LOGIQ V2 and V1 User Guide R1.X.X Rev 10 Oct 2017

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

First CE Marked in 2015. 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 (YYYY/MM/DD)

REV

REASON FOR CHANGE

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

Rev. 10

2017/10/31

Add ECG option

List of Effective Pages

CHAPTER NUMBER

REVISION NUMBER

CHAPTER NUMBER

REVISION NUMBER

Title Page

Rev. 10

Chapter 3

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Revision History

Rev. 10

Chapter 4

Rev. 10

Regulatory Requirements

Rev. 10

Chapter 5

Rev. 10

Chapter 1

Rev. 10

Index

Rev. 10

Chapter 2

Rev. 10

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 – User Guide Direction 5610736-100 Rev. 10

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LOGIQ V2/LOGIQ V1 – User Guide Direction 5610736-100 Rev. 10

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

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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).

•

General Electric Medical Systems is ISO 13485 certified.

Certifications

Original Documentation •

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The original document was written in English.

LOGIQ V2/LOGIQ V1 – User Guide Direction 5610736-100 Rev. 10

Country-Specific Approval •

JAPAN Certified Number:

Importer Information •

Turkey

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LOGIQ V2/LOGIQ V1 – User Guide Direction 5610736-100 Rev. 10

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 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

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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

ECG Option (For R1.2.0 and above) Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-43 ECG Trace Monitor Display - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-44 ECG menu - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-45

Using the Fast Key Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-46 Create a Fast Key - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-46 Start a Fast Key - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-47 Backup and Restore the Fast Key - - - - - - - - - - - - - - - - - - - - - - - - - - 2-47

Quantitative Analysis (QAnalysis) Activating QAnalysis - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-48 Exiting QAnalysis - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-48

Measurement and Analysis Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-49 Location of Measurement Controls - - - - - - - - - - - - - - - - - - - - - - - - - - 2-50 B-Mode Measurements - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-51 Doppler Mode Measurements - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-59

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M-Mode Measurements- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-63 Wide Dual Screen Measurements (For R1.1.x) - - - - - - - - - - - - - - - - - 2-65 Viewing and Editing Worksheets - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-66 Defining Hot Keys - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-70 Clinical Measurement Accuracy - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-71

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

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EMC (Electromagnetic Compatibility) - - - - - - - - - - - - - - - - - - - - - - - - 4-15 Patient Environmental Devices- - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-25 Acoustic Output - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-27 RoHS LOGIQ V2/LOGIQ V1 Hazardous Substances - - - - - - - - - - - - - 4-30

Device Labels Label Icon Description- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-32 Label Locations - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-39 Probe Label Explanation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-44 Probe Box Label - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-45 UDI Global Trade Item Number (GTIN) Label and Probe Box Barcode Locations - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-45

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

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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

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Getting Started

Overview

Attention 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. 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.

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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LOGIQ V2/LOGIQ V1 – User Guide Direction 5610736-100 Rev. 10

Overview 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.

LOGIQ V2/LOGIQ V1 – User Guide Direction 5610736-100 Rev. 10

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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.

Intended Use The LOGIQ V2/LOGIQ V1 is intended for use by a qualified physician for ultrasound evaluation.

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LOGIQ V2/LOGIQ V1 – User Guide Direction 5610736-100 Rev. 10

Overview Indications for Use 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).

Frequency of Use Daily (Typically 8 hours)

Operator Profile

NOTE:

•

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

•

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.

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Getting Started 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.

CAUTION

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

Contraindication 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.

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

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LOGIQ V2/LOGIQ V1 – User Guide Direction 5610736-100 Rev. 10