manual

2009-02-13 TD6002650740 Rev. C www.stryker.com

SpineMap™ 3D Version 1.0

REF 6002-650-000 REF 6002-651-000

User Manual

c1275

SpineMap™ 3D Navigation Manual

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Table of Contents

1 HOW TO READ THE MANUAL ........................................................................................4

1.1 SCOPE ............................................................................................................................................ 4 1.2 CONVENTIONS USED ..................................................................................................................... 4 1.3 RELATED INFORMATION SOURCES ............................................................................................... 4 1.4 MANUAL STRUCTURE ................................................................................................................... 5

2 NEED HELP DURING A PROCEDURE? .........................................................................6

3 INTRODUCTION ...............................................................................................................7

3.1 SYSTEM INFORMATION ................................................................................................................. 7 MESSAGES............................................................................................................................................ 9 3.2 TOP ROW TOOL ICONS .................................................................................................................. 9 3.3 IMAGE BOX TOOL ICONS............................................................................................................. 10 3.4 IMAGE TOOL ICONS..................................................................................................................... 11 3.5 BOTTOM ROW INFORMATION ..................................................................................................... 15 3.6 NAVIGATION TOOL ICONS........................................................................................................... 16

4 HOME – THE START-UP PAGE ....................................................................................17

4.1 NEW IMAGES ............................................................................................................................... 18 4.2 RECENTLY PLANNED................................................................................................................... 19 4.3 READY FOR SURGERY ................................................................................................................. 19 4.4 ADMINISTRATION........................................................................................................................ 20 4.5 HELP............................................................................................................................................ 24

5 SCANNING PATIENT IMAGE SETS ..............................................................................25

6 IMAGE SET .....................................................................................................................27

6.1 PREVIEWING IMAGES .................................................................................................................. 29 6.2 IMPORTING IMAGES..................................................................................................................... 31

7 PATIENT .........................................................................................................................32

8 PLANNING ......................................................................................................................33

8.1 SEGMENTATION........................................................................................................................... 35 8.1.1 Manual Segmentation.......................................................................................................... 36 8.1.2 Automatic Segmentation...................................................................................................... 39

8.2 IMAGE CORRELATION ................................................................................................................. 41 8.3 SCREWS ....................................................................................................................................... 44

8.3.1 Screw Placement ................................................................................................................. 45 8.3.2 Screw Oriented View ........................................................................................................... 46

8.4 MEASUREMENTS ......................................................................................................................... 47 8.4.1 Length Measurement ........................................................................................................... 47 8.4.2 Angle-3-Point Measurement................................................................................................ 48 8.4.3 Angle-2-Line Measurement ................................................................................................. 48

8.5 ANNOTATION POINTS.................................................................................................................. 49 8.6 PLANES........................................................................................................................................ 50

8.6.1 Axis Definition..................................................................................................................... 50 8.6.2 3 Points Definition............................................................................................................... 51

8.7 TRAJECTORIES............................................................................................................................. 52 8.8 COMPOSITIONS ............................................................................................................................ 53 8.9 SCREENSHOTS ............................................................................................................................. 54


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9 REGISTRATION PLANNING..........................................................................................55

9.1 REFERENCE POINTS..................................................................................................................... 55 9.2 SURFACE MATCHING .................................................................................................................. 56

10 SYSTEM SETUP .............................................................................................................57

10.1 TOOL CALIBRATION................................................................................................................ 58 10.1.1 Straight Calibration ..................................................................................................... 60 10.1.2 Point Calibration ......................................................................................................... 61

10.2 TOOL VALIDATION.................................................................................................................. 62

11 REGISTRATION..............................................................................................................63

11.1 POINT-TO-POINT REGISTRATION ............................................................................................ 64 11.2 SURFACE REFINEMENT ........................................................................................................... 66 11.3 REGISTRATION OF RESCUE POINTS......................................................................................... 67

12 NAVIGATION ..................................................................................................................68

12.1 TRAJECTORY NAVIGATION ..................................................................................................... 71 12.2 SCREW NAVIGATION............................................................................................................... 72 12.3 NAVIGATED INSTRUMENT NAVIGATION................................................................................. 74 12.4 NAVIGATION IMAGE BOX TOOLS AND IMAGE TOOLS ............................................................ 75

12.4.1 Freeze Image................................................................................................................ 75 12.4.2 Cut 3D Image............................................................................................................... 75 12.4.3 Show / Hide Planes ...................................................................................................... 75 12.4.4 Show / Hide Measurements.......................................................................................... 76 12.4.5 Show / Hide Screws...................................................................................................... 76 12.4.6 Virtual Tip Extension and Virtual Tip Diameter ......................................................... 77 12.4.7 Screenshot .................................................................................................................... 78 12.4.8 Zoom In / Zoom Out ..................................................................................................... 78 12.4.9 Rotate 3D ..................................................................................................................... 79 12.4.10 Annotations .................................................................................................................. 80 12.4.11 Intra-operative Distance Measurement ....................................................................... 81 12.4.12 Intra-Operative Angle-3-Point Measurement .............................................................. 82 12.4.13 Angle-2-Line Measurement.......................................................................................... 83 12.4.14 Browse Images ............................................................................................................. 84

12.5 C-ARM IMAGE ACQUISITION................................................................................................... 85 12.5.1 Set-Up for Ziehm C-arms............................................................................................. 86 12.5.2 Set-Up for Siemens C-arms.......................................................................................... 89 12.5.3 C-arm Images for Planning ......................................................................................... 93

INDEX ....................................................................................................................................94

INDEX OF FIGURES .............................................................................................................95


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1 How to Read the Manual

1.1 Scope This manual provides general instructions on the use of the Stryker® Navigation System software for Spine Navigation. It contains information on the planning and navigational features, functions and the general concept of operations for SpineMap™ 3D Navigation 1.0.

1.2 Conventions Used Carefully read this manual and follow its instructions. The word “NOTE” carries special meaning and should be observed with care. NOTE This provides special information to make important instructions clearer.

An exclamation mark within a triangle is intended to alert the user to the presence of important operating instructions.

This icon indicates optional features that must be licensed in order to be available.

Some paragraphs in this manual are marked with colored background. The meanings of these background colors are: Yellow background: Requests user action.

Green background: Requests user attention.

1.3 Related Information Sources

Prior to surgery, carefully review the respective Safety Information and the Imaging Protocol for the Stryker Navigation Systems supplied with the software package.

For instructions on how to use surgical instruments, refer to the user documentation supplied with these instruments. For optimum task performance, read each user interface task instruction and message displayed by the Navigation System.


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1.4 Manual Structure Starting with section 4, this manual is structured according to the tabs on the top bar of the start-up screen. Home Image Sets Patient Planning Registration Planning System Setup Registration Navigation


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2 Need Help during a Procedure? Only operators who have received special training should use this system. Keep all user manuals where they are easily accessible for the Stryker Navigation System operators. If you have questions, contact your Stryker Navigation sales representative.


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3 Introduction

3.1 System Information Software Control: The Navigation System software is organized to be controlled like standard up-to-date software products. Devices for Intra-Operative Software Control: The navigation software functions, System Setup, Registration and Navigation, can be controlled remotely from the sterile field by using navigated instruments with three buttons or wheel control. For more information on how to control navigation software with navigated instruments, refer to their Instructions for Use. Instruments with one button can perform only the “SELECT” functionality. From the non-sterile field, the software can be controlled with the mouse. Note the following for the use of navigated instruments: By repeatedly clicking forward you toggle from the top down through the menu buttons as indicated by the white arrows in Fig. 1. Depending on the work-flow step, only certain buttons can be reached by using the instruments, whereas the mouse is unrestricted. Clicking back-ward, the direction of the cycle is reversed. The currently selected menu item is high-lighted. To execute the selected function, press the SELECT button or wheel control of the instrument.

Fig. 1: Toggle with Instrument Buttons

Throughout this manual you will repeatedly be asked to click on a symbol or a button. Clicking involves highlighting the symbol or button by using the forward or back function of the instrument, and then pressing the SELECT button or wheel control. Alternatively, use the mouse.


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The screen displayed by the system is generally divided into the following areas:

Take these terms into account when reading the following descriptions.

Status Bar

Workflow Tabs

Image-Box Tools Patient Record Tree View

Tool Panel

Tree-View Buttons

Image Box

View Tabs

Image

Image Tools

Top Row


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Messages Depending on the priority, the software generates different kinds of messages:

Confirmation Messages Prompts the user to select “Yes” or “No”.

Information Messages Include important information or recommendations.

Warning Messages Indicate that an input or a status differs from the expected result or has to be consid-ered carefully.

Error Messages Indicate a dangerous status or that an input has failed the plausibility check.

3.2 Top Row Tool Icons The following icons are available in all functions of the application:

Screenshot Takes a screenshot of the complete screen. Screenshots are stored in the archive directory of the selected patient record.

Help Opens the navigation software user manual or the navigation software "About…" screen. For more information on navigation software help, refer to the paragraph “Help” later in this manual.

Minimize application Removes the window from the viewing area without closing it. You can restore the window to full size by clicking on the “Generic Package” button at the bottom of your viewing area.

Exits the application


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3.3 Image Box Tool Icons The following icons are available for certain functions of the application:

Zoom Enlarges or scales down the size of a patient image. To zoom in or out in a patient image, use the zoom icons to move the zoom slider, or click on the image with the middle mouse button and drag the mouse until you

have reached the desired zoom factor, or use the mouse wheel to resize an image.

Window Width / Window Level Alters the contrast of the patient images. Window level affects all images of one se-ries. For more information on window level, refer to the detailed description in chapter 7 “Planning”.

Screenshots Takes a screenshot of the complete screen. Screenshots are stored in the archive directory of the selected patient record.

Print Sends the selected part of the screen to the Windows standard printer if a printer is configured. If not, the default value is “print to file”.

Series / Tiles Slice view and screenshot view: Tiles images in the image box according to your needs.

one tile 4 tiles 9 tiles 16 tiles 64 tiles

Show/Hide Trajectories Shows / hides all trajectories within an image set (if defined)

Show/Hide Annotation Points Shows / hides all annotation points within an image set

Show/Hide Planes Shows / hides all planes within an image set

Show/Hide Measurements Shows / hides all measurements within an image set


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Show/Hide Screws Shows / hides all screws within an image set

Image Correlation Opens a panel with which you can define the ratio of correlated fusions.

3.4 Image Tool Icons When applicable, the patient image provides controls appearing if the mouse cursor is moved over the image.

Zoom Function

Is available during planning and navigation. For more information on how to use zoom function, see chapter 3.3.

Distance Measurement Is available during planning and for “frozen” 2D images during navigation. Measure distances within an image by clicking one point, keeping the mouse but-

ton pressed, dragging the mouse cursor to a second point, and finally releasing the mouse button, or

click the icon to clear measurements from image. If not cleared before, the measurement values are displayed until the view tab, the image set, or the workflow tab is changed.

Camera Angle Changes the angle of the camera within the 3D view only. The angle range reaches between a parallel projection and a maximum angle of 100°. Use the slider to adjust the camera angle as requested.

Print For more information, see the description in chapter 3.3.

Take Screenshot Is available during planning and navigation. By clicking on the screenshot icon, the image is captured. Screenshots are stored in the archive directory of the selected patient record.


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Change View Is available during planning and navigation. Alters the view of the patient images from four tiles to one tile Alters the view of the patient images from one tile to four tiles.

Show/Hide Toolbars Is available during planning and navigation. Alters image tools visibility on the lower image edge.

Show toolbar. Hide toolbar.

Slider Multiplanar view: Moving the slider below the image “moves” the current point through the image series perpendicular to the dis-played image.

3D Image Settings

Fig. 2: Image Settings Box (Adjust) The settings for the 3D images are divided into two main items; “Adjust” and “Cut”. Click “Save as Default” for keeping the individual settings as values for the current series until the default button is pressed again.


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3D Image Settings (cont.) Adjust Surface Level

Adjust the surface level in order to display the different structures such as bone or soft tissue in the 3D image.

Brightness / Contrast Select the brightness and contrast settings that best fit the desired view.

Projection The parallel projection of the image displays an image in which all parts are shown in the same proportion. The perspective differentiates between the parts closer and more distant to the spectator. As in the natural view, the closer parts are shown larger. Use the Camera angle setting to define the proportions of the perspective view.

Fig. 3: Same 3D Image in Parallel View, 45° Perspective and 75° Perspective

Using the perspective view and zooming the view along a body aperture can give you the impression of a moving camera inside the body.

Rotation Axis The rotation option allows the 3D image to be rotated in space while one axis re-mains fixed. “x-z constrained” means that the z-axis (head-feet) remains fixed during rotation and “y-z constrained” means that the y-axis (anterior-posterior) stays fixed during rotation.

Cursor Select whether crosshairs should be shown or hidden in the 3D view.

Lighting You can select the lighting as standard, which means the light comes from one single source behind the camera, or as advanced, which means that the light comes from three different sources around the 3D object.

Fig. 4: Same 3D Image with Advanced and Standard Lighting Transparency

Select to display the surface of the 3D image of a CT or MR or PET series trans-parent and to make a planning item (e.g. a plane) visible.


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3D Image Settings (cont.)

Fig. 5: Image Settings Box (Cut) Cut

Cutting Planes With the cutting option, you may cut the 3D model open along three planes. You can use the sliders to position the cut. When automatic cut is selected, the cut changes with the position of the 3D image.

Fig. 6: The 3D Model Cut along Three Planes.


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3.5 Bottom Row Information The bottom row displays the following information about the selected image in the image box: Type of image set Current point coordinates of cursor position on image

During navigation, the name of the active instrument is displayed below the image box.

If the “fullscreen” mode is active, the appropriate “Close Fullscreen” button is displayed in the bot-tom row.

During navigation, the software indicates the system status in the lower left corner.

Attention — Active Tool not Visible If followed only by an instrument denomination, the symbol indicates that the system camera cannot track this instrument. In case more than one required instrument cannot be tracked, the instruments are listed in one row:

Attention — Battery Low

If an Instrument Battery has to be replaced, the system displays the error symbol fol-lowed by the name of the instrument and the battery low symbol.


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3.6 Navigation Tool Icons During navigation, the system offers a range of tools in the image box tools bar.

Detailed descriptions of each tool can be found in chapter 12.


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4 Home – the Start-up Page The start-up page offers access to the system via highlighted items on the screen.

Fig. 7: The Start-up Page of SpineMap™ 3D Navigation


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4.1 New Images If images arrive via the network, the link “There are nn new image sets” leads you directly to the Image Sets page and displays the new sets. The software includes a media detection process. Navigation software detects and displays in-serted media (e.g. CD, USB sticks) automatically. Click “Start new case” to create a new patient record using new images.

Click “Start C-arm 3D scan” to create a new patient record by activating C-arm imaging. See the detailed description in chapter 12.5.


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4.2 Recently Planned This functionality contains a link list with the names of the last 4 recently used patient records in-cluding the patients’ dates of birth. It also contains a link to a complete list of all patient records. Click either on “patient” (if not yet completed) or on “planning”.

4.3 Ready for Surgery This functionality contains a link list with the names of the completely planned patient records in-cluding the patients’ dates of birth. It also contains a link to a list of all completely planned cases. Planning is completed when registration planning is done. Clicking on a name from the link list, you reach “System Setup” and “Navigation”.


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4.4 Administration “Administration” allows you to backup/restore patient data to/from different media and to define several user settings. Backup / Restore Patient Data

Fig. 8: Patient Backup/Restore Use backup of patient data to archive patient records of already treated patients, free disk space for new cases by deleting backed up patient records, or Use restore of patient data to transfer planned patient records from a planning station to a navigation system running the

same SpineMap™ 3D software. Click on “Start Backup” to save the patient data. Click on “Start Restore” to load already saved patient data. You can use either a CD/DVD for patient data backup/restore or a folder from any other location connected with your computer. Select/deselect patient name by a mouse click. Delete the selected patient data from the system hard disk by pressing the “Delete” button. The backup/restore progress is indicated in the bar at the bottom of the window.


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“Change user settings” dialog For different users logged into the Navigation System, different user settings can be specified and stored. To satisfy individual preferences, we recommend assigning individual user IDs (logins) to different users of the navigation system. The user might change the appearance of planning and navigation screens in different ways. Enter here the address of your Stryker support center. This data will appear if you click the “Get support…” item or if the system assumes that the user needs help.

Fig. 9: User Settings for Planning

Planning Colors Enter your preferred colors for the different entities of Planning. Clicking the color field offers a range of colors that still can be enlarged by clicking the button “more” which then appears. Image Annotations Adapt the image annotations if necessary. Selecting or deselecting the listed items lets them appear or disappears on the pa-tient image. The sample image shows the effects simultaneously. Note that the patient name set by radiology cannot be affected here.

Displayed Orientation Select the default display orientation for the image set (“Posterior “up”, “Anterior up” or “Head up”). Automatic Image Contrast for New Image Sets If “Automatic Image Contrast…” is selected, the images of the series to be loaded next are dis-played according to a heuristic, histogram-based algorithm. If deselected, the images of the series to be loaded next will be displayed with the same contrast as currently adjusted. Note that the automatically computed contrast will also be used as default for Surface Refinement, if the contrast is not changed manually during Planning. Default Selection Set the default selection for screws, measurements, annotations, planes, or trajectories in order to make all of the selected items visible during the planning phase. If deselected, you can show or hide the items by clicking the appropriate button.


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Fig. 10: User Settings for Navigation

Fig. 11: Full Screen Display for Navigation

Navigation

Colors Enter your preferred colors for the different entities of Navigation. Sound Select your preferred sound features. “Button click feedback” triggers a click sound each time an instrument button is pressed. “Action feedback” triggers a pronounced “OK” when a reference point is accepted during setting of reference points. Accuracy Select “Show predicted error zones for Point to Point registration” if you prefer to see an indication of predicted error zones as result of this registration type. If preferred, select “Show current point tickmarks”. This option adds ruler-like marks to the current point crosshairs. Select “Display current tool tip position” if you prefer to have the tool tip coordinates displayed in the status bar during naviga-tion. Views Use “Default zoom factor” to set the default value for navigation. Select “Show video when tool not visible” if you prefer to change to the video input image as one large image in the image box when no navigation tools are visible. Select “Automatic full screen…” if you want the system to enlarge the image box to a full screen automatically after a certain delay, when no tool button has been pressed. Select “Use perpendicular cut…” if you want to see a cut perpendicular to the tool axis in the 3D model. This is only valid for instruments with defined axis.


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Fig. 12: User Settings for Stryker Contact

Stryker Contact

Here, user or Stryker representative can enter the necessary contact information. It can be looked up from the start-up page “Get support…”

“Change video settings” dialog

Fig. 13: Video Settings

Different video sources (endoscopes, etc.) can be connected to the system VIDEO IN input. Use the “Change video settings” dialog to select the appropriate settings for your avail-able video source. Video Preset Select here one of the previously saved set-tings, if available. To save current video settings, click the “Save As...” button. Video Norm Select NTSC or PAL as format of the current video source.

Input Channel Select either “Composite” in case of a BNC connector or “SVideo” in case of a serial video connec-tor as the current input channel. Undo Resets the video settings to those previously saved under this name.


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4.5 Help “Open user manual” opens the PDF file of this manual. With “Get support…” you receive the contact information for support items entered in the

“Change user settings” dialog. With “About…” you receive information about the current software version and about the in-

stallation history.

Fig. 14: Get Support

Fig. 15: About…


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5 Scanning Patient Image Sets Scanned image sets of the patient in appropriate quality are crucial for accurate navigation. Note the following prerequisites that must be followed CT and MRI imaging:

Fig. 16: Scan without Gantry Tilt

Fig. 17: Scan from Inferior to Superior

Fig. 18: Scan the Entire Region of Interest

No oblique angle of locator/survey lines. No gantry tilt (CT) Perform axial scan from inferior to superior. DO NOT scan from superior to infe-rior. Scan including one vertebra above and below vertebra(e)of interest

To achieve optimum image quality: Keep slice thickness, gap and field of view (FOV) to a minimum. However, ensure to scan the

entire area/pathology of interest. Verify image orientation and scan quality (no motion artifacts).


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Note the following chart with the coverage requirements for different anatomic parts. Anatomy FOV / Coverage Chart Pelvis Include entire pelvis - skin to skin; 50 mm above crest, 50 mm below

lesser trochanter; minimum FOV to cover area of interest/pathology/ coil

Hip Include affected hip; crest to 50 mm below lesser trochanter; lateral skin line to 50 mm PASS midline symphysis; minimum FOV to cover area of interest/pathology

Knee Skin to skin; include approximately 80-100 mm of tibia; minimum FOV for area of interest/pathology/coil

Upper Extremity Skin to skin; include joint closest to area of interest, if not both joints; minimum FOV to cover area of interest/pathology/coil

Lower Extremity Skin to skin, include joint closest to area of interest; minimum FOV to cover area of interest/pathology/coil

Note the following scan parameters: All images must have the same series ID. The field of view (FOV) must respect the coverage requirements.

Refer to the FOV/coverage chart before. Pixel/Matrix must be square – 512 x 512 best; 256 x 256 minimum. For CT: Slice thickness – 1-2 mm best; 3 mm maximum,

constant, contiguous, no gap, no overlapping soft tissue windows (if helical, reconstruct in axial slices)

For MRI: Slice thickness – 1-2 mm best; 3-6 mm maximum, Gap: 0 best, 30% maximum, no overlapping, T1 or T2 Axial, 2D SINGLE echo only

Note for patient positioning: Patient must be in supine position, with feet first. Contrast agents may be used before scanning. Note the data archiving prerequisites: Archive image data in an UNCOMPRESSED DICOM ONLY format on CD, DVD, Network,

Optical Disk or USB thumb drive. Exclude scout/localizer on archive Note for scan review: There must be no motion artifacts. The region of interest must be visible. The patient image orientation must be correct

Allowed Image Orientation (CT / MRI)

P/F* A/F* R/F* L/F*L/P* R/P* R/A* L/A* * L = Left, R = Right, A = Anterior, P = Posterior, H = Head, F = Feet


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6 Image Set Importing CT, MR, or PET data, which are the scanned images of the patient, is the first step for any planning procedure.

Make sure that you read and understood the Imaging Protocol for SpineMap™ 3D Navigation before scanning a patient. Make sure that you read and understood the Safety Information for SpineMap™ 3D Navigation before importing patient data.

Fig. 19: Image Set Area

The image-set page contains all im-port functionalities to easily load im-age data from various media via the media selector into the system. The Media can be: CD or DVD, Magneto Optical Disk (MO) device, removable media, or Network. If an image set has an unknown mo-dality, the system prompts you to select a modality (CT, MR, or PET) for loading. With “Browse…” the hard disk can be browsed. The selected image set is loaded and shown in the image preview box as multiplanar or slice view. Details of the image sets are listed in the media content tree and under the image preview box.

Note that the order of the displayed entries in the media content tree can be rearranged by clicking on the table header. There are two tabs under the image box. Click on “Slices” to switch to a slice sequence view. Click on “Multi Planar” to switch to the multi-planar and 3D view. The application performs consistency checks on image series to detect and select the most appro-priate images for navigation use. If the module cannot decide automatically, the user is prompted with options (like deselect, change orientation, etc.) to manually correct the image set to fit the sys-tem. It is the surgeon’s responsibility to use only admitted image sets. The patient images must be imported successfully before patient treatment.

Image preview box Media content tree

Target patient record

Media selector


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With the selection of images, you define the image data available for treatment. Before any patient treatment, carefully examine the images which were taken of the patient. To import new images follow these steps: 1. Insert media containing images, e.g., CD, DVD or a memory stick, into the Navigation System.

The system detects automatically the media and shows the content within the media content tree view. In case of a memory stick or MOD, browse the media selector.

2. If images arrive via the network, select the Network option in the upper right media selector, the media content tree view lists available image sets of patients.

3. Select a patient. 4. Select image sets for preview in the media content tree view. For more information on picking

image sets, refer to chapter 5.1 “Previewing Images”. 5. Verify image sets (image orientation, number of slices, etc.) using the slice sequence or Multi-

planar preview. Make appropriate changes, if required. 6. Images not suited for navigation are deselected. You may select them for import in the Slice

Sequence view. 7. Select an existing or create a new patient record, to which you will assign the images. 8. Press “Import” button to load new images into the patient record. 9. Check and confirm image-set parameters. The surgeon has to ensure that the images shown meet the expected direction of view. The preview function can be helpful for this decision. ANALYZE™ 7 raw data files might not contain all relevant data required to immediately load the patient images. In this case, specify missing parameters. Carefully verify given parameters like image orientation and assignment of image data to an existing or a new patient record.


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6.1 Previewing Images When picking an image set for preview from the media content tree, the image box shows the im-age sets. The software differentiates between image sets, which are suitable for volumetric display and those which are not suitable. The volumetric display is the prerequisite for patient navigation using image sets.

This icon marks image sets which are suitable for volumetric display, import and treatment. If selected, image sets are displayed in the multiplanar view in the image box.

This icon marks image sets which are not suitable for volumetric display, import, or treat-

ment. These image sets may have duplicates or other non-displayable characteristics. If se-lected, such image set is displayed only in the slice view in the image box.

While previewing the image sets, you can use this button to change the viewing direction of images between “View from head” and “View from feet”. The system initially displays the original viewing direction according to the previewed images.

After pressing the “Import” button, changes to the viewing direction are no longer possible.

Select the default display orientation for the image set (“Posterior up”, “Anterior up” or “Head up”). While previewing and using the image sets, you can use this button to choose what is shown at the top of the sagittal images. “Posterior up”, “Anterior up”, or “Head up” stand for the anatomical direction on the image that is displayed at the top of the sagittal image. When changing the sagittal image, the other images change accordingly to maintain the logic of the displayed directions. The system initially displays the default direction ac-cording to the user settings.

By clicking this button, all changes are reset to the original data settings.


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Examine every image in the image box and verify if the image orientation of the image corre-sponds with the displayed patient orientation (for example, if "A" on the image is really "anterior" in relation to the patient's position). Use the option B from the image below to change the orientation of the image. Note the following options, which occur depending on the position of the mouse cursor.

(A)

(B)

(C)

(D)

(E)

Fig. 20: Image Series Controls

(A) Mouse cursor outside the pa-tient image.

(B) Mouse cursor over the image: labels for changing the image orientation appear. If necessary, select a different orientation and check the result on the images. The surgeon is responsible for proper orientation of the images in the program. Image orienta-tions are "A" for Anterior, "P" for Posterior, "L" for Left, "R" for Right, "F" for Feet, and “H" for Head. The changed orientation can be reset to default.

(C) Mouse cursor over the image: the control panel appears: You can zoom the image in/out, print it, measure distances, move the current image plane perpen-dicularly and maximize/ minimize the image. With the

buttons you can show or hide the control panel.

(D) Mouse cursor near any edge of the patient image: the mouse cursor shape changes and the image can be moved in the im-age frame (if image is zoomed in).

(E) When you selected “Slices”, you have the choice to either accept or omit the displayed slice from the series by selecting or dese-lecting the import checkmark. Deselected images are marked by a red X across the image.

When the mouse cursor is posi-tioned over the current point cross-hairs in 2D images near the edge of the image, it changes its shape into a hand. Then you can move the current cursor point along the per-pendicular axis with the left mouse button pressed.


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6.2 Importing Images

Fig. 21: Image Import

You can import one image set after the other into the target patient re-cord by pressing the “Import” but-ton. You can assign several image sets to one patient record. Make sure the data for different patients is not mixed within one record. You can also select a given patient from the list below “Select destina-tion for import” or from the list of all patients when you click the “All patients…” button.

If no patient record is loaded (indicated by “New case” in the list), a new record is created with the patient name given in the set. When importing an image set with a name different from the patient’s name, first select the set and then the patient name – otherwise, the image set name will be used. The name of the image set displayed for planning and navigation can be adapted to the user needs, if the original radiology description is not useful (refer to chapter 7, “Configure the Image Set”). The radiology description is, nevertheless, still visible on the tool panel of the image set. Before an image import, you must verify the image-set parameters. If you want to import the image set to a patient record, the system requires a confirmation of the parameters. The successful import is confirmed in a message box. All imported image sets for the patient are listed in the “Patient Image Set List” of the target patient record. Press the “Next” button to continue with selecting the Patient page. By clicking the “Delete” button, the raw DICOM images of the selected image set are permanently deleted from the local network folder after confirmation.


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7 Patient

Fig. 22: Patient Page

Fig. 23: Patient Data

Fig. 24: Change Patient Related Data

Confirm Patient Data In the Patient page you complete patient data imported from an im-age set. You may enter a diagnosis in the Diagnosis box. If patient data is to be corrected, click the “Change patient data…” button. A window opens (see fig. 24) where you can enter the correct data. In order to proceed through the workflow it is mandatory to enter the patient’s date of birth and sex. Customize Planning and Naviga-tion Features Select or deselect the features that will be available for the current pa-tient. As a default, the system offers “Measurements”, “Planes” and “Im-age correlations”. Clicking “Save current selection as default” presets your selection for future patients.


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8 Planning

Fig. 25: Automatic Correlation

Automatic Correlation When the patient is newly loaded, and has a minimum of two image series, and at least one image se-ries is not yet correlated, the corre-lation window appears when enter-ing the planning workflow. Please choose the pairs of series to be matched automatically or via identity from the list. For more de-tails refer to chapter 7.1 “Image Correlation”.

Fig. 26: Planning Window

Configure the Image Set The Planning window offers a wide range of possibilities to adapt the patient images for optimal surgery preparation. You can perform the planning task only if patient images are available. The “Image set” dia-log appears in the tool panel when a series is selected. The selected set is listed in the pa-tient record tree view on the upper right page corner. Additionally to the description, you can provide the image set with a name. This additional image set name is neither shown nor avail-able in the Navigation dialogs. In the “Image set” dialog, possible actions are: - Change window width/level - Create a new segment - List available segments - Remove holder from 3D.


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Fig. 27: Window Width/Level

Change window width/level You can change the contrast of the images by setting the window width and window level. The different color ramps allow stressing certain anatomic structures on the images according to your needs. There are some default settings for optimal display of different tissues on CT images and an “Auto-Adjust” button for automatic adjustment. You can add or remove your own settings by pressing the applicable buttons in the window. Pressing “Undo” cancels the last step, press-ing “Restore all” cancels all changes and reconstructs the pre-vious image. Create a new segment Refer to the chapter “Segmenta-tion”. List available segments To view and modify existing seg-ments, select those from the list of available segments within this im-age set in the patient record tree view.

Fig. 28: Remove Holder

Remove holder from 3D Remove holder from 3D view if dis-turbing within the image set, by pressing “Remove holder from 3D” in the tool panel. This opens a new window. Adjust the surface level in the 3D image using the slider in such a way that the holder is no longer in contact with the patient in the image. Click on the holder in the 3D view in order to remove it from the image.


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8.1 Segmentation To mark different anatomical structures within an image set, create a segment. Segments can be overlaid on correlated image sets. Create a new segment

Fig. 29: Select Segment Type

Fig. 30: Refine Segment Selection

Create a new segment You can create new segments from the patient record tree view by opening the “New segment” item of the image set, the tree view button “Create…”, or selecting “Create a new segment” from the tool panel of the image set. The system offers different prede-fined segments. You can change the name and the color for the new segment. You can delete a segment with “De-lete” from the tree view buttons. You can select “Warn if navigated tip is about to collide with this seg-ment” to receive a warning each time a navigated tip approaches to the segment within a defined mar-gin (starting with 0 mm). This collision warning is given dur-ing navigation for all items of the navigation base series as well as the items correlated with the navi-gation base series, independent of visualization. Collision warnings are both audible and displayed in the status bar of the screen. The screen frame is displayed in red.

The volume of the segment is calculated automatically.

Segmentation can be performed manually or automatically, for maximum eight segments per se-ries. When segmentation is performed and the segment selected, the 3D image of the Multiplanar view displays only the 3D representation of the segment.


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8.1.1 Manual Segmentation

Segments can be created and modified with several editing tools in Multiplanar view. As soon as a segment type is defined, the manual segmentation tool bar is available. You can create segments manually with these tools. Segmentations can be changed with the tools explained in the following paragraphs. The three icons marked with the yellow square apply to 3D images; the five icons marked with the green square apply to 2D images.

Use this tool to change the current point without drawing anything.

Use this tool to draw in several slices at a time with a sphere-shaped brush. It is possible to change the diameter of the sphere with a slider, generated with the arrow-down symbol next to the button.

Use this tool to delete parts of the displayed graphic in a sphere-drawing mode. You can delete in several slices at a time with this sphere-shaped “eraser”. It is possible to change the diameter of the eraser sphere with a slider, generated with the arrow-down symbol next to the button.

Use this mode to delete whole structures. Click on the selected structure and the structures connected to it will be deleted.


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The function of this icon is similar to the sphere drawing mode mentioned before, but with this, you can only draw in one slice, so it’s not a sphere shaped brush, but a disc. As the arrow indicates, the diameter of the disc is changeable with a slider.

The function of this icon is an eraser disc. It is similar to the sphere shaped eraser described before, but it affects only one slice. As the arrow indicates, the diameter of the disc is changeable with a slider.

Use this tool to delete an element in a single slice. You don’t delete anything in other slices, but only in the selected slice where you use the tool.

Use this tool to fill closed structures in the selected slice. When, e.g., a circle is drawn, you can fill it with this paint-bucket-tool.

Use this tool to fill equal or similar structures in the selected slice. It is possible to change the degree of similarity with the threshold slider, generated with the arrow-down symbol next to the button. The default value for the slider is 9.


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Use this icon to cancel the most recent action. As long as you are performing patient plan-ning, there is no limit of possible steps for going back.

Use this icon to delete all classified parts of the segment. The entry of the tree view is not removed, it only becomes empty (for example, if you want to start anew).


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8.1.2 Automatic Segmentation Depending on the selected predefined segmentation type, the system offers different workflows of automatic segmentation to achieve the optimal result. Follow the instructions on the screen. As a first step, the user may limit the segmentation space by setting boundaries. The system sets the boundaries automatically outside the image of the patient. If the boundaries are not visible, you can zoom out the image until the boundaries are on the screen. By clicking on a white boundary line in the 2D image with the left mouse button, the boundary can be moved as long as the mouse button is pressed. Only the area inside the individual boundaries is used for segmentation. Note for the starting point based segmentations: Tumor Vasculature User Defined that the boundaries are automatically expanded up to the starting point if the starting point is set outside the boundaries. The system processes the segmentation showing a progress indicator with a “Stop” button next to it in the workflow’s dialog. Click “Finish” to store the segment. Click “Cancel” to cancel the segmentation workflow.

Fig. 31: Automatic Segmentation

Note that the outcome of the auto-matic segmentation depends on the data-set quality. Thus, data sets with large slice distances cause corresponding segment surface structures.


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Automatic Bone Segmentation Follow the instructions on the screen. Use the slider to adjust the grey scale (Hounsfield unit). By adjusting the grey scale, the number of the included grey values to be segmented is changed and the segment volume is increased or decreased correspondingly. Automatic Bone Segmentation is only possible for CT image sets. Automatic Segmentation The procedure for automatic segmentation is almost the same for all three types. Vasculature Tumor User Defined The workflow starts with the definition of one point in the patient’s anatomy to be segmented. Adapt the image for best visibility of the selected kind of tissue. Set the crosshair cursor in the area of the selected kind of tissue. Initially keep the tolerance value at 10 as it is the default value. Click the “Start” button. If you want to ameliorate the result, move the tolerance slider in the workflow to change the toler-ance and the system starts automatically a new segmentation. Change the tolerance until the structure has reached its best shape. Tolerance here means the range of similar colors or similar gray scale, as the system presumes that same structures are displayed in the same colors or same gray scale. Click “Replace” to change the last segmented area. In some cases, some structures are not sufficiently connected to be segmented with only one seed point. In this case, use the “More” button to add a new seed point with its own tolerance value to the already segmented item.


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8.2 Image Correlation

To correlate a pair of series means to match the anatomy contained in each series in such a way that both can be precisely overlaid and displayed simultaneously. It is particularly useful to corre-late multi-modal images (for example CT, MR) although image datasets acquired at different times can also be correlated. For image correlation, select an item in the patient record tree view. Successful correlations can only be performed if the images match well. Consider that each vertebra of a spinal column can move in relation to a neighboring vertebra depending on patient positioning. Image Correlation is offered by the system if there is more than one image set for one patient.

Fig. 32: Image Correlations

The system offers a list of all possi-ble combinations of correlations with the available image set. Select a pair of sets to calculate their correlation. Unconfirmed correlations are marked with the red icon. Select one out of four offered corre-lation methods: Full automatic matching Landmark matching Identity matching Indirect correlation If you are satisfied with the result, click "Confirm" in the lower right corner.


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Fig. 33: Correlated Images

Full Automatic Matching Automatic matching requires no user input. The system displays the results of the ongoing automatic matching step by step on the screen. If the displayed result seems sufficient, you can stop the matching by pressing the “Finish” button. To start the matching, select “Full automatic matching” from the tool panel. With “Reset Correlation” you re-store the original position of the image sets among each other.

Fig. 34 (1-2): Manual Landmark Correlation

Landmark Matching In this technique, the user chooses a series of anatomic reference points (at least three) in each image set. These points should be dis-crete landmarks which are easy to visualize in both image series to be matched.

Define at least three pairs of anat-omic reference points in the two image sets to be matched. How-ever, it is useful to define five or six pairs of points which are well dis-tributed throughout the displayed volume. To do so, select a point in the left image set and press the left “Set…” button for Landmark 1. Then, select the corresponding point in the right image set and press the right “Set…” button for Landmark 1. Repeat this for the subsequent pairs of points. The cursor is set at the defined image point after it is selected.

Click “Link Images” to correlate the images or to decouple them if al-ready correlated.


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Note the computed deviation values. They refer to the digitized points and not to the complete matching. You can take out a pair of points from the correlation by deselecting it with the appropriate check mark. This action does not delete the points, but take them out of the calculation. Identity Matching

Select “Identity matching” to correlate two series taken with the patient precisely in the same posi-tion. Thus, the correlation procedure can be abbreviated remarkably. Indirect Correlation

Select “Indirect correlation” to correlate two series, which are correlated with the same third series. By selecting indirect correlation, the direct correlation does not need to be performed and the cor-relation procedure can be abbreviated.

Fig. 35: Manual Correlation Corrections

Manual Matching Correction With the series-fusion tool on the top of the image box, you can change the appearance of one im-age series with respect to the other. This function is available for all se-ries. Unconfirmed correlations can al-ways be changed manually. For this purpose, one image set can be moved with the matching handles while the other stays fixed. If automatic matching is not satis-factory, the manual matching can be used to roughly align two image sets. Using this alignment as a ba-sis, repeat the automatic matching in order to successfully and exactly align both sets.

Matching handles


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8.3 Screws Screw Planning allows for planning and simulating the implantation of various screws. Screw Planning assists you with: • Finding anatomical structures for best placement of screws • Selecting diameter and length of screws • Finding the optimal position and orientation of the screws

Fig. 36: Screw Planning

Click on the “Screws” item in the patient record tree view. From here, you can start the screw planning feature by: opening the “New Screw… item clicking on the tree view button

“Create…” clicking on an image set link listed

in the tool panel


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8.3.1 Screw Placement For placing a screw, perform the following steps: 1. Click "New Screw". 2. Select a point representing the virtual-screw-head on the image. 3. Click “Set Head Point”. 4. Select a point representing the virtual-screw-tip (axis point) on the image. 5. Click “Set Axis Point”. With the handles near head point and axis point, you can refine the screw placement. Changing the head point you can move the screw completely. By changing the axis point you can turn the screw around the head point. Moving the mouse over the midline of the screw, the mouse cursor shape changes and the screw can be moved without changing its orientation

Fig. 37: Setting New Screw

Fig. 38: Screw Definition

Set length, diameter, and head (i.e. the diameter of the head) using the sliders, the size arrows, or entering the values in the tool panel. Note that the length slider changes the length in 5 mm steps while the arrows at the ends of the slider change the length in 1 mm steps. Head and diameter are changed in 0.5 mm steps. If desired, change name and color of the screw.


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8.3.2 Screw Oriented View

Fig. 39: “Screw Oriented” View

The “Screw Oriented” view consists of the following image windows: Perpendicular means that the

image plane is perpendicular to the screw (red window frame).

Along 0 Degree means that you see an image plane along the screw axis (green window frame).

Along 90 Degree means that you see an image plane along the screw axis perpendicular (90 degree) to the “Along 0 Degree” view (blue window frame).

The colored lines define the loca-tion of the planes in the other win-dows. In the "Along 0" and in the "Along 90" windows, the red dotted lines show the plane perpendicular to the screw axis. The "Perpendicular" window displays the perpendicular cut of the screw at the red plane.

Like the trajectories, you can move the red dotted lines when the mouse pointer placed on them changes into a hand. Move the lines and observe the changes of the anatomic environment along the planned screw in the "Perpendicular" window. Screws and blue or green colored dotted lines in the "Perpendicular" window can be moved analo-gously. The green line represents the "Along 0" plane, the blue line the "Along 90" plane. Moving these lines produces a circular movement of the appropriate planes around the screw axis.


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8.4 Measurements On each image, the user can execute length and angle measurements. These measurements are stored and can be displayed when necessary. Click on the “Measurements” item in the patient record tree view. From here, you can create a new measurement by: Opening the “New Measurement” item Clicking on the tree view button “Create…” Clicking on the image set link on which a new measurement is to be defined with the tool panel With the handle icons on the ends of the line, you can move the line and thus, redefine the meas-urement. If the handle icons are not available, click “Show” beside the corresponding “Set …” but-ton. The angle measurement displays both inner and outer angle values.

8.4.1 Length Measurement

Fig. 40: Length Measurement

Define with the crosshair cursor two end points of a virtual line in one image. Then, the system displays the defined line and the distance between the two points. Rename the measurement if desired and select a color.


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8.4.2 Angle-3-Point Measurement

Fig. 41: Angle-3-Point Measurement

Define with the crosshair cursor three points which form an angle defined by two lines on the image. Then, the system displays the lines and the angle formed by the two lines. Rename the angle measure-ment if desired and select a color. With the handle icons on the ends of the lines, you can move the lines and thus, redefine the angle meas-urement.

8.4.3 Angle-2-Line Measurement

Fig. 42: Angle-2-Line Measurement

Define with the crosshair cursor two lines by setting their end points. Then, the system displays the lines and the angle formed by them. Re-name the angle measurement if desired and select a color. With the handle icons on the ends of the lines, you can move the lines and thus, redefine the angle meas-urement.


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8.5 Annotation Points Each point in each image can be annotated with personal notes to mark a point of interest. Click on the “Annotations” item in the patient record tree view. From here, you can create a new annotation by: Opening the “New Annotation Point” item Clicking on the tree view button “Create…” Clicking on the image set link on which a new annotation point is to be defined with the tool

panel

Fig. 43: Annotation

Place the crosshair cursor where you want the annotation to be, click “Set Point”, rename if desired and select a color. You may also add values and a description if required. With the “Warn if…” checkmark, you can select to receive a warning each time a navigated tip ap-proaches to the annotation point in a defined margin (minimum of 1 mm).

The annotation point on the basis image set selected for one patient can be seen from other image sets if correlated. If you click on any defined annotation point in the tree view, the system displays it in the multipla-nar view images. The “Show Point” button effects the same.

“Show/Hide Annotation Points” Button With this button you can show or hide all annotation points within an image set.


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8.6 Planes The user may add planes to each image. Planes are defined by defining two or three points in the image, depending on the desired definition mode. They can be used to plan cutting planes as they can be displayed in the navigation stage. The user may define color and text label for each plane. Click on the “Planes” item in the patient record tree view. From here, you can create a new plane by: Opening the “New Plane” item Clicking on the tree view button “Create…” Clicking on the image set link on which a new plane is to be defined with the tool panel The shape of the plane can be selected between ellipse and rectangle. Size of the planes, their opacity and rotation can be changed with the corresponding sliders.

“Show/Hide Planes” Button With this button you can show or hide all planes within an image set. If it is turned on, the system displays the angle in-between the selected and all other planes.

8.6.1 Axis Definition

Fig. 44: Plane from Axis Definition

Define with the crosshair cursor two end points of a virtual axis in one image. Then, the system displays the plane which lies perpendicular to the defined axis. Rename the plane if desired and select a color. With the handle icons on the ends of the axis, you can move the plane by dragging the axis. Click “Show” if you are not exactly over the end points of the axis to make them visible. The distances between the plane and the ends of the axes are displayed. With the hand on the displayed plane, you can move the plane along the definition axis.


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8.6.2 3 Points Definition

Fig. 45: Plane from 3 Points Definition

Define with the crosshair cursor three points lying on a virtual plane in one image. Then, the system displays the plane which connects the three definition points. Rename the plane if desired and select a color. With the handle icons on the dis-played plane, you can move the plane on the image. If the handle icons are not available, click “Show” beside the corresponding “Set Plane Point” button.


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8.7 Trajectories The trajectories task allows the user to define surgical trajectories by selecting target and entry points in image displays. This allows for visualizing of a planned surgical trajectory in the image data either in 3D renderings or various 2D planes. Click on the “Trajectories” item in the patient record tree view. From here, you can create a new trajectory by: Opening the “New Trajectory… item Clicking on the tree view button “Create…” Selecting an image set link listed in the tool panel

Fig. 46: Trajectories

Create a new trajectory When creating a new trajectory, you can change the proposed name and color of the trajectory. Then set the target and the entry point in the images. When target point or entry point are set, you can move the cursor to the applicable point if you click the “Show” button. The images are displayed accordingly. With the check marks, you can se-lect or deselect displaying the point. Deselecting the display does not delete points.

Fig. 47: Trajectory Oriented View

Trajectory assessment For assessment of the trajectory, the system offers the Trajectory Oriented View. Thus, you can visu-ally follow the trajectory slice-by-slice on the screen, through a per-pendicular cut and two cuts along 0° and 90° with respect to the tra-jectory axis. With the mouse, you can move the trajectory (with cross arrow cursor), and change the entry or target point (with hand cursor). The Trajectory Oriented View can be accessed from the view list beneath the im-age box. Check the trajectory by grabbing (left mouse click and hold) the red disks in the “along 90” or “along 0” windows (top right or bottom left).


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8.8 Compositions

Use compositions to visualize all modalities, segments and planned items (trajectories, planes) in a scene most suited for the intended intervention. Starting with any basis image sets, compositions can be created and stored using the “Compose” and “Store” buttons above the Image Box.

Click on the “Compositions” item in the patient record tree view. From here, you can create a new composition by Opening the “store as new composition…” item Clicking on the tree view button “Create…” Selecting an image set listed in the tool panel and clicking “Store” in the image-box tools row

Fig. 48: New Composition

Fig. 49: Composition Items

Fig. 50: Composition: Object Opacity

Planned compositions are available during navi-gation.

The system offers the following default compo-sitions: “All Segments” with all defined seg-ments and “Correlation” for each correlation that has been confirmed.

A composition is defined when its name is de-fined and stored.

For a composition, you can compose any planned item from the basis set and from any patient sets correlated with it. Clicking on the “Compose” button above the Image Box offers the items like segments, trajectories, planes, or annotation points, already prepared during planning, sorted by associated image set.

Once a stored composition is selected, a list of all items already prepared in the planning is shown in the tool panel. From there, you can select or deselect the items and define their appearance on the com-position, both for 2D and 3D. Changes are dis-played immediately.

Rendering Rendering can be selected for single segments in the 3D view only. Please choose between ISO or Phong in order to change the shading.

Phong provides a more plastic image, however, it can slow down the processing.

Resolution Resolution can be changed for all images by selecting the value from the drop-down list.

Please note, that a higher resolution can slow down the processing.

Volume To display the entire 3D image of the series, select “Volume” under the “3D” tab.


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8.9 Screenshots The screenshot functions allow for the documentation of single images, the complete view or the full screen, depending on which camera button is being used.

Fig. 51 (1-2): Screenshot

In order to take a screenshot, select one of the camera buttons provided within each image (single image), above the images or in the right top corner (full screen). The system creates a screenshot with a sequential number ID at the top of the image. The screenshot images can be found under “Screenshots” in the patient re-cord tree view. The screenshots can be deleted by pressing the “Delete” button. In order to export all screenshots to-gether, click on “Export all screenshots” when the screenshot folder is selected in the patient record tree view. If you want to export only single screenshots, click on “Export screenshot” when a single screenshot is selected in the tool panel.


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9 Registration Planning With the registration planning, the surgeon or staff member is required to set the reference points for what is being registered. This applies only to CT and MR series, not for PET. Unlike on the planning page, there are only image sets in the tree view, without the additional elements defined during planning.

9.1 Reference Points Point registration is based on well known anatomical landmarks or attached markers, which can easily be found on the patient. At least three of these points have to be defined. For better registra-tions, however, Stryker recommends defining more points. These reference points are physically correlated to the landmarks at the beginning of the naviga-tion procedure, and should therefore be easy to locate on the patient. If there is more than one set for the selected patient, the user can select the appropriate set for the registration in the navigation. In each set you can define reference-point sets. In order to do so, click on the series and choose “New reference point set…”, or click the “Create…” button. Adjust the surface level of the images for best visibility of the selected reference points. If you want to delete a reference-point set, click the “Delete” button.

Fig. 52: Registration Planning Tool Panel

On the tool panel, you can define a name or change the proposed name of the point set. Also, you can define the points by clicking the crosshair cursor in the images and then clicking on “Set” to digitize the point. You have to de-fine at least three points. For higher registration accuracy, however, we recommend to define as much landmarks as possible. These land-marks are used for point registra-tion.

For adequate registration, ensure that the reference points are dis-tributed asymmetrically on ana-tomically distinctive areas, including points close to the target of the sur-gery. Avoid symmetrical distribu-tions like lines, circles, or cylinders. Select points on rigid, connected structures only. If there is a move-able joint or a fracture, select the reference points on the side where the patient tracker will be fixed.


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With the checkmark, you can switch already defined points on or off. With the “Delete Point” button, you can delete single points from the set. Points are only accepted, if they are a minimum distance of 10 mm from each other.

9.2 Surface Matching With Surface Matching, you can compare real anatomical structures of the patient with the dis-played images of the patient. Surface matching is supported for CT images, only. The Surface Matching registration needs a well defined surface level of the 3D image, which will be useful for the surface refinement for navigation. Surface Matching may enhance the point-to-point registra-tion.

For adequate matching, ensure that you use large areas, which are shaped asymmetrically, on anatomically distinctive areas, including areas close to the target of the surgery and well accessi-ble. Avoid symmetrical shapes like lines, circles, or cylinders. For navigation accuracy, make sure that the actual surface matches the displayed scanned surface.

Fig. 53: Surface Matching

Adjust the surface level with the slider in the tool panel. With “Save as Default”, this level can be saved as default for all images of the im-age set.


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10 System Setup Click on the “System Setup” tab to initialize the camera and position the system towards the oper-ating area.

Fig. 54: System Setup Page

Place a battery into the instrument, then press and hold its SELECT button to connect it. Note the difference between con-necting an instrument and activat-ing it: To connect an instrument means that the system is prepared to accept it when it will be activated. Active instruments are currently in use and are displayed on the screen. The number of connected instruments can be greater than the number of active instruments. When initializing a tracker for the first time, the user is asked to choose between "Track Instrument" and "Track Patient". Only one tracker type is active at a time. If a second tracker is activated, the first one is automatically inactivated.

The working space of the camera is indicated on the screen. The working space is the area where the instruments are visible for the camera. Position the instruments near the center of the working space to achieve the best visibility. Selecting the “Manage Tools…” item opens the tool management window where you find a list of all connected instruments. The instruments can be switched off only from this list. If required, you can start the calibration process by clicking on “Calibrate Tool”. After activation and possible validation of the navigation tracker on a tool (refer to chapter 10.2 “Tool Validation”), proceed to the registration by clicking on the “Next” button.

If the C-arm option is licensed, you can use the “Start C-arm 3D scan” to import images from your C-arm. Refer to chapter 12.5 “C-arm Image Acquisition”.


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10.1 Tool Calibration There are several situations during a surgery in which it might be necessary to calibrate a tool. If a navigated instrument fails the validation, the tool must be recalibrated before being used

for navigation. When you are adapting a conventional tool with a Tracker, the tool must be calibrated before

using it for navigation. Depending on the tool shape, there are different calibration methods: Straight Calibration is recommended for straight tools with a dedicated working axis. Point Cali-bration is intended for curved tools which do not have a dedicated working axis, or if the user is only interested in the tip position. Tool calibration is activated by switching on a Tracker for Tool Tracking, or if the tool validation fails and calibration is selected. Alternatively, you can start the tool calibration by clicking on “Calibrate Tool” on the System Setup page. When entering the Tool Calibration, please follow the instructions provided on the screen to suc-cessfully calibrate an instrument. If the calibration device is not yet activated, you are asked to switch it on: Place battery into the instrument and initialize it by pressing the SELECT button on the instrument. Depending on the selected tool shape and adapter type, the system leads you to the appropriate calibration method: Straight Calibration or Point Calibration If you do not want to perform a calibration, select “Cancel”. Note: Regard the descriptions of the calibration methods in the following chapters. The calibration work-flow is an example for straight calibration with the Vector Calibration Device (VCD). With respective changes in the images, the calibration workflow is basically the same for point calibration and for different calibration tools.


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Fig. 55: Tool Calibration, Step 1



Take the calibration device you are going to use and switch it on. Select the type of adapter you use for tool tracking. For the rotational adapter “Tool Axis Adapter” (REF 1815-1000), a point calibration is performed ini-tially. As the geometry of the axis is a known value for this adapter, the instrument is axis calibrated auto-matically if the values are reason-able. Select the shape corresponding to the tip shape of the tool you are going to calibrate. For straight cali-bration, click “Straight Tip”. Point calibration cannot be used for straight tip calibration.


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10.1.1 Straight Calibration If you are performing a straight calibration, the Navigation System software will have information about the tip position of the tool as well as the axis of the tool. Therefore, the Navigation System software will visualize not only the tip of the tool, but also the projection of the axis over the im-ages. Straight calibration is recommended for straight tools with a dedicated working axis.

Fig. 58: Tool Calibration, Step 4, Insert Instrument

Follow the instructions on the screen on how to proceed with the calibration. The calibration device and the tool to be calibrated, must be placed in the center of the working space. Insert the instrument into the cali-bration device as indicated and press the SELECT button. Note the instructions for use of the calibration device.

Fig. 59: Tool Calibration, Step 4, Final Validation

In the last step, you must verify that the calibration was successful. Vali-date the tool by centering the tip of the tool onto the applicable valida-tion disk and press the SELECT button. If this procedure is success-ful, you will be able to use this tool for navigation.


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10.1.2 Point Calibration If you perform a point calibration, the navigation software will only have information about the tip position of the tool. Therefore, only the tip of the tool will be visualized during navigation. Point calibration is recommended for curved tools which do not have a dedicated working axis, or if you are only interested in the tip position. Follow the instructions on the screen, they react to your selections of calibration device and in-strument shape.

Fig. 60: Point Calibration, Step 4

Select “Angled Tip” if you have se-lected the Vector Calibration Device (according to fig. 68): The system prompts you to touch one of the validation disks with the instrument tip in order to calibrate, and then to touch the other valida-tion disk in order to validate. If you selected a Point Calibration Device (PCD), the system leads you automatically to the point cali-bration workflow.


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10.2 Tool Validation If you activate a tool tracker/pointer for the first time, you have to validate it in order to ensure that the instrument has not been compromised geometrically.

Fig. 61: Tool Validation

Fig. 62: Tool Validation Failed

In order to validate the navigated instrument, touch the validation point of a patient tracker or a cali-bration device with the tool tip and push the SELECT button on the instrument. You can also click the "Validate Tool" button. If the tool validation is successful, the system validates the instrument data. If validation failed, the software indicates the deviation and an ad-vice that the instrument requires a new validation or, alternatively, calibration.

You can perform a validation at any time during the operation by touching the validation point on the Patient Tracker with the tip of the instrument and clicking. Note: You must recalibrate the instrument with the calibration tool if the instrument might be bent, e.g., after being dropped.


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11 Registration After all required instruments are activated in the “System Setup” dialog, and a registration had been prepared in the “Registration Planning” dialog, the registration workflow starts. The user has to confirm a previously performed registration or start a new registration.

Fig. 63: Start Registration

If several registration point sets are available, you have to select one in order to digitize all previously planned points on the patient.

For navigation accuracy, do not let a moveable joint or a fracture be located between your rigidly fixed tracker position and your surgical site. Ensure that the patient tracker is rigidly fixed to the same bone that is registered because the scanned patient position usually differs from the intra-operative pa-tient position. Always register each vertebra indi-vidually since scanned vertebra position and actual position may not match.


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11.1 Point-to-Point Registration

Fig. 64: Digitize Points

Digitize all points which you planned before by touching the displayed point with the tool tip on the patient and clicking SELECT. After 3 digitized points, a registra-tion can be calculated. Instantly, you see a mean deviation value. Note that the mean deviation value only relates to the digitized points and not to the complete registra-tion. After all points are digitized, the cursor is automatically set to the “>” button.

Points can be re-digitized if you highlight the related point: A first click deletes the point and a sec-ond click stores the new point position. If you are satisfied with the digitized points, click on “>” to proceed to the confirmation dialog. When selected in the “Change user settings” dialog, the system displays the predicted error zones on the 2D images after digitizing 4 points. Best accuracy will be achieved in the green zone. The green zone should cover the operation area. It is not recommended to operate in the yellow or red zones.


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Confirmation

In the “Confirmation” dialog, you must check the result of the registration by checking well known landmarks on the patient.

As the point-to-point registration never fails, it is very important to follow the verification instructions given in the “Confirmation” dialog.

Fig. 65: Confirm Registration

Fig. 66: Improve Registration

Use the zoom and the rotate 3D functions to verify the displayed landmarks on the images. When satisfied, click “Accept” and then the system allows you to con-tinue with the navigation. Other-wise, click “Reregister” to repeat the registration process. For the image box tools “Zoom” and “Rotate 3D Image” refer to chapter 12.5.7 and 12.5.8 respectively. After confirmation, the system of-fers you automatically to improve the registration with the “Surface Refinement” dialog.

The system provides the possibility to improve a confirmed “Point-to-Point” registration if the refer-ence point set has not been changed. When you open the “Registration” dialog again, you can select between “Confirm Registration”, “Start Registration”, “Surface Refinement”, and “Define Rescue Points”. Selecting “Start Registration” brings you to a new selection page: Make your choice between “Im-prove registration”, “Start new registration”, and “Cancel”.


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11.2 Surface Refinement Selectable image sets is the CT image set that has been used for the base registration as well as CT image sets which are correlated with this base sets.

Fig. 67: Adjust Surface Level

Select the image set, which will be the base for the surface refinement. Optionally, click “Adjust the surface level” and adjust the surface level until you receive the optimal sur-face display according to the sur-face of the patient you will be work-ing on. This means the surface where the real patient matches the scanned patient. When satisfied, click “>” to proceed.

The system prompts you to digitize at least 30 surface points. For adequate registration, ensure that the surface points are distributed asymmetrically on ana-tomically distinctive areas, including points close to the target of the surgery. Avoid symmetrical distributions like lines, circles, or cylinders. Select points on rigid, connected structures. If there is a moveable joint or a fracture, select the surface points on the side where the patient tracker will be fixed. Ensure that surface matching will only be done on the vertebra which is used as a reference for navigation because the scanned patient position does not have to match the intra-operative patient position. The digitized points are displayed on the surface model, based on your initial registration. If you are satisfied with the number and distribution of the digitized points, click “>” to proceed to the confirmation dialog where you can accept or redo the registration (see also page 75). Click “Accept” if you are satisfied with the registration. If not, click “Reregister”. If surface refinement failed, or if you are unsatisfied with the result, consider repeating the initial reg-istration (point-to-point registration). With “Cancel” you reactivate the former registration. For the image box tools “Zoom” and “Rotate 3D Image” refer to chapter 12.5.7 and 12.5.8 respec-tively.

Note that the surface refinement is based on a point-to-point registration. If you have an inade-quate point-to-point registration, the surface matching will not be able to enhance it substantially.


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11.3 Registration of Rescue Points In case the registration is lost during surgery (e.g. when the patient tracker has moved relative to the registered anatomy), the rescue points shall enable the user to make a new registration, even if a re-registration is not possible because, e.g., the fiducial markers were moved. It is strongly rec-ommended to define rescue points immediately after successful initial registration.

Fig. 68: Rescue Points

The rescue point’s workflow prompts the user to digitize at least a set of four landmarks (by touching them on the patient). This set must be reachable intra-operatively. Pick a set of at least four points using a validated instrument. Click forward to proceed. The rescue points are stored and can be recovered under the Regis-tration tabs clicking “Start Registra-tion” and then selecting “Start new registration”.


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12 Navigation The current position of the tool tip of navigated instruments is displayed as moving an object on top of the images with the tip indicated as cross-hair cursor.

For axis-calibrated instruments, the projection of the tool’s axis into the image plane is shown. For point-calibrated tools, no axis projection is shown. Therefore, no image can be shown in the Tool’s Eye and Target view.

Fig. 69: Start “Navigation”

In “Navigation”, all functions se-lected on the “Patient” page can be controlled using the mouse and using the remote buttons of the navigated instruments. In the tool panel, you can select between trajectory navigation and screw navigation. Refer to the re-spective chapters 12.1 or 12.2.

Press the button with the two arrows to toggle between trajectory and screw handling options.


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Views

Possible Views Multiplanar Three navigating sections: coronal, sagittal, axial

Multiplanar 3D Three navigating sections: coronal, sagittal, axial, and one 3D image

with opaque or translucent surface properties.

Multiplanar Video Three navigating sections: coronal, sagittal, axial, and one image dis-playing the input from a defined video input device.

Multiplanar Perpen-dicular

Three navigating sections: coronal, sagittal, axial, and one image per-pendicular to the along axes.

Target

The currently selected target point is shown in an MPV reconstruction. The projected location of the current active instrument axis is displayed over the fixed image. A cone displays the position of the tool tip with respect to the target.

Screw Section of the image respecting the screw axis (along 0°, along 90°, and perpendicular to it) and one 3D image with displayed screw.

Tool’s-Eye Section of the image based on the tool axis (along 0°, along 90°, and perpendicular to it) and one 3D image.

The appearance of views on the Navigation page can be adapted to the user preferences in the “Change user settings” dialog. Depending on the entries in the “Change user settings” dialog, the image box changes to the “full-screen” mode after a defined time without instrument clicks or if the tool is not visible. (A sample can be seen in fig. 11.) The fullscreen mode can be closed by clicking “Close Fullscreen”.

Fig. 70: Select Views


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Compositions In “Navigation”, the system offers a selection of trajectories, views and compositions for the patient image as they were defined during planning.

Fig. 71: Select from Planned Items

If compositions are defined in the planning, they can be selected during navigation: Compositions only show the currently selected trajec-

tory. Only compositions, which are based on the registered

base set or are directly correlated with it, are available. Select the preferred applicable image composition for the navigated operation from the listed selection points. The “Compose” button opens a pull down list where you can add/remove segments and 3D volumes to/from the current composition.


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12.1 Trajectory Navigation

Prepared trajectories on the registered image set or on images, which are correlated with the regis-tered image set, can be displayed. Select the required trajectory from the drop-down list of previously defined trajectories. Only one trajectory can be displayed at the same time. With “Define Trajectory” you can define a new entry point for the current trajectory. To do so, posi-tion the tool tip at the desired entry point and click on “Define Trajectory”. Then, the view is changed to Target view and the system prompts you to verify the newly defined trajectory and, if desired, to change the new trajectory name. The trajectory is defined and stored if you click the “Accept” button. For tools with a virtual tip extension, the physical instrument tip is taken as entry point. Note the value “Target Dist.” displayed for “Trajectories”: This value indicates the distance of the pointer to the target. The value is displayed in red, if the pointer meets the target level or passes through it. In full screen mode, the target distance is displayed within the image, near the center of the screen.

Fig. 72: Distance to Target


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12.2 Screw Navigation

Prepared screws on the registered image set or on images, which are correlated with the regis-tered image set, can be displayed.

Fig. 73: Screw Navigation

Fig. 74: Pick up or Drop Screw

Select the required screw from the drop-down list of previously defined screws. Only one screw can be manipulated at the same time. With “Modify Screw” you can define new screw values for the selected screw. With “Pick Up” you take the screw

virtually to your tool tip. With “Drop” you release the screw

from the displayed tool tip and have it displayed in the patient images.

With “Delete Screw, you delete a displayed screw from the patient image.

With “Cancel Pick Up”, you delete the displayed screw from the dis-played tool tip without releasing it on the patient image.

The screw is displayed virtually on the tool tip.


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With “Modify Screw” you can define new screw values for the selected screw. Then, the window is changed to the Define Screw window where you can change the screw attributes length, diameter and head-length. Select the item that you want to change from the right side of the image box and adapt the values with the buttons on the top of the window. Click on the “OK” button to confirm.

Fig. 75: Pick Up / Drop Screw

The “Define Screw” window is dis-played in the Screw view. Perpendicular means that the

image plane is perpendicular to the screw (red window frame).

Along 0 Degree means that you see an image plane along the screw axis (green window frame).

Along 90 Degree means that you see an image plane along the screw axis perpendicular (90 degree) to the Along 0 Degree view (blue window frame).

A screw is defined and stored if you click the “Drop Screw” button.


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12.3 Navigated Instrument Navigation During navigation, the active tracked tool is shown in the navigation images. Only one instrument can be tracked at a time. You can connect multiple navigated instruments to the system at a time. The active tool being tracked can be changed if you click the remote tool button on the tool to be activated.

Fig. 76: Sample: Tracker not Visible

Fig. 77: Low Battery Symbol

The loss of visibility of the active tool and patient tracker is reported to the user in the status bar if the system needs the current position of these trackers for the current task. A low battery status of navi-gated instruments in use is also reported to the user, if the system needs the current position of these tools for the current task.

Follow the system instructions for tool validation and calibration if they are requested.


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12.4 Navigation Image Box Tools and Image Tools The icons that show the status of the actual active tool are displayed pressed in, when their func-tion is selected. If not selected, they are displayed not pressed in. If you move the mouse cursor (icon is grey) or tool cursor (icon is blue) over the tool icon, the icon is selected but not active (deepened).

12.4.1 Freeze Image

By clicking the “freeze" button, the image becomes static and the position of the navigated instrument on the im-ages cannot be updated. In order to freeze the images, select "freeze" and click the SELECT button. The freeze icon is displayed pressed in. In order to return to the normal navigation mode, select "Freeze" and click the SELECT button again. The freeze icon is now displayed not pressed in.

12.4.2 Cut 3D Image

By clicking the "Cut 3D image" button, the 3D image is cut open at the current cursor point. The cuts are aligned to the three planes of the cursor axes. If in the “Change user settings” dialog “Use Perpendicular Cut…” is selected, you see a perpendicular cut of the 3D model respective to the navigated instrument axis. This is only valid for instruments with a defined axis.

12.4.3 Show / Hide Planes

By clicking the “show hide planes" button, the defined planes can be displayed on the image or can be hidden.


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12.4.4 Show / Hide Measurements

By clicking the “show hide measurements" button, the defined measurements can be displayed on the image or can be hidden.

12.4.5 Show / Hide Screws

By clicking the “show hide screws" button, the defined screws can be displayed on the image or can be hidden.


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12.4.6 Virtual Tip Extension and Virtual Tip Diameter

Fig. 78: Virtual Tip icon and Values

Fig. 79: Tip Adjustments

Fig. 80: Tip Extension Display

In order to virtually extend the axis of the tool, you can perform a virtual tip extension. Click the tip-extension icon. This calls up an adjustment bar: 1. Click on [v] to extend the tip. 2. Click on [^] to shorten the tip. 3. Click on [O] to finish the tip extension. Hold this button

pressed to reset the tip extension to zero. Extending is performed in 5 mm steps, while shortening is performed in 1 mm steps. The virtual diameter can be adjusted analogously in steps of 0.5 mm. The effective tip extension & diameter is displayed next to the tip extension icon.


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12.4.7 Screenshot

By clicking on the screenshot icon, the image box is cap-tured and the image is stored in the patient’s archive di-rectory. During navigation, the captured image can be seen via “Browse Images – Screenshots”.

12.4.8 Zoom In / Zoom Out

Fig. 81: Zoom Adjustment

Click the zoom icon and adapt the images to your needs by using the adjustment bar. Refer also to the paragraph “Zoom” in the chapter “Dedicated Functional Icons” of this manual. Click on [v] to zoom in. Click on [^] to zoom out. Click on [O] to finish the tip extension. Hold this button pressed to reset the zoom factor to the default value. The zoom icon only functions for 2D images. The mini-mum zoom factor is 80%. Both 2D and 3D images can also be zoomed using mouse with the middle button.


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12.4.9 Rotate 3D

If you cannot see the region of interest in the 3D image adequately, you can rotate the 3D image remotely. Click the Rotate 3D icon in the task manager, then point to the patient with the tool and press the SELECT button. Then, the 3D model is rotated in such a way that the pa-tient's side, to which the tool was pointed, is rotated in front of the screen. In order to shift the 3D image interactively, move the mouse to the border of the 3D image. Grab the 3D image with the mouse, keep the left mouse button pressed, and move it in such a way that you can see the region of inter-est. A 3D image can be rotated by clicking on the image and moving the mouse while keeping the left mouse button pressed.


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12.4.10 Annotations Each point in each image can be annotated with personal notes to mark a point of interest.

Place the instrument tip where you want the annotation to be, click the “Create annotation” icon, and rename if de-sired. Click “Accept”. When you use tools with elongated tool tips, the annota-tion point is taken from the end of the elongation.

By clicking the “Show/Hide Annotation” icon, you can dis-play or hide all annotations in the image. The annotations come from the current image sets and from the possibly correlated image sets.


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12.4.11 Intra-operative Distance Measurement With this function, the system offers easy distance measurements using any remote tool.

Fig. 82: Distance Measurement

Touch the start point of the meas-urement with the tool tip and press the SELECT button. From that moment, the instrument tip becomes the end point of meas-urement. A line between start point and tool tip is displayed. This line follows the movement of the tool tip and displays continuously the dis-tance between the points on the screen. Touch the end point with the tool tip and press the SELECT button. The line between the points and the distance value of the measurement stays visible. The system prompts you to accept or change the offered name for the measurement in order to keep it with “Create”, or to delete the measurement with “Cancel”.

When you use tools with an elongated tool tip, the measurement point is taken from the end of the elongation. If not cleared before, the measurement values are displayed until the view tab, the image set, or the workflow tab are changed. The measurement function can be used both in 2D and 3D images. “Freeze” an image in order to perform 2D measurement with the measurement tool of the Image tools, which is similar to measurement during planning. Freezing can only be performed with the mouse. Un-freezing the images leads to a reset of the measurement mode and clears all current measurements.

When you click the ruler icon, you can show or hide all defined measurements on the screen.


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12.4.12 Intra-Operative Angle-3-Point Measurement

Fig. 83: Angle-3-Point Measurement

Touch the vertex point of the angle measurement with the tool tip and press the SELECT button, then touch the first end point with the tool tip and SELECT. This defines one line. Then touch the second end point with the tool tip and SELECT in order to define the sec-ond line of an angle. Then, the sys-tem displays the lines and the angle formed by the two lines. The system prompts you to accept or change the offered name for the measurement with “Create” in order to keep it, or to delete the meas-urement with “Cancel”.



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12.4.13 Angle-2-Line Measurement

Fig. 84: Angle-2-Line Measurement

Touch the start point of the meas-urement with the tool tip and press the SELECT button, then touch the end point with the tool tip and SELECT. This defines one line. Then define the second line of the angle with the second start point and second end point in the same way with placing the tool tip and SELECT. Then, the system dis-plays the lines and the angle formed by the two lines. The system prompts you to accept or change the offered name for the measurement with “Create” in order to keep it, or to delete the meas-urement with “Cancel”.



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12.4.14 Browse Images With the Browse Images function, the system provides an additional view of original image-set slices for all image sets or on screenshots.

Fig. 85: Browse Images Function

Fig. 86: Browse Screenshots

Pressing the Browse Images icon brings up a new window in front of the current navigation window. Select an image set or the screen-shot button. Then use the tool or mouse buttons to scroll up or down to the selected image, or to finish the browse function.


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12.5 C-arm Image Acquisition

The C-arm 3D scan option allows different C-arms to be connected to the navigation system. SpineMap™ 3D Navigation System supports exclusively the following C-arms: - Siemens SIREMOBIL Iso C 3D

- Siemens ARCADIS®

Orbic 3D - Ziehm Vision Vario 3D - Ziehm Vision FD Vario 3D You need a separate license if you want to enable your navigation system to acquire images from your Siemens or Ziehm C-arm.

Fig. 87: C-arm Option on the “Home” Screen

When the C-arm license is active, you have the option to start C-arm image acquisition from the “Home” screen and from the “System Setup” screen. The C-arm must be connected to the navigation system according to the Installation Instructions supplied with the navigation system.


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12.5.1 Set-Up for Ziehm C-arms If you activate a Ziehm C-arm for the first time, you have to validate it in order to ensure that the device can be used for accurate navigation.

Fig. 88: Intra-Operative Image Acquisition Ziehm (Step 1)

Fig. 89: Select Scan Options

Fig. 90: Intra-Operative Image Acquisition Ziehm (Step 2).

Step 1 Make sure that a network connec-tion with a crossover cable exists between the C-arm and the naviga-tion system. The screen with the select option for C-arm system is only displayed if the scan is initiated from the Navigation system. If you use the "Navigated 3D" scan option on the C-arm console, the system skips this step and pro-ceeds with the step 2 of the work-flow because in this case the C-arm type is known via network. Select “Ziehm C-arm”. Then, the system offers the two options "Scan Intra-Operative" and "Transfer Im-ages": With “Scan Intra-Operative” you come to the "normal" image acqui-sition mode and the system expects a new scan. The "Transfer Images" option can be used if a navigated scan has already been performed, but trans-ferring the images via network failed. In this case, you can use this option to send the images from the C-arm again, once the network connection has been re-established. Thus, this option en-ables you to continue without hav-ing to scan the patient again. Step 2 Follow the instructions on the navi-gation screen: Switch on the re-quested instruments. You need a Patient Tracker, and a Knee Pointer or Small Pointer as C-arm digitizer.


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Fig. 93: Transfer Position (Step 4) .

Follow the instructions on the screen and validate the C-arm digi-tizer with the patient tracker. Step 3 Step 3 is reserved for Siemens C-arm; it is skipped for this Ziehm set-up procedure. Step 4 Do not move C-arm or patient dur-ing this step. Move the camera until all navigated instruments are placed within the camera’s field of view. Ensure that the C-arm is connected and is in its registration state. Use the digitization tool in order to digitize the registration points on the registration ring of the Ziehm C-arm image intensifier. With the “Up” button of the tool you can delete and re-digitize a point if necessary. When three registration points are digitized, click the “Transfer Posi-tion” button to send the positions to the Ziehm C-arm When the digitization accuracy has been accepted on the C-arm con-sole, the system is ready to scan patient. You can scan the patient with the C-arm.


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Fig. 94: Transfer in Progress (Step 4)


Start the scan. Do not interrupt the 3D scan. Stay on the foot switch until the scan is complete. Incom-plete scans cannot be used for navigation. The images are auto-matically transferred as soon as the scan is finished. Step 5

Verify the navigation accuracy by touching well known landmarks on the patient and comparing them with the displayed images. Check the image accuracy with the zoom function or rotating the 3D image. When the accuracy is ac-ceptable, click the “Accept” button. Then the images can be used as image set for the navigation sys-tem. The accepted images are available in the navigation system. The navi-gation system changes to the “Navigation” page when the images are accepted.


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12.5.2 Set-Up for Siemens C-arms If you activate a Siemens C-arm for the first time, you have to validate it in order to ensure that the device can be used for accurate navigation.

Fig. 96: Intra-Operative Image Acquisition Siemens (Step 1)

Fig. 97: Select Scan Options

Fig. 98: Intra-operative Image Acquisition Siemens (Step 2)

Step 1 Make sure that a network connec-tion with a crossover cable exists between the C-arm and the naviga-tion system. The screen with the select option for C-arm system is only displayed if the scan is initiated from the Navigation system. If you use the "Navigated 3D" scan option on the C-arm console, the system skips this step and pro-ceeds with the step 2 of the work-flow because in this case the C-arm type is known via network. Select “Siemens C-arm”. Then, the system offers the two options "Scan Intra-Operative" and "Transfer Im-ages": With “Scan Intra-Operative” you come the "normal" image acquisi-tion mode and the system expects a new scan. The "Transfer Images" option can be used if a navigated scan has already been performed, but trans-ferring the images via network failed. In this case, you can use this option to send the images from the C-arm again, once the network connection has been re-estab-lished. Thus, this option enables you to continue without having to scan the patient again. Step 2 Follow the instructions on the navi-gation screen: Switch on the re-quested instruments. The C-arm must be prepared for navigation with a C-Arm Tracker. You need a Patient Tracker and a navigated instrument which can be used as digitizer, for example a pointer.


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Fig. 101: Transfer Position (Step 3) .

Follow the instructions on the screen and validate the digitizer tool with the patient tracker. Step 3 Do not move C-arm or patient dur-ing this step. Move the camera until all navigated instruments are placed within the camera’s field of view. To continue, all tools must be visi-ble and in a stable position. If all tools are visible and do not move (stable position) the green light indicates that the system is ready to scan. You can scan the patient with the C-arm.


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Fig. 102: Transfer in Progress (Step 3)

Fig. 103: Open Browser on SIREMOBIL Iso C 3D

Fig. 104: “Patient Browser” page on SIREMOBIL Iso C 3D

Start the scan. Do not interrupt the 3D scan. Stay on the foot switch until the scan is complete. Incom-plete scans cannot be used for navigation. If the scan has been completed, the system is awaiting the images. For ARCADIS® Orbic 3D only:

The images are transferred auto-matically as soon as the scan is finished. Proceed with “Step 5”. For SIREMOBIL Iso C 3D only:

The description of the actions to be performed at the SIREMOBIL Iso C 3D is typical and may vary depend-ing on the software version installed at the C-arm. For details how to use the C-arm, refer to the user manual of the SIREMOBIL Iso C 3D. After the 3D scan at the SIREMOBIL Iso C 3D has been completed, the navigation system waits for the images to be trans-ferred. To transfer the images from the SIREMOBIL Iso C 3D to the navi-gation system, select "Browser" from the "Patient" menu at the SIREMOBIL Iso C 3D. In the "Patient Browser" locate the 3D dataset you acquired. Click on the dataset and select "Send to…" from the "Transfer" menu. DO NOT use the "Transfer" menu of the 3D main menu as this will transfer single images only.


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Fig. 105: “Send To” window on SIREMOBIL Iso C 3D


Select "StrykerNavigation" and click on the "Send" button. The navigation system recognizes automatically, when all images have been transferred successfully. The images are imported automati-cally. Proceed with “Step 5”. Step 4 Step 4 is reserved for Ziehm C-arm, it is skipped for this Siemens set-up procedure. Step 5

Verify the navigation accuracy by touching well known landmarks on the patient and comparing them with the displayed images. Check the image accuracy with the zoom function or rotating the 3D image. When the accuracy is ac-ceptable, click the “Accept” button. Then the images can be used as image set for the Navigation sys-tem. The accepted images are available in the navigation system. The navi-gation system changes to the “Navigation” page when the images are accepted.


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12.5.3 C-arm Images for Planning You can import C-arm images for planning a surgery. In this case you start the procedure the same way as described for intra-operative image acquisition. In step 1 you select your C-arm and then you select the "Transfer Images" option. Thus, existing images can be transferred via network with a crossover cable from the C-arm to the navigation system. Note that 3D image sets from C-arm image acquisitions do not provide Hounsfield units (HU) like CT scanners but are handled like CT image sets within the application. Therefore presets based on Hounsfield units (e.g. bone window, soft tissue window) might need to be readjusted per acquired image set to fit to the image data.


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Index 3 points definition 51 accuracy indication 22 add trajectory 52 administration 20 administration tools 20 angle 3 point measurement 82 angle-2-line measurement 48, 83 angle-3-point measurement 48 annotation points 49 annotations 80 automatic correlation 42 automatic full screen images 22 automatic segmentation 39 axis definition 50 backup patient data 20 bone segmentation 40 browse images 84 C-arm image acquisition 85 C-arm images for planning 93 C-arm set-up for Siemens 89 C-arm set-up for Ziehm 86 change patient data 32 colors 21 configure image set 33 confirm correlation 41 conventions 4 correlation combinations 41 correlation methods 41 create segment 35 cut 3D image 75 dedicated functional icons 10 entry point 52 freeze image 75 functional icons 9 help 24 home 17 how to read the manual 4 image annotations 21 image correlation 41 image import 31 image orientation 29 image selection 27 image series 27 image set 27 image set configuration 33 image tool icons 11 importing images 31 intra-operative distance measurement 81 introduction 7 landmark matching 42 length measurement 47 manual correlation correction 43 manual structure 5 measurements 47 messages 9 navigated instrument validation 74 navigation 68

navigation image box tools 75 navigation image tools 75 need help? 6 new images 18 patient 32 patient data 32 patient image set 25 patient record 31 perpendicular cut 22 planes 50 planning 33 point calibration 61 point registration & surface matching 56 point-to-point registration 64 previewing images 29 ready for surgery 19 recently planned 19 registration 63 registration of rescue points 67 registration planning 55 related information sources 4 restore patient data 20 rotate 3D 79 scanning 25 scene composition 53 scope 4 Screenshot 78 screenshots 54 screw planning 44 segmentation 35 segmentation boundaries 39 show / hide measurements 76 show / hide planes 75 show / hide screws 76 software control 7 sound 22 start-up page 17 stereotactic trajectories 52 straight calibration 60 surface matching 56 surface refinement 66 surgical trajectories 52 system information 7 target point 52 tool calibration 58 tool validation 62 trajectories 52 trajectory assessment 52 tumor segmentation 40 user defined segmentation 40 user settings 21 vasculature segmentation 40 ventricle segmentation 40 video input 22 video settings 23 virtual tip extension 77 zoom in/out 78


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Index of Figures Fig. 1: Toggle with Instrument Buttons ................................................................................................................................7 Fig. 2: Image Settings Box (Adjust) ...................................................................................................................................12 Fig. 3: Same 3D Image in Parallel View, 45° Perspective and 75° Perspective ................................................................13 Fig. 4: Same 3D Image with Advanced and Standard Lighting..........................................................................................13 Fig. 5: Image Settings Box (Cut)........................................................................................................................................14 Fig. 6: The 3D Model Cut along Three Planes...................................................................................................................14 Fig. 7: The Start-up Page of SpineMap™ 3D Navigation ..................................................................................................17 Fig. 8: Patient Backup/Restore ..........................................................................................................................................20 Fig. 9: User Settings for Planning ......................................................................................................................................21 Fig. 10: User Settings for Navigation .................................................................................................................................22 Fig. 11: Full Screen Display for Navigation........................................................................................................................22 Fig. 12: User Settings for Stryker Contact .........................................................................................................................23 Fig. 13: Video Settings ......................................................................................................................................................23 Fig. 14: Get Support ..........................................................................................................................................................24 Fig. 15: About….................................................................................................................................................................24 Fig. 16: Scan without Gantry Tilt........................................................................................................................................25 Fig. 17: Scan from Inferior to Superior...............................................................................................................................25 Fig. 18: Scan the Entire Region of Interest ........................................................................................................................25 Fig. 19: Image Set Area.....................................................................................................................................................27 Fig. 20: Image Series Controls ..........................................................................................................................................30 Fig. 21: Image Import ........................................................................................................................................................31 Fig. 22: Patient Page .........................................................................................................................................................32 Fig. 23: Patient Data..........................................................................................................................................................32 Fig. 24: Change Patient Related Data ...............................................................................................................................32 Fig. 25: Automatic Correlation ...........................................................................................................................................33 Fig. 26: Planning Window..................................................................................................................................................33 Fig. 27: Window Width/Level .............................................................................................................................................34 Fig. 28: Remove Holder.....................................................................................................................................................34 Fig. 29: Select Segment Type ...........................................................................................................................................35 Fig. 30: Refine Segment Selection ....................................................................................................................................35 Fig. 31: Automatic Segmentation.......................................................................................................................................39 Fig. 32: Image Correlations ...............................................................................................................................................41 Fig. 33: Correlated Images ................................................................................................................................................42 Fig. 34 (1-2): Manual Landmark Correlation......................................................................................................................42 Fig. 35: Manual Correlation Corrections ............................................................................................................................43 Fig. 36: Screw Planning.....................................................................................................................................................44 Fig. 37: Setting New Screw ...............................................................................................................................................45 Fig. 38: Screw Definition....................................................................................................................................................45 Fig. 39: “Screw Oriented” View..........................................................................................................................................46 Fig. 40: Length Measurement............................................................................................................................................47 Fig. 41: Angle-3-Point Measurement .................................................................................................................................48 Fig. 42: Angle-2-Line Measurement ..................................................................................................................................48 Fig. 43: Annotation ............................................................................................................................................................49 Fig. 44: Plane from Axis Definition.....................................................................................................................................50 Fig. 45: Plane from 3 Points Definition ..............................................................................................................................51 Fig. 46: Trajectories...........................................................................................................................................................52 Fig. 47: Trajectory Oriented View ......................................................................................................................................52 Fig. 48: New Composition .................................................................................................................................................53 Fig. 49: Composition Items................................................................................................................................................53 Fig. 50: Composition: Object Opacity ................................................................................................................................53 Fig. 51 (1-2): Screenshot ...................................................................................................................................................54 Fig. 54: System Setup Page..............................................................................................................................................57 Fig. 55: Tool Calibration, Step 1 ........................................................................................................................................59 Fig. 56: Tool Calibration, Step 2 ........................................................................................................................................59 Fig. 57: Tool Calibration, Step 3 ........................................................................................................................................59 Fig. 58: Tool Calibration, Step 4, Insert Instrument ...........................................................................................................60 Fig. 59: Tool Calibration, Step 4, Final Validation..............................................................................................................60 Fig. 60: Point Calibration, Step 4 .......................................................................................................................................61 Fig. 61: Tool Validation......................................................................................................................................................62 Fig. 62: Tool Validation Failed ...........................................................................................................................................62 Fig. 63: Start Registration..................................................................................................................................................63 Fig. 64: Digitize Points.......................................................................................................................................................64 Fig. 65: Confirm Registration .............................................................................................................................................65 Fig. 66: Improve Registration.............................................................................................................................................65 Fig. 67: Adjust Surface Level.............................................................................................................................................66 Fig. 68: Rescue Points ......................................................................................................................................................67


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Fig. 69: Start “Navigation”..................................................................................................................................................68 Fig. 70: Select Views .........................................................................................................................................................69 Fig. 71: Select from Planned Items....................................................................................................................................70 Fig. 72: Distance to Target ................................................................................................................................................71 Fig. 73: Screw Navigation..................................................................................................................................................72 Fig. 74: Pick up or Drop Screw..........................................................................................................................................72 Fig. 75: Pick Up / Drop Screw............................................................................................................................................73 Fig. 76: Sample: Tracker not Visible..................................................................................................................................74 Fig. 77: Low Battery Symbol..............................................................................................................................................74 Fig. 78: Virtual Tip icon and Values ...................................................................................................................................77 Fig. 79: Tip Adjustments....................................................................................................................................................77 Fig. 80: Tip Extension Display ...........................................................................................................................................77 Fig. 81: Zoom Adjustment .................................................................................................................................................78 Fig. 82: Distance Measurement.........................................................................................................................................81 Fig. 83: Angle-3-Point Measurement .................................................................................................................................82 Fig. 84: Angle-2-Line Measurement ..................................................................................................................................83 Fig. 85: Browse Images Function ......................................................................................................................................84 Fig. 86: Browse Screenshots.............................................................................................................................................84 Fig. 87: C-arm Option on the “Home” Screen....................................................................................................................85 Fig. 88: Intra-Operative Image Acquisition Ziehm (Step 1)................................................................................................86 Fig. 89: Select Scan Options .............................................................................................................................................86 Fig. 90: Intra-Operative Image Acquisition Ziehm (Step 2)................................................................................................86 Fig. 91: Tool Validation......................................................................................................................................................87 Fig. 92: Intra-Operative Image Acquisition Ziehm (Step 4)................................................................................................87 Fig. 93: Transfer Position (Step 4).....................................................................................................................................87 Fig. 94: Transfer in Progress (Step 4) ...............................................................................................................................88 Fig. 95: Intra-Operative Image Acquisition Ziehm (Step 5)................................................................................................88 Fig. 96: Intra-Operative Image Acquisition Siemens (Step 1) ...........................................................................................89 Fig. 97: Select Scan Options .............................................................................................................................................89 Fig. 98: Intra-operative Image Acquisition Siemens (Step 2)............................................................................................89 Fig. 99: Tool Validation......................................................................................................................................................90 Fig. 100: Intra-Operative Image Acquisition Siemens (Step 3) .........................................................................................90 Fig. 101: Transfer Position (Step 3)...................................................................................................................................90 Fig. 102: Transfer in Progress (Step 3) .............................................................................................................................91 Fig. 103: Open Browser on SIREMOBIL Iso C 3D ............................................................................................................91 Fig. 104: “Patient Browser” page on SIREMOBIL Iso C 3D...............................................................................................91 Fig. 105: “Send To” window on SIREMOBIL Iso C 3D ......................................................................................................92 Fig. 106: Intra-Operative Image Acquisition Siemens (Step 5) .........................................................................................92

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