GE Healthcare
LOGIQ E10 Advanced Reference Manual Rev 4 June 2020
Advanced Reference Manual
254 Pages
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Technical Publications Direction 5750003-1EN English Rev. 4 LOGIQ E10 Advanced Reference Manual Version R1
Operating Documentation Copyright 2018 - 2020 By General Electric Co.
Regulatory Requirement LOGIQ E10 complies with regulatory requirements of the following European Directive 93/42/EEC concerning medical devices.
First CE Marked in 2020. 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
Rev. 4
2020/06/14
CE Mark update
List of Effective Pages
PAGE NUMBER
REVISION NUMBER
PAGE 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 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. 4
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LOGIQ E10 – Advanced Reference Manual Direction 5750003-1EN English Rev. 4
Regulatory Requirements
Authorized EU Representative GE Medical Systems SCS European registered place of business: 283 rue de la Minière 78530 BUC, France
Manufacturer GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC 9900 Innovation Drive Wauwatosa, WI 53226 U.S.A.
Full Listing For a full listing of regulatory requirements, see the Basic User Manual. LOGIQ E10 Direction 5750001-1xx
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LOGIQ E10 – Advanced Reference Manual Direction 5750003-1EN English Rev. 4
Table of Contents
Authorized EU Representative - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-3 Manufacturer - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-3 Full Listing - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-3
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 Doubilet - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-21 Ebbing - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-22 Eik-Nes - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-24
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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. 4
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. 4
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. 4
20707-5906
1-3
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. 4
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. 4
X
X
X
X
X
Tissue Velocity Imaging (TVI)
Micro Vascular Imaging (MVI)
P2D
M5Sc-D
Transducer Model
X
1-5
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 ToTissue 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 ToTissue 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
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LOGIQ E10 – Advanced Reference Manual Direction 5750003-1EN English Rev. 4
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. 4
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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. 4
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. 4
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. 4
Acoustic and Thermal Output Data M5Sc-D (continued) Table 1-9:
Probe Model: M5Sc-D; Mode Group: Color Mode (2D+CF, 2D+CF+PW, 2D+M+CM, TVI, TVM)
LOGIQ E10 – Advanced Reference Manual Direction 5750003-1EN English Rev. 4
1-11
Acoustic and Thermal Output Table 1-9:
1-12
Probe Model: M5Sc-D; Mode Group: Color Mode (2D+CF, 2D+CF+PW, 2D+M+CM, TVI, TVM) (Continued)
LOGIQ E10 – Advanced Reference Manual Direction 5750003-1EN English Rev. 4