T rT Relative Table Movement X 0 em WY em TZ C o em IEC61217 Coordinate System Fraction Event History 1 1 25 2011 7 10 PM 2 1 25 2011 7 12 PM Figure 48 The Patients window with selected treatment site Logged in as Christine Operator 2 Ifyou want to get more information about a fraction click on the corresponding entry in the Fraction Event History box 09 001 1068_EN HexaPOD evo RT System Rev 1 1 User Manual Page 72 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Managing Patient Data Managing the Patient Treatment Sites The iGUIDE software displays the event history of the selected fraction Patients SC f gt Test Patient 1 12345678901 Patient ID 05432 gt Test Patient 2 12345678902 _ 4 Miller Susan 05432 Last Name Susan Pelvis Date of birth 1 1 1990 Sex Comment Relative Table Movement TK L 00 enm TY __2 00Jem TZ __3 00 em IEC61217 Coordinate System Fraction Event History 1 1 25 2011 7 10 PM 7 10 PM Fraction opened 2 1 25 2011 7 12 PM 7 11 PM Patient position registered 7 11 PM Started RTM 1 2 3 7 12 PM Target reached RTM 7 12 PM Received imaging permission request acq 7 12 PM Imaging complete 7
138. t Sites 5 3 Managing the Patient Treatment Sites This section describes how to manage the treatment sites of a patient and how to display the fraction event history of a treatment site 1 Select a patient in the Patients list see Section 5 2 1 Searching and Selecting a Patient on page 65 The treatment site names for the selected patient are displayed below the patient and a Treatment Site Overview table is displayed on the right side Patients 9 S gt Test Patient 1 12345678901 Patient ID 12345678904 gt Test Patient 2 12345678902 Test Patient 3 12345678903 First Name 4 Test Patient 4 12345678904 000 Last Name me Date of birth 7471991 Sex oe smallRTM seven field pelvic plan phase 1 to Pharynx or one centre uses a mix of CT plan number along with field arrangement and area Comment Treatment Site Overview Treatment Site Last Opened Fractions 12 22 2010 1 25 2011 1 25 2011 Logged in as Christine Operator Figure 47 The Patients window with Treatment Site Overview HexaPOD evo RT System 09 001 1068_EN User Manual Rev 1 1 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Page 71 Managing Patient Data Managing the Patient Treatment Sites 5 3 1 Displaying Information on a Treatment Site 1 Select the treatment site you want to manage in the Patients list The Fraction Event History with the list of treatment site fractions is displayed SLI S g
139. t record Edits a patient record Deletes a patient record from the archive Adds a treatment site Add Treatment Site Edits a treatment site Only enabled when a treatment site Edit Treatment Site is selected Deletes a treatment site Only enabled when a treatment site Delete Treatment Site is selected Moves a patient record to the archive It is recommended that this is done Archive patient once the treatment cycle of a patient is complete Opens the archive and show all archived patient records or to close the archive Open Close Archive Restores a patient record from the archive Restore Patient 5 3 2 HexaPOD evo RT System User Manual 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Managing Patient Data Working on the Patient Record 5 2 Working on the Patient Record Always ensure that you have selected the correct patient before editing patient records 5 2 1 Searching and Selecting a Patient The Patients list on the left side of the Patients window displays all currently available patients Patients that have been moved to the archive will not be displayed User action To search for a patient you may enter a name a patient ID or parts of a name or patient ID in the input field of the Patients list The input is used as a filter and the corresponding entries are listed in the Patients list To select a patient click the pa
140. t the planned maintenance was made according to schedule e Never remove covers or cables from the HexaPOD evo RT System e If the HexaPOD evo RT System is operated in teams careful coordination of workflow tasks is necessary Ensure that water or other liquids do not enter any of the components of the HexaPOD evo RT System CAUTION In particular before you attempt to work with the equipment you must read and be aware of the emergency procedures described in Section 1 7 3 Emergency Procedures on page 22 Patient fixation Note Medical Intelligence recommends the use of the BodyFIX System for immobilizing patients The BodyFIX System ensures stable repeatable positioning 1 7 2 Safety Features The HexaPOD evo system has the following safety features e Two hands are required to enable movements of the robotic couchtop e The robotic couchtop is locked from moving during treatments e The robotic couchtop is blocked by Touchguard signals from the Linac HexaPOD evo RT System 09 001 1068_EN User Manual Rev 1 1 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Page 21 Before You Begin Safety Position Guard and EXTERNAL INHIBIT signal 1 7 3 1 7 4 WARNING 09 001 1068_EN Rev 1 1 Page 22 e Treatments are only possible when the robotic couchtop is in the required position The main safety feature of the HexaPOD evo system is the Position Guard The Position Guard monitors the position of the
141. the camera correlate Perform Checks with the expected movements Correlation Check See Running the Correlation Check on page 111 Signal Interface Interlock Check Activates and releases the EXTERNAL INHIBIT signal DOOR 3 to ensure the EXTERNAL Perform Checks INHIBIT signal is detected by the Linac Interlock Check See Running the Interlock Check on l page 112 Measuring System s No actions available Alignment Check Isocenter l l Manager Aligns the reference frame with the lasers See Running the Alignment Check on page 113 Perform Checks System Calibration alignment Cec Starts the system calibration procedure See System Calibration the 09 001 1078 HexaPOD evo RT System iGUIDE 2 0 Set to Work Manual Reference Serial Number Shows the serial number of the reference frame in the database This must match the Serial Number serial number of the physical reference frame 09 001 1068_EN HexaPOD evo RT System Rev 1 1 User Manual Page 110 2012 Medical Intelligence Medizintechnik GmbH All rights reserved 7 5 Managing the iGUIDE Software Running the Daily Safety Checks Running the Daily Safety Checks The following safety checks are run at the beginning of the day These safety checks must be successfully passed before patients can be treated e HexaPOD Enable Check e Correlation Check e Interlock Check e Alignment Check If a safety check was not successful the status of the
142. the coordinate system cannot be configured The iGUIDE software is adapted to the XVI coordinate system This coordinate system can be displayed by clicking on the Synergy Coordinate System button Positional Error Translation cm Rotation deg Set Value Actual Value Set Value Actual Value X 0 30 0 30 1 30 1 30 Y 0 12 0 13 359 10 359 10 Z 0 02 0 02 0 60 0 60 Figure 13 Coordinate system button below the Positional Error values Figure 14 Display of the coordinate system according to Synergy CS To remove the display of the coordinate system click Synergy Coordinate System again HexaPOD evo RT System 09 001 1068_EN User Manual Rev 1 1 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Page 33 Overview of the HexaPOD evo RT System How the HexaPOD evo RT System Positions Patients 2 5 Configuring RTMs in the iGUIDE software 09 001 1068_EN Rev 1 1 Page 34 How the HexaPOD evo RT System Positions Patients The HexaPOD evo system is designed for sub millimeter exact patient positioning for radiotherapeutical treatments The HexaPOD evo system uses Relative Table Movements RTMs to move to a treatment target that does not match external markings It uses Positional Error PE values from an external measurement system such as XVI to position the treatment target so that it is exactly oriented at the isocenter as defined by the treatment planning system The Position Guard monitors the
143. the current fraction The iGUIDE software stores the slot selection for the next fraction Registering the Patient Before you register a patient make sure that the patients external marks e g tattoos for the selected treatment site have been aligned with the lasers To confirm that the patient has been aligned to the lasers click Register Patient Do not move the reference frame to another slot after the patient has been registered WARNING HexaPOD evo RT System 09 001 1068_EN User Manual Rev 1 1 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Page 85 Positioning the Patient Performing the Relative Table Movements RTMs Note 6 4 WARNING 09 001 1068_EN Rev 1 1 Page 86 If any movements of the robotic couchtop or the Linac Precise Table are required at this stage you will see the corresponding requests or movement hints refer to Section 3 3 Performing Movements on page 45 Performing the Relative Table Movements RTMs If RTM values have been defined for the treatment site see Section 2 5 How the HexaPOD evo RT System Positions Patients on page 34 for details the robotic couchtop will now have to perform the movements You will have to enable them using the HHC or ESB The iGUIDE software shows the defined RTMs and the current position of the robotic couchtop in relation to the registered position Positioning Miller Susan 05432 2 RTM to
144. the moistened cloth wipe all surfaces that come into contact with patients e Alternatively you may also use denaturated alcohol ethanol lint free wipes e When parts of the HexaPOD evo system get in direct contact with body fluids then disinfect it Pay additional attention to the areas of the mechanical joints both of the carbon fibre tabletop and of the extensions e In any case make sure that you dry all surfaces afterwards with a soft clean and lint free cloth Dusting of the equipment Use a soft lint free cloth to remove any dust from e rhe robotic couchtop For further information refer to the P10105 152 iBEAM evo Couchtop User Manual e the HHC e the GUIDE terminal in the treatment room and the iGUIDE workstation in the control room including keyboard and mouse Remove dust and fingerprints from the VDU by using a recommended cleaning fluid HexaPOD evo RT System User Manual 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Description of the System Components Final Disposal 8 14 Final Disposal Final disposal means the disposal of the equipment or any part of it in such a way that it can no longer be used for its intended purpose s Prior to disposal always contact Medical Intelligence for advice and for a list of the substances that require specialist attention For contact details see the inner cover page Always do the disposal in an environmentally sensitive manner that complie
145. tient name in the Patients list The iGUIDE software displays the personal and treatment data of the patient on the right side Patients om J9 Miler Susan Patient ID First Name Last Name Date of birth OSS Sex eme notes Comment Treatment Site Overview Treatment Site Last Opened Fractions description 1 25 2011 0 Logged in as Christine Operator Figure 40 How to select a patient The following patient data is displayed e unique patient ID e g 05432 e first name e g Susan e last name e g Miller e date of birth e g 01 01 1990 e sex e g Female e comment e g treatment description e treatment site overview consisting of treatment site date and number of fractions for each treatment site HexaPOD evo RT System 09 001 1068_EN User Manual Rev 1 1 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Page 65 Managing Patient Data Working on the Patient Record 5 2 2 hy 09 001 1068_EN Rev 1 1 Page 66 Adding a New Patient 1 Click the Add Patient button The Add Patient dialog box is opened where you can enter the patient data Fill in the relevant patient data on the corresponding fields and check boxes e Patient ID type it in e g 05432 The patient ID must be unique If you type in a patient ID that already exists the GUIDE software will not create a new patient record data typed in the other fields will be lost e
146. treatment room must have priority Do not perform movements of the robotic couchtop from the WARNING control room until all treatment personnel has left the treatment room HexaPOD evo RT System 09 001 1068_EN User Manual Rev 1 1 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Page 47 Operating the HexaPOD evo RT System Performing Movements Troubleshooting The following dialog box may appear in some cases AY Adjusting HexaPOD Position Enable the movement until the HexaPOD reaches its destination E gt Adjusting HexaPOD Position EnableSwitch Board Press the OPERATE buttons Handheld Controller Press the OPERATE button and ENABLE buttons The HexaPOD needs to perform a submillimeter movement This move is mandatory and will not compromise the patient s position Figure 28 Adjusting robotic couchtop position In this case you have to click the required buttons and the robotic couchtop is moved slightly Then the dialog box disappears 09 001 1068_EN HexaPOD evo RT System Rev 1 1 User Manual Page 48 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Operating the HexaPOD evo RT System Mounting the iGUIDE Reference Frame 3 4 Mounting the iGUIDE Reference Frame The reference frame is used to track the position of the robotic couchtop during treatments It is clamped to both sides of the robotic couchtop Mount the reference frame in the
147. tware to control the HexaPOD evo RT Couchtop position The installation use and operation of this equipment are subject to the law in the jurisdictions in which the equipment is being used You must only install use and operate the equipment in such ways that do not conflict with applicable laws or with regulations which have the force of law Nothing stated in these documents reduces your professional responsibilities for sound judgement and best practice The use of the equipment for purposes other than those intended and expressly stated by Medical Intelligence as well as incorrect use or operation of the equipment may relieve Medical Intelligence or their agent of all or some of the responsibility for any resultant non compliance damage or injury In the United States Federal law restricts this equipment to sale distribution and use by or on order of a licensed physician Indications The intended use of the HexaPOD evo system is to support aid in and control positioning a patient during radiation therapy of various body regions The system is not restricted to certain sub populations e g those defined by age sex ethnicity organ function and disease severity or similar Contraindications The HexaPOD evo system is not suitable for human beings with a weight of more than the maximum weight stated on the robotic couchtop or for veterinary purposes Due to the construction of the carbon fibre table top a higher skin dose h
148. urrent test and test after repair of medical electrical equipment defines requirements to ensure the in service electrical safety of electromedical equipment and systems The tests defined in IEC 62353 are a measure for establishing the safety of an active non implantable medical device The goal is the early recognition of device deficiencies and the risks for patients users or third parties The technical safety of the medical device shall be tested according to IEC 62353 National laws or regulations for testing the technical safety of medical devices must also be heeded According to IEC 62353 medical devices are to be tested at the following intervals e before putting into service e recurrent test once a year e after repair The IEC 62353 Test covers the following points e Inspection Is there any visible damage to the medical device e Electrical measurements Is the electrical safety of the medical device ensured e Functional test Does the medical device function as required e Safety Do the safety precautions of the medical device function correctly e Evaluation Can the medical device be used See 09 001 1074 HexaPOD evo RT System HexaPOD RT System IEC 62353 Test Documentation Depending on the location of the medical equipment national regulations may require technical safety testing of medical equipment upon installation after any service or repairs and at regular intervals Such testing is the responsibility of th
149. ved Managing the GUIDE Software HexaPOD evo RT System Property Screens Tools Properties System Overview Subsystems Tools Reference Frame Calibration Tool Coordinate System IEC 61217 mm and degrees Coordinate System IEC 61217 mm and degrees Position 0 0 0 0 0 0 0 0 0 0 0 0 Position 0 0 0 0 0 0 0 0 0 0 0 0 7 Isocenter 0 0 0 0 0 0 C 0 0 0 0 0 0 Isocenter 0 0 0 0 0 0 0 0 0 0 0 0 Base point 0 0 0 0 128 5 0 0 0 0 0 0 Base pomt 0 0 36 0 33 0 0 0 0 0 0 0 Logged in as service Administrator Figure 102 Tools properties The following properties are available for the Tools Table 25 Tools properties ien TTT Provides the geometric data of the reference frame in respect to Reference Frame the isocenter Provides the geometric data of the calibration tool in respect to Calibration Tool the isocenter Position Values used for the internal calculation of the reference frame or Isocenter ie calibration tool position Base point HexaPOD evo RT System 09 001 1068_EN User Manual Rev 1 1 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Page 123 Managing the iGUIDE Software HexaPOD evo RT System Property Screens Isocenter Manager Properties System Overview Subsystems Isocenter Manager Current isocenter Registration date Wed Apr 27 10 41 02 2011 Registered by service Isocenter Tra
150. vice Isocenter Manager There is no valid isocenter system calibration is necessary See the 09 001 1078 HexaPOD evo RT System iGUIDE 2 0 Set to Work Manual for instructions Tools There is no valid ROM file for the reference frame or calibration tool Install the ROM file from CD See Section 7 6 3 Installing ROM Files on page 116 You can click a symbol to open a status box with relevant actions Note When you click a symbol with the right mouse button the properties of the selected equipment are shown See Section 7 8 HexaPOD evo RT System Property Screens on page 119 The following status boxes appear when you click a symbol with the left mouse button Table 19 IGUIDE Software status boxes HexaPOD Enable Check Ensures that the buttons required for enabling movements are not stuck See Running the HexaPOD Enable Check on page 111 Perform Checks Correlation Check Moves the robotic couchtop and checks if the movements measured by the camera correlate HexaPOD Enable Check Correlation Check with the expected movements See Running the Correlation Check on page 111 HexaPOD evo RT System 09 001 1068_EN User Manual Rev 1 1 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Page 109 Managing the iGUIDE Software Identifying Startup Problems Table 19 IGUIDE Software status boxes Camera Correlation Check Moves the robotic couchtop and checks if the movements measured by
151. vo RT System HexaPOD evo system The complete system for patient positioning HexaPOD evo RT Couchtop iGUIDE Tracking System iGUIDE Reference Frame GUIDE software and workstation HexaPOD OFF Button Used to switch off the HexaPOD evo RT Couchtop HexaPOD ON Button Used to switch on the HexaPOD evo RT Couchtop HexaPOD ON LED Indicates that the HexaPOD evo RT Couchtop has been switched on GUIDE Calibration Tool calibration tool Tool used for calibrating the HexaPOD evo RT System to the XVI system iGUIDE Key For enabling disabling the HexaPOD evo RT System When disabled the HexaPOD evo RT System does not set the EXTERNAL INHIBIT signal GUIDE Reference Frame reference frame A carbon fiber frame equipped with infrared reflective markers used for calculating the position of the HexaPOD evo RT Couchtop GUIDE Terminal The monitor keyboard and mouse in the treatment room iGUIDE Tracking System camera Monitors the position of the iGUIDE Reference Frame or iGUIDE Calibration Tool iGUIDE Workstation sa The PC on which the iGUIDE software runs LINAC READY LED LED on the EnableSwitch Board that indicates that no equipment is inhibiting HexaPOD evo RT Couchtop movements LOAD Button Button on the HexaPOD evo RT Couchtop control panel for requesting a movement to the LOAD position LOAD Position The lowest position of the HexaPOD evo RT Couchtop MOVEMENT PENDING LED on the EnableSwitch Board and LED Handheld Contro
152. wing table shows some typical settings Table 17 IGUIDE user rights Operator Administrator iGUIDE Administrator plans and performs treatments also responsible for managing the HexaPOD evo system See Recommendations for the User Rights It is recommended that the following users be set up e Set up a separate user for each user who will be performing treatments These users should have only Operator rights e Only the iGUIDE Administrator and service users should receive Administrator rights Users who perform the system calibration procedure need to have Administrator rights HexaPOD evo RT System 09 001 1068_EN User Manual Rev 1 1 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Page 107 Managing the iGUIDE Software Getting Information from Users 7 3 PRINT 7 4 09 001 1068_EN Rev 1 1 Page 108 Getting Information from Users If users run into a problem they can save the monitor contents and a comment that you can look at later When a user presses the PRINT button on the keyboard a dialog box opens showing the current screen and providing a field for comments Save the screen contents L m n R n R m Optionally enter a comment Figure 85 Saving screen contents Double click the Screenshots symbol on the desktop to view the current screenshots Screenshots and comments are saved under the following names Screenshots Screen_dum
153. xx Ib MAX Figure 2 Maximum point load Distributed Load This label indicates the safe working load i e the maximum permissible patient weight of the robotic couchtop if the load is distributed evenly xxx kg xxx Ib MAX Figure 3 Maximum distributed load Never exceed the safe working loads specified on the robotic couchtop CAUTION 09 001 1068_EN HexaPOD evo RT System Rev 1 1 User Manual Page 16 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Before You Begin Labelling Warning Symbols on the HexaPOD evo RT Couchtop The following warning symbols can be found on the robotic couchtop Figure 4 Labels on the robotic couchtop Indicates that the iBEAM evo Extension must be correctly seated and secured before using the robotic couchtop 2 Indicates that the weight limits of the accessory rails must be heeded Do not exceed the maximum load of the accessory rails 40 kg 88 Ib CAUTION Device Plate of the HexaPOD evo RT Couchtop The device plate of the robotic couchtop is located on the T end Figure 5 Location of the device plate HexaPOD evo RT System 09 001 1068_EN User Manual Rev 1 1 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Page 17 Before You Begin Labelling Note 09 001 1068_EN Rev 1 1 Page 18 The device plate of the robotic couchtop appears as follows P10603 100 C P SN xxxxxx Associated equipment HexaPOD
154. y function or design Medical Intelligence reserves the right to change the product without notice This manual is provided without warranty of any kind either implied or expressed including but not limited to the implied warranties of merchantability and fitness for a particular purpose HexaPOD evo RT System 09 001 1068_EN User Manual Rev 1 1 2012 Medical Intelligence Medizintechnik GmbH All rights reserved Page 11 Before You Begin About this User Manual Names in examples Warnings cautions and notes WARNING CAUTION Note 09 001 1068_EN Rev 1 1 Page 12 Conventions Example patient names physician names and hospital names may be used in this manual Any resemblance to persons and or organisations is entirely coincidental The following are examples of how warnings cautions and notes appear throughout this document The text within the examples explains their purpose Warnings are directions If you do not obey the warnings you can cause serious injury and or clinical mistreatment Cautions are directions If you do not obey the cautions you can cause damage to the equipment to goods or to the environment Notes provide advice and highlight unusual points Accompanying documentation This manual is part of the accompanying documentation for the HexaPOD evo RT System with iGUIDE 2 0 The complete set of documents for this product is listed below e 09 001 1077 HexaPOD evo RT System i

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