GE Logiq 9 User Manual
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GE Healthcare Technical Publications Direction 5180302-100 Rev. 1 LOGIQ E9 User Guide R1.x.x Operating Documentation Copyright 2008 By General Electric Co. 0459
GE Healthcare 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 E9. It applies to all versions of the R1.x.x software for the LOGIQ E9 ultrasound system. 0459 GE Medical Systems: Telex 3797371 P.O. Box 414, Milwaukee, Wisconsin 53201 U.S.A. (Asia, Pacific, Latin America, North America) GE Ultraschall: TEL: 49 212.28.02.208 Deutschland GmbH & Co. KG: FAX: 49 212.28.02.431 Beethovenstrasse 239 Postfach 11 05 60 D-42655 Solingen GERMANY
LOGIQ E9 User Guide i-1 Direction 5180302-100 Rev. 1 Revision History Reason for Change List of Effective Pages Please verify that you are using the latest revision of this document. Information pertaining to this document is maintained on ePDM (GE Medical Systems 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. REVDATEREASON FOR CHANGE Rev. 1 September, 2008 R1.x.x PAGE NUMBER REVISION NUMBER PA G E N U M B E R REVISION NUMBER Title Page Rev. 1 Chapter 2 Rev. 1 Revision History Rev. 1 Chapter 3 Rev. 1 Regulatory Requirements Rev. 1 Chapter 4 Rev. 1 Table of Contents Rev. 1 Index Rev. 1 Chapter 1 Rev. 1
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LOGIQ E9 User Guide i-3 Direction 5180302-100 Rev. 1 Regulatory Requirements Conformance Standards The following classifications are in accordance with the IEC/ EN 60601-1:6.8.1: • According to 93/42/EEC Medical Device Directive, this is Class IIa Medical Device. • According to IEC/EN 60601-1, Equipment is Class I, with BF or CF Applied Parts. • According to CISPR 11, LOGIQ E9 system is Group 1, Class A (commercial use only). • According to IEC 60529, the footswitch rate IPx8 is suitable for use in surgical rooms. This product complies with the regulatory requirement of the following: • Council Directive 93/42/EEC concerning medical devices: the CE label affixed to the product testifies compliance to the Directive. The location of the CE marking is shown in Chapter 2 of this manual. Authorized EU Representative European registered place of business: GE Medical Systems Information Technologies GmbH (GEMS IT GmbH) Munzinger Strasse 3, D-79111 Freiburg, GERMANY Tel: +49 761 45 43 -0; Fax: +49 761 45 43 -233
i-4 LOGIQ E9 User Guide Direction 5180302-100 Rev. 1 Conformance Standards (continued) • International Electrotechnical Commission (IEC). • IEC/EN 60601-1 Medical Electrical Eqiupment, Part 1 General Requirements for Safety. • IEC/EN 60601-1-1 Safety requirements for medical electrical systems. • IEC/EN 60601-1-2 Electromagnetic compatibility - Requirements and tests. • IEC/EN 60601-1-4 Programmable electrical medical systems. • IEC 61157 Declaration of acoustic output parameters. • International Organization of Standards (ISO) • ISO 10993-1 Biological evaluation of medical devices. • Underwriters’ Laboratories, Inc. (UL), an independent testing laboratory. • UL 60601-1 Medical Electrical Equipment, Part 1 General Requirements for Safety. • Canadian Standards Association (CSA). • CAN/CSA 22.2, 601.1 Medical Electrical Equipment, Part 1 General Requirements for Safety. • NEMA/AIUM Acoustic Output Display Standard (NEMA UD-3, 1998). • Medical Device Good Manufacturing Practice Manual issued by the FDA (Food and Drug Administration, Department of Health, USA). Certifications • General Electric Healthcare Ultrasound is ISO 9001 and ISO 13485 certified. Original Documentation • The original document was written in English. Software License Acknowledgements • WindowBlinds ™ OCX © Stardock ® • Roxio® Powered
LOGIQ E9 User Guide i-5 Direction 5180302-100 Rev. 1 Country Specific Approval • JAPAN MHLW Approved Number: 220ABBZX00177000
i-6 LOGIQ E9 User Guide Direction 5180302-100 Rev. 1
LOGIQ E9 User Guide i-7 Direction 5180302-100 Rev. 1 Table of Contents Conformance Standards - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-3 Certifications - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-4 Original Documentation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-4 Software License Acknowledgements - - - - - - - - - - - - - - - - - - - - - - - - - - i-4 Country Specific Approval - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-5 Table of Contents Chapter 1 — Getting Started Console Overview Indications for Use - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-2 Contraindication - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-2 Important Notices - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-3 Console graphics - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-5 Moving the System Before moving the system - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-13 When moving the system - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-15 Operator Panel Movement Controls - - - - - - - - - - - - - - - - - - - - - - - - - 1-16 Setting the front wheels lock - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-17 System Start-Up Power On - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-18 Power Off- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-19 Circuit breaker - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-20 Probes Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-21 Connecting the Probe - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-22 Cable Handling - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-23 Activating the Probe - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-23 Disconnecting the Probe - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-24 LOGIQ E9 Applications - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-25 LOGIQ E9 Features - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-26 Beginning an Exam Scanning a New Patient - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-27 Patient Screen - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-29 Chapter 2 — Performing an Exam Optimizing the Image B-Mode Controls- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-2 M-Mode Controls - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-5 Color Flow Mode Controls - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-6 Doppler Mode Controls - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-8 Other Controls - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-10
i-8 LOGIQ E9 User Guide Direction 5180302-100 Rev. 1 Measurement and Analysis B-Mode Measurements - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-13 Doppler Mode Measurements - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-25 M-Mode Measurements- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-28 Viewing and Editing Worksheets - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-30 Chapter 3 — After the Exam is Over Probe Overview Probe Naming Conventions - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-2 Probe handling and infection control - - - - - - - - - - - - - - - - - - - - - - - - - - 3-3 Endocavitary Probe Handling Precautions- - - - - - - - - - - - - - - - - - - - - - 3-4 Probe Cleaning Process - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-5 Coupling gels - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-11 System Presets Foreign Language Keyboard Setup - - - - - - - - - - - - - - - - - - - - - - - - - 3-12 Data Backup EZBackup and EZMove- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-18 Backup procedure: user-defined configurations - - - - - - - - - - - - - - - - - 3-25 Restore procedure: patient data - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-26 Restore procedure: user-defined configurations - - - - - - - - - - - - - - - - - 3-27 Configuring Connectivity Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-28 Connectivity Functions - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-29 Electronic Documentation Accessing Documentation Via a PC - - - - - - - - - - - - - - - - - - - - - - - - - 3-30 Accessing Documentation on the Ultrasound Scanner Via the media- - 3-31 Using Online Help Via F1 - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-32 System Care and Maintenance Inspecting the System - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-33 Weekly Maintenance - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-34 System Cabinet - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-34 Touch Panel - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-34 Operator Controls - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-35 Other Maintenance - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-36 Supplies/Accessories - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-39 Chapter 4 — Safety Safety Precautions Precaution Levels - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-2 Hazard Symbols - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-3 Patient Safety - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-5 Equipment and Personnel Safety - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-8 Device Labels- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-14 EMC (Electromagnetic Compatibility) - - - - - - - - - - - - - - - - - - - - - - - - 4-18 Patient Environmental Devices- - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-29 Acoustic Output - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-31 Warning Label Locations - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-34 Index