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Invivo UroNav Quick Reference Manual

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UroNav
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

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  • Page 1 UroNav 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...
  • Page 2 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...
  • Page 3 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...
  • Page 4 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.
  • Page 5 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 Foot Pedal Switch...
  • Page 6 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.
  • Page 7 Section 1.3: Shut Down - Power OFF UroNav 1. Press Shut Down from the Patient Browser Window Shut Down exits the application and powers off UroNav hardware Exit from Patient Browser Page 4...
  • Page 8 Section 1.4: Import MRI Data 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: •...
  • Page 9 Manual download MRI data with the Show All filter 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.
  • Page 10 Section 1.6: Patient Worklist – Schedule – Timeline 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.
  • Page 11 MRI Fusion Biopsy Procedure (Biopsied) (Scheduled) Right Click Context Menu Options Procedure Status Icons for DynaLync (sold separately) Delete: Deletes the patient data from the UroNav Download in Progress Upload Failed system. Go to patient folder: Takes the user directly to the...
  • Page 12 Section 2: UroNav Intra-Procedure Overview of Transrectal Targeting Steps 2.1 Review Segmentation & Targets Screen 1. Navigate to Targets / Maintain Anatomical 2.2 Tool Setup/Field Generator Positioning Alignment 2.3 TRUS Sweep & 3D Segmentation 2. Activate Target from list for viewing •...
  • Page 13 Section 2: UroNav Intra-Procedure Section 2.1: Review Segmentation & Targets Screen Preview MRI-defined prostate boundary and biopsy targets in Tri-planar MRI format 1. Image Action Icons 2. MRI-defined Target and Biopsy list or Add New Mouse pointer Targets Pan image 3.
  • Page 14 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. Confirm Biopsy Needle/Gun 3. Verify FG Tracker Connection, US Model and Probe Selection 4.
  • Page 15 Section 2.3: TRUS Sweep and 3D Segmentation 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.
  • Page 16 Section 2.3: TRUS Sweep & 3D Segmentation (continued) 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.
  • Page 17 Section 2.4: Registration - Align US Volume with MR 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 •...
  • Page 18 Section 2.5: Biopsy Navigation – Rotational Adjustment *(end-fire 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.
  • Page 19 Section 2.6: Transrectal Biopsy Procedure Navigation Guidance to Pre-Defined 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...
  • Page 20 Section 2.6: Transrectal Biopsy Procedure (continued) Locate pre-defined 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 identified 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...
  • Page 21 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 •...
  • Page 22 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...
  • Page 23 Section 3: Post-Procedure/Support Section 3.1: Post Procedure Overview and Exporting DICOM Data 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.
  • Page 24 *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.
  • Page 25 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.
  • Page 26 Section 3.4: UroNav Service Support 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.
  • Page 27 Section 3.5: Customer Resources Portal Please visit our Customer Resources Portal to view instructional video libraries, image galleries, and written resources for UroNav. Written Resources Image Gallery Video Library To Create an Account: 1. You can create a new account on our Customer Resources Portal via the following link: http:/ /www.
  • Page 28 Section 3.6: Shut Down - Power OFF UroNav 1. Press Shut Down from the Patient Browser Window Shut Down exits the application and powers off UroNav hardware Exit from Patient Browser Page 23...
  • Page 29 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 30 Section 4: UroNav Tips & Cleaning Section 4.1: UroNav Keyboard Shortcuts Key Stroke Function Workflow Context Toggle patient information bar visible/hidden N/A Display prostate volume information 2D viewport Cursor Keys Pan U/S registration, small step U/S-MR blended viewports Shift + Cursor Keys...
  • Page 31 Preparation The following steps should be followed on DynaCAD to T2W Axial High Resolution ensure proper data preparation for use with UroNav: Slice coverage from bladder to pubis, with slices 1. Configure DynaCAD to automatically calculate the angled perpendicular to the prostate/rectal gland segmentation using the recommended T2W plane.
  • Page 32 • Follow all infection control policies established by your facility to avoid cross-contamination. EM Tracker Refer to the "Cleaning and Disinfection of the UroNav EM Tracker" Section of the UroNav Instructions for Use provided with your system. EM Tracker Probe Holder Refer to the "Cleaning of the disposable EM Tracker Probe Holder...
  • Page 33 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 Arm Refer to the "Cleaning of the Stepper Arm" Section of the UroNav Instructions for Use provided with your system.
  • Page 34 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...
  • Page 35 UroNav Supported Supplies Section 5.1: Probe Holder Attachment *TRUS probe make/model and probe holder may vary. Please refer to the UroNav Instructions for Use (Section C) for probe holder installation instructions specific to your compatible TRUS probe. Install cover per the manufacturer’s instructions over transducer and UroNav probe and holder.
  • Page 36 Section 5.2: Supported Biopsy Guns & Needles for Transrectal Procedures Supported Biopsy Guns & Needles for Transrectal Procedures Manufacturer Needles Core Biopsy Needle, 18Gx20cm, CBN1820 Argon Medical Devices Fully Automated Core Core Biopsy Needle, 18Gx25cm, CBN1825 (US Biopsy®) Biopsy System, MBD-23 Core Biopsy Needle, 18Gx30cm, CBN1830 Pro-Mag™...
  • Page 37 Section 5.2: Supported Biopsy Guns & Needles for Transrectal Procedures To order additional Invivo supplies, consumable instrumentation, or accessories, please contact: Invivo Customer Service at 1-877-468-4861 BK 3000/5000 and E10C4 Supported Accessories - Available through Invivo Description Part Number Reorder Part Number...
  • Page 38 Section 5.2: Supported Biopsy Guns & Needles for Transrectal Procedures (Continued) BK Falcon EXL and 8808 Supported Accessories - Available through Invivo Description Part Number Reorder Part Number FCS0140 (Set of 3) EM Tracker Assembly 4598-007-83602 Probe Holder 4535-303-65881 FCS0134 (Set of 25)
  • Page 39 Section 5.2: Supported Biopsy Guns & Needles for Transrectal Procedures (Continued) BK Flex 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)
  • Page 40 Section 5.2: Supported Biopsy Guns & Needles for Transrectal Procedures (Continued) BK Hawk and 8808 Supported Accessories - Available through Invivo Description Part Number Reorder Part Number FCS0140 (Set of 3) EM Tracker Assembly 4598-007-83602 Probe Holder 4535-303-65881 FCS0134 (Set of 25)
  • Page 41 Section 5.2: Supported Biopsy Guns & Needles for Transrectal Procedures (Continued) GE Logiq F8 (software version R2.x.x) and BE9CS Supported Accessories - Available through Invivo Description Part Number Reorder Part Number EM Tracker Assembly 4598-007-83602 FCS0140 (Set of 3) Probe Holder...
  • Page 42 Section 5.2: Supported Biopsy Guns & Needles for Transrectal Procedures (Continued) GE Logiq F8 (software versions R1.x.x and R2.x.x) and E8C Supported Accessories - Available through Invivo Description Part Number Reorder Part Number EM Tracker Assembly 4598-007-83602 FCS0140 (Set of 3)
  • Page 43 Section 5.2: Supported Biopsy Guns & Needles for Transrectal Procedures (Continued) GE Logiq P5/A5/A5Pro/P6/P6Pro and E8C 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 44 Section 5.2: Supported Biopsy Guns & Needles for Transrectal Procedures (Continued) GE Logiq S7 (software versions R3.x.x) and BE9CS Supported Accessories - Available through Invivo Description Part Number Reorder Part Number EM Tracker Assembly 4598-007-83602 FCS0140 (Set of 3) Probe Holder...
  • Page 45 Section 5.2: Supported Biopsy Guns & Needles for Transrectal Procedures (Continued) Hitachi Arietta Precision 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 46 Section 5.2: Supported Biopsy Guns & Needles for Transrectal Procedures (Continued) Philips Affiniti 50/70 and C10-4ec Supported Accessories - Available through Invivo Description Part Number Reorder Part Number *NOTE: Probe Holder EM Tracker Assembly 4598-007-83602 FCS0140 (Set of 3) re-orders for the...
  • Page 47 Section 5.2: Supported Biopsy Guns & Needles for Transrectal Procedures (Continued) 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)
  • Page 48 Section 5.2: Supported Biopsy Guns & Needles for Transrectal Procedures (Continued) 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...
  • Page 49 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)
  • Page 50 Section 5.3: Supported Biopsy Guns & Needles for Transperineal Procedures Supported Biopsy Guns & Needles for Transperineal Procedures Manufacturer Needles Core Biopsy Needle, 18Gx20cm, CBN1820 Argon Medical Devices Fully Automated Core Core Biopsy Needle, 18Gx25cm, CBN1825 (US Biopsy®) Biopsy System, MBD-23 Core Biopsy Needle, 18Gx30cm, CBN1830 Pro-Mag™...
  • Page 51 Section 5.3: Supported Biopsy Guns & Needles for Transperineal Procedures (Continued) Supported Accessories for Transperineal Procedures Manufacturer Description Manufacturer’s Part Number Sterile 17G Grid 610-905 Sterile 18G Grid 610-906 CIVCO Sterile 14G Grid 610-977 Sterile Flat Polyethylene Drape UA2007 Latex-Free Endocavity Balloon 610-898 Perineologic* PrecisionPoint™...
  • Page 52 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) BK Flex Focus and 8848...
  • Page 53 Section 6: Transperineal Workflow 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 •...
  • Page 54 Transperineal Workflow 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. Confirm Biopsy Needle/Gun 3. Verify FG Tracker Connection, US Model and Probe Selection...
  • Page 55 Apply force until both EM trackers are flush. Position FG directly (Second generation stepper shown) over tracking device(s) following US probe Note: See Section 5: UroNav Supported Supplies insertion of this document for list of US models, probes and biopsy supplies compatible with UroNav. Page 47...
  • Page 56 Section 6.2: Transperineal Biopsy Procedure 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...
  • Page 57 Section 6.2: Transperineal Biopsy Procedure (Continued) Navigation Guidance to Pre-Defined 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.
  • Page 58 Section 6.2: Transperineal Biopsy Procedure (Continued) 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.
  • Page 59 UroNav 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...
  • Page 60 © 2018 Invivo Corporation All Rights Reserved 4598-015-71681 Rev 1...

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