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
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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...
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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....
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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...
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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...
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LOGIQ E9 User Guide i-5 Direction 5180302-100 Rev. 1 Country Specific Approval • JAPAN MHLW Approved Number: 220ABBZX00177000
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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 - - - - - - - - - -...
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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...