Versana Active User Manual Rev 9

Regulatory Requirement This product complies with regulatory requirements of the following European Directive 93/42/EEC concerning medical devices.

First CE Marked in 2019. This manual is a reference for the Versana Active ultrasound system. It applies to all revisions of the R1.1.x / R1.2.x software for the Versana Active ultrasound system.

GE P.O. Box 414, Milwaukee, Wisconsin 53201 U.S.A. (Asia, Pacific, Latin America, North America) GE Ultraschall Deutschland GmbH & Co. KG Beethovenstrasse 239 Postfach 11 05 60 D-42655 Solingen GERMANY TEL: 49 212.28.02.208; FAX: 49 212.28.02.431

Revision History Reason for Change REV

DATE (YYYY/MM/DD)

REASON FOR CHANGE

Rev. 1

2020/01/03

Initial release

Rev. 2

2020/03/19

Update Indications for Use

Rev. 3

2020/05/10

Update the Table for Label Icons and the description for 3D/4D Mode

Rev. 4

2020/11/09

Add the description for battery status icons Update “Compatible Chemicals for Cleaning” section Add “All Third-Party or Open-Source Software” section Add Brazilian registration number and importer information Update Brazil telephone number

Rev. 5

2021/09/20

Update cleaning and disinfection information

Rev. 6

2022/05/10

Add India factory site information

Rev. 7

2022/10/30

Add software R1.2.x information

Rev. 8

2023/01/07

Update typo error R1.0.x to R1.1.x

Rev. 9

2023/05/30

Update Brazil Importer Address

List of Effective Pages REVISION NUMBER

CHAPTER NUMBER

CHAPTER NUMBER

REVISION NUMBER

Title Page

Rev. 9

Chapter 2

Rev. 9

Revision History

Rev. 9

Chapter 3

Rev. 9

Regulatory Requirements

Rev. 9

Chapter 4

Rev. 9

Chapter 1

Rev. 9

Chapter 5

Rev. 9

Please verify that you are using the latest revision of this document. Information pertaining to this document is maintained on MyWorkshop/ePDM (GE Electronic Product Data Management). If you need to know the latest revision, contact your distributor, local GE Sales Representative or in the USA call the GE Ultrasound Clinical Answer Center at 1 800 682 5327 or 1 262 524 5698.

Versana Active – User Guide 5840761-100 English Rev. 9

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Versana Active – User Guide 5840761-100 English Rev. 9

Regulatory Requirements

Conformance Standards •

According to 93/42/EEC Medical Device Directive, this is Class IIa Medical Device.

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According to IEC/EN 60601-1, •

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Equipment is Class I, Type BF or CF Applied Part for probes, DEFIBRILLATION-PROOF Type CF Applied Part for ECG.

According to CISPR 11, •

Equipment is Group 1, Class A ISM Equipment.

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Continuous Operation.

According to IEC 60529, •

The footswitch rate IPx8 is suitable for use in surgical rooms.

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Probe head (immersible portion) and cable are IPX7 Probe connector is not waterproof.

This product complies with the regulatory requirement of the following: •

Council Directive 93/42/EEC concerning medical devices: the CE label affixed to the product testifies compliance to the Directive. The location of the CE marking is shown in Chapter 2 of this manual. Authorized EU Representative

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Conformance Standards (continued) •

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International Electrotechnical Commission (IEC). •

IEC/EN 60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.

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IEC/EN 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances- Requirements and tests.

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IEC/EN 62366(Usability), EN 1041 (Information supplied with medical devices).

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IEC/EN 60601-2-37 Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic monitoring equipment.

International Organization of Standards (ISO) •

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ANSI/AAMI ES60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.

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Canadian Standards Association (CSA). •

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ISO 10993-1 Biological evaluation of medical devices.

CAN/CSA-22.2, NO. 60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.

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NEMA/AIUM Acoustic Output Display Standard (NEMA UD3).

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Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment NEMA UD2.

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Medical Device Good Manufacturing Practice Manual issued by the FDA (Food and Drug Administration, Department of Health, USA).

Versana Active – User Guide 5840761-100 English Rev. 9

Certifications •

GE Medical Systems (China) Co., Ltd. is ISO 13485 certified.

Original Documentation •

The original document was written in English.

Country-Specific Approval •

Japan MHLW Certificated Number: 301ACBZX00017000

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Brazil ANVISA Nº: 80071260409

Importer Information Table i-1:

Importer

Turkey

Brazil

Versana Active – User Guide 5840761-100 English Rev. 9

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Authorized Representative in Kazakhstan Authorized representative in Kazakhstan which is responsible for accepting claims is General Electric Kazakhstan LLP.

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Versana Active – User Guide 5840761-100 English Rev. 9

Table of Contents

Conformance Standards - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-3 Certifications - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-5 Original Documentation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-5 Country-Specific Approval - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-5 Importer Information - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-5 Authorized Representative in Kazakhstan - - - - - - - - - - - - - - - - - - - - - - - i-6

Table of Contents Chapter 1 - Getting Started Overview

Attention - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-2 Principles of Operation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-4 Contraindications - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-5 Intended Use - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-5 Indications for Use - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-6 Clinical applications - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-7 Prescription Device - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-7 Site Requirements - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-8 Console graphics - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-11 Battery- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-12 Peripheral/Accessory Connection- - - - - - - - - - - - - - - - - - - - - - - - - - - 1-24 Footswitch (Option)- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-26 Control Panel Map - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-27 Primary Menu Keys- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-30 Button Description - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-31 Monitor Display- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-33

Monitor

Adjusting the Monitor - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-34 Brightness and Contrast - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-35 Brightness - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-37 Volume - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-38

Moving the system

Before moving the system - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-39 Moving the System - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-40 Transporting the System - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-40

System Start-Up

Connecting the System - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-41 Power On- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-45 Power Off- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-57 Standby Mode - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-58

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Check System Date and Time - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-59 Crash Recovery Instructions - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-60 Temporary Buffer - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-61

Database Protection Mechanism Probes

Connecting the Probe - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-63 Cable Handling - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-66 Activating/Deactivating the Probe - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-66 Deactivating the Probe - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-66 Disconnecting the Probe - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-67

Beginning an Exam

Patient Screen - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-68 Scanning a New Patient - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-69 Entering a Patient List - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-72 Starting a new exam on an existing patient - - - - - - - - - - - - - - - - - - - - 1-72 Scanning without entering any patient data - - - - - - - - - - - - - - - - - - - - 1-73 Ending a Patient - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-73 Changing Current Patient to Existing Patient (with Patient ID) - - - - - - 1-74 Changing Current Patient to Existing Patient (without Patient ID) - - - - 1-75 Delete the existing patient/exam/image- - - - - - - - - - - - - - - - - - - - - - - 1-77 Follow-up Tool (Option) - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-80

Chapter 2 - Performing an Exam Optimizing the Image

B-Mode Controls- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-2 M-Mode Controls - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-5 Color Flow Mode Controls - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-6 M Color Flow Mode- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-8 Doppler Mode Controls - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-9 Easy 3DMode (Option) - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-11 3D/4D Mode (Option) - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-12 Elastography (Option) - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-25 Contrast Imaging (Option) - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-28 Breast Care (Option) - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-33 Other Controls - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-46 Needle Recognition (Option) - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-52 Use of ECG - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-57 Scan Coach (Option)- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-62 Scan Assistant - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-78 My Trainer - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-89

Measurement and Analysis

Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-93 Location of Measurement Controls - - - - - - - - - - - - - - - - - - - - - - - - - - 2-94 B-Mode Measurements - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-95 Doppler Mode Measurements - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-102 M-Mode Measurements- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-106 Auto Bladder Volume Measurement (Option)- - - - - - - - - - - - - - - - - - 2-108 Thyroid Measurement - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-112 Thyroid Productivity Package (Option) - - - - - - - - - - - - - - - - - - - - - - 2-113

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Breast Productivity - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-125 SonoBiometry (AFB) - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-131 Wide Dual Screen Measurements - - - - - - - - - - - - - - - - - - - - - - - - - 2-135 Viewing and Editing Worksheets - - - - - - - - - - - - - - - - - - - - - - - - - - 2-136 Clinical Measurement Accuracy - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-140 Setting up the Off-Line Paper Printer - - - - - - - - - - - - - - - - - - - - - - - 2-142

Chapter 3 - After The Exam Is Over Preset

Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-2 System Presets - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-4 Data Backup - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-10 Configuring Connectivity - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-30

Electronic Documentation

Accessing Documentation Via a PC - - - - - - - - - - - - - - - - - - - - - - - - - 3-32

System Care and Maintenance

Expected Service Life Description - - - - - - - - - - - - - - - - - - - - - - - - - - 3-33 Inspecting the System - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-33 Cleaning and Disinfecting the system - - - - - - - - - - - - - - - - - - - - - - - - 3-36 Cleaning the Trackball- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-45 Probe holder (for Cart only) - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-46 System cabinet- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-46 Other Maintenance - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-47 Cleaning the air filter (for Cart only) - - - - - - - - - - - - - - - - - - - - - - - - - 3-48 Replacing illuminated key caps/lamps- - - - - - - - - - - - - - - - - - - - - - - - 3-50 Battery Replacement and Disposal- - - - - - - - - - - - - - - - - - - - - - - - - - 3-50 Prevention of static electricity interference- - - - - - - - - - - - - - - - - - - - - 3-51 Disposal- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-51 Troubleshooting - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-52 Assistance - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-53

Quality Assurance

Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-60 Typical Tests to Perform - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-61 Baselines - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-64 Periodic Checks - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-64 Results - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-65 System Setup- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-66 Test Procedures - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-66 Setting up a Record Keeping System - - - - - - - - - - - - - - - - - - - - - - - - 3-77 Ultrasound Quality Assurance Checklist - - - - - - - - - - - - - - - - - - - - - - 3-78

Privacy and Security

Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-79 Abbreviations and Definitions- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-80 Privacy and Security Environment - - - - - - - - - - - - - - - - - - - - - - - - - - 3-81 Privacy and Security Capabilities - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-82 Information Protection - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-92 System Protection- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-107 Remote Service - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-111 Personal Information Collected by the Product - - - - - - - - - - - - - - - - 3-112

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Security Vulnerability Scanning - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-115 Potential Hazardous Situations Resulting from Failures of the IT Network - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-116 MDS2 - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-117 Disabled Windows Services- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-124 All Third-Party or Open-Source Software - - - - - - - - - - - - - - - - - - - - 3-125

Contact Information

Contacting GE Ultrasound - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-126 Manufacturer - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-130 Factory Sites - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-130

Chapter 4 - Safety

Owner Responsibility

Owner requirements - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-2

Bioeffect Disclosure

Bioeffect disclosure- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-3

Safety Precautions

Precaution Levels - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-4 Hazard Symbols - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-5 Patient Safety- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-7 Equipment and Personnel Safety - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-11 Material Safe Data - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-17 Electrical safety - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-18 EMC (Electromagnetic Compatibility) - - - - - - - - - - - - - - - - - - - - - - - - 4-19 Minimum distances - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-32 Wireless Adapter Specification- - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-33 Bluetooth Specification - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-33 Basic Safety - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-34 Essential performance- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-34 Patient Environmental Devices- - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-35 Acoustic Output - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-37 General Caution - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-43 ROHS Versana Active Hazardous Substances - - - - - - - - - - - - - - - - - 4-44 Device Labels- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-46 Label Locations - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-53

Chapter 5 - Probes and Biopsy Probe Overview

Ergonomics - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-2 Cable handling - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-2 Probe orientation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-3 Labeling- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-3 Probe Naming Conventions - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-4 Probe Usage - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-4 Care and Maintenance - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-5 Probe Safety - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-43 Special handling instructions - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-45 Probe handling and infection control - - - - - - - - - - - - - - - - - - - - - - - - - 5-47 Coupling gels - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-49

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Planned Maintenance - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-50 Returning/Shipping Probes and Repair Parts- - - - - - - - - - - - - - - - - - - 5-50 Sterile Ultrasound Procedures - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-50

Probe Discussion

Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-51 Application - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-52 Features - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-53 Specifications - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-55 Slice Thickness Specification - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-56 Probe Illustration- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-57

Biopsy Special Concerns

Precautions Concerning the Use of Biopsy Procedures - - - - - - - - - - - 5-60

Preparing for a Biopsy

Index

Displaying the Guidezone - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-62 Preparing the Biopsy Guide Attachment - - - - - - - - - - - - - - - - - - - - - - 5-65 4D Probe Biopsy Needle Path Selection - - - - - - - - - - - - - - - - - - - - - - 5-76 Biopsy Needle Path Verification - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-76 The Biopsy Procedure- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-77 Post Biopsy - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-78

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Chapter 1 Getting Started Console Overview, Moving the System, System Start-up, Probes and Beginning an Exam

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Getting Started

Overview

Attention This manual is for Versana Active. This manual contains information to operate the system safely. Advanced equipment training may be provided by a factory trained Applications Specialist for the agreed-upon time period. Read and understand all instructions in this manual and Basic User Manual (English) before attempting to use the Versana Active system. Keep this manual with the equipment at all times. Periodically review the procedures for operation and safety precautions. NOTE:

The Online Help offers a quick way for the user to access the manual. When there are difference between Online Help and Basic User Manual/User Guide, please refer to Basic User Manual/User Guide for the only right version. Disregarding information on safety is considered abnormal use. Not all features, products, probes or peripherals described in this document may be available or cleared for sale in all markets. Please contact your local GE Ultrasound representative to get the latest information.

NOTE:

Please note that orders are based on the individually agreed upon specifications and may not contain all features listed in this manual.

NOTE:

All references to standards / regulations and their revisions are valid for the time of publication of the user manual.

CAUTION

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Safety instructions must be reviewed before operating the unit.

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Overview Attention (continued) The Versana Active manuals are written for users who are familiar with basic ultrasound principles and techniques. They do not include sonographic training or detailed clinical procedures. NOTE:

The system color varies.

NOTE:

The electronic documentation CD includes English and all translations.

NOTE:

The screen graphics in this manual are only for illustrational purposes. Actual screen output may differ with the different software version.

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Getting Started Principles of Operation Medical ultrasound images are created by computer and digital memory from the transmission and reception of mechanical high-frequency waves applied through a transducer. The mechanical ultrasound waves spread through the body, producing an echo where density changes occur. For example, in the case of human tissue, an echo is created where a signal passes from an adipose tissue (fat) region to a muscular tissue region. The echoes return to the transducer where they are converted back into electrical signals. These echo signals are highly amplified and processed by several analog and digital circuits having filters with many frequency and time response options, transforming the high-frequency electrical signals into a series of digital image signals which are stored in memory. Once in memory, the image can be displayed in real-time on the image monitor. All signal transmission, reception and processing characteristics are controlled by the main computer. By selection from the system control panel, the user can alter the characteristics and features of the system, allowing a wide range of uses, from obstetrics to peripheral vascular examinations. Transducers are accurate, solid-state devices, providing multiple image formats. The digital design and use of solid-state components provides highly stable and consistent imaging performance with minimal required maintenance. Sophisticated design with computer control offers a system with extensive features and functions which is user-friendly and easy to use.

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Overview Contraindications The Versana Active ultrasound system is not intended for ophthalmic use or any use causing the acoustic beam to pass through the eye.

Intended Use The Versana Active is intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid.

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Getting Started Indications for Use The Versana Active is a general-purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid. Versana Active clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Urology, Pediatric, Small Organ (includes breast, testes, thyroid), Neonatal Cephalic, Adult Cephalic, Cardiac (includes Adult and Pediatric), Vascular/ Peripheral Vascular, Musculoskeletal Conventional, Musculoskeletal Superficial, Thoracic/Pleural, Transcranial, Transrectal, Transvaginal, Interventional guidance (includes tissue biopsy, fluid drainage, vascular and non-vascular access). Modes of operation include: B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Coded Pulse, 3D, 4D Imaging mode and Combined modes: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD or CWD. The device is intended for use in an indoor hospital environment, in medical offices/clinics and other Healthcare facilities. Frequency of use

Daily (Typically 8 hours)

Operator profile

•

Qualified and trained physicians or sonographers with at least basic ultrasound knowledge.

•

The operator must have read and understood the user manual.

NOTE:

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Only qualified and trained healthcare professionals should perform ultrasound scanning on human subjects for medical diagnostic reasons. Request training, if needed.

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