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SofTaxic 3.0 - Ems Medical

1. Power Adapter Position Sensor Cable Cable SB Cable oo Bottom Cable Cover Illustration 16 Connecting cables to the Host USB Converter The digitizer will begin a diagnostic evaluation During this evaluation the LEDs on the Position Sensor will flash When the diagnostic evaluation is complete the Position Sensor will emit two tones and the power LED on the Position Sensor will light SofTaxic Neuronavigation System 3 0 38 5 SofTaxic System operating principles The SofTaxic neuronavigation System uses an optical digitizer either the Spectra or Vicra model to record the spatial data of special tools called position indicators the data monitored is the position and spatial orientation of the head of the subject being examined and the stimulation coils For each position indicator within the measurement volume the digitizer provides the following spatial data referred to an arbitrary reference system defined by the digitizer itself The spatial position of the origin of the position indicators the position of the structural origin of every position indicator used is provided in the form of 3 coordinates x y z referring to the main reference system established by the position sensor The location returned by the digitizer is in the middle of a particularly passive marker of the position This position can be altered through a process called calibration which changes the original position indicator The millime
2. SofTaxic 3 0 Neuronavigation System User Manual SofTaxic Neuronavigation System 3 0 Revision number Date yyyy mm dd Description P N Revision 1 2013 06 20 First issue STMANENO1 c 2013 EMS srl Bologna Italy All rights reserved Reproduction in any part without the written permission of EMS srl is prohibited This document contains copyrighted information and is intended for the exclusive use of EMS customers Copying disclosure to others or other use is strictly pohibited without the express wruitten authorization of EMS srl Report any violations to EMS srl EMS srl reserves the right to make changes in any specifications shown herein at any time without notice or obligation All specification are for information only Adress inquires regarding this document or the device described herein to the manufacturer E M S s r l Via G Ceneri 13 40138 Bologna Italy www softaxic com Tel 39 051 398925 Fax 39 051 342953 E Mail sales softaxic com CE SofTaxic Neuronavigation System 3 0 Table of Contents E ELASTE E i SE Re mt ie ea ocak a na me T A A EE MR PUTPOSE OL INC COCUI CE LR D L Teme And aD OreVidtl ONS SSD du ane ue en ee na aan died 6 LS Labels Ans VIN DONS nn mo no ae 7 2Inended seand s ALCL Y urreria isa ten nd don dont 2 Ae Intended USC nn A nist acne ad wR 8 DAN VAIN WIS Ss E sa er is seers a i Gola sa eras tae a ole ce ee is taht ta a sl
3. none MRI values Distance map EEG map SofTaxic Neuronavigation System 3 0 75 7 3 2 Navigation navigation mode When in navigation mode the window changes slightly as in Illustration 60 the radar for the item s repositioning is displayed there are two since you can track two coils simultaneously and you can no more add new locations in this mode If you click on a cell containing a stored location the radar will update itself and track the item s position relative to the desired target 20 30 9 head ar LETCE CECI head repositioning mode Points It tracking OK Computing best fit 2nd step completed Illustration 62 navigation mode A green circle means the stimulation target is correctly centered the green arrows represent the corect orientation of the coil By looking at the drawing below the upper green arrow in the radar represents the orientation expressed by the yellow sign the green arrow on the right of the radar represents the coil orientation in the red direction finally the lower green arrow in the radar espress the orientation marked in blue in the drawing Drawing 1 Coil orientation SofTaxic Neuronavigation System 3 0 76 7 4 Item calibration Each item can be calibrated by accessing the menu Tools Item calibration and the system will bring up a window like shown in Illustration 61 20 30 head aw LELIE head tracking Calibration Ite
4. 39 The Spectra model has a greater measurement volume than that of the Vicra model The following figures show the extent of these volumes Polaris Spectra Volumes M Extended Pyramid Volume 1312 mm 1470 ram E 950 mm 1336 mm 3000 mm u Illustratio Illustration 19 The Spectra digitizer 20 The Vicra digitizer measurement volume measurement volume position indicator may find itself out of volume if all its markers are outside the measurement volume The position sensor detects the position of a position indicator s passive markers by way of an mechanism alternating the emission and capture of infrared light The position sensor s illuminators flood the surrounding area with IR light at 20 Hz which is reflected by the passive sphere markers covered with reflectant material and then captured by the same position sensor s receivers The Position Sensor collects reflected IR for a period of time called the integration time This acts like an electronic shutter The system makes automatic adjustments to the integration time so that the intensity of the brightest IR detected is set to a maximum value and the intensity of all other IR detected falls below this value This process is called dynamic range control The system distinguishes between potential marker data and background IR using a value called the trigger level The trigger level is the minimum IR intensity considered to be valid marker dat
5. Do not use SofTaxic Neuronavigation System either directly or indirectly for medical diagnoses WARNING Before using SofTaxic Neuronavigation System make sure that the cables are connected correctly WARNING Read the attached documents before using SofTaxic Neuronavigation System WARNING SofTaxic Neuronavigation System is a medical device and must only be used in accordance with the manufacturer s instructions WARNING The receivers must be handled using conventional personal protection equipment for healthcare operators i e gloves gown etc WARNING The receivers must be handled using conventional personal protection equipment for healthcare operators i e gloves gown etc WARNING The estimated useful life of this product has been estimated as 10 years WARNING To ship the Polaris Vicra System repack it in the original containers with all protective packaging The provided packaging is designed to prevent damage to the equipment WARNING Make sure that the mains power is disconnected before connecting or disconnecting cables Failure to do so may cause damage to the equipment WARNING Always place the Position Sensor on a rigid support system If not supported the Position Sensor may fall which will affect the calibration and damage the Position Sensor SofTaxic Neuronavigation System 3 0 12 gt Pee D gt gt WARNING Use only 70 isopropanol and a lens cleaning solution formulated f
6. 0 13388 Threshold 892 Illustration 51 step 2 controls The threshold slide lets you control the value used for the scalp detection the higher the value more aggressive is the erosion of the scalp surface The input window is used to specify the limit the upper limit only of the detection and it can be useful if you want to customize how the lower part of the neck of the patient is cut during the 3D scalp reconstruction The Re orient by labels is used in case the MR images are not in the correct order or orientation after selecting for each plane the actual from a drop down list clicking on this button the images will be rotated accordingly Invert L R is used when you need to invert the left and right side of the images flipping since the DICOM format does not offer a standard way to ensure what is right and what is left on the image dataset you can follow chapter 3 9 Calibration platforms in order to evaluate a strategy to solve this limitation SofTaxic Neuronavigation System 3 0 68 In the third step of the dataset creation you can select the 3 reference point over the scalp by clicking on each item on the list in Illustration 50 and then clicking on the subject s head the desired location Craniometric reference points Reset N nasion A1 left preauricular A2 right preauricular Illustration 52 reference points The step 4 the last in this procedure allows you to extract the
7. 3 WARNING It is extremely important to choose the N AT A2 locations on visible spots in order to ensure the maximum accuracy during the neuronavigation It is really important to ensure that the subject s scalp is free of wrinkles or deformations and the subject is not wearing any headrest headphones that may alter the skin surface SofTaxic Neuronavigation System 3 0 92 T 2 Ssorraxic K 20 30 2D New dataset 3 4 New dataset 3 4 Le AE Slice selector niometric referer S 67 Reset _ C 109 E N asion Tr 00 00 A 110 E ge ne TO HZ O A2 rightpreauricular 0 La Overlay n MRI values Distance map EEG map Radar params jax di SaR aasa 6 6h6lc lt lt lt i i 2 3W i i i i RR Bar Ee Oe o OK Computing overlay completed 0 e e Illustration 28 Example location Illustration 29 Example location for the l for the Nasion per auricular left As shown in the Illustration 27 is it possible at any moment to switch to the 2D view and check the chosen location N A1 A2 projected on the MRI planes by clicking on their labels on the left side of the window This gives you a feedback on the MR images if the location where chosen correctly o SofTaxic Optic 3 0 22 30 a New dataset 3 4 2D 3D View Scalp Slice selector ae Craniometric reference points
8. Fractional threshold 0 500 Gradient threshold 0 100 Smooth 1 00 Radius 0 00 Centre of gravity voxels X 229 Y 107 Z 195 Overla uel Compute n Skip brain extract Manual procedure lt Back Abort Next gt Le OK 3D model completed oar 0 Illustration 32 The 3D model of the brain after extraction 6 4 Initiating a new navigation session By clicking the new session button from the Neuronavigation section of the main window Illustration 20 page 42 You ll be guided through the co registration procedure as shown in Illustration 29 you ll be presented with the first step where you have to select on the subject the Nasion left and right pre auricular by using the stylus position indicator 3 6 Position indicators page 27 and pressing the footpedal provided with the system NOTE SofTaxic Neuronavigation System 3 0 DD Before starting the the navigation session you have to initiate the communication with the Polaris digitizer by clicking on the digitizer icon in the lower part of the application window Failing to do so will leave grayed out the buttons needed in order to acquire spatial location Acquire point and Confirm registration 5 SofTaxic Optic 3 0 2D 3D Q 9 a 7 Neuronavigation 3D View Scalp Slice selector E Co registration s 229 Reset j C 107 Points to acquire N nasion s A 195 A1 left prea
9. IT IS EXTREMELY IMPORTANT TO READ ALL THE WARNING MESSAGES AND DANGER NOTICES BEFORE USING THE SOFTAXIC SofTaxic Neuronavigation System 3 0 NEURONAVIGATION SYSTEM THE PURPOSE OF THESE MESSAGES IS TO PROTECT THE USER AND PATIENT FROM ANY POSSIBLE HEALTH HAZARD SofTaxic Neuronavigation System 3 0 10 2 Intended use and safety This chapter contains guidelines and instructions to ensure safe and proper use of the SofTaxic neuronavigation System 2 1 Intended use The SofTaxic Neuronavigation System is intended to be used for the localization and positioning of the TMS coil over the motor cortex for pre procedural planning purposes In addition the SofTaxic Neuronavigation System provides the user with the capability to perform clinical research over other areas of the cortex The SofTaxic System is not intended to be used during a surgical procedure The system is intended to be used by trained clinical professional The device must be used solely for the intended use defined by the manufacturer SofTaxic Neuronavigation System 3 0 11 2 1 Warnings gt gt e eoe LEE WARNING SofTaxic Neuronavigation System can only be used safely if this manual is carefully read and fully understood WARNING Read this manual carefully and thoroughly before using SofTaxic Neuronavigation System to make sure that it is operated in the correct manner WARNING SofTaxic Neuronavigation System is a medical device
10. RS per oeaaereeee 74 8 2 The systems beeps every 2 SCCONG cccccccccssennsnssssssssssscccsccccccccceccceennnssssssssssseseeceececeeeusssces 74 o ICONS COCO TINS GENO aio tv en en tete conn ie a ed 74 GA Registration lO DICIIS es ent dates ati cent 75 8 5 The tracking system does not see the tool sers 75 6 6 Polaris Tracking Unit error COURS Hans naines 76 TO IUCN CC Rd den termine ne ecu nee arenes 78 tO L MaMt nRAnCe WASTE Nc NN ss ie ions 78 SofTaxic Neuronavigation System 3 0 1 Introduction The SofTaxic Neuronavigation System combines MRI based image guidance with non invasive Transcranial Magnetic Stimulation TMS The system uses stereotactic localization of the TMS coil to visualize interactively the calculated spot of the stimulation and to guide the TMS precisely over the cortical areas of interest The SofTaxic system supports a large variety of TMS devices Illustration 1 The Softaxic 3 0 Neuronavigation System The SofTaxic System consists of the following components e SofTaxic Neuronavigation Software e Optical Digitizer NDI Polaris Spectra or Vicra The SofTaxic system is intended for use in clinical and research settings by qualified medical personnel SofTaxic Neuronavigation System 3 0 The individualcomponents are not for use outside of the system and they are always used together as one system The Optical digitizer cannot be used without the Softaxic Neuronavigation software 1 1
11. USB drivers a warning may appear indicating that the drivers have not passed Windows Logo testing Click Continue Anyway 5 Once the first set of drivers is installed the Found New Hardware Wizard will launch a second time Follow steps 2 to 4 above to install the second set of drivers 6 The system will now appear to be connected through a virtual COM port Host USB converters are interchangeable on the same USB port without having to re install drivers or losing the COM port previously established SofTaxic Neuronavigation System 3 0 34 4 7 Mounting the Position sensor The Position Sensor is mounted via a built in 1 4 thread tripod mount The following figures shows the Position Sensor dimensions and mounting arrangement for both models of supported sensors All dimensions in mm Illustration 11 Details for assembling the Vicra sensor All dimensions in mm See Detail A Thread 1 4 20xF 8 7 i ki _ Thread M3x 5x 6 5 on pitch diameter 26 85 Detail A 3 places equally spaced Illustration 12 Details for assembling the Spectra sensor SofTaxic Neuronavigation System 3 0 35 4 9 Mounting the Host USB Converter The Host USB Converter can be free standing or may be mounted via M6 x 1 mm pitch x 4 mm deep threaded holes located in the three mounting feet as shown in the following figure 42 Sem Detal Chet ol All dimensions in mm Illustration 13 Host US
12. View params amp Item s opacity 5 0 Overlay none MRI values Distance map EEG map Radar params amp choose orientation Max dist mm 8 0 Max radius deg 10 0 gt 3D model Illustration 24 New dataset step 2 The system will automatically adjust the image s contrast levels and perform a first reconstruction of the subject s scalp in a 3D model as shown in Illustration 23 The user can modify the thresold for the 3D model reconstruction and higher value may help remove the noise artifacts from the image but exceeding with the threshold value will erode the skin of the subject from the image and bring inaccuracies to the head co registration during the neuronavigation It s very important to be careful when manually adjusting the threshold SofTaxic Neuronavigation System 3 0 49 le o SofTaxic Optic 3 0 20 30 amp 2 SEEN Image cleansing choose orientation choose orientation Re orient by labels Invert L R Input window 0 13388 Threshold 892 Slice selector amp ms 317 C 182 A 125 es View params amp item s opacity 5 0 Overlay none _ MRI values Distance map EEG map Radar params amp choose orientation x Max dist mm 8 0 2 Max radius deg 10 0 lt Back Abort Next gt OK Computing overlay completed Illustration 25 New dataset step
13. Yr Xr Using the Notes field the user can associate a comment to the selected location and by marking it using the Shared flag the desired location will allways be visible in every navigation session using the current dataset That make it possible to use the same location over the same subject during different SeSSIONS SofTaxic Neuronavigation System 3 0 72 The Import and Export buttons let you import export the location s information from to an XML file in order to share the location between different subjects Point detail ID P8 x 129 8 y 113 9 z 215 0 Notes Shared Reset Update Import Export lt Back Abort Illustration 58 Point details The viewport is controlled by the toolbar Illustration 52 by its use it is possible to switch from a full 3D view or a mixed 3D 2D view or the display or either the brain or the scalp In Illustration 57 is represented a typical viewport with a mixed 2D 3D mode it displays the 3D model on the lower left part of the view and the 3 MRI planes You can zoom the 3D model by using the mouse s scroll wheel or by right clicking on the 3D model an moving the mouse up down while keeping the button pressed The head can be rotated by left clicking the mouse button and moving the mouse in the desired direction while holding the button The MRI images can be moved around but not resized by right clicking an holding down the mouse button it ca
14. a subject 20 32 head aw AATE ELO head repositioning mode tracking Points Items Position Re x 144 y 211 z 160 Capture Navigation Target scalp sty co1 co2 man x ly z Target brain x ly z stylus og missing Position x y z Target scalp x ly z Target brain x y z Position x y z Target scalp x ly z Target brain x ly z Import Export lt Back Abort OK Computing best fit 2nd step completed Illustration 39 Neuronavigation Slice selector amp S 229 SS C 107 A 195 View params 3 Item s opacity 5 0 C1 Follow stylus Overlay none MRI values Distance map EEG map Radar params El Max dist mm 8 0 lt Max radius deg 10 0 a 0 Right after the co registration completion the system starts with the actual neuro navigation as shown in Illustration 34 In the central part of the window is displayed the subject s head with the 3D reconstruction on the lower left part next to the MR images in the Sagittal Coronal and Axial plane It is possible to switch from the Scalp view to the Brain View by clicking the Scalp or Brain button on the toolbar 3D ry Illustration 40 Navigation view toolbar SofTaxic Neuronavigation System 3 0 60 2 30 head arn Neuronavigation 2D 3D View Brain Slice selector ae head repositi
15. brain from the scalp and gives you the controls as in Illustration 51 BET2 extraction Fractional threshold 0 500 Gradient threshold 0 100 Smooth 1 00 Radius 0 00 Centre of gravity voxels X 229 Y 107 Z 195 Compute Skip brain extract Manual procedure Illustration 53 BET2 controls The fractional threshold is used by the BET2 algorithm along with the gradient threshold as described in the BET2 technical report The centre of gravity can be selected manually by clicking on the region of the brain you prefer to use as a Starting point for the brain identification It is also possible to alter the position of the centre of gravity by using the slice selectors Illustration 48 By clicking on compute the algorithm will proceed to the extraction of the brain and then to build a 3D model of the brain 3 http www fmrib ox ac uk analysis research bet resolveuid 1a260f0e7aa608d9c9f5268ee012552e SofTaxic Neuronavigation System 3 0 69 The Skip brain extraction button lets you skip this step but you ll miss the ability to navigate over the 3D brain of the subject only on the MR images and on the 3D scalp model The Manual procedure skips the BET2 extraction tool altogether and follows a manual procedure where you have to identify the limits of the brain and then the system will be able to extract the brain using the limits set by you At this point using the toolbar Illustration 52
16. conditioning Is ventilation interfering with the tracking system 8 6 Polaris Tracking unit error codes The Polaris tracking unit provides visual and audio indicators of the tracking system status These are described in Table 9 Power LED is off Position Sensor voltage out of range 1 Refer to Illustration 66 If necessary proceed to 2 below 2 Check for green power LED on Host USB Converter If lit check replace the Position Sensor If not lit check replace the power adapter cables and Host USB Converter Power LED is flashing Normal indication during warm up No action required Error LED is flashing A recoverable system fault has been detected Contact your local Softaxic dealer of EMS technical support Error LED is lit A non recoverable system fault has been detected Replace the Position Sensor Two beep tones emitted Normal indication when power is initially applied to No action required the system or the system is reset Host USB Converter A fault has been detected by the Host USB Converter Refer to Illustration 66 for action Error LED is lit Table 9 PolarisTracking System LEDs indicators and audio codes SofTaxic Neuronavigation System 3 0 80 Host USB Coverter LED js lit Tum system mains power off for 10 seconds then tum back on Yes Disconnect tracking unit Yes No Check Replace 1 Power adapter 2 Host USB Converter Illustration 66 Host USB conve
17. extent of their volume of measurement The Spectra model has a greater volume of measurement compared with that of the Vicra model 3 1 Hardware Components This chapter describes the SofTaxic Neuronavigation System hardware components The system setup is illustrated in Figure X components are explained in table X USB converter Host USB Converter including the8800810 001 communication cable 4 5 m long Power supply 4100139 Supply line 7500012 France Belgium Germany USB cable Universal Serial Bus A B 2m long 2600596 SofTaxic Optic Pointer shaped position indicator 8700340 Position indicator 8700339 8700339 Position indicator 8700338 8700338 Position indicator 8700449 8700449 A stand for the position sensor EMS SSP01 A SofTaxic Optic software installation CD EMSCD STO Position sensor A Vicra position sensor 8800788 xxx VVy Or alternatively A Spectra position sensor 8001096 xxx yy Optional Parts A Host USB Converter including the 8 m communication8800810 002 cable A calibration platform for Magstim coils CAL MAG 9925 CAL MAG 9925 1 CA L MAG 40MM B CAL MAG 3910 A calibration platform for Mag amp more coils CAL M amp M 510519M CAL M amp M 5105 23M A calibration platform for Magventure coils CAL MGV 01 CAL MGV 0G B70 Table 3 System Components SofTaxic Neuronavigation System 3 0 18 3 2 Position sensor Position Sensor js Position Sensor nn
18. it is possible to switch from a full 3D view or a mixed 3D 2D view or the display or either the brain or the scalp 2D 30 Illustration 54 view toolbar SofTaxic Neuronavigation System 3 0 70 7 3 Navigation UI The Neuronavigation window has two working modes capture mode and navigation mode The first mode is used to record location over the brain using different tool stylus coils or manually the second is used to navigate over the recorded location an to keep the position of the current item stylu coils in place by using a radar In the next sections we ll see in detail both modes 7 3 1 Navigation capturing mode Illustration 55 Softaxic navigation in capture mode As shown in Illustration 53 the window is divided in 4 parts from left to right tool tracking status Neuronavigation summary Neuronavigation viewport navigation controls The tool tracking status is optional and can be accessed by the main Menu gt View gt Item details One example of head tracking status is reported in Illustration 54 where the green color indicates that the tool is inside the digitizer s acquisition volume otherwise it would be represented in yellow The Spatial information reported are Position indicating the tool s position inside the acquisizion volume Target scalp indicating the stimulation target on the subject s scalp Target brain indicating the target position on the subject s brain In cas
19. port COMx where x is enumerated and emulates a standard PC serial port such that the Host USB Converter may be communicated with as a standard RS 232 device When you first connect the NDI Host USB Converter to the host computer you will need to install drivers for the Host USB Converter There are two sets of drivers for the Host USB Converter e the first set of drivers enables the Host USB converter to work with the host computer e the second set of drivers sets up the USB port where the Host USB Converter is connected to emulate a serial port 4 6 1 Driver Location If the SofTaxic Optic software has already been installed the USB drivers are installed as part of that installation The default driver location is C Programmi SofTaxic Optic 2 0 USB Driver The drivers are also found in the SofTaxic Optic CD in the USB Driver file 4 6 2 Installing the USB Drivers 1 When you first connect the Host USB Converter to the host computer the Found New Hardware wizard will begin automatically 2 When prompted select the option that allows you to specify the drivers location Install from a specific list or location in Windows XP 3 Browse to the folder containing the drivers either on the host computer or on the SofTaxic System CD Windows will automatically select the correct drivers from the folder 4 Click Next and Finish as required to complete the installation Windows XP only After you have selected the folder containing the
20. position indicators passive markers Indicator LED Three LEDs that provide the following indications left to right Flashes green during system warm up Steady green when system is ready for Power LED DE Steady green when the communications connection is available Status LED L Lights steady amber if a critical error is detected Position Sensor must be returned to factory Flashes amber if a non critical error is detected for example SofTaxic Neuronavigation System 3 0 20 Error LED a firmware update is not completed Table 4 Polaris Vicra LEDs Mou nt Connector F llustration 5 Polaris Vicra Rear View The rear of the Position Sensor incorporates the components detailed below Mount 1 4 thread tripod mount that incorporates three M3 x 0 5 mm x 8 mm threads Connector LEMO A 14 pin connector that provides power to the Position Sensor and allows communications to from the Position Sensor Manufacturer s labels EMS srl Yia G Ceneri 13 40138 Bologna al Prodotto K only j Toi i RA pa aung a ER i J IIF RE rene Sistema di neuronayigazione Connessione allaret AR Oe Modello Via G Ceneri 13 Potenzaassorbtalagw o 40138 Bologna SofTaxic Optic Vicra ITALIA assiflicazione A Consultare il manuale d uso prima di utilizzare l apparecchio Illustration 6 System label Note It is good practice to disconnect mains power before conne
21. proceed to the next step which will refine the co registration space and improve the system accuracy by clicking the Best Fit button Soffaxic Optic 3 0 20 3 head o DEUCE TE yy Slice selector amp head Co registration s 229 tracking Reset osition a C 107 x 144 y 211 z 160 Points to acquire Target scalp a 9 See N nasion lt A 1195 Target brain D A1 left preauricolar RSR M LI A2 right preauricolar i View params amp ty EJ e Distance gaps Item s opacity 5 0 missing ition N A2 x ly z Target scalp Overlay x y z none In D MRI values Target brain Confirm Registration SE x ly z Distance map EEG map l1 EJ Radar params amp oil1 Max dist mm 8 0 disabled mm Position 4 x lyi lz Max radius deg 10 0 Target scalp g LO E x y z Target brain x y z OK Loading dataset 20130327 114926_AVERAGE_JOE completed pa Illustration 35 Location of A1 the red label shows an accuracy over the threshold SofTaxic Neuronavigation System 3 0 97 o SofTaxic Optic 3 0 2D 3D e 9 Gg head Neuronavigation Slice selector E3 head re S 229 trackin a Reset all Position x 144 y 211 z 160 C1 C 107 Target scalp C2 x y z ly C3 A 195 Target brain C4 V r C
22. regulations in force with regard to electrical systems DANGER Before using SofTaxic Neuronavigation System make sure that all the devices are intact and that none of the parts show any sign of damage Should any of the parts be damaged do not use the system under any circumstances Do not tamper with the device in any way Contact the manufacturer s technical assistance service to replace damaged or worn parts with original spare parts DANGER NEVER under any circumstances dip any part of the SofTaxic Neuronavigation System system into a liquid of any kind DANGER The SofTaxic Neuronavigation System system and its components must NEVER under ANY circumstances be used while covered or wrapped in cloth or protective coverings of any material whatsoever or while it is near a source of heat DANGER In case of equipment malfunction never use the SofTaxic Neuronavigation System system Never tamper with the device in any way Contact the manufacturer s technical assistance service for any problems gt gt b PPR RPE SofTaxic Neuronavigation System 3 0 16 A DANGER Never use the SofTaxic Optic where there is an MRI scanner SofTaxic Neuronavigation System 3 0 L7 3 Overview of the Softaxic Neuronavigation System SofTaxic Optic is an advanced neuronavigation system which can use two different optical digitizers the Vicra model or the Spectra model These two digitizer models differ due to the
23. 114926 Name Surname Age years 0 Weight Kg 0 00 lt Back Abort Next gt OK Loading file 020130301_164526CefaleaBonos004a1001A completed Illustration 49 New dataset creation step 1 4 Slice selector amp S 224 C 128 Cy A 128 View params Item s opacity 5 0 Overlay none MRI values Distance map _ EEG map Radar params amp Max dist mm 8 0 5 Max radius deg 10 0 The new dataset creation window is dived in 3 logical areas the left part meant to display the controls that changes for every step of the procedure the central area that displays the MRI data and the right part with controls used for navigating the dataset On the left part for the first step it is possible to associate patient data to the dataset Name Surname and age weight SofTaxic Neuronavigation System 3 0 67 Slice selector EX 5 259 qq C 114 A 215 Illustration 50 Slice selector controls On the right part the only controls meaningful at this step are the slice selectors as shown in detail in Illustration 48 where you can select the displayed slice for each plane Sagittal S Coronal C Axial A In the second step of the dataset creation the left part of the window presents new controls Illustration 49 Image cleansing Re orient by labels Invert L R Input window
24. 2 3D head model i z In order to have a correct ordering of the planes you should have in the 3 MRI views the following planes Sagittal plane nose to the right Coronal plane head up Axial plane nose towards the upper part of the window In case the existing image is not ordered correctly you can re orient the plane choosing from the choose orientation dropdown control the actual orientation you see in the image In the case of Illustration 23 we chose in order the following labels Sagittal nose left Coronal head up Axial nose down By clicking on the Re orient by labels button the image will be re oriented and the 3D model will be computed again like in Illustration 24 SofTaxic Neuronavigation System 3 0 50 SofTaxic Optic 3 0 2D 3D 9 g New dataset 2 4 2D 3D Vi vi i ep Slice selector ae Image cleansing S 214 5 Re orient by labels E Invert L R c 79 gt i m Input window 0 13388 A 180 ce G Threshold 892 View params E3 Item s opacity 5 0 C Overlay none MRI values Distance map EEG map Radar params amp lt Back Abort Next gt la OK Computing overlay completed o 0 Illustration 26 Result of a correct orientation of the planes Max dist mm 8 0 Max radius deg 10 0 om Y Once the 3D model is ready it will be displayed in the lower left quadrant of the application window The model can be rota
25. 3o head g A We fore Best Fit tracking Position x 144 y 211 z 160 Target scalp x y z Target brain x y z stylus amp missing Position x y z Target scalp x y z Target brain x y 1 z coil1 EJ coil1 disabled Position x y z Target scalp x y z Target brain x y z Qa c2 o c Qc Ms cs o c cs co Nearest point Local error Global Error Minimum Maximum Average Std dev lt Back Reset all 10 2 44 5 28 8 9 1 Abort Next gt OK Loading dataset 20130327 114926_AVERAGE_JOE completed Slice selector amp S 229 C 107 CS f v A 195 m View params amp Item s opacity 5 0 C Follow stylus Overlay none MRI values Distance map O EEG map Radar params EJ Max dist mm 8 0 Max radius deg 10 0 RES o Illustration 37 The system report the current average error over the scalp Best fit completed The best fit process has completed successfully Old average distance 28 84 New average distance 20 73 Accept new values Illustration 38 Results of the co registation optimization SofTaxic Neuronavigation System 3 0 59 6 5 Navigating
26. 5 a C6 C7 View params amp stylus E ce Fog item s opacity 5 0 stylus Ic tracking Position Follow stylus x 73 y 172 z 207 Nearest point Target scalp 4 7 Overlay x 76 y 169 z 204 Local error 28 6 none in MRI values Target brain 17 5 Acquire Le _X 84 y 161 z 198 Distance map Global Error EEG map coil1 EJ Minimum us coil1 Maximum Max dist mm 8 0 disabled Average mm Position Std dev Max radius deg 10 0 Target scalp 9 7 a x y z Target brain xX v z lt Back Abort Next gt 12 OK Loading dataset 20130327 114926 AVERAGE_JOE completed es _ Illustration 36 Refine co registration In order to improve the accuracy of the system the system need the location of other 9 arbitrary points over the subject s scalp The system will suggest you optimal locations in order to take the reference point in a wide area but you don t have to be exact in choosing the spot as soon as the label displays the center name C1 C2 in green you can acquire the location As soon as you complete the acquisition of the 9 locations the system will perform an additional optimization of the subject s co registation and show the results as in Illustration 36 where are reported the min max average error with standard deviation SofTaxic Neuronavigation System 3 0 58 Soffaxic Optic 3 0 2D
27. B Converter mounting options SofTaxic Neuronavigation System 3 0 36 4 10 Connecting the hardware llustration 14 Connecting the Vicra sensor Position Sensor Position Sensor i C i 0 4 Position Sensor Cabl Position Sensor Cable i aa USB Cable Host USE Converter Host USE Converter LE Power Adapter Cable Power Adapter Cable Ei i To Computer Power Adapter use Cable To Mains Power I llustration 15 Connecting the Spectra sensor Note It is good practice to disconnect mains power before connecting or disconnecting cables Failure to do so may cause damage to the equipment Connect the Position Sensor cable attached to the Host USB Converter to the connector located on the back of the Position Sensor Align the red marking on the Position Sensor connector with the red marking on the cable connector Connect the USB cable B plug and power adapter cable to the Host USB Converter as shown in the following figure Locate the top and bottom cable covers in place on the Host USB Converter Secure the covers with the thumbscrew as shown in figure 14 Plug the USB cable A plug into the host computer Make sure all the cables are connected firmly and placed where they will not be stressed stepped on or bent Plug the power cable into the power adapter and plug the power cable into the power mains and turn on the mains SofTaxic Neuronavigation System 3 0 37
28. E EEE EEE 9 2 CAUHONS SENS Et TN re nn Sn de ne 13 3 Overview of the Softaxic Neuronavigation System 15 9 L ara Ware Componer A Rita lient 15 BZ POSITION SCOOTERS Re a lens des ii iles cie 16 72 PONS NICE etai nat Net 17 2 22 POLIS SPC CU aise ela aa ab ae tee nant ee tee isa ou a di 20 Jo HOSC USB CONVE eT e Re nt ss eaicale Dleesta cance 23 7 PROMO ACDC Se 24 Di ANOS RS A A AR An A MON de A ie tale r 24 3 0 POSILIOMANGICALONS yiee dede solaires dec tte ae eee 25 D ON MOOD ne aa a Do a Dee de TAE O 26 20 POSILION SCNSOM SAN sn en ae d teste ne init 26 309 CAND Fall ON plai Or Sasca T TE 27 A SorToxiC SYS CMS AN AMON E EE NE A NT 28 d L PrecautionS coreeana a E T E E E eieeeietetoees Peineedeacse me a ereneeiee 28 4 2 Hardware and software Prerequisites sss 28 Ao Unpack iNo THE Sy tee wee na eine a a 28 AA Operating CIVITO EN aieia D E E E OEO 29 Ao Operi ne environmen iarasi A E E a 29 4 6 Installing the USB drivers WindOWS cccccccsssssssssssessssecsecccccccccccccenennssssssssssseseecceeeeeceeeeas 30 AE Oe OT IVT EOC Oieee nee dessine edit e 30 4 6 2 Installing the USB DAVE S seance ET ORTO OOT 30 4 7 Mounting the POSITION SENS OF 52 Re A sd sen D ie 31 4 9 Mounting the Host USB Conve rtel ccccccccccssssesnnsssssssssseseccscccececceccccennnaasesceceasseccesuasssces 32 4 10 COnnecting The Nard Ware SE nids 33 D SOf AXE System operating DINICIDIeS 4 ni
29. Points items Capture Navigation sty col co2 man p1 P2 P3 P4 P5 P6 P7 pe Illustration 43 Acquired locations It is possible to acquire new locations over the scalp or over the brain pointing the stylus or directing the coil over the area of interest and clicking the Acquire new button The systems gives you the ability to mark with the mouse locations of interest directly on the MRI images or on the 3D model of either the brain or the scalp All the locations acquired will be added to the list of target points as in Illustration 41 where data is represented in a table format each row is the location s of interest the columns represent the tool used for the acquisition stylus sty coil 1 co1 coil 2 co2 manual SofTaxic Neuronavigation System 3 0 62 man Clicking on the green symbol on one of the cells when you are in navigation mode the radar tool will be activated and you can use it in order to reposition your tool stylus coil 1 or coil 2 over the same location as in Illustration 42 20 30 head ow Neuronavigation Slice select head repositioning mode mal 457 tracking Points Items osition J x 144 y 211 z 160 Capture Navigat c 120 Target scalp sty co co2 man x y Z Le P1 A 211 ee P2 x y z y P3 P4 View params stylus DRE eee PS Item s opacity 5 0 stylus P6 tracking osition P7 Follow stylus x 73 y 120 z 213 P8 gt T
30. Purpose of the document The purpose of this document is to describe the features of the SofTaxic System and to provide detailed instructions on the usage of the system NOTE Please make sure that all users of the SofTaxic System read these instructions and understand the conditions for safe use of the system Failure to understand the information may lead to dangerous situations We also reccomaned that you familiarize yourself with the use of the operating system before using the SofTaxic computer Chapter 2 Intended use and safety includes important safety information about using the SofTaxic Neuronavigation System This document does not include detailed use and maintenance instructions of the computer and its screen Please refer to the user manual of the computer manufacturer and the operating system manual 1 2 Terms and abbreviations The following table describes the most commonly used terms in this document Analyze format File format for the storage of biomedical images It is used for medical tomographic scans from magnetic resonance imaging computed tomography and positron emission tomography DICOM Standard by Digital Imaging and Communications in Medicine Hotspot Location of the stimulus in the brain MRI Magnetic Resonance Imaging or Image NIfTI Neuroimaging Informatics Technology Initiative An Analize like data format to facilitate inte operation of functional MRI data analysis
31. S 391 Reset C 106 N nasion x 117 01 y 203 00 z 135 00 A 102 E A1 left preauricular x 33 50 y 110 00 z 110 00 View params amp A2 right preauricular x 195 51 y 106 00 z 102 00 Item s opacity 5 0 Overlay none MRI values Distance map EEG map Radar params amp Max dist mm 8 0 lt Max radius deg 10 0 lt Back Abort Next gt OK Computing overlay completed Illustration 30 Checking the location on the MRI planes SofTaxic Neuronavigation System 3 0 33 6 4 3 New dataset step 4 The final step performs the brain extraction and the construction of a 3D model of the brain The system supports two methods for separating the brain from the scalp The Brain Extraction Tool developed at the Oxford Centre for Functional MRI of the Brain A manual extraction procedure that identifies the limits of the brain volume and performs the extraction f Soffaxic Optic 3 0 2030 New dataset 3 4 2D 3D View Brain ce selector K BET2 extraction 7 Fractional threshold 0 500 Gradient threshold 0 100 Smooth 1 00 Radius 0 00 Centre of gravity voxels X 229 Y 107 Z 195 Overlay o none MRI values Distance map EEG map Radar params SRE Max dist mm 8 0 Max radius deg 10 0 gt lt Back Abort OK Converting image completed a 0 Illustration 31 Brain extraction us
32. Sensor as this may cause irreversible damage to its components Reliance on data provided by a damaged Position Sensor may lead to inaccurate conclusions If your application involves personal safety these inaccurate conclusions increase the possibility of personal injury 10 2 Position sensors Regularly inspect the Position Sensor for cleanliness The Position Sensor and particularly the illuminator filters and lenses should be cleaned only when necessary The frequency of cleaning must be determined by the user SofTaxic Neuronavigation System 3 0 82 CAUTION Use only 70 isopropanol and a lens cleaning solution formulated for multi coated lenses for example AR66 to clean the Position Sensor Other fluids may cause damage to the illuminator filters Do not use any paper products for cleaning Paper products may cause scratches on the illuminator filters To clean the Position Sensor follow the procedure detailed below 1 Remove dust from each illuminator filter and lens using a photographic lens duster brush Gently wipe the surface in one direction only by pulling the brush across the surface 2 Gently wipe the illuminator filters and lenses with disinfectant wipes containing 70 isopropanol Continue cleaning the remainder of the Position Sensor taking care not to wipe debris from the Position Sensor case onto the illuminator filters or lenses Avoid prolonged contact between the wipes and the Position Sensor 3 Cl
33. Treating measurements as absolute may result in an incorrect interpretation of results If your application involves personal safety these incorrect interpretations increase the possibility of personal injury WARNING Do not use a wireless tool whose design does not conform to the SofTaxic Optic System s unique geometry constraints When a SofTaxic Optic System attempts to track more than one wireless tool in the measurement volume these unique geometry constraints ensure that they are distinguishable from each other Reliance on data produced by two indistinguishable tools can lead to inaccurate conclusions and increase the possibility of personal injury WARNING Do not use a tool with a tip without first performing a pivot procedure to verify the tip offset Reliance on data produced by a tool with an inaccurate tip offset may lead to inaccurate conclusions and increase the possibility of personal injury WARNING Do not use markers without inspecting them for cleanliness and damage both before and during a procedure Reliance on data produced by unclean or damaged markers may lead to inaccurate conclusions and increase the possibility of personal injury WARNING The Position Sensor requires a thermal stabilization period in order to provide reliable measurements Up to 10 minutes are required for the optical components to reach operating temperature from a cold start at normal room temperature WARNING The SofTaxic Optic Sy
34. a Background IR that falls below the trigger level is rejected by the Position Sensor The trigger level generally increases with integration time In order to identify the position and spatial orientation of a position indicator the system must be capable of determining the position of each of that particular position indicator s passive markers The IR light reflected by the passive markers is recorded by the position sensor s receivers CCDs If the system is unable to detect individual IR sources or has detected more IR sources than it can process it will report an error Otherwise the system will calculate the position of the IR sources To determine the position of an IR source the Position Sensor calculates a line between the source of IR and each sensor displayed as dotted lines in the following figure Where the lines cross each other the SofTaxic SofTaxic Neuronavigation System 3 0 40 Opticcalculates the line separation distance between the lines If the line separation at this point is less than a predefined limit the system considers the point to be a possible marker position Otherwise the point is discarded Marker 7 Ilustration 21 Identifying the position of a marker Once the system has measured the position of all a position indicator s markers it then calculates the inter marker distance between each pair of markers and the angle between each segment It then compares this data with
35. al anatomy of the brain may differ from the MR images Hence always evaluate the validity of the MR images WARNING It is very important that there are no wrinkles or skin folds on the patient s scalp due to a headrest for example during the MR imaging or during stimulation If there is a discrepancy in the patient s head surface between the MR images and the SofTaxic head registration there will be inaccuracies in TMS stimulation Field of view e Neither the scanning table or the headrest should be included in the FOC FOV e MRI markers and landmarks must be included in the scan if used e The forehead eyes ears and entire nose the tip of the nose must not be cropped must be included in the scan e There must be no markers over the face or ears of the patient if needed a marker may be used on the chin of the patient Scan attributes e T1 weighted images required e 3D MR scans may be used e Voxel size 0 9 1 1 mm 1X1x1 mm recommended e Sagittal images are recommended axial and coronal images are supported too e Sequential scans of 1 mm thickness and Omm slice gap required SofTaxic Neuronavigation System 3 0 44 e Pixel size matrix size and table position must not be altered during the scan Suggested 3D T1 e Siemens MPRAGE sequences e GE SPGR scanner specific e Philips T1 FFE or TFE e Acquire anatomical images without using sensitivity encoding SENSE technique because
36. arget scalp 6 4 Overlay x 66 y 119 z 218 none Target brain 8 0 MRI values x 78 y 120 z 210 Distance map EEG map coil1 Radar param coil1 Max dist mm 8 0 missin g Position x ly M d de 10 0 Target scalp deg x y Target brain x y Delete Point detail ID P7 x 78 6 j Yy 120 3 Z 211 3 0 0 yx 0 0 z 0 0 Not Shared Reset Update Import Export lt Back Abort i Af 0 OK Computing best fit 2nd step completed SN Illustration 44 Pointer repositioning gt mi _P8 man P3 sty i Ial Illustration 45 Detail of a manual target over the axial plane In order to select which tools you want to use for the neuronavigation you can use the items tab on the SofTaxic Neuronavigation System 3 0 63 left part of the navigation window as shown in Illustration 44 within this area you can select the desired tools and eventually load an existing calibration for each one of them Neuronavigation capturing mode Points Items Pointers Calibration stylus Load Save amp coil Load C coil Load Illustration 46 Items selection tab SofTaxic Neuronavigation System 3 0 64 6 6 Tool calibration The stylus and the coil tool items need to be properly calibrated in order to achieve a correct neuronavigation thus it is possible to activate the tool calibration procedure
37. bort button on the lower left part of the window The Back Next pair of buttons can be used to navigate back and forth during the procedure in order to advance to the next step or to go back and change the parameters of the previous step NOTE In the first step of dataset creation the contrast for the image may not be optimized yet Don t worry if the image appears too bright or too dark it will be adjusted automatically on the next step NOTE It is quite common that the image planes could appear in an inverted order like shown in Illustration 22 where the sagittal and axial views are inverted You will learn in this chapter how to correct this probem 6 4 2 New dataset step 2 By clicking on the next button you will be guided to the step 2 of the dataset creation as shown in Illustration 22 At this step it is possible to adjust the orientation of the MR views Sagittal Coronal and Axial in order to correct the image s planes and the left right orientation in this case please refer to chapter 6 1 1 Acquiring MR images and the to the use of a visible MRI marker SofTaxic Neuronavigation System 3 0 48 T SofTaxic Optic 3 0 20 30 New dataset 2 4 2D 3D View Scalp i h rientation a rientation Image cleansing choose orientation choose orientation Slice selector E3 nm s 229 Re orient by labels N Invert L R C 182 Ss Input window 0 13388 A 170 Threshold core ase
38. cting or disconnecting cables Failure to do so may cause damage to the equipment Serial Number Label The serial number label is located on the bottom of the Position Sensor and shows the Item ID model serial number and manufacture date of the Position Sensor SofTaxic Neuronavigation System 3 0 21 Audio Codes In addition to the indicator LEDs the Position Sensor emits audio tones to alert the user to events The codes are interpreted as follows e Two tones are emitted on reset or when power is applied to the Position Sensor e If the host computer does not send a command to the system within a given time the Position Sensor will emit two quick tones every three seconds Shock sensor The position sensor also houses a shock sensor which detects whether the position sensor has received a shock of a greater intensity than the threshold limit value If a bump is detected above this threshold the error LED on the Position Sensor will flash indicating that a non critical error has been detected The bump sensor circuit derives its power from an internal battery that has an operational life of approximately 10 years As the battery begins to lose power the battery alert flag will be set intermittently The Position Sensor must be returned to factory to have the battery replaced Ingress Protection The Position Sensor is designed to an ingress protection level of IP 54 The 5 denotes that the Position Sensor is p
39. e set intermittently SofTaxic Neuronavigation System 3 0 24 The Position Sensor must be returned to factory to have the battery replaced Ingress Protection The Position Sensor is designed to an ingress protection level of IP 54 The 5 denotes that the Position Sensor is protected against dust The 4 denotes that the Position Sensor is protected against liquid sprayed in all directions To maintain an ingress protection level of IP 54 the Position Sensor cable attached to the Host USB Converter must be plugged in SofTaxic Neuronavigation System 3 0 25 3 3 Host USB Converter The Host USB Converter provides the interface between the Position Sensor the power adapter and the host computer The attached Position Sensor cable connects the Host USB Converter to the Position Sensor The communication between the Host USB converter and the PC is handled by a serial protocol speed 9600 bps hardware handshake 8 bit no parity stop bit The power adapter and USB cable plugs into the Host USB Converter Position Sensor Cable Indicator LED Error D lt Indicator LED r Power Power Connector cece Mounting Feet x 3 j f Sd Cable Covers Po top and bottom Z LS USB Connector Illustration 9 Host USB converter The Host USB Converter incorporates the sub assemblies detailed below Cable Covers Two covers top and bottom that are secured together by means of thumbscrews The cove
40. e the pointer is directed to an area outside the subject s head the missing information will be reported by a series of SofTaxic Neuronavigation System 3 0 71 head eow head tracking Position x 144 y 211 z 160 Target scalp x y z Target brain x y z Illustration 56 Head tracking status The navigation summary is reprented in Illustration 55 ritght after the title is showed the current navigation modality capturing mode navigation mode the selector for switching between the two modes and finally the list of acquired points Each row in the table represent a recorded location and in every column is represented the tool used to mark that location e Sty The stylus item was used to record the position e Col The first coil was used to record the position e Co2 The second coil was used to record the position Man the user manually marked the postuion using the mouse over the navigation viewport capturing mode Points Items Capture Navigation sty col co2 man P1 P2 P3 P4 P5 P6 P7 pe Illustration 57 Neuronavigation summary Clicking on each row in the table the location details will be displayed in the lower part of the Neuronavigation summary as in Illustration 56 for each location it s assigned a unique ID the location s coordinates will be reported either in the MRI space x y z either in Talairach s space Xt
41. ean the illuminator filters and lenses using a commercial lens cleaning solution formulated for multi coated lenses for example AR66 and a clean knitted microfibre optical cleaning cloth for example Hitecloth Avoid prolonged contact between the lens cleaner and the illuminator filters and lenses 10 2 Cables and connectors To avoid damage to cables make sure the cables are not bent at sharp angles CAUTION Make sure that mains power is disconnected before connecting or disconnecting cables Failure to do so may cause damage to the equipment SofTaxic Neuronavigation System 3 0
42. er CAL MAG 3910 to be used with the Magstim coil model AIR FILM COIL 3910 Calibration platform part number CAL MGV 0G B70 to be used with the Magventure coil B70 Calibration platform part number CAL M amp M 510523M to be used with the Mag amp More coil model 510523M Table 7 Coil calibration platforms SofTaxic Neuronavigation System 3 0 31 4 SofTaxic System Installation This chapter describers the steps to take in orther to setup the system including the connections of the various components and the software setup 4 1 Precautions Different devices in the same area as the patient must be at the same earthing connection potential Specific care must be taken when connecting several devices to a patient or when the devices are connected together The leakage currents of a particular device might add up and exceed the normal threshold value 4 2 Hardware and software Prerequisites In order to properly function the Softaxic Neuronavigation System software must be installed on a personal computer not supplied which must meet the following minimum technical characteristcs Hardware requirements e Intel multi core CPU at least Intel Core i3 or higher e 4GBRAM e 300 hard disk e Video adapter with OpenGL hardware support and 1GB dedicated memory e Recommended screen resolution at least 1600x900 e 20inch LCD display or better Software requirements The Softaxic Neuronavigation System has been d
43. er aa Position Sensor Cabl USE Cable Position Sensor Cable p F y Host USE conet A Host USB aiii Z Power Adapter Cable Power Adapter Gable x Power Adapter is To Computer Power Adapter USB Cable To Mains Power Illustration 3 Spectra position sensor Illustration 2 Vicra Position sensor p p The position sensor is the main hardware component of the SofTaxic neuronavigation system the system can support two different models the Polaris Vicra digitizer and the Polaris Spectra digitizer The position sensor has a dual function 1 It emits infrared rays IR from its illuminator 2 It captures the light reflected from passive markers on the position indicators which are positioned inside the measurement volume This information is used to calculate the position and the spatial orientation of the abovementioned position indicators The following section will describe in detail the functionality of the two sensors SofTaxic Neuronavigation System 3 0 19 3 2 1 Polaris Vicra NDI POLARIS f r F k Fi Sensor Indicator LEDs 3 Sensor i F w r Iuminator Illuminator Illustration 4 Polaris Vicra front view In the anterior part of the position sensor there are Two emitter diodes the emitter diodes emit infrared light IR Two receivers the receivers each of which comprises a lens and a CCD sensor receive the infrared light reflected from the
44. ery 2 seconds Situation e The system beeps every 2 seconds during the co registration phase and the tracking unit icon shows a warning mark rah Solution 1 The stylus is not visible and a possible solution is to check via the Tool calibration window chapter 7 4 Item calibration the relative position of the head and stylus tools They should be at the center of the acquisition volume 2 The reflective markers are damaged and cannot be seen by the tracking device In case solution 1 does not work you should try to change the markers on the stylus 8 3 License code missing Situation e The system cannot load the license code and runs in DEMO mode for a limited period of time During the demo mode it will report how many days are left before expiration as in Illustration 65 after that time the software will not work if you don t provide a valid license key Solution Contact your local Softaxic representative or EMS technical support Additional keys are available at extra charge SofTaxic Neuronavigation System 3 0 78 S License This software js running in demo mode it will expire in 31 days To obtain a valid license file please contact the software producer Activation Key 46C0D WDUA DOIN CCNC YEGU CH2FPMN ES Sistemi Elettromedicali MS gt via G Cenen 13 40138 Aologne hitte wwwemsmedical met Illustration 65 DEMO mode 8 4 Registration problems Situation e The head registratio
45. esigned and tested to run on the following operating systems Windows XP Windows 7 4 3 Unpacking the system The system SofTaxic Optic SofTaxic Opticis shipped with a position sensor a mounting stand a Host USB Converter a power adapter cables the SofTaxic System CD and documentation When unpacking the SofTaxic Optic SofTaxic Optic be sure to handle all system components with care Keep SofTaxic Neuronavigation System 3 0 32 the packaging in good condition you will need to use it if the system ever needs to be returned for repair Carefully open the packages containing the various components See list of components chapter 3 1 Table 3 Perform a visual check on the material received to make sure that it is not damaged Be sure to keep the shipping and delivery documents and the software license in case you need to return the goods owing to damage 4 4 Operating enviroment In order for the SofTaxic Optic SofTaxic Optic system to operate correctly the system must be set up in an environment that meets the following criteria e There must be a clear line of sight between the position sensor and the postion indicator to be tracked The position indicator must be inside the characterized measurement volume e Make sure that sources of background IR light in the 800 nm to 1100 nm range e g sunlight some operating room lights are minimized The Position Sensor is sensitive to IR light Since the Position Sensor fu
46. ime you acquire a new dataset from a MR scanner ensure to use a MR visible marker as suggested in chapter 6 1 1 Acquiring MR images6 1 1 Acquiring MR images in order to correctly distinguish the left right side of the subject on your dataset After the selection of the desired data file a guided procedure will show up like the one shown in Illustration 21 Softaxic Optic 3 0 2D 3D e ga New dataset 1 4 2D 3D View Scalp Slice selector EJ Subject informations n _ n 224 ELAI I 0 en ee sy Fev au TA KA 8 A Dataset name 7 _ aie 6 i y 20130327 114926 FER ra C 128 A 128 Surname Age years 0 View params E3 Weight Kg 0 00 item s opacity 5 0 Overlay none MRI values Distance map EEG map Radar params E Max dist mm 8 0 Max radius deg 10 0 Abort Next gt OK Loading file 020130301_164526CefaleaBonos004a1001A completed lt gt gt 0 Illustration 23 New dataset step 1 SofTaxic Neuronavigation System 3 0 47 6 4 1 New dataset step 1 The dataset name is automatically generated it may contain the subject s name if the MRI data header contains such information The user can choose to fill the Name Surname and other demographic data for the subject but that s optional and can be left blank During all the steps it is always possible to cancel the procedure by pressing the A
47. ing the BET2 The default method used by the SofTaxic Neuronavigation System is the BET2 Brain Extraction Tool v2 as described in the technical report published on the FMRIB centre web site The principal parameter of this procedure is the choice of a centre of gravity the system will suggest a preferred position computed based o the intersection of N A1 A2 In general a good choice could a point be near the corpus callosum The parameters smooth and radius are used to filter the 3D model once the brain is extracted by the BET2 algorithm 1 http www fmrib ox ac uk analysis research bet 2 The technical report can be fond at http www fmrib ox ac uk analysis research bet resolveuid 1a260f0e7aa608d9c9f5268ee012552e SofTaxic Neuronavigation System 3 0 54 Once the brain has been extracted a 3D model reconstruction of the subject s brain will be displayed in the lower left quadrant of the window like in Illustration 28 Like for the scalp the brain model can be rotated with the use of the mouse and you can switch now between the following views accessible by the buttons on the upper left part of the window 2D 3D displays only the 3D model Scalp select the scalp 3D model Brain select the brain 3D model i SofTaxic Optic 3 0 2 30 New dataset 3 4 2D 3D View Brain Slice selector BET2 extraction S 229 ae C 107 A 1195 E View params amp Item s opacity 5 0
48. mirror image of another tool s marker geometry is not SofTaxic Neuronavigation System 3 0 41 considered unique e Each tool has its own local coordinate system This is defined during the tool characterization process and is often dependent on the tool s intended use 5 1 1 Position indicators definition files The digitizer manufacturer provides the definition files for the position indicators used The Tool definition file has a rom extension and describes its spatial characteristics 5 1 1 Passive sphere markers The passive sphere markers have a retroreflective coating that reflects IR light back to its source instead of scattering it As such the IR light from the Position Sensor illuminators reflects off the markers directly back to the sensors The SofTaxic System can report the positions of passive markers individually and calculate the position and orientation of tools that incorporate them The measured position is the centre of the marker When a passive sphere marker is attached to an NDI mounting post the centre of the sphere is located at the top of the mounting post SofTaxic Neuronavigation System 3 0 42 6 Using the SofTaxic Neuronavigation System This chapter gives instructions on how to use the SofTaxic neuronavgation System Do not install any software in the SofTaxic Neuronavigation System computer or change the BIOS Operating System settings WARNING The settings of the operating
49. ms Position x 216 y 337 z 169 Item coil1 es C 1120 Target scalp Calib stylus x y z A211 Target brain Reset TOE set Points to acquire View params amp stylus amp Focus point Right point tracking aE racking Handle point Position x 144 y 211 z 160 Target scalp Acquire point s x v z none Target brain Focus calibration error MRI values x ly z Old x 9 4 y 22 0 z 24 3 Distance map New x ly z EEG map Dist coil1 Radar params EJ coil1 Update item s calibration z Max dist mm 8 0 tracking Position x 182 y 263 z 150 Target scalp Max radius deg 10 0 x y z Target brain x y z Abort OK Saving session 20130327 152108 completed par H 0 Illustration 63 Item calibration SofTaxic Neuronavigation System 3 0 77 8 Troubleshooting 8 1 The coil or stylus tracking is not Situation e The tracking of the tool is not performed the Acquire point button is grayed out Solution 1 Check if the tracking unit icon Illustration 64 is green If not click on the tracker and it will initialize the connection with the tracking unit If the problem persists follow chapter 8 6 Polaris Tracking unit error codes 0 LE i z Illustration 64 Tracking unit status 8 2 The systems beeps ev
50. n and the Best fit procedures fail to complete correctly Solution e For instructions on how to perform the registration refer to chapter 6 4 Initiating a new navigation session e Make sure the MR images are of good quality e Make sure the reference locations are clearly visible in the MR images e Try to perform the registration several times it is very important that the procedure completes with the lowest error as possible e See chapter 8 5 The tracking system does not see the tool in order to ensure proper functionality of the tracker 8 5 The tracking system does not see the tool Situation e The navigation system does not display the tracking tool and the LED of the stimulation coil stylus and or the head tracker Solution e Check that nothing is between the tracking system and the tool Since the tracking system is based upon a optical technology the line of sight of the Polaris unit must be clear e Check that other tracking tools are not visible the presence of other reflective markers except the ones supported by the SofTaxic system could interfere with the tracking e Check your tracking tools use Are you pointing them in the direction towards the tracking unit Does one of the tool cover the other SofTaxic Neuronavigation System 3 0 79 e Check the markers and replace worn out markers e Check the lighting Is a bright light interfering with the tracking system e Check the air
51. n be translated up down and left right On single click with the left mouse button on one of the four views lets you select a desired position and the location will be added in the table like in Illustration 55 under the last column man SofTaxic Neuronavigation System 3 0 73 Illustration 59 navigation viewport The navigation controls are displayed in the right part of the window the first set of controls is for the Slice selection Illustration 58 which can be used to select the desired slice to view in the 3 MRI planes Sagittal Coronal Axial Slice selector E S 259 C 114 AD 215 Illustration 60 Slice selector The second set of controls is used for controlling the radar parameters see 7 3 2 Navigation navigation mode for details the accuracy of the tool positioning over a recorded location is controlled by its parameters an example if shown in Illustration 59 SofTaxic Neuronavigation System 3 0 74 Radar params E Max dist mm 8 0 _ Max radius deg 10 0 Illustration 61 Radar parameters The last set of controls is used to regulate the viewport options you can choose the transparency of the displayed items stylus and coils in order to be able to view the brain model without cluttering The Follow stylus option is used to automatically rotate the subject s head View params x Item s opacity 5 0 Follow stylus Overlay
52. n the right window area You can adjust the sensitivity of the target location either expressed as the distance from the target either as the angular distance of the coil orientation The Capture modality allows you to capture new locations with one of the available methods stylus coil 1 coil 2 and manual Pressing the Acquire new button the system will capture and save the locations of all the visible items in the acquisition volume of the position sensor SofTaxic Neuronavigation System 3 0 61 2 30 9 head amp Neuronavigation 2D 3D View Brain Slice selector capturing mode S 229 tracking Points Items osition 4 Pi x 144 y 211 z 160 Capture Navigation c 107 Target sca lp sty co1 co2 man x y Target brain x y Iz A 195 View params d B Item s opacity 5 0 Follow stylus Overlay none MRI values Distance map EEG map Radar params amp Max dist mm 8 0 gt Position mE Max radius deg 10 0 gt Import Export lt Back Abort OK Computing best fit 2nd step completed oh gt 0 Illustration 42 Capture mode displaying the brain 3D model and the MRI planes Via the toolbar it is possible to switch from the 2D 3D view configuration the former is shown in Illustration 40 in this view it is still possible to switch to Scalp Brain mode and to Navigation capture mode capturing mode
53. na nat dates 39 5 L POSITIORIAOEALOS en entendent AN 37 5 1 1 Characteristics of the position indicators ss 37 5 1 1 Position indicators definition TUES ss siennes nenenetieinenieelsieiientes 38 2 LL Passive sphere Markers Ad ed ne dla tite Grille 38 6 Using the SofTaxic Neuronavigation System 39 6 1 Prerequisites for using the SofTaxic Software 39 ed ACQUIS IVER TIM ACCS n a a E 40 6 2 Staring the S tTaxic SOWAT dt ec 42 6o Man ApphCdtion WIRCOW sorena a E N E rs 42 SofTaxic Neuronavigation System 3 0 64 Loads anew SUDE iorsin a ene a te let sen et ete ne etes anaes 43 G34 AINGW TASSE a ne a db a nn 43 0 4 2 New dataset Step 2na A MR E 44 6 43 NENEAATASCE Step rare encre a ere da a tee mt ind 47 6 45 INOW AAA SOA at del mi irotiioiihence 50 6 4 Initiating a new navigation SESSION ni esters nantes net etes esse ol OSa AVG ANS SUD CE sg dic dd A A 56 06 LOOrCa Drao rii tort dti tert guaeatoaterenteaieeioteatertnestisaadedes 61 7 SOU TAXIC SySterm USER IMTELACES no dia 62 LL Mi ADP CAUOM W WAG Waruna nn Nue a ton moine io 62 PA Dataset ereat on U easken O unset sneeatwasteseeetee nese eset eoseun te 63 VD NVC aO U osae A TEET A TO TE A EE 67 Aol NAVIGON Capturing MOU seai E NEET E wens teamimasiatenoussasies 67 7 a 2 Navigation navigation MOd E E detente a Na 72 FATE Cal D Fall oeae a A OE D ein nitrie 73 D TToOubDIESRNOOUNE seeria A tee ae 74 Del Ne COMOF Sus tacking 15 DOC RU CR
54. nctions by detecting IR light reflected from or emitted by markers other sources of IR light can interfere with the SofTaxic Optic SofTaxic Optic e Make sure that there are no large reflective surfaces within the field of view e Make sure that the tools do not have flat reflective surfaces which can cause reflections that may interfere with the SofTaxic Optic SofTaxic Optic e The system requires a warm up time from storage temperature to operating temperature equivalent to 10 minutes plus one minute for every 1 C of difference between storage temperature and operating temperature If the temperature difference is within 5 C the warm up time will be 10 minutes e The operating environment is as close as possible to 20 C 4 5 Operating enviroment The software installation consists of a guided installation procedure To install the software for the Softaxic Neuronavigation System follow the instructions that appear after inserting the software CD in the reader If the autorun feature of the OS is disabled you must manually explorer the contents of the software CD and execute the installation procedure SofTaxic 3 0 Setup The default installation path for the software is C Program Files SofTaxic 3 0 SofTaxic Neuronavigation System 3 0 33 4 6 Installing the USB drivers Windows The Windows driver model consists of two parts low level USB and high level virtual serial port It appears as a Windows serial
55. oning mode S 157 j tracking Points Items Position x 144 y 211 z 160 Capture Navigation c 120 Target scalp sty co co2 m Penn X P1 A 211 Target brain P2 eS ly es View params amp stylus GE es PS item s opacity 5 0 stylus P6 trackin Position i Fy Follow stylus x 73 y 120 z 213 P8 a 4 Target scalp 6 4 Overlay none x 66 y 119 z 218 Target brain 8 x 78 y 120 z 210 x _ 78 6 y 120 3 z 2113 x _00 y 00 z 0 0 Notes Shared Import Export lt Back Abort OK Computing best fit 2nd step completed oh gt 0 Illustration 41 Brain navigation The 3D view displays the brain s model in the lower part of the central area of the window On the left part of the window you can find the tool items needed to monitor the visibility of the stylus and of the coil and their position relative to the subject s head The other tools on the right area of the window are used to control the visualization of the data selection of a particular MRI slice or controlling the visualization transparency of the coil over the brain The Circles over the green background are called Radars and are used to precisely position the coils over a location of interest They are active only when the Navigation modality is active The parameters used to control the accuracy of the repositioning of the coil via the Radar Params tools o
56. or multi coated lenses for example AR66 to clean the Position Sensor Other fluids may cause damage to the illuminator filters Do not use any paper products for cleaning Paper products may cause scratches on the illuminator filters WARNING Do not handle the passive sphere markers with bare hands as this will leave residue from skin that affects the marker s reflectivity Take care not to drop or scuff the markers as this also affects the reflectivity of the markers WARNING Do not use the SofTaxic Neuronavigation System in the presence of flammable materials such as anaesthetics solvents cleaning agents and endogenous gases Flammable materials may ignite causing personal injury or death WARNING Do not transport or store the Position Sensor outside the recommended storage temperature range as this may cause the system to go out of calibration Reliance on data provided by an out of calibration Position Sensor may lead to inaccurate conclusions and may cause personal injury A calibration procedure must be performed before using the Position Sensor after it has been transported or stored outside the recommended storage temperature range WARNING Do not protect or shield either the Position Sensor or tools with methods not approved by the manufacturer Non approved methods will interrupt the optical path and degrade the performance of the system Reliance on data provided by a Position Sensor without an uninterrupted optical pa
57. pdate item s calibration button The procedure can be repeated for the coil 2 in the same way you just have to use the coil 2 tool SofTaxic Neuronavigation System 3 0 65 7 SofTaxic System user interface 7 1 Main Application Window gt New subject gt Open subject Creates a new dataset by importing the MRI from file Opens an existing dataset from repository DICOM Analyze NIFTI gt Estimated MRI Creates a new dataset by adapting empirical data gt Open session Opens an existing session From repository Illustration 48 Main application Window The main software windows of the SofTaxic Neuronavigation System has been structured in three logical areas e Dataset dedicated to manage the MR data for the subject in involves the import of the images from various formats creating ann estimated MRI dataset using a probabilistic model or opening an existing subject s repository file e Neuronavigation the actual neuronavigation activity is recorded in a session the user can start a new session or loading an existing session for data review the session contains all the spatial data recorded during the neuronavigation e Maps the last area covers the visualization tools needed for advanced data plotting SofTaxic Neuronavigation System 3 0 66 7 2 Dataset creation UI o SofTaxic Optic 3 0 20 3 9 amp New dataset 1 4 2D 3D View Scalp Subject informations Dataset name 20130327
58. read tripod mount that incorporates three M3 x 0 5 mm x 8 mm threads Connector LEMO A 14 pin connector that provides power to the Position Sensor and allows communications to from the Position Sensor Manufacturer s labels Note It is good practice to disconnect mains power before connecting or disconnecting cables Failure to do so may cause damage to the equipment Serial Number Label The serial number label is located on the bottom of the Position Sensor and shows the Item ID model serial number and manufacture date of the Position Sensor Audio Codes In addition to the indicator LEDs the Position Sensor emits audio tones to alert the user to events The codes are interpreted as follows e Two tones are emitted on reset or when power is applied to the Position Sensor e Ifthe host computer does not send a command to the system within a given time the Position Sensor will emit two quick tones every three seconds Shock sensor The position sensor also houses a shock sensor which detects whether the position sensor has received a shock of a greater intensity than the threshold limit value If a bump is detected above this threshold the error LED on the Position Sensor will flash indicating that a non critical error has been detected The bump sensor circuit derives its power from an internal battery that has an operational life of approximately 10 years As the battery begins to lose power the battery alert flag will b
59. rotected against dust The 4 denotes that the Position Sensor is protected against liquid sprayed in all directions To maintain an ingress protection level of IP 54 the Position Sensor cable attached to the Host USB Converter must be plugged in SofTaxic Neuronavigation System 3 0 22 3 2 2 Polaris Spectra si minator si minator Indicator LEDs 3 Sensor stration 7 Polaris Spectra front view In the anterior part of the Spectra position sensor there are Two emitter diodes the emitter diodes emit infrared light IR Two receivers the receivers each of which comprises a lens and a CCD sensor receive the infrared light reflected from the position indicators passive markers Indicator LED Three LEDs that provide the following indications left to right Flashes green during system warm up Steady green when system is ready for Power LED mors D Steady green when the communications connection is available Status LED I Lights steady amber if a critical error is detected Position Sensor must be returned to factory Flashes amber if a non critical error is detected for example Error LED a firmware update is not completed Table 5 Polaris Spectra LEDs SofTaxic Neuronavigation System 3 0 23 SerialNumber Mount Connector Label Ilustration 8 Polaris Spectra rear view The rear of the Position Sensor incorporates the components detailed below Mount 1 4 th
60. rs retain the USB and power adapter cables in place Position Sensor Cable Provides connection for data and power between the Position Sensor and Host USB Converter This cable is permanently connected to the Host USB Converter and is either 4 5 m or 8 m depending on the configuration of your system Power Indicator Lights green when power is applied to the Host USB Converter Error Indicator Lights amber when the Host USB Converter has detected a fault Mounting Feet Three feet that incorporate an internal thread M6 x 1 mm pitch x 4 mm depth to allow the Host USB Converter to be attached to an external structure for example a cart Serial Number Label SofTaxic Neuronavigation System 3 0 26 ITEM ID amp 700336 001 001 MODEL Polaris USB Converter 4 5m cable MFG DATE September 2005 The serial number label is located on the bottom of the Host USB Converter and shows the Item ID model serial number and manufacture date of the Host USB Converter 3 4 Power adapter The system is powered by a power adapter which connects to the mains supply and provides DC power to the Position Sensor via the Host USB Converter 3 5 Cables Additional cables are supplied for use with the system Position Sensor Cable Provides connection for data and power between the Position Sensor and Host USB Converter This cable is permanently connected to the Host USB Converter and is either 4 5 m or 8 m depending on the configura
61. rter error LED fault chart Fault cleared Replace tracking umt SofTaxic Neuronavigation System 3 0 81 10 Maintenance The user s system maintenance operations are limited to the following procedures e Cleaning the Position Sensor e Care of cables and connectors The Position Sensor is the only system unit that requires special consideration The power adapter and Host USB Converter can be cleaned by following standard procedures 10 1 Maintenance Warnings Before carrying out any type of maintenance on the position sensor read the following warnings gt gt bP gt WARNING Any maintenance must be carried out by adequately trained personnel The individual components of the position sensor do not contain any parts which can be maintained by the user Any maintenance performed by untrained personnel carries the risk of an electric shock WARNING Do not use the Position Sensor without inspecting it for cleanliness and damage both before and during a procedure Reliance on data provided by an unclean or damaged Position Sensor may lead to inaccurate conclusions If your application involves personal safety inaccurate conclusions increase the possibility of personal injury WARNING Do not immerse any part of the Polaris Vicra System or allow fluid to enter the equipment If fluids enter any part of the system they may damage it and present a risk of personal injury WARNING Do not sterilize the Position
62. software packages TMS Transcranial Magnetic Stimulation rTMS Repetitive Transcranial Magnetic Stimulation Table 1 Terms and abbreviations SofTaxic Neuronavigation System 3 0 SofTaxic Neuronavigation System 3 0 1 3 Labels and symbols Table 2 describes the labels used in the product and documentation Label or symbol Description CE Conformity mark as per Directive 93 42 EC on medical devices Read carefully This symbol indicates a special note or something very important that must absolutely be read r EH rbk 1 SPA E faa This symbol indicates that the word about to be described is a term used in Windows This symbol indicates a warning warning tells the user to take particular precautions to provide for the product s safe and efficient use and to prevent potential damage to the product Attention read carefully the documentation attached to the product This symbol indicates a danger that informs the user of a potential hazard to the operator s or subject s health A yi Symbol according to European Community directive 2002 96 EC on Waste Electrical and Electronic Equipment WEEE Serial number Manufacturer A Laser radiation K only Dispensing pohibited without prescription Federal law USA restricts this device to sale by or on the order of a physician Table 2 labels used in the product and documentation wa
63. stem emits IR light that may interfere with IR controlled devices such as operating room tables It is recommended not to use the SofTaxic Optic System in such circumstances WARNING Do not supplement the SofTaxic Optic system with components which are not expressly indicated by the manufacturer The accuracy of results produced by applications using different components with the SofTaxic Optic system is unknown If SofTaxic Neuronavigation System 3 0 14 the application involves personal safety the reliability of these results could increase the possibility of causing physical injury SofTaxic Neuronavigation System 3 0 15 2 3 Cautions Attention to avoid the risk of physical injury read these warnings before using the SofTaxic Neuronavigation System DANGER The improper use of the SofTaxic Neuronavigation System is forbidden DANGER This system is not equipped with alarms appropriate for the monitoring of a subject s clinical parameters where it is necessary to warn the user of situations which might lead to the subject s death or to serious deterioration of his her health DANGER Before using SofTaxic Neuronavigation System make sure that the power supply cables and the connecting cables are in perfect condition If they are damaged do not use the system under any circumstances DANGER Before using SofTaxic Neuronavigation System make sure that the power mains comply with the relevant safety
64. system have been set by the EMS company to optimize the performance of the neuronavigation software Changing the settings may affect the functionality of the SofTaxic software Third party software can cause unexpected malfunctioning of the SofTaxic software EMS takes no responsibility for malfunction if such software has been installed NOTE When using the SofTaxic software never use other programs simultaneously Never use the CD writer simultaneously with the SofTaxic software 6 1 Prerequisites for using the SofTaxic Software Before you can use the SofTaxic Neuronavigation System you need to acquire and setup the MR images of the patient There are two possible ways to proceed 1 Importing the patient s images acquired by a MR scanner 2 Building a probabilistic set of MR images for the patient This chapter will describe the requirements for correctly importing the MR data into the system The procedure of building a probabilistic head model for the subject s head is described in the chapter XX SofTaxic Neuronavigation System 3 0 43 6 1 1 Acquiring MR images When you acquire the MR images from a scanner please ensure good quality images comprising of the whole head so that ears nose and the head surface are all clearly visible Preferably use an MRI visible marker on one side while acquiring the MR images NOTE Do not use visible hearing protection inside the MRI WARNING in some cases the actu
65. taset by adapting empirical data A 0 View params SRE Opens an existing session from repository item s opacity 5 0 Overlay none Maps ca Distance map EEG map Radar params amp Max dist mm 8 0 l Max radius deg 10 0 _ Illustration 22 Soflaxic Main Window The main software windows of the SofTaxic Neuronavigation System has been structured in three logical areas e Dataset dedicated to manage the MR data for the subject in involves the import of the images from various formats creating ann estimated MRI dataset using a probabilistic model or opening an existing subject s repository file e Neuronavigation the actual neuronavigation activity is recorded in a session the user can start a new session or loading an existing session for data review the session contains all the spatial data recorded during the neuronavigation SofTaxic Neuronavigation System 3 0 46 e Maps the last area covers the visualization tools needed for advanced data plotting 6 4 Loading a new subject When you have the MRI data for the subject ready you can click on the New subject menu item from the main windows and browse for the data files The system can read natively the DICOM Analyze and NifTY file format please refer to chapter 6 1 1 Acquiring MR images6 1 1 Acquiring MR images WARNING The DICOM file format has no indication of the left right side of the subject therefore the first t
66. ted using the mouse by left clicking on the head and moving the mouse in the desired direction By clicking the 3D button on the upper left of the window the 3d view will be maximized like in Illustration 24 6 4 3 New dataset step 3 The step 3 requires the individuation of 3 reference locations on the subject s scalp Nasion N pre auricular left A1 pre auricular right A2 This locations must be taken in visible locations that can be easily identified on the real life subject It is very important to be as accurate as possible in the selection of these locations since it will affect the accuracy of the whole neuronavigation The system will automatically switch to the 3D model view in order to display the subject s head in greater detail During the selection of the location you can go back and forth between one location and another SofTaxic Neuronavigation System 3 0 ol m no SofTaxic Optic 3 0 2D 3D e New dataset 3 4 3D View Scalp Slice selector E Craniometric reference points S 236 Reset E E c 203 N nasion x 118 01 y 203 00 z 136 00 Ee a A1 left preauricular View params E3 A2 right preauricular Item s opacity 5 0 A Overlay none MRI values _ Distance map _ EEG map Radar params amp Max dist mm 8 0 5 Max radius deg 10 0 ou Vv us Back __ Abort OK Computing overlay completed Illustration 27 New dataset step
67. th may lead to inaccurate conclusions If your application involves personal safety inaccurate conclusions increase the possibility of personal injury WARNING Radio frequency communications equipment including portable and mobile devices may affect the SofTaxic Optic system and result in personal injury WARNING Do not use cables or accessories other than those listed in this guide The use of other cables or accessories may result in increased emissions and or decreased immunity of the SofTaxic Optic System and may result in personal injury WARNING All user maintenance must be done by appropriately trained personnel Individual components of the SofTaxic Optic System contain no user serviceable parts Maintenance by untrained personnel may present an electric shock hazard SofTaxic Neuronavigation System 3 0 13 gt BE gt gt gt gt WARNING Do not sterilize the SofTaxic Optic Sensor as this may cause irreversible damage to its components Reliance on data provided by a damaged Position Sensor may lead to inaccurate conclusions If your application involves personal safety these inaccurate conclusions increase the possibility of personal injury WARNING Do not use the SofTaxic Optic Sensor without inspecting it for cleanliness and damage before a procedure WARNING Do not use the SofTaxic Optic System for absolute measurements the system is designed for relative measurements only
68. the geometric data of the position indicators contained in the definition file in order to identify the position indicator used Any marker deemed not to belong to a position indicator is considered casual The system has acquired the position and the spatial orientation of a certain position indicator when it is able to determine the position of the minimum number of markers required to establish its position and its spatial orientation 5 1 Position indicators The position indicators used are wireless and incorporate passive markers The system can track up to six indicators at the same time The position sensor can establish the position and spatial orientation of the position indicators based on the spatial position of its passive markers and on its geometric characteristics which are specified in the particular indicator s definition file 5 1 1 Characteristics of the position indicators The position indicators used in the neuronavigation system have the following characteristics e A position indicator with 6 DOF degrees of freedom has from three to six markers which are not colinear i e not on the same straight line For a 6 DOF position indicator the system will report the 3D position as well as the 3D orientation e The geometry of each tool must follow the unique geometry constraints Tools must have different marker geometries from one another so the Position Sensor can distinguish between them A marker geometry that is the
69. the scanner reconstruction algorithm removes noise and alters the image gray scale histogram Angulation e Positive and negative values may be used but must not be altered during the scan e Angulation should be less than 10 degrees Patient orientation Head first supine Make sure that the patient scalp is as smooth as possible no wrinkles in the skin caused by a headrest for example Image Save the MRI data on a CD ROM in uncompressed format compression Format NifTY format is recommended DICOM and Analyze formats are supported DICOM file meta Every DICOM file shall include identifying preamble information on the information encapsulated data set The DICOM file header consists of e a128 byte file pramble e a4 byte DICOM prefix e the meta file elements Table 8 MR image requirements SofTaxic Neuronavigation System 3 0 45 6 2 Starting the SofTaxic Software 1 Open the SofTaxic neuronavigation System computer and logon 2 Start the SofTaxic software 1 by clicking on the SofTaxic software icon on the desktop or 2 by selecting All Programs gt Softaxic Neuronavigation System gt SofTaxic 3 0 6 3 Main Application Window v o SofTaxic Optic 3 0 Slice selector S O gt New subject gt Open subject Creates a new dataset by importing the MRI from file Opens an existing dataset from repository clo DICOM Analyze NIFTI i gt Estimated MRI Creates anew da
70. tion of your system USB Cable Provides connection for data between the host computer and Host USB Converter This cable is a USB A B male double shielded 5 m cable Power Adapter Output Cable Provides connection for power to the Host USB Converter This cable is permanently connected to the power adapter and has a plug in jack connector to connect to the Host USB Converter Power Adapter Power Cable Connects the power adapter to the mains supply This cable is a medical grade AC line cord SofTaxic Neuronavigation System 3 0 3 6 Position indicators A position indicator consists of a rigid structure with 4 reflective passi it The digitizer can determine the position and spatial orientation c situated within its measurement volume based on the particular geom themselves A maximum of 6 position indicators may be used simultan For each position indicator it is necessary to have the relevant geo described in specific files called ROM provided by the manufacturer The external surface of the position indicators passive sphere markers is made of material which reflects the IR light emitted by the illuminators located on the position sensor Table 6 Position indicators SofTaxic Neuronavigation System 3 0 28 3 7 Software CD SofTaxic C Optic V 3 0 E MLS s r l Via G Ceneri 13 40138 Bologna Italy Tel 051398925 Fax 051342953 WEB http 3 ical n e mail Illustration 10 SofTaxic sof
71. tre metric scale is used The position indicators spatial orientation the spatial orientation of each position indicator used is provided An error value the system returns an error value for each position indicator used This RMS value supplied in mm is the result of the smallest quadratic reduction between the geometry of the marker in the file defining the position indicator and the measured positions of the position indicator s marker Information about the status of the position indicators for each position indicator used the system returns information relating to its position with respect to the measurement volume The origin of the arbitrary reference system established by the digitizer is localized in the position sensor itself and the axes aligned as shown in the figure below This main reference system is defined during manufacture and cannot be changed Origin f Illustration 17 Main reference a Illustration 18 Main system position Vicra ai reference system position Spectra The digitizer s measurement volume represents the portion of space within which the digitizer is able to establish the position and spatial orientation of a position indicator with a precision of 0 25 RMS root mean square The precision of the measurements performed outside the measurement volume is not known The extent of the measurement volume depends on the particular optical digitizer model used SofTaxic Neuronavigation System 3 0
72. tware installation CD The CD contains the software required to install the product on a personal computer 3 8 Position Sensor Stand The position sensor stand consists of a supporting base on which the telescopic rod is fitted the rod is provided with sensor support and clamping screws for fixing the sensor Place the stand base on a firm flat horizontal surface SofTaxic Neuronavigation System 3 0 29 3 9 Calibration platforms The calibration platforms are made of Plexiglas and are provided with notches to house both the stimulation coil and the Stylus There is a specific calibration model to match the coil intended for use The part number is screen printed onto each platform The characteristics of any other calibration platforms may be seen on the internet site softaxic com the current calibration platform available are listed in Table 7 Calibration platform part number CAL MAG 9925 to be used with the Magstim coil model 9925 Calibration platform part number CAL MAG 9925 1 to be used with the Magstim coil model 9925 Calibration platform part number CAL M amp M 510519M to be used with the Mag amp More coil model 510519M Calibration platform part number CAL MGV 01 to be used with the Magventure coil SofTaxic Neuronavigation System 3 0 30 Calibration platform part number CAL MAG 40MM B to be used with the Magstim coil model 40 mm Calibration platform part numb
73. uricolar A2 right preauricolar View params E3 Distance gaps Item s opacity 5 0 N A1 iz ee N A2 cqui Overlay 7 none p _ MRI values firs J Distance map _ EEG map Radar params amp Max dist mm 8 0 Z Max radius deg 10 0 Best lt Back Abort OX LY L OK Loading dataset 20130327 114926_AVERAGE_JOE completed Cr 0 Illustration 33 Neuronavigation subject co registration After taking the Nasion location the system will ask for the left pre auricular point A1 While you move the stylus the system will inform you about the current location and the expected Al s location changing the color of the label N A1 Illustration 30 When the label is green with an accuracy of 2 mm you have located the right spot on the subject Illustration 31 SofTaxic Neuronavigation System 3 0 56 Z Overla z no D M lues Z D Distance mal P EEG ma p l Radar params E coil1 Max dist mm mi disabled aE mm jon x ly get scalp Max radius deg x y get brain x v PT OK Loading dataset 20130327 Illustration 34 Selecting Al the red label shows the location error After picking the 3 locations the system will calculate the distance gap between the A AT segment and the N A2 segment and display an estimated co registration error If the co registration error is acceptable under 5 mm you can
74. via the Tools Calibrate menu you can select which tool you want to calibrate and the type of calibration D G head w Calibration tracking Calibration Items Position x 216 y 337 z 169 Item coil1 Target scalp ly lz x y Target brain x ly lIz Points to acquire stylus amp Focus point stylus D Right point tracki TE Handle point Position x 144 y 211 z 160 Target scalp Acquire point x y z Target brain Focus calibration error x ly Old x 9 4 y 22 0 z 24 3 New x y z Dist coil1 amp coil1 tracking Position x 182 y 263 z 150 Target scalp x y z Target brain x y z Calib stylus Reset Abort OK Saving session 20130327 152108 completed Illustra tion 47 Tools calibration window Max radius deg 10 0 om 1 0 S The tools can be calibrated via a calibration platform see 3 9 Calibration platforms on page 29 or via a manual procedure The manual procedure can be applied to the coil tools only it consists of the following steps 1 2 4 Place the coil on a flat surface Next to the coil place the head reference item You sample the position over the coil of 3 points Focus Right coil wing Handle via the acquire point button Once you have selected the 3 locations you can click the U

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