Invivo UroNav User manual

UroNav
VERSION 3.0 QUICK REFERENCE GUIDE
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© 2018 Invivo Corporation All Rights Reserved
4598-015-71681 Rev 1

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Section 1: UroNav Pre-Procedure
Note: for detailed instructions on how to operate UroNav 3.0, please refer to the Instructions
for Use provided with your system.
1.1 Connections to Peripheral Equipment
1.2 Power ON Sequence
1.3 Shut Down - Power OFF UroNav
1.4 Import MRI data
1.5 Downloading MRI data using DynaLync (sold separately)
1.6 Patient Worklist & Schedule
• Patient Scheduling
• Timeline
• Screen layout / Icons
UroNav
Pre-Procedure

Page1
Section 1: UroNav Pre-Procedure
Rear Panel Connections
Front Panel Connections
Section 1.1: Connections to Peripheral Equipment
1. Wireless: Keyboard, mouse (not pictured)
2. S-video Input: Ultrasound video input
3. USB: 3-pedal foot switch, supplied with UroNav
system, and end-user supplied portable USB
memory drives
4. HDMI Video Input: Ultrasound video input
5. RJ-45 Network Coupler: End user hospital or out-
patient oce network
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2

6. EM Tracker connectors x 4 (arrows on the cable connector face
forward)
7. Field Generator cable connector (red dot on the cable connector
faces forward)
8. USB: 3-pedal foot switch, supplied with UroNav system, and end-user
supplied portable USB memory drives
9. Power ON button
Front Panel Connections
Foot Pedal Switch
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6
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.
Page 2
Section 1.1: Connections to Peripheral Equipment (continued)

1. Connect the AC Mains cord set plug to the AC Mains source (not pictured)
2. Turn On the UroNav Fusion Biopsy System Mains power switch on the rear panel Mains AC appliance inlet
3. Press the power button on the front panel to power the system on. Green power switch LED will illuminate
4. The UroNav application will automatically launch, and the system is now ready for operation
Magnied Front View
Rear View
Page 3
Section 1.2: Power ON Sequence
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1. Press Shut Down from the Patient Browser Window
Shut Down exits the application and powers o UroNav hardware
Exit from Patient Browser
Page 4
Section 1.3: Shut Down - Power OFF UroNav

1. Press Import from the Patient Browser Window
Note: The last selected import option becomes the
default query node and automatically populates
patient names
2. Import from external media using the drop down
list
3. Patient Import will automatically retrieve three
series types:
• DCAD STL Prostate Boundary
• DCAD ROI (targets, if provided)
• High resolution T2 axial MRI
Note: It is suggested to import and view the MRI data
in advance of the procedure to verify data preparation
Import Drop Down List
Page 5
Section 1.4: Import MRI Data
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*DynaLync Prostate is an optional feature, sold separately
1. Press DynaLync from Patient Browser Window
a. Automatic download of MRI data for all procedures scheduled in DynaLync for the current day
b. Manual download MRI data with the Show All lter
i. “Dimmed” entries represent the DynaLync patient database only
ii. “Bright” entries result from
successful download onto
UroNav
2. Right-click on patient entry, select
Download from DynaLync from
the context menu
3. Patient Import will retrieve three
series types:
a. DCAD STL Prostate Boundary
b. DCAD ROI (targets, if provided)
c. High resolution T2 axial MRI
Page 6
Section 1.5: Download MRI Data from DynaLync Server
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1. Select patient study from the All Patient
List
2. Move patient into a Schedule or active
Worklist
Preview or Begin a New Procedure:
3. Select patient from Worklist
4. Select study from chronological Patient
History Timeline
5. Click Start to proceed to Review
Segmentation and Targets Screen
Patient Worklist & Timeline
Page 7
Section 1.6: Patient Worklist – Schedule – Timeline
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5

Delete: Deletes the patient data from the UroNav
system.
Go to patient folder: Takes the user directly to the
folder storing the patient’s procedure data.
Download from DynaLync: Transfers patient procedure
data from DynaLync Prostate to UroNav.
Upload to DynaLync: Transfers patient procedure data
from UroNav to DynaLync Prostate.
Procedure Status Icons for DynaLync (sold separately)
Procedure Status Icons (Note: Not all shown)
Download in Progress
Download Failed
Upload Failed
Upload Completed
Upload Not Ready
Download Completed
Download Cancelled
Right Click Context Menu Options
Page 8
Section 1.6: Patient Worklist – Schedule – Timeline (Continued)
MRI Fusion Patient Ready
U/S Only Patient Ready
MRI Fusion Biopsy Procedure
(Scheduled)
U/S Only Biopsy Procedure
(Scheduled)
MRI Fusion Biopsy Procedure
(Biopsied)
U/S Only Biopsy Procedure
(Biopsied)

UroNav
Intra-Procedure
Section 2: UroNav Intra-Procedure
2.1 Review Segmentation & Targets Screen
2.2 Tool Setup/Field Generator Positioning
2.3 TRUS Sweep & 3D Segmentation
• Start/Stop – Side/End Fire probes
• Edit 3D Segmentation
• Anatomical Landmarking
• Segmentation Edit Commands
2.4 Registration – Align US Volume with MR
• Edit Fusion Overlay
• Elastic Deformation
2.5 Biopsy Navigation – Rotational
Adjustment*
*End-re TRUS probe only
2.6 Transrectal Biopsy Targeting Procedure
Steps
1. Navigate to Targets / Maintain Anatomical
Alignment
2. Activate Target from list for viewing
3. Target Icon Appearance
4. Use color-coded guidance bars to locate
target
5. Advance needle when target intersects
biopsy needle guideline
6. Press Freeze after sample is taken
Scroll to visualize needle tip to record biopsy location
7. Double Click to mark needle tip location
8. Press Add to date stamp and associate
the location to the current target and
resume real-time, cine imaging
9. Repeat for subsequent targets or
Systematic Regions
10. Post Procedure Screenshots, Export,
Shutdown
Overview of Transrectal Targeting Steps

Rename: Allows changes to a selected target label.
Delete: Removes selected target.
PI-RADS: Displays Prostate Imaging Reporting and
Data System information for the selected target.
Right Click Context Menu Options
MRI-imported target
Note: The bull’s-eye for MRI-imported targets represents
the calculated center of the identied target
Manually-added target
Note: Manually added targets are visually distinct from
imported targets
MRI-imported sub-region
Note: A sub-region target is drawn in relation to the
parent target (blue)
Systematic plan region
Note: Systematic plan regions do not include a bull’s-eye
Section 2.1: Review Segmentation & Targets Screen
Section 2: UroNav Intra-Procedure
Page 9
Preview MRI-dened prostate boundary and biopsy targets in Tri-planar MRI format
1. Image Action Icons
2. MRI-dened Target and
Biopsy list or Add New
Targets
3. PI-RADS Target
Metadata
4. Target Identication
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Mouse pointer
Pan image
Zoom the image
Auto Window & Level
Show/Hide all targets

Page 10
Section 2.2: Tool Setup / Field Generator Positioning
Initialize Navigation Tools to create Electromagnetic
(EM) Field for Fusion Registration, Targeting, and
Recording Biopsy Core Samples
1. Match Depth on UroNav to Depth Display on US
2. Conrm Biopsy Needle/Gun
3. Verify FG Tracker Connection, US Model and
Probe Selection
4. EM Tracker Status
A. The color represents the range found
within the generated EM eld
B. Green color shows tracking “In Range”
5. Verify live US Video feed and Biopsy Needle
Trajectory
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Position FG directly
over tracking device(s)
following US probe
insertion Attach Tracker to Probe Holder
Apply Force Until Flush
*TRUS probe and holder may vary
Note: See Section 5: UroNav Supported Supplies
of this document for list of US models, probes and
biopsy supplies compatible with UroNav.
4

Acquire US Sweep to Reconstruct a 3D Model of the
Prostate
1. Recording Commands
2. TRUS Information / EM Tracker Status and Depth
Selection
3. Ultrasound Imaging Plane
4. Sweep Commands
A. Alternatively, the 3-pedal foot switch
may be used.
i. Press the Start button or depress
and hold the Sweep Pedal on the
supplied 3-pedal foot switch to
begin collecting ultrasound images
of the prostate gland
ii. Press the Stop button or lift the foot
o the Sweep Pedal to halt image
collection and allow for 3D
reconstruction
The sweep is best performed as a smooth, steady
motion, applying constant pressure. Sweeps of the
gland are supported with the patient in the left
decubitus, right decubitus, or lithotomy positions.
For end-re TRUS: Sweep transversely from base to
apex (or apex to base) of the prostate without rotation
and keeping the needle guide upward, closest to the FG.
For side-re TRUS: Sweep in the sagittal view and
completely from one side of the prostate to the other.
Alternatively, the sweep can be performed in the
transverse plane, perpendicular to the gland, from the
base to apex, or apex to base.
Page 11
Section 2.3: TRUS Sweep and 3D Segmentation
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Following a sweep, the default Anatomical Fiducial
Landmark Tool allows as many as six axis
endpoints be placed to support 3D reconstruction.
Segmentation Action Commands to Edit 3D Boundary:
1. Press Segment button to complete segmentation
and view 3D rendering
2. Modify boundary by clicking Action Commands
or, by dragging the left mouse button using the
default Adjust Mesh US Boundary Tool in any
viewport
Page 12
Section 2.3: TRUS Sweep & 3D Segmentation (continued)
12

A semi-automatic 3D rigid registration is applied to
both volumes. Align and superimpose the green US
prostate boundary with the magenta MR prostate
boundary using anatomical landmarks.
1. Image Action Commands
• Manually complete registration through pan,
zoom, and rotation tools
• Conrm complete alignment using multiple
anatomical landmarks in at least two planes
Verify depth setting selection when switching
imaging planes with multi-planar US probes.
2. Elastic Deformation (toggle)
• Compute Elastic Deformation only after initial, rigid registration alignment
• Based on segmentation results, Elastic Deformation maps the MR volume elastically to the US volume
3. Multi-Modality Blend Tool adjusts blending superimposition for optimal visualization
Page 13
Section 2.4: Registration - Align US Volume with MR
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3

*(end-re US TRUS probe only)
Fine tune the initial registration for possible
variances in the apex location after rotating
the probe 180° from the original sweep
orientation.
1. Select Rotational Adjustment icon in the
top left viewport
2. Follow screen prompts to rotate the
TRUS probe 180± 5° from original sweep
position
3. When indicated, press Freeze
4. Use Pan from the MR view (bottom
panel) to align the magenta contour
with the live, U/S view (top panel). Press
Apply.
Page 14
Section 2.5: Biopsy Navigation – Rotational Adjustment
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Navigation Guidance to Pre-Dened Targets
and Anatomical Alignment Maintenance
1. Image Action Commands within any
2D viewport realign the anatomical
landmarks of the magenta MR boundary
to be in line with the US image
Maintaining alignment is necessary
throughout the procedure and may
require multiple adjustments
Failure to successfully align the US
with the MRI requires returning to the
Sweep and Segmentation screen
2. Targets and Biopsies List / PI-RADS
Metadata
Right Click for a Context Menu to:
• Delete / Rename biopsy
• View PI-RADS (if available)
• Add to record a screenshot of biopsy
location Page 15
Section 2.6: Transrectal Biopsy Procedure
1
2

Locate pre-dened targets
3. Biopsy Procedure: Target Icon Appearance
MRI-imported target
Note: The bull’s-eye for MRI-imported targets represents
the calculated center of the identied target
Manually-added target
Note: Manually added targets are visually distinct from
imported targets
MRI-imported sub-region
Note: A sub-region target is drawn in relation to the
parent target (blue)
Systematic plan region
Note: Systematic plan regions do not include a bull’s-eye
4. Color-coded guidance bars (blue/yellow) assist to
navigate to the selected target
Page 16
Section 2.6: Transrectal Biopsy Procedure (continued)
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