GE LOGIQ V2, LOGIQ V1 Operating Manual

Technical Publication

Direction 5610736-100

Rev. 9
LOGIQ V2/LOGIQ V1 User Guide
R1.X.X
Operating Documentation
Copyright 2015-2017 By General Electric
Co.
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
Rev. 2 2015/10/14 Add onboard help
Rev. 3 2015/11/23 Remove secure wipe information
Rev. 4 2015/12/14 Update rating plate
Rev. 5 2016/02/25 Add intended use
Rev. 6 2016/06/14 Update rating plate
Rev. 7 2016/08/29 Add probe UDI label
Rev. 8 2016/12/08 Update software features
Rev. 9 2017/04/25 Update onboard help
(YYYY/MM/DD)
List of Effective Pages
REASON FOR CHANGE
REVISION
CHAPTER NUMBER
Title Page Rev. 9 Chapter 3 Rev. 9
Revision History Rev. 9 Chapter 4 Rev. 9
Regulatory Requirements Rev. 9 Chapter 5 Rev. 9
Chapter 1 Rev. 9 Index Rev. 9
Chapter 2 Rev. 9
NUMBER
CHAPTER 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 V1User Guide i-1 Direction 5610736-100 Rev. 9
This page intentionally left blank.
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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 V1User Guide i-3 Direction 5610736-100 Rev. 9
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.
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Country-Specific Approval
• JAPAN
Certified Number:
Importer Information
• Turkey
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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 — Getting Started
Overview
Attention - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-2 Principles of Operation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-4 Intended Use - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-4 Indications for Use - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-5 Contraindication - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-6 Prescription Device - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-6 Site Requirements - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-7 Console Graphics - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-11 Peripheral/Accessory Connector Panel - - - - - - - - - - - - - - - - - - - - - - - 1-22 Control Panel Map - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-32 Monitor Display- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-37
LCD Monitor
Locking/unlocking the LCD monitor - - - - - - - - - - - - - - - - - - - - - - - - - 1-40 Adjusting the LCD monitor - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-40 Brightness - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-41 Volume - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-42
Moving the System
Before moving the system - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-43 When moving the system - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-44 Transporting the System - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-44
System Start-Up
Connecting the System - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-45
Probes
Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-54 Connecting the Probe - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-54 Cable Handling - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-56 Disconnecting the Probe - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-56 2-Probe Port Adapter (option) - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-57
Beginning an Exam
Archive Screen (For R1.0.x)- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-60 Archive Screen (For R1.1.x)- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-62

Table of Contents

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Scanning a New Patient - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-62 Starting a new exam on an existing patient - - - - - - - - - - - - - - - - - - - - 1-69 Scanning without entering any patient data - - - - - - - - - - - - - - - - - - - - 1-70 Changing Current Patient to Existing Patient (For R1.0.x) - - - - - - - - - 1-72 Changing Current Patient to Existing Patient (with Patient ID) (For R1.1.x)
1-74
Changing Current Patient to Existing Patient (without Patient ID) (For R1.1.x)
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-75 End Exam - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-77 Deleting the existing patient/exam/image - - - - - - - - - - - - - - - - - - - - - 1-78
Chapter 2 — Performing an Exam
Optimizing the Image
B-Mode Controls- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-2 Color Flow Mode Controls - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-5 M-Mode Controls - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-7 M Color Flow Mode - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-7 Doppler Mode Controls - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-8 Easy 3D Mode (option) - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-10
Other Controls
Zoom- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-11 Split Screen - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-14 Freezing an Image - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-14 Activating CINE - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-14 Body Patterns- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-15 Annotating an Image - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-16
Scan Coach (Option)
Scan Coach - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-17
SonoBiometry (AFB) (Option)
Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-39 Using SonoBiometry - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-40
Using the Fast Key
Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-43 Create a Fast Key - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-43 Start a Fast Key - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-44 Backup and Restore the Fast Key - - - - - - - - - - - - - - - - - - - - - - - - - - 2-44
Quantitative Analysis (QAnalysis)
Activating QAnalysis - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-45 Exiting QAnalysis - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-45
Measurement and Analysis
Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-46 Location of Measurement Controls - - - - - - - - - - - - - - - - - - - - - - - - - - 2-47 B-Mode Measurements - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-48 Doppler Mode Measurements - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-56 M-Mode Measurements- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-60 Wide Dual Screen Measurements (For R1.1.x) - - - - - - - - - - - - - - - - - 2-62 Viewing and Editing Worksheets - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-63 Defining Hot Keys - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-67
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Clinical Measurement Accuracy - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-68
Setting up the Off-Line Paper Printer
Chapter 3 — After the Exam is Over
Presets
Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-2 System Presets - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-3 Data Backup - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-14 Configuring Connectivity - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-29
Electronic Documentation
Accessing Documentation Via a PC - - - - - - - - - - - - - - - - - - - - - - - - - 3-31
System Data
Features/Specifications - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-32
System Care and Maintenance
Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-36 Inspecting the System - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-37 Cleaning the system - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-39 Prevention of static electricity interference- - - - - - - - - - - - - - - - - - - - - 3-42 Disposal- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-43 Troubleshooting - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-44 System Software Updates (Software Download) - - - - - - - - - - - - - - - - 3-45
Quality Assurance
Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-53 Typical Tests to Perform - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-54 Baselines - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-57 Periodic Checks - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-57 Results - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-58 System Setup- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-59 Test Procedures - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-59 Setting up a Record Keeping System - - - - - - - - - - - - - - - - - - - - - - - - 3-68 Ultrasound Quality Assurance Checklist - - - - - - - - - - - - - - - - - - - - - - 3-69
Assistance
Supplies/Accessories - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-70
Contact Information
Contacting GE Ultrasound - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-73 Manufacturer - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-79
Chapter 4 — Safety
Owner Responsibility
Notice against user modification- - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-2
Safety Precautions
Precaution Levels - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-3 Hazard Symbols - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-4 Patient Safety- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-6 Equipment and Personnel Safety - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-10 EMC (Electromagnetic Compatibility) - - - - - - - - - - - - - - - - - - - - - - - - 4-15 Patient Environmental Devices- - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-25 Acoustic Output - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-27 RoHS LOGIQ V2/LOGIQ V1 Hazardous Substances - - - - - - - - - - - - - 4-30
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Device Labels
Label Icon Description - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-32 Label Locations - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-38 Probe Label Explanation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-43 Probe Box Label - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-44 UDI Global Trade Item Number (GTIN) Label and Probe Box Barcode
Locations - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-44
Chapter 5 — Probes and Biopsy
Probe Overview
Ergonomics - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-2 Cable handling - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-2 Probe orientation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-3 Labeling- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-3 Probe Naming Conventions - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-4 Probe Usage - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-4 Probe Safety - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-6 Special handling instructions - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-8 Probe handling and infection control - - - - - - - - - - - - - - - - - - - - - - - - - 5-10 Probe Cleaning Process - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-11 Coupling gels - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-17
Probe Discussion
Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-19 Application - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-20 Features - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-21 Specifications - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-21 Slice Thickness Specification - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-23 Probe Illustration- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-24
Biopsy Special Concerns
Precautions Concerning the Use of Biopsy Procedures - - - - - - - - - - - 5-26
Preparing for a Biopsy
Displaying the Guidezone - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-28 Preparing the Biopsy Guide Attachment - - - - - - - - - - - - - - - - - - - - - - 5-31 Biopsy Needle Path Verification - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-40 The Biopsy Procedure - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-41 Post Biopsy - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-42
Surgery/Intra-operative Use
Preparing for Surgery/Intra-operative Procedures - - - - - - - - - - - - - - - 5-43
Chapter 6 — Using Onboard Help
Introduction
Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-2
Onboard Help
Getting Started - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-7 System Setting - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-9 Peripheral Connection - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-25 Maintenance - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-39
Index
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Chapter 1

Getting Started

Console Overview, Moving the System, System Start-up, Probes and Beginning an Exam
LOGIQ V2/LOGIQ V1User Guide 1-1 Direction 5610736-100 Rev. 9
Getting Started
Attention
NOTE: The Online Help offers a quick way for the user to access the

Overview

This manual is for LOGIQ V2/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 this manual 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.
manual. When there are difference between Online Help and Basic User Manual/User Guide, please refer to Basic User Manual/User Guide for the only right version.
Disregarding information on safety is considered abnormal use.
Not all features, products, probes, or peripherals described in this document may be available or cleared for sale in all markets. Please contact your local GE Ultrasound representative to get the latest information.
NOTE: Please note that orders are based on the individually agreed
upon specifications and may not contain all features listed in this manual.
NOTE: All references to standards / regulations and their revisions are
valid at the time of publication of the user manual.
NOTE: The system color varies.
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.
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Attention (continued)
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 screen graphics in this manual are only for illustrational
purposes. Actual screen output may differ with the different software versions.
NOTE: The Electronic Documentation CD includes English and all
translations.
Overview
LOGIQ V2/LOGIQ V1User Guide 1-3 Direction 5610736-100 Rev. 9
Getting Started
Principles of Operation
Medical ultrasound images are created by computer and digital memory from the transmission and reception of mechanical high-frequency waves applied through a transducer. The mechanical ultrasound waves spread through the body, producing an echo where density changes occur. For example, in the case of human tissue, an echo is created where a signal passes from an adipose tissue (fat) region to a muscular tissue region. The echoes return to the transducer where they are converted back into electrical signals.
These echo signals are highly amplified and processed by several analog and digital circuits having filters with many frequency and time response options, transforming the high-frequency electrical signals into a series of digital image signals which are stored in memory. Once in memory, the image can be displayed in real-time on the image monitor. All signal transmission, reception and processing characteristics are controlled by the main computer. By selection from the system control panel, the user can alter the characteristics and features of the system, allowing a wide range of uses, from obstetrics to peripheral vascular examinations.
Intended Use
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.
The LOGIQ V2/LOGIQ V1 is intended for use by a qualified physician for ultrasound evaluation.
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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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Getting Started
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 images.
This machine should be used in compliance with law. Some jurisdictions restrict certain uses, such as gender determination.
Contraindication
Prescription Device
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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Site Requirements
WARNING
CAUTION
CAUTION
Introduction
Overview
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 3-73 for more information.
Perform regular preventive maintenance. See ‘System Care and Maintenance’ on page 3-36 for more information.
The LOGIQ V2/LOGIQ V1 does not contain any operator serviceable internal components. Ensure that unauthorized personnel do not tamper with the unit.
Maintain a clean environment. Turn off the system and disconnect the power cord before cleaning the unit. See ‘Cleaning the system’ on page 3-39 for more information.
The LOGIQ V2/LOGIQ V1 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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Getting Started
CAUTION
Before the system arrives
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.
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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Before the system arrives (continued)
WARNING
To avoid risk of fire, the system power must be supplied from a separate, properly rated outlet. See ‘Before the system arrives’ on page 1-8 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 1-1. Example Plug and Outlet Configurations
1. 100-120 VAC, 10A
Plug and Outlet Configuration
2. 220-240 VAC, 10A
Overview
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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Getting Started
CAUTION
CAUTION
CAUTION
Environmental Requirements
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 1-1: System Environmental Requirements
Operational
(with probes)
Storage
(LOGIQ V2/LOGIQ
V1)
Transport
(LOGIQ V2/LOGIQ V1)
Temperature 10° - 40 °C
50° - 104 °F
Humidity 30 - 80% non-condensing 10 - 90%
Pressure 700 - 1060hPa 700 - 1060hPa 700 - 1060hPa
-5° - 50 °C 23° - 122 °F
non-condensing
-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.
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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Console Graphics
Overview
The following are illustrations of the console:
Figure 1-2. 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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Getting Started
CAUTION
WARNING
Console Graphics (continued)
Figure 1-3. 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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Battery
WARNING
Overview
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 about 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:
• Storage temperature:
NOTE: It is recommended that the battery remaining capacity
Do not expose the battery to temperature over 60°C (140°F). Keep it away from fire and other heat sources.
Charge: 10 - 30°C (50 - 86°F).
Discharge: 10 - 40°C (50 - 104°F)
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)
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Getting Started
WARNING
WARNING
CAUTION
Battery (continued)
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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Discharge/Charge Cycle
CAUTION
NOTE: A full discharge/charge cycle means the system is turned on
Overview
When the battery is stored for three months or more, the customer should perform one full discharge/charge cycle.
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 one hour for discharge).
When storing packs for more than 6 months, charge the pack at least once during the 6 month time frame to prevent leakage and deterioration in performance.
Use only GE recognized batteries.
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Getting Started
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.
Figure 1-4. Battery icon
Figure 1-5. Low Power Battery Icon
Figure 1-6. Warning Battery Icon
Figure 1-7. Charging Battery icon
Select the battery icon and the following information window appears:
Figure 1-8. Battery Status Message
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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.
Overview
Figure 1-9. Low battery power warning
Figure 1-10. 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 1-11. 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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Getting Started
Battery error
If there is an error on the battery, the battery error icon displays.
Figure 1-12. 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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