LOGIQ E10 Advanced Reference Manual Ver R1 Rev 3 March 2019

Regulatory Requirement LOGIQ E10 complies with regulatory requirements of the following European Directive 93/42/EEC concerning medical devices.

0459 First CE Marked in 2018. This manual is a reference for the LOGIQ E10 Version R1.

GE P.O. Box 414, Milwaukee, Wisconsin 53201 U.S.A. (Asia, Pacific, Latin America, North America) GE Healthcare GmbH 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

2018/02/05

Initial Release

Rev. 2

2018/07/10

Update

Rev. 3

2019/03/13

R1.5 update

List of Effective Pages

PAGE NUMBER

REVISION NUMBER

PAGE NUMBER

REVISION NUMBER

Title Page

Rev. 3

Chapter 1

Rev. 3

Revision History

Rev. 3

Chapter 2

Rev. 3

Regulatory Requirements

Rev. 3

Chapter 3

Rev. 3

Table of Contents

Rev. 3

Index

Rev. 3

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

LOGIQ E10 – Advanced Reference Manual Direction 5750003-1EN English Rev. 3

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LOGIQ E10 – Advanced Reference Manual Direction 5750003-1EN English Rev. 3

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, Type B with BF or CF Applied Parts.

According to CISPR 11, •

Equipment is Group 1, Class A ISM Equipment.

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 SCS 283 rue de la Minière 78530 BUC, France

LOGIQ E10 – Advanced Reference Manual Direction 5750003-1EN English Rev. 3

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Conformance Standards (continued) •

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International Electrotechnical Commission (IEC). •

IEC/EN 60601-1 Medical Electrical Eqiupment, Part 1 General Requirements for Safety.

•

IEC/EN 60601-1-2 Electromagnetic compatibility Requirements and tests.

•

IEC 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.

•

IEC 62359 Ultrasonics - Field characterization. Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields.

•

IEC 62127-1 Ultrasonics - Hydrophones, Part1: Measurement and characterization of medical ultrasonic fields up to 40 MHz using hydrophones.

•

IEC 62127-2 Ultrasonics - Hydrophones, Part 2: Calibration of hydrophones to be used in ultrasonic fields up to 40 MHz.

•

IEC 62127-3 Ultrasonics - Hydrophones, Part 3: Properties of hydrophones for ultrasonic fields up to 40 MHz.

•

IEC 61161 Ultrasonics - Power measurement Radiation force balances and performance requirements.

LOGIQ E10 – Advanced Reference Manual Direction 5750003-1EN English Rev. 3

Conformance Standards (continued) •

International Organization of Standards (ISO) •

•

Underwriters’ Laboratories, Inc. (UL), an independent testing laboratory. •

•

ISO 10993-1 Biological evaluation of medical devices.

UL 60601-1 Medical Electrical Equipment, Part 1 General Requirements for Safety.

Canadian Standards Association (CSA). •

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

•

NEMA Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment (NEMA UD-2).

•

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

•

EN/ISO 15223-1 Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied -- Part 1: General requirements

LOGIQ E10 – Advanced Reference Manual Direction 5750003-1EN English Rev. 3

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Certifications •

General Electric Medical Systems is ISO 13485 certified.

Original Documentation •

The original document was written in English.

Country Specific Approval •

KOREA KFDA License 18-4342

Importer Information •

Turkish Importer

Manufacturer GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC 9900 Innovation Drive Wauwatosa, WI 53226 U.S.A.

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LOGIQ E10 – Advanced Reference Manual Direction 5750003-1EN English Rev. 3

Table of Contents

Conformance Standards - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-3 Certifications - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-6 Original Documentation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-6 Country Specific Approval - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-6 Importer Information - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-6 Manufacturer - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-6

Table of Contents Chapter 1 - Acoustic and Thermal Output Bioeffects Bioeffects Associated with Diagnostic Ultrasound - - - - - - - - - - - - - - - - 1-2

Acoustic and Thermal Output Data Measurement Uncertainty - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-4 Maximum Output Summary - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-5 Maximum Probe Patient Contact Temperature - - - - - - - - - - - - - - - - - - 1-6 Acoustic Output - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-7

Chapter 2 - System Formulas Measurement Abbreviations Cardiac measurement abbreviation list - - - - - - - - - - - - - - - - - - - - - - - - 2-2

Measurement Formulas Formulas–Generic - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-14 Formulas–Generic (Shear wave) - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-18 Formulas–OB - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-19 Formulas–GYN - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-25 Formulas–Vascular - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-30 Formulas-Cardiac - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-32

DICOM SR Measurements Structured Reporting - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-61

Chapter 3 - OB Tables OB Tables Alexander - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-2 ASUM - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-2 Bahlmann - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-11 Baschat - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-12 Berkowitz - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-12 Bertagnoli - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-13 Brenner - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-14 Campbell - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-14 Chervenak - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-15 Chitty- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-16

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Doubilet - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-21 Ebbing - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-22 Eik-Nes - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-24 Eriksen - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-27 French College of Fetal Ultrasound (CFEF)- - - - - - - - - - - - - - - - - - - - 3-28 Goldstein - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-33 Hadlock - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-34 Hansmann - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-41 Hellman - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-51 Hill - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-51 Hohler - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-52 Jeanty - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-52 JSUM - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-72 Kramer - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-77 Kurmanavicius - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-78 Kurtz - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-79 Mari- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-79 Mayden - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-80 Mercer - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-81 Merz - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-82 Moore - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-94 Nelson - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-94 Osaka - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-95 Paris - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-99 Pexsters - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-102 Rempen- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-104 Robinson - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-110 Sonek - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-111 Tokyo - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-112 Tokyo Shinozuka - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-115 Williams - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-121 WHO (World Health Organization) - - - - - - - - - - - - - - - - - - - - - - - - - 3-122 Yarkoni - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-130

Index

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LOGIQ E10 – Advanced Reference Manual Direction 5750003-1EN English Rev. 3

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

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Acoustic and Thermal Output

Bioeffects

Bioeffects Associated with Diagnostic Ultrasound During a diagnostic ultrasound examination, high frequency sound waves penetrate and interact with tissue in and around the area of anatomy to be imaged. Typical values of Center Frequency and Transmit Repetition Rate for these sound pulses are, respectively, from 1 to 20 MHz and from 1000 to 30000 pulses per second (1 KHz to 30 KHz). Only a small portion of the sound energy of each pulse is reflected all the way back to the probe for use in constructing the image while the remainder is dissipated within the tissue. Although the generation of biological effects (aka bioeffects) is intentional with therapeutic ultrasound, it is generally undesired in diagnostic applications and may be harmful in some conditions. The interaction of sound energy with tissue at sufficiently high levels can produce bioeffects of either a mechanical or thermal nature. Mechanical bioeffects are primarily related to the pressure amplitude of individual pulses. Thermal bioeffects are primarily related to absorbed energy, and therefore contributing factors are the amplitude and length of the pulses, as well as the spatial distribution and repetition rate of the acoustic pulse stream, and the overall dwell times of the exam. NOTE:

1-2

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.

LOGIQ E10 – Advanced Reference Manual Direction 5750003-1EN English Rev. 3

Bioeffects Bioeffects Associated with Diagnostic Ultrasound (continued) Ultrasound users should read the AIUM booklet to become more familiar with Ultrasound safety. A copy of this document is included as part of the documentation package (Document 2163920-100). 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

LOGIQ E10 – Advanced Reference Manual Direction 5750003-1EN English Rev. 3

20707-5906

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Acoustic and Thermal Output

Acoustic and Thermal Output Data

Measurement Uncertainty Measurement uncertainty of the tools and process used to measure the acoustic and thermal output values is provided in the following table: In accordance with IEC 60601-2-37, the measurement uncertainty are declared as expanded uncertainty corresponding to a level of confidence of 95%. The method of combining the Type A and Type B uncertainties follow the methods specified by the Guide to the Expression of Uncertainty in Measurement, International Organization for Standardization (ISO). Table 1-1: Center Frequency Measurement Uncertainty

± 1.0%

Table 1-2:

1-4

Acoustic Power +6% / -13%

Acoustic Pressure and MI +14% / -16%

Acoustic Intensity ± 32%

Measurement Uncertainty (Part 2)

TI Non-Scan Modes Measurement Uncertainty

Measurement Uncertainty (Part 1)

+29% / -31%

TI Scan Modes +6% / -13%

Surface Temperature ± 0.8 deg. C

LOGIQ E10 – Advanced Reference Manual Direction 5750003-1EN English Rev. 3

Acoustic and Thermal Output Data Maximum Output Summary The following tables list the typical maximum acoustic and thermal output levels sachievable with the LOGIQ E10 for all probes and operational modes. It is intended that this information be useful in making ALARA decisions and selecting the most appropriate probe for the application. The Operating Modes Summary Table show all of the probes' operating modes. The following pages contain probe acoustic and thermal output tables for the noted probes. Table 1-3:

Operating Modes Summary Table

ML6-15-D

C1-6-D/C1-6VN-D

IC5-9-D

L8-18i-D

RIC5-9-D

C2-7-D/C2-7VN-D

C2-9-D/C2-9VN-D

C3-10-D

L2-9-D/L2-9VN-D

RAB6-D

6Tc-RS

B-Mode

X

X

X

X

X

X

X

X

X

X

X

X

M-Mode (includes B-Mode)

X

X

X

X

X

X

X

X

X

X

X

X

Color Flow (includes B-Mode)

X

X

X

X

X

X

X

X

X

X

X

X

Pulsed Doppler (includes B-Mode)

X

X

X

X

X

X

X

X

X

X

X

X

Color M-Mode (includes B-Mode)

X

Operating Mode

Shear wave Mode

X X

X

Continuous Wave Mode (includes B-Mode, except P2D)

X

2D Harmonic

X

X

X

B-Flow

X

X

X

Contrast

X

X

X

X X X

X

X

X X

X

3D/4D

X

X

X

X

X

X

X

X

X

X

X

X

X

Strain Elastography

X

X

X

X

X X

X

X

X

X

Tissue Velocity M-Mode (TVM)

X

X

Tissue Velocity Doppler (TVD)

X

X

LOGIQ E10 – Advanced Reference Manual Direction 5750003-1EN English Rev. 3

X

X

X

X

X

Tissue Velocity Imaging (TVI)

Micro Vascular Imaging (MVI)

P2D

M5Sc-D

Transducer Model

X

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Acoustic and Thermal Output Maximum Probe Patient Contact Temperature Transducer face temperature measurements were performed according to the methods in IEC 60601-2-37. Table 1-4:

Maximum Probe Patient Applied Part Surface Temperature (Degrees C) Max Temp

Probe Mode

Coupled To Tissue Mimic Material

In Air (23 deg. C ambient)

M5Sc-D

B + Color Flow

41.5

37.7

ML6-15-D

B + Pulsed Doppler

42.6

37.6

C1-6-D/C1-6VN-D

B + Color Flow

42.9

43.4

IC5-9-D

B + Pulsed Doppler

42.9

37.2

L8-18i-D

B + Pulsed Doppler

41.3

37.2

RIC5-9-D

B + Pulsed Doppler

42.8

35.3

C2-7-D/C2-7VN-D

B + Color Flow

42.4

41.6

C2-9-D/C2-9VN-D

B + Pulsed Doppler

42.7

39.6

C3-10-D

B + Pulsed Doppler

42.8

40.7

L2-9-D/L2-9VN-D

B + Color Flow

41.6

39.7

RAB6-D

B + Color Flow

42.0

44.6

6Tc-RS

B + Pulsed Doppler

43.0

36.5

P2D

Continuous Wave Doppler

36.2

34.2

Table 1-5:

Maximum Probe Temperature for Shear Wave Probes (Degrees C) Max Temp

Probe Mode

Coupled To Tissue Mimic Material

In Air (23 deg. C ambient)

ML6-15-D

Shear Wave

43.0

40.6

C1-6-D/C1-6VN-D

Shear Wave

41.3

38.2

L2-9-D/L2-9VN-D

Shear Wave

36.2

30.8

1-6

LOGIQ E10 – Advanced Reference Manual Direction 5750003-1EN English Rev. 3

Acoustic and Thermal Output Data Acoustic Output Table Key Table 1-6: Symbol

Table Key

Term-per IEC 60601-2-37

α

Acoustic Attenuation Coefficient

Aaprt

-12db Output Beam Area

CMI

Normalizing Coefficient

deq

Equivalent Beam Diameter

ƒawf

Acoustic Working Frequency

Ipa

Pulse-Average Intensity

Ipa,α

Attenuated Pulse-Average Intensity

pii

Pulse-Intensity Integral

piiα

Attenuated Pulse-Intensity Integral

Isppa,α

Attenuated Spatial-Peak Pulse-Average Intensity

Ispta

Spatial-Peak Temporal-Average Intensity

Ispta,α

Attenuated Spatial-Peak Temporal-Average Intensity

Ita

Temporal-Average Intensity

Ita,α

Attenuated Temporal-Average Intensity

MI

Mechanical Index

npps

Number of Pulses per Ultrasonic Scan Line

P

Output Power

Pα

Attenuated Output Power

P1x1

Bounded-Square Output Power

pr

Peak-Rarefactional Acoustic Pressure

pr,α

Attenuated Peak-Rarefactional Acoustic Pressure

prr

Pulse Repetition Rate

srr

Scan Repetition Rate

TI

Thermal Index

TIB

Bone Thermal Index

LOGIQ E10 – Advanced Reference Manual Direction 5750003-1EN English Rev. 3

1-7

Acoustic and Thermal Output Table 1-6:

Table Key (Continued)

Symbol

Term-per IEC 60601-2-37

TIC

Cranial-Bone Thermal Index

TIS

Soft-Tissue Thermal Index

td

Pulse Duration

X, Y

-12 dB Output Beam Dimensions

zb

Depth for TIB

zbp

Break-Point Depth

zpii

Depth for Peak Pulse-Intensity Integral

zMI

Depth for Mechanical Index

zpii,α

Depth for Peak Attenuated Pulse-Intensity Integral

zsii

Depth for Peak Sum of Pulse-Intensity Integrals

zsii,α

Depth for Peak Sum of Attenuated Pulse-Intensity Integrals

zs

Depth for TIS

-

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

Table 1-7: Note

Meaning of Notes in the Acoustic Output Tables Meaning

Note A

The Operating Control Condition resulting in a maximum Index value for this Mode Group has No Scanning Component.

Note B

The Operating Control Condition resulting in a maximum Index value for this Mode Group has No Non-Scanning Component.

Note C

There are No Non-Scanning Components for this Mode Group.

Note D

There are No Scanning Components for this Mode Group.

Note E

This Mode Group is not enabled for this Probe Model.

Note F

The maximum MI value results from a non-scanning component.

Note G

CW components do not have 'prr', 'npps', 'srr' or ‘td’ values.

NOTE:

1-8

The Acoustic Output tables are in English only.

LOGIQ E10 – Advanced Reference Manual Direction 5750003-1EN English Rev. 3

Acoustic and Thermal Output Data Acoustic Output Tables NOTE:

Values listed in the Acoustic Parameter and Other Information portion of the MI Column are only for the component pulses resulting in the maximum MI values. This includes the values of the time-average quantities: ‘prr’, ‘srr’, npps’, ‘Ispta’, and ‘Ispta,α‘ listed in the column.

LOGIQ E10 – Advanced Reference Manual Direction 5750003-1EN English Rev. 3

1-9

Acoustic and Thermal Output M5Sc-D Table 1-8:

1-10

Probe Model: M5Sc-D; Mode Group: B, M Mode (2D, 2D+M, 2D-Harmonic, B-Flow, Contrast)

LOGIQ E10 – Advanced Reference Manual Direction 5750003-1EN English Rev. 3