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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.

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Содержание UroNav

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 60: ...2018 Invivo Corporation All Rights Reserved 4598 015 71681 Rev 1...

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