Venue 50 Advanced Reference Manual Rev 4 Jan 2015

Regulatory Requirement Venue 50 complies with regulatory requirements of the following European Directive 93/42/EEC concerning medical devices.

This manual is a reference for the Venue 50. It applies to R4.x.x software version for the Venue 50 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

2013/01/11

Initial Release

Rev. 2

2013/10/09

Update acoustic output

Rev. 3

2014/01/07

Add MHLW number and update acoustic output

Rev. 4

2015/01/08

Update the notes in section “Maximum Probe Temperature”.

List of Effective Pages

SECTION NUMBER

REVISION NUMBER

SECTION NUMBER

REVISION NUMBER

Title Page

Rev. 4

Chapter 1

Rev. 4

Revision History

Rev. 4

Chapter 2

Rev. 4

Regulatory Requirements

Rev. 4

Chapter 3

Rev. 4

Table of Contents

Rev. 4

Index

Rev. 4

Please verify that you are using the latest revision of this document. Information pertaining to this document is maintained on 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.

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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 B with BF Applied Parts.

•

Docking Station/Cart is Class 1.

•

Continuous Operation.

According to CISPR 11, •

Equipment is Group 1, Class A ISM Equipment.

•

Docking Station/Cart is Group 1, Class A ISM Equipment.

According to IEC 60529, •

The footswitch rate is IP X8 (MKF 2 1S/1S-MED HID GP 26)

•

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 60601-2-37 Medical electrical equipment. 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.

Canadian Standards Association (CSA). •

CSA 22.2, 601.1 Medical Electrical Equipment, Part 1 General Requirements for Safety.

•

ANSI/AAMI ES60601-1

•

NEMA/AIUM Acoustic Output Display Standard (NEMA UD-3, 2004).

•

Medical Device Good Manufacturing Practice Manual issued by the FDA (Food and Drug Administration, Department of Health, USA).

•

General Electric Medical Systems is ISO 9001 and ISO 13485 certified.

Certifications

Original Documentation •

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The original document was written in English.

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Country Specific Approval •

JAPAN MHLW Certified Number: 221ABBZX00092000

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Table of Contents

Conformance Standards - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-3 Certifications - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-4 Original Documentation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-4 Country Specific Approval - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-5

Table of Contents Chapter 1 - Acoustic Output Bioeffects Concerns Surrounding the Use of Diagnostic Ultrasound - - - - - - - - - - - 1-2 Measurement Precision and Uncertainty - - - - - - - - - - - - - - - - - - - - - - - 1-3 TI and MI Display Accuracy - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-3 Modify Acoustic Output - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-3

FDA Acoustic Output Data Maximum output summary- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-4

Acoustic Output Table Key - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-6 Acoustic Output Tables - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-30 Acoustic Output Tables for Ophthalmology Applications - - - - - - - - - - - 1-48

Chapter 2 - Measurement Formulas Formulas-OB Amniotic Fluid Index (AFI) - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-5

Chapter 3 - OB Tables OB Tables ASUM - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-2 Hadlock - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-5 Hansmann - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-12 JSUM - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-13 Osaka - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-15 Robinson - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-18 Tokyo - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-19 Tokyo Shinozuka - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-22

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Chapter 1 Acoustic Output Provides Acoustic Output information and tables, as well as possible bioeffects and prudent use.

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Acoustic Output

Bioeffects

Concerns Surrounding the Use of Diagnostic Ultrasound During a diagnostic ultrasound examination, high frequency sound penetrates and interacts with tissue in and around the area of anatomy to be imaged. Only a small portion of this sound energy is reflected back to the probe for use in constructing the image while the remainder is dissipated within the tissue. The interaction of sound energy with tissue at sufficiently high levels can produce biological effects (aka bioeffects) of either a mechanical or thermal nature. Although the generation of bioeffect is intentional with therapeutic ultrasound, it is generally undesired in diagnostic applications and may be harmful in some conditions. NOTE:

US Only

The American Institute of Ultrasound in Medicine (AIUM) has published a document entitled "Medical Ultrasound Safety". This three part document covers Bioeffects and Biophysics, Prudent Use and Implementing ALARA. Ultrasound users should read the AIUM documents to become more familiar with Ultrasound safety. A copy of this document is included as part of the documentation package. To contact the AIUM concerning their publications: •

In the USA, by telephone at 1-800-638-5352.

•

To write them, use the following address: AIUM 14750 Sweitzer Lane Suite 100 Laurel, MD, USA

1-2

20707-5906

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Bioeffects Measurement Precision and Uncertainty Precision and measurement uncertainty of the system used to measure the acoustic output is provided in the following table. These values are determined in accordance with Section 6.4 of the Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment, rev 2 AIUM/NEMA 2004, and the Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment, rev 3 NEMA 2004. Table 1-1:

Measurement Uncertainty

Measurement Precision and Uncertainty

Center Frequency

Acoustic Power

2.03%

35.6%

Peak Rarefactional Pressure 12.78%

Acoustic Intensity

dT on phantom

dT in still air

28.87%

1°C

1.64°C

TI and MI Display Accuracy When display MI >= 0.6, TI >= 3.6, the displayed values of MI and TI is not lower than 50% or higher than 150% of the measured values. When display MI < 0.6, TI < 3.6, the absolute error of MI <= 0.3, the absolute error of TI <= 1.8.

Modify Acoustic Output The acoustic output display provides the operator with real-time indication of acoustic levels being generated by the system. To modify the Acoustic Output by press Utility -> Image -> User Define first. Then you may modify the AO per different Mode and probe. There are three levels of Power Output currently.

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Acoustic Output

FDA Acoustic Output Data

Maximum output summary The following tables list the typical maximum acoustic output levels achievable with Venue 50 for all probes and operational modes. It is intended that this is information be useful in making ALARA decisions and selecting the most appropriate probe for the application. In accordance with US FDA Guidelines, the overall maximum acoustic SPTA.3 intensity for Venue 50 is limited to 720 mW/cm2 and MI is limited to 1.9. The Summary tables show all of the probes’ operating modes. The following pages contain probe acoustic output tables for the noted probes. Table 1-2: Operating Mode

Summary table Transducer Model:

12L-SC

3S-SC

4C-SC

L8-18i-SC

E8CS-SC

10C-SC

B-Mode

X

X

X

X

X

X

Color flow

X

X

X

X

X

X

M-Mode

X

X

X

X

X

X

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FDA Acoustic Output Data Maximum Probe Temperature Table 1-3:

Maximum Probe Temperature oC) Max Temp (oC)

Probe

With TMM Phantom

In Air

Mode

4C-SC

40.1

38.5

B

3S-SC

41.8

40.5

B

12L-SC

37.0

31.5

CFM

L8-18i-SC

39.6

38.4

CFM

E8CS-SC

41.3

34.4

CFM

10C-SC

40.9

45.1

M

Notes: 1. In accordance with IEC 60601-2-37, the maximum lens temperature is limited to 43°C with thermal phantom, while 50°C in air. 2. Lens temperature measured under following conditions per IEC 60601-2-37: • The temperature is measured on the surface of the APPLIED PART of the TRANSDUCER ASSEMBLY in those areas that give the highest surface temperature. • Probe placed upright in contact with above thermal phantom. • Autofreeze capability disabled. • Lens temperature monitored for 30 min.

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Acoustic Output

Acoustic Output

Table Key

Table 1-4: FDA

IEC

Table Key

Meaning-IEC 60601-2-37 / FDA & NEMA UD2, UD3

a

α

Acoustic Attenuation Coefficient / Derating factor (usually 0.3 dB/cm-MHz)

Aaprt

Aarpt

-12db Output Beam Area / Active aperture area

CMI

Normalizing Coefficient

Deq

Deq

Equivalent Aperture Diameter / (same)

d-6

d-6

Pulse Beam Width / Beam diameter at –6 dB

deq

deq

Equivalent Beam Diameter

fc

awf

Acoustic Working Frequency / Center frequency

Ipa

Ipa

Pulse-Average Intensity

Ipa.3

Ipa,α

Attenuated Pulse-Average Intensity

PII

Ipi

Pulse-Intensity Integral

PII.3

Ipi,α

Attenuated Pulse-Intensity Integral

ITA

Ita(z)

Temporal-Average Intensity

ITA.3(Z)

Ita,α(z)

Attenuated Temporal-Average Intensity / (at depth z)

ISPTA(Z)

Izpta(z)

Spatial-Peak Temporal-Average Intensity

ISPTA.3(Z)

Izpta,α(z)

Attenuated Spatial-Peak Temporal-Average Intensity

MI

MI

Mechanical Index

Wo

P

Output Power / Time average acoustic power at the source

W.3(Z)

Pα

Attenuated Output Power / Time average acoustic power derated to depth z

Wo1

P1

Bounded Output Power / Power emitted from the central 1cm of aperture

PII

pi

Pulse Pressure Squared Integral / Pulse intensity integral

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Acoustic Output Table 1-4: FDA

IEC

Table Key (Continued)

Meaning-IEC 60601-2-37 / FDA & NEMA UD2, UD3

pr

pr

Peak-Rarefactional Acoustic Pressure / (same)

pr.3

pr α

Attenuated Peak-Rarefactional Acoustic Pressure / (same)

PRF

prr

Pulse Repetition Rate / Pulse repetition frequency

TI

TI

Thermal Index / (same)

TIB

TIB

Bone Thermal Index / (same)

TIC

TIC

Cranial-Bone Thermal Index / (same)

TIS

TIS

Soft-Tissue Thermal Index / (same)

PD

td

Pulse Duration / (same)

x-12,y-12

X, Y

-12 dB Output Beam Dimensions / (same)

Z

Z

Distance from the Source to a Specified Point / (same)

Zsp

Zb

Depth for TIB / Depth at which the relevant index is maximum

Zbp

Zbp

Break-Point Depth / (same)

Zsp

Zs

Depth for TIS / Depth at which the relevant index is maximum

-

-

This parameter is not applicable to the specified probe/mode combination.

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Acoustic Output Table 1-5:

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Table Key (in French 1)

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Acoustic Output Table 1-6:

Table Key (in French 2)

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Acoustic Output Table 1-7:

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Table Key (in German 1)

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