Monteris Medical Neuroblate Instructions For Use Manual Download Page 156

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NeuroBlate® System Instructions for Use

80469 Rev D – Nov 16, 2018

- 156 -

11.

Contact Information

11.1.

ISTRIBUTOR

ONTACT

Monteris Medical Corporation

14755 27th Avenue North

Suite C

Plymouth, MN 55447

(763) 253-4710 / (866) 799-7655

[email protected]

11.2.

ANUFACTURED

Monteris Medical Corporation

14755 27th Avenue North

Suite C

Plymouth, MN 55447

(763) 253-4710 / (866) 799-7655

www.monteris.com

Summary of Contents for Neuroblate

Page 1: ...Instructions for Use ...

Page 2: ...ic 3 3 Directional Laser Probe 13 1 2 3 FullFire Optic Diffusing Tip Laser Probes 14 1 2 4 Laser Delivery Probe Selection 15 1 2 5 Advanced Probe Driver APD and Robotic Probe Driver RPD 16 1 3 OPERATING MODES 19 2 INDICATIONS FOR USE 20 3 CONTRAINDICATIONS 21 4 WARNINGS CAUTIONS SAFETY REQUIREMENTS 22 4 1 IDENTIFICATION LABELS 22 4 2 EQUIPMENT LABELS 23 4 3 GENERAL WARNINGS 25 4 3 1 Electronics Ra...

Page 3: ...d Plan 66 8 2 OPERATING ROOM PRE PROCEDURE PREPARATION 67 8 2 1 Sterile Probe Delivery Platform 67 8 2 2 Anesthesia 67 8 2 3 Head Fixation 67 8 2 4 Image Guided Surgery IGS System Registration Non Sterile 67 8 2 5 Prepping and Sterile Draping for Trajectory Guidance Devices 68 8 2 6 Image Guided Surgery IGS Registration Sterile 68 8 2 7 Laser Delivery Probe LDP Platform Attachment 68 8 2 7 1 Skull...

Page 4: ...25 8 8 2 2 Philips MRI Thermal Sequence Prescription Procedure 132 8 8 3 Initiate Thermal Monitoring in M Vision 135 8 8 3 1 For Philips MRI Only for all other MRI types skip to 8 8 3 2 135 8 8 3 2 Initiate Thermal Monitoring for all Other MRI Types 137 8 8 3 3 Initiate Delivery of Laser Energy to Tissue 142 9 ELECTRICAL RACK REQUIREMENTS AND TECHNICAL DATA 150 10 TECHNICAL SUPPORT 155 11 CONTACT ...

Page 5: ... Transfer Setup Begin Real Time Measurements Temperature Calculation Setup Ref Points Thermal Dose Monitoring End Lasing Move Patient from MRI Bore Remove Probe and APD Close Patient Move APD Probe Linear Travel Move APD Probe Rotation Remove AXiiiS Pre Planning Next Trajectory Next Probe Movement Linear NeuroBlate Procedure Overview Patient Placement in MRI MRI Trajectory Confirm Wand Procedure F...

Page 6: ...hich resides in an equipment area adjacent to the MRI containing the system control computers electronic hardware laser light source and CO2 cooling components MR Unsafe Control Workstation containing M Vision Pro Software A system workstation which resides in the MRI control area and includes a laser foot pedal keyboard mouse and display for the graphic user interface MR Unsafe NeuroBlate Advance...

Page 7: ...mm 5 259mm DTP 000 01 DTP 001 01 DTP 101 01 DTP 201 01 DTP 301 01 DTP 401 01 DTP 501 01 Gas cooled diffusing laser delivery probe LDP used to deliver thermal energy in all directions from the probe tip to the intended target zone The appropriate probe length is determined by the M Vision software 3 3mm Outside Diameter MRI Conditional 1 5T 3 0T Sterile Single Use Only FullFire Optic 2 2 Diffusing ...

Page 8: ... Sterile Single Use Only Instrument Adapter IA300 01 Set of three reducing tubes 1 9 2 2 and 2 6mm designed to guide neurosurgical devices Example a biopsy needle through the AXiiiS Stereotactic Miniframe Directional Interface MRI Safe Sterile Single Use Only MRI Trajectory Wand MW300 01 MRI visible fluid filled tube which when placed into the AXiiiS Stereotactic Miniframe allows confirmation of A...

Page 9: ...to 1 5T o Trio 3 0T o Espree 1 5T o Verio 3 0T o Aera 1 5T o Skyra 3 0T IMRIS NEURO II 1 5T or NEURO III 3 0T Siemens MRI software versions listed above GE minimum software version 12 X 15 X to 26 X o Signa HDx HDxT 1 5T 3 0T o Optima MR450 450W 1 5T o Discovery MR750 750W 3 0T o Signa Artist 1 5T software version 26 X using 16 channel GE Flex Coil Philips software version R3 R4 R5 o Achieva 1 5T ...

Page 10: ...o be co located in the MRI Control Room Figure 1 1 Typical Layout of the NeuroBlate System within the MRI Suite Figure 1 2 NeuroBlate Components in the MRI Environment MRI Scan Room MRI Equipment Room MRI Control Room Interface Platform Electronics Rack Control Workstation Laser Delivery Probe inserted into the Monteris Mini Bolt Probe Driver Mounted on Interface Platform Head Stabilized in AtamA ...

Page 11: ...ditional at 1 5T and 3T The Probe allows for gas cooling during simultaneous laser application and thermal imaging The LDP s are available in multiple lengths and configurations in two outside diameters 3 3 and 2 2 mm The appropriate length is determined during clinical use by the NeuroBlate M Vision software The appropriate probe configuration and diameter is determined by the physician depending...

Page 12: ...Cooling Probe Detection Figure 1 5 LDP Locking Interface and Depth Stop The Laser Delivery Probe Locking Interface attaches to the Advanced Probe Driver Follower the Robotic Probe Driver Follower or an appropriate skull anchoring device To remove the Ruler Protective Cover the green button on the Locking Interface is pressed to release it Figure 1 5 The Depth Stop Figure 1 5 is adjustable see doub...

Page 13: ... LDP can be visualized through the LDP lens An optical fiber terminates inside the lens at the Fiber Line tip and emits controlled laser energy in a uniform direction at approximately 78 degrees from the long axis of the SFP An integrated cooling line circulates CO2 gas inside the LDP tip to cool during laser delivery A fiber optic temperature sensor measures the temperature of the LDP tip and del...

Page 14: ...be The FullFire Optic 3 3 and smaller diameter FullFire Optic 2 2 Diffusing Tip Laser Probes are comprised of the same components and mechanical interfaces as the SideFire Optic 3 3 Directional Laser Probe The FullFire probe is differentiated by laser energy dispersion in all directions dimensions see representative red arrows in Figure 1 7 and emanating from a 6mm long emission area Figure 1 7 ...

Page 15: ...region The FullFire probe provides support for the ablation of symmetrical areas with a diffuse beam The SideFire probe allows conformal control of the ablation area FullFire probe may create a concentric ablation area If the target and path to target demands a smaller diameter probe the FullFire Optic 2 2 is a suitable LDP ablation tool The selection of a 2 2 probe follows the same considerations...

Page 16: ... APD and RPD Position Feedback Plug Figure 1 8 connects to the Interface Platform to communicate the Laser Delivery Probe s position in the brain to the system user interface The APD RPD rotates or translates extends or retracts the NeuroBlate Laser Delivery Probe The APD RPD provides linear translation of up to 40 mm and total rotation of 340 The APD and RPD is comprised of two components the Com...

Page 17: ...ring the procedure in two ways o Manual the knobs can be manipulated by pressing them in toward the main body of the Commander and turning knobs will not turn unless pressed in Blue knob controls linear translation Green knob controls rotation o Remote the knobs can be managed from the Control Workstation by manipulating the software rendered LDP in the graphical user interface GUI of the M Vision...

Page 18: ...o the Laser Probe during use Figure 1 10 Detail of APD Follower The RPD requires the use of a locking sleeve for attachment to an appropriate skull anchoring device Figure 1 11 illustrates how the RPD and the locking sleeve accessory attach to a skull bone anchor Figure 1 11 Details of RPD Follower and its attachment to a skull bone anchor Mounting Interface for AXiiiS Interface for AXiiiS Locking...

Page 19: ...avel and Laser b Sounds alarm The system is in Active mode if at least one essential function is activated as noted or at least one of the following Receiving files through the Ethernet connection Probe is cooling Probe via APD or RPD is in motion linear or rotary Laser is shown in Ready mode on the Control Workstation screen enabled for laser emission Laser is shown as Laser mode on the Control W...

Page 20: ...edical NeuroBlate System is intended for planning and monitoring thermal therapies under MRI visualization It provides MRI based trajectory planning assistance for the stereotaxic placement of MRI compatible conditional NeuroBlate Laser Delivery Probes It also provides near real time thermographic analysis of selected MRI images When interpreted by a trained physician this System provides informat...

Page 21: ... the NeuroBlate System Patients who are contraindicated for MRI including patients who may have contraindications due to implanted medical devices Patients who the physician determines are not appropriate candidates for laser interstitial thermal therapy LITT Patients who are not candidates for invasive surgical procedures in the brain ...

Page 22: ...rious hazard with the use of the device A causal relationship need not have been proved Symbols displayed on or in the NeuroBlate System and its documentation are 4 1 IDENTIFICATION LABELS MRI Unsafe item is NOT MRI compatible and is known to pose a hazard in MR environments This equipment should not be taken into the MRI room within the 5 Gauss perimeter line MR Conditional the item poses NO know...

Page 23: ...NeuroBlate System Instructions for Use 80469 Rev D Nov 16 2018 23 4 2 EQUIPMENT LABELS Dornier Laser ...

Page 24: ...NeuroBlate System Instructions for Use 80469 Rev D Nov 16 2018 24 NeuroBlate System ...

Page 25: ...welling seizures general weakness paralysis pain infection e g meningitis or surgical site infection bone fracture allergic anaphylactic reaction cardiac arrest or death The minimally invasive nature of the procedure may result in noticeable effects of edema swelling consider prophylactic steroid administration for all patients and use extreme caution in ablating targets greater than 20cc Increase...

Page 26: ...ient injury Ensure that all loaded image data contains the correct patient identification and image orientation markers prior to the commencement of the NeuroBlate procedure to ensure an unintended area of the brain is not targeted for thermal delivery which may lead to patient injury Failure to determine an accurate baseline temperature may result in inaccurate temperature monitoring and thermal ...

Page 27: ...late System s ability to monitor thermal dose which may lead to patient injury Never pull on the thinner tubular or cable sections of the laser cooling temperature sensor and probe detection lines as this may damage the components or cause unintended probe movement causing patient injury A non existent or weak visible laser aiming beam may be an indication of an improperly connected laser fiber If...

Page 28: ...an be brought into the MR room Any item marked by the symbol should NOT be brought into the MR suite within the 5 Gauss line Serious injury may result if any equipment which is MR unsafe is brought into the MRI suite 4 3 1 Electronics Rack Warnings The following are specific warnings that apply to the NeuroBlate Electronics Rack and Electrical Power Inputs WARNING Potential hazards may occur from ...

Page 29: ...ilization may also create a risk of contamination of the device and or cause patient infection or cross infection including but not limited to the transmission of infectious disease s from one patient to another Contamination of the device may lead to injury illness or death of the patient Ensure that all cables and umbilical in the vicinity of the MRI bore do not form loops as this may result in ...

Page 30: ...tives Failure to follow this guideline may result in improper performance and or damage to the equipment with potential to cause harm Use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous laser radiation exposure Replace damaged equipment If damage is found call your Monteris Medical representative Do NOT power ON the Interface Platfo...

Page 31: ...ation process the Yellow TDT lines should be kept an appropriate distance e g 1 3 mm from eloquent structures or functional white matter tracts i e corticospinal tract optic radiations arcuate fasciculus corpus callosum superior longitudinal fasciculus etc MVision Software supports import of diffusion tensor imaging data obtained using Brainlab neuro navigation software which may aid in monitoring...

Page 32: ... 2003 Irreversible injury may occur Under no circumstances may the retina of the eye or the skin be subjected to direct or reflected laser radiation Each person inside the laser area as described below must wear protective eyewear Two sets of protective eyewear are provided with every NeuroBlate System Contact Monteris Medical for additional protective eyewear Ensure the laser fiber connections ar...

Page 33: ...r so that one click at partial half insertion and a second click at full insertion Prior to Use Carefully inspect the Laser Delivery Probe and Advanced Probe Driver packages for any breach of sterile barrier or damage to the contents DO NOT USE if the sterile barrier integrity is compromised or contents appear damaged contact your Monteris Medical representative for replacement items The Laser Del...

Page 34: ... version R3 or higher Ingenia 1 5T and 3 0T minimum software version R4 or higher Spatial Gradient field of 700 Gauss cm or less Scan only with a maximum whole body averaged specific absorption rate SAR of 2 W kg Advanced Robotic Probe Driver rotary motion can be commanded by the user while the MRI is scanning using the Thermal Sensitive GRE pulse sequence Advanced Robotic Probe Driver linear moti...

Page 35: ...metry Diagnostic Imaging Sequences NeuroBlate Standby Allowed NA Allowed Active DICOM File Transfer NA Allowed Allowed Probe Cooling Disabled Allowed Disabled Probe Travel Linear Allowed Disabled Not Allowed Rotary Allowed Allowed Not Allowed Laser Ready Disabled Allowed Disabled Emergency Stop Engaged Allowed Allowed Allowed Diagnostic Imaging Sequences tested include Gradient Echo GRE Spin Echo ...

Page 36: ...on of the shaft of the probe and the images in the bottom row are perpendicular to these and at the location of the blue line shown in the top row The left most top and bottom images show the MR artifact from the probe and the right most images have a representation of the probe overlaid on the images for reference In order to successfully complete the Insert workflow step in a NeuroBlate procedur...

Page 37: ...D Nov 16 2018 37 Figure 5 2 Parallel top row and perpendicular bottom row MPRAGE 3T MR images near the distal end of the probe with a representation of the probe overlaid on the right most images 2 2 mm 3 3 mm 2 2 mm 3 3 mm 2 2 mm 3 3 mm 2 2 mm 3 3 mm ...

Page 38: ... or overdosing with thermal energy may result in patient injury and permanent neurological deficits Protracted patient immobilization may cause deep venous thrombosis DVT Inaccurate Laser Probe delivery to the intended target within the brain may result in hematoma embolic events bleeding or unintended major tissue damage Inserting the probe along the trajectory to the target tissue and or laser a...

Page 39: ...cuted on the MRI only when linear or rotary probe motion is NOT active During system installation the NeuroBlate Thermal Sequence a Gradient Recalled Echo GRE pulse sequence will be configured to the exact specifications required by the NeuroBlate System The following parameters for the given MRI system MUST be used for temperature monitoring Siemens MRI 2D FLASH TR TE Flip Angle Number of Average...

Page 40: ...grees 128 128 0 75 6 41 kHz Multi Phase Phases per Location Phase Acquisition Order Delay After Acq 170 Interleaved Minimum Acceleration Phase 1 00 Imaging Options ASSET Multi Phase Sequential For GE Signa MRI with v12 X or v26 X Software the configuration variables CV parameter values noted below must be entered manually prior to acquiring the NeuroBlate Thermal Sequence 2D FSPGR Parameter USER_C...

Page 41: ...ter Suppression Phase oversampling Dynamic Stabilization on 3T Coil Selection Dual coil CLEAR Shim Geometry Correction Imaging M2D FFE T1 27msec 19 1msec 30 deg 1 4 346 pixels 99 9Hz 2 175 pixels 99 9Hz 256mm 192mm 16mm 128x196 5mm 0 25mm 1 Parallel Interleaved 3 128 2 mm 3 512 maximum 10000 8 2 sec No 1 M 2 P 3 no None 0 Enabled SENSE Flex L No No Volume Default 2D Note With Philips Flex L coils ...

Page 42: ...straints o Localizers or Surveys these are not needed for NeuroBlate setup and should not be transferred o Dual Echo sequences these sequences produce two image data sets within the same series folder T2 and Proton Density weighted at identical positions and orientations If these are used for T2 weighted images only copy the desired image subset MRI scan execution should only be done when linear o...

Page 43: ...tem use Slide the CO2 Line Yoke over the Tank Valve and align the two fingers protruding from the inside of the Yoke with the two holes on the Tank Valve Tighten the CO2 Line Yoke T Handle clockwise using the Tank Valve Wrench attached to the wire tank holders on the Electronics Rack to ensure an airtight connection Again using the Tank Valve Wrench attached to the wire tank holders on the Electro...

Page 44: ...NeuroBlate System Instructions for Use 80469 Rev D Nov 16 2018 44 Figure 7 2 CO2Tanks Mounted to Electronics Rack CO2Line Yoke CO2Line Yoke T Handle Tank Valve ...

Page 45: ...ion to the MRI conditional robotic system which drives the position of the laser delivery probe in the patient s head All electrical connections on the filter panel are grounded to the RF shield to prevent conduction of noise into the room Typically the NeuroBlate cabling is left permanently attached on both sides of the filter panel If the installation requires the cables to be disconnected betwe...

Page 46: ...used in other applications Figure 7 32 The below instructions highlight the steps to do so Insert tube through Waveguide and fasten nut on either end The tube adapter may be left on permanently depending on the needed size access of the Waveguide Disconnect the latches on the front of the panel and separate from panel box Insert connector module cable ends through tube and connect into back of pan...

Page 47: ...released red light should NOT be on If it is twist the red knob clockwise to release Turn on the power switch at the side of the monitor see Figure 7 4 and the monitor will display NeuroBlate System logo launch screen Double click on the M Vision for NeuroBlate System icon to launch the software application CAUTION The user must perform a Shut down under at the Start menu of the Windows operating ...

Page 48: ...escale of patient data from the MRI is more accurately aligned to events within the NeuroBlate system Contact Monteris Technical Support if changes to the time setting are required Double click the M Vision for NeuroBlate icon to launch the software application Figure 7 4 1 right Figure 7 4 1 Boot Up Display left and Desktop Display right NOTE The M Vision software must be running before any DICOM...

Page 49: ...ine DICOM formatted data is loaded A sample view of the opening screen is shown in Figure 7 5 1 Additionally M Vision provides specific interactions with the NeuroBlate System Hardware assisting the user in selecting and setting hardware parameters all while providing key safety controls data collection and feedback to the user There are eight main software task screens represented by icons in the...

Page 50: ... Register Co register image datasets Volumes Create user defined volume contours Trajectories Define LDP trajectory Align Define LDP rotary orientation Insert Match software rendered probe position to LDP artifact on MRI image Treat Thermometry monitoring during laser delivery Admin Reports procedure details displays screenshots and allows comment insertion Menu Bar Task Icons MRI Type Robotic Man...

Page 51: ...Allows the user to hide the cross reference navigation lines displayed in the image view panes Show Annotations Allows the user to hide the annotations Reset View Settings Resets the viewport settings to the default setting Tools Compare Series Compares two different image data sets Disable DMAX Allows the user to remove controls which monitor incoming thermal imaging data for RF noise and anatomi...

Page 52: ...e noted in table 7 2 System status information is constantly updated and is displayed on the lower left side of the GUI Information may include the last step completed prompts regarding the next step to be performed or system errors The user should monitor the displayed information Error messages that appear should be acknowledged by right clicking on the Status Bar and selecting Dismiss in the co...

Page 53: ...rt click and hold to change the location of an image within the current view pane i e moving the field of view center in the view pane Zoom Click and drag vertically to magnify a single image about its center Zoom to Region zoom to display a rectangular area of interest Zoom to Point click and drag vertically to zoom to a specific point on an image Add Edit Move or Delete Text controls text box ma...

Page 54: ...nnection may be needed between the NeuroBlate System and the MRI internal private LAN in order to receive near real time MRI temperature sensitive data necessary for thermometry calculations Only qualified Monteris service personnel should complete these connections and configure the parameters on both the NeuroBlate System and the target MRI this is part of the system installation procedure For s...

Page 55: ...enetration PDP during trajectory planning The PDP point is identified by the center of the orange circle at the tip of the LDP when the probe position is at 0 mm The three active thermal monitoring planes to be displayed during thermal delivery are described by solid red lines superimposed over the dotted lines The default position for the middle second slice of the three active monitoring planes ...

Page 56: ...apsule denoted by blue region of the virtual FullFire shown in Figure 7 5 73 is positioned at the most distal monitoring plane Figure 7 5 73 FullFire Thermal Monitoring Setup WARNING The ability to monitor ablation progression is limited to a zone that is 15mm in depth along the axis of the probe separated in three 5mm MR acquisition planes and 60mm in diameter within each acquisition plane perpen...

Page 57: ...sk by selecting the appropriate scanner in the drop down menu bar in the middle left of the screen Figure 8 1 1 CAUTION If unusual software behavior is observed at any given workflow task the user should close the treatment profile exit the M Vision application and then re launch If the workflow involves the use of a trajectory platform without the Probe Driver select Manual Probe Movement choice ...

Page 58: ...E menu Load Images DICOM standard format only Once the Load DICOM Data box appears on the screen select Browse and navigate to the desired USB drive to load a DICOM dataset Use Windows Explorer Browse For Folder menu to find the desired data folder to load o Click the desired data folder and click OK o The data will automatically load to the M Vision Software If multiple image datasets are loaded ...

Page 59: ...cons under Registration Tools in the right menu to adjust the secondary image over the Master Note Once the Rotate or Pan icon is selected the master image will be colored red and the secondary image will be colored green as shown in Figure 8 1 22 When images have been aligned they appear in a yellow hue as shown in the image to the right Use the Rotate button to rotate the secondary image around ...

Page 60: ... must be selected Prior to proceeding to the next workflow step the user shall visually inspect alignment to master of ALL previously loaded secondary series NOT ONLY the last one verified If any misalignment is observed with any secondary series to the master the user must remove any incorrectly aligned secondary series of same study WARNING Extreme care should be exercised during visual verifica...

Page 61: ...a guide during thermal delivery but this task is not required to move forward to ablation There are three contouring algorithms to choose from the first two contain a smart brush feature lines snap to borders General used for less complicated spherical structures Irregular used for complicated non spherical structures Freehand left click drag to trace around structure using the Arrow Tool Select t...

Page 62: ...e The size of the push tool can be changed by holding the left mouse button and using the Page Up and Page Down buttons or by scrolling the middle mouse wheel to allow larger or smaller manipulations Note All contour lines can be removed by selecting Clear Note A single slice contour can be removed by selecting Clear One Note If part of the intended structure is not outlined on any given slice a n...

Page 63: ...b handles defined as the two white circular points within the LDP Trajectory view panes seen in Figure 8 18 The Point of Deepest Penetration PDP is defined by the setting the center of the deepest grab handle to the deepest point of Laser Probe insertion Final adjustments to the actual probe trajectory used for treatment can be modified later in the workflow at the Insert task Set the center of ou...

Page 64: ... any saved trajectory and select Save to modify Select a saved trajectory s name and select Rename to edit To show a virtual overlay of the outer contours of the LDP select the checkbox next to Show Probe Overlay Note A treatment strategy should be determined during surgical pre planning A top down treatment strategy can be considered starting at the superior most tumor location and ending at the ...

Page 65: ...oaded into the system during planning Figure 8 1 5 illustrates how to determine the name given to the plan as well where the data will be stored when it is saved The plan profile can be located using Windows Explorer under D MMI AppData AutoLITT data archive plan folder Within this folder a subfolder is first defined by the patient name patient ID number Within this patient folder is a subfolder h...

Page 66: ...gure 8 1 61 Figure 8 1 62 Finding the Saved Plan Browse the open Explorer window which points to the plan folder within the system Select the saved plan by clicking the patient name followed by the correct treatment profile number defined by the date time string see Figure 8 1 62 Note Plans can be opened if stored on USB drive by using the Import Profile selection under File and then following the...

Page 67: ...ation System and MRI imaging coil Refer to Instructions for Use for the head coil and fixation system used WARNING The patient head must be secured with a Head Fixation Device and remain fixed within magnet space for entire imaging portion of the outlined NeuroBlate System workflow WARNING If the patient head position changes relative to the head fixation device or the initial MRI position set dur...

Page 68: ...orm Attachment Follow Instructions for Use to attach the selected LDP Delivery Platform to the skull 8 2 7 1 Skull Mounted Trajectory Devices such as AXiiiS Stereotactic Miniframe Attach the device at or about the desired entry location on the skull Align the device to the intended trajectory Trefenate the skull along the desired trajectory using a 4 5 mm twist drill bit 8 2 7 2 Skull Bone Anchor ...

Page 69: ... 3 mm diameter LDP o This step is required for the thinner FullFire Optic 2 2 Probe to ensure accurate LDP placement along the intended trajectory o Depth from the proximal end of the skull bone anchor to the PDP should be assessed using image guided navigation or via the stereotactic frame planning software in order to mark a stopping point or set a depth stop on the shaft of the dilator probe WA...

Page 70: ...ion IGS pointer into the adapter Extend virtual offset to the deepest point of the target Record this value X to establish probe size and depth stop setting Lessen tool tip offset to the point at which the surgeon wants to initially insert the probe Use the following guide for each Navigation system to establish LDP depth stop setting o Brainlab X 49mm o Medtronic X 5mm o Stryker X 0mm no offset E...

Page 71: ...other stereotactic means in the OR from the proximal surface of the skull bone anchor The following figures describe how distance L is used to compute the depth stop or ruler setting on the LDP when using appropriate skull bone anchors The depth stop setting assumes the LDP is fully inserted and locked to the bone anchor The depth stop calculation makes the following assumptions For standard ancho...

Page 72: ...mputed for the various configurations LDP Size Depth Stop Min Depth Stop Max 000 51mm 71mm 00 72mm 92mm 1 93mm 113mm 2 114mm 134mm 3 135mm 155mm 4 156mm 176mm 5 177mm 197mm When a RPD is intended for use with a skull anchoring device the depth stop calculation is different due to the longer offset the RPD adds to the bone anchor when attached Figure 8 19c below illustrates this issue and notes the...

Page 73: ...P using an bone anchor only from outer skull MAX Depth to PDP using an bone anchor only from outer skull MIN depth with an bone anchor RPD from outer skull MAX depth with an bone anchor RPD from outer skull 000 51mm 71mm 103mm 123mm 8mm 68mm 00 72mm 92mm 124mm 144mm 29mm 89mm 1 93mm 113mm 145mm 165mm 50mm 110mm 2 114mm 134mm 166mm 186mm 71mm 131mm 3 135mm 155mm 187mm 207mm 92mm 152mm 4 156mm 176mm...

Page 74: ...LATFORM IP ATTACHMENT DETACHMENT TABLE OR ATAMA STABILIZATION SYSTEM Refer to the Monteris Medical AtamA Stabilization System Instructions for Use as needed Depending on the site specific workflow the Interface Platform IP may be attached before or after MRI trajectory confirmation The order of these steps may be determined with the MRI or Surgical Support Team during on site training led by the M...

Page 75: ...MR couch Plastic drapes should be placed over the coil connections when not plugged in and over the coil connectors when plugged in Figure 8 40 MR Coil Connections for Siemens Aera and Skyra MRI WARNING Fluids must not come in contact with the MR coil connections at the head end of the MRI table A fluid barrier must be placed over the coil connections to prevent patient or operator injury and dama...

Page 76: ...tely until the stop rings touch the IP arm interface Note A thumb screw is provided on each side to lock the arms in place Do not over tighten these screws as they may damage the arm Figure 8 41 Interface Platform IP to AtamA Connection WARNING Do NOT lower the MRI table after the IP is attached to the AtamA Board Doing so may lead to patient injury or equipment damage IP Power Button APD RPD Atta...

Page 77: ... the headrest receptacles the receptacles may be square or circular depending on model Ensure they are fully inserted and the white plastic portion of the IP arms rest against the table 3 Tighten the IMRIS OR table s Mounting Knob to lock the IP arm brass posts to the table Figure 8 42 e For the square configuration tighten the retaining thumbscrew into the side of the table after full insertion F...

Page 78: ...tighten the screw as this may damage the plastic g h Figure 8 43 g h Interface Platform to IMRIS Side Rail Arm Mounting Attachment Method 4 Siemens Table Slot Attachment 1 Place both Table Blocks on the MRI table as shown Note There are two different arm anchor types depending on table The figures below highlight the differences 2 Slide the Table Anchors up through the second MRI Table Slot on eac...

Page 79: ...v D Nov 16 2018 79 i j Figure 8 44 i j Interface Platform to Siemens Table Thumbscrews 4 each side Table Anchor 2 Connecting Blocks 2 MRI Table Slots Thumbscrews 2 each side Table Anchor 2 Pivot Pin 2 MRI Table Slots Connecting Blocks 2 Pivot Pin 2 ...

Page 80: ...ends furthest away from the interface platform into the IP Arm interface completely until the stop rings touch the IP arm interface Pay attention to the coil connectors and other components of the DStream interface as the arms are installed to prevent damage Note A thumb screw is provided on each side to lock the arms in place Do not over tighten these screws as they may damage the arm 5 If it is ...

Page 81: ...Connectors The portable connector module PCM Figure 8 47 can be placed in multiple positions along the Interface Platform IP arms via an adjustable bracket or on the IP housing itself A strap is provided as redundant securement to the IP arms as well as for storage The bracket is attached to the IP arm as shown in Figure 8 47 right and engaging the bracket locking thumbscrew finger tight Figure 8 ...

Page 82: ...own above no part of the bracket may ever be placed outside of the red boundary lines The PCM may be rotated on the mounting knob at preset rotations of 0 45 or 90 degrees to the patient head WARNING Do NOT place the PCM mounting bracket beyond the acceptable mounting positions noted in Figure 8 48 Equipment damage or malfunction due to radio frequency energy may occur if the PCM is placed too clo...

Page 83: ... the PCM to the desired preset rotational positions 0 45 and 90 Tighten the PCM mounting hub s locking thumbscrews until contact is just felt between the thumbscrews and Mounting Bracket image right shows how far the screws should protrude DO NOT overtighten thumbscrews PCM Mounting Hub PCM Mounting Hub Locking Thumbscrew PCM Hub Locking Thumbscrew Underside of PCM Mounting Hub showing the minimum...

Page 84: ...t ensure the PCM and bracket is fully secured to the desired attachment position Use medium force to lift up and pull back on the PCM to confirm attachment The user must ensure that the PCM cable bundle extending to the penetration panel has sufficient slack in the line to allow the MRI table to move to iso center without snagging the MRI scanner or other equipment Attach the IP Power and Motor Pl...

Page 85: ...ceeding to the self test step necessary for LDP insertion Once the self test step is complete the LDP is inserted and only then can a suitable MR image be acquired to identify the LDP signal void within the MR image as a means for defining the correct trajectory within M Vision The user must then repeat the trajectory and BDM steps described in this section to correctly define the true trajectory ...

Page 86: ...tion via the DICOM node set up on the MRI system Once data is pushed from the MRI to NeuroBlate workstation the data automatically loads into the M Vision software when in the Plan Register or Treat Register workflow task If multiple images are sent to the system all data sets need to be registered to the Master Data Set Any of the image sets brought into Plan Register or Treat Register can be mad...

Page 87: ... Align the two white circular points to match Trajectory Wand orientation to the lesion with the PDP set to the deepest point of allowed LDP penetration see Figure 8 28 8 5 4 Create Trajectories within Plan Trajectories Task without AXiiiS If the LDP has not been inserted yet and the MR image does include a LDP signal void select an arbitrary trajectory to the target This step is only necessary to...

Page 88: ...Marker Selection heading in the right menu once a scan with the trajectory wand is loaded and named the active series see Figure 8 29 Select Set to save the Top and Bottom Beam Direction Marker points before continuing to the Insert workflow task Figure 8 5 5 Align AXiiiS Device Attached to Skull If the auto detection is not used or fails to identify the marker correctly the user must manually sel...

Page 89: ...d in the MRI image Figure 8 30 The fiducial marker attached to RPD shall be visible in an orientation perpendicular to the LDP s trajectory above the skull The probe s eye view pane best illustrates its appearance as shown below in Figure 8 5 6 Ensure Trajectory View and Ball Marker are selected in the right side menu and align view planes to visualize fiducial marker as shown below Figure 8 5 6 A...

Page 90: ...step This will ensure that the software rendered LDP will align to the intended path during LDP insertion During final adjustment of the trajectory the Point of Deepest Penetration PDP location must be set to define the deepest allowable point for delivery into the brain CAUTION PDP LOCATION This position defines the depth setting of the LDP and thus the deepest point of penetration of the probe t...

Page 91: ...tion using the FullFire probe For example Figure 8 6 12 if an ablation area of 7 5mm in the radial direction is created the user can expect a 7 5mm ablation margin in the longitudinal direction as well This would result in an ablation margin extending 2 3mm beyond the FullFire tip In Figure 8 32 PDP is set inside of the intended ablation area to prevent thermal damage from extending beyond the int...

Page 92: ...RPD Laser Delivery Probe and test functionality and then deliver the probe to the established pre insertion depth in the brain Depress the Laser Foot Pedal in the MRI control room for two seconds prior to moving to Self Test Note Interface Platform Display will display the initiation of Self Test see image right prior to depressing activating Foot Pedal Display will automatically advance to the ne...

Page 93: ...tch to the centered position see Figure 8 33 Workflow using AXiiiS and APD Self Test Steps AXiiiS and APD selected for procedure Interface Platform Display Person in sterile field should carefully slide the sterile APD Follower into the AXiiiS Directional Interface until the Directional Interface Tabs are oriented and fully seated see figure 8 34 Note Align the APD Follower Directional Interface T...

Page 94: ...he Position Feedback Plug cable as shown in Figure 8 6 21 When aligning and connecting the APD follower confirm that the position displayed on the IP is correct to ensure laser energy delivery direction is accurate CAUTION Ensure the cable for the Position Feedback Plug does not rest on the patient during imaging Next Button Commander Position Feedback Plug ...

Page 95: ...ternal components of the RPD position feedback system the RPD Follower should be oriented in a way that minimizes fluid ingress into the follower assembly Directional Interface Tab 2 Directional Interface Locking Thumbscrew Directional Interface Notch 2 Dashed line indicates alignment of Directional Interface Tab 1 to Directional Interface Notch 1 ...

Page 96: ... slide the locking sleeve onto the sterile RPD Follower aligning the Directional Interface Tabs and fully seating the locking sleeve see Figure 8 6 24 Slide the RPD Follower onto the bone anchor and tighten brass thumbscrew securing RPD to bone anchor See Figure 8 6 24 Ensure the MR wand attached beneath the follower remains intact Press the Next button when task is complete Connect the Position F...

Page 97: ...NeuroBlate System Instructions for Use 80469 Rev D Nov 16 2018 97 Figure 8 6 24 Attaching the Legacy RPD to the Mini Bolt Figure 8 6 25 Attaching the Current RPD to the Mini Bolt ...

Page 98: ... insertion settings Visually confirm that the Follower Rotary Test Adapter is properly translating and rotating to correspond with the proper APD RPD knob motions Replace the APD RPD if it fails to actuate the follower properly If automation of the APD RPD or Follower fails a manual movement of the knobs can pass Self Test or a new APD RPD can be installed Once the Self Test is complete the IP scr...

Page 99: ...Stereotactic Miniframe refer back to section 8 2 9 1 AXiiiS Stereotactic Miniframe Depth Stop and Size For workflows using a skull bone anchor such as the Monteris Mini Bolt refer back to section 8 2 9 2 Skull Bone Anchor such as Monteris Mini Bolt Depth Stop and Size Remove the selected Probe tray from the sterile pouch and place in the sterile field WARNING Use aseptic technique when handling th...

Page 100: ... Figure 8 6 31 a Lift the clamp shell from the tray by gently pulling up on its plastic body Figure 8 6 31 b Remove tape holding the probe detection and temperature sensor plugs Figure 8 6 31 c and d Carefully pull the laser fiber connector up and out from the tray to ensure the fiber line is not bent near its connector Figure 8 6 31 e Gently lift up on the cooling plug to remove Figure 8 6 31 f ...

Page 101: ...refully slide the Locking Interface so that the LDP tip aligns with the required distance measurement on the ruler Squeeze both yellow locking buttons at their wider end see Figure 8 6 32 an audible click should be heard when locked Confirm depth stop is locked by gently pushing and pulling on the upper portion of the locking interface avoid manipulating the stops unless a change to probe depth is...

Page 102: ...rget which may lead to patient injury Carefully remove the Ruler by depressing the green release button Self Test Steps Interface Platform Display Connect the LDP Connectors Plugs laser cooling temperature sensor and probe detection to the PCM as described in Figure 8 6 33 Figure 8 6 33 LDP Connections on PCM Cooling Laser Fiber Probe Detection Temperature Sensor ...

Page 103: ... the plug with the groove on the adapter Visually verify that the notches on the temperature sensor plug are no longer visible to ensure it is fully connected Figure 8 6 34 Remove the dust cover and insert the laser plug into the mating receptacle two clicks should be heard one at partial half insertion and one at full insertion With medium force pull back on the laser fiber plug to ensure it is s...

Page 104: ...ed throughout the workflow until treatment monitoring begins However the visible pilot laser beam is always enabled The visible pilot laser red color light is a class 2 laser product according to IEC 60825 1 with maximum power of 1 mW The laser will NOT emit higher energy when the foot pedal is pressed during Self Test After system start up the red glow from the pilot laser will be visible in lase...

Page 105: ... lines may result in LDP operation failure or may reduce laser energy delivered to the target tissue Damaged portions of laser fiber lines may interrupt heating and may result in equipment damage or injury to the user or patient WARNING To prevent user or patient injury the cooling connector plug must never be disconnected when the line is pressurized during active LDP cooling WARNING To prevent s...

Page 106: ... Laser Beam Test FullFire Note If the physician does not see a strong visible red aiming laser beam exiting the SideFire Probe Figure 8 39 tip or emanating from fiber tip within the FullFire probe tip s clear capsule Figure 8 40 ensure that LDP Laser Plug is fully inserted two clicks into its connector on the IP Connector Module If the connected probe doesn t produce a red laser beam disconnect th...

Page 107: ...e display A gas cooling test will begin and the LDP will be cooled in steps throughout the test Following a successful cooling test the physician will be instructed to insert the LDP The Self Test display will be automatically powered down within 30 40 seconds Probe Status Bar Display Change with Connection of LDP FO temperature sensor Plug Once a LDP has been plugged into the interface platform t...

Page 108: ...orrect LDP Insertion Technique Right Incorrect LDP Insertion Technique Slowly insert the LDP through the Probe Driver Follower and visually align the LDP thumb grip to the alignment mark grey line on the Mating Adapter Figure 8 6 31 Continue insertion until fully engaged to the Follower Mating Adapter and locked in position an audible click will be heard WARNING To prevent inadvertent unlocking or...

Page 109: ...l and dura to allow the probe to pass without resistance or trajectory deflection Forcing the probe into the brain when resistance is felt can lead to Laser Probe tip fracture and result in patient injury WARNING To prevent patient injury after LDP insertion carefully monitor the Connector Module cable bundle during any movement of the MRI table and ensure there is adequate slack in the cable bund...

Page 110: ...e used to define the actual trajectory as described in section 8 5 Following MR acquisition with LDP inserted return to the Plan Trajectory task and follow the steps described in section 8 5 to create a new and valid probe trajectory Trajectory and BDM location Treat Acquire a new MR image set and load into the views to indicate verification of LDP insertion It is recommended that either a volumet...

Page 111: ... load into the views in order to compare the probe artifact evident during insertion with expected final probe linear position rendered in the software The measurement tool is useful to quantify the progress of insertion Probe Depth If the actual probe depth position within the tissue as shown by the image artifact is deemed to be at an ideal location but it does not align with software rendered p...

Page 112: ... the Laser Delivery Probe in the brain If a match is confirmed the user must select the Confirm Linear and Confirm Rotary icons before selecting yes under Confirm Trajectory Adjust the software rendered LDP image by manipulating the white grab handles to match to the LDP artifact on the acquired image see Figure 8 7 1 top When the software rendered LDP image matches the LDP artifact on the screen ...

Page 113: ... image view panes This applies to the image dataset set as Master as well as any co registered image data sets displayed as background imaging during thermal delivery IMPORTANT NOTE Tissue thermal interactions such as coagulation are not governed by the temperature of the tissue alone The duration for which the tissue is exposed to any given temperature is also of critical consequence The NeuroBla...

Page 114: ...e the real time data transfer interface prior to this point in the workflow To prevent unintended application exit of the host MRI system control software In Advanced User Mode Launch Command Tool Shell and Enable Data Transfer Type Ctrl Esc Select Run Type cmd and click OK Type ideacmdtool enter Type 5 Switches Type in the site specific password if requested The Switches Menu should appear in its...

Page 115: ...requiring an MRI system reboot to clear Special Instruction for Siemens Aera Skyra running software VD13 VE11 or higher Before real time data transfer begins the Siemens MRI must be disconnected from the PACS network and directly connected to the NeuroBlate Main PC forming a direct peer to peer network connection In this case both the NeuroBlate system and the Siemens MRI will be disconnected from...

Page 116: ...cfg in the command window then press Enter Check if SVAT host has become active by repeating steps 1 4 above 5 In the command window type cat svat_hosts cfg then press Enter to display the contents of the file 6 The following should be displayed Check if ILT server is already enabled 1 Open a Command Window TOOLS Icon Dropdown Menu Command Window 2 Type cd w init then press Enter 3 Type lsilt init...

Page 117: ...led by repeating steps 1 4 above If SVT Host ILT server or LAIS server were initially inactive a reboot is required 1 Click Tools Icon 2 Click on Service Desktop Manager page 3 Click System Restart to restart the scanner 4 This will take 5 10 minutes When prompted to log in as the system reboots enter the following username password Username sdc Password adc2 0 Note All three files svat_hosts cfg ...

Page 118: ...indow TOOLS Icon Dropdown Menu Command Window 2 Type killall lais then press Enter 3 Wait one or two minutes 4 Type pgrep lais then press Enter 5 Ensure no processes are running 6 Type setenv LAIS_ENABLE_ALL_CMDS_YES then press Enter 7 Wait 3 minutes then type lais then press Enter 8 Type pgrep lais then press Enter 9 Ensure there are now two processes running ...

Page 119: ...Command Window 2 Become a superuser on the GE LINUX based MR system Type su in the command window then press enter Enter the su password at prompt The prompt turns to a sign with root user name indicating su access 3 Start the samba service by typing service smb start then press enter 4 The following should be displayed indicating smb and nmb services are running 5 Type exit then enter to leave su...

Page 120: ...equence from being started The error message displayed does not make it clear that the Zoom setting is the issue Special Instruction for Philips MRI regarding LAN connectivity Before real time data transfer begins the Philips MRI must be disconnected from the PACS or Hospital network and directly connected to the NeuroBlate Main PC forming a direct peer to peer network connection In this case both...

Page 121: ...Figure 8 8 1 rotary position adjustment for the FullFire LDP is NOT required since it has no impact on laser energy emission A software dialog box will appear asking the user to confirm movement of the LDP to the desired location If the user selects OK the APD RPD if applicable will move the LDP to the location selected As the software rendered probe adjusts on the screen the three active thermal ...

Page 122: ... be adjusted from the buttons within the Monitoring Preference area Center Aligns slice planes centered on laser exit position Deep Aligns slice planes distal to laser exit position Shallow Aligns slice planes proximal to laser exit WARNING If at any point in the procedure it s observed that the Software Rendered Probe s linear position or rotary orientation changes without user input the Robotic ...

Page 123: ... of the software rendered LDP even with the red distal most monitoring plane line see Figure 8 8 12 Figure 8 8 12 FullFire Optic Probe Thermal Monitoring Setup WARNING The thermal monitoring planes must be centered at the middle of the FullFire laser emission area to adequately capture thermal dose WARNING Creating a greater than 7 5mm radial ablation may exceed the NeuroBlate System s ability to ...

Page 124: ... planes FOV position adjustment in plane panning can only be made for the first treatment slice Thereafter the software shall lock onto the 4 corner positions of the images and only allow images along the probe trajectory aligned to these Siemens or IMRIS MRI Select the Scan Plane icon under the Monitoring Preferences heading from the right side menu in the Treat workflow task Enter the displayed ...

Page 125: ...rientation Spacing 0 0 Position entry dialog on v12 X and v15 X systems o Enter Center Position corresponding to Scanning Range Start in All Planes View o Note If position not allowed entry Gradient Mode made need to be changed to allow slice position outside optimal FOV Grad Mode Wide rather than Grad Mode Zoom 2 Acquire End Point Localizer 3 4 sec scan using values from Treat Treat All Planes o ...

Page 126: ...to 1 Note Both top views should show image 2 of 3 of the localizer which is the sagittal view of each localizer in order to correctly display the next step o Setup View Options Clear ALL or Erase All mandatory Display Normal mandatory Disable Update ALL mandatory Enable Cursors or Report Cursor mandatory this displays the center yellow cross hair in view and reports its position in yellow text in ...

Page 127: ... prescription If you move the yellow cursor just disable enable the cursors to return them to their default location o Using ONLY the End Point top right view perform a coarse adjustment of the Graphical prescription by panning and rotating the Graphical prescription blue line so that the Center Cross hair intersects the default yellow cursor location that is displayed in End Point top right view ...

Page 128: ... Parallel FSPGR Scan 1 sec 5 Prescribe NeuroBlate Thermal Sequence or a template version of it having a single slice and single phase to start o Load the parallel or stack scan into all views Use the OK All button when loading series to ensure all views are populated with single parallel series o Perform an Erase All to allow for you to do a keyboard prescription o Setup View Options Clear ALL or ...

Page 129: ... needed in the Start positional information on the MRI console for the scan being prescribed Use this as a guide to help pan cross hair to exact location Again this step MUST ensure the cross hair Start position matches the center of the parallel slice as reported by the yellow cursor o Change number of slices from 1 to 25 through manual entry o Using top right view rotate Graphical prescription s...

Page 130: ...he Template scan using the Copy Rx feature using the Copy FOV thickness and spacing feature o Change the number of slices to 3 by grabbing the center square at either the top or bottom of the stack and dragging up or down Note Ensure the desired 3 slice planes are prescribed within 0 1mm in the GE user interface by comparing the Start and End Point Parameters within M Vision s Current Acquisition ...

Page 131: ...uence change only CV values listed above taking care to not change any others 15 For v20 and up select the dropdown arrow within the Scan icon on the GE user interface and select Auto Pre Scan 16 Select Start Acquisition within M Vision and confirm the dialog message if present 17 Select the Scan icon in the GE user interface which triggers the acquisition 18 Proceed with thermal monitoring in the...

Page 132: ...isition step 1 requires first loading and preparing the NeuroBlate Thermal Monitoring Sequence from the MRI system s sequence protocol list It will be labeled NeuroBlate Thermal Seq GRE o Ensure the thermal sequence is properly configured to accomplish Step 1 Dyn scans 1 Set in the Dyn Ang tab Select the Scan Plane icon under the Monitoring Preferences heading on the right menu Enter the displayed...

Page 133: ...wn below The Base plane or slice orientation is modified in the geometry tab as noted Entering orientation values on Philips also requires the following steps in this order to ensure final entry is correct Enter the required slice orientation coronal sagittal transverse Enter zero for all angles AP RL FH to reset entry Enter the prescribed orientation angles AP RL FH Slice Orientation is set here ...

Page 134: ...ement of Shim Box Step 2 Copy the same scan from step 1 to ensure all parameters are the same except for DynScans Set the Dyn Scans 512 or more measurements than may be needed Note This second scan copied from first provides the thermal data to M Vision in near real time and must have the exact same parameters as step 1 Begin the Header Scan on the MRI as defined in Step 1 noted previously ...

Page 135: ...pes skip to 8 8 3 2 Once this Header Scan is complete perform a DICOM push of this scan to the RTT DICOM node RTT in DICOM node label only AFTER Start Acquisition is pressed on M Vision It is important to monitor the status of this transfer to ensure that it completes successfully prior to starting the next scan step 2 The Queue Manager can be used to monitor the transfer completion For R3 or R4 M...

Page 136: ...lly from the Philips MRI DICOM push for this step WARNING On Philips MRI the treatment slice orientation and position of the second Philips scan step 2 MUST match the first header scan The ONLY parameters that should change between each scan is the dynamics Use the sequence copy feature to rerun scan 1 with only this two parameter changed to ensure all other parameters match Failure to ensure posi...

Page 137: ...e Platform during MR imaging Image quality may be compromised Note For any given trajectory upon successful receipt of the very first measurement from the MRI the M Vision software locks in the acquisition position and orientation and forces all subsequent acquisitions to be aligned precisely to this first accepted acquisition All subsequent scans must have the same orientation the position can on...

Page 138: ...d or rendered transparent in the mask overlay as shown above where the pixels in the center of the mask in the first two image panes are dropped due to LDP artifact As the MR acquisition continues the user must select a minimum of 8 reference points surrounding the treatment area within each view as reference points These reference points map out any proton resonant phase drift inherent to the MRI...

Page 139: ... 8 measurements and does not need new additional measurements CAUTION Reference Point Selection is critical to accurate MR thermal imaging Reference points are used to compensate for normal phase drift of the MR system and thus their location is critical to accurate temperature monitoring They should be selected within the brain tissue and outside the region of expected temperature increase using ...

Page 140: ...less than the patient s actual body temperature Enter the current core body temperature in the new dialog box CAUTION Patient Body Temperature Entry This value should be found through direct measurement not assumed Incorrect body temperatures exceeding 39ºC may affect the accuracy of the thermal dosage computation resulting in a poor prediction of thermal dose WARNING Use extreme care when determi...

Page 141: ...the LDP temperature falls to range of 0 to 5 C for the SideFire and 10 to 15 C for the FullFire Contact Monteris Service if failure of LDP cooling prevents treatment CAUTION If no tissue cooling is noted in the adjacent tissue surrounding the Software Rendered Probe the user should verify that the thermal monitoring planes are properly positioned with respect to the laser exit location on the lase...

Page 142: ...hat laser emission is active If the foot pedal is released the laser mode will revert to Ready The values under Properties will update current values when laser is operational CAUTION Do not initiate laser emission if the LDP is not inserted in tissue or before the LDP connections are made CAUTION Ensure the desired LDP trajectory does not interfere with the MR bore or NeuroBlate equipment prior t...

Page 143: ...rmal dosage contour line adjacent to these structures because this also indicates increased temperature near the contour line boundary Figure 8 8 3 31 Thermal Monitoring Display during Lasing During laser emission temperature maps overlaid on the displayed monitoring images should show elevated temperature near the LDP represented by red color scale If after several thermal measurements no tempera...

Page 144: ...ftware supports import of diffusion tensor imaging DTI data obtained using neuro navigation software which may aid in monitoring of ablated areas near these critical tracts or cortex Figure 8 8 3 32 illustrates an example of an imported DTI image of an eloquent structure and the appropriate distance to the yellow TDT line 2 Blue Thermal Dose Threshold Contained tissue has been exposed to the therm...

Page 145: ...NeuroBlate System Instructions for Use 80469 Rev D Nov 16 2018 145 Figure 8 8 3 32 Appropriate distance between yellow TDT line and eloquent tissue ...

Page 146: ...ance of blue TDT line CAUTION If unexpected or unusual TDT line expansion is encountered e g rapid and erratic or slower than expected it is recommended that the user should stop thermal delivery and perform diagnostic MR imaging to evaluate the area in and around the target ablation zone ...

Page 147: ...erature For tissue adjacent to the probe this may require up to 120 seconds Tissue further away from the probe may take longer to return to baseline temperature The Pixel Temperature Query tool and the temperature map can be used to monitor all tissue Note Internal probe tip cooling continues throughout the MR thermal acquisition even when the laser foot pedal is released It is only stopped when r...

Page 148: ...acquisition on Siemens MRI first stop the scan on the MR console and then stop acquisition receipt on M Vision i e Select Stop Acquisition on M Vision in this order Confirming Probe Position MR imaging may be used to confirm that the actual probe linear position within the tissue aligns to the software rendered target probe position following any translation of probe position Acquire new MR images...

Page 149: ... As necessary reselect the hottest pixel 4 6 mm 3 pixels from the outer surface of the probe tip located in any of the three planes If the temperature at this location exceeds 85 C or should all pixels 4 6 mm 3 pixels from the outer surface of the probe tip drop from view stop firing the laser immediately by releasing the foot pedal switch while maintaining MRI acquisition and internal probe cooli...

Page 150: ...the probe from the patient while still attached to the APD RPD Follower Post treatment MR imaging such as blood sensitive GRE imaging may be used to identify any immediate effect 9 Electrical Rack Requirements and Technical Data Class 1 with protective earth protection against electric shock Type CF degree of protection against electric shock Input voltage 120 V AC 10 A single phase 50 60 Hz throu...

Page 151: ...ions for Use 80469 Rev D Nov 16 2018 151 Table 9 2 Control Workstation Data Electrical Connection Data Class Class I Equipment International Protection rating IPX0 Power Source Electronics Rack Table 9 3 IEC 60601 1 2007 Tables ...

Page 152: ...NeuroBlate System Instructions for Use 80469 Rev D Nov 16 2018 152 ...

Page 153: ...NeuroBlate System Instructions for Use 80469 Rev D Nov 16 2018 153 ...

Page 154: ...NeuroBlate System Instructions for Use 80469 Rev D Nov 16 2018 154 ...

Page 155: ...port 1 866 799 7655 Callers may choose to be connected directly to a Technical Services Representative to leave a message requesting service or product sales or be connected to the Monteris Medical operator for further assistance Monteris Medical Email Reporting System reporting monteris com Contact Monteris via email to request service make product improvement suggestions report system issues or ...

Page 156: ... DISTRIBUTOR REP CONTACT Monteris Medical Corporation 14755 27th Avenue North Suite C Plymouth MN 55447 763 253 4710 866 799 7655 reporting monteris com 11 2 MANUFACTURED BY Monteris Medical Corporation 14755 27th Avenue North Suite C Plymouth MN 55447 763 253 4710 866 799 7655 www monteris com ...

Page 157: ... is already in your plan directory Register Don t use Auto Register if you have a slab image dataset image set that does not include the entire head Register Only switch the Master dataset if you have a different frame of reference Register When creating a trajectory in Plan mode always move it into the approximate location don t just leave it in the default location Trajectory Don t Auto Detect t...

Page 158: ...not interfering with Follower attachment Assess the other AtamA head coil top option for better clearance and switch as needed Ensure the Umbilicals are not coiled or snagged on equipment Reroute the Umbilicals if needed The Follower does not move linearly or rotationally when the knob on the Commander is turned Confirm the Locking Interface on the Follower is not at one of its limits Linear posit...

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