THERACLION SONOVEIN User Manual
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THERACLION SONOVEIN User Manual

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USER MANUAL
Application (EUR)
Document THC903324-F English Version

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Summary of Contents for THERACLION SONOVEIN

  • Page 1 USER MANUAL Application (EUR) Document THC903324-F English Version...
  • Page 3 THERACLION. SONOVEIN® is a registered trademark of THERACLION. Confidential property of THERACLION. Information in this document may be subject to change without notice. THERACLION 240-244 avenue Pierre Brossolette – 92240 Malakoff – France...

  • Page 5: Table Of Contents

    Sonovein User Manual – Application (EUR) THC903324-F TABLE OF CONTENTS Table Of Figures ............................6 How to use this Manual ........................7 1.1. Warnings and Cautions ......................7 Device Intended Use and Intended Users ..................7 2.1. Intended Use ..........................7 2.2.

  • Page 6: Table Of Figures

    Sonovein User Manual – Application (EUR) THC903324-F 6.3. More Information ........................26 TABLE OF FIGURES Figure 1 - Planes (indicative target example) ..................... 9 Figure 2 - Treatment Screen Features ...................... 16...

  • Page 7: How To Use This Manual

    2 DEVICE INTENDED USE AND INTENDED USERS Warning The device should be used only by an operator specially trained by THERACLION and in a proper clinical setting. Warning The product has been tested and validated only for clinical applications specified by THERACLION as indicated in this manual.

  • Page 8: Contraindications, Side Effects, And Recommendations

    Any serious incident that has occurred in relation to the device should be reported to the Theraclion (prrc@theraclion.com) and the competent authority of the Member State in which the user and/or patient is established.

  • Page 9: Targeting Principles: Terms And Definitions

    Sonovein User Manual – Application (EUR) THC903324-F 3 TARGETING PRINCIPLES: TERMS AND DEFINITIONS This chapter describes the device software vocabulary and figures. The operator must be familiar with these concepts before starting treatments with the device. 3.1. TARGET, TARGET SEGMENT The target represents the vein to be coagulated.

  • Page 10: System Installation And Preparation Steps

    Before using the device, the operator must be trained by a certified trainer. This support is necessary and can be adapted according to the confidence level of the operator. Caution Before treating the operator must also read the Commons part of the User Manuals: Sonovein User Manual – Commons (THC903323). Caution Before each treatment, operators must ensure they have read and understood the document Known issues and precautions for Sonovein User Software.

  • Page 11: System Startup, Epack Installation

    Sonovein User Manual – Application (EUR) THC903324-F Connect the device to the mains supply. Switch on the device. The system should be installed at the right of the patient. The front handle of the device should be aligned with the targeted zone as shown in the picture.

  • Page 12: User Login, Patient Preparation

    Sonovein User Manual – Application (EUR) THC903324-F New EPack Installation EPack ref. THC903400-A Before installing the balloon, rinse the transducer and imager with the liquid in the syringe. Discard the liquid. Follow the step by step instructions displayed on the screen. Plug the tubing in line with the integrated degassing system (if feature available).
  • Page 13 Sonovein User Manual – Application (EUR) THC903324-F Patient Data Input Enter patient data and treatment information. Then press Go to Ultrasound Imaging. Patient Installation Install the patient as shown. Place the patient’s head close to the device for full mobility of the robotic arm.
  • Page 14 Sonovein User Manual – Application (EUR) THC903324-F Pre-treatment Ultrasound Imaging Press Hand to to switch to the hand probe and apply a thin layer of gel. Adjust the B-mode imaging parameters as needed, with selected. These are: Auto TGC, Super Compound, Harmonic and gain.

  • Page 15: Vtu Positioning

    Sonovein User Manual – Application (EUR) THC903324-F Caution The operator must ensure that one of the staff members can manage analgesia/anesthesia adverse reactions. 4.4. VTU POSITIONING VTU Orientation Marks Locate the imaging orientation marks on the VTU. The vertical mark shall be placed towards the left of the practitioner.

  • Page 16: Laser Detector Positioning

    Sonovein User Manual – Application (EUR) THC903324-F 4.5. LASER DETECTOR POSITIONING Laser Positioning Screen Follow the on-screen instructions to adjust the laser position. Check that any sudden patient movement is detected. Proper positioning of the laser is key for the treatment safety.

  • Page 17: Live View

    Sonovein User Manual – Application (EUR) THC903324-F 4.6.1. Live View Live Ultrasound View The live ultrasound view displays several overlays over the real-time image: • The HIFU cone and focal point, in grey lines • The transducer edge, represented by a horizontal line on top •...

  • Page 18: Bottom Bar And Information Display

    Sonovein User Manual – Application (EUR) THC903324-F Warning Make sure the skin does not touch the HIFU transducer on the VTU (through the balloon). The transducer edge is represented in the image by a white horizontal line. Warning Be careful to track the skin with precision. The energy delivered to the target depends on its depth. A mismatch between real and monitored skin can lead to the delivery of inappropriate energy.
  • Page 19 Sonovein User Manual – Application (EUR) THC903324-F To set the power for 1-second long pulses (if available): • Select the button and use the Power Slider to adapt the power. • On a given treatment site, deliver a first pulse at default power (for the first site of each segment) or at the power defined based on previous site.

  • Page 20: Left Panel

    Sonovein User Manual – Application (EUR) THC903324-F 4.6.3. Left Panel View Tab View tab displays a top view of the current procedure. Each slice is indicated by a white line (green when treated). Next to any treated slice are indicated the number of pulses and the Linear Endo-venous Energy Density (LEED).

  • Page 21: Repositioning

    Sonovein User Manual – Application (EUR) THC903324-F By default, the skin level is automatically tracked by the system on the ultrasound view. The maximum deliverable power is adapted accordingly by the system (red zone on the Power Slider) in order to optimize treatment efficacy while ensuring safety.

  • Page 22: System Wrap-Up And Cleaning

    Sonovein User Manual – Application (EUR) THC903324-F 5 SYSTEM WRAP-UP AND CLEANING 5.1. EPACK REMOVAL AND SYSTEM SHUTDOWN Follow the step by step instructions displayed on the screen to empty and remove the EPack. Do not press Finish until the arm is folded.
  • Page 23 Sonovein User Manual – Application (EUR) THC903324-F On the home screen press Switch Off. Wait for the system to stop, then switch the device off from the rear panel. Unplug the power cable from the mains supply.

  • Page 24: Vtu

    Sonovein User Manual – Application (EUR) THC903324-F 5.2. VTU Rinse the following VTU elements with demineralized (or clean) water: • The HIFU Transducer • The imager • The 2 inner tubes Use a soft wipe to dry the VTU transducer, the imaging probe and the baffle.

  • Page 25: System Cleaning

    Do not immerse or soak any other part of a probe in any cleaning material. Caution In case any malfunction or damage is noticed on the handheld probe, it must be returned to THERACLION. 5.4. SYSTEM CLEANING Use a slightly damp soft cloth with a mild detergent to clean the system, touchscreen and VTU covers and handles.

  • Page 26: Troubleshooting

    6.1. ERROR MESSAGES Every time an error is detected, the software will display a window with troubleshooting information. If the problem cannot be solved, refer to the document Known issues and precautions for Sonovein User Software for detailed troubleshooting information.
  • Page 27 Sonovein User Manual – Application (EUR) THC903324-F Log Tab section displays the history of main events. Tools to export a screenshot of the software, error messages, system logs and anonymized treatment data are available. Follow the instructions of your service representative when asked to perform these exports.

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