customer release notes 5 · 2018. 6. 28. · medpass international ltd, winsor house bretforton,...

July 2017

Customer Release Notes 5.1

MRIdian® LINAC System Customer Release Notes 5.1

ViewRay, Inc. 22251 REV [Jul 2017] 1

Product

Doc ID

Notice

HIPAA

Copyright

MRIdian® LINAC Treatment Planning and Delivery System Software

22251 (Part #) Information in this release is subject to change without notice and does not represent a commitment on the part of ViewRay. ViewRay is not liable for errors contained in this release note or for incidental or consequential damages in connection with furnishing or use of this material.

ViewRay products and services are specifically designed to include features that help our customers comply with the Health Insurance Portability and Accountability Act of 1996 (HIPAA).

© 2016 ViewRay Inc. All rights reserved. Produced in the USA.


2 22251 REV [Jul 2017] ViewRay, Inc.

Introduction The MRIdian® LINAC System Treatment Planning and Delivery System Software is an end-to-end software system for operating the MRIdian LINAC system. CAUTION: The MRIdian LINAC system is for PRESCRIPTION USE ONLY. Federal law restricts the device to sale by or on the order of a physician, or licensed healthcare provider. Contacting Support Support services are available without charge during the initial warranty period. If you require support or wish to provide feedback, contact ViewRay Inc. using one of the methods listed below. For service: Telephone ― 1.855.286.8875 Submit system issues or product improvement requests online via: www.viewray.com/resource_center_service European Authorized Representative: MedPass International Ltd, Winsor House Bretforton, Eversham, Worcestershire, WR11 7JJ, United Kingdom.



Contents Contents .................................................................................................................................................... 3

Known Issues ............................................................................................................................................. 4

General ................................................................................................................................................... 4

System Administration ............................................................................................................................ 9

Imaging ................................................................................................................................................. 10

Planning ................................................................................................................................................ 11

Treatment ............................................................................................................................................. 20

Physics/QA ............................................................................................................................................ 28

Control Systems .................................................................................................................................... 30

APPENDIX………………………………………………………………………………………………………………………………………………..28



The MRIdian LINAC system software version 5.1 is the first software release for the system This version of the software is dedicated to the second generation system, MRIdian LINAC, which uses a linac-based delivery system. This new version of software is based on the MRIdian system software, ViewRay’s first generation system which was a Cobalt-60 based radiation delivery system, along with new implementations. Please note, this release notes version provides a list of issues that have been discovered in this release, along with legacy issues carried over from the MRIdian software. Please contact ViewRay if you require further clarification on any of the items below.

Known Issues General

1. Multiple issues have been discovered with Delivery Reports: (a) When a treatment is interrupted between beams, there is a possibility, depending on the

timing, that the last delivered beam angle will be incorrectly used in the delivery report as the angle of the beam to be delivered next. This beam angle reporting poses no risk or safety concerns, the correct beam angles are used in the completion plan and confirmation of what was delivered is available in the Delivery Record.

(b) The tolerance used in the delivery report to determine if an individual beam delivered the correct amount of dose is set to 0.2MU but the tolerance for the system specification is Planned +/- 1MU. This means that if the delivered MU is over the planned MU by more than 0.2MU the delivery report will mark that beam with a Red color, indicating a ‘major error’, when in fact it is still within specification of the system. NOTE: If you see a red beam result, indicating an error, then review carefully to ensure it is within the +/- 1MU spec and notify ViewRay if it is outside this range.

2. In legacy software there was an attenuation factor that accounted for the torso coil attenuation. This is no longer available in MRIdian Linac software while we make improvements to the algorithm. If the user wishes to account for the coil attenuation in the plan (less than 1% attenuation) then be sure to contour the torso coils to include for their density in the electron density image. A side effect of removing this from the software has meant that if the prescription states that imaging was allowed during treatment, the delivery report will state an Imaging Coil was applied. NOTE: Although the delivery report may report an Imaging Coil to be applied for daily optimization, the attenuation is actually no longer considered in the Linac optimizer unless the user manually includes it via contouring the dummy coils.

3. Various information & error messages reference the Linac as “Head 1”. NOTE: this is only a display issue and Head 1 refers to the Linac gantry head.

4. In rare instances, after selecting the Done button and while the system is exiting to the Home screen, if the user clicks a different workflow button, the Home screen briefly displays, then reverts to the Patient & Plan workflow. WORKAROUND: Wait until cursor changes back to the arrow and the Home screen displays to choose any other workflow.



5. In the treatment workflow, after the patient and diagnosis is selected, the plan and delivery

calendar are not populated. WORKAROUND: Go back to the Home screen and select a different patient and then re-select the original patient.

6. In the Fraction Review and Dose screens, setting colorwash for the contour which was the primary reference volume set in the prescription for that plan will make the contour disappear. WORKAROUND: If the colorwash doesn't work after plan is reloaded or using another form of refresh, use the outline function to make the contour reappear.

7. In the Contour screen under the Auto-Contouring tab, the threshold input box allows the user to provide/change a threshold value to apply to the Auto-Contour skin, however, after the Auto Contour Skin threshold is applied, the value always changes back to the default value of 272. WORKAROUND: In order to have a different skin threshold value, user needs to change it manually.

8. In rare instances, an error message stating, there was an error saving the plan may occur while in the Contour screen of the planning workflow. WORKAROUND: Navigate away from the Contour screen and Save the plan. Exit the plan, then reload the plan and you will be able to save and approve the contours.

9. Within a Prescription, if the 2D shift Treatment Option is set to Allowed, the Plan Summary Report will state a 2D shift is Required instead of Allowed.

10. During an export of a plan with a PET image, and the PET image’s isotope attribute doesn’t exist, the export fails. WORKAROUND: When the user experiences DICOM import issues, please check the integrity of the data with a third party DICOM viewer.

11. Image is displayed in Fraction Review when no daily imaging was performed. In the current implementation, when a patient is treated with imaging disabled, Fraction Review will still show an image, dose, DVH and statistics for the delivered fraction based off of the electron densities from the original planning image.

12. Currently, the system does not support special characters in plan names, patient names, isocenter names, prescriptions etc. Because of this, planar dose export and Delivery Report printing can fail if a special character was used in the name. WORKAROUND: Do not user special characters in plan, prescription, patient, or isocenter names.

13. Clicking the Save Dose button in Fraction Review may cause the TPS to automatically shut down. WORKAROUND: After the system logs off, log back in and click the Save Dose button again.

14. In any four position window, if the nudge tool is used to modify a contour on the lateral or vertical image set window, then keyboard shortcuts for copy and paste are applied, the contours are not transferred onto the lateral and vertical planes. WORKAROUND: If you zoom into Vertical or Lateral using the mouse and perform copy and paste it functions correctly.



15. Pressing an e-stop button now generates a Table Motor Failure fault in addition to the Interlock Fault, which has always been generated. The Table Motor Failure fault is clearable with user credentials.

16. If an e-stop button is engaged when the RT control system (RTC) is restarted, the PHS will not initialize and will cause the RTC to fail to boot.

17. Pressing an emergency stop button while the Z axis is moving will leave the PHS in an unusable state and the system must be restarted.

18. An error occurs when generating a Treatment Delivery Report if there was a point assigned in the plan as beam isocenter and any RealTarget settings were applied before changing the isocenter to a different point. WORKAROUND: Copy the plan, delete the point, add the point back in (if needed) and save the plan.

19. The point dose information is only available when the dose cloud is turned on. WORKAROUND: When reviewing the dose at a certain point in the image, using the point measurement tool, ensure that the dose cloud is also selected.

20. Although the Advanced Registration tool has an Add Contour functionality in Fusion and Positioning workflows any additional contours generated will not be saved and applied to the final result when exiting Advanced Registration. Do not use the ‘add’ functionality within this tool if the additions are required to be saved, only edit existing structures.

21. There have been instances where information presented in Fraction Review did not update as expected when navigating between fractions using the Arrow buttons. ViewRay is investigating a permanent resolution for this issue. Review all information carefully. If you notice a discrepancy, launch the individual fraction from the Delivery Calendar.

22. After a system restart, the position of the couch will not be detected until it is moved. This means it is possible for the UI to show the couch in the HOME position erroneously. WORKAROUND: Always move the couch after a system restart so it is properly detected by the system.

23. PARS has the ability to become unstable and crash the UI if an attempt is made to purge a patient that is loaded on the UI at the same time. WORKAROUND: Ensure any patients who are going to be archived and purged are not loaded on the UI.

24. When using ScreenConnect to transfer files from a ViewRay system, only one user should be connected to the system (via ScreenConnect). Otherwise, all connected users will get the file transfer but only one of the transfers will complete uncorrupted. WORKAROUND: If using file transfer only connect one remote session to a machine at a time.

25. For a multi-isocenter plan, the Fraction Review window saves all ciné files with the same filename when exporting. WORKAROUND: Export files to different folders and they will not overwrite one another.



26. When purging a patient who has an image set shared with a second patient, the second patient’s plan will be corrupted by the lack of image data. WORKAROUND: Do not share an image set between two patients.

27. After a treatment delivery, multiple image series may be seen in the Images screen for the delivered fraction. An image series may be present for the daily positioning images, predicted plan, and the re-optimized plan. The re-optimized image series is clearly marked as such. The predicted image series appears with the same series description as the daily image series. WORKAROUND: The predicted and re-optimized image sets will only be created if these features are used.

28. The system will format and combine the prefix/suffix, first and middle names during a DICOM import and export of a patient. This means the patient name may not match exactly anymore (just due to formatting). WORKAROUND: Compare the patient name closely when importing and exporting.

29. The surface rendering of structures in the 3D view does not correctly display relative depth.

30. The Fraction Summary PDF cannot be generated if the patient was treated in a decubitus position. WORKAROUND: The delivery text and plan overview reports must be manually compared.

31. The orthogonal to 3D volume view switch intermittently fails to update. WORKAROUND: Restart the application to reset the view.

32. If exporting a file to a memory stick, and the memory stick is pulled from the system before the operation completes, the system may unexpectedly shut down. WORKAROUND: Do not remove a memory stick while an export operation is taking place.

33. Under certain conditions, the user interface can slow down significantly. WORKAROUND: It is recommended to log out and back in to the UI consoles on a daily basis.

34. Pressing the Print Screen button during screen transitions may cause the application to shut down unexpectedly. WORKAROUND: Do not press print screen until the screen is fully loaded.

35. When the destination drive is full, the system will not show an error or warn the user when an export operation has failed due to space constraints. WORKAROUND: Ensure that the destination location of an exported template, plan, or image contains the data and remove data once it is transferred to conserve disk space.

36. In rare instances, an inappropriate Equipment Model Change error can occur. WORKAROUND: Re-calculate dose and save.

37. Occasionally, the axial view will disappear after zooming and un-zooming. WORKAROUND: Reset the view.

38. The RemoteImportService can sometimes not start up automatically on boot/reboot of the Database PC or during a power outage restart. Call Service if this occurs.



39. Dose View tools may be visible when dose is not ready for display, for instance, prior to dose calculation.

40. The Export Dose window may disappear if the mouse moves outside the window on to a visualization viewport. WORKAROUND: Return the mouse cursor to the location where the window was and it will reappear.

41. When using remote review, the scroll wheel may not respond as desired for movement through image slices for certain connections. WORKAROUND: Use the up/down arrow keys to navigate through the volume.

42. Sometimes the coronal image is not displayed. WORKAROUND: Refresh the view by scrolling or zooming, the display will reappear.

43. If the Moving Window is selected, and then the colormap is changed, the window view will not update the colormap as expected. WORKAROUND: Go to the fusion overlay, change the colormap, and then re-enable moving window.

44. The application currently crashes due to an unhandled exception when the file path selected in the save file browser no longer exists.

45. It is possible to select the Moving Window option from the visualization context menu when the Moving Window tool has not been selected. WORKAROUND: Select the tool from the Image View options before selecting it in the context menu.

46. When clicking through fractions on delivery review, the dose volume colorwash is always displayed when a new fraction is selected, even if the display checkbox is unchecked. WORKAROUND: Check and then uncheck the box to reset the display.

47. The application may freeze if the user inappropriately double-clicks on some buttons. WORKAROUND: Restart the application and restore the auto-save plan. All buttons only require a single click, and occasionally processing may result in a slight delay before the software action is apparent.

48. During PACS setup, the import dialog does not always verify the entered data before leaving the screen, possibly causing a failure in a later step. WORKAROUND: Carefully enter and review the PACS data during this workflow.

49. Dialogs may be dragged off the screen by the user, and there is no way to retrieve the dialog to continue. If this occurs, the system must be restarted.

50. In rare instances, the system may shut down while attempting to save a PDF. If this happens, ensure that the output location is valid and retry after a system restart.

51. DICOM export of ViewRay images does not fill in the DICOM instance field. This field is not required as part of the DICOM standard, but may be used for slice ordering in some external systems.



52. In rare instances, a patient inside the database will not appear when searched for. WORKAROUND: Check the "Show Hidden" checkbox and search again, and the patient listing will appear. This may occur on a patient that is not set to be "hidden."

53. After normalizing a plan and saving, when re-opening, the plan statistics may indicate a difference up to 0.01% from saved normalization settings.

54. Sometimes, the 3D dose Window/Level settings will show a bright red or yellow box instead of a dose volume. WORKAROUND: Click the auto W/L button to reset the view.

55. The user interface may behave slowly on screen transitions for plans that contain a large numbers of structures.

56. The user is not warned before overwriting data, when exporting plan data to the same folder as selected previously for the patient. WORKAROUND: Always select a new folder for exporting plan data.

57. The Diagnosis description text field does not wrap around. You must press Enter to begin a new line.

58. A very long patient name may obscure the entries for Oncologist, Physicist, and Dosimetrist during patient selection.

59. An incorrect tooltip may appear if the user enters a patient weight that is too large. The max patient weight entry allowable is 200 kg.

60. In certain cases, the Three-Point Landing tool may place the point in a different location than desired. Review all point placements that use the Three-Point Landing tool and if they are incorrect, use a different point placement method.

61. The user interface only runs on 1920x1200 pixel resolution monitors. Only ViewRay approved and provided monitors should be used with the ViewRay system.

62. A new frame of reference UID is generated for exported dose volumes. This may cause registration issues with other systems.

63. In rare cases, dialogs may temporarily disappear from view when the user moves the mouse over an image viewport. WORKAROUND: Move the mouse back onto the interface element and the dialog will reappear.

64. In rare instances, the system may shut down when an invalid export location is selected. WORKAROUND: Ensure valid locations are selected.

System Administration

1. The System Administration workflow Username and Password boxes will remain as shown after authentication is performed, unlike the Physics/QA workflow.



2. In the System Administration user management screen, textboxes are not limited to the number of allowed characters. However, when saving new or edited users, the system may shut down due to an error if a Username or Password is too long.

3. Newly saved/created Palette Templates may not initially appear in System Administration. If the user enters and exits System Administration while at the Palette Template tab, then creates a Palette Template and returns to System Administration, the newly created template does not appear. WORKAROUND: Navigate away from the tab and return to refresh the list.

Imaging

1. Searching for an exact patient name in the Images screen within the RealView workflow does not populate patient. WORKAROUND: Use "^" as separator not "," when searching for an exact patient name.

2. In rare instances, MR Remote Control fails to establish the communication with TPDS MR service. This requires rebooting of the MR motion controller. The error occurs when the TPDS tries to set a shift of 2.43 cm in the +Z direction. WORKAROUND: User should avoid entering the values outside the defined range. Valid range is > -20cm to <0cm along Z direction.

3. An incorrect resolution is displayed on the UI for the 726 sec scan protocol. Note: The 726 sec scan protocol has a resolution of 0.075 cm in plane and 0.15 cm slice thickness, however the UI displays as 0.075 cm in plane and 0.075 cm slice thickness.

4. CTRL-Z for undo of the contouring is unavailable in the RealTarget screen in the RealView simulation workflow.

5. Rarely, a fault during imaging referring to a .NET error results in a system shutdown. WORKAROUND: Restart the system.

6. The user may save a series taken on the MRIdian system imager with invalid characters in the Series Description. However, upon attempt to export these datasets, an error occurs. WORKAROUND: Do not save image series with special characters in the file name.

7. The application will sometimes shut down unexpectedly when a user attempts to cancel an MR scan.

8. If the couch is not at ISO when trying to acquire an image, in some instances, the system may shut down.

9. A slice mismatch error may occur in some cases for 3-Plane Imaging. WORKAROUND: Reboot the MR system or switch to single-plane imaging.

10. In rare instances, the system will fail to start an MRI scan. WORKAROUND: Check the patient or phantom positioning to confirm that there is signal at isocenter. Then retry, if the error still occurs, reboot the MR scanner system.



11. The user interface and MRI connection state updates may be out-of-sync for a short period of time immediately following the user clicking the Acquire button. WORKAROUND: Only press the Acquire Scan button one time, and then wait for the system to respond before attempting to Cancel or Acquire Scan again. Do not perform multiple button clicks in fast succession.

12. The Siemens console checks the relationship between patient weight and date of birth, even if the record being scanned belongs to a phantom. For instance, an error will occur if a very recent date of birth indicates an infant, but the weight is entered as 100 lbs. WORKAROUND: Enter weights and dates of birth in the range of an average adult in phantom records to prevent this error.

13. An error opening an MR session may occur when special characters are used.

Planning

1. In rare instances, the Treated Adaptive Plan is missing from the Delivery Calendar Assignment. This occurs when a re-optimized plan is interrupted in the treatment workflow, prior to any dose actually being delivered. WORKAROUND: If there is an interruption to the delivery procedure prior to any dos being delivered, reload the plan and restart the workflow rather than just going back to a previous step.

2. In the RealPlan Dose screen when using the Compare workflow, the default Dose View isodose line values are not the same isodose line values for both plans. These values are managed separately for the two selected comparison plans. WORKAROUND: In order to make them the same, manually change the isodose line dose values or use a template.

3. In the RealPlan Dose screen when using the plan comparison tool, the “Diff” checkbox is only available when there are more than two plans in the compare plan window.

4. An Attempt to delete the structure used as the only override in electron density settings results in a shutdown of the application. WORKAROUND: Do not delete the structure used as the only override in Electron Density settings, or select another structure as override before deleting it.

5. During planning when attempting to use the plan comparison tool in the Finish screen once a plan has been saved, some plans may be missing from the “Compare To:” list. WORKAROUND: User can switch to any other workflow within RealPlan, then come back to the Finish screen to refresh the "Compare To " list box. The "Compare To" list will now have the updated list and user can now compare two plans appropriately.

6. When the dose grid resolution for optimization is set to 0.1 cm, depending on the target size and number of IMRT beams, the optimizer may fail to provide a solution. In some scenarios deleting existing objective plans and treatment plans may help to reduce memory usage. In cases where the user has not yet generated any plans, the warning message provides no instructive information for the user to proceed. WORKAROUND: Reduce the dose resolution to 0.2 cm or 0.3 cm, or reduce the number of IMRT beams in the plan.



7. After optimizing dose in the Dose screen, then user proceeds to the Beams screen and reviews the Beam’s Eye View for any given beams, then user goes back to the Dose screen, the system invalidates the dose. WORKAROUND: Recalculate dose on the Finish screen.

8. After closing an opened plan via the ViewRay logo ball, then Home button, then user creates a new plan and enters the Contours workflow, "Beams" are displayed. This is only a cosmetic issue and will not affect your plan. WORKAROUND: Move to the next step (Fusion or Points screen) and the beams will disappear when moving to the next step in the RealPlan workflow.

9. When opening a Plan Summary for an unapproved plan, the user will see an Add Constraint Structures dialog box appear on UI. WORKAROUND: Click NO to this message to avoid adding any additional structures. This is inconvenient, but it won't have any impact on plan integrity since nothing will be saved to the database from the Plan Summary screen.

10. In rare occasions, StudyInstanceUID field has “strange” values. StudyInstanceUID is a primary DICOM attribute. ViewRay has DICOM conformance to ensure this attribute is correct, but in situations this field may be corrupted. WORKAROUND: When the user experiences DICOM import issues, please check the integrity of the data with a third party DICOM viewer.

11. The length of the Manufacturer Model Name sometimes exceeds 127. Manufacturer Model Name is a primary DICOM attribute. ViewRay has DICOM conformance to ensure this attribute is correct, but in situations this may be incorrect. WORKAROUND: When the user experiences DICOM import issues, please check the integrity of the data with a third party DICOM viewer.

12. If a DICOM structure set contains two skin structures importing it may cause a system crash. WORKAROUND: Remove one of the skin contours before importing.

13. The Point Measurement Tool is labeled Density regardless of modality.

14. Non-axial, non-uniform slice spaced volumes are not supported in the ViewRay System. All image sets must have uniform slice spacing upon import, unless the slices are in the axial direction, in which case the image editing functions may be used to create a uniformly spaced volume.

15. In rare occasions, the user will see a ‘Add Constraint Structure’ dialog box when opening Plan Summary for an unapproved plan. This is a defect, due to the fact it uses the same workflow as opening a plan. However, the net effect is that you need to provide an extra click to dismiss the window by clicking NO. Even if the user clicks YES, no structure will be added. WORKAROUND: When the Add Structure window pops-up, click NO.

16. In rare occasions, when user adds a structure constraint, the constraint does not influence the dose result. WORKAROUND: Create a plan with the same structure, electron density and constraint settings and review the results.

17. When RT structure sets are imported from Eclipse, holes in certain structures are filled in on ViewRay. The current ViewRay import function cannot handle structures with a donut shape. WORKAROUND: When importing RT structures from third party software, care must be taken to review the integrity of structures and adjust as needed.



18. When loading a completion plan into the planning system the software currently takes the partial remaining dose for that delivery and multiplies the dose by the number of prescribed fractions. This completion fraction dose should be absolute and only show the actual remaining dose to be delivered for that single fraction. In the case of these completion fractions, the fraction dose is still correct even though it is displayed as a total cumulative dose to the user.

19. When optimizing dose, then the user decides to cancel the optimization the errors, ‘An error has occurred during algorithm calculation (AE00005). Error optimizing dose (UI00246)’, are displayed on the screen. WORKAROUND: Acknowledge the errors and continue.

20. Contour edits performed in the Advanced Registration dialog through the Fusion screen are not

preserved when returning to the planning workflow. You must perform the contour edits again after returning to the planning workflow.

21. When registering in the Advanced Registration dialog, the secondary volume may disappear at times. This does not affect the secondary volume outside of the Advanced Registration dialog. WORKAROUND: The Window Level can be adjusted to visualize the volume, though the window level values needed to do so are not the same as before registering.

22. Improvements made to treat contours marked as non-deformable the same as if applying a Rigid Copy operation are not available in the Advanced Registration dialog, instead those contours will not change shape but will be shifted based off the deformable registration result. WORKAROUND: Lock these contours in the Advanced Registration screen before performing any registration action.

23. Manual registration edits, after clicking Registration, in the Advanced Registration screen will not be applied to the registration when saving and returning to the workflow. WORKAROUND: Apply manual registration edits after returning to the workflow screen on the Fusion or Positioning screen.

24. ROI Lines are listed as a Primary Mask, but they actually mask the secondary volume, take care when using this tool, as all densities beyond the ROI line will be set to zero. Always review the Electron Density image before approving a plan.

25. In rare circumstances, it is possible for the planning application to crash after the user has chosen to exit the workflow without saving.

26. If a secondary image set is added to a plan but the user does not visit the Fusion screen before saving the plan, an error may occur when using the Plan Text Export function. WORKAROUND: This issue can be avoided by visiting the Fusion screen then saving the plan.

27. On the Beam's Eye View in the Beams screen, the CIAO View may draw the connecting line between two completely disjoint MLC areas incorrectly. In most cases it will not finish encapsulating one area before connecting to the other area, causing two lines to connect. WORKAROUND: Use the MLC leaf overlay to confirm the area which has openings. The MLC Leaf overlay display is not affected, only the CIAO outline.

28. Exporting a plan to the same location twice results in a system shutdown. WORKAROUND: Export the same plan to different locations if multiple exports are desired.



29. The system may shut down when attempting to undo a Discontinue Fraction action. WORKAROUND: Ensure that a fraction is not discontinued unless confirmed. If an undo cannot be performed, create a new single-fraction prescription and a scaled-down plan to apply at the end of the Delivery Calendar.

30. Pasting deformations always applies the deformation on the currently displayed volume, which may result in multiple movements if the deformation is pasted multiple times, or is copied and then immediately pasted on the same image set. WORKAROUND: Do not paste a deformation on an already-deformed image set.

31. If Auto-Normalize and allow IMRT Interdigitation are changed after dose has been calculated and the plan saved, the changes will not be reflected in the dose. WORKAROUND: After adjusting auto-normalize or the interdigitation setting, re-optimize the dose.

32. Under rare circumstances, a DVH will return with a very low resolution or have a "choppy” appearance. WORKAROUND: Re-optimize to generate a new DVH.

33. The Dose Colormap may not update on the 3D orthogonal view after several visualization mode switches. WORKAROUND: Restart to reset the view.

34. Numerical margin calculations will display an error if the expansion value is zero or within a 1/2 voxel of zero in any direction.

35. The Colormap will not update if the Moving Window is selected. WORKAROUND: To change the Colormap, switch to Fusion view, update and then switch back.

36. Rarely, the Moving Window tool may stop working. WORKAROUND: The Reset button from the visualization context menu resets the window and will allow movement again.

37. In rare cases, the Copy Plan function from the Patients workflow may result in the application unexpectedly shutting down. WORKAROUND: Open the plan in the Planning workflow, and use the Save As button.

38. Occasionally, an error acquiring plan write privileges occurs. WORKAROUND: Return to the Home screen and then retry.

39. If a Target is outside the skin, the optimizer will fail with an undescriptive error message. WORKAROUND: Ensure that the skin includes all optimization targets.

40. The application may sometimes hang when trying to cancel a Dose calculation. WORKAROUND: Shutdown and restart the software.

41. The contouring tools can become disabled after selecting Save As on an approved plan. WORKAROUND: Leave the screen and return to re-enable the tools.

42. Occasionally, a calculation error will occur during dose optimization due to the write-out of the electron density field failing. WORKAROUND: Reset the electron density settings and retry.



43. Deleting or adding points, even if no beams are associated to them, triggers the revert constraints check before a plan can be saved. WORKAROUND: Do not add or delete points once a desired dose is achieved or re-optimize the plan to continue.

44. The delete operation in the Rx Constraints does not check for references to the constraints within the Plan Normalization Parameters. Following deletion, copying the plan to another prescription cannot be performed, because as part of the copy process the software cannot find the deleted constraint, resulting in a failed copy. WORKAROUND: To create a copy, open the original plan, change normalization constraints to something different and save as.

45. Rarely, the Go To Point will fail and show an error message. WORKAROUND: Retry or use another method to go to the correct slice.

46. If the Diagnosis Label is too long the system will not save the dose volume at the Fraction Summary screen, since the series description is auto-populated using the Diagnosis Label. WORKAROUND: Change the diagnosis label to be shorter.

47. Due to floating point rounding, selecting Go To on a point set exactly halfway between 2 planes may result in the display jumping to either plane.

48. In rare cases, the Moving Window may not be displayed in the sagittal view.

49. For certain cases in the coronal and sagittal views, the mouse movements can lose their association to the Moving Window movement.

50. The system cannot handle a plan normalized to a certain prescription setting and the referenced setting changed or deleted. The issue appears as a problem with Copy or Save As of the plan. WORKAROUND: Change the Normalization settings to reference a different value and retry. It is not recommended to change prescription constraints that are referenced in an underlying plan.

51. The automatic Window/Level of the dose volume in the 3D window may cause the image to appear red. WORKAROUND: Manually adjust the Dose Window/Level.

52. In some circumstances, changing the structure display color will not update the DVH line and label on the Fraction Delivery Review screen.

53. When comparing plans, occasionally turned-off DVH lines will turn on when clicking or dragging the analysis tool within the graph. WORKAROUND: Ensure that the selected DVH line in the dropdown is the correct line.

54. The image registration algorithm will return an error if the two image sets are too dissimilar. This may occur if the user images a different phantom during treatment from the one used to create a plan, and then attempts to get the deformation between the two. Use similar/matching datasets when using Get Deformation, otherwise use Rigid Copy.

55. Rarely, dose optimization will cancel on its own. If this occurs, change the plan settings and retry.

56. The Couch Coordinate textboxes listed on the Points screen are in a different order than other coordinates in the system. WORKAROUND: Double-check the coordinate values for the couch.



57. If the Electron Density Window Set button is clicked, even if there are no changes, the dose volume is cleared. Use the Cancel button if no changes are made.

58. The Save Plan menu item is not immediately available when entering the Contouring screen from the Patients workflow. WORKAROUND: Leave the screen and come back to re-enable the menu item.

59. The system may crash intermittently during contour Copy/Paste. WORKAROUND: Restart and use the auto-save file.

60. Occasionally, the Copy/Paste function for structures will not work. WORKAROUND: Switch to another contouring tool and retry.

61. If the user deletes a point previously used to normalize a plan, the system will not allow the user to save the plan. WORKAROUND: Reset normalization settings, and then retry saving.

62. The system will display a registration error if the user attempts to use a non-matching Secondary Mask, because the mask is not checked for compatibility with the image set upon initial import. WORKAROUND: Ensure the Secondary Mask matches the image set of interest.

63. If the air is contoured as a structure, it will be included in the statistics for determining the overall max dose. If there is a hot spot in air, this can result in the DVH scaling that displays very high dose values. WORKAROUND: Remove any contours in air by using the iso-intensity tool.

64. In rare instances, the autosave function will fail and notify the user. WORKAROUND: Save your work and restart the application to reset the autosave.

65. Normalization to 100% of a structure returns very hot dose volumes due to the method of algorithmic processing on DVH constraint normalization. WORKAROUND: If 100% normalization criteria is desired, the user should use a Min Dose Constraint on the structure to normalize.

66. An intermittent issue occurs during dose optimization resulting in system shutdown. The system must be restarted.

67. If the user attempts to continue after a system warning that an image already exists for import, the system may hang and require a reboot. WORKAROUND: If encountering this message, cancel out of the dialog and do not select those images for import again.

68. In some cases, dose deposition will only appear within a small region of the couch.

69. When a non-isocenter point (calculation point) is added to a plan, the user will erroneously be shown a warning dialog that the Boundary settings are incorrect for the non-isocenter. WORKAROUND: Ignore this dialog and continue.

70. If an approved plan is loaded, and then the corresponding prescription is unapproved and re-approved, the user may encounter an error attempting to re-approve the plan. WORKAROUND: Reload the plan to approve.

71. If DICOM Import fails due to bad data, any data imported up to that point will remain in the system. WORKAROUND: Always check for completeness of image sets when errors have occurred.



72. If a beam is closed because it has zero beam-on time as an optimized conformal beam, and then the beam is changed to a Fixed Conformal Beam type, the user will encounter an error message “that the beam's opening does not contain the weight point upon re-optimization.” WORKAROUND: If this error message occurs, re-open the beam MLCs.

73. The Electron Density Image reports the couch values as 0. This is displayed incorrectly as the couch does have electron densities, which are included in the inherent couch model during dose calculation.

74. The small thumbnails of images displayed on the Images screens may have incorrect aspect ratios. Ignore the aspect ratio on the thumbnails; when loaded into a plan or displayed in a 4-up view, the aspect ratio is corrected.

75. In some cases, after a previous unplanned shutdown, plan deletion is prohibited because the system thinks the plan is open when it is not. WORKAROUND: Restarting the TPS or TDS machine that previously shutdown while the plan was open will clear the database read/write record, and then then plan may be deleted.

76. If a structure has more than one Prescription Constraint, the system may fail to find the matching structure in the plan and display a warning as such. WORKAROUND: Check affected constraints.

77. In rare instances, the system will shut down during Auto-Contouring. WORKAROUND: Reload the plan and retry.

78. Plan names must be unique for a given patient, even if under a different Diagnosis.

79. If loading a plan from the Patients workflow, the Save As menu item is not available on the Contour screen. WORKAROUND: Switch to a different workflow screen to use Save As.

80. The previous dose volume will still be cleared if there is an algorithmic error during a new dose calculation.

81. After reoptimization, small structures can have DVH variations in the 3-5% range due to statistic differences.

82. For structures created on external systems, hollow rings may not be imported correctly. WORKAROUND: Check all structures after import.

83. When Tracking Points are placed on planes 2 and 3 in 3-plane RealTarget mode and the user changes the selection to 1-plane mode, the Tracking Points are not updated automatically to plane 1. This may cause an issue starting delivery. WORKAROUND: If switching from 3-plane to 1-plane mode, be sure to put all active tracking points onto Plane 1.

84. Long Structure Names may be truncated when viewing Plan Comparisons.

85. In rare instances, dose calculation may result in the UPS status message appearing. The message is erroneous, dismiss the dialog message and continue.



86. Cleanup Operations automatically run after Auto-Contouring. This may result in very small structures being removed, which will be indicated in Dose Statistics. WORKAROUND: Ensure that small structures are correctly transferred after Auto-Contouring.

87. When canceling Dose Export, the system will sometimes wrongly display an error message. WORKAROUND: Ignore the message and continue.

88. The user must manually select the CT from the dropdown box when generating Electron Density Settings. If Blank is selected, with skin not selected for bulk densities, the density volume will be set to air inside the patient and a very high dose volume will be generated for dose calculation. If an unexpected warning showing dose greater than 200 Gy is displayed, check the Electron Density Settings for correctness.

89. The IMRT Efficiency value will be reset to 0 any time an Optimization Template is applied.

90. In the images workflow, all images are consistently displayed in the patient orientation of Head-First-Supine. Once loaded in a plan with a matching orientation, the images will be displayed in the acquired orientation.

91. The system may display an unexpected error message if the user attempts to cancel a dose volume export. WORKAROUND: Clear the error message and continue.

92. Occasionally, the dose calculation progress bar will not disappear after completing the calculation. This does not affect the behavior of the system and is a display issue only.

93. The system does not support multiple prosthesis density values, as the CT number versus Electron Density Curve must be monotonically increasing. WORKAROUND: Manually overwrite prosthesis density values using the bulk density custom field.

94. If the user has an Approved Plan open, then views and unapproves the prescription while in the Planning workflow, the user interface will not update the plan status to unapproved. WORKAROUND: Reload the plan to make changes and save or approve them.

95. The Copy Deformation button is disabled after the image fusion is locked.

96. In rare instances, the Auto-Contouring algorithm shuts down the system due to a software error. This error is more likely avoided if the template image and plan image(s) are pre-registered by the user before applying the Auto-Contouring Template. This error is also dataset dependent, so the user may try using a different template if the error occurs.

97. In order to perform Image Registration, the volume must contain at least 3 slices.

98. The Generate New Series operation in the Images UI causes a different series to be selected and displayed after the operation completes. The user must search for and select the newly generated image.

99. If the user selects to import non-supported files in the DICOM image import wizard (such as structure files, .RS or .RP), the wizard can get stuck in a loop if the user continues to click Next. The user must click the Previous button, uncheck the unsupported files and continue the image import.



Note that importing structure files is supported by the ViewRay System, but only in the context of a plan using the structure import wizard, which is different than the image import wizard.

100. Contours exported and then re-imported into the ViewRay System may result in changed contours. The algorithm used to convert voxels (as stored in the ViewRay System) into a set of points (DICOM format) and back is not perfectly reversible. WORKAROUND: To create a new plan with the same contour set, perform a Save As or Copy Plan function inside the ViewRay System software.

101. On entry, the Fusion screen does not automatically Window/Level the secondary volume. WORKAROUND: Click the Auto button to see the image data.

102. Importing structures created on a Pinnacle system may fail in some cases. WORKAROUND: Ensure that the exported structures are within the corresponding volume.

103. In rare instances, the contours for a previously-loaded plan may be shown on a newly-loaded plan upon first screen entry. WORKAROUND: Scrolling or performing any other image refresh action will immediately correct the rendering issue.

104. An error occurs if attempting to Import image data where Patient IDs do not match for the same study or series DICOM UID values. WORKAROUND: Patient IDs must match for any data imported under the same study or series DICOM UID values.

105. In some cases, the Automatic Skin Contouring algorithm will include the CT couch in addition to the patient. If this occurs, it is likely that the system will auto-place the MRIdian System couch too low under the patient, resulting in no valid isocenter regions due to collision-detection algorithms. WORKAROUND: The skin contour must be manually edited to remove portions of the CT couch, and then the MRIdian System couch positioning should be updated, in order to enable the user to place a valid isocenter.

106. A stray, straight isodose line will on rare occasions appear in the isodose overlay. This non-real straight line is a rendering error. The volumetric colorwash dose volume may be consulted to double-check dose in that region.

107. Image sets from Pinnacle with invalid time fields will not import into the MRIdian System database.

108. The system may show non-specific error messages if user-entered fields are too long to be saved.

109. The system will shutdown due to a software error if the user attempts to edit a 4D image set. WORKAROUND: Edit 4D image sets in a third-party system and re-import.

110. In rare cases, an error message is shown indicating that Patient Demographic Information is too long, the dialog will close and lose the previous information. WORKAROUND: Re-start the Patient Edit/Add window with valid entries in order to successfully save.



111. In some cases, DICOM image data sets can have spaces in some of the tags, which will prevent the importing of these files. WORKAROUND: Remove these spaces or use only DICOM data sets that do not have these spaces.

112. If any contours lie outside the region of the plan's primary image set, importing that structure set results in an error.

113. Entering Patient, Diagnosis, Prescription, or Plan names with special characters such as slashes "\" or "/" may cause export failures.

114. The Cancel button may have a delayed response during dose optimization.

115. After dose optimization, the system occasionally shows an error message indicating the Returned DVH structure cannot be selected in a plan. This is an erroneous message and can be ignored.

116. The dose optimization algorithm is non-deterministic and may return slightly different results for each calculation. The dose volume will always correctly match plan settings.

117. If 128 beam angle groups (the maximum number) exist in a plan a tooltip over the Pseudo-Arc Beams textbox indicates that the user must enter a value between 1 and 0, which is not possible. The user may not add any additional beam angle groups if 128 are already present.

118. In certain cases, imported image data may not be displayed in the expected slice order. The system may read some 3D volumes with varied DICOM tags as separate volumes in a 4D volume, when it is actually a single 3D volume. WORKAROUND: Use an external DICOM/image editor to create a uniformly spaced volume, and then import the new volume.

119. For some CT image imports, the automatic Skin Threshold Value may be too high resulting in no skin being contoured. WORKAROUND: Manually change the threshold to a lower value, and re-run skin contouring.

120. Mixed beam type plans may return suboptimal solutions for dose optimization related to beam weighting of the Conformal Beams.

121. The couch position may unexpectedly change in the planning process if points are placed below the top of the couch. WORKAROUND: Do not place any points below the couch level.

122. If the beam type is restricted in the prescription after the plans are created, the planned beam types are not automatically updated to conform to the prescription.

Treatment

1. In the fusion workflow, upon registration of the secondary (CT) image with the primary (MRI), the CT image FOV gets cropped. This is due to the fact that the MRI image provides the primary planning volume and has a smaller FOV compared to the CT image, which is used as the secondary image. WORKAROUND: Use CT as the primary planning image or use a MRI FOV large enough to cover anatomy required in the dose calculation.



2. If a treatment delivery is ended early, on rare occasions, when trying to deliver the completion

fraction, you may receive an un-retrieved dose from previous treatment error message. WORKAROUND: If you are confident that no dose has been delivered then you can choose to clear the TDD from the RTC by following the prompts on the screen, otherwise call ViewRay Customer Support for further instructions.

3. Occasionally, upon acquiring a low resolution image, and starting “Get Deformation And Autocontour” the application becomes unresponsive. WORKAROUND: In the event this happens, please log off and back on to the TPDS.

4. In rare cases, the user may receive a Critical Error while the system is initializing treatment for treatment delivery. Error - Sending plan to RT control system failed due to RTCS is not ready for treatment (SV00140); Critical - A plan was sent to the RT system while a plan already existed there (RT000007) WORKAROUND: Restart the RTCS and retry delivery workflow.

5. On very rare occasions, the UI crashes upon “terminating the treatment early” after a “pause” in treatment was initiated. If this crash happens in the middle of a treatment, the recovery logic on the startup of the system will restore the treatment delivery data. WORKAROUND: Log off and back on to the TPDS and restart treatment with the completion fraction.

6. Isodose lines are not cleared until the user initiates mouse movement on the Predict Dose screen. WORKAROUND: Either scroll on the image view to clear the isodose lines or wait until optimization/calculation finishes and isodose lines will be updated accordingly.

7. When beginning treatment delivery for a patient, beams with a zero second beam-on time may briefly appear on the TDS UI prior to Beam On- These beams would have an exposure time of 0 after the final plan was optimized. The beams will disappear prior to the beam turning on.

8. On rare occasions a 2D shift during treatment may cause the RTCS to shut down. This is due to a defect that is not able to handle a 2D shift when the system is still waiting for the MLC to reach the correct position. WORKAROUND: Avoid sending 2D shift when MLC is still in motion.

9. When an IMRT plan is interrupted and a completion plan is created, if there are no segments on some of the heads in this completion plan, the user will not be able to Predict Dose. WORKAROUND: Load the unapproved completion plan in the planning workflow, and convert to a conformal plan. Reapprove the plan, reapprove the delivery calendar and when the now-conformal plan is created, dose prediction can be performed.

10. In an event when the real-time cine MRI has low similarities with the target image, the algorithm will provide blank images which causes the UI to go blank and stays blank during treatment delivery. WORKAROUND: Pause treatment, then Resuming treatment will reset and restart the imaging.

11. In rare instances, after a “Pause” in treatment, then “Ending Treatment Early”, the user Interface freezes. User will have to restart the UI and reboot the RTC in order to proceed with the treatment delivery workflow.



12. In the event the Transfer (H:) drive loses connection and the user is attempting to re-optimize dose in the Predict Dose screen, the UI will crash while trying to access the H-drive to send out the data. WORKAROUND: Restart the system, ensure the H drive is connected and reload the plan.

13. Click and dragging the image to set the 2D shift during gating preview is not working. WORKAROUND: Setting shift with numeric values or using the scroll wheel functions correctly.

14. Edits can be made to plan settings when accessed via the Predict Dose workflow in treatment. An example of these plan settings are number of histories, structure constraints etc. These settings will be saved on the UI without actually being used to generate the dose, if the plan was not recalculated. Although the plan may be saved with parameters that were not used in dose computation, the displayed dose/statistics/DVH that the user reviews will match what will be delivered. WORKAROUND: Any intended changes made to planning parameters in the on-table adaptive workflow should include a recalculation; if changes were made by mistake the user should revert back to the original values to ensure they are saved with the plan.

15. There has been a number of occurrences where the software will crash after acquiring an image and applying the contours in the Positioning screen, there is no current workaround for this however ViewRay has added extra logging in this release to help investigate the root cause of the issue.

16. In Advanced Registration on the Positioning screen, the arrows for reordering contour rules are available, which should not be the case without the user first having to authenticate to unlock the rules for editing. Note: Reordering of the rules should only be done after authentication by the user.

17. The functionality of the Interpolation Tool in Advanced Registration is different than that in the normal workflow. The Advanced Registration tool will allow Interpolation of contour edits while the normal workflow will not. WORKAROUND: If Interpolation of edits is required during the treatment workflow then perform this task within Advanced Registration before entering the ‘Edit Contours’ screen.

18. Care should be taken when switching a plan between QA mode and Clinical mode as any acquired couch positions will be applied to both modes. WORKAROUND: Use the Acquire Couch Position button to reset to the original planned isocenter position if it was changed during QA mode.

19. When using Get Deformation and Auto-contour in the Positioning screen the plan skin contour is used as a mask to improve the registration result. This masked image is displayed when viewing the Plan image on the Predict Dose screen and may be confusing to the user if there happened to be any image data beyond the skin contour. This is just a display issue and the original plan image will be presented completely in Fraction Review.

20. When the FOV size is close to the size of the Valid Region for MR imaging, in other words, the largest FOV that can fit inside the Valid Imaging region, the system will prevent any adjustment of the FOV. This is done to prevent one type of MR disconnect. WORKAROUND: Use a smaller FOV.

21. The system will occasionally fail to stop the MRI when a user Ends Treatment Early. All radiotherapy delivery components stop, but imaging continues. WORKAROUND: Use the E-stop.



22. During an interruption, the UI may tag a beam angle group with a green checkmark indicating that it completed, when it was actually interrupted. The Completion Plan and delivery information will be correct and treatment can proceed.

23. The system can, in some instances, send the same TDD to the UI twice. When this happens, the TDS will error and force a UI shutdown. Once the UI is restarted, it will try to match the TDDs to the treatment based on IDs. WORKAROUND: Reboot the RTC, Services, and TDS. This should resolve the duplicate TDDs being sent to the UI.

24. The system will allow a treatment to be delivered with all the segments closed, meaning only scatter would be delivered. The system will indicate to the user that no dose was delivered because all the leaves are closed. WORKAROUND: Proper plan QA will prevent this. Verify that the plan has valid open segments before proceeding with a treatment delivery.

25. It is possible, via normalization, to scale segment beam on times to be shorter than the allowed treatable tolerance of 0.2 seconds. The user may not be aware of this until they try to deliver such a plan. WORKAROUND: If the user performs a normalization that is significantly different from the original optimization parameters it is recommended to verify that the beam-on time for each segment is above the 0.2s threshold. This can be done by clicking through the Current Beam Segment list on the Beams Eye View tab in Beams. The estimated beam on time is listed below the segment number. If this issue occurs, it is recommended to re-optimize with parameters that more closely match the goal of normalization. Levels can also be reduced to encourage longer beam on times.

26. The system always displays the original planning volume on the left side of the Positioning screen even if the user has gone to the Predict Dose screen, and marked to treat with a new re-optimized plan. WORKAROUND: If the user would like to see the new re-optimized plan on the left, the user can exit the treatment workflow after authenticating to treat with the new plan. The delivery calendar will then have the new plan in it, and it can be reloaded into positioning.

27. If the Target and Boundary RealTarget structures are set to be the same, the target results may appear confusing. WORKAROUND: Review the Target/Boundary settings before plan approval.

28. An unneeded warning regarding unsaved data appears if going directly to the Patient Plan treatment screen after treatment completes. WORKAROUND: Ignore the warning and proceed.

29. When applying a 2D shift and tracking a structure with repeating anatomy (e.g., spinal column), occasionally the targeting algorithm will lock onto an adjacent area of anatomy. WORKAROUND: Only use 2D shifts for very small setup adjustments in regions with repeating anatomy. If a 2D shift is used, monitor the target setup closely during RealTarget preview and treatment.

30. The system couch as a non-negligible attenuation that can affect delivered dose. WORKAROUND: Always position the patient relative to the couch in an identical manner for simulation and treatment. (See section 6.24 in the operator’s manual)

31. Treating in 3-plane mode can intermittently result in a faulted state due to a slice mismatch error. If an error occurs at the start of treatment indicating a mismatch between expected and actual slice location, the system will attempt to retrieve delivery data from the RT control system even though treatment has not yet started. WORKAROUND: Press the E-Stop to clear the RT control system state.



Then, a service user authentication will be required to mark the fraction as Nothing Delivered, and the system will be unusable until this service action can be performed. A restart of the MRI console may help resolve the 3-plane mismatch. It is recommended to only use 3-plane imaging for treatment if ViewRay Service personnel are available for on-site assistance.

32. On some occasions, the plane settings for RealTarget may default to 1-plane when originally saved as 3-plane. WORKAROUND: If this occurs, the Tracking Points must be checked for consistency with the plane settings, or the user must reselect the 3-plane setting to restore original settings.

33. If the RTC is shutdown and rebooted during the ciné preview, and then treatment is attempted, the fraction may initially turn red upon system startup. WORKAROUND: Reboot the UI to force reprocessing.

34. Between isocenters, the Segment X of Y values displayed on the Delivery screen are not initially updated until beam on for the second isocenter.

35. In rare cases, the Colorwash Settings on the Contouring Editing screen from the Treatment workflow do not update.

36. The Tracking Point Review Graph cuts off the display at 15,000 frames. WORKAROUND: To evaluate frames beyond that value, export the text file and graph into another third-party graphing software package.

37. Canceling RealView planar imaging for targeting during the "slice positioning" portion of the pre-acquisition setup on the MR system does not cancel the scan on the MR, but indicates it as canceled on the UI. WORKAROUND: Use E-Stop to stop the scan. To avoid this issue, only cancel planar imaging once slice positioning is complete.

38. In certain cases, the rectangular FOV for the RealTarget imaging selection is turned 90-degrees from the actual acquired FOV. WORKAROUND: Use the FOV options to ensure that the area selected is the area imaged.

39. If multiple beam angle groups share a common angle, the beam delivery will not be recorded in the PDF Fraction Summary Report. WORKAROUND: Ensure correct delivery using the delivery report input text files and the fraction review window.

40. There is an intermittent issue where the Positioning screen sometimes freezes on a middle mouse click for changing between 1up and 4up views. WORKAROUND: Log out of the UI and back in.

41. Occasionally, a single-slice couch contour will not copy from the planning image to the Pilot Image during Rigid Copy Contours.

42. Exiting the Positioning screen using the Done button, during the Treatment workflow, results in an unexpected system shutdown. WORKAROUND: Restart the application.

43. If the Beam-Off button is pressed during imaging multiple errors can occur.

44. The last-selected segment's individual beam-on time will be displayed, even when All Segments is checked in the Beams view in planning.



45. Occasionally, the preview may fail before starting treatment when all other settings are correct. WORKAROUND: Decrease the time of acquisition and retry.

46. Sometimes, an interlock dialog box will appear after pressing the End Treatment Early button. WORKAROUND: Authenticate to clear the dialog.

47. The green & yellow head indicators are not shown in the treatment delivery review cine if RealTarget is not turned on. During delivery, the head status is clearly indicated on the gantry graphic on the right side of the screen.

48. An error resulting in system shutdown will occur if the user Enables Treatment without selecting all needed parameters for Imaging During Treatment, such as FOV and Resolution. WORKAROUND: Ensure that all parameters are set on the RealTarget setup screen before proceeding to Enable Treatment.

49. If 3-plane imaging is selected with RealTarget turned on, the Target and Boundary contours must be visible in all 3 planes. An unspecific error message indicating "Error processing RealTarget preview data" will occur, preventing continuation to treatment, if any plane does not contain the Target. WORKAROUND: Set the system to image in one plane, or ensure that all 3 planes contain the Target, to continue.

50. If the vault door is opened while a treatment is Paused, the system will automatically End Treatment Early and Generate a Completion Plan. Interlocks still end treatment in the paused state.

51. If the Numerical Margins for RealTarget settings are set too small relative to the system voxel size (less than approximately 0.3 cm), the system will show undescriptive errors such as "Input out of range" and/or "Error processing preview images". If RealTarget is enabled using Numerical Margins, and error messages occur, ensure that the Numerical Margins are set to be greater than at least one voxel in the positioning image.

52. Under rare conditions, an error loading the plan for startup processing of deliveries may occur resulting in a system shutdown. A service call is required to update the database so that the record no longer attempts to process.

53. Due to bad connections between subsystems, system errors may occur upon attempting treatment when the RTC is rebooted without restarting the User Interface application. WORKAROUND: When the RTC is rebooted, the User Interface console should also be logged-out and logged-in to restart the ViewRay console application.

54. A series of RTC errors may occur if the RTC is rebooted without also restarting the console application. The user interface should also be restarted via log off-log in whenever the RTC is rebooted.

55. The Preview Screen sometimes goes to the background behind the main screen when Enable Treatment is pressed. WORKAROUND: Pressing Alt+Tab brings it back to foreground.

56. Using the Tracking Points Set button for 3-plane does not set the point to a different plane. WORKAROUND: Select 1-plane and then 3-plane again to allow placement.



57. If the user elects to treat a Completion Plan immediately, but then exits the treatment workflow before the treatment is performed, the Delivery Calendar is not un-approved. The Completion Plan will remain next in the fraction list to be treated.

58. An error will occur while calculating a Completion Fraction if any points are near the edge of the primary image set, and the position is shifted during treatment. Ensure that the treatment positioning image Field of View is large enough to contain all points in the plan.

59. Window and Level are not tied together for the 3 viewports during 3-plane imaging. Window and Level must be individually adjusted during delivery when using 3-plane imaging.

60. It is not possible to Re-optimize, Normalize or Edit a New Plan after the plan has already been re-optimized and approved for treatment delivery. WORKAROUND: Exit and re-enter the workflow to begin the adaptive workflow process again.

61. If the Beam On button is pressed prior to the Ready light being enabled, the system is unable to retrieve a delivery record from the RTC. An application restart with Service Authentication is required.

62. If the user does not contour in the treatment workflow, the system is currently unable to check for both hard and soft collisions (e.g. couch and patient collisions). If the user sends a couch position that would cause a hard collision, the RTC system will fault and may require a reboot to continue.

63. Rarely, the user may encounter an error that the video capture file is in use when starting treatment. Retry if this occurs.

64. On occasion, skin contouring may not work when performed before the full Get Deformation and Auto-Contour action during Positioning. WORKAROUND: Use Get Deformation, and then adjust the skin contour to continue.

65. A residual shift may be displayed after Positioning couch movement. This is due to the accuracy of the mechanical couch movement. Continue in the treatment workflow as long as the couch shift is less than 0.05 cm (half a millimeter).

66. Occasionally a "Fluence to Beam On Time failure" message appears. Reload the plan and retry.

67. When using the Treat Next Fraction Now button, sometimes the system will automatically deselect a selected patient after clicking the Diagnosis for future treatment deliveries, and force the user to reselect the information to continue. Restart the application.

68. The system may temporarily display a 0.00 second beam when preparing to treat a completion plan. Continue and Enable Treatment, the beam will be removed from the list after treatment is enabled.

69. After a RTC reboot, the cached error messages may display '{0}' instead of the affected head number. Clear the error and continue.

70. There is an issue where the diagnosis and fractions may not be displayed for a patient upon initial entry to the Patients screen for delivery. WORKAROUND: Change the search field characters to refresh the Patients listing view, and reselect the patient to continue.



71. The Treatment Delivery System may time-out loading a plan for treatment while the Treatment Planning System is importing images. The image import locks down the database system. WORKAROUND: It is recommended to import images during non-clinical hours until this issue is resolved.

72. The system cannot initiate treatment while the MRI system is offline.

73. If gating is enabled for the second isocenter of a multi-iso plan, a gating fault may occur upon beginning the second isocenter. WORKAROUND: Treat the second isocenter using a completion plan if gating is desired for multiple isocenters.

74. For images with certain artifacts, the system default value for the Auto-Skin Contouring Threshold is too high. WORKAROUND: If it appears that no skin contour is generated, lower the value significantly, and retry skin contouring.

75. In rare instances, the system may automatically deselect the patient after selecting a Diagnosis for treatment. Reselect the Patient and Diagnosis again to continue. When convenient, restarting the console application will clear this workflow issue.

76. Due to the Registration Algorithm, Tracking Points may appear to track wrongly if placed in a homogeneous region. WORKAROUND: TrackingPoints should be placed on discernable edges or boundaries to obtain good quantitative results.

77. An error message regarding service sessions may appear after rebooting the RT control system. WORKAROUND: Clear the error using Authentication, and continue normally after clearing.

78. When the E-Stop button is used to end treatment, the system may occasionally show an additional fault dialog requiring user Authentication. WORKAROUND: Authenticate and clear the error to continue using the system normally.

79. If the system requires reboot, occasionally the console connection to the RTC will not occur upon first reboot. Multiple reboots may be required before a valid connection is reached.

80. The system may rarely experience a timeout while waiting for a validation result from the RTC, resulting in system shutdown. WORKAROUND: Restart and retry.

81. If the system encounters an error during the gating preview, the user interface may become stuck with a non-interactable dialog shown on the screen. WORKAROUND: Press ALT+CTRL+DEL and restart the system if this occurs.

82. In rare instances upon system startup, the interlocks will not be listed on the user interface. All interlocks are still active and in-place, and will prevent treatment from starting if appropriate. WORKAROUND: Perform a single-beam physics/QA delivery, and upon treatment start, the interlock display will update and continually show the correct state for all future treatments.

83. If a phantom is not placed at isocenter, or has too little MR signal due to its composition, the MRI system will error upon the start of a scan. The Siemens MR console will indicate a pre-scan failure. If an MR scan fails, ensure correct placement of the phantom setup. This will not occur with patients, because standard patient positioning will always result in enough signal.



84. If previous dose record information still exists in the control system, the system will not allow the user to start a new delivery. The console system will automatically shut down, and upon restart, will process the dose information.

85. The console will automatically shut down if it fails to retrieve the Treatment Delivery Data from the control system after a delivery is complete. This behavior is necessary to ensure that the system remains in a safe state. Upon console restart, the system will try to retrieve the data again.

86. Single-segment plans (such as some completion plans) may result in a dose calculation error post-treatment or during dose prediction.

87. A system shutdown may occur if the Tracking Points file is too large. This occurs when a treatment lasts for greater than one hour. Do not treat with RealTarget turned on for more than one hour in a single session.

Physics/QA

1. During MLC commissioning in Physics QA, if MLC leaf offset needs to be adjusted, user is not able to input a negative MLC shift numbers. WORKAROUND: Please call ViewRay Service to execute RW17-0151.

2. During installation, linac dark current is quantified and verified to meet IEC specification (<0.1% of the nominal dose rate). ViewRay recommends a weekly consistency check to detect any deviations from baseline.

3. When comparing RT to MRI translation values in the Configuration Report, some values may not match what was entered into the Machine Model Editor. MRIdian LINAC introduced the Machine Model Editor and in the MRIdian software these same values were adjusted in the Configuration Editor. The Configuration Report shows the values from the Configuration Editor, if they don’t match what is in the Machine Model Editor there could be confusion. NOTE: Modifying the RT to MRI translation in the Configuration Editor will not impact the system in any way; this change must be entered into the Machine Model Editor. For a record of the current system settings contact ViewRay Customer Support for further information.

4. There is a legacy feature on the Calibration screen called “Perform Secondary MU Test”. This is not a functioning tool in the MRIdian Linac but can be checked at any time, including when beaming on. NOTE: The check box is not used anywhere in the software code, so it does not affect Physics QA procedures.

5. Occasionally, the relative electron density (RED) curve smoothing function interpolates the RED curve improperly. If the maximum point is not provided in the RED table, an extra line segment will be drawn from the available end point to (0,0). Note this is a display issue only and the RED table will still work correctly with this anomaly. WORKAROUND: User must add a HU to density value for the 3072 HU value in order for the table to generate correctly

6. In rare instances, the UI stops working on “Calculate and Export Dose” from Physics QA. WORKAROUND: User needs to log off and back onto the TPDS.



7. After running the system in MRI-only mode (only uses the Siemens host to scan), the Services and UI computer may need to be rebooted for the system to continue properly.

8. In instances when the user is finished working in MR only mode, the MR Services sometimes will not restart by pressing the restart button on the Services PC. WORKAROUND: Fully reboot the Services computer when finished with MR only mode.

9. In instances when the user is in the Physics/QA page and has selected the Plan QA tab and tries to re-enter into Physics/QA by using the Main menu, the system gives an error that it must be shut down and re-started. WORKAROUND: Click Done at the top of screen to exit from Physics/QA when trying to re-launch Plan QA.

10. “Treatment Record Processing” options can appear in the Physics/QA Calibration screen. This is confusing to the user as there is no treatment record to clear, it is a QA delivery. WORKAROUND: Although there is no treatment record the user should still select the option to Clear TD Record from RTC Controller in order to proceed.

11. There is an error exporting dose in the Physics/QA Calibration workflow. WORKAROUND: Generate an equivalent plan and calculate dose to a phantom in the Planning workflow and export the dose from there

12. When operating in QA mode, turning off required imaging and RealTarget through authentication may result in a system shutdown when enabling treatment. WORKAROUND: Change the RealTarget settings on the QA plan and retry.

13. On the Physics/QA PlanQA screen, the sorting buttons on the Plan List do not cause the list to resort as requested. WORKAROUND: Scroll the plan list to find the desired plans.

14. If the Beam Off button is pressed during Physics/QA delivery, the system may shut down after turning the beam off. Use the E-Stop or End Treatment Early button to end treatment during physics deliveries. If the Beam Off button is used, log out and in, to restart the console application.

15. The system does not support Auto-Contouring on binary images (synthetic phantoms). A defect under that scenario causes the system to unexpectedly shutdown. The Iso-Intensity Tool can be used to contour binary phantoms more accurately.

16. The console system may freeze if there is not enough signal during an attempt to take a positioning scan. This is unlikely with a patient. Ensure that phantoms are correctly set up at isocenter before starting a scan.

17. For generated (binary) phantoms, the visual interpolation method for voxel display can make it appear that there is a difference between distance measurements and manual point placement.

18. A loaded plan saved from the Plan QA screen displays on the image and 3D volume as red color. WORKAROUND: Use the auto button in the dose display to normalize the dose display.



19. If the DICOM isocenter (0,0,0) is outside the bounds of the QA plan primary image set, the QA plan will fail to save. WORKAROUND: Reset the isocenter to inside the image, and ensure that (0,0,0) is at the center of the phantoms used for QA planning.

20. In some cases, QA plans created using the Plan QA screen may have unexpected Electron Density Settings. WORKAROUND: Open QA plans in the planning workflow to check couch positioning and electron density before delivering.

21. In the Physics/QA workflow, Localization will shutdown the application if dose files are loaded as images. Dose files currently appear in the images list, but cannot be used. WORKAROUND: Do not load dose files in the Localization screen.

22. The auto-placement of the couch for patient-specific QA plans is often not correct, and will result in an invalid ISO error when attempting to treat. WORKAROUND: The plan should be saved in the QA workflow, re-opened in the planning workflow, and checked for couch position before treatment.

23. With phantom image sets, occasionally a calculation out of range error will appear during the Get Deformation algorithm on the Positioning screen. This may occur more often if using a Pilot image instead of a High-Resolution image. WORKAROUND: It is recommended to use the Rigid Copy Contours function with phantom image sets in either case.

24. For plans generated via the Physics Plan QA screen, a warning will appear upon loading that the gating plane orientation is invalid, even though gating is turned off. This warning can be ignored.

25. There is an algorithmic issue calculating spatial integrity results. WORKAROUND: The spatial integrity screen is no longer available, and must be calculated offline from TPDS.

26. When a shape is loaded into the calibration screen after a phantom is loaded, the shape is kept next time you enter the calibration screen again.

27. The Go To function for Points and Structure centers is not available on the Plan QA screen.

28. In the Physics/QA workflow, Image Window/Level does not work.

29. The couch position displayed on the Physics/QA treatment screen may be temporarily wrong on system startup.

Control Systems

1. Under certain conditions an error may present itself “A plan was sent to the RT system while a plan already existed there (RT00007)”. WORKAROUND: In this situation the RT system must be rebooted in order to clear the error.

2. Sometimes when the Motion Controller exhibits CRC faults, it takes more than one restart before a successful reboot.

3. The system may issue a motion controller fault when the user attempts to send the couch to a position that would cause a collision.

www.www.viewray.com

Office Locations

ViewRay Headquarters 2 Thermo Fisher Way

Oakwood Village, Ohio 44146 Phone: +1 440.703.3210

Fax: +1 800.417.3459

West Coast Office 815 E Middlefield Rd

Mountain View, CA 94043 Phone: +1 650.252.0920

customer release notes 5 · 2018. 6. 28. · medpass international ltd, winsor house bretforton,...

Documents