Rev. 6. UroNav 1.2 Quick Reference Guide

Transcription

1 Rev. 6 UroNav 1.2 Quick Reference Guide

2 UroNav Pre-Procedure Accessory component connections Ensure supply main cord and network cable are connected at the lower rear of the cart but main power switch is OFF. Attach keyboard and mouse on left-side rear panel USB port connection(s) Connect the 3-pedal foot switch into the bottom rear USB port. Connect the EM Tracker to one of four connection ports on each side of the cart. The EM Tracker is connected to the Probe Holder and TRUS transducer Refer to the UroNav Instructions for Use for a complete list of all warnings, cautions, and safety information Rev. 6

3 Right side rear panel connections 1 - UroNav Field Generator (FG) connection. 2 - UroNav S-Video In connection. Power-up sequence Power ON the mains supply (lower rear) switch of UroNav Cart. 3 - UroNav Composite Video In connection (not used) Power on the main computer (bottom button, lower right side of monitor screen) The Field Generator cable is plugged into the appropriate connector (1), unique to the Field Generator plug. Connect the S-Video cable to the video-out connector on the ultrasound (refer to ultrasound manufacturer s manual) as well as the S-Video in connector (2) on UroNav. Note alignment tab at connector bottom center. Connector is keyed; do not force insertion prior to proper alignment. Attach the Field Generator to the Articulating Arm with the cord exiting toward the direction of the patient s feet and secured to a fixed surface.* Preparation and login Adjust tray height to appropriate position using the adjustment lever on the right side of the cart. WARNING: Do not operate the field generator within 200mm (8in) of installed pacemaker or other implanted pulse generators. *Refer to UroNav Instructions for Use for further details regarding the field generator and proper positioning Rev. 6 3

4 Enter a valid, customized user name and password at Windows Login prompt to begin UroNav fusion biopsy procedure. Patient Browser The main screen, or patient browser is the first step in preparing for a UroNav procedure. Patients are first added to the All Patients list, where they can be scheduled or placed in an active worklist for image review. A patient study must be added to the worklist in order to start the biopsy procedure. Patients can be added from the All Patients list to the worklist by either dragging or clicking the left arrow button. A patient study can be created without associated MR data using the New Patient window, which can be accessed using the New Patient button. MR data may be imported from various network devices or external media from the drop down list. The default query will be based on the last selected import option. Press Import on the patient browser to import patient MR data prepared with DynaCAD. The Auto Retrieve selection will retrieve the DynaCAD STL Prostate Boundary, the DynaCAD ROI targets (if provided), and the high resolution T2 axial MRI. Refer to the DynaCAD to UroNav Data Preparation section of this document regarding proper data preparation for use with UroNav Rev. 6

5 Procedure Status Procedure Status Icons MRI Fusion Patient Ready U/S Only Patient Ready MRI Fusion Biopsy Procedure (Scheduled) U/S Only Biopsy Procedure (Scheduled) MRI Fusion Biopsy Procedure (Biopsied) U/S Only Biopsy Procedure (Biopsied) Patient Timeline The Patient timeline proves a chronological overview of biopsy procedures. The Patient timeline can be presented in two views; Timeline view or Table view. Timeline View Press the Start button on the Patient Timeline (bottom of the patient browser) for the selected patient in the worklist to begin the biopsy procedure Rev. 6 5

6 UroNav Intra-Procedure Review segmentation and targets Field Generator initialization, tracking, tool selection The Review Segmentation & Targets screen is not displayed for US only procedures. Preview imported target(s) and prostate gland boundary from MRI images. Highlight target(s) in the list to display their location(s). Tools connected to the rear and lower side panels will appear within 30 seconds. Choose the appropriate biopsy needle from the list. Check that the depth on the screen matches the depth selected on the ultrasound. To manually add targets, scroll through the image set using the scrollbar to the right of the viewport to select an area to place a Region of Interest (ROI). Press the + button in the target list to create a new target at the current cursor position. Rename any imported or added target(s) if desired by right mouse context menu. The Alignment tab shows the registration between the prior and current volumes. Manual registration adjustments may be necessary for both volumes to overlap on all three orthogonal views. Examine the live graphic of the TRUS Probe to ensure the EM Tracker near the probe handle is centered within the EM field volume. Correct positioning can be confirmed when the color of the TRUS is shown as green. Re-position the Field Generator if required. The live ultrasound video feed from the ultrasound system is displayed on the bottom of the screen. The default needle guideline alignment can be adjusted as needed. A universal EM tracker can be used in place of a dedicated EM tracker. This universal EM tracker automatically detects the connected TRUS transducer. WARNING: Always confirm that the automatically detected TRUS transducer matches the TRUS transducer that is being used Press Next. When complete, press Next. A purple boundary represents the current prostate gland; a green boundary represents the prostate from the US; a dashpurple boundary/mesh represents a prior MRI. Note: The Alignment screen is only available if a prior procedure exists for the selected patient Rev. 6

7 Sweep and Segmentation This screen enables the user to collect a manual, 2D ultrasound sweep of the prostate gland using the TRUS transducer. The frames collected during the sweep are acquired to reconstruct a 3D model of the prostate which can be used to fuse with the pre-procedure MRI dataset if available. Tip: The TRUS transducer may cause deformation of the prostate during the sweep. It is recommended to use pressure with the transducer to similarly match the anatomy of the prostate of the MRI image. For end-fire TRUS, sweep transversely from base to apex (or apex to base) of the prostate without rotation and keeping the needle guide upward, closest to the field generator. For side-fire TRUS, sweep in the sagittal view and completely from one side of the prostate to the other. Alternatively, the sweep can be performed in the transverse plane, perpendicular to the gland, from base to apex or apex to base. Press Start or depress Sweep pedal on the supplied 3-pedal foot switch. The sweep is best performed as a smooth, steady motion, applying constant pressure. Sweeps of the gland are supported with the patient in left or right decubitus and lithotomy positions. Press Stop or lift the foot off the sweep pedal. Click the Segment button to complete the segmentation. The boundary points can be examined by using the mouse scroll wheel to view multiple frames. Manual adjustments are made by dragging the right mouse button to erase points and by clicking the left mouse to add points. The user can optionally seed the segmentation by identifying anatomical fiducial landmarks (i.e. anterior, segmentation. The segmentation boundary can be modified manually be selecting the boundary adjustment tool. Delete: The action deletes the segmentation of the prostate gland. Smooth: Select to apply incremental smoothing to the segmentation boundary. Undo: This action undoes prior modification of the segmentation boundary including boundary adjustment, smoothing and deletion. Reset: Select in case of poor segmentation to create an initial 3D prostate mesh for manual adjustment. When completed, press Next. If the patient and / or the Field Generator are moved after the TRUS sweep, the live ultrasound image and the MR image will be misaligned. Repeating the TRUS sweep and registration may be required Rev. 6 7

8 Align US volume with MR Coarse and finely tuned registration for fusion of the US volume to the pre-procedure MRI volume is a vital step for accurate specimen sampling when using realtime US images with pre-defined targets. WARNING: Elastic deformation requires accurate segmentation of the prostate on both modalities, and an initial rigid registration that minimizes any misalignment. Once computed, the elastic deformation can be toggled on or off, allowing the use of either elastic or rigid registration for the procedure. Tip: Other viewable anatomical structures may be used to assist with registration. Correct registration is essential for successful tracking and targeting. Verify and adjust gross and fine registration in all three orthogonal planes. Using the Blend slider adjusts the amount of blend of each modality to optimize visualization when adjusting registration. Adjust the position of the ultrasound boundary as needed using the image action commands (pan, rotate, zoom, etc.) available in the top left corner of each viewport. UroNav applies a semi-automatic 3D rigid registration algorithm to both the 3D TRUS and the 3D MR volumes, but the user must manually complete the registration through rotation, translation, and blending tools. Gross and fine registration adjustments may be necessary for both volumes to overlap on all three orthogonal views. The purple boundary represents the 3D volume of the prostate gland borders demarcated from the preprocedure MR images. The green boundary represents the segmentation from the US sweep. Real-time MR/ultrasound fusion based on current registration adjustments is shown in the lower right viewport. Sweep the entire gland to ensure that the MR segmentation of the prostate (solid purple boundary) is properly registered with the real-time ultrasound image of the gland. Biopsy Procedure Re-confirm alignment in two planes using on-screen grid lines and UroNav tools prior to navigating to first target region. The biopsy screen, through the use of guidance navigation presentation, allows users to locate pre-defined targets or add systematic regions as necessary. WARNING: The user is responsible for ensuring that the registration is accurate in all three planes The registration screen provides the option to map the MR volume elastically to the ultrasound volume using the segmentation results in order to improve fusion quality. Press the Compute button to calculate and apply elastic deformation if desired. Once computed, the elastic deformation can be toggled on or off, allowing the use of either elastic or rigid registration for the procedure. Press Next when registration is complete. The user is responsible for ensuring that the system is accurate. The Prostate workflow can be used to assist physicians, but physicians must override the system if it does not appear to be accurate or otherwise working as intended Rev. 6

9 Targeted Biopsy Procedure Steps: 1. Ensure the EM tracker(s) display is green, indicating it is within range of EM field range. 2. Ensure the depth setting on UroNav matches the setting on the ultrasound system. 3. Sweep the whole gland with the TRUS to capture the volume and borders of the prostate gland in its entirety. 4. Examine images in the viewports for accurate alignment. 5. Select the desired target to be viewed or biopsied from the Target Selection commands. 6. Use the color-coded guidance bars (blue/yel low) located on the right side of each viewport to locate the target. 7. Ensure the biopsy guide line intersects the preselected target and advance the needle, moni toring the needle trajectory and insertion line continuously to ensure safety and accuracy. 8. When the biopsy sample is taken, select FREEZE or press the foot pedal to temporarily interrupt real-time, cine viewing. 9. Scroll through the US images using the mouse wheel or slider-bar to locate the point in time where the distal tip of the biopsy needle is visu alized. Press the ADD button to record this location and associate it with the current target. Repeat for additional samples and additional targets Press Done if the procedure is complete. UroNav supports automatic needle tip detection. The system will attempt to find the frame displaying the fully deployed needle and automatically mark the needle tip location. This feature can be manually overridden through the process described above. A predefined systematic biopsy plan can be added by selecting the Add button in the Systematic Regions section on the left side of the screen. Systematic regions are based on a predetermined set of regions, configurable in the System Configuration window. (Refer to UroNav Instructions for Use for details). Target Identification MRI-imported target. Note: The Bulls Eye for MRI-imported targets represents the calculated center of the identified target. Manually-added target. MRI-imported sub region Note: A sub region target is drawn in relation to the parent target (blue). Systematic plan region Note: Systematic plan regions do not include a bulls eye (centroid). Manual realignment of anatomical landmarks may be necessary throughout the procedure and is performed by clicking on either viewport and using the Image Action Commands from the right of the screen to adjust the magenta, MR boundary to be in line with the US image. Rotational Adjustment The rotational adjustment tool only appears when using end-fire TRUS probes. The following 3 simple steps are used to perform a rotational adjustment when the user would like to fine tune the initial registration with an end-fire TRUS probe while on the Navigation Screen. Note: A good initial registration should be performed prior to applying the rotational adjustment. 1) After selecting the Rotational Adjustment button in the top left viewport, rotate the TRUS probe 180±5 from the original sweep orientation used for volume acquisition and segmentation. 2) When the guide-ring indicates you are in the proper orientation, the dialog changes to Step 2. Select Freeze via the foot pedal or the button on the main navigation screen. 3) On the bottom panel (MR view), use the Pan function to adjust the registration to align with the US volume. Click Apply. Note: Only one rotational adjustment can be applied at any given time. To clear the applied adjustment, select the Rotational Adjustment button, and select Clear Rev. 6 9

10 UroNav Post-Procedure Review screen The Review screen displays a 3D view of targets and recorded results of all samples taken during the procedure. Individual targets may be selected from the target list and highlighted on the 3D model. Reporting Following the completion of a procedure, a pathology report can be generated for a selected plan. All biopsies gathered during the selected plan will be included in the pathology report with the labels and screen captures generated by UroNav. Select Report from the Plan Selection screen. Pathology fields can be adjusted for each biopsy including the location, core length, diagnosis, pathology description, Gleason primary score, Gleason secondary score, percent involvement, and tumor length. Three different viewing modes are available to assist in the review of the procedure. Volume displays the 3D model of the prostate rendered with all region targets, point targets spheres, and biopsies. The 3D view can be rotated with a right mouse drag for optimal viewing of biopsy samples and for taking additional screen captures for archive purposes. Video displays a video recording of the procedure with bookmarks along the timeline denoting each collected biopsy during the recording. Screen Capture displays the automatic screen capture taken at the time of the biopsy of the selected target. Additional screen captures of the Review screen may be obtained using the Camera tool in the upper left corner of the screen. Note that Prostate Imaging Reporting and Data System (PI-RADS) information for each selected target is automatically displayed if available. Press Next to generate a draft report, which includes a prostate schematic diagram and a summary table for an overview of the pathology findings. Biopsy details are provided for each biopsy included in the selected plan with a screen capture and pathology results. Electronically sign the report and select Approve Report as PDF to finalize the report. Note: A report must be approved by the signing physician before it can be finalized. It is then saved as a PDF file which can be viewed in UroNav or by a standalone PDF reader. To export data from the Review screen, place a check mark next to the screen captures that are to be exported. Select Export and choose a predefined DICOM destination. Then press Start to begin exporting to the selected destination. Press Done to exit and return to the main screen or patient browser Rev. 6

11 Power down Press Exit in the upper left of the patient browser to close the UroNav program. Power-off main computer using Windows/Shutdown. Following computer power down, Power OFF the mains supply (lower rear) switch of UroNav Cart Rev. 6 11

12 UroNav keyboard shortcuts Key Stroke Function Workflow Context F12 Toggle patient information bar visible/hidden N/A V Display prostate volume information 2D viewport Cursor Keys Pan US registration, small step US/MR blended viewports Shift + Cursor Keys Pan US registration, large step US/MR blended viewports Right-Mouse Drag Adjust window/level values US/MR blended viewports Mouse Wheel Scroll through image frames/slices/cine Sweep, MR volume, cine PgUp/PgDn Scroll through images frames/slices Sweep, MR volume Left-Mouse Drag Add segmentation points Sweep and Segmentation, US Right-Mouse Drag Erase segmentation points Sweep and Segmentation, US G Toggle needle guideline Biopsy Procedure, US Viewport Mouse Wheel Reposition needle guideline depth cursor Biopsy Procedure (Freeze Mode) Left-Mouse Click Reposition needle guildeline depth cursor Biopsy Procedure (Freeze Mode) Left-Mouse Drag Reposition needle guildeline depth cursor Biopsy Procedure (Freeze Mode) Left-Mouse Double-Click Place needle tip marker off of needle guideline and reposition depth cursor Q Toggle uniform grid overlay On/Off Biopsy Procure ALT-F Applies a horizontal flipping transformation to the unltrasound coordinate system Biopsy Procedure (Freeze Mode) Setup, Sweep Biopsy Procedure DynaCAD to UroNav Data Preparation The following steps should be followed on DynaCAD to ensure proper data preparation for use with UroNav: 1. Configure DynaCAD to automatically calculate the gland segmentation using the recommended T2W Axial High Resolution images. 2. Optimize the gland segmentation on the T2 and approve it using the Approve button. 3. Draw 2D or 3D (preferred) ROIs for each target on the recommended T2W Axial High Resolution images. Create additional sub ROI targets if desired. 4. Characterize the ROIs / targets using the PI-RADS menu 5. Save all the target results using the Save All button. 6. Query/Retrieve from DynaCAD to UroNav or select the following series for export to external media: - T2W Axial high resolution series - DynaCAD STL Prostate Boundary series - DynaCAD ROI Series MR Scan Recommendations T2W Axial High Resolution Slice coverage from bladder to pubis Fast/Turbo Spin Echo 2D or 3D Acquisition Thickness 3mm Gap 0mm Slice Spacing 3mm FOV 20cm Voxel Size 1x1x3mm Averages Rev. 6

13 UroNav Supported Supplies Biopsy guns and needles Manufacturer Angiotech BARD US Biopsy Pro-Mag Ultra Automatic Biopsy Instrument 7675 MAX-CORE Disposable Core Biopsy Instrument, 18Gx20cm, MC 1820 MAX-CORE Disposable Core Biopsy Instrument, 18Gx25cm, MC 1825 MAGNUM Reusable Core Biopsy Instrument, MC 1522 Fully Automated Core Biopsy System, MBD-23 Pro-Mag Biopsy Needle, 18Gx20cm, Pro-Mag Biopsy Needle, 18Gx25cm, Pro-Mag Biopsy Needle, 18Gx30cm, MAGNUM Disposable Core Tissue Biopsy Needle, 18Gx20cm, MN1820 MAGNUM Disposable Core Tissue Biopsy Needle, 18Gx25cm, MN1825 MAGNUM Disposable Core Tissue Biopsy Needle, 18Gx30cm, MN1830 Core Biopsy Needle, 18Gx20cm, CBN1820 Core Biopsy Needle, 18Gx25cm, CBN1825 Core Biopsy Needle, 18Gx30cm, CBN Rev. 6 13

14 Philips iu22 and C9-5ec Manufacturer Manufacturer s CIVCO Needle guide CIVCO Needle Guide with Cover Probe Holder ( ) FCS0103 (Set of 25) ( ) C9-5ec installation The C9-5ec Tracker removal Rev. 6

15 Philips HD11XE and C9-5ec Manufacturer Manufacturer s CIVCO Needle guide CIVCO Needle Guide with Cover Probe Holder ( ) FCS0103 (Set of 25) ( ) C9-5ec installation The C9-5ec Tracker removal Rev. 6 15

16 Sonosite MicroMaxx and C8x Manufacturer Manufacturer s part no. CIVCO Needle guide Probe Holder ( ) FCS0077 (Set of 25) ( ) C8x installation The C8x Tracker removal Rev. 6

17 BK Flex Focus and 8808e Manufacturer Manufacturer s BK Medical Single-Use Biplane Biopsy Guide UA1322-S Probe Holder ( FCS0131 (Set of 25) ( ) 8808e Installation The 8808e Tracker Removal Rev. 6 17

18 BK Hawk and 8808 Manufacturer Manufacturer s BK Medical Extended, Single-Use Biopsy Guide UA1257S17E Probe Holder ( ) FCS0130 (Set of 25) ( ) 8808 Installation The 8808 Tracker Removal Rev. 6

19 BK Falcon EXL and 8808 Manufacturer Manufacturer s BK Medical Extended, Single- Use Biopsy Guide UA1257S17E Probe Holder ( ) FCS0130 (Set of 25) ( ) 8808 Installation The 8808 Tracker Removal Rev. 6 19

20 BK Flex Focus and 8818 Manufacturer Manufacturer s BK Medical BK Medical Single-Use Dual Biopsy Guide (All) Single-Use Biplane Biopsy Guide (Sagittal only) UA1329-S UA1322-S Probe Holder ( ) FCS0131 (Set of 25) ( ) 8818 Installation The 8818 Tracker Removal Rev. 6

21 GE Logiq P5/A5/A5Pro/P6/P6 Pro and E8CS Manufacturer Manufacturer s CIVCO Needle Guide Probe Holder ( ) FCS0053 (Set of 25) ( ) E8CS Installation The E8CS Tracker Removal Rev. 6 21

22 GE Logiq P5/A5/A5Pro/P6/P6 Pro and E8C Manufacturer Manufacturer s CIVCO Needle Guide Probe Holder ( ) FCS0053 (Set of 25) ( ) E8C Installation The E8C Tracker Removal Rev. 6

23 BK Pro Focus and 8818 Manufacturer Manufacturer s BK Medical BK Medical Single-Use Dual Biopsy Guide (All) Single-Use Biplane Biopsy Guide (Sagittal only) UA1329-S UA1322-S Probe Holder ( ) FCS0131 (Set of 25) ( ) 8818 Installation The 8818 Tracker Removal Rev. 6 23

24 Philips Epiq 5/7 and C10-4ec Manufacturer Manufacturer s CIVCO Needle Guide End-fire CIVCO probe holders Tracking bracket for endocavity transducer Manufacturer s NOTE: Probe Holder re-orders for the Philips C10-4ec must be purchased directly from CIVCO (manufacturer s part # C10-4ec Installation The C10-4ec Tracker Removal Rev. 6

25 Siemens Acuson X150/X300 and EC9-4 Manufacturer Manufacturer s CIVCO Needle Guide End-fire Probe Holder ( ) FCS00162 (Set of 25) ( ) EC9-4 Installation The EC9-4 Tracker Removal Rev. 6 25

26 BK Flex Focus and 8819 Manufacturer Manufacturer s CIVCO Extended, Single-Use Biopsy Guide Probe Holder ( ) FCS0133 (Set of 25) ( ) 8819 Installation The 8819 Tracker Removal Rev. 6

27 BK 3000 and E10C4 Manufacturer Manufacturer s CIVCO Extended, Single- Use Biopsy Guide Probe Holder ( ) FCS0133 (Set of 25) ( ) E10C4 Installation The E10C4 Tracker Removal Rev. 6 27

28 BK 3000 and E14C4T Manufacturer Manufacturer s BK Medical BK Medical Extended, Single- Use Biopsy Guide Extended, Single Use, Bi-Plane Biopsy Gun UA1329-S UA1322-S Probe Holder ( ) FCS0131 (Set of 25) ( ) E14C4T Installation The E14C4T Tracker Removal Rev. 6

29 Customer Service Customer service representatives are available worldwide to answer questions and to provide maintenance and service. Please contact your local Invivo representative for assistance. Invivo Corporation Customer Service INVIVO1 Invivo Corporation 3545 SW 47th Avenue Gainesville, FL USA Invivo Corporation All rights reserved