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Insightec Exablate 2100V1 - User Manual

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1
Exablate 2100V1
Prostate System
Operator’s Manual
Software Version 8.1
Publication Date (MM YYYY)UAL

Table of Contents

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Summary

1. System Overview

1.1. Introduction

Provides an overview of the Exablate Prostate system's function and procedure.

1.2. Document Conventions

Explains the use of notes, cautions, and warnings in the manual.

1.3. Scope of This Manual

Details the systems covered by this operator's manual.

1.4. System Components

Describes the integrated components of the Exablate Prostate system.

1.5. Exablate Prostate Accessory List

Lists disposable items and accessories required for Exablate Prostate treatment.

2. Safety

2.1. Exablate Safety Considerations

Outlines general safety precautions for operating the Exablate Prostate system.

2.2. Symbols Used in the System

Explains standard symbols and their meanings used on the system.

2.3. Safety Instructions

Provides critical safety instructions for system operation and patient care.

2.4. Water System Precautions

Details precautions related to the system's water circulation and temperature.

2.5. Operator Precautions

Lists essential precautions for the system operator during treatment.

2.6. System Security and Malware Protection

Covers security measures and protection against malware for the system.

2.7. Electromagnetic Compatibility (EMC) Precautions

Discusses precautions related to electromagnetic compatibility of the system.

2.8. Cyber-Security

Addresses precautions and notes related to cybersecurity of the system.

2.9. Environmental Requirements

Specifies environmental conditions for system operation, storage, and transport.

3. Getting Started

3.1. System Power On

Step-by-step guide for powering on the Exablate Prostate system.

3.2. Probe Preparation for Treatment

Details the procedure for preparing the probe for patient treatment.

3.3. Patient Preparatory Procedures

Outlines the necessary preparations for the patient before treatment.

3.4. Patient Positioning and Probe Insertion

Describes how to position the patient and insert the probe correctly.

3.5. Patient Release

Procedures for safely releasing the patient after treatment.

3.6. Shutdown

Step-by-step instructions for shutting down the system.

3.7. Daily Quality Assurance (DQA) Test Procedure

Guide for performing daily quality assurance tests on the system.

3.8. Storage and Maintenance of the DQA Phantom Gel

Instructions for storing and maintaining the DQA phantom gel.

4. System Start-Up

4.1. Start-Up Screen

Describes the elements and functions of the system's start-up screen.

4.2. Treatment Options

Explains the different treatment options available from the start-up screen.

4.3. Begin Treatment Procedure

Details the initial steps to begin a treatment session.

5. Treatment Tools

5.1. Treatment Tools - Overview

Provides an overview of the tools available during the treatment cycle.

5.2.1. Exablate Main Toolbar

Toolbar for navigating treatment stages and accessing utilities.

5.2.2. Treatment Stages

Covers Planning, Treatment, and Evaluation phases of the procedure.

5.2.7. Imaging Tools

Tools for manipulating images: zoom, pan, measure distance, area, angle.

5.2.8. Overlays

Tools for displaying graphical overlays on MR images like contours and text.

5.2.9. Navigation Tools

Tools for selecting and scrolling through image strips.

5.2.10. Image Overlays

Features related to image annotations, cursor coordinates, and 3D display.

6. Planning Stage

6.1. Planning Stage - Overview

Introduction to the first stage of the Exablate Prostate treatment procedure.

6.2. Planning Stage General Action Elements

Describes general action elements used in the planning stage.

6.3. Baseline Thermometry

Establishes the prostate temperature profile before treatment sonications.

6.4. Positioning Verification

Details procedures for verifying patient and probe positioning.

6.5. Acquisition of MR Planning images

Covers methods for acquiring MR images for treatment planning.

6.6. Acquisition of Baseline Anatomy Scans

Describes how to acquire baseline anatomy scans for reference.

6.7. Defining a Treatment Plan

Guide to defining the treatment plan by drawing anatomical structures.

6.8. Selecting a Treatment Protocol (Optional)

Explains how to select or update treatment protocols for specific scenarios.

6.9. Re-Draw; Dose Transfer (Optional)

Procedure for re-acquiring images and transferring accumulated dose.

6.10. Advancing to Treatment Stage

Steps to verify and advance from planning to the treatment stage.

7. Treatment Stage

7.1. Overview

Introduction to the stage where actual treatment is performed.

7.2. Treatment Stage Main Screen Elements

Details the main screen elements for conducting treatment.

7.3. Thermal Evaluation Screen Elements

Screen for evaluating treatment results post-sonication.

7.4. Treatment Procedure

Details the overall procedure for performing therapeutic sonications.

8. Evaluation Stage

8.1. Overview

Introduction to evaluating treatment results using post-treatment imaging.

8.2. Action Tools

Tools for acquiring and analyzing treatment evaluation images.

8.3. Automatic Evaluation Scan Acquisition

Describes how to automatically acquire evaluation scans.

8.4. Manual Evaluation Scan Acquisition

Instructions for manually uploading post-treatment MR series.

8.5. Volume Measurement

Tool for measuring treatment volumes on post-treatment images.

8.6. Exit Evaluation Stage

Procedure to exit the evaluation stage and terminate treatment.

9. Replay Stage

9.1. Overview

Introduction to analyzing results of previous sonications.

9.2. Replay Action Tools

Tools for navigating and viewing past sonication results.

9.3. Exit Replay

How to leave the Replay mode and return to the previous screen.

10. Utilities

10.1. Overview

Introduction to utility functions not part of the nominal treatment flow.

10.1.1. Utilities Action Tools

Lists the relevant tools available in the Utilities mode.

10.2. Utilities Procedures

Step-by-step guides for various utility functions.

10.3. Exit Utilities

How to exit the Utilities mode and return to the previous stage.

11. Data Management

11.1. Overview

Outlines the options for managing treatment records.

11.2. Selecting a Patient

Procedures for selecting patient records for data management operations.

11.3. External Database (Optional)

Information on using an optional external database for data storage.

11.4. Exit Data Management

How to exit the Data Management mode.

APPENDIX A. Advanced Option Mode

A.1. Overview

Introduction to overriding automated treatment plans and setting parameters manually.

A.2. Sonication Parameters

Details the adjustable sonication parameters available in advanced mode.

A.3. MR Scan Parameters

Explains how to modify MR scan parameters for advanced control.

APPENDIX B. Water System Cleaning and High-Level Disinfection

B.1. Overview

Introduction to the water sub-system and its cleaning procedures.

B.2. Water System Troubleshooting

Guide for troubleshooting common water system errors.

APPENDIX C. High-Level Disinfection Procedure

C.1. Introduction

Introduction to the high-level disinfection (HLD) procedure for the probe.

C.2. List of Materials Required for Cleaning

Lists all necessary materials for the cleaning and disinfection process.

C.3. HLD Procedure

Step-by-step instructions for performing the high-level disinfection.

Insightec Exablate 2100V1 Specifications

General IconGeneral
BrandInsightec
ModelExablate 2100V1
CategoryMedical Equipment
LanguageEnglish