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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)

Summary of Contents for UroNav

Page 2: ...u 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 Custo...

Page 3: ...structions 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 so...

Page 4: ...eral 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 HD...

Page 5: ...nnector 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 Fo...

Page 6: ...r 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 automaticall...

Page 7: ...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 Section 1 3 Shut Down Power OFF UroNav...

Page 8: ...t 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...

Page 9: ...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 Dyna...

Page 10: ...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...

Page 11: ...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 Com...

Page 12: ...y 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 Adva...

Page 13: ...ly 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 b...

Page 14: ...d Probe Selection 4 EM Tracker Status A The color represents the range found within the generated EM field B Green color shows tracking In Range 5 Verify live US Video feed and Biopsy Needle Trajector...

Page 15: ...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 decubit...

Page 16: ...uction 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 mous...

Page 17: ...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 Deform...

Page 18: ...tation 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...

Page 19: ...taining 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...

Page 20: ...ed 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...

Page 21: ...o 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 s...

Page 22: ...cedure 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 P...

Page 23: ...rt 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 scree...

Page 24: ...Nav 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 R...

Page 25: ...p 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...

Page 26: ...rom 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 credenti...

Page 27: ...ate 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...

Page 28: ...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 Section 3 6 Shut Down Power OFF UroNav...

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: ...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 Viewpor...

Page 31: ...asso ciated 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...

Page 32: ...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 contami...

Page 33: ...leaning 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...

Page 34: ...tion 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 Suppl...

Page 35: ...nstructions specific to your compatible TRUS probe Section 5 1 Probe Holder Attachment Section 5 UroNav Supported Supplies Page 28 Apply force until flush Install cover per the manufacturer s instruct...

Page 36: ...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...

Page 37: ...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 Gu...

Page 38: ...vo 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...

Page 39: ...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 Manu...

Page 40: ...art 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 Numbe...

Page 41: ...ber 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 C...

Page 42: ...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 A...

Page 43: ...e 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...

Page 44: ...sembly 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 Pa...

Page 45: ...ilable 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 an...

Page 46: ...ing 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 Reor...

Page 47: ...uides 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...

Page 48: ...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 De...

Page 49: ...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 Pa...

Page 50: ...eedle 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 18Gx...

Page 51: ...es 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...

Page 52: ...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 th...

Page 53: ...ote 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...

Page 54: ...sperineal 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...

Page 55: ...Tracker Status The color represents the range found within the generated EM field Green color shows tracking In Range 4 4 Note See Section 5 UroNav Supported Supplies of this document for list of US...

Page 56: ...edure 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...

Page 57: ...rovides 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 T...

Page 58: ...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...

Page 59: ...ick 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...

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