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Stereotaxis / Navigant manual

1. 33 Group xis ev D 55 GIOUp e e 55 cn epee 52 A A 46 mage Recall EE 39 cU 40 KEV DO ANG m 13 Ba EE 40 Left Mouse Mode 46 EE EE 40 Load Palentino t CC 18 Magnetic Navigation System See MNS Manual APO eienn ico 35 Marca e 53 Master Volume Settings ccccccssseseeeeeeeeeeees 33 d LE 11 68 70 76 Moving Magnet Positioners Manually 78 Navigation tel DEER 38 Using 2D Anatomic Views 50 navigator TUONO EE 39 Navigation Fiuoro 11 Navigation Mode ooocccccccocccnncccnonconccononcnncnonanonns 35 Navigation View 62 Navigation Volume 11 MISI D LT T 64 Marker Reset E 66 Mares loc 64 Preset Adjustment nnannneneannnennennennnenennnne 65 Stored Navigation Markers 66 New Procedure 23 OBJEC TOPICI EE 47 OPAQUE eebe onde 47 ODEn PrOGOQUFe iiie sei Resa iudei 24 Opening Crean siii cds 23 Overriding Magnet Positioner Interlocks 78 xf X 40 D cema ker nennen nnne nnns 21 Patient Preparation sesseessssse 18 Patient Hetrachon 76 Point wi e e etica E eebe 53 Points seio M 54 Basic Instructions Page 80 HDW 0161 Rev B Preoperative View 45 Proset VIEW anidar ic 58 Presets SYSTE BE 58 User Defined eee 58 Primary WINdOWS cccocccccccncccccncccccnconcncconcnnnos 29 43 Pn OCES 6 E 30 A P MO 40 Recall Imag
2. 13 Figure 3 Navigation PresSet Keys uoo satos cies vau aso v Gic add 14 Figure 4 Anatomic Direction Keys EE 14 Figure 5 Rotation and Deflection Keys AA 15 Figure 6 AutoCAS and Step Gcrpikeys nennen nnne nain nn nnns sna aar nnns naa 15 Figure 7 CAS Advance and Retract kees 15 Figure 8 Display relative Deflection Keys esses nnne nnnm nnne nnns 16 Figure 9 Opening Gcreen nennen n nn nssnnnaa nnns nis ssiaa ains riis s sn saa enn s siis anna a annis 23 Figure 10 Information WiNdOW nennen nnne nn enn nn enhn ns an nnns nnn nnns 24 Figure 11 Open Previous Procedure Window ccccccsseeceeeceeeeeeeeecaeeseceeeceeseeeeeseaeeceeessaaeceeessaaseeeesssaeeeees 25 FIGUIC 12 NeW Patent WINGOW EE 26 Figure 13 Clinical Workflow Manager Layout cccccoonncnncccccnncnncccconcnnncnononcnnnononnnnnnnnnnnnnnnnnonnnnnnnnnonannnnnnnnnnaness 26 Figure 14 Device Selection BUWOR nas ta diaria 27 Figure 15 Device Override VV INGOW occitano 27 Figure 15 Navigant Sotware BUUOM DEE 28 Figure 17 Capture Screen Bull Minas iii 30 Figure T9 Mode On UE 31 Figure TS ADDV Gell et queer Dc mb 34 Figure 20 Navigation Mode Buttons Direction and Target nne 35 Figure 21 Select Anatomy BUllOic iod Oe a a eo EU 36 Figure 22 Two Window Four Window Clinical Workflow Manager Buttons seus 36 Figure 23 Field Angle Step Size Butt0n ea a a E 37 Figure 24 S16 DIZ BUMO Mises toes et
3. Figure 20 Navigation Mode Buttons Direction and Target Direction Mode Using two valid reference images vectors may be drawn overlaying the fluoro images in the direction the user wishes to change the magnetic field This is the default mode of navigation and will be active when a procedure is started Target Mode Using two valid reference images the base or fulcrum of the sheath holding the catheter is defined by the user allowing the end target to be specified rather than simply changing the direction of the device bend Target mode is not available in basic navigation 5 3 2 1 Direction Navigation Mode To use Direction Navigation click the Direction Navigation button on the drop down list in the menu bar or on the Mode toolbar Direction navigation requires two valid reference images in 3D fluoro A and B window Valid reference images must have between 40 and 140 degrees of separation between the two images Using these images vectors must be drawn overlaying the fluoro images in both windows in the direction the user desires to change the magnetic field The cursor will be represented as an arrow with a circle at the opposite end Vectors are indications of the direction of the magnetic field as projected onto the respective x ray image plane A vector is drawn to indicate the position from which the field strength should be set and indicating the direction the magnetic field needs to point to orient the distal tip of the
4. gt Add Override Filter Overrides e Al C Catheters C Wires Overrides Used Figure 15 Device Override Window Stereotaxis Inc Basic Instructions Page 27 HDW 0161 Rev B Effective Date 07 19 06 Once a device is added the user may select any device from the list for use Only one device may be selected at a time If a different device or type of device is to be used the new one must be selected After a procedure is started and a device is selected Navigant is ready for operation Note If you are using a Clinical Workflow Manager script you will not need to select a device in this way Device selection is normally part of the Start section of most scripts Note lf a filter is selected and there are no devices matching the filter the Device List will appear empty Click the All option to remove the filter and view all available devices 4 6 Navigant Software Procedure Restart If the Navigant application is erroneously terminated restart it by double clicking the Navigant button on the desktop The button is shown in Figure 16 Figure 16 Navigant Software Button otereotaxis Inc Basic Instructions Page 28 HDW 0161 Rev B Effective Date 07 19 06 o Navigating with Navigant 5 1 Display Layout The Navigant display includes a title bar status bar reference images 3D visualization display and UI windows The Title Menu and the Navigant Toolbar focus on the procedure type information and
5. 6 942 766 6 562 019 6 630 879 6 662 034 6 677 752 6 02 804 6 33 511 6 40 103 6 55 816 6 86 219 6 817 364 6 931 818 6 902 528 6 911 026 6 940 379 6 968 846 6 975 197 6 980 843 7 008 418 7 010 338 7 019 610 7 017 584 7 020 512 Other U S patents pending Foreign patents issued and pending Niobe and Cardiodrive are registered trademarks of Stereotaxis Inc Navigant is a trademark of Stereotaxis Inc Tangent is a registered trademark of Stereotaxis Inc CARTO is a trademark of Cordis Corporation Inc Biosense Webster is a registered trademark Cordis Corporation Inc NAVISTARO is a registered trademark of Cordis Corporation Inc AXIOM Artis dFC Magnetic Navigation System is a trademark of Siemens Corporation Allura amp is registered trademark of Philips Electronics NV Stereotaxis Inc Basic Instructions li HDW 0161 Rev B Effective Date 07 19 06 TABLE OF CONTENTS ADs CO e eencstact ase 8 Vel eat All OM EE 8 be CIEN UE Dm 8 li COMPAS EE sudes dica 8 1 4 Intended USe 316 t 9 GE ET ue E en 9 1 6 Acronyms Abbreviations and Deimtons nennen nennen nnne nnns nn nns 10 1 7 Referenced Documents nenne nenne nnnnnni nnn RR RR RR nnn rsssna aisi ssssa arsi snas anri snas reis 11 2 NAVIGANT USER CONTROLS AND HARDWARE nennen nnnnnnnnnnaii nnn nnns nnns sns nns 12 2 1 Operating fcu EE 12 22 SBD EE 12 Zo MPU Ee 12 2 3
6. Other Group Views nnne nnn nnns nnnai nnn nnn sss ssaa iain rris sss ageres rins n sanis 63 7 3D NAVISPHERE NAVIGATION 64 7 1 3D Navisphere Cardinal Direction Markers eene 64 Tse DU TOSOLIVIII KelS EE 65 7 2 1 3D Navisphere Preset Direction Markers Adjustment nnnn0nnnnnnnnnnnnnnnnnnnnnnnrrnsrnrrnnrnnsrrerernreenene 65 ieee 8D Navisphore Marker EE 66 7 3 3D Navisphere Stored Navigation Markers sisian uunien a a E A E A A NATE 66 17 3D Navisphere Field een EE 66 TO S9DJINavisphere VIGw AUSTEN Laia a 66 7 5 1 Orientation and Synchronization Options eene nnne nnns 67 75 51 Jdealized Eer ele EE 67 8 MAINTENANCE TROUBLESHOOTING MESSAGES esses nennen nennen nnne nennen nnns 68 ol IMalten Me Me 68 e elen Le Led Le arrene 68 0 9 E A N 69 9 EMERGENCY cd un t UM uua MM tM E pute 76 9h Emergency Patient Relacion is 76 92 EMergeney olp E SIOD EE 76 9 2 1 EE Ee 76 SP EN ne o e EE T4 9 3 Overriding Magnet Positioner Interlocks sss nnne nnns 78 9 4 Moving Magnet Positioners Manually o cccoconcnncconcnncononcncononcnnonnnononnnnnnnnnnnrononnnrnnnonnnrnnonnnrnnnnnnrnnonas 78 9 5 Removing an Item That Has Become Stuck toaMaonet 79 10 INDE uc ET 80 Stereotaxis Inc Basic Instructions V HDW 0161 Rev B Effective Date 07 19 06 List of Figures Tables FOUS joe a 13 Figure 2 Apply Field Reduce Field Transfer Image and Store Points Store Navigation Keys
7. which includes preset directions for superior inferior anterior posterior right and left Below is an example of an IC preset list Left Main Circ Proximal Circ Middle i a Ramus i d ic right d cardinal Obtuse Marginal Pos Lateral LAND E r Figure 51 Preset View 6 7 2 1 System Presets Regardless of what procedure is chosen System Presets are always available System presets are marked with the Stereotaxis emblem Device specific System Presets will be displayed once a device has been selected in the device selection window System preset lists may not be changed 6 7 2 2 User Defined Presets A new preset list can be created by right clicking in the Preset view and then choosing New List A Preset List window will appear The user may name the list to be created and choose to make the list User or Shared If the list is marked as User one person the list will only be available to the current physician If the list is marked as Shared two people it will be available to all users Once named the preset list will be available in the Preset View window Stereotaxis Inc Basic Instructions Page 58 HDW 0161 Rev B Effective Date 07 19 06 Vectors may now be stored in this new list First set the vector desired and then right click over the list and select Store Direction from the drop down menu that appears This will cause a Preset Direction window to appear and through which the vecto
8. 1 Ve 12 Ets IS ee ANC CPAP APO RS 13 2 3 2 1 Apply or Reduce Field Transfer Image Store Points or Navigation 13 2 3 2 2 INavigaliol Presl E 14 2 3 2 3 Anatomic Direction Adjustment Keys AE 14 2 3 2 4 Rotation and Deflection Keys only available with Target Navigation 14 2 3 2 5 Auto AS dnd Step OCP KEYS cao E 15 2 3 2 5 1 CAS Advance and Retract Using Keyboard nnnnnnaannnnnennnnnnennnnersnnnnresnnnrnsrnnrrersenreeenne 15 2 3 2 6 Display Relative Field Deflection Using Keyboard ooccccconncccoconcnccconconconononconanenonnanonconanennos 16 2 39 Wana Licensed Feature E 17 EDU A a eee Ce eee ne ere ee 17 zr DISDIBY MONOS TE UU LT 17 Os NIE IPE E AON EE 18 3 1 Recommended Patient Loading Procedure ccccccoocccnccccconccnnccononnonncnonancnnnonnnnnnnnnnnnancnnnnnnnanennnnnnnncnnnnss 18 Sz Automatic Positioner GCentening ssec uere E A AE AA AA A RS 20 Sel GOVE Force Sensor EE 20 o Pre procedure Las ku andes 21 o WMavigauombProcedule Tas Sion II N 22 OA IPOSEProcedute Tasa mm 22 A STARTING APROGEDURE cucuta iio do dello eher 23 Ad Slan New Pro e IEN 23 42 ee eelere EE 24 4 3 Procedure Initiated by Fluoroscopy System ccooconnncconnccccnononnccnnnnonnonononnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnns 26 4 4 Clinical Workflow Manager CWM cccccsssssececceeeseeeeeceeeeceeceauseeeeessaueeeessaauseeeeesauaseseesssageeeessaaass 26 A VIC EE
9. Position Niobe adjusts the Navigate Position center based on this new location and displays a message Magnets in Navigate Position otereotaxis Inc Basic Instructions Page 20 HDW 0161 Rev B Effective Date 07 19 06 3 2 Pre procedure Tasks CAUTION If a patient is to receive a permanent pacemaker or internal cardiac defibrillator ICD de novo in the MNS room the Niobe magnets must be moved and kept in the stowed position The magnets should stay in their stowed positions during the entire period starting from the moment the ICD or pacemaker is brought inside the procedure room and ending when the patient with the ICD or pacemaker implanted is moved out of the procedure room Proper functioning of ICDs and pacemakers should be verified following the removal of the patient from the MNS room CAUTION During patient loading and unloading there is a very definite squeeze risk for personnel in the vicinity of the magnet positioners and the C arm All personnel should take care to ensure they are not in the vicinity of this risk when the magnets are moving between the stowed pivoted or navigate positions An audio signal will sound when magnets have completed their movement operation CAUTION Do not enter the area between the C arm and magnet positioner when the magnets are in the pivoted position Ensure no ferrous objects are in the area Ensure credit cards watches floppy disks cell phones etc are not in the area Clean
10. and clear magnet positioner floor tracks QOO D Power up system Home system by pressing and holding the Navigate AP button on the tableside controller Hold button until status bar displays Homing Complete This may take up to 60 seconds f Retract magnet positioners back to stowed position to aid in patient loading D otereotaxis Inc Basic Instructions Page 21 HDW 0161 Rev B Effective Date 07 19 06 3 3 Navigation Procedure Tasks Place patient on table as described in section 3 1 Prep patient per hospital procedure and apply sterile drape over tableside user interface Using X rays determine preferred RAO LAO projections Take two images between 40 and 140 degrees apart RAO LAO or cranial and caudal Transfer images after each one as described in Section 5 if necessary e Adjust images on Navigant if necessary f Introduce magnetic device and advance manually to desired anatomy User may use Cardiodrive catheter advancer with approved catheters g Place C arm and table in C arm table safe position h Move magnets to Navigate AP position by pressing the button on the tableside controller Perform Magnetic Assisted Procedure j Press the Reduce Field key or move magnet positioners to retracted position to reduce magnetic influence to relatively null in the navigational volume k When procedure is complete move magnets to stowed position by pressing button on bedside controller Hold button unt
11. control windows serve two purposes to illustrate the desired and present vector orientations display and to allow adjustment of the desired vector orientation control The 2D display vectors are displayed as arrows and follow the same color scheme as described in section 6 4 General Display The vector orientation is displayed but not the origin always displayed as the center of the image The lengths of the vectors are adjusted to indicate the relative directions in the three views These views are displayed down the left side of the Navigant screen The 2D anatomic display can also be in the Primary window All vectors are updated whenever the desired or present fields change In the bottom corner of each of the smaller 2D anatomic displays along the left side of the screen the clock notation of the vector in the plane of view are displayed whenever valid vectors exist The present field notation is displayed on the left in yellow and the desired field notation is displayed on the right in green The color scheme for the numbers is the same as for the vectors A vector pointing straight up in the view is labeled as 12 00 Moving the vector straight down would be 6 00 The default view of a dot is for no vector and 00 00 will be displayed Right clicking in a 2D window causes a drop down menu of display options to appear The display can be changed like any other view in Navigant Options are available according to the procedure type chose
12. determines how large the change in field direction is each time the keys or buttons are selected For small more precise changes this value should be set low and for large movements it should be set higher Figure 23 Field Angle Step Size Button 5 3 6 Cardiodrive Step Size The Cardiodrive Step Size button when selected provides a drop down list with a range of distances to set the CAS step size This value determines the distance a catheter will be advanced or retracted each time the keys or buttons are selected For small more precise changes this value should be set low and for large movements it should be set higher The default value for this setting is 2mm Figure 24 Step Size Button 5 3 7 Field History The Field History buttons allow the user to navigate through the ten most recent applied field directions This allows recalling a recent field direction later in the procedure even if the navigation was not stored using the Stored Navigation Controls Note When the system is in Auto Apply mode the Field History still operates as though it were in Manual Apply mode This allows the user to move through the list and find the desired navigation without applying undesired field changes When the desired field direction is changed by something other than the Field History the list will reset so that it is only possible to step backward through the list and the first step backward will select the most recently applied
13. enable the user to implement procedure flow and preferential settings The Primary Windows provide various views for the user In these windows the user may choose to visualize 3D anatomical 3D constellations 2D navigation 3D Navisphere 3D fluoro transferred x ray images or preoperative optional views The 2D Navigation Controls offer the user an idealized anatomic model in various planes of view and allows the user to see the current fields and adjust those fields in that plane The Selectable Controls provide the user more defined methods for navigation The System Indicator window informs the user the status of the communication the magnet positioners safe position of c arm and table and the status of the magnetic field 5 2 Title and Menu Bar The title bar blue background of the Navigant displays the name of the application and in parentheses the procedure description followed by a colon and the specific procedure type selected when the procedure was started The menu bar gray background below the title bar implements procedure flow controls navigation options fluoro and preference settings 5 2 1 Procedure Menu The procedure menu allows the user to perform the following functions e Edit the procedure information Review current features available Change the current layout to the default screen layout Save the current screen layout Restore the current layout to user defined default layout Capture an image of the
14. layout for physician Te Thedefaultlayoutwillbe used Failed to create device model e Error in device modeling data or in the application of this data Redraw device base and reselect target Device model failed to reach the e Target navigation could not identify a device identified target curve and field that would place the device at the selected target Choose another target Device may flip if this field is applied e Multiple paths exist between the current device configuration and the desired field At least two paths will result in different device configurations which could cause the device to flip Connection to Magnetic Navigation e Check operation of MNS Restart MNS if System lost necessary Check Ethernet cables It will not be possible to apply fields until connection reestablished Group type invalid for point to store Select another group e Check if trying to store fluoro points in a group marked for preop or vessel Same if trying to store preop points in a group marked for fluoro or vessel Apply disabled Navigant cannot apply a In the current mode no fields can be applied field until switched to another mode To apply a field switch to manual apply or auto apply mode Failed to E NE screen image Screen A A failed Check destination and A A DE to access printing device Unable to print until connection restored or established WARNING Printer cannot print graphics e Print fail
15. or a linear lesion With the smooth curve constellation the display may not intersect with the exact points but will be a best fit for the group of points The order of the points in a group is important in some of the constellations in which case it affects the shape displayed To change the order of the points use the Edit Group window select the point to be moved and use the arrows to move the point up or down to the desired position otereotaxis Inc Basic Instructions Page 57 HDW 0161 Rev B Effective Date 07 19 06 First vessels must be constructed by storing multiple points overlaying the vessel s Once enough points are stored to satisfactorily outline the vessel as determined by the user the points may be made into a vessel spline constellation by right clicking over the Group name and selecting Create Vessels The various vessels will be assigned to different groups and displayed as vessel splines on the 3D displays After using the Create Vessels option assure the vessel overlay is correct If it is not correct the vessels may be adjusted by moving points from one vessel to another by dragging a point to the correct group as described in section 6 7 1 3 The drop down option Create Vessels creates one vessel per group of points 6 7 2 Preset View The Preset View displays a selection of general preset directions as defined by the device and procedure selected The preset group available for basic navigation is Cardinal
16. part of a screen layout for the currently selected physician and procedure type 6 2 4 Center View Options The Center View button allows the user to determine what the 3D view should be centered around The 3D Center on Desired Vector window may be centered on Table 5 Center View Options 6 2 5 Fit Objects to Window Click the Fit Objects to Window button to fit all 3D objects within the window constraints Figure 40 Fit Objects to Window Button 6 2 6 Object Opacity Figure 41 Object Opacity Button This button allows the objects on the fluoro screen to be seen as opaque or translucent Stereotaxis Inc Basic Instructions Page 47 HDW 0161 Rev B Effective Date 07 19 06 6 3 Right Mouse Options in 3D Display Windows Right clicking within the Primary Window brings up a drop down list as shown below Change Window Left Mouse Mode gt Show Hide User Views Center View At Fit To Window Figure 42 Right click Options Several of these options are also in the display windows toolbar and are duplicated here The use of each has been described above 6 4 General Displays 6 4 1 Vectors Vectors are indications of the direction of the magnetic field as projected on the respective x ray image plane Vectors will be displayed throughout the various views on the screen The vector is drawn or controlled indicating the position from which the field strength should be set and indicati
17. positioner safe The bi plane gantry is not in a safe range to continue position Cannot transfer the image The table e Image transfer disallowed if table cradle too was cradled for this image great Correct position to continue WARNING yagrotatedfortisimage O was rotated for this image Cannot transfer the image The L Arm e L arm not in correct navigate position when was not in the working position for this image was acquired Correct position to transfer image image Cannot transfer the image The image is not transferable unknown reason X ray system does not allow magnet e Magnets are not allowed to move unless the L movement The L Arm longitudinal arm longitudinal position is in the Navigate position is not in range position f Magnetic navigation is not possible The e Move L arm to the working position L arm is not in the working position Homing in progress Continue holding e To successfully home the system press and button hold the Navigate AP button down for approximately 60 seconds until the monitor indicates homing is complete Homing cancelled The homing button e To successfully home the system press and was released hold the Navigate AP button down for approximately 60 seconds until the monitor indicates homing is complete Patient changed Closing the current e This message displays when a new patient is procedure is recommended registered on the x ray system but a new study has not been star
18. the applied field Default Stored Navigation Names assigns default names i e Navigation 1 2 etc to stored vectors Applied Field Sound Setting can be assigned the following options e Play sound when any field is applied e Play sound when interrogation field is applied e Nosound Keyboard Catheter Control View Controlled By Keyboard is used to select which Navigant view will allow keyboard controlled field deflection via the arrow keys otereotaxis Inc Basic Instructions Page 32 HDW 0161 Rev B Effective Date 07 19 06 5 2 4 2 Graphic Display Settings The Graphic Display Settings window allows the user to change the display options on the Navigant screen and on live fluoro Point Annotations do not appear on live fluoro windows General Graphics Display Show Target allows set reference target orange circle to be displayed Display on Live causes graphics to be displayed on x ray system s live fluoro screen Display on LIH causes graphics to be displayed on x ray Last Image Hold Constellation Display Brightness provides a sliding bar from dark to bright Show Vessel Outer Tube provides a check box to turn the Endoluminal vessel outer tube display on and off 3D Nav Fluoro Object Opacity provides a sliding bar from opaque to transparent Fluoro Zoom Factor allows control of the magnification factor for fluoro images Point Annotation Font Size Sets the size at which point annotations will be displayed Default is 1
19. 27 4 6 Navigant Software Procedure Hestart nennen nennen nnn nnne n ann nnns 28 5 NAVIGATING WITH INAVIGAN RRE 29 A A R 29 S2 FIG ae KE ER EE 29 5 2 1 Bretelle EE 29 5 2 1 1 View Edlt Procedure EE 30 5 2 1 2 Rat ug ie lara a ados 30 5 2 1 3 AA PP nn 30 5 2 1 4 Mestore We EE 30 5 2 1 5 Cap Odds 30 5 2 1 6 o EE 31 521 7 Olose ele e id 31 PR NOSNO EE 31 IAS ten WEE ER E A A 32 5 2 4 1 General SOMOS NER Rm m 32 5 2 4 2 Graphic Display Settings ecciesie cess iieeeeeee onn a naa nha con anna aka aa g sarai aaa kae s Re cr a aA 33 Stereotaxis Inc Basic Instructions lil HDW 0161 Rev B Effective Date 07 19 06 5 2 4 3 Constellation Sequencing Tools 33 5 2 4 4 xj wr ge e Cm 33 5 2 4 5 M ster Volume SoNg S iia da 33 5 2 4 6 LO oo dere aira a 34 220 THO IOAIVI Mmmm 34 O20 NaVIGaht Reie 34 5 3 1 ele OPIONS EE 34 S32 Navigation Mode ideo 35 5 3 2 1 Direction Navigation Mode 35 5 3 2 2 EIN TA 36 5 33 Anatomy Display cccoonccncccnncnccconcnnconononcononcnnononnnnnn nennen nnne nnn nnna nn a a aapa aaan Raai 36 5 3 4 Window Display 36 Boa Elda Angle Sleep SIZ OR raat a odian A 37 596 Candiodrive Step Size dana daa tdo dos 37 397 Fed HSO EE 37 9 0 0 olore NEIE Ee dues Selen dae 38 599 SIS POIDS ias aia cata nai ds 39 09 10 mage Reca TaMSler Madura a 39 E E A EE 40 5 5 12 Sp Display Orientation TOODA asnata e e 40 SST WIEW SVMCNFOMI
20. 43 PIDOKOVIGHONS EE 10 eieiei eg 10 Anatomic Direction Adjustment Keys 14 Anatomy Display 36 EE 40 Apply Disabled Mode 35 ele Field A er ri 13 APON ODUOMS EE 35 A Seide 40 AUTO APON Mode sidra eio dd 35 EH eer 15 Bulls Eye Met VIA italia cos 61 A em MR CC 61 B lls EVO AM nta dais 60 Bulls Eye Central Avis 60 Bulls Eye OrientatiON oooccccccccccccconnccnnnncnnnnnos 60 Bulls Eye VIE Winrar 59 Capture Screen hennan aaa e 30 CAS See Catheter Advancement System Catheter Advancement System 10 Center View Options eese 47 Clinical Workflow Manager 26 Constellation Sequencing Tools 33 CORnSIellatiOHS E 56 CUM m 26 Matt e EE 30 DONOSO di 10 Deflection Keys AAA 14 Device ee el Ee EE 27 Device Selection Button 27 Device Selection Window 27 Direction Mode EE 35 Direction Navigation 36 Drawing VeclOfS ir s 36 Edit Giele ele crit to o uris 30 EIN PONS EE 54 Stereotaxis Inc Effective Date 07 19 06 Emergency ccccccnnccnconncnncononcnnnnnnnnnnnannnnonannnnnnnnnannss 76 Emergency Giop 76 A O PO 76 A dn cedhetaentcen std Giordana OO 9f Fit Objects to Window sees 47 General Settings necare a 32 Graphic Display Settings
21. 8 pt X ray System Live Fluoro Display Selected Points and Constellations allows the user to display points and constellations Magnetic Navigation Status displays the status of magnetic field change Virtual Catheter allows the user to display the desired and present device curves as well as the catheter base Catheter Adjustment Tools allows user to display the Catheter Adjustment graphics on the live fluoro images Magnetic Field Vectors allows the user to display the desired and present magnetic field vectors 5 2 4 3 Constellation Sequencing Tools The Constellation Sequencing Tools Settings window allows the user to control the initial configuration and operation of the Constellation Sequencing Tools used with imported preoperative images 5 2 4 4 RMT Settings The RMT remote magnetic technology settings window allows the user to set display settings tolerances and view the status of the link to CARTO system 5 2 4 5 Master Volume Settings This window allows the user to set the volume of the audio speaker in the control room and the procedure room Stereotaxis Inc Basic Instructions Page 33 HDW 0161 Rev B Effective Date 07 19 06 5 2 4 6 Preop Settings This window allows the user to set view preferences for the Preop view For more information consult HDW 0098 Preoperative Imaging Instructions Note Preop is an optional licensed feature of Navigant 5 2 5 Help Menu The help menu provides the Navi
22. HDW 0161 Rev B Effective Date 07 19 06 HDW 0161 THE HDW 0161 MANUAL COMPONENTS 1 HDW 0161 LABEL DOCUMENT PRINTING INSTRUCTIONS THE DOCUMENT SHOULD BE PRINTED ON A COLOR PRINTER Print on 3 holed paper AFTER PRINTING DOCUMENT DISCARD THIS PAGE AND SUBMIT MANUAL TO INSPECTION REVISION HISTORY ECO Initial release J Thebeau 03 10 06 06 062 B NWS 2006 Commercial Release updates J Thebeau 07 19 06 06 488 HDW 0161 Rev B Effective Date 07 19 06 Navigant Navigation Work Station Basic User s Instructions Navigant 2006 i V um 4320 Forest Park Avenue Suite 100 St Louis MO 63108 USA Manual P N HDW 0161 1 866 646 2346 Hevision B 1 314 678 6100 Revision Date 07 19 06 www stereotaxis com O Stereotaxis 2006 Rev B Effective Date 07 19 06 SYMBOL LEGEND REF Part Number HDW 0161 Attention See Instructions For Use Authorized Representative in the European Community EC REP Manufactured under one or more of the following patents United States 4 869 247 9 125 888 9 303 807 9 094 864 5 707 335 5 779 694 5 843 093 5 931 818 6 014 580 6 015 414 6 096 048 6 128 174 6 148 823 6 152 933 6 157 853 6 212 419 6 216 030 6 241 671 6 292 678 6 296 604 6 298 297 6 304 768 6 311 082 6 315 709 6 330 467 6 392 363 6 364 823 6 375 606 6 385 472 6 401 723 6 428 551 6 459 924 6 475 223 6 505 062 6 507 751 6 522 909 6 524 303 6 527 782 6 929 761 6 937 196
23. Instructions Page 10 HDW 0161 Navigation Fluoro Rev B Effective Date 07 19 06 da Fluoroscopy or Fluoroscopic Magnet positioners are pivoted toward the patient and at the farthest distance from the patient T Head First Supine Interventional Cardiology Stee Joint Photographic Experts Group Sg Left Anterior Oblique o Last Image Hold Gnomes Magnetic Navigation System Steeg The fluoroscopy images used for magnetic navigation Navigation Volume Spatial volume defined for a MNS where the MNS is capable of generating any magnetic field direction at the target magnetic field strength provided by the MNS a Magnetic Navigation system which utilizes two opposing permanent magnets to generate the magnetic fields required for navigation Navigation Workstation The SD location and direction of the magnetic field presently being generated by the MNS e Right Anterior Oblique m Remote Magnetic Technology short for CARTO RMT EP Navigation System and the integrated CARTO Niobe MNS environment Supraventricular Tachycardia pm User Interface 1 7 Referenced Documents The following Stereotaxis documents are referenced herein Document Number HDW 0144 HDW 0137 HDW 0134 HDW 0169 HDW 0097 HDW 0098 HDW 0156 Document Title Navigant Navigation Workstation Installation and Maintenance Manual Niobe MNS Maintenance and Service Manual Niobe User s Manual NaviView Instructions EP Ins
24. NG Navigant does not track the location or orientation of the catheter If the user purchases the Biosense Webster CARTO RMT EP Navigation System and uses an appropriate Biosense Webster Navistar RMT catheter Navigant can be instructed to display the location and orientation of the catheter tip WARNING The graphical representation of the catheter on the Navigant display represents an approximate location and orientation of the catheter inside the patient s heart after the user acquires a new fluoro image and subsequently transfers it from the x ray to Navigant using the Transfer Image button WARNING The Target Navigation mode is intended to serve as a tool to assist the physician in placing the compatible magnetic device to the intended location inside the heart chambers The navigation field is static so results may vary in the beating heart Stereotaxis neither claims nor quantifies the accuracy of the device tip localization via Target Navigation Physicians should monitor fluoroscopic visualization and ECG to correlate between the visual representation and final resulting device tip position WARNING The user should not provide any type of therapeutic treatment while changing magnetic fields or while moving the device with the Cardiodrive Catheter Advancement System WARNING Exercise caution with moving parts of the system to prevent inadvertent contact or damage to the patient operator or equipment Moveable items include both mag
25. W 0161 Rev B Effective Date 07 19 06 1 Scope 1 1 Identification This manual describes how to operate the Navigant Navigation Workstation NWS a highly sophisticated software system for use with the Niobe Magnetic Navigation System MNS 1 2 General The Niobe MNS is a medical device designed for electrophysiological and interventional procedures The MNS facilitates the control of the distal tip of compatible magnetic devices via magnetic fields Navigant is a tightly integrated companion of the Niobe MNS The Navigant NWS is the user interface to the Niobe MNS The purpose of this manual is to provide the user of the Niobe MNS and Navigant with instructions for operating the equipment This manual has been written to describe Navigant operation specifically The Niobe MNS is described in a separate manual The instructions for the use of associated magnetic disposables are not addressed in this manual 1 3 Companion Systems The Niobe MNS and Navigant communicate with a choice of digital fluoroscopy systems either the Siemens AXIOM Artis dFC Magnetic Navigation System with flat panel imaging the Siemens AXIOM Artis dBC Magnetic Navigation System with flat panel imaging offering Bi Plane capability with magnets stowed or the Philips Allura amp Xper FD10 The Niobe MNS and Navigant also communicate with the Biosense Webster amp CARTO M RMT EP Navigation System The MNS integrates with a digital fluoroscopy system to p
26. ZE OMe OM ee A 41 S PRAEERAT ee ie 41 5319 Wand Liconsa EE 42 6 PRIMARY WINDOWS le T 43 E E e 43 6 1 1 AS A A ant 44 6 2 SD GoOnstellatlon EE 44 BAS SD Tele 44 SN NO Bei 45 sm M ZIDVANATOMIC EE 45 6 16 espace 45 6 1 7 Preoperative View Licensed Feature sese nn nnns 45 o 2 Display WINDOW hee EE 46 6 2 1 Eert Mose MOGE EE 46 E o A In 46 029 O EA O AI ig tee eee sda ede 47 o2 Denier View OPINE EE 47 020 Ole Ens A r a E E T aA 47 6026 A m 47 6 3 Right Mouse Options in 3D Display VWumdowes nnne 48 s MEE ID AA a 48 6 4 1 MESS A 48 SE CR elle RI 49 An o FP saa ces on decaae ye esse teasoe etasede iassea cee 49 642 EE 49 SS IU Dadas 50 60 20 Navidatlon CONTO EE 50 6 7 Seleciable CONTO EE T EOD m 52 6 7 1 GOUD VIEW mr NS 52 6 7 1 1 Mark UREA cie cocoa 53 6 7 1 2 A a Udeansi E a a 53 6 7 1 3 EANO EON EE 54 6 7 1 4 STOU ODON EE 55 SA Pr MEINE 56 6 7 2 Wicca Ac MEME MICI A clause salaca th A E 58 6 7 2 1 SA A O s pL tees 58 Stereotaxis Inc Basic Instructions iV HDW 0161 Rev B Effective Date 07 19 06 6 7 2 2 PESA a a edid eset edi eO veda oeste 58 67 BUIS Eye VOW CCS 59 6 7 3 1 BUIS EVS net 60 6 7 3 2 BUS Eye Orie Malo EE 60 6 7 3 3 Bulls Eye Central AXIS urinii a ee 60 6 7 3 4 DiSplaying INE BUISEVS EE 61 6 7 3 5 Bulls Eye Interrogaton ne 61 Mr MEME VIVI ATION Ve EE 62 6 75 Guidewire Bend Control View 62 6 7 6
27. an only be rotated more superior until the superior direction is reached Figure 4 Anatomic Direction Keys 2 3 2 4 Rotation and Deflection Keys only available with Target Navigation The Rotation and Deflection Keys are useful for small adjustments in catheter rotation and deflection The keys are designed to imitate the actions of a standard non magnetic deflecting catheter The outside keys cause counter clockwise left key and clockwise right key rotation which mimics torque of the device The middle keys cause an increase bottom key or decrease upper key in the deflection of the device Stereotaxis Inc Basic Instructions Page 14 HDW 0161 Rev B Effective Date 07 19 06 Figure 5 Rotation and Deflection Keys 2 3 2 5 AutoCAS and Step Script Keys The AutoCAS key allows the Cardiodrive if available to automatically advance the catheter The Step Script key runs the current step in a Clinical Workflow Manager script and advances to the next one AUTO Figure 6 AutoCAS and Step Script keys 2 3 2 5 1 CAS Advance and Retract Using Keyboard Pressing the CAS Advance and Retract keys cause catheter advancement and retraction See Figure 7 e Press and release the CAS Advance Key to advance the catheter by one step e Press and release the CAS Retract Key to retract the catheter by one step Figure 7 CAS Advance and Retract keys Stereotaxis Inc Basic Instructions Page 15 HDW 0161 Rev B Effecti
28. and magnet isocenters match Navigant has field changes disabled e he joystick to move the positioners is disabled The joystick is disabled when Navigant is in the field locked mode The current field cannot be changed Cannot move the magnet positioners e Allura C arm longitudinal axis must be in c arm The C arm is not at the magnet and magnet isocenter isocenter movement unknown reason position is not in range X ray system does not allow magnet Alllura table lateral position is out of range movement The table lateral position is out of range X ray system does not allow magnet e Allura L arm is rotated Correct position to X ray system does not allow magnet e Allura C arm LAO RAO is out of range Correct movement The C arm LAO RAO angle LAO RAO range to continue is out of range X ray system does not allow magnet e Allura E stop is active Deactivate E stop to active movement Magnet movement is only path before overriding movement possible using the override buttons X ray system does not allow magnet e Allura table tilt is out of range Correct position movement The table tilt angle is out of range Cannot transfer the image The patient e Patient orientation is not HFS or FFS Correct orientation must be HFS or FFS patient orientation to transfer image Inc Basic Instructions Page 73 HDW 0161 Rev B Effective Date 07 19 06 Cannot move the magnet positioners e Park Bi plane gantry in magnet
29. ariety of options for the display layout Four Panel Two Panel Clinical Workflow Manager These are primary window layout options of two or four windows to be displayed or the Clinical Workflow Manager CWM layout Toolbars When selected this expands to provide a list of available toolbars Any currently displayed toolobars will have a check mark in front of them 5 2 4 Settings Menu The settings menu allows viewing or changing the default settings for general graphic display catheter tools voice control RMT master volume and guidewire settings 5 2 4 1 General Settings The General Settings window allows the user to change navigation settings fluoro settings and miscellaneous screen settings Navigation Guidewire Lag Angle Compensation causes Navigant to adjust field direction to account for guidewire stiffness and vessel curvature The field is deflected toward the vessel center of the curvature Fluoro Auto Image Transfer causes the last image of any fluoro run to be transferred to the most suitable Navigant 3D fluoro view A or B window otop at Pivot Position towards Stowed causes the magnet positioners to stop at the pivot position instead of moving completely to the stowed position Miscellaneous Auto Set Bull Eye Axis on Preset causes the Bulls Eye to be assigned to the desired field specified by a chosen preset vector Auto Set Bulls Eye Axis on Applied Field caused the Bulls Eye to be assigned to
30. avigate AP controller button Unrecoverable error Please cycle power e Procedure A using the power on off switch box e Procedure C m The floor lock is not set Hold the e Using the tableside magnet control move the controller button until the positioner magnet into the Navigate AP Retracted or move is complete otowed position The field is currently being changed e Wait until the current operation is complete and Please wait then try again Cannot move the magnet positioners e Move the C arm to the head end position and The C arm is not in the head end reattempt the positioner move position Cannot move the magnet positioners e Move the C arm and table to a Navigate safe The C arm and table must be in the position and reattempt positioner move Navigate safe range Cannot move the magnet positioners e Move the C arm and table to a Retracted safe The C arm and table must be in the position and reattempt positioner move Retracted safe range Cannot move the magnet positioners The C arm or table is moving before attempting to move the positioners X ray system reports a position error e Procedure C Magnet movement is restricted to the Bu RN Stowed position X ray system reports an active proximity e Deactivate the x ray system proximity switch or switch Magnet movement is only use override to move the positioners possible using the override buttons Movement can only be away from patie
31. ayout during the procedure 5 2 1 5 Capture Screen To save a screen image as a jpeg image click the Capture Screen button on the main toolbar Navigant will automatically save the screen image and displays a message at the bottom of the screen describing where the image was saved JES Figure 17 Capture Screen Button Note The saved image is placed in C Navigant Save a subfolder with the same name as the current procedure Stereotaxis Inc Basic Instructions Page 30 HDW 0161 Rev B Effective Date 07 19 06 5 2 1 6 Print Screen To print the current screen to the system printer select Procedure gt Print Screen 5 2 1 7 Close Procedure To exit the current procedure select Procedure gt Close Procedure or use the shortcut key Ctrl C This returns the system to the Main Window 5 2 2 Mode Menu The mode menu provides a drop down list of apply and navigation options The apply options are Auto Manual and Disable The navigation options are Direction and Target All of these options are described later in this section The option currently in use will have a check mark in front of it v Auto Apply Manual Apply Disabled Apply v Direction Navigation Target Navigation Field Strength Figure 18 Mode Menu Note Field Strength is an optional feature Stereotaxis Inc Basic Instructions Page 31 HDW 0161 Rev B Effective Date 07 19 06 5 2 3 View Menu The View Menu provides access to a v
32. ce Figure 8 Display relative Deflection Keys Stereotaxis Inc Basic Instructions Page 16 HDW 0161 Rev B Effective Date 07 19 06 2 3 3 Wand Licensed Feature The Wand is a user interface device that can be connected to the Navigant The Wand can be used to control the field direction in Navigant and to control the advancement and retractions of a Cardiodrive CAS The Wand is a licensed option for Navigant For more information see HDW 0156 Wand 2 3 4 CD DVD Drive The CD DVD drive is used to import data to Navigant 2 4 Display Monitors The Navigant 23 display monitors are available in both the procedure room and the control room The arrangement of these monitors is site specific otereotaxis Inc Basic Instructions Page 17 HDW 0161 Rev B Effective Date 07 19 06 3 Patient Preparation This section outlines the basic procedure to be followed in order to perform a generic magnetic navigation procedure 3 1 Recommended Patient Loading Procedure The recommended procedure for loading a patient is illustrated below The intent of this procedure is to keep the patient and attending medical staff in a low magnetic field less than 5 gauss during the transfer The 5 gauss line for the system in the stowed position is marked on the floor WARNING The Niobe system produces a strong magnetic field which is always on Patients and operators with pacemakers internal cardiac defibrillators ICD neurostimulato
33. choosing Edit or double clicking Navigation 1 and typing a new name Stored directions can be deleted from this view by highlighting the direction to be deleted and then choosing Delete A confirmation of the deletion is required All stored directions are procedure dependent and will not be carried over to a new procedure 6 7 5 Guidewire Bend Control View The Guidewire Bend Control includes e Buttons to deflect desired magnetic field in four directions Indicator controls to show the current desired and applied fields Indicator controls to show the current desired fields deflections A reset button Show hide button for Guidewire Bend graphics in 3D views To Open the Guidewire Bend Control View 1 Right click in the Views area of the Navigant screen 2 Select Change Window 3 From the View list choose Guide Wire Bend View otereotaxis Inc Basic Instructions Page 62 HDW 0161 Rev B Effective Date 07 19 06 AP PA rim LL RL sat Di e cardinal Presets ESAE Y E NEE AY IS Guide Wire Bend View Figure 60 Guidewire Bend Menu Item Ki Z ca o S E O Figure 61 Guidewire Bend View e Click directly on the More or Less curve to set guidewire bend e The Bend and Rotate buttons use the Field Angle Step Size as the increment for adjustments 6 7 6 Other Group Views The Cardiodrive Alignment RMT Navigation Constellation Sequencing and Voice Control Views do not have any applica
34. circular regional or radial choose the desired angle range from the center axis Choose Play similar to a standard DVD player to play programmed interrogation pattern twice Bulls Eye Settings Bulls Eye Properties Interrogation Properties View Spacing degrees SCH pacing degrees 30 Back Pause Time 1 sec Range C 30 C 60 90 C 120 Figure 59 Bulls Eye Settings Window Stereotaxis Inc Basic Instructions Page 61 HDW 0161 Rev B Effective Date 07 19 06 To stop the interrogation click the square Stop button However if the system is between points the magnetic field change will complete the move before stopping and may not stop immediately To immediately stop the field from changing depress the E stop to stop all magnet positioners and stop the field from changing Additionally you may stop the interrogation immediately by double clicking on the large Bulls Eye icon This will cause the field to move to the selected point WARNING Depressing the E stop will immediately stop all magnetic field changes by stopping the magnet movement and will also prevent the positioners from being moved from navigate to stowed until the E stop is reset 6 7 4 Navigation View The navigation view allows storage of a specific field direction for use at a later time during the current case A field must be applied and then choose Store The stored direction will automatically be named Navigation 1 but can be changed by
35. current screen displayed and save it to the system s hard drive Print the current screen on a printer Close the current procedure otereotaxis Inc Basic Instructions Page 29 HDW 0161 Rev B Effective Date 07 19 06 5 2 1 1 View Edit Procedure To view or edit the procedure information select Procedure gt Information Or use the shortcut key Ctrl 1 The procedure information window appears see Figure 10 allowing viewing and editing of the procedure information Press OK to accept the changes and continue or Cancel to discard the changes and continue 5 2 1 2 Default Layout To restore the screen layout to the default layout for the current procedure type select Procedure gt Default Layout 5 2 1 3 Save Layout To save the screen layout for current physician select Procedure gt Save Layout The screen layout positioning of various control windows toolbars and current options will be saved for the current physician and current procedure type Once a layout is saved each time this procedure is started with this physician that layout will be loaded The Physician field must be completed before a layout can be stored 5 2 1 4 Restore Layout To restore the screen layout to the layout previously saved for the current physician and procedure type select Procedure gt Restore layout The layout will be restored to the saved layout This allows the physician to easily return to his her standard layout after changing the l
36. distal to base for target mode navigation define the catheter base The device base must be defined firstin e Define the device base press set base button order to use Target Navigation Drag a on mode toolbar before using target navigation INFO line in each view along the sheath tip from proximal to distal to define the virtual catheter base INFO Select a device on Navigant to use e Device must be defined in Device Selection Target navigation window INFO Device is straight rotation has no effect e Device must be deflected for rotation to have an effect INFO Device is fully deflected e No further deflection is possible in that direction and mode Device model could not reach identified e Target navigation is unable to reach the target Use another mode of navigation or another target e Any further use of this anatomic direction INFO adjustment key will have no effect until the field direction is changed by some other method successfully to the navigation preset key listed successfully recalled as the desired field No field stored to this preset Press Ctrl e By default no fields are stored to the navigation INFO and a preset key to store a preset presets Follow the given instructions to store a field Please assess the state of the e Verify the procedure data actually matches the INFO procedure Any change in the patient s current procedure Stored points and vectors position or orientation can invalida
37. e cccsecccccseeeeeceeeseeeeenseeeeaeeeesnaaeees 39 Reduce Field eeeeeeseeeeeesse eee 13 Remote Magnetic Technology See RMT Removing an Item That Has Become Stuck to a Magnet eessseseeeeeeeen nennen nnns 79 Restore Lavoe aa 30 Right Mouse Ootons cesses 48 m 40 RMT SI MENTONIZS eegene 41 2 e C 55 63 INavigallorisencpsosutuat e eoo eU a Lope READ UU RUE 45 KREE le qe t 33 Rotan IK cc daca siihis cans ntoetveasanrdearttouniny enn 14 ENEE 30 Save Screen Image an aeaacn aniani 30 Screen Capture maea 30 Sor eet I middes ee ee 30 Selectable Control 52 Selecting a DEVICE ssia 27 Selecting a POIN EE 53 Sequencing Gonstella e Mra MT 33 Settings BUIS EE 61 ISP 33 ECIRER MIGG Medical Device Safety Service GmbH Burckhardtstrasse 1 D 30163 Hannover Germany C 0086 Stereotaxis Inc Effective Date 07 19 06 EE 32 Era dd 33 RP O NS AAE AN 33 A TE 33 Settings Menu sisun iaee is 32 Show Options cccocooccccnnncccccnocccnnnnncnnnnnannnnnnnnnnos 46 AUS EE 50 Step Script cese nnne 15 corri 51 Step Gize nennen 37 Store Navigation 13 38 Store P Ol ee eege dee 53 Store PO Susa 13 39 Stuck items FICMMOVING eec r 79 SUP eea RN 40 oVhnchronize VIS Wisin nie 41 System Rresels estat int ceat eei 58 Taget ee EE 35 TH VT EE 29 transito EE 71 Transfer Image s
38. e Date 07 19 06 If there are images in both fluoro windows the transferred image will go to the image window with C arm orientation closest to the C arm orientation of the transferred image The Recall Image Transfer button allows previously transferred images to be recalled and placed on 3D fluoro A or B screen The image will be transferred to the screen that is most similar in C arm position Figure 29 Recall and Transfer Image Buttons 5 3 11 Field Motion Display The Field Motion Display toolbar indicates the rate of change in the field direction The figure shows the display at 0 when the field is not changing and at 100 when the field is changing at the maximum rate When a field is applied the display will increase from 096 to the current rate of change with the percentage displayed and green and yellow bars filling a portion of the toolbar to correspond with the percentage For most changes in field the rate will be 10096 for the fastest rate change NEZ Nm Figure 30 Field Motion Display 5 3 12 3D Display Orientation Toolbar This toolbar allows the user to reorient the active 3D window to any of the views on the toolbar ao Toa oo a e Figure 31 3D Orientation Toolbar The ARB arbitrary option provides a drop down list of combination RAO LAO angles specific to each coronary artery Stereotaxis Inc Basic Instructions Page 40 HDW 0161 Rev B Effective Date 07 19 06 5 3 13 View Synchronize Orien
39. e screen The E Stop is active Push in and pull out the E Stop button to continue or Deactivate E stop to continue There are two E stop buttons on the Niobe system when used with a Siemens x ray system Both E stops perform the same functions and both must be enabled pulled out for the system to operate They are located e On the Tableside controller in the procedure room e Onthe MNS system power control panel in the control room Once the E stop button is depressed it must be twisted and pulled back out to re enable magnet motion When the MNS system is powered off the E stop is automatically activated If the system is powered on with the E stop button pulled out then the positioners will immediately be active Caution There are different emergency stop buttons for the Niobe and the x ray system Pressing the Niobe E stop will cause an x ray E stop via hardware connection Pressing the x ray E stop will cause the Niobe to stop via software otereotaxis Inc Basic Instructions Page 76 HDW 0161 Rev B Effective Date 07 19 06 Emergency E stop 1s activated when illuminated Red System power on when illuminated green Emergency Stop E Stop Press to halt all mechanical System power On Off motion Figure 69 Siemens System Control and Remote Stop Box 9 2 2 Philips E Stop The Niobe E stop can only be activated by Philips E stop on the Geometry module in the procedure room or the con
40. e sets the desired field in the plane identified by the anatomic 2D control Stereotaxis Inc Basic Instructions Page 51 HDW 0161 Rev B Effective Date 07 19 06 6 7 Selectable Controls Various additional controls located either above or to the right of the Primary Windows depending on window layout may be selected The available controls include Group View Bulls Eye View Cardiodrive View Preset View Navigation View Alignment View RMT Navigation View Constellation Sequencing View and Guidewire Bend Control View To change the window displayed right click the window and select the desired control to view 6 7 1 Group View The Group view window allows points marked to be stored to note a point in three dimensional space for reference and or future navigation The use of points can help with visualization of the layout of various locations in the heart or over vessels and can help to return to a previous location later in a case Multiple points can be marked and displayed as points or constellations and used as targets for navigation All point data is written to the procedure file upon storage of the point or any changes to the information associated with the point Note Images transferred should be in the same cardiac and respiratory cycle Point A A Point A A Point A Points amp Constellations Figure 45 Group View CAUTION If the patient position changes points should be redrawn Note If
41. ealized anatomic models displayed in the anatomic views are not accurate registered models They are idealized only and may not agree with patient anatomy These should be used for reference only Within these views the current yellow desired green or other vectors will be shown The Bulls Eye umbrella will not be shown in the 3D anatomic view for EP Note some of the toolbar options are not available in each view as they do not apply Stereotaxis Inc Basic Instructions Page 43 HDW 0161 Rev B Effective Date 07 19 06 6 1 1 3D Anatomic View The 3D Anatomic views offer an idealized anatomy to use as a reference The Bulls Eye may be displayed to use for navigating Set the window to display the 3D Anatomic surface as if it were viewed from the inside or outside by clicking the toggle button Figure 36 Inside and Outside View Toggle Button Points on the surface of the 3D Anatomic model can be selected and used as targets for magnetic navigation See EP Instructions HDW 0097 6 1 2 3D Constellation View The 3D Constellation views display user selected points defined in 3D space These points can be connected to display vascular or anatomical constellations These constellations may be used for reference or may be used in Target Navigation mode The constellation view also displays the NaviView reconstructed vessel when defined 6 1 3 3D Fluoro View The user may choose to display fluoro reference images Fi
42. ed Check connection and retry otereotaxis Inc Basic Instructions Page 70 HDW 0161 Rev B Effective Date 07 19 06 Status Messages Explanation Solution Unable to get procedure information e Procedure data file format is not supported or data file is corrupt Patient table moved Previously stored e Stored points and vectors should be assumed to points and vectors may no longer be be correct for the patient s anatomy or position valid Verify the validity or mark new points Desired vector origin has been reset to e In Bulls Eye mode the desired vector direction the Bulls Eye origin is set with the origin always at the Bulls Eye origin Cannot transfer the image The C arm e Re acquire the image with the C arm and table or table was moving during the image stationary and retransfer the image acquisition WARNING Cannot transfer the image An image is transfer the image An image is A B WARNING C Prien ay e add for transfer Cannot transfer the i image An i loud D B SE E cJ image is zoomed LIES RP MN NN image is a looping image CCAA os S oB image orientation is not correct WARNING kage isa pamed mages o e image is a panned image WARNING ee oee o Proewe B orientation must be HFS Cannot transfer the image The transfer e Attempt to transfer image again WARNING process imed cu uan ior me mage o Procedure Coo on Cannot transfer the image Cannot e Ensure x ray system is r
43. ess than 5 gauss during the transfers only one patient at a time should be in the procedure room Stereotaxis Inc Basic Instructions Page 19 HDW 0161 Rev B Effective Date 07 19 06 3 1 1 Automatic Positioner Centering The Niobe system has the capability to automatically center the positioners in the Navigate position based on the patient table lateral and vertical position The recommended procedure for using this feature is described below General Procedure for Automatic Positioner Centering 1 Place the patient on the table a Center the patient on the tabletop laterally If the patient is too far off center it can interfere with successful automatic positioning b Use arm guards c Make sure that no excess table padding protrudes outside the edge of the tabletop Using the table controls and fluoroscopy center the patient anatomy to be navigated at X ray isocenter Press one of the Navigate buttons on the Niobe controller and hold it down The Niobe system will calculate the target position including an offset based on the lateral and vertical position of the patient table and begin moving to that position 4 f motion stops and the message Magnets in Navigate Position is displayed the automatic positioner centering has been successful The Niobe system also gives an audio signal that the system is in Navigate position 5 If contact between the cover and patient activates a cover sensor then that cover wi
44. f the preset keys pressing the appropriate preset button recalls the desired field direction and origin that was stored By default no navigations are stored and pressing a preset key will have no effect and a message will be displayed indicating no navigation has been stored And Figure 3 Navigation Preset Keys 2 3 2 3 Anatomic Direction Adjustment Keys The Anatomic Direction Adjustment Keys are useful for small adjustments in the field direction toward a prescribed anatomic oriented direction The keys are designed to adjust the field relative to the anatomic directions illustrated on the keys Starting at the upper left most of these keys and moving clockwise the adjustments cause the field to be adjusted more superior anterior right left posterior and inferior Caution The idealized anatomic models displayed in the Navigant display are not accurate registered models They are idealized only and may not agree with patient anatomy These should be used for reference only Pressing a key a single time causes a single change in field direction of the chosen step size The step size is selected using the Step Size Button Pressing and holding a key causes a continuous change in field direction As a field direction is rotated the vector displays in all views are updated to reflect the changes The field direction can only be rotated until the specified anatomic direction is reached i e if the superior key is pressed the field c
45. field direction All Field History data is written to the procedure file upon application of the field The field history list is procedure specific and is removed at the start of a new procedure Figure 25 Field History Buttons Stereotaxis Inc Basic Instructions Page 37 HDW 0161 Rev B Effective Date 07 19 06 5 3 8 Store Navigation The Store Navigation button Figure 26 stores the current field direction in the Navigations View Figure 23 If the Cardiodrive is calibrated and being used in the procedure the CAS catheter position is also stored with the Stored Navigation The stored navigation is labeled Navigation 1 by default The user may edit the name by double clicking the name or by choosing the Edit button in the Store Navigation window The user may also store the present field direction using the Store Navigation key on the keyboard or the Store Navigation button on the toolbar Figure 26 Store Navigation Button Navigations Store Navigation 1 Reference E Set Remove i Figure 27 Navigation View To Store a Navigation 1 2 3 4 Use Rotate Field mode to locate desired field direction If using CAS ensure catheter is advanced retracted to the desired position Click the Store Navigation button or click Store in the Navigation View A default name is given to the stored position To enter a name for the stored position click the Edit button in the Navigations Vie
46. fully inserted Step 4 Turn hand crank to pivot magnet on the curved floor track Figure 71 Manual Hand Crank otereotaxis Inc Basic Instructions Page 78 HDW 0161 Step 1 Remove side cover by twisting the two fasteners Step 2 slide lever to allow release of floor Step 3 The floor lock lever will drop down by itself releasing the floor lock otep 4 Turn the hand crank to pivot magnet on the curved floor track Hev B Effective Date 07 19 06 lock lever m Figure 72 Manual Hand Crank 9 5 Removing an Item That Has Become Stuck to a Magnet If all safety precautions are followed ferrous items should never be near the magnet and there should never be an incident of something being attracted to and becoming stuck to a magnet positioner However in the event an item does become stuck to a magnet positioner please review the following before attempting removal Stereotaxis Inc The permanent magnets are always on and cannot be turned off The larger the mass of the item stuck the harder it will be to remove it Use work gloves or other protective equipment around hands to prevent injury e g skinned or scraped knuckles when removing large items from a magnet The magnetic forces are strongest at the front flat face of the magnet The force decays rapidly with increased distance from the front face of the magnet If the item is sharp consider potential damage to oneself o
47. gant version and copyright information Help information is also available through tool tips pop up windows that appear when the mouse is held over a button 5 3 Navigant Toolbar The Navigant toolbar is located at the top of the screen below the menu bar The functions available are described below 5 3 1 Apply Options This button when selected provides a drop down list with the apply mode options Manual Auto Apply or Apply Disabled Figure 19 Apply Options Manual Apply the desired field is only applied when the Apply Field button is selected Auto Apply Mode the desired field is automatically applied whenever it is changed after the mouse button or keyboard key is released This mode is applicable in most navigation modes Auto Apply does not work when changing the desired field through the Field History or when changing vectors via the 3D fluoro A B windows Apply Disabled Mode the desired field can be adjusted but the applied field cannot be changed This mode is used to avoid accidental field changes The selected mode will be displayed on the toolbar and the default mode is determined by the layout selected Stereotaxis Inc Basic Instructions Page 34 HDW 0161 Rev B Effective Date 07 19 06 5 3 2 Navigation Mode This button when selected provides a drop down list with the navigation mode options Direction or Target The active mode will have a pink background the other will have a blue background
48. hub 2 3 Input Devices Navigant Niobe provide two standard wheel mice a specialized keyboard a CD DVD drive and an optional Wand as input devices in the control room 2 3 1 Mouse A wheel mouse is supplied in the control room and a second mouse is located tableside in the procedure room Stereotaxis Inc Basic Instructions Page 12 HDW 0161 Rev B Effective Date 07 19 06 2 3 2 Keyboard The Navigant keyboard has all 104 industry standard alphanumeric function arrow number pad and editing keys It also includes specialized shortcut keys The use of each of these keys is explained below Print Screen EISE Figure 1 Keyboard 2 3 2 1 Apply or Reduce Field Transfer Image Store Points or Navigation The Apply Field Reduce Field Transfer Image Store Points and Store Navigation keys allow the user to activate these commands via the keyboard instead of using the mouse The icons on these keys are similar to the icons used in the Navigant software Figure 2 Apply Field Reduce Field Transfer Image and Store Points Store Navigation Keys Stereotaxis Inc Basic Instructions Page 13 HDW 0161 Rev B Effective Date 07 19 06 2 3 2 2 Navigation Preset Keys The Navigation Preset Keys allow navigation presets to be stored and recalled later for use Pressing Ctrl and one of the navigation preset keys simultaneously stores the current desired field direction and origin to that preset key After storing to one o
49. il status bar displays Magnets in Stowed Position 22380 CAUTION The Niobe MNS utilizes a magnetic field to orient the tip of the catheter to the desired intracardiac orientation When magnetic field direction is defined through two X ray views the views are not acquired simultaneously as with the use of any single plane X ray system similar to the one employed with the MNS As a result the overlay on the X ray views is an approximate representation of the magnetic field direction relative to the heart s location because the two X ray views may have been acquired at different phases in the patient s respiratory and cardiac cycle It is recommended the user confirm the orientation of the device tip with localization methods e g fluoroscopy and electrograms if using a catheter when changes are made to the magnetic orientation of the device tip If the device tip is not at the desired orientation update the magnetic field direction and repeat the magnetic navigation procedure if desired 3 4 Post procedure Tasks Depress the E Stop in the control room b Remove the patient from the room The recommended procedure for removing a patient is to reverse the process described for patient loading Close the procedure on the Navigant screen d Choose Shutdown System if this is the last case of the day otereotaxis Inc Basic Instructions Page 22 HDW 0161 Rev B Effective Date 07 19 06 4 Starting a Procedure After sta
50. ill have the expected field direction only the strength is reduced Table 6 Vector Descriptions 6 4 2 Points Display Points are 3D locations marked on the fluoro display which can be displayed in the 3D visualization display Points are marked as circles The currently selected point is displayed as a star See Editing Points in section 6 7 1 3 6 4 2 1 Field Buttons The field buttons provide options for Reducing or Applying the magnetic field in the navigational volume Figure 43 Field Buttons Stereotaxis Inc Basic Instructions Page 49 HDW 0161 Rev B Effective Date 07 19 06 6 5 Status Bar The Status Bar displays messages at the bottom of the Navigant display screen The status bar is only visible when there is a message to be displayed Most messages appear for five seconds and then disappear Some messages will persist while the associated condition exists The background color of the message corresponds to the level of the message e Error messages have a red background e Warning messages have a yellow background e Informational messages have a background Status messages warnings and errors are described in detail in Maintenance Troubleshooting Messages Section 8 3 6 6 2D Navigation Controls The 2D anatomic controls show the reference present and desired field vectors an idealized anatomic model step buttons for field adjustment and a clock notation of the vector positions in the view The anatomic
51. in the Notes box at this time The Device window will be grayed out as the user will select a device later from the Navigant display screen Click OK to start the new Navigant procedure Procedure data are saved within Navigant with an automatically generated filename based on the date and time of the procedure Start 6 30 2005 3 36 14PM Study ID unknown 0000372 Description ERN Physician Procedure Full Heat EP Devices Notes CWM Script No Script gt Figure 10 Information Window 4 2 Open Procedure When Open Procedure is selected from the Main Window a list of previously created procedures is displayed as in Figure 11 Select the appropriate procedure from the list on the left The procedures are listed by date time and the procedure description entered when the procedure was started Additional procedural information is displayed on the right Stereotaxis Inc Basic Instructions Page 24 HDW 0161 Rev B Effective Date 07 19 06 Select a Navigant Workstation Procedure to Open Start Time Description 2004 11 19 1 Start 2004 11 19 1 2004 11 19 1 Study ID 2004 11 19 1 Description Physician Procedure Devices Navigant Notes Figure 11 Open Previous Procedure Window Click Open to start the selected procedure When the selected procedure starts a warning will appear in the status bar indicating the data may no longer be valid for the current
52. ing the point there are no more points in the group no point will be selected Moving and Copying Points Points may be moved from one group to another by selecting them in the point list and dragging them to the desired group name Points may be copied from one group to another by dragging selected points from one group to another while holding the Ctrl key 6 7 1 4 Group Options Points are collected in groups which have common display attributes and allow the points to be sorted by location device etc so different groups can have different display attributes Group attributes include a label identifying the display group a color a navigation fluoro display indicator show or hide and a 3D display indicator show or hide a constellation type and a point display type selector shape only ID or Annotation Every point must belong to a group At the start of a procedure a default group is created The default group can be edited and new groups created All new points are added to the currently selected group When the first point is selected the colored box in the group window will display a letter indicating the source of the data point An F would indicate the point was selected from fluoro a P indicates preoperative image a V indicates the points originated from the NaviView window and C indicates the points were transferred from the CARTO RMT Change Window New Edit Delete Create Vessels Figu
53. int Right clicking a point name in the point list causes the Point Menu to appear Change Window Edit Recall Field oet As Target Delete Figure 46 Point Menu A single point or multiple points may be selected by clicking a point in the point list To select more than one point from a single group use Shift and click to select a series of points in order or Ctrl and click to select multiple nonconsecutive points Multiple points from different groups may only be selected by holding the Ctrl key and selecting points via the 3D view where the points are displayed In the 3D view selected points are displayed as a star rather than a circle In the navigation fluoro images selected points are displayed as unfilled circles or bold IDs rather than filled circles or normal IDs for unselected points Points can also be selected by using the Point Select Cursor in the 3D view It is not possible to select multiple points from different groups with this method When a point is selected by a method other than selecting it from the point list the point name is selected in the list and made visible Stereotaxis Inc Basic Instructions Page 53 HDW 0161 Rev B Effective Date 07 19 06 Figure 47 Point Display Options 6 7 1 3 Editing Points Selecting Edit from the Point menu or double clicking a point causes the Edit Point window to appear For a single selected point the window displays the point ID group Annotatio
54. irection and then identifying the preset marker to adjust Right click the marker to adjust and choose Adjust Marker This adjustment will change the location of the marker and set the associated preset direction in the preset list An will appear in the window next to the adjusted preset Any adjustments are procedure specific and will not be used for subsequent procedures S Change Window Adjust Marker Reset Marker Reset All Markers Advanced Figure 64 Adjust Marker Window RS PV RS X id a e Figure 65 Adjusted Preset Display Stereotaxis Inc Basic Instructions Page 65 HDW 0161 Rev B Effective Date 07 19 06 7 2 2 3D Navisphere Marker Reset To reset a specific adjusted preset marker or all adjusted markers back to the original direction right click over an adjusted marker and choose Reset Marker or Reset all Markers Change Window Adjust Marker Reset Marker Reset All Markers Advanced Figure 66 Reset Marker Window 7 3 3D Navisphere Stored Navigation Markers Stored navigation markers are displayed on the 3D Navisphere as small spheres as shown in Figure 67 Figure 67 3D Navisphere Stored Navigation Marker 7 4 3D Navisphere Field Selection Select locations or markers on the 3D Navisphere to update the desired field Apply this field to change the current magnetic field direction 7 5 3D Navisphere View Adjustment Manipulate the orientatio
55. ll stop and retract slightly The other cover s position will be adjusted to attempt to reach the Navigate Position 6 If motion stops before the system reaches the Navigate Position one of these conditions has occurred e The operator did not hold down the Navigate button until the system reached the Navigate position In this case the operator may continue to the Navigate position by simply pressing and holding the Navigate button on the tableside controller e Both cover force sensors have activated The Niobe system displays a message and gives an audio signal if the system does not reach Navigate position due to cover force sensor activation 3 1 2 1 Cover Force Sensor The Niobe magnet covers contain cover force sensors that detect when an obstacle is pressing against the face of the cover When a cover force sensor is activated the magnet positioner pauses then retracts slightly and Stops If a single cover force sensor is activated the operator may choose to continue holding the movement button and Niobe will automatically retract the individual cover that is contacting the patient slightly and advance the opposite cover to continue movement to the Navigate position e f the second cover force sensor is activated before the positioner reaches Navigate Position an error message is displayed Both Cover Force Sensors Activated Cannot Further Advance the Covers e lf the second positioner does have enough room to reach Navigate
56. magnetic catheter or guidewire A vector consists of a line with a circle at the starting point and an arrow at the ending point of the vector The circle contains a dot representing the arrow tip if the vector in 3D space is pointing out of the screen and a cross representing the crossed feathers of an arrow if it is going away from the user into the screen Stereotaxis Inc Basic Instructions Page 35 HDW 0161 Rev B Effective Date 07 19 06 5 3 2 2 Drawing Vectors 1 2 Starting with either 3D fluoro A or B window click and hold the left mouse button at the starting point or desired origin of the vector Release the left mouse button at the location where the vector should end The vector will appear red because it does not yet have a valid second vector In the second window follow the cue line and start the second vector anywhere on the plane of that cue line The beginning of the second vector must be green in color in order to start a valid vector Start the origin of the second valid vector along the cue line by pressing and holding the left click button Once the origin of the second vector has been started and is considered valid the first cue line will disappear and a second cue line will appear While still holding the left mouse button drag the second vector to any point along the plane of the second cue line Once the end of the vector is at the desired spot and is green release the left mouse button The vector
57. maintenance actions to be performed by the user are described in HDW 0137 Niobe MNS Maintenance and Service Manual and HDW 0144 Navigant Navigation Workstation Installation and Maintenance Manual 8 2 Troubleshooting Possible problems and solutions with Navigant system are listed in the table below Problem Cannot Reduce Field button s dnd Ines l grayed out e MNS is not connected to Navigant Check operation of MNS Restart MNS if necessary Check Ethernet cables No valid desired magnetic field vector has been drawn Magnets not in Navigate position Move to one of Navigate positions MNS is not connected to Navigant Check operation of MNS Restart MNS if necessary Check Ethernet cables Opened procedure is more than 24 hours old Start new procedure button grayed out delete grayed out edit Vector history back forward e No vector has been applied button is unavailable grayed e Current desired vector is at beginning end of vector out history list There are no more vectors to step through No Bulls Eye is displayed in the e The Bulls Eye display is hidden Select the show option 3D Display or on the fluoro button in Bulls Eye Ul navigation displays e Select Set Bulls Eye axis button Cannot set Bulls Eye Axis e No valid desired magnetic field vector has been drawn button grayed out Draw a valid vector or select a valid magnetic field Cannot Apply Field button grayed out Caution If the service mode is acti
58. n and only those options will be available on the list Stereotaxis Inc Basic Instructions Page 50 HDW 0161 Rev B Effective Date 07 19 06 ANTERIOR Figure 44 2D Display Caution The idealized anatomic models displayed in Navigant are not accurate registered models They are idealized only and may not agree with patient anatomy These models should be used for reference only The vector rotation buttons in the top corners of the 2D views allow the desired vector to be adjusted either clockwise or counterclockwise in the plane of the view Pressing a button a single time causes a single step of the chosen size The step size for rotation of the vectors is selected using the Step Size toolbar as described in section 5 3 5 Clicking and holding a button causes a continuous rotation of the vector As a vector is rotated in one view the vectors in all other views are updated to reflect the changes in vector direction In addition to the vector rotation buttons the desired vector can also be adjusted by clicking the arrow and dragging to the desired angle or by clicking the 2D anatomic display in the desired location Clicking inside or outside of the clock face circle of the display makes a difference in the orientation of the plane e Clicking inside the click face circle reorients the desired field in the direction specified but keeps the orientation of the vector out of the specified plane e Clicking outside of the clock face circl
59. n and position The group or annotation can be edited If multiple points are selected only the group can be changed Edit Point ID DON Group Group Annotation o e Position x Ze Y 150507 z 569546 Figure 48 Edit Point Window The Annotation is a text string that is stored with the point It can be displayed on all but live fluoro images through the use of the Edit Groups window Recall Field Selecting Recall Field from the Point menu sets the desired field direction and origin to the present field direction and origin that were active when the point was acquired This command is only valid for a single selected point and only if a field was applied when the point was taken If there was no field applied a message will appear at the bottom of the screen indicating The magnetic field was reduced or unknown when this point was stored oet as Target Selecting Set as Target from the Point menu sets the selected point as the target for Target Navigation This command is only valid for a single selected point Stereotaxis Inc Basic Instructions Page 54 HDW 0161 Rev B Effective Date 07 19 06 Deleting Points Selecting Delete from the Point menu causes a window to appear to confirm or cancel the deletion of the currently selected point s After deleing a point the next point in that group list will be selected If the point was the last point in the list the previous point will be selected If after delet
60. n from which the 3D Navisphere is viewed through view rotation options and zoom The view position inside or outside cannot be changed by adjusting the view s zoom Stereotaxis Inc Basic Instructions Page 66 HDW 0161 Rev B Effective Date 07 19 06 7 5 1 Orientation and Synchronization Options Set the window to display the 3D Navisphere as if it were viewed from the inside or outside by clicking the Navisphere toggle button Figure 68 3D Navisphere Options Set the view orientation of the 3D Navisphere to any of a set of predefined view orientations or set the view to match its orientation to one of a standardized set of synchronized views 7 5 2 Idealized Anatomy The idealized anatomy model is displayed in the 3D Navisphere A default idealized anatomy model will be displayed according to which procedure was chosen in the opening screen The anatomy displayed can be changed by right clicking over the display and choosing one of the options available Options will be dependent on the type of procedure chosen The interior view will show a sliced transparent view of the anatomical model but the active surface for selections will remain the Navisphere surface otereotaxis Inc Basic Instructions Page 67 HDW 0161 Rev B Effective Date 07 19 06 8 Maintenance Troubleshooting Messages This section describes routine maintenance that should be performed troubleshooting and status bar messages 8 1 Maintenance Care and
61. n the bedside control The magnets will not move into Navigate positions but will move to all other positions WARNING When using the interlock override visually ensure there will not be a physical collision between magnet and x ray system components Closely monitor the magnet positioner movement and be ready to release the movement button if a collision is imminent Failure to heed these warnings may cause damage to equipment 9 4 Moving Magnet Positioners Manually There is a manual positioner hand crank that allows the user to manually move the magnet positioners in the event of a facility power failure or if a mechanical or electrical failure renders the system unable to move normally See Niobe user manual for specific hand crank use WARNING When using the positioner manual hand crank EXTREME CAUTION must be taken to ensure proper patient table C arm and magnet positioning clearance Also ensure no one attempts to use the tableside control while manually moving the positioners Failure to heed these warnings may cause an unsafe condition resulting in personal injury and or damage to equipment To move the positioners follow the steps outlined below When power is restored and the tableside control is again used the interlocks will automatically re engage Step 1 Remove side cover by manually pulling it off Step 2 Remove hand crank bar from clips Step 3 Insert bar in slot for hand crank Make sure the bar is
62. net positioners as well as the accompanying fluoroscopy system s C arm and patient table WARNING The Magnetic Navigation System should be used only with magnetic devices and accessories appropriately labeled as compatible with MNS navigation applications WARNING Make sure that the patient table pivot is in the central position centered between the Niobe pods before moving the Niobe pods out of the Stowed position towards the Navigate position WARNING Operator should always confirm device location using live fluoroscopic image WARNING If the device is moved manually instead of using Cardiodrive the Cardiodrive display and any previously stored position data may become invalid The physician should remove all previously set markers after moving the device manually 1 6 Acronyms Abbreviations and Definitions DD ra e Two Dimensional p RE Three Dimensional PP cte a Anterior Posterior Bulls Eve Used in reference to a navigation scheme devised that allows vector direction changes to be made on a polar map projected onto a plane CAS Quite esM s Cardiodrive Catheter Advancement System CRT EE Cardiac Resynchronization Therapy CWM aa Clinical Workflow Manager DVD CD RW Digital Video Disk Compact Disk Read Write Desired Vector The 3D location and direction of the next or desired magnetic field to be generated by the MNS A iced Electrophysiology E unir Feet First Supine Stereotaxis Inc Basic
63. ng the direction the magnetic field needs to point to orient the distal tip of the magnetic catheter or guidewire The symbology for vectors is color coded as detailed in the table below All vectors are updated whenever the desired or present fields change whether through Navigant or the MNS Stereotaxis Inc Basic Instructions Page 48 HDW 0161 Rev B Effective Date 07 19 06 Vector gt Color Proposed changes to the magnetic field that are valid and match up three dimensionally with a vector drawn in the opposite plane Currently applied magnetic field direction Gold changing present magnetic field direction whether the field is being applied or reduced present magnetic Changing present magnetic field direction whether the field is being applied or reduced direction whether the field is being applied or reduced orange Selected reference magnetic field direction Current and requested vectors will appear on the screen simultaneously in order to show the degree of change between the reference vector and the current or requested vector Rm Proposed changes to magnetic fields that are not valid three dimensionally where the vectors drawn on the two planes do not coincide This will only be shown during direction navigation Equivalent to yellow vectors but have reduced less than expected field strength In CTS practice blue vectors should not be encountered In any case the field represented by a blue vector w
64. ngle of the desired field vector from the central axis of the Bulls Eye can be selected within a range from 30 120 degrees Range 30 c 60 v 90 c 120 Figure 54 Bulls Eye Range Figure 55 Bulls Eye The lines of the Bulls Eye are displayed in 10 degree increments the bolder lines are 30 degree increments 6 7 3 2 Bulls Eye Orientation The red and blue orientation markers on all of the Bulls Eye displays indicate the orientation of the Bulls Eye relative to the other objects in the display This correlates the different Bulls Eye displays with one another The 3D displays are also shaded to indicate which part of the Bulls Eye is closer and which is farther The inside of the Bulls Eye umbrella is shaded dark purple and the outside is bright blue On the Bulls Eye display window the shading is similar The orientation can be set in the settings window The Bulls Eye orientation markers are locked to the live fluoro display The blue marker always points superior on the display View Front Back Figure 56 Bulls Eye Orientation 6 7 3 3 Bulls Eye Central Axis The Bulls Eye window allows the selection of a central vector which aligns with the center of the Bulls Eye and then allows small adjustments to be made to the vector using the Bulls Eye graphic This is designed to contribute to precise navigation Markers are displayed on the Bulls Eye graphic for each of the six cardinal directions and are visible when inside the
65. nt with the override option continuing The hand crank cover is off Magnet e Check the hand crank cover is on correctly override buttons The specified field direction could not be e The specified target point for the field is likely applied outside the navigation volume and should be redefined otereotaxis Inc Basic Instructions Page 72 HDW 0161 Message HUET Stereotaxis Rev B Effective Date 07 19 06 Status Messages Explanation Solution Caution The patient s arms may be e This is a caution message to alert the user of a contacted by the magnets if the patient possible contact of the magnet positioners with is not positioned properly the patient when moving to the Retracted or Navigate AP position from Stowed the first time Use arm guards to prevent patient contact with positioners moving Motor power contactor has e Procedure C malfunctioned Contact field service for Bn RN further instructions Caution Do not enter the area between e This is a caution message shown when the the C arm and magnet positioner magnets are in the pivoted position to alert the user of a possible squeeze risk between the magnet positioner and C arm There is a collision risk with the C arm There is a collision risk with the table X ray system does not allow magnet e Magnets are not allowed to move unless the L movement The L arm longitudinal arm longitudinal position is in the Navigate position i e C arm
66. r 3 whether the group is shown in the 3D display 4 whether the group is shown in the fluoro display 5 if shown as shapes only with ID letters or with full annotations displayed 6 constellation type 7 point order 6 7 1 4 1 Constellations A group may be displayed as a constellation to provide a better 3D representation of the group By default a group has No constellation and is merely a collection of individual points The group may be assigned one of the following constellation types from the drop down menu in the Edit Group window Stereotaxis Inc Basic Instructions Page 56 HDW 0161 Rev B Effective Date 07 19 06 Closed Curve Exact Creates a closed spline curve constellation if the display group contains three or more points A curve will be constructed that intersects every point in the display group and connects the last point back to the first point This constellation is point order dependent as the spline is constructed to pass from one point to the next The order the points are assigned will be maintained in the constellation type Closed Curve Smooth Creates an ellipsoid constellation from a display group that contains three or more points An Ellipsoid will be constructed that best fits the points contained in the display group to the surface of the ellipsoid It may not intersect exactly with the points but applies a best fit curve to the points in the exact order they were saved Open Curve Exact Same a
67. r may be labeled and saved for use within the current and future cases Edit or delete a user created preset list by right clicking over the appropriate list The drop down list will appear and the Edit or Delete option may be selected Only user created preset lists may be edited or deleted ID Direction Adj distal R vg i ic right cardinal AM Dr Smith Figure 52 User Preset 6 7 3 Bulls Eye View The Bulls Eye View window allows navigation around a central axis To use the Bulls Eye center the axis on the current desired or present vector and then double click anywhere on the surface of the Bulls Eye Alternatively display the Bulls Eye in the 3D window and double click the surface of the Bulls Eye in the 3D window The Bulls Eye display is drawn in the 3D view as an umbrella shape depicting the specified range as a portion of a sphere The Bulls Eye is displayed on the navigation fluoro images as ellipses Settings icon Interrogation box DE 888 Figure 53 Bulls Eye View Patterns circular regional radial i Stereotaxis Inc Basic Instructions Page 59 HDW 0161 Rev B Effective Date 07 19 06 6 7 3 1 Bulls Eye Angle The Bulls Eye angle indicates the range of directions the Bulls Eye can assign to the desired field vector The maximum deflection a
68. r others if the user or the item slips or is re attracted to the magnet during removal The general strategy should be to slide the item on the surface of the cosmetic cover away from the front face of the magnet and then quickly and firmly pull the item away without hesitation Sliding an item towards an outside corner of the cosmetic cover before making the pull off attempt over the edge of the cover is most effective Be aware that the forces around the magnet change If an item becomes stuck to the positioner and one attempts to navigate or attempts to move the magnet from the navigate position to the retracted or stowed position the field will change and the item could fall on its own or become stuck even firmer DO NOT remove any of the cosmetic covers in an attempt to remove a stuck item The magnet itself which the covers protect could be irreversibly damaged if it is contacted Contact MNS service personnel for assistance if user is unable to remove an item stuck to a magnet Basic Instructions Page 79 HDW 0161 Rev B 10 Index 2D Anatomic View 45 NE 50 2D Navigation GON TOS ras 50 2D Navigation Controls ccccccconccnnccccocncnncccconos 29 3D Anatomic View 44 3D Constellation View 44 3D Display Orientation Toolbar 40 SDO FIUO VEW e UP 44 SL INAVISDNENG e eege ee 45 3D Navisphere Navigation 64 3D Preset Markers NAVISDNGNG asis 65 OL Ee eg
69. range of the Bulls Eye These markers uniquely identify each direction to facilitate orientation To use the Bulls Eye navigation first select a desired vector Then set the desired vector as the central axis by pressing the Central Bulls Eye Axis button If the Bulls Eye was already active and a new vector is drawn and set as the central axis the Bulls Eye displays will all be recomputed and redrawn for the new axis If Bulls Eye navigation is attempted before setting the central axis the axis will automatically be set to the currently applied magnetic field vector If no field is applied then the Bulls Eye navigation is unavailable Stereotaxis Inc Basic Instructions Page 60 HDW 0161 Rev B Effective Date 07 19 06 e Figure 57 Set Bulls Eye Axis 6 7 3 4 Displaying the Bulls Eye The Bulls Eye display and controls will be available in all modes except Target navigation mode While in Target mode features on the Bulls Eye control window will not be selectable The Bulls Eye window may be hidden from display views by clicking the Hide Bulls Eye button Figure 58 Hide Show Bulls Eye Button 6 7 3 5 Bulls Eye Interrogation Within the Bulls Eye window a navigation pattern can be selected for the magnetic device to be navigated Initiate the pattern by checking the box in the interrogation area To choose the point spacing and delay open the Bulls Eye settings window as shown in Figure 59 After selecting the desired pattern
70. re 49 Group Options Select Group To select a group click the group in the list The group selected will be highlighted There is always one group selected which is the group to which all new points are added Right clicking a group name causes the Group menu to appear New Group Selecting New from the Group menu causes the Edit Group window to appear A new name for the group can be entered the color of the group can be changed display options for the group in 3D and on fluoro can be set and a constellation type for the group can be set The new group will be selected after it is created Delete Group Selecting Delete from the group menu causes the currently selected group to be deleted including all the points the group contains A prompt window appears to verify the group should be deleted or the action may be canceled If only a single group remains it may not be deleted Edit Group Selecting Edit from the Group menu or double clicking a group name causes the Edit Group window to appear with the display group information for the currently selected group Stereotaxis Inc Basic Instructions Page 55 HDW 0161 Rev B Effective Date 07 19 06 Edit Group Constellation Type No Constellation Point Sequence Order ID 0 A V Show in 3D Show in Fluoro Show Points as Shapes with IDs e with Annotations Figure 50 Edit Group Window Options to be edited are as follows 1 group name 2 group colo
71. re 58 Hide Show Bulls Eye Button 61 Figure 59 Bulls Eye Settings Wimdow nnne nennen nnne nnns nnn aan nnns nnn naa 61 Figure 60 Guidewire Bend Menu em nennen nnne nn nnne nsns n naa nnn rss nnn 63 Figure 61 Guidewire Bend View seeeeeeeisssssseeeee nennen nennen nnn n nnns nnn naa a 63 Figure 62 3D NaviSphere E 64 Figure 63 Preset Marker on 3D Navisphere E 65 Figure 64 Adjust Marker Wmdow nnne nnnm nnn nnns nn nnns snis nnns nnns 65 Figure 65 Adjusted Preset Display oocccccccconcconccononccnncnononcnnnnnnanconnononnncnnnnnnnnnrnnnnnnnnnrnnnnrnnnnrnnrnnanrrnnnnnnnaness 65 Figure 66 Reset Marker Window eesssssssesseeseeeeeee nennen nennen nnnm nnne nna nnn nnne nnne a sensn nnne nnns 66 Figure 67 3D Navisphere Stored Navigation Marker nennen nnne nnns 66 Figure 69 SD Navisphere OPUN S usmod n s olia Red aeo ha cocti d sto n LL ais doses idilio ee rea pesada 67 Figure 69 Siemens System Control and Remote Stop Box 77 Figure 70 Philips System Control and Power Box 77 FOUT t Manual Hand ras EE 78 Figure 22 Manta Farid Grasa otto 79 List of Tables Table 1 Navigant Controls and Hardware 12 Table 2 23D VIEWS EE 41 Table 3 Let Mouse ele 46 Ree Oe e ODION S He cH 46 Table 5 Center Vew ODIONS soinn e cas 47 Table 6 Vector Baden 49 Table 7 Gonsiellation ODIO KEE 57 Table s Cardinal Direction Markers ee 64 Stereotaxis Inc Basic Instructions vii HD
72. reset and saved to the previous file Pressing No will continue with the current procedure all current data will be retained and the data may or may not be accurate for the current MNS procedure The accuracy of the data must be verified 4 4 Clinical Workflow Manager CWM If a script was selected before the procedure was opened the procedure will open in CWM mode as shown below Harigant Waorkalathin 2 CO Procedure Mode View Settings Help Testing gt ep LJ ep retro D epr d rave E Reference cardinal Set Remove Basic SVT Navigation Left Side Use presets to choose starting direction Adjust target positions using 3D anatomic control Optonally use x ray views to select targets Acquire x rays during diastole and transfer Mark base of sheath from proximal to distal STEREOTAXIS Figure 13 Clinical Workflow Manager Layout Stereotaxis Inc Basic Instructions Page 26 HDW 0161 Rev B Effective Date 07 19 06 The CWM dialog window appears on the left under the name of the script to be run SVT in this example and the mini Navisphere Each tab lists a series of steps to be executed with the currently active step in blue The buttons at the bottom of the CWM window can be used to start over run the current step and move to the next step or jump to the next section respectively The Step Script key on the keyboard runs the current step in a Clinical Workflow Manager sc
73. ript and advances to the next step 4 5 Selecting a Device After starting a procedure the device to be used must be defined From this selection the software will load the device characteristics needed for various navigation functions In the upper left hand corner 2 or 4 panel mode or the upper right hand corner CWM mode of the Navigant screen click the Select Device button The Device Selection Window will appear showing any devices that have previously been selected There will be no devices selected if this is a new procedure The list of devices may be filtered by type NO DEVICE SELECTED Please click an the down arrow to select a navigable device Figure 14 Device Selection Button Assuming no devices are shown click the Override button Within the Override window Figure 15 select the appropriate device to be used and click Add device Several devices may be added to the Device Selection list for the procedure However only a certain number of overrides will be allowed per system Note Please contact your Stereotaxis Account Manager regarding the addition of overrides Device Override Cronus TM Moderate Support Guidewire 1 001 001457 Cronus TM Soft Support Guidewire 001 001462 Cronus TM CS Guidewire 001 001470 Cronus TM Endovascular Guidewire 001 001096 Helios TM CAUTION Investigational Device 001 001140 1 Cancel Tangent TM Mapping Catheter 001 001223 1 Cronus TM Floppy Guidewire 001 001232 lt
74. rovide real time guidance to the physician during an interventional procedure The fluoroscopy system must be able to operate in the high magnetic field environment produced by the MNS The documentation for the companion fluoroscopy system is provided by its manufacturer and is not duplicated herein The Stereotaxis Cardiodrive Catheter Advancement System CAS allows remote advancement and retraction only of compatible magnetic electrophysiology devices In the United States it may only be used with the Stereotaxis Tangent Electrophysiology Mapping Catheter of 7F shaft diameter and 8F tip Refer to the Cardiodrive Installation Operation and Service Manual for further information indications and instructions for this product Stereotaxis Inc Basic Instructions Page 8 HDW 0161 Rev B Effective Date 07 19 06 1 4 Intended Use Navigant Navigation Workstation NWS is a component of the Niobe MNS The Niobe MNS with NWS is intended to navigate compatible magnetic devices through tissue to designated target sites in the right and left heart and coronary vasculature by orienting the device tip in a desired direction Navigant provides an enhanced navigation interface for the physician to control the MNS In the United States the Stereotaxis Cardiodrive is intended for automatically advancing and retracting only the Stereotaxis Tangent Electrophysiology Catheter of 7F shaft diameter and 8F tip The Cardiodrive is intended to advance the Stereo
75. rs magnetic sensitive or ferromagnetic implants should contact the manufacturer of their respective implant prior to entering the procedure room Serious injury may result PROCEDURE STEP ILLUSTRATION Place Niobe Magnets into the Stowed position using the bedside control panel Translate the tabletop back fully away from the x ray C arm and magnets Stereotaxis Inc Basic Instructions Page 18 HDW 0161 Rev B PROCEDURE STEP Rotate the tabletop 90 degrees Roll the patient into the room on the hospital bed Transfer patient from the bed onto the procedure table Note Place arm guards on both sides of patient to prevent pinching or squeezing of appendages Remove the bed from the procedure room Rotate the tabletop 90 degrees back to its normal orientation Translate the tabletop to place the heart or femoral access point as required at isocenter Begin x ray imaging as required Move magnets to navigate position as required Effective Date 07 19 06 ILLUSTRATION The recommended procedure for removing a patient from the system is to first place the magnets in the stowed position and reverse the process described for patient loading CAUTION To keep patients in a low magnetic field l
76. rst the user must transfer an image as described in section 5 3 10 Image Recall Transfer Image For transfers initiated through the transfer key on the keyboard the button in the main toolbar or through external inputs Navigant assigns images loaded or transferred to either navigation fluoro image A or navigation fluoro image B based on the following circumstances e he new image is assigned to the Fluoro A view if the image has an LAO orientation that is negative or zero with degrees rounded to integral numbers e he new image is assigned to the Fluoro B view if the image has an LAO orientation that is positive e f only one fluoro image is currently displayed and a new image is assigned to the other fluoro image Navigant will automatically show the new fluoro image Stereotaxis Inc Basic Instructions Page 44 HDW 0161 Rev B Effective Date 07 19 06 The fluoro window will have a specialized set of buttons with the following functions Drawing Mode Window Level Zoom Pan can pan Bulls Eye or fluoro image Large Small Objects changes the size of objects on image Hide Graphics Cardiodrive Calibration for RMT navigation Figure 37 Fluoro Toolbar 6 1 4 3D Navisphere The 3D Navisphere is a spherical navigation object which contains regularly spaced polar lines and is used for spherical navigation See Section 7 for further instructions on using the Navisphere 6 1 5 2D Anatomic View The 2D anatomic con
77. rting the Navigant software the Navigant Main Window shown below will appear The buttons on the left side of the screen are for starting a new procedure The Open Procedure option opens a previously saved existing procedure The Shutdown System option closes Navigant and shuts down the Navigation Workstation b Navigant rumm m de Basic Open Procedure h EN ER Import Procedures A IC Export Procedures ES Shutdown System IR Figure 9 Opening Screen Note IR is currently not available in the United States 4 1 Start New Procedure Select the desired procedure option from the main window A drop down menu may appear allowing selection of a specific procedure type or the use of a Clinical Workflow Manager script All scripts that are licensed will appear in the menus Note the Navigant Version number that appears may be different from the depiction shown in Figure 10 Once the specific procedure type has been selected the application will determine which anatomic model is displayed as well as the default layout otereotaxis Inc Basic Instructions Page 23 HDW 0161 Rev B Effective Date 07 19 06 Once the procedure type has been selected the Procedure Information Window will appear as shown below A Study ID the date and time are automatically assigned Fill in the procedure type description and physician by typing or selecting from a drop down list if available Any other notes can also be entered
78. ructions Page 75 HDW 0161 Rev B Effective Date 07 19 06 9 Emergency 9 1 Emergency Patient Retraction To move the magnets out of the way for an emergency patient retraction press the Stowed position button on the tableside control Note the magnets do not have to swing to the full 90 degrees and lock in the stowed position The user can release the button when the magnets are sufficiently out of the way approximately 20 degrees If there is a power or other failure that keeps the magnets from moving see section 9 4 for manual movement of the magnets 9 2 Emergency Stop E stop The System Control and Remote Stop box controls all MNS system power It provides a centralized means of enabling or disabling power for magnet motion and provides a secondary E stop to stop magnet positioner motion The primary E stop is located tableside The System Control and Remote Stop box is normally located on the System Power Control Panel in the control room If your system has a remote stop box as pictured below the E stop can be activated on the remote box or at the bedside E Stops are dependent upon x ray systems as described below 9 2 1 Siemens E Stops Pressing an Emergency Stop E stop button immediately stops all MNS mechanical motion This includes not only physical motion of the two magnet positioners but also all motion of the magnets within the cosmetic covers When the E stop is pressed the user will see the following message on th
79. s magnetic sensitive or ferromagnetic implants should contact the manufacturer of their respective implant prior to entering the procedure room Serious injury may result WARNING The user should not attempt to upgrade configure or run any other software programs on the MNS or Navigant computers other than those specifically called out in the product documentation WARNING There are no user serviceable parts inside the MNS or Navigant The user should not remove any covers other than the hand crank covers guards or attempt to disassemble any portion of the MNS or Navigant WARNING All equipment brought into the procedure e g IV poles patient monitoring equipment oxygen tanks etc must be safe in a magnetic environment All equipment that is MRI compatible meets these criteria WARNING Target navigation is most effective in open chamber navigation Target navigation does not directly account for patient anatomy and is not intended to predict navigation across a valve Stereotaxis Inc Basic Instructions Page 9 HDW 0161 Rev B Effective Date 07 19 06 WARNING When Navigant displays a graphical representation of the catheter tip and shaft on the Navigant display screen the graphical representation is a display of the calculated catheter shape based on the initial location and orientation of the catheter base and distance of catheter shaft advancement or retraction by the Cardiodrive Catheter Advancement System WARNI
80. s 13 39 75 ES A ete LP D LA D RR EI EE 47 Deia 48 User Defined Presets id 58 USE EE 47 jf Tele Rr ME 11 A coenal actin eee oto 36 48 DRAWING EE 36 View Procedure EE 30 View Synchronize Orientation ccccccccee 41 Vitual Gamers 33 WINDOW RI 37 Basic Instructions Page 81
81. s closed curve exact except the last point will not be connected back to the first point Open Curve Smooth Same as closed curve smooth except the last point will not be connected back to the first point Ostium Creates an ostium constellation from a display group that contains three or more points The ostium is defined by the ellipse that fits the points contained by the display group The constellation generated will be an elliptical surface ring around the ostium and an elliptical collar at the ostium The surface patch will be represented in 3D displays as a solid surface viewable from one side or the other otep Along Constellation option not available with this constellation Surface Patch Creates a surface patch constellation from a display group that contains three or more points The surface generated will pass through each point in the display group This constellation models a surface that has both local concavity and convexity The surface patch will be displayed in 3D displays as a solid surface viewable from one side or the other Step Along Constellation option not available with this constellation Vessel Creates a smoothed curved line that passes through and best fits the points in a fashion that would connect each one in a best fit manner to represent a vessel The order of the points determines the shape of the vessel Table 7 Constellation Options The open curve constellation might be used to mark a linear catheter
82. s iia eae ee 37 Figure 25 Ella HIStory inte EE 37 Figure 26 S10re Navigation DUO iba 38 Figure 27 Navigation TEE 38 Figure 29 Stre Pon BUTON A A AE IAE AAA 39 Figure 29 Recall and Transfer Image Buttons 40 Figure 30 Felid Motorn DIS Vara eii 40 Figure 31 e a3bOtrentatorn Ee ie e EE 40 Figure 92 Display Syne BUON EE 41 FIQUre 33 II BUON ELT lille 41 FIQUIC 34 VV ANG BURO caricia in ici aio sarta cai 42 Figure 35 Primary Window RTE e EU Ae rel 43 Figure 36 Inside and Outside View Toggle Button seeeeeeeeesssssseeeseeeeeeeeennnn nnne nnns 44 EIgure 37 Eege Re Lei EE 45 Figure 99 9D DISbDIay TOODA EE 46 wis SES AA E sal aea 47 Figure 40 FIFODJIECIS to WINGOW BUNTON cesiones 47 Figure 41 Object OBaci BULIOD arcaico oline 47 Figure 42 RIGMI ClICK leren 48 FIQUre 43 gt FICA BU TON E 49 UE 22 DIS DIA E 51 Figure 4S Grou VIEW tt di 52 Figure 46 Ge le MON E 53 Figure d 7 Pot Display CDUOHIS ucranianos 54 FIGUIE AS Edit POINt WINDOW D A A AA a ci 54 Figure 49 SOU ODIONS EE 55 Figure 30 Edit Group lee ds 56 Figure 51 LEE 58 o A 59 Figure 53 EIER 59 Figure 54 Bulls Eye Range EE 60 Figure cS BUIS ENEE 60 Stereotaxis Inc Basic Instructions vi HDW 0161 Rev B Effective Date 07 19 06 Figure 36 Bulls Eye Orlentallofi ai hee teo eee dae oc basate tu de sae rd t ede Deus ud ui Vela ette cede diu adis 60 Flg re 57 er BUIS EE 61 Figu
83. s on both windows should now be green If they are red correct either vector to assure both are green Select the Apply Field button on the toolbar or on the keyboard and the vector will change to yellow once the magnetic field change is complete If a set of vectors is already drawn and the user wishes to just tweak the position of one slightly simply left click and hold on tip of the arrowhead and adjust as desired To draw a new vector the user may start drawing normally at some point other than the point of the arrowhead 5 3 3 Anatomy Display This button when selected opens a window of idealized anatomy display options The options are procedure dependent Idealized anatomy is for reference only and may not match the current patient Figure 21 Select Anatomy Button 5 3 4 Window Display By using the Window Display the user may select the two window display four window display or the Clinical Workflow Manager see section 4 4 The current selection is displayed Figure 22 Two Window Four Window Clinical Workflow Manager Buttons Stereotaxis Inc Basic Instructions Page 36 HDW 0161 Rev B Effective Date 07 19 06 5 3 5 Field Angle Step Size The Field Angle Step Size button when selected provides a drop down list with a range of degrees to set the field angle step size The step size is used by the 2D anatomic control windows the anatomic direction adjustment keys and the rotation deflection keys This value
84. sible options Every option will not be available in every window Constrained Anatomy Mode el Arbitrary Rotation Mode e 2 Translation mode E Selection mode Es p Rotate Field F in corner SC Rotate Bulls Eye B in corner Table 3 Left Mouse Modes 6 2 2 Show Hide Options The Show Hide option button when selected provides a drop down list of options to be shown or hidden in the 3D view Table 4 lists these buttons and their functions Every option will not be available in every window The button will have a pink background when it is active Show Hide Grid Show Hide Picture in a Picture rc Show Hide Desired Catheter Pts Show Hide Desired and Present d Curves hor Vectors as l y Show Hide Stored Navigation ate Show Hide Navigation Volume ud 3D Navisphere NON Show Hide Ultrasound if available Table 4 Show Hide Options Show Hide IsoSurface Clip Plane Stereotaxis Inc Basic Instructions Page 46 HDW 0161 Rev B Effective Date 07 19 06 6 2 3 User Views These buttons are used to set preferred views and return to those views with a single click To save or set the User View put the view in the desired position then right click the Roman numeral button desired to represent that view The status bar will display a message to confirm view has been set To use the previously saved view left click the appropriate Roman numeral button Figure 39 User Views User preferred views can be saved as
85. stem may be transferred to the Primary Windows for reference and utilization in navigation Target and Direction navigation modes require two valid images to be transferred In order to navigate using the transferred images these images must have between 40 and 140 degrees between them either RAO LAO or cranial caudal Images acquired during table or C arm movement cannot be transferred to Navigant Images that are electronically zoomed and or panned cannot be transferred to Navigant Only images with a patient orientation of head first supine as noted within fluoroscopy system and with the image plate not rotated more than 2 5 degrees from its normal position can be transferred to Navigant For transfers initiated through the transfer key on the keyboard the button in the main toolbar or through external inputs Navigant assigns images loaded or transferred to either navigation fluoro image A or navigation fluoro image B based on the following circumstances e he new image is assigned to the Fluoro A view if the image has an LAO orientation that is negative or zero with degrees rounded to integral numbers e he new image is assigned to the Fluoro B view if the image has an LAO orientation that is positive e f only one fluoro image is currently displayed and a new image is assigned to the other fluoro image Navigant will automatically show the new fluoro image Stereotaxis Inc Basic Instructions Page 39 HDW 0161 Rev B Effectiv
86. study or patient position All previously saved display options for this procedure will be restored If the procedure is from a previous day e Magnetic navigation will be available only if no navigation was performed in the procedure e Magnetic navigation will not be available if navigation was performed in the procedure In this case a warning will appear on the status bar indicating Procedure expiration period has been exceeded Magnet control will be disabled WARNING After opening a procedure you must visually assess the state of the procedure Any change in the patient s position or orientation can invalidate the data recovered from the procedure file Note When continuing a previous procedure verify the validity of the stored data as it is possible to delete previously saved data To start a new procedure or close the software click Cancel to return to the previous screen To delete the selected case click Delete and confirm the deletion otereotaxis Inc Basic Instructions Page 25 HDW 0161 Rev B Effective Date 07 19 06 4 3 Procedure Initiated by Fluoroscopy System When a new case is initiated using the digital fluoroscopy system the window shown below will appear Navigant Workstation 2 A new patient has been registered on the imaging system Do you wish to close this procedure and start a new one Figure 12 New Patient window Pressing Yes will start a new Navigant procedure and all previous data will be
87. tation O Figure 32 Display Sync Button When the 3D view synchronization button is selected a drop down list of buttons is displayed The table below describes each button Synchronize to 3D mE Synchronize to gt Synchronize to 3D Anatomy A View Ho 3D cM Constellation A View AL Anatomy B View Synchronize to 3D a Synchronize to gate Synchronize to Constellation B View Nous 3D CRES Bulls Eye View Navisphere View Synchronize to 3D e Synchronize to E Synchronize to Fluoro A View kL 3D ee Live X ray Fluoro B View Synchronize to position Synchronize to Synchronize to of C Arm CARTO RMT Ultrasound if system available if available Synchronize to Wand if i Synchronize to available Guidewire Bend Control Table 2 3D View Sync Options When window A is synchronized to window B the display orientation information from window B to is used to continuously update the display of window A They remain synched until objects in window A are manually rotated 5 3 14 3D NaviView Figure 33 NaviView Button The NaviView button opens up the window to the program to set up a vessel for reconstruction This is an optional feature and is explained in HDW 0169 IC NaviView Stereotaxis Inc Basic Instructions Page 41 HDW 0161 Rev B Effective Date 07 19 06 5 3 15 Wand Licensed Feature The Wand button appears on the Navigant Main Toolbar when the Wand is connected and oriented with Na
88. taxis Tangent Electrophysiology Catheter in the right side of the heart only It is not intended to advance the Tangent Electrophysiology Catheter through the coronary vasculature or the coronary sinus Outside the United States the Stereotaxis Cardiodrive Catheter Advancement System is intended for automatically advancing and retracting only compatible magnetic electrophysiology EP catheters inside the patient s heart when used in conjunction with a Stereotaxis Magnetic Navigation System MNS 1 5 Warnings Precautions While Navigant and the Niobe MNS provide skill amplification and an automated means of steering the distal tip of catheters and guidewires they do not replace the physician s knowledge expertise or judgment WARNING Federal USA law restricts this device to sale by or on the order of a physician WARNING The MNS and Navigant should be used only by qualified medical professionals who have been thoroughly trained in its use WARNING The MNS has permanent magnets that always produce a strong magnetic field The field cannot be turned off This field could cause metal objects in the procedure room to become airborne projectiles if not kept sufficiently far away from the magnet The magnetic field is present in the vicinity of the magnets at all times WARNING The Niobe6 system produces a strong magnetic field which is always on Patients and operators with pacemakers internal cardiac defibrillators ICD neurostimulator
89. te the should not be assumed to be correct for the data recovered from the procedure file patient s anatomy or position Can not delete the last group e The last group in the system may not be INFO deleted However you can remove all the points from that group Stereotaxis Inc Basic Instructions Page 69 HDW 0161 Rev B Effective Date 07 19 06 navigation volume arm and magnet positioner magnets would be moved to Navigate AP INFO Magnets in Navigate position e SEH magnets are in the Navigate AP position INFO Magnets in Pivoted position e Confirmation magnets are in the fully pivoted position Homing complete e Confirmation homing process successful wo Magnets in Stowed position e Confirmation magnets are in the fully stowed position Error cleared If the problem persists e No action An automated error recovery was cycle power using the power on off successful switch box No wo iae Navigation the toolbar or on the menu WARNING colision condition has been detected e X ray system and positioners are in close contact for Siemens only WARNING Movement limit reached e X ray system and positioners are in close contact for Philips only Failed to connect to Cardiodrive all e Cardiodrive use with Navigant will be markers will be cleared and the display unavailable until the connection is restored reset Navigation can continue without the Cardiodrive features WARNING Failed to load
90. ted in Navigant The message clears when a new study is started on Navigant Position Error Recovery in progress e Wait for recovery process to complete then Please wait Check for Left cover continue interference Position Error Recovery in progress e Wait for recovery process to complete then obstacle Position Error Recovery in progress e Wait for recovery process to complete then Please wait Check for Right cover continue interference Position Error Recovery in progress e Wait for recovery process to complete then me Please wait Check for Right magnet continue floor obstacle rd continue Internal Motion Error Recovery in progress continue ERROR Niobe Startup Error Niobe Startup Error Could not initialize the Magnet Control System Power on e Procedure A e Procedure C the Niobe system and restart the software otereotaxis Inc Basic Instructions Page 74 HDW 0161 Rev B Effective Date 07 19 06 cc Status Messages Explanation Solution X ray system reports CPR mode is e This is an instruction to move the magnets to active Move the magnets to the Stowed the Stowed position for greater patient access position when in the CPR mode of the x ray system otowing the magnets when the system e Home the system before stowing the magnets is not homed may result in unacceptable to ensure the magnets are positioned properly magnetic field levels outside the room to minimi
91. the patient table moves all previously stored point data is adjusted to account for the new position of the patient table maintaining stored point validity otereotaxis Inc Basic Instructions Page 52 HDW 0161 Rev B Effective Date 07 19 06 6 7 1 1 Mark a Point After transferring valid reference images to 3D fluoro A and B windows left click the point in space desired on either window In the opposite window identify the point matching the first point following along the yellow dashed cue line left click to make the matching point and select the Store Point button on the menu bar or on the Store Navigation toolbar or press the Store Point key on the keyboard When selecting the point on the second 3D fluoro window it will remain red invalid until a point is chosen on the cue line at which time the point will appear green until stored Once the point is stored it will be displayed in the color selected by default or by the user See Editing a Group for further instructions to change the color of the points All fluoroscopic points are added to the Navigant list of points when they are created When a point is saved on fluoro it is assigned a default name by Navigant and added to the currently selected group Each stored point in the list includes the following information an ID the group it belongs to a unique name the 3D coordinates of the point and the field vector that was active when the point was stored 6 7 1 2 Selecting a Po
92. tion in Basic Navigation and will be explained in specific IC and EP Instruction manuals Stereotaxis Inc Basic Instructions Page 63 HDW 0161 Rev B Effective Date 07 19 06 3D Navisphere Navigation 3D Navisphere is a spherical navigation object which contains regularly spaced polar lines e g latitude and longitude lines and is used for spherical navigation Figure 62 3D Navisphere 7 1 3D Navisphere Cardinal Direction Markers Cardinal direction markers are always displayed on the 3D Navisphere and are displayed as cones and labeled as shown in Figure 62 po Inferior R Right Pp Posterior Table 8 Cardinal Direction Markers Stereotaxis Inc Basic Instructions Page 64 HDW 0161 Rev B Effective Date 07 19 06 7 2 3D Preset Markers Preset direction markers are displayed on the 3D Navisphere when a preset list is selected Each preset direction marker will have a specified text ID that is visible whether 3D Navisphere is viewed from the inside or outside User defined presets will be displayed with text if they have been assigned text ID otherwise they will be displayed as colored markers without text Preset markers are displayed as disks or pucks Figure 63 Preset Marker on 3D Navisphere 7 2 1 3D Navisphere Preset Direction Markers Adjustment The user may adjust the magnetic field direction associated with a preset marker This adjustment is made by first identifying a new desired field d
93. trol room This E stop stops all motion on the x ray system and the MNS A yellow message will appear saying the E Stop is Active and the red light on the Niobe Power Box will be illuminated The E stop function is performed by pressing the red Stop button in the upper right hand corner of the Allura Xper Geometry TSO Module not pictured in either the procedure room or control room The E stop is reset by pressing the green Reset button in the upper left hand corner of the Allura Xper Review Module in the control room To restart both systems press and hold down the green button on the review module in the control room Niobe E Stop will be deactivated approximately 5 10 seconds after the Allura begins to reinitialize At this time the yellow message will change to X ray E Stop is Active until the Allura is completely recovered Niobe movement is not possible even with override until the Allura is completely recovered Emergency e stop indicator Illuminated red when active System power on when illuminated green ll System power On Off Figure 70 Philips System Control and Power Box Stereotaxis Inc Basic Instructions Page 77 HDW 0161 Rev B Effective Date 07 19 06 9 3 Overriding Magnet Positioner Interlocks System software interlocks prevent the positioner from moving into and colliding with the x ray system components The user can override this interlock by simultaneously pressing and holding the Stowed and F1 keys o
94. trols show the present and desired field vectors an idealized anatomic model and buttons for field adjustment This view is usually synchronized to the c arm to have the idealized anatomy change as the live image is changed See Section 6 6 for a description of the 2D anatomic views 6 1 6 No Display in Primary Window Any window may be displayed as a black screen Right click within the Primary window then select Change Window Close from the drop down menu and the contents of that window will be cleared To open it again right click within the window choose Change Window and select an option 6 1 7 Preoperative View Licensed Feature Preop images may be loaded into Navigant by loading a set of DICOM images that were acquired prior to the current procedure using a 3D medical scanning device CT or MRI from a list of compatible medical scanners This view allows the user to navigate directly on the imported image Preoperative image navigation is an optional feature and is explained in HDW 0098 NWS Preoperative Imaging Instructions Stereotaxis Inc Basic Instructions Page 45 HDW 0161 Rev B Effective Date 07 19 06 6 2 Display Window Tools Figure 38 3D Display Toolbar 6 2 1 Left Mouse Mode The left mouse mode button when selected provides a drop down list of buttons which allows the user to select panning zooming or rotation options for the viewing and manipulation of the 3D display The list below represents all pos
95. tructions Preoperative Imaging Instructions Wand Instructions for Use The following commercial third party document is referenced herein Document Number ISBN 0974541006 Stereotaxis Inc Document Title Reference Manual for Magnetic Resonance Safety Implants amp Devices Basic Instructions Page 11 HDW 0161 Rev B Effective Date 07 19 06 2 Navigant User Controls and Hardware The hardware components and user controls that make up Navigant are identified in the following table CONTROL ROOM EQUIPMENT ROOM PROCEDURE ROOM Navigant Niobe MNS Monitor Navigant Computer Navigant Niobe MNS Monitor l Niobe Magnetic Navigation Navigant Keyboard Navigant Mouse Navigant Mouse Niobe Magnet Positioners Niobe Magnet Positioner Navigar USE Hub FI ANA Cardiodrive RE Unit i Wand Licensed Feature Table 1 Navigant Controls and Hardware This section describes each of the Navigant system controls and indicators the user will encounter 2 1 Operating System The Navigant computer uses the Microsoft Windows 2000 operating system 2 2 USB Hub Navigant provides a USB hub in the control room for connection of Navigant accessories and a facility supplied printer if desired If the user desires to transfer saved images and other data off of the Navigant computer Stereotaxis recommends the user purchase a commercially available USB storage device such as a memory stick for use in the Navigant USB
96. unning Restart x ray detect the imaging system system e Verify Ethernet communication cables between MNS and x ray system are in place e Procedure C Cannot transfer the image The e Procedure B displayed image is not the last acquired image Cannot transfer the image The DICOM e Verify Ethernet communication cables between transfer process has failed MNS and x ray system are in place e Procedure C Cannot transfer the image Cine or e Procedure B aro transferring an image WARNING plate was rotated for this image WARNING ee IO was tilted for this image al TE PUE e Procedure C The magnets must be in Navigate e Press a Navigate position button and hold until otereotaxis Inc Basic Instructions Page 71 HDW 0161 Rev B Effective Date 07 19 06 I Status Messages Explanation Solution The magnets have not been aligned e Procedure C Contact field service for further instructions The E stop is active Deactivate the E stop button to continue A motor drive fault has been detected If the problem persists cycle power using the switch on the E stop box The system needs homing Press and e Hold the button until the status bar displays hold the appropriate controller button Homing complete until homing complete up to 60 sec e For PM 3 0 and PM 3 1 systems appropriate is defined as the Semi Stowed controller button e For PM 32 systems appropriate is defined as the N
97. ve Date 07 19 06 2 3 2 6 Display Relative Field Deflection Using Keyboard The arrow keys may be used to deflect the field direction in Navigant see Figure 8 Field deflection with the arrow keys is display relative meaning that the deflection directions are relative to the display type selected in General Settings Select a View for Keyboard Control in General Settings 1 From the Settings Menu choose General The General Settings dialog box appears 2 Click the View Controlled By Keyboard drop down box near the bottom of the dialog box A list of available views appears 3 Choose a view for keyboard field control and click OK Display that View in Navigant 4 Inthe desired window right click the mouse and select Change View 5 From the list of views choose the one set up to utilize keyboard control Use the Arrow Keys to Deflect Field Direction Press and release the up arrow key to deflect the magnetic field in a vertical up direction Press and release the down arrow key to deflect the magnetic field in a vertical down direction Press and release the right arrow key to deflect the magnetic field in a horizontal right direction Press and release the left arrow key to deflect the magnetic field in a horizontal left direction Note he field deflection is executed in a rotational adjustment about the axis vertical or horizontal like a cone Note The arrow key must be pressed and released for the field deflection to take pla
98. ve on the display monitor choose Exit Service Mode and then toggle the input to Input 1 Some displays have a button on the right side of display frame labeled 1 Some newer displays have an invisible selection bar that lights up when touched First touch the selection bar then press Input until the correct input displays Note If the magnetic field doesn t line up properly or in the wrong direction notify service to perform a consistency check to verify calibration Stereotaxis Inc Basic Instructions Page 68 HDW 0161 Rev B Effective Date 07 19 06 8 3 Status Messages Status Messages are indicated at the bottom of the Primary Window display There are three types of messages informational warning and error Status messages are listed in the table below along with the type and an explanation and solution where applicable Informational messages raves we background and black text messages have a background and black text messages have a BB background and white text a Pod Status Messages Explanation Solution The magnetic field was reduced or e Unable to recall the vector stored with this point unknown when this point was stored The magnetic field was reduced when the point INFO was stored Only applied fields can be recalled The vector for this point must be redrawn rather than recalled Drag a line in each view along the e Instructional message for defining the device INFO sheath tip from proximal to
99. vigant The Wand is a licensed feature For more information on the Wand consult HDW 0156 Wand Instructions for Use Le A ile dam Figure 34 Wand Button otereotaxis Inc Basic Instructions Page 42 HDW 0161 Rev B Effective Date 07 19 06 6 Primary Windows The Primary Windows allow the user to select various 2D 3D fluoro and preoperative views in either the two or four window layout Upon starting Navigant the window layout will default to a two window display The anatomic display will be determined by the type of procedure selected i e coronary arteries for IC procedure Any window may be changed by right clicking within the window and selecting Change Window then selecting the desired view All views except Preoperative 2D Anatomic and 3D Navisphere have an A and B option The anatomy displayed in the primary windows will be dependent on the procedure type chosen i e coronary vasculature for an IC procedure full heart for an EP procedure torso for basic procedure or coronary veins for a CRT procedure Below are examples from each category Figure 35 Primary Window Display Options 6 1 3D Views The 3D Views include 3D Anatomic view 3D Constellation view 3D fluoro view and 3D Navisphere The anatomy displayed is dependent on the procedure chosen Basic torso EP full heart right or left atrium IC all coronaries or right or left coronary only CRT coronary sinus CAUTION The id
100. w or double click the name in Navigations list To Return to a Stored Navigation Click on the name of the stored navigation and the field direction will return to the previously saved position Press and hold the AUTO key down and click on the name of the stored navigation and the CAS will start to auto drive to the stored distance Release the AUTO key and the CAS will stop moving Note Calibrating the CAS during a procedure invalidates any stored CAS positions in Stored Navigation Stereotaxis Inc Basic Instructions Page 38 HDW 0161 Rev B Effective Date 07 19 06 5 3 9 Store Points Points may be stored using the MNS navigation fluoro images Points allow a location in 3D space to be stored for later use as a reference or a target This can help with visualization of the layout of various locations in the heart and can help to return to a previous location later in a case A point or a group of points may be selected by clicking a point in space on the 3D fluoro A and B screens After a valid point in space is identified select the Store Points button or Store Points key The user may also store a point from the button on the floating Store Navigation toolbar Further instruction of how to store edit and utilize points is discussed in section 6 7 1 1 Mark a Point 6 7 1 2 Select a Point and 6 7 1 2 Editing Points Figure 28 Store Point Button 5 3 10 Image Recall Transfer Image Images acquired with the fluoroscopy sy
101. ze the magnetic field outside the room There was an error updating the e Procedure C configuration Call service if the problem continues A problem has been detected in the magnet system Cycle power using the power on off switch box positioners Cycle power using the e Procedure C power on off switch box LN EMEN NEN image e Procedure C ERROR Failed to set procedure type e Unknownprocedure type specified Cannot communicate with the x ray e Ensure x ray system is running restart x ray system system if necessary e Verify Ethernet communication cables between MNS and x ray system are in place e Procedure C mm emm e Continuous navigation failed to generate a continuous navigation path for the requested movement WEM TTT Der transfer image reacquire if necessary Where more than one recovery procedure is listed try each listed recovery procedure in succession Procedure A Restart procedure Refer to the Power Up and Power Down section of this manual Power the system down to the standby mode and then bring it back up from standby to fully operational Procedure B Valid X ray procedure Obtain a compatible x ray image consulting the error message text for the source of the problem then press Transfer Image button Procedure C Notify Field Service at earliest opportunity of the occurrence of this event whether the recovery procedure s resolves the problem or not otereotaxis Inc Basic Inst

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