Invivo UroNav Quick Reference Manual

VERSION 3.0 QUICK REFERENCE GUIDE

Technical Support

(USA) 1-877-468-4861

International + 44 07867908926

© 2018 Invivo Corporation All Rights Reserved

4598-015-71681 Rev 1

Please visit our Customer Resources Portal to view our complete
UroNav instructional video library.

You can create a new account on our Customer Resources Portal
through the following link: http://www.invivocorp.com/member-

registration-uronav

Once you’ve created an account, you can access the UroNav Customer
Resources Portal anytime via this following link:

http://www.invivocorp.com/customerresources/uronav

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 out­patient oce network

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5

4

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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.

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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3

2

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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1

*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

1

2

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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2

1

4

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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4

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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5

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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3

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4

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)

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2

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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2

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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1

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

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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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3

4

Section 2.6: Transrectal Biopsy Procedure (continued)

Acquiring a Biopsy Sample

5. Ensure the biopsy guideline intersects the
target

• Advance the needle / Monitor needle
trajectory

6. After the biopsy sample is taken, select
Freeze or depress/release the foot pedal to
interrupt real-time, cine viewing

• Scroll through the US frames to where
the distal tip of the biopsy needle is
visualized

7. Double Click to mark the distal tip

8. Press Add to automatically record a
screen capture of the biopsy location and
associate it with the current target and
resume real-time, cine viewing

9. Repeat alignment registration for
additional samples or select next lesion
and proceed to navigate

10. Press Done when complete

Page 17

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Section 3: Post-Procedure/Support

3.1 Post Procedure Overview and Exporting DICOM Data

3.2 Uploading Procedure Data to DynaLync Server (sold separately)

3.3 UroNav Data Backup

3.4 UroNav Service Support

3.5 Customer Resources Portal

3.6 Shut Down - Power OFF UroNav

UroNav Post-

Procedure/Support

Section 3: Post-Procedure/Support
Section 3.1: Post Procedure Overview and Exporting DICOM Data

Page 18

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2

The 3D image can be zoomed and examined from
multiple viewpoints

1. Recording Commands

• Video Recording - Start/Stop acquiring
Mp4-formatted video recording

• Acquire Additional Screen Captures

2. Images Review displays all targets and associated
biopsies in 2D tri-planar MRI format

3. Target List includes screen captures collected
during the current procedure

• Each biopsy has a corresponding screen
capture

4. The Export checkbox identies screen captures to
be exported

• Select Export to choose a predened
DICOM destination

*DynaLync Prostate is an optional feature, sold
separately

Upload procedure data to the DynaLync Prostate
system for permanent storage, and subsequent
removal from the UroNav computer.

If connected to the network, data will be
uploaded automatically to DynaLync following
each procedure.

To manually transfer all biopsy data:

1. Select patient(s) from the All Patients list

2. Right Click to Upload to DynaLync

Upload Status Icons

Upload Failed

Upload Completed

Upload Not Ready

Page 19

Section 3.2: Uploading Procedure Data to DynaLync Server

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2

Backup Overview:

1. Select Setup from the main browser menu

2. Select the Service tab

3. Click the Start Backup button to backup UroNav data
to the selected external drive. Backup operation is
indicated by a progress bar. Once complete, UroNav
data is available in the external media.

4. Click the Refresh button to refresh the available
external drives in the dropdown list.

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Section 3.3: UroNav Data Backup

Page 21

The UroNav system can be connected remotely with a service representative via a support session. Support
sessions require a live network connection.

To Start a Support Session:

1. Select Setup from the main browser menu

2. Select the Service tab

3. Select Start Support Session to establish a remote
connection to a service representative. The service
representative will need to validate credentials to
gain access to UroNav.

Technical Support Contact Information:

email: [email protected]
Phone: (USA) 1-877-468-4861

Phone: (International) + 44 07867908926

2

3

Section 3.4: UroNav Service Support

1

Please visit our Customer Resources Portal to view instructional video libraries, image galleries, and written
resources for UroNav.

To Create an Account:

1. You can create a new account on our Customer
Resources Portal via the following link: http://www.
invivocorp.com/customer-registration/

2. Once you have created an account, you can access
the Customer Resources Portal anytime via
the following link: http://www.invivocorp.com/

customerresources/

Written Resources Image Gallery Video Library

Section 3.5: Customer Resources Portal

Page 22

1. Press Shut Down from the Patient Browser Window

Shut Down exits the application and powers o UroNav hardware

Exit from Patient Browser

Page 23

Section 3.6: Shut Down - Power OFF UroNav

Section 4: UroNav Tips & Cleaning

4.1 UroNav Keyboard Shortcuts

4.2 DynaCAD to UroNav Data Preparation

4.3 MR Scan Recommendations

4.4 Cleaning Overview

UroNav Tips &

Cleaning

Page 24

Section 4.1: UroNav Keyboard Shortcuts

Section 4: UroNav Tips & Cleaning

Key Stroke Function Workow Context

F12 Toggle patient information bar visible/hidden N/A

V Display prostate volume information 2D viewport

Cursor Keys Pan U/S registration, small step U/S-MR blended viewports

Shift + Cursor Keys Pan U/S registration, large step U/S-MR blended viewports

Right-Mouse Drag Adjust window/level values U/S-MR blended viewports

Mouse Wheel Scroll through image frames/slices/cine Sweep, MR volume, cine

PgUp/PgDn Scroll through images frames/slices Sweep, MR volume

Left-Mouse Drag Add segmentation points Sweep and Segmentation, U/S

Right-Mouse Drag Erase segmentation points Sweep and Segmentation, U/S

G Toggle needle guideline Biopsy Procedure, US Viewport

Mouse Wheel Reposition needle guideline depth cursor Biopsy Procedure (Freeze Mode)
Left-Mouse Click Reposition needle guideline depth cursor Biopsy Procedure (Freeze Mode)
Left-Mouse Drag Reposition needle guideline depth cursor Biopsy Procedure (Freeze Mode)

Left-Mouse

Double-Click

Place needle tip marker o of needle
guideline and reposition depth cursor

Biopsy Procedure (Freeze Mode)

Q Toggle uniform grid overlay On/O Biopsy Procedure

ALT-F Applies a horizontal ipping transformation

to the ultrasound coordinate system

Setup, Sweep Biopsy Procedure

Page 25

Section 4.2: DynaCAD to UroNav Data

Preparation

Section 4.3: MR Scan Recommendations

The following steps should be followed on DynaCAD to
ensure proper data preparation for use with UroNav:

1. Congure DynaCAD to automatically calculate the
gland segmentation using the recommended T2W
Axial High Resolution images.

2. Optimize the gland segmentation on the T2 and
approve it using the Approve button.

3. Draw 2D or 3D (preferred) ROIs for each target asso­ciated with T2W Axial High Resolution images. Create
additional sub ROI targets if desired.

4. Characterize the ROIs / targets using the PI-RADS
menu.

5. Save all the target results using the Save All
button.

6. Select the following series to export DynaCAD data
to an external media device or network DICOM
connection

- T2W Axial high resolution series

- DynaCAD STL Prostate Boundary series

- DynaCAD ROI Series

T2W Axial High Resolution
Slice coverage from bladder to pubis, with slices

angled perpendicular to the prostate/rectal
plane.

Fast/Turbo Spin Echo
2D or 3D Acquisition
Thickness ≤ 3mm

Gap 0mm
Slice Spacing ≤ 3mm

FOV ≤ 20cm
Voxel Size 1x1x3mm
Averages 2

EM Tracker

Refer to the "Cleaning and Disinfection of the UroNav EM Tracker"
Section of the UroNav Instructions for Use provided with your
system.

Refer to the Instructions for Use for detailed cleaning instructions.

• Users are responsible to provide the highest degree of infection control to patients, co-workers, and
themselves.

• Follow all infection control policies established by your facility to avoid cross-contamination.

EM Tracker Probe Holder

Refer to the "Cleaning of the disposable EM Tracker Probe Holder
before use" Section of the UroNav Instructions for Use provided with
your system.

Page 26

Section 4.4: Cleaning Overview

Page 27

Refer to the Instructions for Use for detailed cleaning instructions.

Section 4.4: Cleaning Overview (Continued)

Stepper

Refer to the "Cleaning of the Stepper" Section of the UroNav Instructions
for Use provided with your system.

Stepper Stand

Refer to the "Cleaning of the Stepper Stand" Section of the UroNav
Instructions for Use provided with your system.

Stepper Arm

Refer to the "Cleaning of the Stepper Arm" Section of the UroNav
Instructions for Use provided with your system.

Section 5: Supported Supplies

5.1 Probe Holder Attachment

5.2 Supported Biopsy Guns & Needles for Transrectal Procedures

5.3 Supported Biopsy Guns & Needles for Transperineal Procedures

UroNav Supported

Supplies

*TRUS probe make/model and probe holder may vary.
Please refer to the UroNav Instructions for Use (Section
C) for probe holder installation instructions specic to
your compatible TRUS probe.

Section 5.1: Probe Holder Attachment

Section 5: UroNav Supported Supplies

Page 28

Apply force until ush.

Install cover per the manufacturer’s
instructions over transducer and
UroNav probe and holder.

The transducer cover is not shown.

Apply force to reseat.
The transducer cover is not shown.

Page 29

Section 5.2: Supported Biopsy Guns & Needles for Transrectal Procedures

Supported Biopsy Guns & Needles for Transrectal Procedures

Manufacturer Gun Needles

Argon Medical Devices
(US Biopsy®)

Fully Automated Core
Biopsy System, MBD-23

Core Biopsy Needle, 18Gx20cm, CBN1820

Core Biopsy Needle, 18Gx25cm, CBN1825

Core Biopsy Needle, 18Gx30cm, CBN1830

Argon Medical Systems
(Angiotech)

Pro-Mag™ Ultra Automatic
Biopsy Instrument 7675

Pro-Mag™ Biopsy Needle, 18Gx20cm, 765018200

Pro-Mag™ Biopsy Needle, 18Gx25cm, 765018250

Pro-Mag™ Biopsy Needle, 18Gx30cm, 765018300

BARD®

MAX-CORE® Disposable Core Biopsy Instrument, 18Gx20cm, MC 1820

MAX-CORE® Disposable Core Biopsy Instrument, 18Gx25cm, MC 1825

MAGNUM® Reusable Core
Biopsy Instrument, MC 1522

MAGNUM® Disposable Core Tissue Biopsy Needle, 18Gx20cm, MN1820

MAGNUM® Disposable Core Tissue Biopsy Needle, 18Gx25cm, MN1825

MAGNUM® Disposable Core Tissue Biopsy Needle, 18Gx30cm, MN1830

To order additional Invivo supplies, consumable instrumentation, or accessories, please contact:
Invivo Customer Service at 1-877-468-4861

Page 30

BK 3000/5000 and E10C4

Needle Guides - Available through CIVCO
Manufacturer Description Manufacturer’s part no.

CIVCO Extended, Single-Use Biopsy Guide 610-958

Section 5.2: Supported Biopsy Guns & Needles for Transrectal Procedures

Supported Accessories - Available through Invivo
Description Part Number Reorder Part Number

EM Tracker Assembly 4598-007-83602

FCS0140 (Set of 3)

Probe Holder 4598-007-92361

FCS0136 (Set of 25)

BK 3000/5000 and E14C4T

Needle Guides - Available through BK Medical
Manufacturer Description Manufacturer’s part no.

BK Medical Single-Use Dual Biopsy Guide (All) UA1329-S
BK Medical Single-Use Biplane Biopsy Guide (Sagittal only) UA1322-S

Supported Accessories - Available through Invivo
Description Part Number Reorder Part Number

EM Tracker Assembly 4598-007-83602

FCS0140 (Set of 3)

Probe Holder 4535-303-64631

FCS0135 (Set of 25)

Page 31

BK Falcon EXL and 8808

Needle Guides - Available through BK Medical
Manufacturer Description Manufacturer’s part no.

BK Medical Extended, Single-Use Biopsy Guide UA1257S17E

Section 5.2: Supported Biopsy Guns & Needles for Transrectal Procedures (Continued)

Supported Accessories - Available through Invivo
Description Part Number Reorder Part Number

EM Tracker Assembly 4598-007-83602

FCS0140 (Set of 3)

Probe Holder 4535-303-65881

FCS0134 (Set of 25)

BK Flex Focus and 8808e

Needle Guides - Available through BK Medical
Manufacturer Description Manufacturer’s part no.

BK Medical Single-Use Biplane Biopsy Guide UA1322-S

Supported Accessories - Available through Invivo

Description Part Number Reorder Part Number

EM Tracker Assembly 4598-007-83602

FCS0140 (Set of 3)

Probe Holder 4535-303-64631

FCS0135 (Set of 25)

Page 32

BK Flex Focus and 8818

Needle Guides - Available through CIVCO
Manufacturer Description Manufacturer’s part no.

CIVCO Extended, Single-Use Biopsy Guide 610-958

Section 5.2: Supported Biopsy Guns & Needles for Transrectal Procedures (Continued)

Supported Accessories - Available through Invivo
Description Part Number Reorder Part Number

EM Tracker Assembly 4598-007-83602

FCS0140 (Set of 3)

Probe Holder 4535-303-64631

FCS0135 (Set of 25)

BK Flex Focus and 8819

Needle Guides - Available through BK Medical
Manufacturer Description Manufacturer’s part no.

BK Medical Single-Use Dual Biopsy Guide (All) UA1329-S
BK Medical Single-Use Biplane Biopsy Guide (Sagittal only) UA1322-S

Supported Accessories - Available through Invivo
Description Part Number Reorder Part Number

EM Tracker Assembly 4598-007-83602

FCS0140 (Set of 3)

Probe Holder 4598-007-92361

FCS0136 (Set of 25)

Page 33

BK Hawk and 8808

Needle Guides - Available through BK Medical
Manufacturer Description Manufacturer’s part no.

BK Medical Extended, Single-Use Biopsy Guide UA1257S17E

Section 5.2: Supported Biopsy Guns & Needles for Transrectal Procedures (Continued)

Supported Accessories - Available through Invivo
Description Part Number Reorder Part Number

EM Tracker Assembly 4598-007-83602

FCS0140 (Set of 3)

Probe Holder 4535-303-65881

FCS0134 (Set of 25)

BK Pro Focus and 8818

Supported Accessories - Available through Invivo

Description Part Number Reorder Part Number

EM Tracker Assembly 4598-007-83602

FCS0140 (Set of 3)

Probe Holder 4535-303-64631

FCS0135 (Set of 25)

Needle Guides - Available through BK Medical
Manufacturer Description Manufacturer’s part no.

BK Medical Single-Use Dual Biopsy Guide (All) UA1329-S
BK Medical Single-Use Biplane Biopsy Guide (Sagittal only) UA1322-S

Page 34

GE Logiq F8 (software version R2.x.x) and BE9CS

Needle Guides - Available through CIVCO
Manufacturer Description Manufacturer’s part no.

CIVCO Needle Guide 742-338

Section 5.2: Supported Biopsy Guns & Needles for Transrectal Procedures (Continued)

Supported Accessories - Available through Invivo
Description Part Number Reorder Part Number

EM Tracker Assembly 4598-007-83602

FCS0140 (Set of 3)

Probe Holder 4535-303-71191

FCS0055 (Set of 25)

GE Logiq F8 (software version R2.x.x) and E8CS

Needle Guides - Available through CIVCO
Manufacturer Description Manufacturer’s part no.

CIVCO Needle Guide 742-306
CIVCO Needle Guide with latex cover 742-270

Supported Accessories - Available through Invivo
Description Part Number Reorder Part Number

EM Tracker Assembly 4598-007-83602

FCS0140 (Set of 3)

Probe Holder 4535-303-71181

FCS0054 (Set of 25)

Supported Accessories - Available through Invivo
Description Part Number Reorder Part Number

EM Tracker Assembly 4598-007-83602

FCS0140 (Set of 3)

Probe Holder 4535-303-71181

FCS0054 (Set of 25)

Supported Accessories - Available through Invivo
Description Part Number Reorder Part Number

EM Tracker Assembly 4598-007-83602

FCS0140 (Set of 3)

Probe Holder 4535-303-71181

FCS0054 (Set of 25)

Page 35

GE Logiq F8 (software versions R1.x.x and R2.x.x) and E8C

Section 5.2: Supported Biopsy Guns & Needles for Transrectal Procedures (Continued)

GE Logiq P5/A5/A5Pro/P6/P6 Pro and E8CS

Needle Guides - Available through CIVCO
Manufacturer Description Manufacturer’s part no.

CIVCO Needle Guide 742-306
CIVCO Needle Guide with latex cover 742-270

Needle Guides - Available through CIVCO
Manufacturer Description Manufacturer’s part no.

CIVCO Needle Guide 742-306
CIVCO Needle Guide with latex cover 742-270

Supported Accessories - Available through Invivo
Description Part Number Reorder Part Number

EM Tracker Assembly 4598-007-83602

FCS0140 (Set of 3)

Probe Holder 4535-303-71181

FCS0054 (Set of 25)

Page 36

GE Logiq P5/A5/A5Pro/P6/P6Pro and E8C

Section 5.2: Supported Biopsy Guns & Needles for Transrectal Procedures (Continued)

GE Logiq S7 (software versions R2.x.x) and IC5-9-D

Supported Accessories - Available through Invivo
Description Part Number Reorder Part Number

EM Tracker Assembly 4598-007-83602

FCS0140 (Set of 3)

Probe Holder 4535-303-71181

FCS0054 (Set of 25)

Needle Guides - Available through CIVCO
Manufacturer Description Manufacturer’s part no.

CIVCO Needle Guide 742-306
CIVCO Needle Guide with latex cover 742-270

Needle Guides - Available through CIVCO
Manufacturer Description Manufacturer’s part no.

CIVCO Needle Guide 742-306
CIVCO Needle Guide with latex cover 742-270

Supported Accessories - Available through Invivo
Description Part Number Reorder Part Number

EM Tracker Assembly 4598-007-83602

FCS0140 (Set of 3)

Probe Holder 4535-303-71191

FCS0055 (Set of 25)

Supported Accessories - Available through Invivo
Description Part Number Reorder Part Number

EM Tracker Assembly 4598-007-83602

FCS0140 (Set of 3)

Probe Holder 4535-303-71181

FCS0054 (Set of 25)

Needle Guides - Available through CIVCO
Manufacturer Description Manufacturer’s part no.

CIVCO Needle Guide 742-338

Page 37

GE Logiq S7 (software versions R3.x.x) and BE9CS

Section 5.2: Supported Biopsy Guns & Needles for Transrectal Procedures (Continued)

GE Logiq S7 (software versions R3.x.x) and IC5-9-D

Needle Guides - Available through CIVCO
Manufacturer Description Manufacturer’s part no.

CIVCO Needle Guide 742-306

Needle Guides - Available through CIVCO
Manufacturer Description Manufacturer’s part no.

CIVCO Needle Guide 644-068

Needle Guides - Available through CIVCO
Manufacturer Description Manufacturer’s part no.

CIVCO Needle Guide 644-068

Hitachi Noblus and C41V

Supported Accessories - Available through Invivo
Description Part Number Reorder Part Number

EM Tracker Assembly 4598-007-83602

FCS0140 (Set of 3)

Probe Holder 4598-013-25761

FCS0146 (Set of 25)

Page 38

Hitachi Arietta Precision and C41V

Section 5.2: Supported Biopsy Guns & Needles for Transrectal Procedures (Continued)

Supported Accessories - Available through Invivo
Description Part Number Reorder Part Number

EM Tracker Assembly 4598-007-83602

FCS0140 (Set of 3)

Probe Holder 4598-013-25761

FCS0146 (Set of 25)

*NOTE: Probe Holder
re-orders for the
Philips C10-4ec
must be purchased
directly from CIVCO
(Manufacturer’s part
#667-145)

*NOTE: Probe Holder
re-orders for the
Philips C10-4ec
must be purchased
directly from CIVCO
(Manufacturer’s part
#667-145)

Page 39

Philips Epiq 5/7, Anity and C10-4ec

Needle Guides - Available through CIVCO
Manufacturer Description Manufacturer’s part no.

CIVCO Needle Guide End-re 667-133
CIVCO Tracking Bracket for Endocavity Transducer 667-145

Section 5.2: Supported Biopsy Guns & Needles for Transrectal Procedures (Continued)

Supported Accessories - Available through Invivo
Description Part Number Reorder Part Number

EM Tracker Assembly 4598-007-83602

FCS0140 (Set of 3)

Needle Guides - Available through CIVCO
Manufacturer Description Manufacturer’s part no.

CIVCO Tracking Bracket for Endocavity Transducer 667-145
CIVCO Needle Guide 667-133

Philips Aniti 50/70 and C10-4ec

Supported Accessories - Available through Invivo
Description Part Number Reorder Part Number

EM Tracker Assembly 4598-007-83602

FCS0140 (Set of 3)

Page 40

Philips iU22 and C9-5ec

Section 5.2: Supported Biopsy Guns & Needles for Transrectal Procedures (Continued)

Supported Accessories - Available through Invivo
Description Part Number Reorder Part Number

EM Tracker Assembly 4598-007-83602

FCS0140 (Set of 3)

Probe Holder 4598-010-06681

FCS0105 (Set of 25)

Needle Guides - Available through CIVCO
Manufacturer Description Manufacturer’s part no.

CIVCO Needle Guide 613-246
CIVCO Needle Guide with Cover 613-245

Philips HD11XE and C9-5ec

Supported Accessories - Available through Invivo

Description Part Number Reorder Part Number

EM Tracker Assembly 4598-007-83602

FCS0140 (Set of 3)

Probe Holder 4598-010-06681

FCS0105 (Set of 25)

Needle Guides - Available through CIVCO
Manufacturer Description Manufacturer’s part no.

CIVCO Needle Guide 613-246
CIVCO Needle Guide with Cover 613-245

Needle Guides - Available through CIVCO
Manufacturer Description Manufacturer’s part no.

CIVCO Needle Guide End-re 676-132

Supported Accessories - Available through Invivo
Description Part Number Reorder Part Number

EM Tracker Assembly 4598-007-83602

FCS0140 (Set of 3)

Probe Holder 4598-007-92371

FCS0164 (Set of 25)

Page 41

Siemens Acuson X150/X300 and EC9-4

Section 5.2: Supported Biopsy Guns & Needles for Transrectal Procedures (Continued)

Needle Guides - Available through CIVCO
Manufacturer Description Manufacturer’s part no.

CIVCO Needle Guide 676-157

Siemens Acuson S2000 / S3000 and MC9-4

Supported Accessories - Available through Invivo
Description Part Number Reorder Part Number

EM Tracker Assembly 4598-007-83602

FCS0140 (Set of 3)

Probe Holder 4598-007-92382

FCS0165 (Set of 25)

Needle Guides - Available through CIVCO
Manufacturer Description Manufacturer’s part no.

CIVCO Needle Guide 674-015

Page 42

Section 5.2: Supported Biopsy Guns & Needles for Transrectal Procedures (Continued)

Sonosite MicroMaxx® and C8x

Supported Accessories - Available through Invivo

Description Part Number Reorder Part Number

EM Tracker Assembly 4598-007-83602

FCS0140 (Set of 3)

Probe Holder 4535-303-65891

FCS0078 (Set of 25)

Supported Biopsy Guns & Needles for Transperineal Procedures

Manufacturer Gun Needles

Argon Medical Devices
(US Biopsy®)

Fully Automated Core
Biopsy System, MBD-23

Core Biopsy Needle, 18Gx20cm, CBN1820

Core Biopsy Needle, 18Gx25cm, CBN1825

Core Biopsy Needle, 18Gx30cm, CBN1830

Argon Medical Systems
(Angiotech)

Pro-Mag™ Ultra Automatic
Biopsy Instrument 7675

Pro-Mag™ Biopsy Needle, 18Gx20cm, 765018200

Pro-Mag™ Biopsy Needle, 18Gx25cm, 765018250

Pro-Mag™ Biopsy Needle, 18Gx30cm, 765018300

BARD®

MAX-CORE® Disposable Core Biopsy Instrument, 18Gx20cm, MC 1820

MAX-CORE® Disposable Core Biopsy Instrument, 18Gx25cm, MC 1825

Mission™ Disposable Core Biopsy Instrument Kit, 18Gx20cm, MC 1820MSK

Mission™ Disposable Core Biopsy Instrument, 18Gx20cm, MC 1820MS

TruGuide® Disposable Coaxial Biopsy Needle, 17Gx17.8cm, C1820A

MAGNUM® Reusable Core
Biopsy Instrument, MC 1522

MAGNUM® Disposable Core Tissue Biopsy Needle, 18Gx20cm, MN1820

MAGNUM® Disposable Core Tissue Biopsy Needle, 18Gx25cm, MN1825

MAGNUM® Disposable Core Tissue Biopsy Needle, 18Gx30cm, MN1830

Page 43

Section 5.3: Supported Biopsy Guns & Needles for Transperineal Procedures

Page 44

*Note: Perineologic parts can be ordered directly from the manufacturer by phone [phone]) or email ([email protected]).

Section 5.3: Supported Biopsy Guns & Needles for Transperineal Procedures (Continued)

Supported Accessories for Transperineal Procedures

Manufacturer Description Manufacturer’s Part Number

CIVCO

Sterile 17G Grid 610-905

Sterile 18G Grid 610-906

Sterile 14G Grid 610-977

Sterile Flat Polyethylene Drape UA2007

Latex-Free Endocavity Balloon 610-898

Perineologic* PrecisionPoint™ Transperineal Access System P1001, P1002

Page 45

Section 5.3: Supported Biopsy Guns & Needles for Transperineal Procedures (Continued)

BK 3000/5000 and E14CL4b

Supported Accessories - Available through Invivo
Description Part Number Reorder Part Number

EM Tracker Assembly 4598-007-83602

FCS0140 (Set of 3)

Supported Accessories - Available through Invivo
Description Part Number Reorder Part Number

EM Tracker Assembly 4598-007-83602 FCS0140 (Set of 3)

BK Flex Focus and 8848

BK Pro Focus and 8848

Supported Accessories - Available through Invivo
Description Part Number Reorder Part Number

EM Tracker Assembly 4598-007-83602 FCS0140 (Set of 3)

Hitachi Noblus and C41L47RP

Supported Accessories - Available through Invivo
Description Part Number Reorder Part Number

EM Tracker Assembly 4598-007-83602 FCS0140 (Set of 3)

Section 6: Transperineal Workow

6.1 Tool Setup / Field Generator Positioning

6.2 Transperineal Biopsy Procedure

Note: Refer to “Pre-Biopsy Steps” in Section 2: UroNav Intra-Procedure of this document for:

• Review Segmentation & Targets Screen

• TRUS Side-Fire Sweep & Edit 3D Segmentation

• Registration – Align US Volume with MR

Note: Refer to the Instructions for Use Appendix E for Transperineal Hardware Setup

UroNav Transperineal

Workow

Page 46

Section 6: Transperineal Workow
Section 6.1: Tool Setup / Field Generator (FG) Positioning

Initialize Navigation and Biopsy Instrument Tools

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

Note: Transperineal V2 indicates second generation
stepper

Select for 17 gauge grid with B/H side facing user

Select for 17 gauge grid with S-side facing user

Select for 18 gauge grid with B-K side facing user

Select for 18 gauge grid with S-side facing user

Select for 14 gauge grid

Note: See Section 5: UroNav Supported Supplies
of this document for list of US models, probes and
biopsy supplies compatible with UroNav.

1

3

2

Indicates rst generation stepper

Indicates second generation stepper

Note:

Page 47

Section 6.1: Tool Setup / Field Generator (FG) Positioning (Continued)

Initialize Navigation Tools to create Electromagnetic
(EM) Field for Fusion Registration, Targeting, and
Recording Biopsy Core Samples

4. EM Tracker Status

• The color represents the range found within
the generated EM eld

• Green color shows tracking “In Range”

4

4

Note: See Section 5: UroNav Supported Supplies

of this document for list of US models, probes and
biopsy supplies compatible with UroNav.

Position FG directly
over tracking device(s)
following US probe
insertion

Apply force until both EM trackers are ush.
(Second generation stepper shown)

Page 48

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 using the
Stepper and Stepper Arm devices

Failure to successfully align the US
with the MRI requires returning to the
Sweep and Segmentation screen

2. Select Target(s) and Biopsies List

Right Click for a Context Menu to:

• Delete / Rename biopsy

• View PI-RADS (if available)

• Add to record a screenshot of biopsy

location

Section 6.2: Transperineal Biopsy Procedure

2

1

4

3

Navigation Guidance to Pre-Dened Targets

3. Rotate the transducer in the stepper
assembly. Use the projected U/S plane
intersection to view the target

• The rectangular grid array provides
navigation guidance on where the
needle is to be inserted

4. Ensure the biopsy guideline intersects the
target

• Advance the needle through the
highlighted grid hole (3)

• Monitor needle trajectory

The clinician has the exibility to use the
highlighted grid hole or manually override the
selection to insert the needle

Page 49

Section 6.2: Transperineal Biopsy Procedure (Continued)

10

8

6

5

7

Acquiring a Biopsy Sample

5. When the biopsy sample is taken, select
Freeze or depress/release the foot pedal to
interrupt real-time, cine viewing

6. Scroll through the US frames to where
the distal tip of the biopsy needle is fully
deployed

7. Double Click to mark the distal tip

8. Press Add to automatically record a screen
capture the location and associate it with
the current target and resume real-time, cine
viewing

9. Repeat alignment registration for additional
samples or select next lesion and proceed to
navigate

10. Press Done when complete

Page 50

Section 6.2: Transperineal Biopsy Procedure (Continued)

This Quick Reference Guide is intended for use only with UroNav software version 3.0

To determine version number, press F1 after logging into UroNav.

© 2018 Invivo Corporation All Rights Reserved

4598-015-71681 Rev 1

Page 51

© 2018 Invivo Corporation All Rights Reserved

4598-015-71681 Rev 1