Vivid q N Reference Manual Rev 01

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.

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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 •

iv

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

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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.

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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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