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Profound TULSA-PRO Transurethral Ultrasound Ablation System Operator's Manual

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Transurethral Ultrasound Ablation
System
Operator's Manual
General Electric MR750w 3T

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Summary of Contents for Profound TULSA-PRO Transurethral Ultrasound Ablation System

  • Page 1 Transurethral Ultrasound Ablation System Operator’s Manual General Electric MR750w 3T...
  • Page 2 All rights reserved. No part of this document may be reproduced or transmitted in any form or by any means, electronic, mechanical, photocopying, recording, or otherwise, without prior written permission from Profound Medical Inc. Federal law restricts this device to sale by or on the order of a Physician.

  • Page 3: Table Of Contents

    Table of Contents Table of Contents PUBLISHER’S NOTICE ........................2 TABLE OF CONTENTS ........................3 1. INTRODUCTION ........................7 2. ABBREVIATIONS ........................8 3. GENERAL INSTRUCTIONS ......................9 3.a Suggested Personnel ........................9 3.b Workflow Overview ........................10 3.c Operator, Personnel, and Patient Requirements ..............10 3.d TULSA-PRO®...

  • Page 4: Table Of Contents

    Table of Contents 7.d.i To insert the ECD the first time: ..................36 7.d.ii To adjust the ECD position or address bubbles lateral to the ECD: ......37 7.d.iii If using an ECD with bubble removal channels: ............37 8. MRI PATIENT POSITIONING ....................38 8.a Securing the patient ........................
  • Page 5 Table of Contents 11.b Entering Treatment Milestones ....................74 11.c Treatment Reports ........................75 11.c.i Viewing treatment videos .................... 76 11.c.ii Exporting reports and videos ..................77 11.d Post-Treatment Session Export ....................78 12. DEVICE REMOVAL AND PATIENT RECOVERY ................80 12.a Device Removal ........................
  • Page 6 Table of Contents 41-110: The Ultrasound Applicator fluid-circuit pump pressure is too high ........ 100 42-107: The ECD fluid-circuit bag volume is too low ..............101 42-109: The ECD fluid-circuit pump pressure is too low .............. 102 42-110: The ECD fluid-circuit pump pressure is too high ............. 103 B.2.
  • Page 7 Table of Contents TULSA-PRO® Operator’s Manual Page 7 of 130 - GE MR750w 3T 111229B...

  • Page 8: Introduction

    If you need additional copies of the TULSA-PRO® Instructions For Use or Operator’s Manual for any MRI system, or have questions about this document’s contents, please contact: Profound Medical Inc. 2400 Skymark Avenue, Unit 6 Mississauga ON L4W 5K5...

  • Page 9: Abbreviations

    Abbreviations 2. Abbreviations This manual uses the following abbreviations: ECD ..... Endorectal Cooling Device MR ...... Magnetic Resonance MRI ..... Magnetic Resonance Image/Imaging/Imager PS ......Positioning System PSIB ....Positioning System Interface Box TDC ..... Treatment Delivery Console software TULSA-PRO ..Transurethral Ultrasound Ablation System UA .......

  • Page 10: General Instructions

    General Instructions 3. General Instructions 3.a Suggested Personnel The following table describes the suggested roles and responsibilities required for a TULSA-PRO® procedure. At your site, some personnel might perform multiple roles. Instructions throughout this manual are color-coded by role based on the shading colors in the following table. ROLE TYPICAL ACTIVITIES WITHIN A TULSA-PRO®...

  • Page 11: Workflow Overview

    General Instructions 3.b Workflow Overview The following table summarizes the workflow of a TULSA-PRO® procedure. Detailed instructions for each step are described in subsequent sections of this document. Steps involving multiple personnel, or performed in parallel, are listed on the same row. The primary role for each step is indicated in bold.

  • Page 12: Tulsa-Pro® System Commissioning

    3.d TULSA-PRO® System Commissioning Before first using the TULSA-PRO® System at any MRI site, the system must undergo initial setup and acceptance testing by service personnel authorized by Profound Medical. • Setup involves calibrating Fluid Circuit sensors and verifying the correct electrical connections.

  • Page 13: Equipment Setup

    Equipment Setup 5. Equipment Setup MRI Technologist: Complete the equipment setup for the TULSA-PRO® by following these steps: • inside the MRI suite: o set up the TULSA-PRO® base plate, patient pad, head pad, clips, and straps on the MRI bed o prepare a work surface and connect the Positioning System Interface Box to the Filter Box and Positioning System •...
  • Page 14 Equipment Setup The TULSA-PRO® System must be used only within MRI systems that are tested and approved by Profound Medical. MRI systems that have not been tested might not produce desired treatment results. Refer to the ‘Specifications Sheet’ in the TULSA- PRO®...

  • Page 15: Setup Inside The Mri Magnet Room

    Equipment Setup 5.a Setup Inside the MRI Magnet Room 5.a.i Setting up the Base Plate, Patient Pad, and Straps 1. MRI Technologist: Attach the base plate onto the foot end of the MRI table and secure using the four base plate straps (Figure 2, some configurations not exactly as shown). The feet of the base plate should fit in the rails of the MRI table and not move around when in position.

  • Page 16: Preparing The System Cart Outside The Mri Magnet Room

    Equipment Setup Be careful when installing the cable between the Filter Box and the PSIB. The cable pins must be carefully mated to the receptacle connector and not forced into place. Too much force will damage the cable pins. 5.b Preparing the System Cart Outside the MRI Magnet Room MRI Technologist: The System Cart contains the fluid circuit hardware used to cool the Ultrasound Applicator (UA) and the Endorectal Cooling Device (ECD).

  • Page 17: B.iii Tube Setup

    Equipment Setup 1. Designate one of the water-filled 1000mL IV bags as an ECD IV bag. Using a 30-60mL syringe with a 16G needle, extract 5mL of ECD Fluid Supplement – Manganese Chloride. Inject this solution into the syringe port of the ECD IV bag. 2.

  • Page 18: Connecting The System Electronics

    Filter Box. One large, black cable connects the Filter Box to the System Electronics. The System Electronics, Filter Box, and cable are installed by Profound Medical, and can remain connected when not in use. To prepare the System Electronics for use, ensure the following connections are secure: NOTE: If any cables are not connected, ensure they are free from damage before connecting.

  • Page 19: Register Patient On The Mri Console

    System Electronics and the MRI Host via Ethernet cables. 2. Power on the TDC computer and monitor. 3. Log in to Windows on the TDC computer when it powers up. Profound Medical will provide the username and password after system training has been completed.

  • Page 20: E.iii Treatment Delivery Console (Tdc) Initialization

    Equipment Setup 1. On the TDC computer, right-click on the computer time in the bottom right of the screen, and click Adjust date/time from the list. 2. In the Date & Time dialog, use the Time Zone drop-down list and Daylight Saving toggle switch to select the same Time Zone settings as the MRI host.

  • Page 21: Performing Pre-Treatment Equipment Checks In The Mri Magnet Room

    Equipment Setup Figure 5: Setup workspace of the TDC software 3. In the Positioning System (PS) quadrant of Setup, click Turn ON beside PSIB Display. NOTE: On any TDC screen—except during Treatment Delivery—you can press F1 on your keyboard to open and review the TULSA-PRO® Operator’s Manual. Click X in the top corner to close the document window.
  • Page 22 Equipment Setup Figure 6: UA sealed inside a sterile package Prepare the UA and ECD on a clean work surface and prime with fluid from the Fluid Circuit before inserting into a patient. Follow these instructions for priming the UA and ECD: 1.
  • Page 23 Equipment Setup Figure 7: PSIB Display - Fluid Circuit tab Figure 8: Fluid Circuit information box in TDC Setup workspace. 5. During the two-minute device purging, check for leaks in the UA, ECD, and the entire UA and ECD tube sets. 6.
  • Page 24 Equipment Setup c. Place and secure the ECD on the work surface until ready to be inserted into the patient. If for any reason the ECD tube set is detached after initial fill and purge, you must purge the ECD of bubbles again. 7.
  • Page 25 Equipment Setup Figure 10. Recommended procedure for purging air from ultrasound applicator. c. Rotate the UA package so that the flat side is facing down. Inspect the UA closely through the plastic package and ensure there are no signs of water in the package, which would indicate a leak.
  • Page 26 Equipment Setup NOTE: Ensure that the ECD fluid circuit (blue and yellow channels) has been purged and checked for leaks before priming the lubricant channels (green and black) for bubble removal. a. Connect the provided three-way stopcock and the syringe adapter to both the green and black-labeled channels (Figure 12).

  • Page 27: F.ii Pre-Treatment Equipment Checks

    Equipment Setup Lubricant exiting at the tip Figure 13: Lubricant emerging from ECD pores iii. On the injection (black) channel, connect a new full syringe of low-viscosity lubricant. The extraction (green) channel will be used for suction, so leave the empty syringe attached. Only use the provided low-viscosity lubricant in the bubble removal channels.
  • Page 28 Equipment Setup Figure 14: RF tab on PSIB display after successful RF connectivity test. Figure 15: RF information box in Setup workspace after successful RF connectivity test. TULSA-PRO® Operator’s Manual Page 28 of 130 - GE MR750w 3T 111229B...
  • Page 29 Equipment Setup 2. PS Test a. Check that no UA is attached to the PS gripper. Ensure that the cable between the PS and the PS Interface Box (PSIB) does not prevent the PS from moving along its translation axis. b.
  • Page 30 Equipment Setup Figure 17: PS information box in Setup workspace TULSA-PRO® Operator’s Manual Page 30 of 130 - GE MR750w 3T 111229B...

  • Page 31: Initial Patient Positioning

    Initial Patient Positioning 6. Initial Patient Positioning Initial patient positioning involves transferring the patient to the already-prepared MRI table, positioning them correctly over the imaging coil, securing them using the leg rests and appropriate straps, and establishing MRI anesthesia and patient monitoring. This step is led by the MRI Technologist, with specific assistance from the Anesthesiologist, and physical assistance in safely moving the patient from all members of the clinical team.
  • Page 32 Initial Patient Positioning Figure 18. Initial patient positioning and attachment of leg supports. TULSA-PRO® Operator’s Manual Page 32 of 130 - GE MR750w 3T 111229B...

  • Page 33: Device Insertion

    Device Insertion 7. Device Insertion The Urologist inserts the Ultrasound Applicator (UA) and the Endorectal Cooling Device (ECD) into the patient, with assistance from the MRI Technologist. 7.a Preparing the UA Before inserting the Ultrasound Applicator (UA), perform a final test for bubbles or leaks. 1.

  • Page 34: Inserting The Ua

    Device Insertion 7. Urologist: Closely inspect the UA along the length of the shaft for any water leakage, paying attention to the areas of interest shown in Figure 20. If you see water, the UA is defective and must not be used. Figure 20: Areas to inspect for water leaks in the UA 8.
  • Page 35 Device Insertion Figure 21. Secure the Positioning System using the latch on the base plate. 3. MRI Technologist: Manually move the PS into position so that the UA gripper aligns with the natural angle of the UA in the patient. Manually adjust the base of the PS forward and backward and up and down, and tilt the linear axis of the PS up and down (Figure 22).
  • Page 36 Device Insertion Figure 22: Adjusting the Positioning System 4. MRI Technologist: Capture the UA handle in the UA gripper of the PS (Figure 23). Ensure that the UA is not being ‘forced’ into position. If so, release the UA from the UA gripper and adjust the PS axes to achieve better alignment with the UA.

  • Page 37: Inserting The Ecd

    Device Insertion Figure 23: UA resting on PS with UA handle sitting in UA gripper 7.d Inserting the ECD The Urologist inserts the Endorectal Cooling Device (ECD), with assistance from the MRI Technologist who passes the ECD, lubricant and saline syringes to the Urologist. 7.d.i To insert the ECD the first time: 1.

  • Page 38: D.ii To Adjust The Ecd Position Or Address Bubbles Lateral To The Ecd

    Device Insertion 5. Urologist: After you confirm alignment, inflate the ECD balloon with 15-20 ml of saline to maintain upward pressure against the anterior rectal wall. Be prepared to fill the balloon up to a maximum capacity of 30ml, if needed, until the ECD is securely positioned in the rectum.

  • Page 39: Mri Patient Positioning

    MRI Patient Positioning 8. MRI Patient Positioning After transferring the patient to the MRI table and inserting the Ultrasound Applicator (UA) and Endorectal Cooling Device (ECD), the MRI Technologist secures the patient and imaging coils, and checks that the devices are ready for imaging. The Anesthesiologist does a final check. 8.a Securing the patient The MRI Technologist places restraint straps around the patient to prevent motion of the pelvis during MR imaging and positions the anterior coil.
  • Page 40 MRI Patient Positioning Figure 25. Placement of the anterior imaging coil. 3. For the patient’s comfort, use sheets to keep him warm and pads to avoid pressure points. Also, to avoid electrical burns, ensure that the patient’s skin is not directly touching the coils or MRI bore.

  • Page 41: Device Check

    MRI Patient Positioning 5. Anesthesiologist: Check that IV, gas, and monitoring lines are providing reliable readings and routed appropriately along the MRI table. Check that none of the straps are applying excessive pressure to the patient’s skin or joints. If using a supra-pubic catheter, ensure that the urine collection bag is secured and unobstructed.

  • Page 42: Entering Treatment Milestones

    MRI Patient Positioning 3. Ensure that the PSIB screen is off by pressing and holding Screen off on the PSIB screen (or by clicking Turn Off beside the PSIB Display in the TDC software). 8.c Entering Treatment Milestones MRI Technologist: After homing is complete, the icons in the Treatment Milestones section on the right side of the TDC Setup workspace will pulse to remind you to enter some data.

  • Page 43: Treatment Planning

    3. At the MRI console, click on the icon to verify that the TDC computer is communicating with the MRI. If an ILT connection is not active, contact Profound Service for further instructions. 4. Verify that the correct anterior and posterior coils are selected in the Coil tab (‘GEM Body’).

  • Page 44: A.ii Moving The Patient To Landmark Position

    Treatment Planning 9.a.ii Moving the patient to landmark position To maintain alignment of scan volumes, it is important to always return the patient to the same landmarked position in the MR bore. To accomplish this, with the MR bed outside the bore, press the Back to Landmark button ( ) on the magnet control panel.
  • Page 45 Treatment Planning a. The cooling window should cover the prostate and expected range of ultrasound energy from the UA, as confirmed on the sagittal MRI (Figure 29). b. The orientation of the cooling window should face the prostate (anterior), as confirmed on the axial MRI (Figure 30).
  • Page 46 Treatment Planning Figure 30. Axial images depicting ECD oriented incorrectly (left, rotated more than 20 degrees) and correctly (right, facing up towards the prostate). 4. If the ECD placement is not ideal or there are air bubbles in the rectum, manually adjust the ECD position in the rectum, use the ECD bubble removal channels, or both.

  • Page 47: B.ii Pushing Planning Images From The Mri To Tdc

    Treatment Planning 5. Once the Radiologist is satisfied with the gross positioning of the ECD the MRI Technologist acquires the SAG T2 sequence and then pushes the images to the TDC computer using the instructions below. 9.b.ii Pushing planning images from the MRI to TDC MRI Technologist: Follow these steps to push images (such as SAG T2, AX T2, and AX T1) to the TULSA-PRO®...

  • Page 48: Alignment

    Treatment Planning Always check that you have selected the image sequence from the correct patient and that the sequence was taken after you last adjusted the patient’s position. Note that it takes a few seconds for the newest scan to appear. 9.c Alignment Radiologist: Use the Alignment workspace to define the location and angulation of the UA in the TDC software by aligning a graphical representation of the UA with the actual UA on the MRI image...

  • Page 49: Coarse Planning

    Treatment Planning Figure 32: UA before alignment Figure 33: UA after alignment 9.d Coarse Planning Radiologist: Define the treatable volume so that it covers the targeted tissue while sparing critical structures and minimizing the impact of small calcifications on the heating pattern, by adjusting the location of the UA inside the prostate and selecting which transducer elements should be enabled.
  • Page 50 Treatment Planning the sagittal and coronal views are anatomical regions expected to be spared fully from thermal coagulation (Figure 34). 1. Radiologist: Move the UA overlay in and out of the gland to prescribe the intended UA location, placing the active transducer elements beside the intended ablation volume. Click- and-drag the UA overlay to move it within the prostate in a linear, head-to-foot direction.
  • Page 51 Treatment Planning calcification between two adjacent ultrasound elements rather than directly in front of an element (Figure 35). a. MRI Technologist: Acquire a SAG SWI scan and send it to the TDC. b. Radiologist: Click Load … Scan and select the SAG SWI scan to import it. The SWI scan will replace the existing Sag T2 3D scan in all three imaging planes.

  • Page 52: Detailed Planning

    Treatment Planning b. MRI Technologist: For the new SAG T2 scan, manually input the Start / End Location coordinates displayed in Coarse Planning on the TDC (Figure 36). Acquire the scan and send it to the TDC. c. Radiologist: Click Load … Scan to import the new scan and confirm that the UA is in the intended location.

  • Page 53: Acquiring The Treatment Planning Images For Ge

    Treatment Planning 9.e.i Acquiring the treatment planning images for GE MRI Technologist: On the MR Console, follow these instructions to acquire device-aligned AX T2 and AX THERM images. To prescribe AX THERM, you will need to modify additional scan control variables called Research CVs.
  • Page 54 Treatment Planning 7. On the MRI console, open the dropdown list next to the Scan button again and select Research > Display CVs. 8. In the new window that appears (Figure 38), type ‘dda’ (all lowercase) next to CV Name, set the Current Value to 0, and then click Accept.

  • Page 55: E.ii How To Draw Prostate Boundaries

    Treatment Planning Figure 39. Detailed Planning workspace displaying AX T2, AX THERM magnitude, and AX THERM temperature uncertainty view. 9.e.ii How to draw prostate boundaries 1. Radiologist: Before drawing boundaries, ensure that the UA center overlay on the AX THERM is aligned with the UA center on the images. Because of geometrical distortion on AX THERM, it is possible that the first UA center alignment is incorrect and needs to be readjusted manually.
  • Page 56 Treatment Planning Figure 40: Detailed Planning after drawing boundaries 2. Radiologist: To draw the prostate boundary, select the drawing tool and outline the tissue to be ablated on each slice based on the corresponding AX T2 and THERM magnitude images (Figure 40). You can select individual slices by clicking the numbered tab at the bottom of the screen, or by pressing the left and right arrow keys on the keyboard.

  • Page 57: E.iii Treatment Planning Guidelines

    Treatment Planning • A red boundary represents an area that is excluded from the target prostate volume because it is too close to the UA. NOTE: You can progress to Treatment if parts of the boundary are red, but ultrasound energy will not be directed to those areas. •...
  • Page 58 Treatment Planning • Bone may be at risk of significant heating during treatment if located within 32 mm from the UA center and the defined prostate boundary is greater than 14 mm in those areas (i.e. low-frequency ultrasound heating). • Soft tissues adjacent to bone may be at risk of significant heating if they are located within 40 mm from the UA center and the defined prostate boundary is greater than 14 mm in those areas (i.e.

  • Page 59: E.iv Mpmri Vision

    Treatment Planning 9.e.iv mpMRI Vision Radiologist: When prescribing the treatment volume, use the mpMRI Vision feature in Detailed Planning to load a set of axial diffusion weighted images (DWI), which can be used to visualize intraprostatic differences in prostate tissue to help select tissue intended for ablation (Figure 41). 1.
  • Page 60 Treatment Planning 1. To apply a software-assisted contour on a selected slice in Detailed Planning, click the Contouring Assistant button in the bottom left of the transverse view. If prostate tissue is detected on that slice, a software-assisted contour will appear. 2.

  • Page 61: Delivery

    Delivery 10. Delivery Radiologist: Start prostate ablation according to the treatment plan defined in Detailed Planning. Confirm the treatment plan with the Urologist, notify the Anesthesiologist to prepare the patient for treatment, and instruct the MRI Technologist to initiate MR thermometry. The Delivery workspace displays information from 12 axial slices in real time: 10 slices corresponding to the elements (E1-E10) that can deliver heating, and two additional slices corresponding to the Monitoring Elements, M0 and M11 (Figure 43).

  • Page 62: Starting Position And Direction Of Rotation

    Delivery Figure 43: Delivery workspace of TDC 10.a Starting position and direction of rotation Radiologist: Before initiating treatment, adjust the starting position and direction of the UA rotation in the TDC Delivery tab. Avoid starting ablation therapy with the UA pointed at sensitive structures, such as the neurovascular bundles or rectum.

  • Page 63: Treatment Initialization For Ge

    Delivery Figure 44: Starting position for ultrasound delivery and device rotation 10.b Treatment Initialization for GE Radiologist: When you have finished planning and are ready to start treatment, instruct the Anesthesiologist to administer a second dose of GI anti-spasmodic drug if appropriate. This will reduce GI peristalsis during treatment delivery and help maintain stable temperature maps.
  • Page 64 Delivery Figure 45: Enter the patient’s core body temperature before proceeding to delivery Figure 46: Treatment Initialization state TULSA-PRO® Operator’s Manual Page 64 of 130 - GE MR750w 3T 111229B...

  • Page 65: Treatment Delivery

    Delivery 10.c Treatment Delivery Radiologist: After receiving 26 thermometry dynamics, heating begins (Figure 47). Throughout the ablation, actively monitor real-time treatment images on all slices, ensuring that: 1. The observed heating pattern on the Current Temperature display matches the expected heating direction and depth.

  • Page 66: Toggling Power To One Of More Treatment Elements

    Delivery 10.d Toggling power to one of more treatment elements Radiologist: The power and frequency delivered on each active element is shown for each slice in real-time; power is shown by a solid, green bar. Hover the cursor over the power bar to display the actual value of the frequency and delivered power.
  • Page 67 Creating a new Treatment Segment) to suspend ultrasound delivery and thermometry acquisition. Enter the MRI room to ensure the UA is properly mated to the PS. It the problem persists, contact a Profound Medical authorized service representative. TULSA-PRO® Operator’s Manual...
  • Page 68 Delivery Figure 50: Misaligned ultrasound heating and UA beam angle. Button to expand or minimize the tools panel on the right of the Delivery workspace is marked. To adjust the UA beam angle at any time, expand the right panel in the Delivery workspace to access the beam angle adjustment buttons .

  • Page 69: Delivery Paused

    Delivery The Beam Alignment buttons are used to adjust the beam angle in increments of The beam angle is now The UA is treating in the 1 degree each time it is clicked. In this positioned more clockwise direction and image the counter-clockwise button has accurately as it is situated the UA beam angle leads...
  • Page 70 Delivery Pausing treatment enables the following options: • Rotate the UA to a new position and/or change the direction of treatment rotation. In some instances, you might want to set the UA to a new position and/or change the treatment rotation direction. To execute this command, follow the steps in 10.a Starting position and direction of rotation section and when the system is ready to resume treatment, click Resume Heating.

  • Page 71: Editing The Prostate Boundary During Treatment

    Delivery 10.g Editing the Prostate Boundary during Treatment Radiologist: In some cases, instances during treatment delivery, the patient anatomy may change from the originally planned target volume over time. For minor changes, the prostate boundaries can be modified while thermometry acquisition continues. To do this: Pause the treatment delivery.

  • Page 72: Creating A New Treatment Segment

    Delivery The prostate boundary The prostate boundary Treatment is paused, and the prostate does not match the now better matches the boundary is changed with the drawing tool. prostate in the image. prostate. Figure 54: Editing the prostate boundary 10.h Creating a new Treatment Segment Radiologist: Sometimes during treatment delivery, the current temperature maps may no longer be valid.

  • Page 73: History Slider

    Delivery 4. MRI Technologist: Duplicate the MRI planning sequences into the queue and follow the instructions from that point in the workflow (between sections 9.b Gross Positioning to 10 Delivery). 5. Radiologist: Repeat the instructions sections Section 9.b Gross Positioning to Section 10 Delivery.
  • Page 74 Delivery Figure 55: History slider in Delivery workspace Figure 56: “You are not viewing the latest image” message below history slider TULSA-PRO® Operator’s Manual Page 74 of 130 - GE MR750w 3T 111229B...

  • Page 75: Post-Treatment Imaging And Reports

    Post-Treatment Imaging and Reports 11. Post-Treatment Imaging and Reports After the post-delivery cooldown period, the TDC software will advance to the Reports workspace where the MRI Technologist acquires post-treatment images, generates treatment reports, and exports treatment session data. 11.a Post-treatment Imaging MRI Technologist: Acquire Contrast-Enhanced (CE)-MR images to evaluate the extent of acute thermal coagulation using the following steps from the MRI console: 1.

  • Page 76: Treatment Reports

    Post-Treatment Imaging and Reports Figure 57: Treatment Milestones panel in Reports workspace 11.c Treatment Reports When the Treatment Delivery Console (TDC) enters the Reports workspace, users see a brief summary of the treatment session (Figure 58). At the same time, the TDC starts to generate videos of the treatment, which might take several minutes.

  • Page 77: Viewing Treatment Videos

    Post-Treatment Imaging and Reports • the number of treatment segments (which will include any segments on which no treatment was performed) • the physician’s name (if entered for the MRI scans) • an estimate of the total time spent on the treatment, separated into two timeframes: o Ablation Time: An estimate of time spent in treatment delivery, over all the segments.

  • Page 78: C.ii Exporting Reports And Videos

    Post-Treatment Imaging and Reports Figure 59: Treatment video displayed in Reports workspace You can play ( ) the video for the treatment segment (or if the session had multiple segments, use the segment selector (Figure 59) to choose an individual segment) and choose to see the anatomy with an overlay of the current temperature, maximum temperature, or thermal dose.

  • Page 79: Post-Treatment Session Export

    MRI Technologist: From the Treatment Delivery Console (TDC), you can export a patient’s session data in order to: • send session data to Profound Medical for help with troubleshooting problems • back up the session information for future retrieval and use.
  • Page 80 Post-Treatment Imaging and Reports On the Export Wizard, complete the Session Export Options: a. You can export the session software logs and related data. In addition, you can export the temperature map images during treatment. To include images in the export, select Include all treatment therm images.

  • Page 81: Device Removal And Patient Recovery

    Device Removal and Patient Recovery 12. Device Removal and Patient Recovery After treatment and all post-treatment imaging is complete, the MRI technologist leads equipment dismantling, the Urologist removes the UA and ECD and examines the patient, and the Anesthesiologist recovers the patient. 12.a Device Removal 1.

  • Page 82: Equipment Dismantling

    Device Removal and Patient Recovery technique, to be kept in place for several days. Catheters (suprapubic or urethral) should only be removed after a successful voiding trial at the discretion of the prescribing physician. 4. Anesthesia: Wheel the patient to the patient preparation area and follow patient recovery procedures according to anesthesia standard of care.

  • Page 83: Cleaning And Disposal

    Base Plate and Patient Pad o Leg supports o Straps NOTE: Straps shall be disposed of if soiling occurs, contact Profound service for replacements The following equipment is not intended to contact intact skin and shall be cleaned and disinfected after each patient use: TULSA-PRO®...

  • Page 84: B.ii General Cleaning Reagents, Methods And Tools

    Cleaning Reagents TULSA-PRO components which are intended for reprocessing, excluding the computer are compatible with the following cleaning/disinfection reagents. Profound has not evaluated the use of cleaning/disinfection reagents that do not appear on the following list and their use should be avoided.

  • Page 85: B.iii Performing Manual Cleaning And Disinfection

    Cleaning and Disposal 4. Immediately after use wipe any visible soil or contaminants from the surfaces of these components using a damp cloth or cleaning wipe to prevent drying of contaminants. If soiled components must be transported to a designated cleaning area, ensure individual closed containers are available to limit cross contamination.

  • Page 86: B.iv Positioning System - Cleaning And Disinfection Instructions

    Cleaning and Disposal 4. Use a fresh disinfecting wipe to thoroughly wet all external surfaces of the device, ensuring all surface areas have been in contact with the wipe, and allow to remain visibly wet for the manufacturers specified contact time 5.
  • Page 87 Cleaning and Disposal 5. Wipe all surfaces with a lint free cloth wet with water to remove cleaner residue TULSA-PRO® Operator’s Manual Page 87 of 130 - GE MR750w 3T 111229B...

  • Page 88: Software Alarms

    Software Alarms 14. Software Alarms 14.a Alarm Indicators An area at the bottom-left of the Treatment Delivery Console (TDC) screen shows alarm indicators when a session is in progress (Figure 61). Figure 61: Alarm indicators (all indicators are clear) The following table lists and describes the alarm indicators: Table 1: Alarm indicators INDICATOR ALARM AND INFORMATION RELATED TO…...

  • Page 89: Description Of Alarm Conditions

    Software Alarms 14.b Description of Alarm Conditions Though the TDC software has five indicators associated with distinct hardware components and a single indicator associated with physiological parameters of the patient under treatment, each indicator can have multiple conditions classified as information or warning. An information condition happens when the corresponding subsystem detects a minor deviation from normal functionality.

  • Page 90: Multiple Alarm Conditions

    Software Alarms obstruction and the system detects pressure normalization, the alarm indicator returns to a normal, or clear, state. NOTE: Though operators do not need to interact with the TDC to clear the alarm and corresponding condition, you might need to return the TDC system to normal workflow. If the scenario discussed above happened during Treatment Delivery, the system would stop Ultrasound Applicator (UA) rotation and heat.

  • Page 91: Alarm Condition Log

    Software Alarms Figure 65: Multiple condition messages in the pop-up message 14.d Alarm Condition Log Each warning or information condition detected in a session is registered in the session’s Audit Log and can be reviewed any time during the session by switching to the Session workspace. You can see the conditions of each remote hardware subsystem (MRI, RF, FC and PS) individually by switching to the Setup workspace at any time during the session.

  • Page 92: Tulsa-Pro® Mri Troubleshooting Tips

    TULSA-PRO® MRI Troubleshooting Tips A. TULSA-PRO® MRI Troubleshooting Tips A.1. Patient Motion Concerns The MR Thermometry of the prostate is adversely affected by any motion. Here are the motions of concern and how to address them: MOTION CONCERN TO ADDRESS THIS CONCERN… Respiratory Tightly strap the coils down.

  • Page 93: Access To User Documentation From Tdc

    TULSA-PRO® MRI Troubleshooting Tips 4. Temperature changes are integrated over the MR thermometry image acquisition time. To ensure accurate temperature measurements, the MR Protocol specifies the image acquisition time, which can range from 5 to 6.5 seconds. 5. Ultrasound heating in the presence of large cysts and calcifications has not been validated using the TULSA-PRO®.

  • Page 94: Troubleshooting Guide: Alarm Signals

    Describes why the alarm has been raised. The TDC-generated software-code associated with the condition. This code is used Error Code by Profound Medical authorized service representatives in addressing complex issues Delay Represents the period of time from when the issue began, to when the alarm was raised.
  • Page 95 Resume Heating treatment with the current segment. Complete Treatment and View Report the current session. For additional help, contact a Profound Medical authorized service representative as directed in the ‘Service and Maintenance’ section of the TULSA-PRO® Instructions For Use. TULSA-PRO® Operator’s Manual...

  • Page 96: Fluid Cart

    Troubleshooting Guide: Alarm Signals B.1. Fluid Cart 40-201: TDC lost a network connection to the System Cart Condition The System Cart has lost network connection to the TDC computer. Error Code 40-201 Delay Immediate System Setup: UA & ECD purging will be cancelled. RF test cannot be performed. Response Alignment, Coarse, Detailed: No system response.

  • Page 97: 40-202: The Cable Between The System Cart And The System Electronics Has Been Disconnected

    Troubleshooting Guide: Alarm Signals 40-202: The cable between the System Cart and the System Electronics has been disconnected Condition The cable connecting the System Cart (SC) to the System Electronics (SE) is not connected. Error Code 40-202 Delay Immediate System Setup: UA and ECD purging will be cancelled.

  • Page 98: 40-206: The Room Temperature For The System Cart Is Too High

    Troubleshooting Guide: Alarm Signals 40-206: The room temperature for the System Cart is too high Condition The System Cart temperature is greater than or equal to 37˚C Error Code 40-206 Delay Immediate System Setup, Alignment, Coarse, Detailed: No system response. Response Delivery - Initialization: Ablation will not start.

  • Page 99: 41-107: The Ultrasound Applicator Fluid-Circuit Bag Volume Is Too Low

    Troubleshooting Guide: Alarm Signals 41-107: The Ultrasound Applicator fluid-circuit bag volume is too low Condition The volume in the Ultrasound Applicator (UA) circuit is less than or equal to 400 mL. Error Code 41-107 Delay Immediate System Setup: UA purging will be cancelled. RF test cannot be performed. Response Alignment, Coarse, Detailed: No system response.

  • Page 100: 41-109: The Ultrasound Applicator Fluid-Circuit Pump Pressure Is Too Low

    Troubleshooting Guide: Alarm Signals 41-109: The Ultrasound Applicator fluid-circuit pump pressure is too low Condition • During Ultrasound Applicator (UA) Purging: The UA pressure is less than or equal to 3 psi after the purging cycle is completed. • During normal operation: The UA pressure is less than or equal to 3 psi, with the pumps on for at least 20 seconds.

  • Page 101: 41-110: The Ultrasound Applicator Fluid-Circuit Pump Pressure Is Too High

    Troubleshooting Guide: Alarm Signals 41-110: The Ultrasound Applicator fluid-circuit pump pressure is too high Condition • During Setup (purging): The Ultrasound Applicator (UA) pressure is greater than or equal to 30 psi after the purging cycle is completed. • During Delivery (Initialization or Ablation): The UA pressure is greater than or equal to 30 psi, with the pumps on for at least 20 seconds.

  • Page 102: 42-107: The Ecd Fluid-Circuit Bag Volume Is Too Low

    Troubleshooting Guide: Alarm Signals 42-107: The ECD fluid-circuit bag volume is too low Condition The volume in the ECD circuit is less than or equal to 400 mL. Error Code 42-107 Delay Immediate System Setup: ECD purging will be cancelled. RF test cannot be performed. Response Alignment, Coarse, Detailed: No system response.

  • Page 103: 42-109: The Ecd Fluid-Circuit Pump Pressure Is Too Low

    Troubleshooting Guide: Alarm Signals 42-109: The ECD fluid-circuit pump pressure is too low Condition • During ECD Purging: The ECD pressure is less than or equal to 13 psi after the purging cycle is completed. • During normal operation: The ECD pressure is less than or equal to 13 psi, with the pumps on for at least 20 seconds.

  • Page 104: 42-110: The Ecd Fluid-Circuit Pump Pressure Is Too High

    Troubleshooting Guide: Alarm Signals 42-110: The ECD fluid-circuit pump pressure is too high Condition • During ECD Purging: The ECD pressure is greater than or equal to 37 psi after the purging cycle is completed. • During normal operation: The ECD pressure is greater than or equal to 37 psi, with the pumps on for at least 20 seconds.

  • Page 105: Magnetic Resonance Imaging

    Troubleshooting Guide: Alarm Signals B.2. Magnetic Resonance Imaging 50-201: The IP address or port for the MRI cartridge is wrong or in use Condition The IP Address and Port specified by the MRI cartridge is being used by another program. Error Code 50-201 Delay...

  • Page 106: 50-202: Tdc Lost Network Connection To The Mri

    Troubleshooting Guide: Alarm Signals 50-202: TDC lost network connection to the MRI Condition The TDC has lost the network connection to the MRI. Error Code 50-202 Delay Immediate System Setup, Alignment, Coarse: User cannot load a SAG T2 image. Response Detailed: User cannot load AX T2 images.

  • Page 107: 50-203: There Is A Delay In Receiving The Thermometry Image

    Troubleshooting Guide: Alarm Signals 50-203: There is a delay in receiving the thermometry image Condition The thermometry image is being received slower than normal (longer than typical 5-6 seconds). Error Code 50-203 Delay 1.3x MR sampling period System Setup, Alignment, Coarse: No system response. Response Detailed: TDC will stop processing thermometry images from the MRI Delivery - Initialization: Ablation will not start.

  • Page 108: 50-204: Tdc Has Not Received New Thermometry Images In The Last 30 Seconds

    Troubleshooting Guide: Alarm Signals 50-204: TDC has not received new thermometry images in the last 30 seconds Condition A new thermometry image has not been received in the last 30 seconds or so. Error Code 50-204 Delay 5x MR sampling period System Setup, Alignment, Coarse: No system response.

  • Page 109: 50-209: The Thermometry Images Cannot Be Used

    Troubleshooting Guide: Alarm Signals 50-209: The thermometry images cannot be used Condition The thermometry images have become corrupted and can no longer be used. Patient motion or an MRI artifact is suspected. Error Code 50-209 Delay Immediate System Setup, Alignment, Coarse: Not applicable. Condition and alarm will not occur. Response Detailed: TDC will stop processing thermometry images from the MRI Delivery –...

  • Page 110: 50-212: The Therm Sequence Parameters Are Out Of Range

    Cause 1. Reload the sequence from the exam card to restore original default values. 2. If the problem continues, contact a Profound Medical authorized service representative. 3. If using a GE MRI, check that the Research CV ‘dda’ has been set correctly.

  • Page 111: 50-213: The Thermometry Images Cannot Be Used

    Troubleshooting Guide: Alarm Signals 50-213: The thermometry images cannot be used Condition The image shift calculated after 100 dynamics is greater than 1 mm in the frequency- encoding direction or 2 mm in the phase-encoding direction for any slice. Error Code 50-213 Delay Every 100 imaging dynamics...

  • Page 112: 50-214: The Anatomy Scan Required For Alignment Is Older Than 2 Hours

    Troubleshooting Guide: Alarm Signals 50-214: The anatomy scan required for alignment is older than 2 hours Condition Only when not in Delivery - Ablation: The SAG T2 treatment planning image used to establish the Ultrasound Applicator (UA) position cannot be trusted. A new SAG T2 image is required to confirm the location of the UA in the MRI Image.

  • Page 113: 50-215: Check That The Patient Is In A Head-First, Supine Position

    Troubleshooting Guide: Alarm Signals 50-215: Check that the patient is in a head-first, supine position Condition The Patient Orientation is not head-first, supine and was set incorrectly during patient registration. Error Code 50-215 Delay Immediate System Setup, Alignment, Coarse: No system response. Response Detailed: TDC will stop processing thermometry images from the MRI Delivery –...

  • Page 114: Positioning System

    Troubleshooting Guide: Alarm Signals B.3. Positioning System 10-102: TDC lost the network connection to the Positioning System Interface Condition The Positioning System Interface Box (PSIB) network connection has been lost and the TDC software can no longer communicate with the PSIB. Error Code 10-102 Delay...

  • Page 115: 20-102: The Cable Between The Positioning System (Ps) And Ps Interface Box Is Disconnected

    Troubleshooting Guide: Alarm Signals 20-102: The cable between the Positioning System (PS) and PS Interface Box is disconnected Condition The Positioning System (PS) cable is disconnected from the PS Interface Box (PSIB). Error Code 20-102 Delay Immediate System Setup: User will not be able to Test PS or Home UA Response Alignment: No system response.
  • Page 116 Troubleshooting Guide: Alarm Signals 6. Do not move the UA in Coarse Planning; instead, select Accept Position. 7. Confirm treatment planning. You will not need to re-acquire new TUV or AX T2 images. 8. Proceed through the normal workflow. 1. Click End Thermometry and Re-plan. DELIVERY - ABLATION 2.

  • Page 117: 20-201: There Is A Problem With The Rotary Motion

    Troubleshooting Guide: Alarm Signals 20-201: There is a problem with the rotary motion Condition A rotary motion fault occurred. Error Code 20-201 Delay Immediate System Setup: PS Test or Rotary Home will stop. Response Alignment, Coarse: Not applicable. Condition and alarm will not occur. Detailed: The Ultrasound Applicator (UA) will not reach the intended starting position.

  • Page 118: 20-202: The Tdc Computer Is Busy And Cannot Process Thermometry Images Fast Enough

    Troubleshooting Guide: Alarm Signals 20-202: The TDC computer is busy and cannot process thermometry images fast enough Condition The Positioning System (PS) is receiving new hardware commands slower than usual, because TDC is not processing images fast enough. Error Code 20-202 Delay 8 seconds...

  • Page 119: 20-203: Something Went Wrong With The Positioning System Communications

    Troubleshooting Guide: Alarm Signals 20-203: Something went wrong with the Positioning System communications Condition There was a Positioning System Interface Box (PSIB) communication failure with a motion controller, which has stopped motion. Error Code 20-203 Delay Immediate System Setup, Alignment, Coarse, Detailed: No system response. Response Delivery - Ablation: Ablation will be paused.

  • Page 120: 21-201: The Positioning System's Linear Axis Moved Unexpectedly

    Troubleshooting Guide: Alarm Signals 21-201: The Positioning System's linear axis moved unexpectedly Condition The Positioning System (PS) linear axis has unexpectedly moved and the Ultrasound Applicator (UA) is no longer registered to the MRI Image. Error Code 21-201 Delay Immediate System Setup, Alignment, Coarse, Detailed: No system response.

  • Page 121: 22-201: The Positioning System Is Not Rotating The Ultrasound Applicator At The Expected Rate

    Troubleshooting Guide: Alarm Signals 22-201: The Positioning System is not rotating the Ultrasound Applicator at the expected rate Condition The Positioning System (PS) is not rotating the Ultrasound Applicator (UA) at the expected rate. Error Code 22-201 Delay Immediate System Setup, Alignment, Coarse, Detailed, Delivery - Initialization: Not applicable.

  • Page 122: 22-202: The Rotary Home Position Has Been Lost

    Troubleshooting Guide: Alarm Signals 22-202: The rotary home position has been lost Condition The Ultrasound Applicator (UA) is not properly seated in the Positioning System (PS) gripper or the PS Interface Box (PSIB) lost power, which caused the known position to be lost. Error Code 22-202 Delay...

  • Page 123: 22-206: The Ultrasound Applicator (Ua) Has Rotated Too Far In One Direction

    Troubleshooting Guide: Alarm Signals 22-206: The Ultrasound Applicator (UA) has rotated too far in one direction Condition The Ultrasound Application (UA) has rotated too far in one direction. The UA must be unwound to proceed with heating. Error Code 22-206 Delay Immediate System...

  • Page 124: 22-208: The Positioning System's Rotary Axis Moved Unexpectedly

    Troubleshooting Guide: Alarm Signals 22-208: The Positioning System's rotary axis moved unexpectedly Condition The Positioning System (PS) rotary axis has unexpectedly moved and the UA beam may point in an unintended direction. Error Code 22-208 Delay Immediate System Setup, Alignment, Coarse, Detailed: No system response. Response Delivery - Initialization: It will not be possible to start initialization.

  • Page 125: Radio Frequency

    Troubleshooting Guide: Alarm Signals B.4. Radio Frequency 30-201: Emergency switch button has been activated Condition Someone pressed the emergency switch on the System Electronics. Error Code 30-201 Delay Immediate System Setup: Linear and rotary axes will turn off, ultrasound power for all elements will turn off, Response UA and ECD fluid pumps will turn off.

  • Page 126: 30-202: The Tdc Computer Is Busy And Cannot Process Thermometry Images Fast Enough

    Troubleshooting Guide: Alarm Signals 30-202: The TDC computer is busy and cannot process thermometry images fast enough Condition The System Electronics (SE) have not received a new power-update command in the last 8 seconds, because the TDC is not processing images fast enough. Error Code 30-202 Delay...

  • Page 127: 31-201: The System Electronics Amplifiers Are Overheating

    Troubleshooting Guide: Alarm Signals 31-201: The System Electronics amplifiers are overheating Condition One or more amplifiers inside the System Electronics (SE) are overheating. Error Code 31-201 Delay Immediate System Setup, Alignment, Coarse, Detailed: No system response. Response Delivery - Initialization: It will not be possible to start initialization or initialization will stop.

  • Page 128: 31-202: The System Electronics Amplifiers Have Turned Off

    Troubleshooting Guide: Alarm Signals 31-202: The System Electronics amplifiers have turned off Condition One or more amplifiers inside the System Electronics (SE) have switched off unexpectedly. Error Code 31-202 Delay Immediate System Setup, Alignment, Coarse, Detailed: Not applicable. Condition and alarm will not occur. Response Delivery –...

  • Page 129: 32-102: Tdc Lost The Network Connection To The System Electronics

    Troubleshooting Guide: Alarm Signals 32-102: TDC lost the network connection to the System Electronics Condition The System Electronics (SE) network connection has been lost. Error Code 32-102 Delay Immediate System Setup: UA and ECD purging will be cancelled. RF test cannot be performed. Response Alignment, Coarse, Detailed: No system response.

  • Page 130: System

    Delivery - Ablation: Ablation will be paused. Address the Contact an authorized Profound Medical service representative. Cause Steps After At any stage, follow the instructions from the authorized Profound Medical service Addressing representative. the Cause TULSA-PRO® Operator’s Manual Page 130 of 130...

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