LOGIQ e User Guide Rev 11 sw ver R8.x.x and R9.x.x Sept 2018

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

This manual is a reference for the LOGIQ e. It applies to all versions of the R8.x.x, R9.x.x software for the LOGIQ e ultrasound system.

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

Revision History Reason for Change

REV

DATE (YYYY/MM/DD)

REASON FOR CHANGE

Rev. 1

2015/02/28

Initial Release

Rev. 2

2015/03/18

Update Probes and Accessories information

Rev. 3

2015/04/15

Update software features

Rev. 4

2015/10/30

Update rating plate and add software wiping

Rev. 5

2016/02/25

1. Add upgrade UDI label 2. Update system start up time 3. Update software wiping information

Rev.6

2016/04/08

Update external display information

Rev.7

2016/07/07

Update UDI label

Rev.8

2016/08/23

Add probe UDI label

Rev.9

2017/03/15

Update rating plate

Rev.10

2017/05/05

Update rating plate

Rev.11

2018/09/19

Update Korea address

List of Effective Pages

CHAPTER NUMBER

REVISION NUMBER

CHAPTER NUMBER

REVISION NUMBER

Title Page

Rev. 11

Chapter 2

Rev. 11

Revision History

Rev. 11

Chapter 3

Rev. 11

Regulatory Requirements

Rev. 11

Chapter 4

Rev. 11

Table of Contents

Rev. 11

Chapter 5

Rev. 11

Chapter 1

Rev. 11

Index

Rev. 11

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.

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LOGIQ e – User Guide Direction 5561645-100 English Rev. 11

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 B with BF or CF Applied Parts.

•

Docking Cart console is Class I.

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Continuous Operation

According to CISPR 11, •

Equipment is Group 1, Class A ISM Equipment.

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Docking Cart is Group 1, Class A ISM Equipment.

According to IEC 60529, •

The footswitch rate is IPx8 (MKF 2-MED GP26)

•

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 e – User Guide Direction 5561645-100 English Rev. 11

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Conformance Standards (continued) Authorized Representative in Ukraine

•

•

International Electrotechnical Commission (IEC). •

IEC/EN 60601-1 Medical Electrical Equipment, Part 1 General Requirements for Safety.

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IEC/EN 60601-1-2 Electromagnetic compatibility Requirements and tests.

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IEC/EN 60601-1-6 (Usability), EN 1041 (Information supplied with medical devices).

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IEC 60601-2-37 Medical electrical equipment. 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.

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

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Canadian Standards Association (CSA). •

CSA 22.2, 601.1 Medical Electrical Equipment, Part 1 General Requirements for Safety.

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

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

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General Electric Medical Systems is ISO 13485 certified.

Certifications

Original Documentation •

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The original document was written in English.

LOGIQ e – User Guide Direction 5561645-100 English Rev. 11

Country Specific Approval •

JAPAN MHLW Certified Number: 218ABBZX00060000

Importer Information •

Turkey

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LOGIQ e – User Guide Direction 5561645-100 English Rev. 11

Table of Contents

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 System Overview Attention - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-2 Prescription Device - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-3 Principles of Operation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-4 Indications for Use - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-5 Site Requirements - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-7 Console Graphics - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-11 Peripheral/Accessory Connector Panel - - - - - - - - - - - - - - - - - - - - - - - 1-23 Control Panel Map - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-37 Top/Sub Menu - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-39 Keyboard - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-40 Monitor Display- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-41 Adjusting the LCD Monitor - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-42 Brightness - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-43 Volume - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-44

Moving the System Before moving the system - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-45 Moving the System - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-46 Transporting the System - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-47

System Start-Up Connecting the System - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-48 Power On - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-50 Power Off- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-51 Sleep Mode - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-52 Check System Date and Time - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-53

Probes Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-55 Connecting the Probe - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-55 Cable Handling - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-58 Disconnecting the Probe - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-58

Beginning an Exam Patient Screen - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-59

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Scanning a New Patient - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-68 Starting a new exam on an existing patient - - - - - - - - - - - - - - - - - - - - 1-73 Scanning without entering any patient data - - - - - - - - - - - - - - - - - - - - 1-74 Applications - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-75 Emergency Department- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-76

Chapter 2 - Performing an Exam Optimizing the Image B-Mode Controls- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-2 M-Mode Controls - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-6 Color Flow Mode Controls - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-7 M Color Flow Mode- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-9 Doppler Mode Controls - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-10 3D Mode - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-12 Needle Recognition- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-14 Other Controls - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-19 Zoom- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-19 Split Screen - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-21 Simultaneous mode - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-21 Freezing an Image - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-21 Freezing an Image (Footswitch Option)- - - - - - - - - - - - - - - - - - - - - - - 2-22 Freezing an Image (Probe Button Option) - - - - - - - - - - - - - - - - - - - - - 2-22 Activating CINE - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-22 Body Patterns- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-23 Annotating an Image - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-24 eSmart Trainer - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-26 Follow-up Tool - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-32

Measurement and Analysis Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-49 Location of Measurement Controls - - - - - - - - - - - - - - - - - - - - - - - - - - 2-50 B-Mode Measurements - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-51 Doppler Mode Measurements - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-58 M-Mode Measurements- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-62 Fusion - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-64 Viewing and Editing Worksheets - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-68 Defining Hot Keys - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-71 Clinical Measurement Accuracy - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-72 Setting up the Off-Line Paper Printer - - - - - - - - - - - - - - - - - - - - - - - - 2-75

Chapter 3 - After the Exam is Over Presets Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-2 Foreign Language Keyboard Setup (For R8.x.x) - - - - - - - - - - - - - - - - - 3-3 System Setup Procedure to display the messages in Japanese (For R8.x.x) - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-6 Foreign Language Keyboard Setup (For R9.x.x) - - - - - - - - - - - - - - - - 3-11 System Setup Procedure to display the messages in Japanese (For R9.x.x) - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-16 Backup and Restore - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-17 EZBackup and EZMove- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-20

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Backup and restore strategy: user-defined configurations - - - - - - - - - - 3-30 Preset synchronization - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-30 Restore procedure: user-defined configurations- - - - - - - - - - - - - - - - - 3-31 Configuring Connectivity - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-32 Anti-Virus Software Note - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-34

Electronic Documentation Documentation Distribution - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-36 Electronic media - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-37

System Data Features/Specifications - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-38

System Care and Maintenance Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-49 Weekly Maintenance- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-51 Cleaning the system - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-52 Other Maintenance - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-55 Disposal- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-56 System Software Updates (Software Download) - - - - - - - - - - - - - - - - 3-57 Software Wiping to Erase Patient Data (For R9.x.x only) - - - - - - - - - - 3-65

Quality Assurance Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-68 Typical Tests to Perform - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-69 Setting up a Record Keeping System - - - - - - - - - - - - - - - - - - - - - - - - 3-82 Ultrasound Quality Assurance Checklist - - - - - - - - - - - - - - - - - - - - - - 3-83

Assistance Supplies/Accessories - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-84

Contact Information Contacting GE Ultrasound - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-87 Manufacturer - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-93 Factory Sites - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-94

Chapter 4 - Safety Owner Responsibility Owner requirements - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-2 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 General Caution - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-15 EMC (Electromagnetic Compatibility) - - - - - - - - - - - - - - - - - - - - - - - - 4-16 Patient Environmental Devices- - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-26 Acoustic Output - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-28

Device Labels Label Icon Description- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-32 Warning Label Locations - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-40 Probe Label Explanation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-45 Probe Box Label - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-46

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UDI Global Trade Item Number (GTIN) Label and Probe Box Barcode Locations - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-46

RoHS LOGIQ e Hazardous Substances Name and Concentration of Hazardous Substances - - - - - - - - - - - - - 4-49

Chapter 5 - Probes and Biopsy Probe Overview Ergonomics - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-2 Cable handling - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-2 Probe orientation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-3 Labeling- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-4 Probe Naming Conventions - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-4 Probe Usage - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-5 Care and Maintenance - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-5 Probe Safety - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-7 Special handling instructions - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-12 Probe handling and infection control - - - - - - - - - - - - - - - - - - - - - - - - - 5-14 Probe Cleaning Process - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-15 Coupling gels - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-21 Planned Maintenance - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-22 Returning/Shipping Probes and Repair Parts- - - - - - - - - - - - - - - - - - - 5-22

Probe Discussion Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-23 Applications - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-24 Features - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-25 Specifications - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-27 Slice Thickness Specification - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-28 Probe Illustration- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-29

Biopsy Special Concerns Precautions Concerning the Use of Biopsy Procedures - - - - - - - - - - - 5-31

Preparing for a Biopsy Displaying the Guidezone - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-33 Preparing the Biopsy Guide Attachment - - - - - - - - - - - - - - - - - - - - - - 5-37 The Biopsy Procedure- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-47 Post Biopsy - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-48

Surgery/Intra-operative Use Preparing for Surgery/Intra-operative Procedures - - - - - - - - - - - - - - - 5-49

Index

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LOGIQ e – User Guide Direction 5561645-100 English Rev. 11

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

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Getting Started

System Overview

Attention 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 manual supplied with the system before attempting to use the LOGIQ e system. Keep this manual with the equipment at all times. Periodically review the procedures for operation and safety precautions. NOTE:

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

NOTE:

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

NOTE:

All references to standards / regulations and their revisions are valid at the time of publication of the user manual. The LOGIQ e 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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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.

NOTE:

The system color varies.

LOGIQ e – User Guide Direction 5561645-100 English Rev. 11

System Overview Attention (continued) NOTE:

The software R8.x.x and R9.x.x which are used to distinguish the different features of the system in all the manuals only refer to the systems which are originally installed with the software version R8.x.x and R9.x.x. Not all the features of R9.x.x will be supported when upgrading the software from R8.x.x to R9.x.x on the system which is originally installed with software R8.x.x.

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

LOGIQ e – User Guide Direction 5561645-100 English Rev. 11

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

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LOGIQ e – User Guide Direction 5561645-100 English Rev. 11

System Overview Indications for Use For R8.x.x: The LOGIQ e is intended for ultrasound imaging, measurement and analysis for human body for multiple clinical applications including: Ophthalmic; Fetal/OB; Abdominal (GYN & Urology); Pediatric; Small Organ (breast, testes, thyroid); Neonatal and Adult Cephalic; Cardiac (adult & pediatric); Peripheral Vascular; Musculoskeletal Conventional & Superficial; Transrectal; Transvaginal; Intraoperative (abdominal, thoracic and peripheral); Thoracic/Pleural for motion and fluid detection and imaging guidance of interventional procedures (e.g. Nerve Block; Vascular Access). For R9.x.x: The LOGIQ e is intended for ultrasound imaging, measurement and analysis for human body for multiple clinical applications including: Ophthalmic; Fetal/OB; Abdominal (GYN & Urology); Pediatric; Small Organ (breast, testes, thyroid); Neonatal and Adult Cephalic; Cardiac (adult & pediatric); Peripheral Vascular; Musculoskeletal Conventional & Superficial; Transrectal; Transvaginal; Intraoperative (abdominal, thoracic and peripheral); Thoracic/Pleural for motion and fluid detection and imaging guidance of interventional procedures (e.g. Nerve Block; Vascular Access), Transesophageal.

Frequency of Use Daily (Typically 8 hours)

Operator Profile

NOTE:

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

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The operator must have read and understood the user manual.

Only qualified physicians or sonographers should perform ultrasound scanning on human subjects for medical diagnostic reasons. Request training, if needed. Image Acquisition is for diagnostic purposes, including measurements on acquired images.

LOGIQ e – User Guide Direction 5561645-100 English Rev. 11

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Getting Started Indications for Use (continued) CAUTION

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

WARNING

To avoid injury to the patient, be sure to select the Ophthalmic or Orbits preset under ED before eye scanning begins. The system will not exceed the acoustic energy limits for ophthalmic use only if the Ophthalmic or Orbits preset is selected. Only the applicable probes can be used for eye exams. See ‘Applications’ on page 5-24 for more information.

NOTE:

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Ophthalmic and Orbits are not available in Japan.

LOGIQ e – User Guide Direction 5561645-100 English Rev. 11

System Overview Site Requirements Introduction

WARNING

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

CAUTION

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 3-87 for more information. Perform regular preventive maintenance. See ‘System Care and Maintenance’ on page 3-49 for more information. The LOGIQ e 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 3-52 for more information.

CAUTION

The LOGIQ e 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.

CAUTION

The Docking Cart is not waterproof. Do not expose the Docking Cart to water or any kind of liquid. Never set liquids on the Docking Cart to ensure that liquid does not drip into the unit.

LOGIQ e – User Guide Direction 5561645-100 English Rev. 11

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Getting Started 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 amp circuit breaker for 220-240 VAC or a 10 amp circuit breaker for 100-120 VAC. 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:

CAUTION

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Operate the console at least 15 feet away from motors, typewriters, elevators, and other sources of strong electromagnetic radiation.

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Operation in an enclosed area (wood, plaster or concrete walls, floors and ceilings) helps prevent electromagnetic interference.

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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.

LOGIQ e – User Guide Direction 5561645-100 English Rev. 11