GE LOGIQ V2, LOGIQ V1 Basic User Manual

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Technical Publication

Direction 5610735-100 English

Rev. 2

LOGIQ V2/LOGIQ V1 Basic User Manual

R1.X.X

Operating Documentation

Regulatory Requirement

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

This manual is a reference for the LOGIQ V2, LOGIQ V1. It applies to all versions of the R1.x.x for the LOGIQ V2/LOGIQ V1 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

DATE

REV

Rev. 1 2015/07/14 Initial release

(YYYY/MM/DD) REASON FOR CHANGE

Rev. 2 2015/11/24 1. Update label information and probe feature

2. Update B steer description

3. Update peripheral list

List of Effective Pages

REVISION

PAGE NUMBER

Title Page Rev. 2 Chapter 9 Rev. 2

Revision History Rev. 2 Chapter 10 Rev. 2

Regulatory Requirements Rev. 2 Chapter 11 Rev. 2

Chapter 1 Rev. 2 Chapter 12 Rev. 2

Chapter 2 Rev. 2 Chapter 13 Rev. 2

Chapter 3 Rev. 2 Chapter 14 Rev. 2

Chapter 4 Rev. 2 Chapter 15 Rev. 2

Chapter 5 Rev. 2 Chapter 16 Rev. 2

Chapter 6 Rev. 2 Chapter 17 Rev. 2

Chapter 7 Rev. 2 Chapter 18 Rev. 2

Chapter 8 Rev. 2 Index Rev. 2

NUMBER PAGE NUMBER

REVISION

NUMBER

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.

LOGIQ V2/LOGIQ V1 – Basic User Manual i-1 Direction 5610735-100 English Rev. 2

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i-2 LOGIQ V2/LOGIQ V1 – Basic User Manual

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Regulatory Requirements

Conformance Standards

The following classifications are in accordance with the IEC/ EN 60601-1:

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

• According to IEC/EN 60601-1,

• Equipment is Class I, Type BF Applied Parts.

• Continuous Operation

• According to CISPR 11,

• Equipment is Group 1, Class A ISM Equipment.

• According to IEC 60529,

• The footswitch rate is IPX8.

• 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 the safety chapter of this manual.

Authorized EU Representative

European registered place of business:

GE Medical Systems Information Technologies GmbH

(GEMS IT GmbH)

Munzinger Strasse 5, D-79111 Freiburg, Germany

Tel: +49 761 45 43 -0; Fax: +49 761 45 43 -233

LOGIQ V2/LOGIQ V1 – Basic User Manual i-3 Direction 5610735-100 English Rev. 2

Conformance Standards (continued)

• International Electrotechnical Commission (IEC).

• IEC/EN 60601-1 Medical Electrical Equipment, Part 1

General Requirements for Safety.

• IEC/EN 60601-1-2 Electromagnetic compatibility -

Requirements and tests.

• IEC/EN 60601-1-6 (Usability), EN 1041 (Information

supplied with medical devices)

• IEC/EN 60601-2-37 Particular requirements for the

safety of ultrasonic medical diagnostic and monitoring equipment.

• International Organization of Standards (ISO)

• ISO 10993-1 Biological evaluation of medical devices.

• ANSI/AAMI ES60601-1 Medical Electrical Equipment, Part 1 General Requirements for Safety.

• Canadian Standards Association (CSA).

• CSA 22.2, 601.1 Medical Electrical Equipment, Part 1

General Requirements for Safety.

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

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

Certifications

• General Electric Medical Systems is ISO 13485 certified.

Original Documentation

• The original document was written in English.

i-4 LOGIQ V2/LOGIQ V1 – Basic User Manual

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Country-Specific Approval

• JAPAN

Certified Number:

Importer Information

• Turkey

LOGIQ V2/LOGIQ V1 – Basic User Manual i-5 Direction 5610735-100 English Rev. 2

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Conformance Standards - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-3 Certifications - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-4 Original Documentation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-4 Country-Specific Approval - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-5 Importer Information - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-5

Table of Contents Chapter 1 — Introduction

Overview

Attention - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-2 Documentation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-3 Principles of Operation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-4 Indications for Use - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-5 Contraindication - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-7 Prescription Device - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-7

Contact Information

Contacting GE Ultrasound - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-8 Manufacturer - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-14

Chapter 2 — Safety

Owner Responsibility

Notice against user modification - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-2

Safety Precautions

Precaution Levels - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-3 Hazard Symbols - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-4 Patient Safety- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-6 Equipment and Personnel Safety - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-10 EMC (Electromagnetic Compatibility) - - - - - - - - - - - - - - - - - - - - - - - - 2-15 Patient Environmental Devices- - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-24 Acoustic Output - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-26 RoHS LOGIQ V2/LOGIQ V1 Hazardous Substances - - - - - - - - - - - - - 2-29

Device Labels

Label Icon Description - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-31 Label Locations - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-37

Chapter 3 — Preparing the System for Use

Site Requirements

Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-2 Before the system arrives - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-3 Environmental Requirements - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-5

Console Overview

Console Graphics - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-6

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Battery- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-8 AC Adapter - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-16 Peripheral/Accessory Connection - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-17

Powering the System

Connecting to the electrical outlet- - - - - - - - - - - - - - - - - - - - - - - - - - - 3-27 Power On - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-31 Power Off- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-35 Check System Date and Time - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-36 Crash Recovery Instructions - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-37

System Positioning/Transporting

Moving the system - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-38 Before moving the system - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-38 When moving the system - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-39 Transporting the System - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-39 Attaching the Security Cable - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-40

LCD Monitor

Locking/unlocking the LCD monitor - - - - - - - - - - - - - - - - - - - - - - - - - 3-41 Adjusting the LCD monitor - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-41 Brightness - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-42 Volume - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-43

Probes

Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-44 Selecting probes- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-44 Connecting the Probe - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-45 Transporting Probes - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-52 Storing the Probe - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-52

Operator Controls

Control Panel Map - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-53 Keyboard - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-54 User Defined Key - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-55 Primary Menu keys - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-55 Button description - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-56

Monitor Display

Monitor Display- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-58 Using the Monitor Display Controls to Manage Images- - - - - - - - - - - - 3-60

Chapter 4 — Preparing for an Exam

Beginning an Exam

Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-2 Beginning a New Patient - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-3 Retrieving and editing archived information - - - - - - - - - - - - - - - - - - - - 4-15 Review images in archive - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-18 Selecting an Application Preset and a probe - - - - - - - - - - - - - - - - - - - 4-21

Chapter 5 — Optimizing the Image

Optimizing B-Mode

Intended Uses - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-2 B-Mode Scanning Hints - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-4 Depth - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-5

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Gain - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-6 Focus - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-7 Auto Optimize- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-8 CrossXBeam - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-9 SRI-HD (High Detection Speckle Reduction Imaging) - - - - - - - - - - - - 5-11 Coded Harmonic Imaging (CHI) - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-13 Frequency - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-13 B Steer - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-14 M/D Cursor - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-14 Virtual Convex - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-14 TGC - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-15 Scan Area - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-15 Tilt- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-16 Dynamic Range - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-16 Revert - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-17 Line Density - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-18 Colorize - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-19 PRF- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-20 Edge Enhance - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-20 Frame Average- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-20 Gray Map- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-21 Rejection - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-21 Rotation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-21 Suppression - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-21 Needle Recognition- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-22 LOGIQ View (Option) - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-24

Optimizing M-Mode

Intended Use - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-26 Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-26 Typical exam protocol - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-26 M-Mode Display - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-27 Scanning Hints - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-28 Sweep Speed- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-28 Anatomical M-Mode - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-29

Optimizing Color Flow

Intended Use - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-30 Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-30 Uses - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-32 Flow Model - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-34 Gain - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-34 PRF/Scale (Velocity Scale) - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-34 Wall Filter- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-35 Wall Filter Target Override (Hz) - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-35 Size/Position of the color window - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-36 CF/PDI Width - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-36 CF/PDI Vertical Size - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-36 Invert (Color Invert) - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-37 Baseline- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-37

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Angle Steer - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-38 Accumulation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-38 Color Flow Line Density- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-39 Map- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-40 Map Compress - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-40 Threshold- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-40 Frame Average- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-41 Transparency Map - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-41 Spatial Filter - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-41 Flash Suppression - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-41 Packet Size - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-42 Sample Vol (Sample Volume) - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-42 CF/PDI Sample Volume - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-42 CF/PDI Center Depth - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-42 CF/PDI Focus Depth (%) - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-42 CF/PDI Frequency (MHz) - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-43 CF/PDI Auto Frequency - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-43 CF/PDI Vertical Size - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-43 CF/PDI Width - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-43 Power Doppler Imaging (PDI) - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-44 Tissue Velocity Imaging (Option) - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-45

Optimizing M Color Flow

M Color Flow Mode- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-48

Optimizing Spectral Doppler

Intended Use - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-50 Doppler Mode Display - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-54 Doppler Sample Volume Gate Position (Trackball)- - - - - - - - - - - - - - - 5-55 Doppler Sample Volume Length - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-55 Angle Correct/Auto Angle - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-56 Quick Angle - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-56 Steer/Fine Steer - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-56 Volume - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-57 Auto Spectrum Optimize (Auto) - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-57 Cycles to Average- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-57 Display Format - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-57 Set/ B Pause - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-58 Simultaneous - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-58 Baseline- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-58 Compression - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-59 Invert - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-59 Cursor Moving - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-59 PRF- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-60 Wall Filter- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-61 Trace Method - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-61 Trace Sensitivity - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-61 Trace Direction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-61 Continuous Wave Doppler (CWD) (Option) - - - - - - - - - - - - - - - - - - - - 5-62

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TruScan Q Analysis (Option)

Activating QAnalysis - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-65 Q-Analysis Screen Description - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-66 Selecting QAnalysis Image Range - - - - - - - - - - - - - - - - - - - - - - - - - - 5-67 Generating a Trace - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-68 Manual tracking of the sample area (dynamic anchored sample area) - 5-69 Delete a trace- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-70 Manipulating the Sample Area - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-70 Disabling/Enabling the frame - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-74 Smoothing - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-75 Horizontal Sweep - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-75 Drift Compensation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-75 Statistics - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-76 Trace Measurements - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-76 Exporting Traces (Saving the Trace Data)- - - - - - - - - - - - - - - - - - - - - 5-77 Annotating the QAnalysis Data- - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-78 Exiting QAnalysis - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-78

Using Easy 3D (Option)

Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-79 3D Acquisition - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-80 3D Acquisition Parameter Description- - - - - - - - - - - - - - - - - - - - - - - - 5-85 Easy 3D- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-87 Movie 3D - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-90

Scan Assistant

Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-91 Scan Assistant Definitions - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-92 Scan Assistant Description - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-93 Setting up Scan Assistant - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-94 Using Scan Assistant - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-99 Exporting Scan Assistant Programs - - - - - - - - - - - - - - - - - - - - - - - - 5-101

Scan Coach

Scan Coach - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-102 Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-104 Using Scan Coach - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-105 Edit Scan Coach Protocol - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-109

SonoBiometry (AFB) (Option)

SonoBiometry- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-113

Chapter 6 — Scanning/Display Functions

Zooming an Image

Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-2 Bioeffect - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-2 Read vs. Write Zoom - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-3 Using Read/Write Zoom - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-4

Split Screen

Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-6

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Freezing an Image

Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-7 Freezing an image - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-7 Post processing - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-8

Using CINE

Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-10 Activating CINE - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-10 Cine gauge and Monitor Display- - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-10 Using CINE - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-11 Preview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-13

Annotating an Image

Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-14 Adding Comments to an Image - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-16 Body Patterns- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-21

Using the Fast Key

Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-26 Create a Fast Key- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-26 Start a Fast Key - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-27 Backup and Restore the Fast Key - - - - - - - - - - - - - - - - - - - - - - - - - - 6-27

Using InSite ExC

InSite ExC - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-28 Types of InSite ExC Service - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-28 Configure Agent - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-29 Initiating a Request for Service (RFS) - - - - - - - - - - - - - - - - - - - - - - - - 6-30 Initiating a Technical or Clinical Support Request- - - - - - - - - - - - - - - - 6-34 InSite ExC Definitions - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-36 Exiting InSite ExC - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-36

Electronic Documentation

Documentation Distribution - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-37 Using Online Help Via F1 - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-38 Electronic media - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-43

Chapter 7 — General Measurements and Calculations

Introduction

Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-2 Location of Measurement Controls - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-4 General Instructions - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-7

Measurement and Calculation Setup

Starting Study and Measurement SetUp - - - - - - - - - - - - - - - - - - - - - 7-12 Specifying Which Measurements Go in a Study or Folder- - - - - - - - - - 7-20 Changing Measurements- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-24 Adding Folders and Measurements - - - - - - - - - - - - - - - - - - - - - - - - - 7-25 M&A Advanced Preset - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-33 Manual Calcs Presets - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-36 Application Measurement Preset - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-37

Mode Measurements

B-Mode Measurements - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-38 Doppler Mode Measurements - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-46

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M-Mode Measurements- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-53 Viewing and Editing Worksheets - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-55

Generic Measurements

Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-59 B-Mode Measurements - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-61 M-Mode Measurements- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-69 Doppler Mode Measurements - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-72 Auto vs. Manual Calculations - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-78 Performing Measurements on Saved Images - - - - - - - - - - - - - - - - - - 7-80 Helpful hints - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-82

Chapter 8 — Abdomen and Small Parts

Abdomen/Small Parts Exam Preparation

Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-2 General Guidelines - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-2

Abdomen

Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-3

Small Parts

Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-4

Chapter 9 — OB/GYN

OB Exam

Exam Preparation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-2 Acoustic Output Considerations - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-2 To Start an Obstetrics Exam - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-3 OB Type change- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-3

OB Measurements and Calculations

Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-4 B-Mode Measurements - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-5 M-Mode Measurements- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-15 Doppler Mode Measurements - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-16 OB Worksheet - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-19

Anatomical Survey

Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-23

OB Graphs

Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-25 To View OB Graphs - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-25

OB-Multigestational

Multiple Fetus- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-31

OB Table Editor

OB Table Settings Menu - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-36 OB Table Templates - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-38 OB Table Edit Menu - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-45 EFW for OB User Table/Formula Editor - - - - - - - - - - - - - - - - - - - - - - 9-47

GYN Measurements

Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-51 To Start a Gynecology Exam - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-52 B-Mode Measurements - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-53 M-Mode Measurements- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-56

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Doppler Mode Measurements - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-57

Chapter 10 — Cardiology

Cardiology Exam Preparation

Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 10-2 General Guidelines - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 10-2

Cardiology Measurements

Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 10-3 Naming Format for Cardiac Measurements - - - - - - - - - - - - - - - - - - - - 10-4 Cardiac Measurements - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 10-8 Steps to perform a measurement - - - - - - - - - - - - - - - - - - - - - - - - - - - 10-9 B-Mode Measurements - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 10-12 M-Mode Measurements- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 10-18 Doppler Mode Measurements - - - - - - - - - - - - - - - - - - - - - - - - - - - - 10-21 Color Flow Mode - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 10-28 Cardiac Worksheet - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 10-29 Setting up and Organizing Measurements and Calculations - - - - - - - 10-30 Generic Study - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 10-31 Cardiac Doppler Measurements - - - - - - - - - - - - - - - - - - - - - - - - - - - 10-32

Chapter 11 — Vascular

Vascular Exam Preparation

Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-2 General Guidelines - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-2

Vascular Measurements

Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-3 Naming format for vessels - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-5 B-Mode Measurements - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-9 M-Mode Measurements- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-14 Doppler Mode Measurements - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-15

Vascular Worksheet

To view the Vascular Worksheet - - - - - - - - - - - - - - - - - - - - - - - - - - 11-22 Worksheet Display - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-23 To edit a worksheet- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-24 Examiner’s Comments - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-27 Intravessel ratio - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-28 Vessel Summary - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-29 Recording Worksheet - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-31

Chapter 12 — Urology

Urology Exam Preparation

Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12-2 General Guidelines - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12-2

Urology Calculations

Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12-3 Urology B-Mode Measurements - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12-4

Chapter 13 — Pediatrics

Pediatrics Exam Preparation

Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 13-2 General Guidelines - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 13-2

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Pediatrics Calculations

Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 13-3 Ped Hip - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 13-4

Chapter 14 — ReportWriter

Standard Report Pages

Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 14-2 Creating a report- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 14-2 Activating the Report - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 14-3 Editing a Report - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 14-8

Designing Your Own Template

Template Designer - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 14-24 File Menu- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 14-25 Edit Menu - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 14-28 Insert Menu - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 14-29 Customize Menu- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 14-47

Direct Report

Direct Report - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 14-49

Report Presets

Utility Report Page - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 14-52

Chapter 15 — Recording Images

Introduction

Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 15-2 Adding Devices - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 15-4 Adding a Dataflow- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 15-4 Adding Devices to a Print Button - - - - - - - - - - - - - - - - - - - - - - - - - - - 15-4 Formatting Removable Media - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 15-4

Image/Data Management

Reviewing Patient Images - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 15-5 Backup/Restore Images - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 15-5 Clipboard - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 15-6 Storing Images and Cineloops - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 15-7 Save As - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 15-9 Data Transfer - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 15-16 External drives - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 15-35

Printing Options

Setting up the Off-Line Paper Printer - - - - - - - - - - - - - - - - - - - - - - - 15-46 Setting Up a Network Printer - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 15-52

Chapter 16 — Customizing Your System

Presets

Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 16-2

System Presets

Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 16-3 Changing system parameters - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 16-3 System/General Preset Menu - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 16-4 System/System Imaging Preset Menu - - - - - - - - - - - - - - - - - - - - - - 16-10 System/System Measure Preset Menu - - - - - - - - - - - - - - - - - - - - - - 16-13 System/Backup and Restore Preset Menu - - - - - - - - - - - - - - - - - - - 16-16

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System/Peripherals Menu - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 16-34 System/User Configurable Key - - - - - - - - - - - - - - - - - - - - - - - - - - - 16-35 System/About Preset Menu - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 16-36

Imaging Presets

Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 16-37 Changing imaging presets - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 16-39 General - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 16-41

Comments Libraries Presets

Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 16-42 Comments Libraries/Libraries Preset Menu - - - - - - - - - - - - - - - - - - - 16-42 Comments Libraries/Comments Preset Menu - - - - - - - - - - - - - - - - - 16-44 Comments Libraries/Applications Preset Menu - - - - - - - - - - - - - - - - 16-45

Body Patterns Presets

Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 16-47 Body Pattern Libraries/Libraries Preset Menu - - - - - - - - - - - - - - - - - 16-47 Body Pattern Libraries/Body Patterns Preset Menu - - - - - - - - - - - - - 16-50 Body Pattern Libraries/Applications Preset Menu- - - - - - - - - - - - - - - 16-51

Application Presets

Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 16-53

Test Patterns

Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 16-58

Configuring Connectivity

Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 16-59 Structured Reporting- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 16-59 Connectivity Functions - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 16-60 TCPIP - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 16-61 Device - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 16-71 Service - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 16-72 Dataflow - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 16-89 Button - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 16-90 Removable Media - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 16-91 Miscellaneous - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 16-93

Measure Reports System Administration

Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 16-98 System Admin - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 16-99 Users- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 16-100 Logon - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 16-102

Service Scan Assistant

Scan Assistant Manager - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 16-104 Activating the Scan Assistant Creator - - - - - - - - - - - - - - - - - - - - - - 16-104 Scan Assistant Creator - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 16-105 Exporting the Scan Assistant Creator to a PC - - - - - - - - - - - - - - - - 16-137

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Chapter 17 — Probes and Biopsy

Probe Overview

Ergonomics - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 17-2 Cable handling - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 17-2 Probe orientation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 17-3 Labeling- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 17-3 Probe Naming Conventions - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 17-3 Probe Usage - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 17-4 Probe Safety - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 17-6 Special handling instructions - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 17-8 Probe handling and infection control- - - - - - - - - - - - - - - - - - - - - - - - 17-10 Probe Cleaning Process - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 17-11 Coupling gels - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 17-17

Probe Discussion

Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 17-19 Application - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 17-20 Features - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 17-21 Specifications - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 17-21 Slice Thickness Specification - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 17-23 Probe Illustration- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 17-24

Biopsy Special Concerns

Precautions Concerning the Use of Biopsy Procedures - - - - - - - - - - 17-26

Preparing for a Biopsy

Displaying the Guidezone - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 17-28 Preparing the Biopsy Guide Attachment - - - - - - - - - - - - - - - - - - - - - 17-31 Biopsy Needle Path Verification - - - - - - - - - - - - - - - - - - - - - - - - - - - 17-40 The Biopsy Procedure - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 17-41 Post Biopsy - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 17-42

Surgery/Intra-operative Use

Preparing for Surgery/Intra-operative Procedures - - - - - - - - - - - - - - 17-43

Chapter 18 — User Maintenance

System Data

Features/Specifications - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 18-2 Clinical Measurement Accuracy - - - - - - - - - - - - - - - - - - - - - - - - - - - - 18-6

Anti-Virus Software Note System Care and Maintenance

Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 18-10 Inspecting the System- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 18-11 Cleaning the system - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 18-13 Prevention of static electricity interference- - - - - - - - - - - - - - - - - - - - 18-16 Disposal- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 18-17 Troubleshooting - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 18-18 System Software Updates (Software Download) - - - - - - - - - - - - - - - 18-19 Wipe Tool - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 18-26

Quality Assurance

Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 18-30

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Assistance

Index

Typical Tests to Perform - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 18-31 Baselines - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 18-34 Periodic Checks - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 18-34 Results - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 18-35 System Setup- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 18-36 Test Procedures - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 18-36 Setting up a Record Keeping System - - - - - - - - - - - - - - - - - - - - - - - 18-45 Ultrasound Quality Assurance Checklist - - - - - - - - - - - - - - - - - - - - - 18-46

Supplies/Accessories - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 18-47

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Chapter 1

Introduction

This chapter consists of information concerning indications for use/contraindications, and how this documentation is organized.

LOGIQ V2/LOGIQ V1 - Basic User Manual 1-1 Direction 5610735-100 English Rev. 2

Introduction

CAUTION

Attention

Overview

This manual is for LOGIQ V2 and LOGIQ V1, .

This manual contains necessary and sufficient 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 all manuals supplied with the system before attempting to use the LOGIQ V2/LOGIQ V1 system.

Keep this manual with the equipment at all times. Periodically review the procedures for operation and safety precautions.

Disregarding information on safety is considered abnormal use.

Not all products, features, 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

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.

Safety instructions must be reviewed before operating the unit.

NOTE: The system color varies.

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Documentation

Overview

LOGIQ V2/LOGIQ V1 documentation consists of various manuals:

• The Basic User Manual (ENGLISH ONLY), and Online Help (ENGLISH ONLY) provides information needed by the user to operate the system safely. It describes the basic functions of the system, safety features, operating modes, measurements/calculations, probes, user care and maintenance.

• The User Guide (TRANSLATED) is a condensed user instruction guide.

• The Release Notes (TRNASLATED) provide precautions and instructions that supplement the Basic User Manual.

• The Advanced Reference Manual (ENGLISH ONLY) contains data tables, such as OB and Acoustic Output tables.

• The Basic Service Manual (ENGLISH ONLY) supplies block diagrams, lists of spare parts, descriptions, adjustment instructions or similar information which help adequately qualified technical personnel in repairing those parts of the system which have been defined repairable by the manufacturer.

• AIUM Booklet (USA only)

The LOGIQ V2/LOGIQ V1 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: Dates on screenshots are represented in MM/DD/YYYY format

throughout the manual. Information on how to change the system’s date can be found in Customizing Your System.

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 versions.

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Introduction

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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Indications for Use

Frequency of Use

Operator Profile

Overview

The LOGIQ V2/LOGIQ V1 is intended for ultrasound imaging, measurement and analysis of the human body for multiple clinical applications including: Fetal/OB; GYN; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal and Adult Cephalic; Cardiac (adult & pediatric); Peripheral Vascular; Musculoskeletal Conventional & Superficial; Urology; Transrectal; Transvaginal; imaging guidance of interventional procedures (e.g Nerve Block; Vascular Access; Tissue Biopsy/ Fluid Drainage).

Daily (Typically 8 hours)

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

• The operator must have read and understood the user manual.

NOTE: Only qualified physicians or sonographers should perform

ultrasound scanning on human subjects for medical diagnostic reasons. Request training, if needed.

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Introduction

CAUTION

Clinical Applications

Specific clinical applications and exam types include:

• Abdominal

• Obstetrics

• Gynecological

• Cardiac

• Vascular

• Transcranial

• Musculoskeletal

• Urological

• Small parts

• Pediatric and Neonatal

Image Acquisition is for diagnostic purposes including measurements on acquired image.

This machine should be used in compliance with law. Some jurisdictions restrict certain uses, such as gender determination.

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Contraindication

Prescription Device

Overview

The LOGIQ V2/LOGIQ V1 ultrasound system is not intended for ophthalmic use or any use causing the acoustic beam to pass through the eye.

CAUTION: United States law restricts this device to sale or use by, or on the order of a physician.

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Introduction

Contact Information

Contacting GE Ultrasound

For additional information or assistance, please contact your local distributor or the appropriate support resource listed on the following pages:

INTERNET http://www.gehealthcare.com

http://www.gehealthcare.com/usen/ultrasound/products/ probe_care.html

Clinical Questions For information in the United States, Canada, Mexico and parts

of the Caribbean, call the Customer Answer Center. TEL: (1) 800-682-5327 or (1) 262-524-5698

In other locations, contact your local Applications, Sales, or Service Representative.

Service Questions For service in the United States, call GE CARES.

TEL: (1) 800-437-1171

In other locations, contact your local Service Representative.

Information Requests

Placing an Order To order accessories, supplies, or service parts in the United

To request technical product information in the United States, call GE Healthcare.

TEL: (1) 800-643-6439

In other locations, contact your local Applications, Sales, or Service Representative.

States, call the GE Healthcare Technologies Contact Center.

TEL: (1) 800-558-5102

In other locations, contact your local Applications, Sales, or Service Representative.

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Contacting GE Ultrasound (continued)

AMERICAS

ARGENTINA GEME S.A.

Miranda 5237 Buenos Aires - 1407 TEL: (1) 639-1619 FAX: (1) 567-2678

BRAZIL GE Healthcare do Brasil Comércio e Serviços para

Equipamentos Médico- Hospitalares Ltda Av. Das Nações Unidas, 8501 3º andar parte - Pinheiros São Paulo SP – CEP: 05425-070 C.N.P.J.: 02.029.372/0001-40 TEL: 3067-8010 FAX: (011) 3067-8280

CANADA GE Healthcare

Ultrasound Service Engineering 9900 Innovation Drive Wauwatosa, WI 53226 TEL: (1) 800-668-0732 Customer Answer Center TEL: (1) 262-524-5698

Contact Information

LATIN & SOUTH

AMERICA

MEXICO GE Sistemas Medicos de Mexico S.A. de C.V.

USA GE Healthcare

GE Healthcare Ultrasound Service Engineering 9900 Innovation Drive Wauwatosa, WI 53226 TEL: (1) 262-524-5300 Customer Answer Center TEL: (1) 262-524-5698

Rio Lerma #302, 1° y 2° Pisos Colonia Cuauhtemoc 06500-Mexico, D.F. TEL: (5) 228-9600 FAX: (5) 211-4631

Ultrasound Service Engineering 9900 Innovation Drive Wauwatosa, WI 53226 TEL: (1) 800-437-1171 FAX: (1) 414-721-3865

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Introduction

Contacting GE Ultrasound (continued)

ASIA

ASIA PACIFIC

JAPAN

AUSTRALIA Building 4B, 21 South St

CHINA GE Healthcare - Asia

INDIA Wipro GE Healthcare Pvt Ltd

KOREA 8F, POBA Gangnam Tower

GE Healthcare Asia Pacific 4-7-127, Asahigaoka Hinoshi, Tokyo 191-8503, Japan TEL: +81 42 585 5111

Rydalmere NSW 2116 Australia TEL: 1300 722 229

No. 1, Yongchang North Road Beijing Economic & Technology Development Area Beijing 100176, China TEL: (8610) 5806 8888 FAX: (8610) 6787 1162

No. 4, Kadugodi Industrial Area Bangalore, 560067 TEL: +(91) 1-800-425-8025

343, Hakdong-ro, Gangnam-gu Seoul 135-820, Korea TEL: +82 2 6201 3114

NEW ZEALAND 8 Tangihua Street

Auckland 1010 New Zealand TEL: 0800 434 325

SINGAPORE ASEAN

1 Maritime Square #13-01 HarbourFront Center Singapore 099253 TEL: +65 6291 8528

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Contacting GE Ultrasound (continued)

EUROPE

For all other European countries not listed, please contact your local GE distributor or the appropriate support resource listed on www.gehealthcare.com.

AUSTRIA General Electric Austria GmbH

Filiale GE Healthcare Technologies EURO PLAZA, Gebäude E Wienerbergstrasse 41 A-1120 Vienna TEL: (+43) 1 97272 0 FAX: (+43) 1 97272 2222

Contact Information

BELGIUM &

LUXEMBURG

CZECH REPUBLIC GE Medical Systems Ultrasound

DENMARK GE Medical Systems Ultrasound

ESTONIA &

FINLAND

FRANCE GE Medical Systems Ultrasound

GE Medical Systems Ultrasound Eagle Building Kouterveldstraat 20 1831 DIEGEM TEL: (+32) 2 719 7204 FAX: (+32) 2 719 7205

Vyskocilova 1422/1a 140 28 Praha

Park Alle 295, 2605 Brøndby TEL: (+45) 43 295 400 FAX: (+45) 43 295 399

GE Medical Systems Kuortaneenkatu 2, 000510 Helsinki P.O.Box 330, 00031 GE Finland TEL: (+358) 10 39 48 220 FAX: (+358) 10 39 48 221

and Primary Care Diagnostics F-78457 Velizy General Imaging TEL: (+33) 13 449 52 43 Cardiology TEL: (+33) 13 449 52 31 FAX: (+33) 13 44 95 202

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Introduction

EUROPE (continued)

GERMANY GE Healthcare GmbH

GREECE GE Healthcare

HUNGARY GE Hungary Zrt. Ultrasound

IRELAND NORTHERN IRELAND

Beethovenstrasse 239 42655 Solingen TEL: (+49) 212-28 02-0 FAX: (+49) 212-28 02 28

8-10 Sorou Str. Marousi Athens 15125 Hellas TEL: (+30) 210 8930600 FAX: (+30) 210 9625931

Division, Akron u. 2. Budaors 2040 Hungary TEL: (+36) 23 410 314 FAX: (+36) 23 410 390

GE Healthcare Victoria Business Park 9, Westbank Road, Belfast BT3 9JL. TEL: (+44) 28 90229900

REPUBLIC OF IRELAND

GE Healthcare Unit F4, Centrepoint Business Park Oak Drive, Dublin 22 TEL: (+353) 1 4605500

ITALY GE Medical Systems Italia spa

Via Galeno, 36, 20126 Milano TEL: (+39) 02 2600 1111 FAX: (+39) 02 2600 1599

LUXEMBORG See Belgium.

NETHERLANDS GE Healthcare

De Wel 18 B, 3871 MV Hoevelaken PO Box 22, 3870 CA Hoevelaken TEL: (+31) 33 254 1290 FAX: (+31) 33 254 1292

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EUROPE (continued)

NORWAY GE Medical Systems Ultrasound

POLAND GE Medical Systems Polska

PORTUGAL General Electric Portuguesa

RUSSIA GE Healthcare

Contact Information

Tåsenveien 71, 0873 Oslo TEL: (+47) 2202 0800

GE Medical Systems Ultrasound Strandpromenaden 45 P.O. Box 141, 3191 Horten TEL: (+47) 33 02 11 16

Sp. z o.o., ul. Woloska 9 02-583 Warszawa, Poland TEL: (+48) 22 330 83 00 FAX: (+48) 22 330 83 83

SA. Avenida do Forte, n° 4 Fraccao F, 2795-502 Carnaxide TEL: (+351) 21 425 1309 FAX: (+351) 21 425 1343

Krasnopresnenskaya nab. 18, bld A, 10th floor 123317 Moscow, Russia TEL: (+7) 4957 396931 FAX: (+7) 4957 396932

SPAIN GE Healthcare Espana

C/ Gobelas 35-37 28023 Madrid TEL: (+34) 91 663 2500 FAX: (+34) 91 663 2501

SWEDEN GE Medical Systems Ultrasound

PO Box 314, 17175 Stockholm TEL: (+46) 8 559 50010

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Introduction

EUROPE (continued)

SWITZERLAND GE Medical Systems Ab

Europastrasse 31 8152 Glattbrugg TEL: (+41) 1 809 92 92 FAX: (+41) 1 809 92 22

TURKEY GE Healthcare Türkiye

Istanbul Office Levent Ofis Esentepe Mah. Harman Sok. No:8 Sisli-Istanbul TEL: +90 212 398 07 00 FAX: +90 212 284 67 00

UNITED ARAB

EMIRATES (UAE)

UNITED KINGDOM GE Medical Systems Ultrasound TEL: (+44) 1707 263570

GE Healthcare Dubai Internet City, Building No. 18 P. O. Box # 11549, Dubai U.A.E TEL: (+971) 4 429 6101 or 4 429 6161 FAX: (+971) 4 429 6201

71 Great North Road FAX: (+44) 1707 260065 Hatfield, Hertfordshire, AL9 5EN

Manufacturer

GE Medical Systems (China) Co., Ltd. No. 19, Changjiang Road WuXi National Hi-Tech Development Zone Jiangsu, P.R. China 214028 TEL: +86 510 85225888; FAX: +86 510 85226688

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Chapter 2

Safety

Describes the safety and regulatory information pertinent for operating this ultrasound system.

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Safety

Owner Responsibility

It is the responsibility of the owner to ensure that anyone operating the system reads and understands this section of the manual. However, there is no representation that the act of reading this manual renders the reader qualified to operate, inspect, test, align, calibrate, troubleshoot, repair or modify the system. The owner should make certain that only properly trained, fully-qualified service personnel undertake the installation, maintenance, troubleshooting, calibration and repair of the equipment.

The owner of the ultrasound unit should ensure that only properly trained, fully qualified personnel are authorized to operate the system. Before authorizing anyone to operate the system, it should be verified that the person has read, and fully understands, the operating instructions contained in this manual. It is advisable to maintain a list of authorized operators.

Should the system fail to operate correctly, or if the unit does not respond to the commands described in this manual, the operator should contact the nearest field GE Ultrasound Service Office.

For information about specific requirements and regulations applicable to the use of electronic medical equipment, consult the local, state and federal agencies.

Notice against user modification

Never modify this product, including system components, software, cables, and so on. User modification may cause safety hazards and degradation in system performance. All modification must be done by a GE qualified person.

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Precaution Levels

DANGER

WARNING

CAUTION

Icon description

Safety Precautions

Various levels of safety precautions may be found on the equipment and different levels of concern are identified by one of the following flag words and icons which precede the precautionary statement.

Indicates that a specific hazard is known to exist which through inappropriate conditions or actions will cause:

• Severe or fatal personal injury

• Substantial property damage.

Indicates that a specific hazard is known to exist which through inappropriate conditions or actions may cause:

• Severe personal injury

• Substantial property damage.

Indicates that a potential hazard may exist which through inappropriate conditions or actions will or can cause:

• Minor injury

• Property damage.

NOTE: Indicates precautions or recommendations that should be used

in the operation of the ultrasound system, specifically:

• Maintaining an optimum system environment

• Using this Manual

• Notes to emphasize or clarify a point.

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Safety

Hazard Symbols

Icon Description

Icon Potential Hazard Usage Source

Potential hazards are indicated by the following icons:

Table 2-1: Potential Hazards

Biological Hazard

Describes precautions necessary to prevent the risk of disease transmission or infections.

• Patient/user infection due to contaminated equipment.

Electrical Hazard

Describes precautions necessary to prevent the risk of injury through electric hazards.

• Electrical micro-shock to patient, e.g., ventricular

Moving Hazard

Describes precautions necessary to prevent the risk of injury through moving or tipping hazard!

• Console, accessories or optional storage devices that can fall on patient, user, or others.

• Collision with persons or objects may result in injury while maneuvering or during system transport.

• Injury to user from moving the console.

Acoustic Output Hazard

• Patient injury or tissue damage from ultrasound radiation.

• Cleaning and care instructions

• Sheath and glove guidelines

• Probes

• Connections to back panel

• Moving

• Using brakes

• Transporting

• ALARA, the use of Power Output following the ‘as low as reasonably achievable’ principle

ISO 7000 No. 0659

Explosion Hazard

Describes precautions necessary to prevent the risk of injury through explosion hazard!

• Risk of explosion if used in the presence of flammable anesthetics.

Fire and Smoke Hazard

• Patient/user injury or adverse reaction from fire or smoke.

• Patient/user injury from explosion and fire.

• Flammable anesthetic

• Replacing fuses

• Outlet guidelines

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Important Safety Considerations

CAUTION

The following topic headings (Patient Safety, and Equipment and Personnel Safety) are intended to make the equipment user aware of particular hazards associated with the use of this equipment and the extent to which injury can occur if precautions are not observed. Additional precautions may be provided throughout the manual.

Improper use can result in serious injury. The use of the system outside the described conditions or intended use, and disregarding safety related information is considered abnormal use. The user must be thoroughly familiar with the instructions and potential hazards involving ultrasound examination before attempting to use the device. Training assistance is available from GE if needed.

Disregarding information on safety is considered abnormal use.

The manufacturer is not liable for damage caused by abnormal use of the device.

Safety Precautions

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Safety

WARNING

Patient Safety

Related Hazards

Patient identification

The concerns listed can seriously affect the safety of patients undergoing a diagnostic ultrasound examination.

Always include proper identification with all patient data and verify the accuracy of the patient's name and ID numbers when entering such data. Make sure correct patient ID is provided on all recorded data and hard copy prints. Identification errors could result in an incorrect diagnosis.

The ultrasound system is not meant to be long term storage for patient data or images. The customers are responsible for the data on the system and a regular backup is highly recommended.

It is advisable to back up system data prior to any service repairs to the hard drive. It is always possible during system failure and repair to lose patient data. GE will not be held responsible for the loss of this data.

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Diagnostic information

CAUTION

Safety Precautions

The images and calculations provided by the system are intended for use by competent operators, as a diagnostic tool. They are explicitly not to be regarded as the sole, irrefutable basis for clinical diagnosis. Operators are encouraged to study the literature and reach their own professional conclusions regarding the clinical utility of the system.

The operator should be aware of the product specifications and of the system accuracy and stability limitations. These limitations must be considered before making any decision based on quantitative values. If in doubt, the nearest GE Ultrasound Service Office should be consulted.

Equipment malfunction or incorrect settings can result in measurement errors or failure to detect details within the image. The equipment user must become thoroughly familiar with the equipment operation in order to optimize its performance and recognize possible malfunctions. Applications training is available through the local GE representative. Added confidence in the equipment operation can be gained by establishing a quality assurance program.

The system provides calculations (e.g estimated fetal weight) and charts based on published scientific literature. The selection of the appropriate chart and clinical interpretation of calculations and charts is the sole responsibility of the operator. The operator must consider contraindications for the use of a calculation or chart as described in the scientific literature. The diagnosis, decision for further examinations and medical treatment must be performed by qualified personnel following good clinical practice.

Be certain to ensure privacy data of patient information.

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Safety

Electrical Hazard

CAUTION

Mechanical hazards

The use of damaged probes or improper use and manipulation of intracavity probes can result in injury or increased risk of infection. Inspect probes often for sharp, pointed, or rough surface damage that could cause injury or tear protective barriers. Become familiar with all instructions and precautions provided with special purpose probes.

A damaged probe can also increase the risk of electric shock if conductive solutions come in contact with internal live parts. Inspect probes often for cracks or openings in the housing and holes in and around the acoustic lens or other damage that could allow liquid entry. Become familiar with the probe's use and care precautions outlined in Probes and Biopsy.

Ultrasound transducers are sensitive instruments which can easily be damaged by rough handling. Take extra care not to drop transducers and avoid contact with sharp or abrasive surfaces. A damaged housing, lens or cable can result in patient injury or serious impairment or operation.

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Scanner and electrosurgical units

CAUTION

This equipment provides no special means of protection from high frequency (HF) burns that may result from using an electrosurgical unit (ESU). To reduce the risk of HF burns, avoid contact between the patient and ultrasound transducer while operating the ESU. Where contact cannot be avoided, make sure the transducer is not located between the ESU active and dispersive electrodes and keep the ESU cables away from the transducers.

ALARA

Ultrasound can produce harmful effects in tissue and potentially result in patient injury. Always minimize exposure time and keep ultrasound levels low when there is no medical benefit. Use the principle of ALARA (A

chievable), increasing output only when needed to obtain

A diagnostic image quality. Observe the acoustic output display and be familiar with all controls affecting the output level. See the Bioeffects section of the Acoustic Output chapter in the

Advanced Reference Manual for more information.

Safety Precautions

s Low As Reasonably

Training

The operator of the device must sufficiently understand the acoustic output and be able to obtain the related thermal index values. The probe with self-heating in the air cannot be used in transvaginal scanning. Always minimize exposure time to the irradiation and keep ultrasound acoustic output level low for embryos or fetuses.

It is recommended that all users receive proper training in applications before performing them in a clinical setting. Please contact the local GE representative for training assistance.

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Safety

CAUTION

WARNING

Electrical Hazard

Smoke &

Fire Hazar

Equipment and Personnel Safety

The concerns listed below can seriously affect the safety of equipment and personnel during a diagnostic ultrasound examination.

Do not use this equipment if a safety problem is known to exist. Have the unit repaired and performance verified by qualified service personnel before returning to use.

Related Hazards

This equipment contains dangerous voltages that are capable of serious injury or death.

If any defects are observed or malfunctions occur, stop operating the equipment and perform the proper action for the patient. Inform a qualified service person and contact a Service Representative for information.

There are no user serviceable components inside the console. Refer all servicing to qualified service personnel only.

Ensure that unauthorized personnel do not tamper with the unit.

To avoid injury:

• Do not remove protective covers. No user serviceable parts are inside. Refer servicing to qualified service personnel.

• To assure adequate grounding, connect the attachment plug to a reliable (hospital grade) grounding outlet (having equalization conductor ).

• Never use any adaptor or converter of a three-prong-to-two-prong type to connect with a mains power plug. The protective earth connection will loosen.

• Do not place liquids on or above the console. Spilled liquid may contact live parts and increase the risk of shock.

The system must be supplied from an adequately rated electrical circuit. The capacity of the supply circuit must be as specified.

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Related Hazards (continued)

WARNING

Explosion Hazard

CAUTION

Only approved and recommended peripherals and accessories should be used.

All peripherals and accessories must be securely mounted to the LOGIQ V2/LOGIQ V1.

The LOGIQ V2/LOGIQ V1 is not intended to be used as a data storage device; backup of the Patient and Image Database is your institution’s responsibility. GE is NOT responsible for any lost patient information or for lost images.

Risk of explosion if used in the presence of flammable anesthetics.

Safety Precautions

Never operate the equipment in the presence of flammable or explosive liquids, vapors or gases. Malfunctions in the unit, or sparks generated by fan motors, can electrically ignite these substances. Operators should be aware of the following points to prevent such explosion hazards.

• If flammable substances are detected in the environment, do not plug in or turn on the system.

• If flammable substances are detected after the system has been turned on, do not attempt to turn off the unit, or to unplug it.

• If flammable substances are detected, evacuate and ventilate the area before turning off the unit.

Do not unpack the LOGIQ V2/LOGIQ V1. This must be performed by qualified service personnel only.

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Safety

Biological

Hazard

CAUTION

Related Hazards (continued)

For patient and personnel safety, be aware of biological hazards while performing invasive procedures. To avoid the risk of disease transmission:

• Use protective barriers (gloves and probe sheaths) whenever possible. Follow sterile procedures when appropriate.

• Thoroughly clean probes and reusable accessories after each patient examination and disinfect or sterilize as needed. Refer to Probes and Biopsy for probe use and care instructions.

• Follow all infection control policies established by your office, department or institution as they apply to personnel and equipment.

To avoid injury or system damage, NEVER place any object or liquid on the operator panel.

Archived data is managed at the individual sites. Performing data backup (to any device) is recommended.

• Make sure to verify the media after writing of data, such as EZBackup, SaveAs or Export.

• Before deleting a patient or image from the patient screen, make sure you have saved the data by EZBackup/Backup or Export and verify that the media transfer of data was successful.

DO NOT load non-system software on the system computer.

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Related Hazards (continued)

CAUTION

DO NOT touch the patient and any of the connectors on the ultrasound unit simultaneously, including ultrasound probe connectors.

DO NOT touch the conducting parts of the USB, Ethernet, Video, Audio cables when connecting equipment to the unit.

To minimize accidental loss of data, perform EZBackup and Backup on a regular basis.

1. First, perform EZBackup to save the images.

2. Next, perform Backup at Utility -> Backup/Restore. Enable the following checkboxes under Backup:

• Patient Archive

• Report Archive

• User defined configuration

• Service

Safety Precautions

• DO NOT scratch or press on the panel with any sharp objects, such as a pencil or pen, as this may result in damage to the panel.

• To avoid injury or damage, make sure nothing is within the range of motion before moving the system. This includes both objects and people.

• The LCD screen may have defective pixels. These pixels may appear as a slightly light or dark area on the screen. This is due to the characteristics of the panel itself, and not the product.

• The backlight of the LCD panel has a fixed life span. When the screen becomes dark or begins to flicker, contact a qualified Service Representative for information.

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Safety

CAUTION

Material Safe Data

Rubber part

Material: Silicon

Where Used: Handle Screw Cap/LCD Rubber

Allergic reactions to latex-containing medical devices

Due to reports of severe allergic reactions to medical devices containing latex (natural rubber), the FDA advises health-care professionals to identify latex-sensitive patients, and be prepared to treat allergic reactions promptly. Latex is a component of many medical devices, including surgical and examination gloves, catheters, incubation tubes, anesthesia masks and dental dams. Patient reaction to latex has ranged from contact urticaria, to systemic anaphylaxis.

For more details regarding allergic reaction to latex, refer to FDA Medical Alert MDA91-1, March 29.

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EMC (Electromagnetic Compatibility)

NOTE: This equipment generates, uses and can radiate radio

frequency energy. The equipment may cause radio frequency interference to other medical and non-medical devices and radio communications. To provide reasonable protection against such interference, this product complies with emissions limits for a Group 1, Class A Medical Devices Directive as stated in EN 60601-1-2. However, there is no guarantee that interference will not occur in a particular installation.

NOTE: If this equipment is found to cause interference (which may be

determined by turning the equipment on and off), the user (or qualified service personnel) should attempt to correct the problem by one or more of the following measure(s):

• reorient or relocate the affected device(s)

• increase the separation between the equipment and the

affected device

• power the equipment from a source different from that of the affected device

• consult the point of purchase or service representative for further suggestions.

Safety Precautions

NOTE: The manufacturer is not responsible for any interference caused

by using other than recommended interconnect cables or by unauthorized changes or modifications to this equipment. Unauthorized changes or modifications could void the users’ authority to operate the equipment.

NOTE: To comply with the regulations on electromagnetic interference

for a Class A FCC Device, all interconnect cables to peripheral devices must be shielded and properly grounded. Use of cables not properly shielded and grounded may result in the equipment causing radio frequency interference in violation of the FCC regulations.

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Safety

EMC (Electromagnetic Compatibility) (continued)

NOTE: Do not use devices which intentionally transmit RF Signals

(cellular phones, transceivers, or radio controlled products) other than those supplied by GE (wireless microphone, broadband over power lines, for example) in the vicinity of the equipment as it may cause performance outside the published specifications. Keep the power to these type devices turned off when near this equipment.

The medical staff in charge of this equipment is required to instruct technicians, patients, and other people who maybe around this equipment to fully comply with the above requirement.

EMC Performance

All types of electronic equipment may characteristically cause electromagnetic interference with other equipment, either transmitted through air or connecting cables. The term EMC (Electromagnetic Compatibility) indicates the capability of equipment to curb electromagnetic influence from other equipment and at the same time not affect other equipment with similar electromagnetic radiation from itself.

Proper installation following the service manual is required in order to achieve the full EMC performance of the product.

The product must be installed as stipulated in ‘Notice upon Installation of Product’ on page 2-18.

In case of issues related to EMC, please call your service personnel.

The manufacturer is not responsible for any interference caused by using other than recommended interconnect cables or by unauthorized changes or modifications to this equipment. Unauthorized changes or modifications could void the users’ authority to operate the equipment.

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Safety Precautions

EMC Performance (continued)

Portable and mobile radio communications equipment (e.g. two-way radio, cellular/cordless telephones and similar equipment) should be used no closer to any part of this system, including cables, than determined according to the following method:

Table 2-2: Portable and mobile radio communications equipment distance

requirements

Frequency Range: 150 kHz - 80 MHz 80 MHz - 800 MHz 800 MHz - 2.5 GHz

Calculation Method: d=[3.5/V

of P

Where: d= separation distance in meters, P = rated power of the transmitter, V conducted RF, E

If the maximum transmitter power in watts is rated

5 2.6 2.6 5.2

20 5.2 5.2 10.5

100 12.0 12.0 24.0

= compliance value for radiated RF

The separation distance in meters should be

] square root

d = [3.5/E1] square root of P

d = [7/E1] square root of P

=compliance value for

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Safety

Notice upon Installation of Product

Separation distance and effect from fixed radio communications equipment: field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast, and TV broadcast transmitter cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the ultrasound system is used exceeds the applicable RF compliance level as stated in the immunity declaration, the ultrasound system should be observed to verify normal operation. If abnormal operation is observed, additional measures may be necessary, such as re-orienting or relocating the ultrasound system or using an RF shielded examination room may be necessary.

1. Use either power supply cords provided by GE or ones designated by GE. Products equipped with a power source plug should be plugged into the fixed power socket which has the protective grounding conductor. Never use any adaptor or converter to connect with a power source plug (e.g. three-prong-to-two-prong converter).

2. Locate the equipment as far away as possible from other electronic equipment.

3. Be sure to use only the cables provided by or designated by GE. Connect these cables following the installation procedures (e.g. wire power cables separately from signal cables).

4. Lay out the main equipment and other peripherals following the installation procedures described in the service manuals and peripherals manufacture’s manuals.

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General Notice

Safety Precautions

1. Designation of Peripheral Equipment Connectable to This Product.

The equipment indicated in the Supplies/Accessories section can be hooked up to the product without compromising its EMC performance.

Avoid using equipment not designated in the list. Failure to comply with this instruction may result in poor EMC performance of the product.

2. Notice against User Modification

The user should never modify this product. User modifications may cause degradation in EMC performance.

Modification of the product includes changes in:

a. Cables (length, material, wiring, etc.)

b. System installation/layout

c. System configuration/components

d. Securing system parts (cover open/close, cover

screwing)

3. Operate the system with all covers closed. If a cover is opened for some reason, be sure to shut it before starting/ resuming operation.

4. Operating the system with any cover open may affect EMC performance.

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Safety

Peripheral Update for EC countries

The following is intended to provide the users in EC countries with updated information concerning the connection of the LOGIQ V2/LOGIQ V1 to image recording and other devices or communication networks.

Peripherals used in the patient environment

The LOGIQ V2/LOGIQ V1 has been verified for overall safety, compatibility and compliance with the image recording devices listed in Supplies/Accessories section.

The LOGIQ V2/LOGIQ V1 has also been verified for compatibility, and compliance for connection to a local area network (LAN) via the rear panel Ethernet connection, provided the LAN components are IEC/EN 60950 compliant.

The LOGIQ V2/LOGIQ V1 has also been verified for compatibility, and compliance for connection to a DVD-RW via the system USB port, provided the DVD-RW is IEC/EN 60950 compliant.

A Wireless LAN option is available.

The LOGIQ V2/LOGIQ V1 may also be used safely while connected to devices other than those recommended above if the devices and their specifications, installation, and interconnection with the system conform to the requirements of IEC/EN 60601-1.

Accessory equipment connected to the analog and digital interfaces must be certified according to the respective IEC standards (i.e., IEC60950 for data processing equipment and IEC60601-1 for medical equipment). Furthermore, all complete configurations shall comply with the valid version of the system standard IEC60601-1. Everyone who connects additional equipment to the signal input part or signal output part of the LOGIQ V2/LOGIQ V1 system configures a medical system, and is therefore responsible to ensure that the system complies with the requirement of the valid version of IEC60601-1. If in doubt, consult the technical service department or your local GE representative.

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Peripherals used in the patient environment (continued)

CAUTION

General precautions for installing an alternate on-board device would include:

1. The added device(s) must have appropriate safety standard conformance and CE Marking.

2. The total power consumption of the added devices, which connect to the LOGIQ V2/LOGIQ V1 and are used simultaneously, must be less than or equal to the rated supply of the LOGIQ V2/LOGIQ V1.

3. There must be adequate heat dissipation and ventilation to prevent overheating of the device.

4. There must be adequate mechanical mounting of the device and stability of the combination.

5. Risk and leakage current of the combination must comply with IEC/EN 60601-1.

6. Electromagnetic emissions and immunity of the combination must conform to IEC/EN 60601-1-2.

General precautions for installing an alternate off-board, remote device or a network would include:

1. The added device(s) must have appropriate safety standard conformance and CE Marking.

2. The added device(s) must be used for their intended purpose having a compatible interface.

3. Signal or mains isolation devices and additional protective earth may be needed to assure compliance with IEC/EN 60601-1.

Safety Precautions

The connection of equipment or transmission networks other than as specified in the user instructions can result in an electric shock hazard or equipment malfunction. Substitute or alternate equipment and connections requires verification of compatibility and conformity to IEC/EN 60601-1 by the installer. Equipment modifications and possible resulting malfunctions and electromagnetic interference are the responsibility of the owner.

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Safety

Declaration of Emissions

This system is suitable for use in the following environment. The user must assure that it is used only in the electromagnetic environment as specified.

Table 2-3: Declaration of Emissions

Guidance and manufacturer’s declaration - electromagnetic emissions

The system is intended for use in the electromagnetic environment specified below. The

user of the system should assure that it is used in such an environment.

Emission Type Compliance Electromagnetic Environment

RF Emissions CISPR 11

Harmonic Emissions IEC 61000-3-2

Voltage Fluctuations/Flicker Emissions IEC 61000-3-3

Group 1 This system uses RF energy only for its internal function.

Class A This system is suitable for use in all establishments, other than

Class A

Complies

Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes, provided the following warning is heeded: WARNING: This system is intended for use by healthcare professionals only. This system may cause radio interference or may disrupt the operation of nearby equipment. It may be necessary to take mitigation measures, such as re-orienting or relocating the system or shielding the location.

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Declaration of Immunity

This system is suitable for use in the following environment. The user must assure that the system is used according to the specified guidance and only in the electromagnetic environment listed.

Safety Precautions

Table 2-4: Declaration of Immunity

Immunity

Typ e

IEC 61000-4-2 Static discharge (ESD)

IEC 61000-4-4 Electrical fast transient/burst

IEC 61000-4-5 Surge Immunity

IEC 61000-4-11 Voltage dips, short interruptions and voltage variations on mains supply

IEC 61000-4-8 Power frequency (50/ 60 Hz) magnetic field

IEC 61000-4-6 Conducted RF

IEC 61000-4-3 Radiated RF

Equipment

Capability

± 6 kV contact

± 8 kV air

± 2 kV for mains

± 1 kV for SIP/SOP

± 1 kV differential

± 2 kV common

< 5% U in U 40% U U 70% U U < 5% U U

3 A/m 3 A/m

3 V 150 kHz - 80 MHz

3 V/m 80 MHz - 2.5 GHz

(> 95% dip

) for 0.5 cycle;

(60% dip in

) for 5 cycles;

(30% dip in

) for 25 cycles;

(>95% dip in

) for 5 sec

RMS

Acceptable Level

± 6 kV contact

± 8 kV air

± 2 kV for mains

± 1 kV for SIP/SOP

± 1 kV differential

± 2 kV common

< 5% U in U 40% U U

) for 5 cycles;

70% U U

) for 25 cycles;

< 5% U U

) for 5 sec

3 V

RMS

150 kHz - 80 MHz

3 V/m 80 MHz - 2.5 GHz

Regulatory

(> 95% dip

) for 0.5 cycle;

(60% dip in

(30% dip in

(>95% dip in

EMC Environment and

Guidance

Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. Mains power quality should be that of a typical commercial and/or hospital environment. If the user requires continued operation during power mains interruptions, it is recommended that the system be powered from a UPS or a battery. NOTE: UT is the a.c. mains voltage prior to application of the test level. Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial and/or hospital environment. Separation distance to radio communication equipment must be maintained according to the method below. Interference may occur in the vicinity of equipment marked with the symbol:

Image degradation or interference may occur due to conducted RF noise on the equipment mains power supply or other signal cable. Such interference is easily recognized and distinguishable from patient anatomy and physiological waveforms. Interference of this type may delay the examination without affecting diagnostic accuracy. Additional mains/ signal RF isolation or filtering may be needed if this type interference occurs frequently.

NOTE: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people. If noise generated from other electronic equipment is near the probe’s center frequency, noise may appear on the image. Good power line isolation is required.

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Safety

Patient Environmental Devices

Figure 2-1. Patient Environmental Devices for LOGIQ V2/

LOGIQ V1

1. Rear panel:

• Port for DC In (AC Adapter)

• Composite out

• S-Video Out

• 1 HDMI Port

• 1 Network Port

• 1 Security Lock

2. Left side:

• 1 Isolated USB printer port

• 2 general USB ports — USB Flash Drive, USB HDD,

DVD-RW, Footswitch, Wireless Lan Adapter

• 1 SD Card port

3. Bottom side: Lithium-ion battery port

4. Right side: Probe port

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Acceptable Devices

CAUTION

Unapproved Devices

Safety Precautions

The Patient Environmental devices shown on the previous page are specified to be suitable for use within the PATIENT ENVIRONMENT.

DO NOT connect any probes or accessories without approval by GE within the PATIENT ENVIRONMENT.

See ‘Supplies/Accessories’ on page 18-47 for more

information.

DO NOT use unapproved devices.

If devices are connected without the approval of GE, the warranty will be INVALID.

Any device connected to the LOGIQ V2/LOGIQ V1 must conform to one or more of the requirements listed below:

1. IEC standard or equivalent standards appropriate to devices.

2. The devices shall be connected to PROTECTIVE EARTH (GROUND).

Accessories, Options, Supplies

Unsafe operation or malfunction may result. Use only the accessories, options and supplies approved or recommended in these instructions for use.

For compatibility reasons, use only GE-approved probes, peripherals, or accessories.

DO NOT connect any probes or accessories without approval by GE.

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Safety

CAUTION

Acoustic Output

Allowing the machine to transmit acoustic output with the probe not in use (or in its holder) can cause the transducer to build up heat. Always lower the acoustic power or freeze the image when not in use.

When the “Auto Freeze” preset is selected on the Utility -> System -> System Imaging screen, the system auto freezes if it detects no change in the image.

Located on the upper right section of the system display monitor, the acoustic output display provides the operator with real-time indication of acoustic levels being generated by the system. See the Acoustic Output chapter in the Advanced Reference Manual for more information. This display is based on NEMA/AIUM Standards for Real-time Display of Thermal and Mechanic Acoustic Output Indices on Diagnostic Ultrasound Equipment.

Acoustic Output Display Specifications

The display consists of three parts: Thermal Index (TI), Mechanical Index (MI), and a relative Acoustic Output (AO) value. Although not part of the NEMA/AIUM standard, the AO value informs the user of where the system is operating within the range of available output.

Thermal Index

Always be aware of the acoustic output level by observing the Acoustic Output Display. In addition, become thoroughly familiar with the Acoustic Output Display and equipment controls affecting output.

Depending on the examination and type of tissue involved, the TI parameter will be one of three types:

• Soft Tissue Thermal Index (TIS). Used when imaging soft tissue only, it provides an estimate of potential temperature increase in soft tissue.

• Bone Thermal Index (TIB). Used when bone is near the focus of the image as in the third trimester OB examination, it provides an estimate of potential temperature increase in the bone or adjacent soft tissue.

• Cranial Bone Thermal Index (TIC). Used when bone is near the skin surface as in transcranial examination, it provides an estimate of potential temperature increase in the bone or adjacent soft tissue.

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Acoustic Output Display Specifications (continued)

Mechanical Index

MI recognizes the importance of non-thermal processes, cavitation in particular, and the Index is an attempt to indicate the probability that they might occur within the tissue.

Changing the Thermal Index Type

You can select the displayed TI type on Utility -> Imaging -> B-Mode. This preset is application dependent so each application could specify a different TI type.

TI and MI Display and Accuracy

The TI and MI display starts at a value of 0 and increments do not exceed 0.2 for the entire range of display.

When display MI>= 0.6, TI>= 3.6, the displayed values of MI and TI is not lower than 50% or higher than 150% of the measured value.

When display MI < 0.6, TI < 3.6, the absolute error of MI <= 0.3, the absolute error of TI <= 1.8.

Safety Precautions

Controls Affecting Acoustic Output

The potential for producing mechanical bioeffects (MI) or thermal bioeffects (TI) can be influenced by certain controls.

Direct. The Acoustic Output control has the most significant effect on Acoustic Output.

Indirect. Indirect effects may occur when adjusting controls. Controls that can influence MI and TI are detailed under the Bioeffects portion of each control in the Optimizing the Image sections.

Always observe the Acoustic Output display for possible effects.

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Safety

HINTS

WARNING

Acoustic Output Hazard

Best practices while scanning

Raise the Acoustic Output only after attempting image optimization with controls that have no effect on Acoustic Output, such as Gain and TGC.

NOTE: Refer to the Optimizing the Image sections for a complete

discussion of each control.

Be sure to have read and understood control explanations for each mode used before attempting to adjust the Acoustic Output control or any control that can effect Acoustic Output.

Use the minimum necessary acoustic output to get the best diagnostic image or measurement during an examination. Begin the exam with the probe that provides an optimum focal depth and penetration.

Acoustic Output Default Levels

In order to assure that an exam does not start at a high output level, the LOGIQ V2/LOGIQ V1 initiates scanning at a reduced default output level. This reduced level is preset programmable and depends upon the exam category and probe selected. It takes effect when the system is powered on or Patient is selected.

To modify acoustic output, adjust the Power Output level.

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RoHS LOGIQ V2/LOGIQ V1 Hazardous Substances

This symbol indicates the product contains hazardous materials in excess of the limits established by the Chinese standard GB/T

26572 Requirements for Concentration Limits for Certain restricted Substances in electrical and electronic Products.

The number in the symbol is the Environment-friendly Use Period (EFUP), which indicates the period during which the hazardous substances contained in electrical and electronic products will not leak or mutate under normal operating conditions so that the use of such electrical and electronic products will not result in any severe environmental pollution, any bodily injury or damage to any assets. The unit of the period is "Year".

In order to maintain the declared EFUP, the product shall be operated normally according to the instructions and environmental conditions as defined in the product manual, and periodic maintenance schedules specified in Product Maintenance Procedures shall be followed strictly.

Consumables or certain parts may have their own label with an EFUP value less than the product. Periodic replacement of those consumables or parts to maintain the declared EFUP shall be done in accordance with the Product Maintenance Procedures. This product must not be disposed of as unsorted municipal waste, and must be collected separately and handled properly after decommissioning.

Safety Precautions

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Safety

Name and Concentration of Hazardous Substances

Table 2-5: Table of hazardous substances' name and concentration for LOGIQ V2/

LOGIQ V1

Hazardous substances' name

Component Name

LCD Panel X O O O O O

Printed Circuit Board Assemblies

Keyboard Assemblies X O O O O O

Power Assemblies X O O O O O

Battery X O O O O O

Ultrasound Probes X O O O O O

This table is prepared according to SJ/T 11364. O: Indicates that hazardous substance contained in all of the homogeneous materials for this part is below the limit requirement in GB/T 26572. X: Indicates that hazardous substance contained in at least one of the homogeneous materials used for this part is above the limit requirement in GB/T 26572.

• Data listed in the table represents best information available at the time of publication.

• Applications of hazardous substances in this medical device are required to achieve its intended clinical uses, and/or to provide better protection to human beings and/or to environment, due to lack of reasonably (economically or technically) available substitutes. For example: Lead is could be used in Printed circuit solder.

Pb Hg Cd Cr (VI) PBB PBDE

XOOO OO

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Label Icon Description

The following table describes the purpose and location of safety labels and other important information provided on the equipment.

Label/Icon Purpose/Meaning Location

Device Labels

Table 2-6: Label Icons

Identification and Rating Plate • Manufacture’s name and

address

• Date of manufacture

• Model and serial numbers

• Electrical ratings (Volts, Amps, phase, and frequency)

Identification and Rating Plate Date of manufacture: The date

could be a year, year and month, or year, month and day, as appropriate. See ISO 8601 for date formats.

Serial Number Rating Plate, labels

Catalog Number Rating Plate, labels

Direct Current: For products to be powered from a DC supply

Input Rating Plate, labels

Rating Plate, labels

Description Rating Plate, labels

Made in China Rating Plate, labels

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Safety

Table 2-6: Label Icons (continued)

Label/Icon Purpose/Meaning Location

Model Rating Plate, labels

AC adapter for LOGIQ V2/LOGIQ V1AC adapter

No-Load power consumption AC adapter

Average Active Efficiency AC adapter

Test Battery

Rechargeable Smart Battery Pack

Only for LOGIQ V2/LOGIQ V1 system

Output Rating Plate, labels

Type/Class Label Used to indicate the degree of

IP Code (IPX8) IPX8: FSU-1000, MKF 2-MED GP26

safety or protection.

Indicates the degree of protection provided by the enclosure per IEC60 529.

Authorized European Representative address.

United States only Prescription Requirement label. CAUTION: United States law restricts this device to sale or use by, or on the order of a physician.

Type BF Applied Part (man in the box) symbol is in accordance with IEC 60878-02-03.

Battery

Bottom of footswitch

Bottom panel

Beside the probe connector

General Warning. Various

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Device Labels

Table 2-6: Label Icons (continued)

Label/Icon Purpose/Meaning Location

“CAUTION” - Dangerous voltage” (the lightning flash with arrowhead) is used to indicate electric shock hazards.

Indicates the power on and power off position of the power switch.

CAUTION: This Power Switch DOES NOT ISOLATE Mains

Supply.

“Protective Earth” indicates the protective earth (grounding) terminal.

NRTL Listing and Certification Mark is used to designate conformance to nationally recognized product safety standards. The Mark bears the name and/or logo of the testing laboratory, product category, safety standard to which conformity is assessed and a control number.

Do not use the following devices near this equipment: cellular phone, radio receiver, mobile radio transmitter, radio controlled toy, broadband power lines, etc. Use of these devices near this equipment could cause this equipment to perform outside the published specifications. Keep power to these devices turned off when near this equipment.

Var ious

See the Console Overview section for location information.

Inside Power Box and Console

Bottom

Bottom of the system

Be careful of static Bottom of the system

“Consult accompanying documents“ is intended to alert the user to refer to the operator manual or other instructions when complete information cannot be provided on the label.

The CE Mark of Conformity indicates this equipment conforms with the Council Directive 93/42/EEC

Var ious

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Safety

Table 2-6: Label Icons (continued)

Label/Icon Purpose/Meaning Location

CISPR CAUTION: The LOGIQ V2/LOGIQ V1 conforms to the CISPR11, Group 1, Class A of the international standard for Electromagnetic disturbance characteristics.

This symbol indicates that waste electrical and electronic equipment must not be disposed of as unsorted municipal waste and must be collected separately. Please contact an authorized representative of the manufacturer for information concerning the decommissioning of your equipment.

The separate collection symbol is affixed to a battery, or its packaging, to advise you that the battery must be recycled or disposed of in accordance with local or country laws. The letters below the separate collection symbol indicate whether certain elements (Pb=Lead,Cd=Cadmium, Hg=Mercury) are contained in the battery. To minimize potential effects on the environment and human health, it is important that all marked batteries that you remove from the product are properly recycled or disposed. For information on how the battery may be safely removed from the device, please consult the service manual or equipment instructions. Information on the potential effects on the environment and human health of the substances used in batteries is available at this url: http:// www.gehealthcare.com/euen/ weee-recycling/index.html

Bottom of the system

Bottom and probe connector

Battery Pack if contains Pb/Cd/ Hg

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Device Labels

Table 2-6: Label Icons (continued)

Label/Icon Purpose/Meaning Location

This symbol indicates that this electrical and electronic product does not contain any hazardous substances above the maximum concentration value established by the Chinese standard GB/T 26572, and can be recycled after being discarded, and should not be casually discarded.

This symbol indicates the product contains hazardous materials in excess of the limits established by the Chinese standard GB/T 26572 Requirements of concentration limits for certain restricted substances in electrical and electronic products. The number in the symbol is the Environment-friendly Use Period (EFUP), which indicates the period during which the hazardous substances contained in electrical and electronic products will not leak or mutate under normal operating conditions so that the use of such electrical and electronic products will not result in any severe environmental pollution, any bodily injury or damage to any assets. The unit of the period is "Year"

When closing the LCD cover, use caution to avoid injuring hands or fingers as there is a closing mechanism which allows the LCD cover to automatically close.

Probe and Bottom, China Rating Plate.

Bottom of the system

Do not connect the DVD-RW to the system while scanning.

GOST symbol: Russia Regulatory Country Clearance.

DVD-RW

Rating plate Note: Only after Russian regulatory registration is complete, this label will be located on the console.

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Safety

Table 2-6: Label Icons (continued)

Label/Icon Purpose/Meaning Location

INMETRO Certification: TUV Rheinland Brazil

“Eurasian Conformity” mark; the single conformity mark for circulation of products on the markets of member-states of

Customs Union. This product passed all conformity assessment (approval) procedures that correspond to the requirements of applicable technical regulations of the Customs Union.

This machine should be used in compliance with law. Some jurisdictions restrict certain uses, such as gender determination.

Rating plate Note: Only after Brazilian regulatory registration is complete, this label will be located on the console.

Bottom.

Bottom of the system Note: For China, Korea and India only.

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Label Locations

Device Labels

LOGIQ V2/LOGIQ V1 labels are provided in English.

The labels are at the bottom of the system. The label content may be different for different regions. Please refer to the labels on the system for the actual content

Figure 2-2. LOGIQ V1 Label Locations

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Safety

Label Locations (continued)

Figure 2-3. LOGIQ V2 Label Locations

1. Warning label

2. Rating Plate

3. Gender Caution (For China, Korea and India only)

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Label Locations (continued)

Device Labels

Figure 2-4. LOGIQ V2/LOGIQ V1 Label Locations (for China)

1. Warning label

2. Rating Plate for China

3. Gender Caution (For China, Korea and India only)

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Safety

Label Locations (continued)

Figure 2-5. AC Adapter label

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Label Locations (continued)

CAUTION

Device Labels

Figure 2-6. Battery Label

1. Do not put the battery in fire.

2. Do not disassemble or mistreat the battery.

Do not disassemble or mistreat the battery. Do not put the battery in fire. Replace the battery with the same battery type only. Failure to follow these instructions many present risk of explosion fire or high temperature. See the battery user manual for additional safety instructions.

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Safety

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Chapter 3

Preparing the System for Use

Describes the site requirements, console overview, system positioning/transporting, powering on the system, adjusting the display monitor, probes and operator controls.

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Preparing the System for Use

WARNING

CAUTION

Introduction

All the warnings in the Safety chapter should be read and understood before operating the unit.

Always use the system on a flat surface in the patient environment.

Do not attempt to install the system alone. General Electric, Affiliate, or Distributor Field Engineers and Application Specialists will install and setup the system. See ‘Contact Information’ on page 1-8 for more information.

Site Requirements

The LOGIQ V2/LOGIQ V1 does not contain any operator serviceable internal components. Ensure that unauthorized personnel do not tamper with the unit.

Perform regular preventive maintenance. See ‘System Care and Maintenance’ on page 18-10 for more information.

Maintain a clean environment. Turn off the system and disconnect the power cord before cleaning the unit. See ‘Cleaning the system’ on page 18-13 for more information.

The LOGIQ V2/LOGIQ V1 system and probe connector are not waterproof. Do not expose the device to water or any kind of liquid.

Never set liquids on the unit to ensure that liquid does not drip into the control panel or unit.

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Before the system arrives

CAUTION

The ultrasound unit must operate within the proper environment and in accordance with the requirements described in this section. Before using the system, ensure that the requirements are met.

Power Requirements

• A separate power outlet with a 6.5 amp circuit breaker.

• Frequency: 50/60 Hz

• 100V - 240V AC (+/-10%)

Electromagnetic interferences

This medical equipment is approved, in terms of the prevention of radio wave interference, to be used in hospitals, clinics and other institutions which are environmentally qualified. The use of this equipment in an inappropriate environment may cause some electronic interference to radios and televisions around the equipment.

Site Requirements

Ensure that the following is provided for the new system:

• Take precautions to ensure that the console is protected from electromagnetic interference.

Precautions include:

• Operate the console at least 15 feet away from motors,

typewriters, elevators, and other sources of strong electromagnetic radiation.

• Operation in an enclosed area (wood, plaster or

concrete walls, floors and ceilings) helps prevent electromagnetic interference.

• Special shielding may be required if the console is to be

operated in the vicinity of radio broadcast equipment.

Do not operate the system in the vicinity of a heat source, of strong electric or magnetic fields (close to a transformer), or near instruments generating high-frequency signals, such as HF surgery. These can affect the ultrasound images adversely.

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Preparing the System for Use

WARNING

Before the system arrives (continued)

To avoid risk of fire, the system power must be supplied from a separate, properly rated outlet. See ‘Before the system arrives’ on page 3-3 for more information.

Under no circumstances should the AC power plug be altered, changed, or adapted to a configuration rated less than specified. Never use an extension cord or adapter plug.

To help assure grounding reliability, connect to a “hospital grade” or “hospital only” grounded power outlet.

Figure 3-1. Example Plug and Outlet Configurations

1. 100-120 VAC, 10A

Plug and Outlet Configuration

2. 220-240 VAC, 10A

Plug and Outlet Configuration

NOTE: Country-specific power cords are currently available for

Argentina, Australia/New Zealand, China, Denmark, India/South Africa, Switzerland, United Kingdom, Europe, the United States, Israel, Brazil and Japan.

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Environmental Requirements

CAUTION

The system should be operated, stored, or transported within the parameters outlined below. Either its operational environment must be constantly maintained or the unit must be turned off.

NOTE: You may get an overheating message with regard to fan speed.

Ensure adequate system/room ventilation.

Table 3-1: System Environmental Requirements

Site Requirements

Storage Operational (with probe)

Temperature 10 - 40° C

50 - 104° F

Humidity 30 - 80%

non-condensing

Pressure 700 - 1060hPa 700 - 1060hPa 700 - 1060hPa

(LOGIQ V2/LOGIQ

V1)

-5 - 50° C 23 - 122° F

10 - 90% non-condensing

Transport

(LOGIQ V2/LOGIQ

-5 - 50° C 23 - 122° F

10 - 90% non-condensing

Ensure that the probe face temperature does not exceed the normal operation temperature range.

Operating Environment

Ensure that there is sufficient air flow around the ultrasound unit when installed in a fixed location.

Do not cover the ventilation holes of the LOGIQ V2/LOGIQ V1.

V1)

The LOGIQ V2/LOGIQ V1 system and probe connector are not waterproof. Do not expose the device to water or any kind of liquid.

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Preparing the System for Use

Console Graphics

The following are illustrations of the console:

Console Overview

Figure 3-2. LOGIQ V2/LOGIQ V1 System - an example

1. Handle

2. LCD

3. Primary Menu keys

4. Alphanumeric keys

5. Control Panel

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Console Graphics (continued)

CAUTION

WARNING

Console Overview

Figure 3-3. LOGIQ V2/LOGIQ V1 System

Do not push objects into air vents and openings of LOGIQ V2/ LOGIQ V1. Doing so can cause fire or electric shock by shorting out interior components.

DO NOT touch the patient and any of the connectors on the ultrasound unit simultaneously, including ultrasound probe connectors.

DO NOT touch the conducting parts of the USB, Ethernet, Video, Audio cables when connecting equipment to the unit.

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Preparing the System for Use

WARNING

Battery

The lithium ion battery provides power when an AC power source is not available. A battery in the battery bay is standard with the LOGIQ V2/LOGIQ V1. Lithium ion batteries last longer than conventional batteries and do not require replacement as often. You can expect 30 minutes of battery life with a single fully charged battery in use to supply power to the system.

NOTE: While scanning with the battery supplying power only, the

battery life may be shorter. Always archive the data and keep your attention on the battery status. When the battery power is low, charge the battery immediately in case that scanning will be interrupted and the data will be lost due to the automatic shutdown of the system.

The lithium ion technology used in your system’s battery is significantly less hazardous to the environment than the lithium metal technology used in some other batteries (such as watch batteries). Used batteries should not be placed with common household waste products. Contact local authorities for the location of a chemical waste collection program nearest you.

NOTE: The battery is designed to work with LOGIQ V2/LOGIQ V1

systems only. Only use the batteries authorized by GE.

Temperature Requirements

The battery should be charged, discharged and stored within the parameters outlined below:

• Operating temperature:

• Charge: 10 - 40°C (50 - 104°F).

• Discharge: 10 - 40°C (50 - 104°F)

• Storage temperature:

NOTE: It is recommended that the battery remaining capacity

should be 40% ~ 60% when the battery storage begins.

It is recommended that the battery remaining capacity should be 40%~60% when the battery storage begins.

• Storage time < 3 months: -20 - 40°C (-4 - 104°F)

• Storage time >= 3 months: -20 - 20°C (-4 - 68°F)

Do not expose the battery to temperature over 60°C (140°F). Keep it away from fire and other heat sources.

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Battery (continued)

WARNING

CAUTION

Console Overview

• The battery has a safety device. Do not disassemble or alter the battery.

• Do not short-circuit the battery by directly connecting the negative terminals with metal objects.

• Do not heat the battery or discard it in a fire.

• Do not charge the battery near a heat source, such as a fire or heater.

• Do not leave the battery in direct sunlight.

• Do not pierce the battery with a sharp object, hit it, or step on it.

• Do not use a damaged battery.

• Do not solder a battery.

• Do not connect the battery to an electrical power outlet.

If the LOGIQ V2/LOGIQ V1 is not being used on a monthly basis, the battery needs to be removed during the lengthy non-use period.

To avoid the battery bursting, igniting, or fumes from the battery causing equipment damage, observe the following precautions:

• Do not immerse the battery in water or allow it to get wet.

• Do not put the battery into a microwave oven or pressurized container.

• If the battery leaks or emits an odor, remove it from all possible flammable sources.

• If the battery emits an odor or heat, is deformed or discolored, or in a way appears abnormal during use, recharging or storage, immediately remove it and stop using it. If you have any questions about the battery, consult GE or your local representative.

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Preparing the System for Use

CAUTION

Discharge/Charge Cycle

When the battery is stored for three months or more, the customer should perform one full discharge/charge cycle.

NOTE: A full discharge/charge cycle means the system is turned on

using battery power until the battery loses its charge completely and the system shuts down. Plug the LOGIQ V2/LOGIQ V1 in until the battery is fully charged as indicated by a green LCD light.

Upon receipt of the LOGIQ V2/LOGIQ V1 and before first time usage, it is highly recommended that the customer perform one full discharge/charge cycle.

If the battery has not been used for >2 months, the customer is recommended to perform one full discharge/charge cycle. It is also recommended to store the battery in a shady and cool area with FCC (full current capacity).

One Full Discharge/Charge Cycle Process:

1. Full discharge of battery to let the LOGIQ V2/LOGIQ V1 automatically shut down.

2. Charge the LOGIQ V2/LOGIQ V1 to 100% FCC (full current capacity).

3. Discharge of LOGIQ V2/LOGIQ V1 for complete shut down (takes about one hour for discharge).

When storing packs for more than 6 months, charge the pack at least once during the 6 month timeframe to prevent leakage and deterioration in performance.

Use only GE recognized batteries.

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View current battery status

When the system is running on battery, there is a battery icon in the system status bar, When there is no battery, the AC plug Icon is displayed in the system status bar.

If the battery is in charge, the battery icon appears as being charged in the system status bar.

Console Overview

Figure 3-4. Battery icon

Figure 3-5. Low Power Battery Icon

Figure 3-6. Warning Battery Icon

Figure 3-7. Charging Battery icon

Select the battery icon and the following information window appears:

Figure 3-8. Battery Status Message

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Preparing the System for Use

Battery power low warning

If the battery is in use and the battery power is low, the battery icon become yellow. A warning message appears to warn the user that the battery power is low and it needs to be charged.

The same warning message in red will continually appears in the status bar at the bottom of the screen.

Figure 3-9. Low battery power warning

Figure 3-10. Low battery power warning on status bar

When the estimated current power remaining time is less than 3 minute, the below warning message appears on the screen to warn the user to charge the battery immediately, or the system will shut down automatically in 1 minute.

Figure 3-11. System shutdown warning

NOTE: When the battery power is low and the user cannot charge the

battery in time, the system automatically shuts down in 1 minute. This protects the whole system. You need to charge the battery immediately before the system shuts down or you may lose useful information.

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Battery error

Console Overview

If there is an error on the battery, the battery error icon displays.

Figure 3-12. Battery Error Icon

Follow below steps to resolve the issue:

1. Shutdown the system and disconnect AC power cable if it is connected.

2. Remove and install the battery

3. Connect the AC power cable

4. Power on the system with AC power supply

5. Disconnect AC power cable to use the battery to supply power to the system.

If it is still error, shutdown the system, disconnect AC power cable if it is connected, remove the battery and contact GE Service.

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Preparing the System for Use

Battery Installation

To install the battery to the bottom cover of the system:

1. Shut down the system and disconnect the AC/DC power cord.

2. Put the battery into the battery box through the opening place.

Figure 3-13. Place the battery on the bottom cover

3. Push the battery completely into the box until the battery is locked and the battery lock is in the lock position.

Figure 3-14. Lock the battery

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Battery Removal

Console Overview

To remove the battery from the bottom cover of the system:

1. Shut down the system and disconnect the AC/DC power cord.

2. Push up the battery lock to another end of the slot. While hold on to the lock without release, put another hand at the embossed position on the battery and push the battery in the direction away from the battery box.

Figure 3-15. Unlock and push the battery

3. When the battery is away from the lock, remove it from the battery box.

Figure 3-16. Remove the battery

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Preparing the System for Use

CAUTION

AC Adapter

Do not use an AC adapter without approval by GE.

Be sure that nothing rests on the AC adapter’s power cable and that the cable is not located where it can be tripped over or stepped on.

Place the AC adapter in a ventilated area, such as a desk, when you use it to run LOGIQ V2/LOGIQ V1. Do not cover the AC adapter with paper or other items that will reduce cooling; do not use the AC adapter inside a carrying case.

To prevent damage to the power cable of the AC adapter, DO NOT pull excessively on the cable; DO NOT make any sharp bends; DO NOT bend the power cable frequently.

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Peripheral/Accessory Connection

CAUTION

Peripheral/Accessory Connector Panel

LOGIQ V2/LOGIQ V1 peripherals and accessories can be properly connected using the connector panel.

Each outer (case) ground line of peripheral/accessory connectors are Earth Grounded.

Signal ground lines are Not Isolated.

For compatibility reasons, use only GE-approved probes, peripherals, or accessories.

DO NOT connect any peripherals and accessories without approval by GE.

The connection of equipment or transmission networks other than as specified in these instructions can result in electric shock hazard. Alternate connections will require verification of compatibility and conformity to IEC/EN 60601-1 by the installer.

Console Overview

DO NOT touch the patient and any of the connectors on the ultrasound unit simultaneously, including ultrasound probe connectors.

DO NOT touch the conducting parts of the USB, Ethernet, Video, Audio cables when connecting equipment to the unit.

When using peripheral device, observe all warnings and cautions given in peripheral operator manuals.

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Preparing the System for Use

Peripheral/Accessory Connector Panel (continued)

Figure 3-17. Peripheral/Accessory Connector Panel

1. LCD Monitor Locker

2. Security lock

3. Port for DC In (AC Adapter)

4. Composite out port

5. S-Video out port

6. HDMI Port

7. Network Port

8. 1 Isolated USB printer port

9. 2 general USB ports — USB Flash Drive, USB HDD, DVD-RW, Footswitch, Wireless Lan Adapter

10. 1 SD Card port

11. 1 Probe Connector Port

12. Probe Connector Locking Lever

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Peripherals Connection

1. Connect the printer to the system. The printer can be

Printers Illustration

Sony UP-D897 printer

Console Overview

properly connected using the Isolated USB printer port.

Table 3-2: Printers Connection

Sony UP-D898MD printer

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Preparing the System for Use

Table 3-2: Printers Connection

Printers Illustration

Sony UP-D25MD printer

HP Officejet 100 printer

HP Officejet Pro 8100 printer

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Peripherals Connection (continued)

2. The USB connection peripherals in below table can be properly connected using general USB ports.

Table 3-3: Peripherals Connection

Peripherals Illustration

1 Pedal Footswitch

Console Overview

3 Pedal Footswitch

You can configure 3-pedal Footswitch functionality via the Utility -> Applications -> Footswitch parameters.

DVD-RW Note: Do not connect the DVD-RW to the system while scanning. Note: Be sure the 2 connectors on the USB Y cable are connected to the system at the same time.

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Preparing the System for Use

Table 3-3: Peripherals Connection

Peripherals Illustration

Wireless Card

USB Flash Drive

USB Hard Disk

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Peripherals Connection (continued)

3. Other peripheral ports connection

Table 3-4: Other Peripheral ports connection

Peripherals Illustration

SD Card connection

Ethernet connection

Console Overview

HDMI port connection

VGA output connection (through an external video adapter from HDMI)

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Preparing the System for Use

CAUTION

Table 3-4: Other Peripheral ports connection

Peripherals Illustration

Composite out port You can configure the output format via the Utility -> System -> Peripherals.

S-Video out port You can configure the output format via the Utility -> System -> Peripherals.

When using the Footswitch, DO NOT hold down the footswitch pedal. Press and release the Footswitch pedal. Pushing and holding down the pedal behaves the same way as pushing and holding down a key on the keyboard.

NOTE: Please refer to the manufacture’s operation manual of each

peripheral for information needed by the user to operate the peripheral safely.

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GE LOGIQ V2, LOGIQ V1 Basic User Manual

Specifications and Main Features

Frequently Asked Questions

User Manual

Direction 5610735-100 English

Table of Contents

Introduction

Overview

Contact Information

Safety

Owner Responsibility

Safety Precautions

Device Labels

Preparing the System for Use

Site Requirements

Console Overview