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GE Medical Systems
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Vivid q N 0470
Reference Manual
GEMS #: FQ092007 Rev. 01 Copyright© 2011 By General Electric Co. Reference Documentation
Regulatory Requirements This product complies with regulatory requirements of the following European Directive 93/42/EEC concerning medical devices.
0470 This manual is a reference for Vivid q N. It applies to all versions of the 11.x.x software for the Vivid q N ultrasound system.
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GE Medical Systems MANUAL STATUS FQ092007 Rev. 01 8-September-2011
COMPANY DATA
© GE Medical Systems. All rights reserved. No part of this manual may be reproduced, stored in a retrieval system, or transmitted, in any form or by any means, electronic, mechanical, photocopying, recording, or otherwise, without the prior written permission of GE Medical Systems. GE VINGMED ULTRASOUND A/S Strandpromenaden 45 N-3191 Horten, Norway Tel.: (+47) 3302 1100 Fax: (+47) 3302 1350
Revision History
Revision History Revision
Date
Reason for Change
1
8 September 2011
Initial release
List of affected pages Revision
Affected Pages
1
All
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.
Vivid q N Reference Manual FQ092007-01
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Regulatory information
Regulatory information CAUTION
Any changes to accessories, peripheral units or any other part of the system must be approved by the manufacturer. Ignoring this advice may compromise the regulatory approvals obtained for the product.
Directives The GE Healthcare Ultrasound product families are tested to meet all applicable requirements in relevant EU Directives and European/International standards. • Council Directive 93/42/EEC concerning MDD (Medical Devices Directive): the CE label affixed to the product testifies compliance to this Directive. The location of the CE marking is shown in the User Manual, Direction FQ092004, Chapter 1 - "Safety" as specified on the “Device Labels”.
Product Classifications The Vivid q N ultrasound unit confirms to the following classifications, 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, Type B with BF or CF Applied Parts. • According to CISPR 11, this is Group 1, Class A ISM Equipment. • According to IEC 60529, the footswitch rate IPx8 is suitable for use in surgical rooms. • Classification according to the degree of protection against ingress of water as detailed in the current edition of IEC 529 (section 6.1.1): Ordinary for Main Unit (PC), IPX1, IPX7, IPX8 for ultrasound probes (transducers).
Conformity to Standards To fulfill the requirements of relevant EC directives and/or European Harmonized/ International standards, the following documents/standards have been used: • International Electrotechnical Commission (IEC). • IEC/EN 60601-1: Medical Electrical Equipment, Part 1 General Requirements for Safety
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Vivid q N Reference Manual FQ092007-01
Regulatory information
•
•
•
• IEC/EN 60601-1-2: Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests • EN 55011/ CISPR11+A2: Emitted noise according to Class A requirements + Electromagnetic Susceptibility • IEC/EN 60601-1-4: Medical electrical equipment - Part 1-4: General requirements for safety - Collateral standard: Programmable electrical medical systems • IEC/EN 60601-1-6: Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral Standard: Usability • IEC/EN 60601-2-37: Medical Electrical Equipment Part 2-37: Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment • EN60601-1-1: Medical Electrical Equipment Part 1-1: General Requirements for Safety Collateral Standard: Safety Requirements for Medical Electrical Systems International Organization of Standards (ISO) • ISO 10993-1: Biological Evaluation of Medical Devices - Part 1: Evaluation & Testing • ISO 10993-5: Biological Evaluation of Medical Devices - Part 5: Tests for In Vitro Cytotoxicity • ISO 10993-10:Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity 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 UD-3, 2004).
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Regulatory information
Certifications •
Quality management standards for medical devices: GE Vingmed Ultrasound AS is ISO 9001 and ISO13485 certified.
Software License Acknowledgements •
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WindowBlinds ™ OCX © Stardock ®
Vivid q N Reference Manual FQ092007-01
Table of Contents Revision History List of affected pages... i
Regulatory information
Directives ... ii Product Classifications... ii Conformity to Standards ... ii Certifications... iv Software License Acknowledgements ... iv
Introduction
Contacting GE Healthcare Ultrasound ... 2
Chapter 1 Measurements Measurement overview ... 8 Cardiac measurements... 8 AFI Measurements ... 21 Auto-EF measurements... 24 Measurement formulas ... 26 Formulas–Cardiac ... 26 Formulas–Generic ... 56 Formulas–Vascular... 58 Formulas–OB... 59 Formulas–GYN ... 63 Measurement accuracy... 65 General ... 65 Sources of error ... 65 Optimizing Measurement Accuracy ... 67 Measurement Uncertainties... 67 DICOM SR Measurements ... 70
Vivid q N Reference Manual FQ092007-01
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Chapter 2 OB Tables ASUM... 72 Berkowitz ... 74 Brenner ... 75 Campbell ... 75 Eriksen ... 76 Goldstein... 77 Hadlock ... 78 Hansmann... 85 Hellman ... 94 Hill...94 Hohler... 95 Jeanty... 95 JSUM ... 108 Kurtz ... 112 Mayden... 113 Mercer ...114 Merz ... 115 Moore ... 125 Nelson ...125 Osaka ... 126 Paris ... 130 Rempen ... 133 Robinson... 138 Tokyo... 138 Tokyo Shinozuka... 142 Williams... 149 Yarkoni ... 149
Chapter 3 Acoustic information The real-time display of acoustic output indices... 153
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Vivid q N Reference Manual FQ092007-01
Thermal Index... 153 Mechanical Index:... 154 Concerns Surrounding the Use of Diagnostic Ultrasound... 155 Default Settings and Output Levels... 155 Controls Affecting Acoustic Output ... 156 Track 3 Summary Table ... 158 Acoustic Parameters as Measured in Water... 161 Definitions, symbols and abbreviations ... 161 Translations of definitions, symbols, and abbreviations ... 162 Acoustic Output Reporting Tables for Track 3/IEC 60601-2-37... 186 Explanation of Footnotes ... 186 Multiple focal-zones ... 186 Operating Conditions ... 187 Transducer Model: M4S-RS ... 188 Transducer Model: 5S-RS ... 194 Transducer Model: 6S-RS ... 200 Transducer Model: 7S-RS ... 206 Transducer Model: 10S-RS ... 212 Transducer Model: e8C-RS ... 218 Transducer Model: 3C-RS ... 223 Transducer Model: 4C-RS ... 228 Transducer Model: 8C-RS ... 233 Transducer Model: 8L-RS... 238 Transducer Model: 9L-RS... 243 Transducer Model: 12L-RS... 248 Transducer Model: i12L-RS... 253 Transducer Model: 6T-RS ... 258 Transducer Model: 6Tc-RS... 264 Transducer Model: 9T-RS ... 270 Transducer Model: P2D-RS... 276 Transducer Model: P6D-RS... 277 Transducer Model: AcuNav8 ... 278 Transducer Model: AcuNav10/SoundStar 3D... 284
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Chapter 4 Electromagnetic Compatibility Guidance and manufacturer’s declaration ... 291
Appendix
Statements on the safety of ultrasound... 298 AIUM Statement on Clinical Safety ... 298 AIUM Statement on Mammalian in Vivo Ultrasonic Biological Effects ... 298 Medical Ultrasound Safety - AIUM... 299 Track 3 ALARA Educational Program ... 299
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Vivid q N Reference Manual FQ092007-01
Introduction
Introduction The Vivid q N ultrasound unit is a compact, high performance portable digital ultrasound imaging system. The system provides image generation in 2D (B Mode), Color Flow Mapping (CFM), Power Doppler (Angio), M-Mode, Color M-Mode (CMM), PW and CW Doppler spectra, Tissue Velocity Imaging / Tissue Tracking (TVI/TT), Tissue Synchronization Imaging (TSI), B Flow Imaging (BFI/Bflow) and LVO Contrast option applications. The fully digital architecture of the Vivid q N unit allows optimal usage of all scanning modes and probe types, throughout the full spectrum of operating frequencies.
Vivid q N Reference Manual FQ092007-01
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Introduction
Contacting GE Healthcare Ultrasound For additional information or assistance, please contact your local distributor or the appropriate support resource listed on the following pages:
2
INTERNET
http://www.gehealthcare.com http://www.gehealthcare.com/usen/ultrasound/products/ probe_care.html
USA
GE Healthcare TEL: (1) 800-437-1171 Ultrasound Service Engineering FAX: (1) 414-721-3865 9900 Innovation Drive Wauwatosa, WI 53226
Clinical Questions
For information in the United States, Canada, Mexico and parts of the Caribbean, call the Customer Answer Center TEL: (1) 800-682-5327 or (1) 262-524-5698 In other locations, contact your local Applications, Sales or Service Representative.
Service Questions
For service in the United States, call GE CARES TEL: (1) 800-437-1171 In other locations, contact your local Service Representative.
Accessories Catalog Requests
To request the latest GE Accessories catalog or equipment brochures in the United States, call the Response Center TEL: (1) 800-643-6439 In other locations, contact your local Applications, Sales or Service Representative.
Placing an Order
To place an order, order supplies or ask an accessory-related question in the United States, call the GE Access Center TEL: (1) 800-472-3666 In other locations, contact your local Applications, Sales or Service Representative.
Vivid q N Reference Manual FQ092007-01
Introduction CANADA
GE Healthcare TEL: (1) 800-664-0732 Ultrasound Service Engineering 9900 Innovation Drive Wauwatosa, WI 53226 Customer Answer Center TEL: (1) 262-524-5698
LATIN & SOUTH AMERICA
GE Healthcare TEL: (1) 262-524-5300 Ultrasound Service Engineering 9900 Innovation Drive Wauwatosa, WI 53226 Customer Answer Center TEL: (1) 262-524-5698
EUROPE
GE Ultraschall TEL: 0130 81 6370 toll free Deutschland GmbH & Co. KG TEL: (33) 130.831.300 Beethovenstrasse 239 FAX: (49) 212.28.02.431 Postfach 11 05 60 D-42655 Solingen
ASIA
GE Ultrasound Asia (Singapore) TEL: 65-291 8528 Service Department - Ultrasound FAX: 65-272-3997 298 Tiong Bahru Road #15-01/06 Central Plaza Singapore 169730
JAPAN
ARGENTINA
GE Healthcare Japan Corporation TEL: (81) 42-648-2910 Customer Service Center FAX: (81) 42-648-2905 GEME S.A. TEL: (1) 639-1619 Miranda 5237 FAX: (1) 567-2678 Buenos Aires - 1407
AUSTRIA
GE GesmbH Medical Systems Austria TEL: 0660 8459 toll free Prinz Eugen Strasse 8/8 FAX: +43 1 505 38 74 A-1040 WIEN TLX: 136314
BELGIUM
GE Medical Systems Benelux TEL: 0 800 11733 toll free Gulkenrodestraat 3 FAX: +32 0 3 320 12 59 B-2160 WOMMELGEM TLX: 72722
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Introduction BRAZIL
GE Sistemas Medicos TEL: 0800-122345 Av Nove de Julho 5229 FAX: (011) 3067-8298 01407-907 Sao Paulo SP
CHINA
GE Healthcare - Asia TEL: (8610) 5806 9403 No. 1, Yongchang North Road FAX: (8610) 6787 1162 Beijing Economic & Technology Development Area Beijing 100176, China
DENMARK
FRANCE
GERMANY
GREECE
ITALY
LUXEMBOURG
MEXICO
4
GE Healthcare TEL: +45 43295400 Park Alle 295 FAX: +45 4329 5399 DK-2605 Brøndby GE Medical Systems TEL: 05 49 33 71 toll free 738 rue Yves Carmen FAX: +33 1 46 10 01 20 F-92658 BOULOGNE CEDEX GE Ultraschall TEL: 0130 81 6370 toll free Deutschland GmbH & Co. KG TEL: (49) 212.28.02.207 Beethovenstrasse 239 FAX: (49) 212.28.02.431 Postfach 11 05 60 D-42655 Solingen GE Medical Systems Hellas TEL: +30 1 93 24 582 41, Nikolaou Plastira Street FAX: +30 1 93 58 414 G-171 21 NEA SMYRNI GE Medical Systems Italia TEL: 1678 744 73 toll free Via Monte Albenza 9 FAX: +39 39 73 37 86 I-20052 MONZA TLX: 3333 28 TEL: 0800 2603 toll free GE Sistemas Medicos de Mexico S.A. de C.V. Rio Lerma #302, 1° y 2° Pisos TEL: (5) 228-9600 Colonia Cuauhtemoc FAX: (5) 211-4631 06500-Mexico, D.F.
Vivid q N Reference Manual FQ092007-01
Introduction UNITED KINGDOM
GE Medical Systems TEL: 0800 89 7905 toll free Coolidge House FAX: +44 753 696067 352 Buckingham Avenue SLOUGH Berkshire SL1 4ER
OTHER COUNTRIES
NO TOLL FREE TEL: international code + 33 1 39 20 0007
Manufacturer
GE VINGMED ULTRASOUND AS Strandpromenaden 45 N-3191 Horten, Norway Tel.: (+47) 3302 1100 Fax: (+47) 3302 1350
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Vivid q N Reference Manual FQ092007-01
Chapter 1 Measurements This chapter includes the following information:
• Measurement overview ... 8 • Cardiac measurements ... 8 • AFI Measurements ... 21 • Auto-EF measurements ... 24 • Measurement formulas... 26 • Formulas–Cardiac ... 26 • Formulas–Generic... 56 • Formulas–Vascular ... 58 • Formulas–OB ... 59 • Formulas–GYN ... 63 • Measurement accuracy ... 65 • General ... 65 • Sources of error ... 65 • Optimizing Measurement Accuracy ... 67 • Measurement Uncertainties ... 67 • DICOM SR Measurements ... 70
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Measurements
Measurement overview The following table shows the cardiac measurements available on the Vivid q N ultrasound unit.
Cardiac measurements Abbreviation
Definition
Unit
%FS
LV Fractional Shortening, 2D
%
%FS
LV Fractional Shortening, M-mode
%
%IVS Thck
IVS Fractional Shortening, 2D
%
%IVS Thck
IVS Fractional Shortening, M-mode
%
%LVPW Thck
LV Posterior Wall Fractional Shortening, 2D
%
%LVPW Thck
LV Posterior Wall Fractional Shortening, M-mode
%
Ao Arch Diam
Aortic Arch Diameter
cm
Ao asc
Ascending Aortic Diameter
cm
Ao Desc Diam
Descending Aortic Diameter
cm
Ao Isthmus
Aortic Isthmus
cm
Ao Root Diam
Aortic Root Diameter
cm
Ao Root Diam
Aortic Root Diameter, M-mode
cm
AR ERO
PISA: Regurgitant Orifice Area
cm2
AR Flow
PISA: Regurgitant Flow
ml/s
AR PHT
AV Insuf. Pressure Half Time
ms
AR Rad
PISA: Radius of Aliased Point
cm
AR RV
PISA: Regurgitant Volume Flow
ml
AR Vel
PISA: Aliased Velocity
m/s
AR Vmax
Aortic Insuf. Peak Velocity
m/s
AR VTI
Aortic Insuf. Velocity Time Integral
cm
ARed max PG
Aortic Insuf. End-Diastole Pressure Gradient
mm Hg
ARed Vmax
Aortic Insuf. End-Diastolic Velocity
m/s
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Vivid q N Reference Manual FQ092007-01
Measurements Abbreviation
Definition
Unit
AV Acc Slope
Aortic Valve Flow Acceleration
m/s2
AV Acc Time
Aortic Valve Acceleration Time
ms
AV AccT/ET
AV Acceleration to Ejection Time Ratio
AV CO
Cardiac Output by Aortic Flow
l/min
AV Cusp
Aortic Valve Cusp Separation, 2D
cm
AV Cusp
Aortic Valve Cusp Separation, M-mode
cm
AV Dec Time
Aortic Valve Deceleration Time
ms
AV Diam
Aortic Diameter, 2D
cm
AV max PG
Aortic Valve Peak Pressure Gradient
mm Hg
AV mean PG
Aortic Valve Mean Pressure Gradient
mm Hg
AV SV
Stroke Volume by Aortic Flow
ml
AV Vmax
Aortic Valve Peak Velocity
m/s
AV Vmean
AV Mean Velocity
m/s
AV VTI
Aortic Valve Velocity Time Integral
cm
AVA (Vmax)
AV Area by Continuity Equation by Peak V
cm2
AVA (VTI)
AV Area by Continuity Equation VTI
cm2
AVA Planimetry
Aortic Valve Area
cm2
AVET
Aortic Valve Ejection Time
ms
AVET
Aortic Valve Ejection Time, M-mode
ms
CO (A-L A2C)
CO 2CH, Single Plane, Area-Length
l/min
CO (A-L A4C)
CO 4CH, Single Plane, Area-Length
l/min
CO (Biplane)
CO, Bi-Plane, MOD
l/min
CO (bullet)
CO, Bi-Plane, Bullet
l/min
CO (MOD A2C)
CO 2CH, Single Plane, MOD(Simpson)
l/min
CO (MOD A4C)
CO 4CH, Single Plane, 4CH, MOD(Simpson)
l/min
CO(Cube)
Cardiac Output, 2D, Cubic
l/min
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Measurements Abbreviation
Definition
Unit
CO(Cube)
Cardiac Output, M-mode, Cubic
l/min
CO(Teich)
Cardiac Output, 2D, Teicholtz
l/min
CO(Teich)
Cardiac Output, M-mode, Teicholtz
l/min
D-E Excursion
MV Anterior Leaflet Excursion
cm
D-E Excursion
Mitral Valve D-E Slope
cm
EDV (bullet)
LV Volume, Diastolic, Bi-Plane, Bullet
ml
EDV(Cube)
Left Ventricle Volume, Diastolic, 2D, Cubic
ml
EDV(Cube)
Left Ventricle Volume, Diastolic, M-mode, Cubic
ml
EDV(Teich)
Left Ventricle Volume, Diastolic, 2D, Teicholz
ml
EDV(Teich)
Left Ventricle Volume, Diastolic, M-mode, Teicholz
ml
EF (A-L A2C)
Ejection Fraction 2CH, Single Plane, Area-Length
%
EF (A-L A4C)
Ejection Fraction 4CH, Single Plane, Area-Length
%
EF (Biplane)
Ejection Fraction, Bi-Plane, MOD
%
EF (bullet)
Ejection Fraction 2CH, Bi-Plane, Bullet
%
EF (MOD A2C)
Ejection Fraction 2CH, Single Plane, MOD(Simpson)
%
EF (MOD A4C)
Ejection Fraction 4CH, Single Plane, 4CH, MOD(Simpson)
%
E-F Slope
Mitral Valve E-F Slope
m/s
EF(Cube)
Ejection Fraction, 2D, Cubic
%
EF(Cube)
Ejection Fraction, M-mode, Cubic
%
EF(Teich)
Ejection Fraction, 2D, Teicholtz
%
EF(Teich)
Ejection Fraction, M-mode, Teicholtz
%
EPSS
E-Point-to-Septum Separation, M-mode
cm
EPSS 2D
E-Point-to-Septum Separation, 2D
cm
ERO
Effective Regurgitant Orifice
cm2
ESV (bullet)
LV Volume, Systolic, Bi-Plane, Bullet
ml
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Vivid q N Reference Manual FQ092007-01
Measurements Abbreviation
Definition
Unit
ESV(Cube)
Left Ventricle Volume, Systolic, 2D, Cubic
ml
ESV(Cube)
Left Ventricle Volume, Systolic, M-mode, Cubic
ml
ESV(Teich)
Left Ventricle Volume, Systolic, 2D, Teicholz
ml
ESV(Teich)
Left Ventricle Volume, Systolic, M-mode, Teicholz
ml
HR
AV Heart Rate, Dop
BPM
HR
Heart Rate, 2D, Teicholtz
bpm
HR
Heart Rate for 2CH study
bpm
HR
Heart Rate for 4CH study
bpm
HR
Heart Rate for 2CH AL study
bpm
HR
Heart Rate for 2CH MOD study
bpm
HR
Heart Rate for 4CH AL study
bpm
HR
Heart Rate for 4CH MOD study
bpm
HR
Heart Rate for Bullet study
bpm
HR
Heart Rate for BiPlane MOD study
bpm
HR
LV Heart Rate, Dop
bpm
HR
Heart Rate, M-mode, Teicholtz
bpm
HR
Heart Rate
bpm
IVC
Inferior Vena Cava
cm
IVCT
Isovolumic Contraction Time
ms
IVRT
Isovolumic Relaxation Time
ms
IVSd
Interventricular Septum Thickness, Diastolic, 2D
cm
IVSd
IVS Thickness, Diastolic, M-mode
cm
IVSs
Interventricular Septum Thickness, Systolic, 2D
cm
IVSs
IVS Thickness, Systolic, M-mode
cm
LA Diam
Left Atrium Diameter, 2D
cm
LA Diam
Left Atrium Diameter, M-mode
cm
LA Diam
Right Atrium Diameter, 2D
cm
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