LOGIQ P9 and P7 Advanced Reference Manual ver R3 Rev 4 Jan 2019

Regulatory Requirement LOGIQ P7/P9 complies with regulatory requirements of the following European Directive 93/42/EEC concerning medical devices.

0459 First CE marked in 2014. This manual is a reference for the LOGIQ P7/P9.

GE Healthcare 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

2018/04/11

Initial Release

Rev. 2

2018/07/17

Update C1-5-RS AO tables

Rev. 3

2018/08/02

Update EU rep.

Rev. 4

2019/01/07

Update IOTA LR2

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

Chapter 4

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.

LOGIQ P7/P9 Advanced Reference Manual 5791625-100 English Rev. 4

i-1

This page intentionally left blank.

i-2

LOGIQ P7/P9 Advanced Reference Manual 5791625-100 English Rev. 4

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, •

•

According to CISPR 11, •

•

Equipment is Class I, Type BF or CF Applied Parts. Equipment is Group 1, Class B ISM Equipment.

According to IEC 60529, •

the footswitch rate IPx8 is suitable for use in surgical rooms.

•

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 Chapter 2 of this manual. European registered place of business: GE Medical Systems SCS 283 rue de la Miniere 78530 BUC, France Tel: +33 (0) 1 30 70 4040

LOGIQ P7/P9 Advanced Reference Manual 5791625-100 English Rev. 4

i-3

Conformance Standards (continued) •

•

International Electrotechnical Commission (IEC). •

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

•

IEC/EN 60601-1-1 Safety requirements for medical electrical systems.

•

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

•

IEC/EN 60601-1-4 Programmable electrical medical systems.

•

IEC/EN 60601-1-6 (Usability), EN 1041 (Information supplied with medical devices)

•

IEC/EN 60601-2-37 Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment.

•

IEC 61157 Declaration of acoustic output parameters.

International Organization of Standards (ISO) •

•

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

•

ANSI /AAMI ES60601-1:2005/(R)2012 medical electrical equipment, part1 general requirement for basic safety and essential performance

Canadian Standards Association (CSA). •

i-4

ISO 10993-1 Biological evaluation of medical devices.

Certified to CSA CAN/CSA-C22.2 NO. 60601-1 :14 General requirements for safety

•

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).

LOGIQ P7/P9 Advanced Reference Manual 5791625-100 English Rev. 4

Certifications •

General Electric Medical Systems is ISO 13485 certified.

Original Documentation •

The original document was written in English.

LOGIQ P7/P9 Advanced Reference Manual 5791625-100 English Rev. 4

i-5

i-6

LOGIQ P7/P9 Advanced Reference Manual 5791625-100 English Rev. 4

Table of Contents

Conformance Standards - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-3 Certifications - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-5 Original Documentation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 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

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

Acoustic Output Table Key - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-8 3Sc-RS Probe - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-10 4C-RS Probe - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-20 6S-RS Probe - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-30 8C-RS Probe - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-40 9L-RS Probe - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-48 12L-RS Probe - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-56 C1-5-RS Probe- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-64 E8C-RS Probe - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-74 L6-12-RS Probe - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-82 L8-18i-RS Probe- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-90 ML6-15-RS Probe- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-98 P8D Probe - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-106 RAB2-6-RS Probe - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-108 12S-RS Probe - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-116 BE9CS-RS Probe - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-126 E8CS-RS Probe - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-134 L3-9i-RS Probe- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-142 L4-12t-RS Probe- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-150 L10-22-RS Probe - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-158 RIC5-9A-RS Probe - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-166 L12n-RS Probe- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-174 P6D Probe - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-182 L3-12-RS Probe - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-184 IC9-RS Probe- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-194 6Tc-RS Probe - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-202 P2D Probe - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-212 M+ Probe - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-214 XL+ Probe - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-216

LOGIQ P7/P9 Advanced Reference Manual 5791625-100 English Rev. 4

i-7

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

Measurement Formulas Formulas–Generic - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-14 Formulas–OB - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-17 Formulas–GYN - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-23 Formulas–Vascular - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-25 Formulas-Cardiac - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-26

DICOM SR Measurements Structured Reporting - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-53

Chapter 3 - OB Tables OB Tables ASUM - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-2 Berkowitz - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-11 Bertagnoli - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-12 Brenner - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-13 Campbell - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-13 Chitty- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-14 Eriksen - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-20 Eik-Nes - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-21 French College of Fetal Ultrasound (CFEF)- - - - - - - - - - - - - - - - - - - - 3-23 Goldstein - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-28 Hadlock - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-29 Hansmann - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-36 Hellman - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-45 Hill - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-45 Hohler - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-46 Jeanty - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-46 JSUM - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-58 Kurtz - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-62 Mayden - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-63 Mercer - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-64 Merz - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-65 Moore - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-75 Nelson - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-75 Osaka - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-76 Paris - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-80 Rempen- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-83 Robinson - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-88 Tokyo - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-89 Tokyo Shinozuka - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-92 Williams - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-98 Yarkoni - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-98

Estimated Fetal Body Weight (EFBW) Hadlock - EFBW - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-99 Brenner - EFBW - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-99

i-8

LOGIQ P7/P9 Advanced Reference Manual 5791625-100 English Rev. 4

Williams - EFBW- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-100 Estimated Fetal Body Weight Tables - - - - - - - - - - - - - - - - - - - - - - - 3-101

What is the difference between "AUA" and "CUA"? AUA - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-104 CUA - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-105 Variability between CUA and AUA - - - - - - - - - - - - - - - - - - - - - - - - - 3-106

Chapter 4 - Gynecolocy References IOTA LR2 IOTA LR2- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-2

LOGIQ P7/P9 Advanced Reference Manual 5791625-100 English Rev. 4

i-9

i-10

LOGIQ P7/P9 Advanced Reference Manual 5791625-100 English Rev. 4

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

LOGIQ P7/P9 Advanced Reference Manual 5791625-100 English Rev. 4

1-1

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:

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 (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 20707-5906

1-2

LOGIQ P7/P9 Advanced Reference Manual 5791625-100 English Rev. 4

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

± 1%

± 22%

Peak Rarefactional Pressure ± 11%

LOGIQ P7/P9 Advanced Reference Manual 5791625-100 English Rev. 4

Acoustic Intensity

Thermal (external use)

Thermal (internal use)

± 22%

± 1.12°C

± 0.98°C

1-3

Acoustic Output

FDA Acoustic Output Data

Maximum output summary The following tables list the typical maximum acoustic output levels achievalbe with LOGIQ P7/P9 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. 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:

Summary Table (Part 1)

C1-5-RS

8C-RS

E8C-RS

L6-12-RS

12L-RS

9L-RS

ML6-15-RS

L8-18i-RS

3SC-RS

6S-RS

RAB2-6-RS

B-Mode

X

X

X

X

X

X

X

X

X

X

X

X

M-Mode (includes B-Mode, CM-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

X

X

Operating Mode

Continuous Wave Mode

1-4

P8D

4C-RS

Transducer Model

X

LOGIQ P7/P9 Advanced Reference Manual 5791625-100 English Rev. 4

FDA Acoustic Output Data Table 1-3:

Summary Table (Part 1)

L4-12t-RS

L10-22-RS

RIC5-9A-RS

L12n-RS

L3-12-RS

IC9-RS

6Tc-RS

X

X

X

X

X

X

X

X

X

M-Mode (includes B-Mode, CM-Mode)

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

Pulsed Doppler (includes B-Mode)

X

X

X

X

X

X

X

X

X

X

X

Continuous Wave Mode

X

LOGIQ P7/P9 Advanced Reference Manual 5791625-100 English Rev. 4

X

X

XL+

L3-9i-RS

X

M+

E8CS-RS

X

P2D

BE9CS-RS

B-Mode

Operating Mode

P6D

12S-RS

Transducer Model

X

X

X

1-5

Acoustic Output Maximum Probe Temperature Table 1-4:

Maximum Probe Temperature (Degrees C)

Max Temp

Probe

Max Temp

Probe

With Phantom

In Air

With Phantom

In Air

12L-RS

40.43

31.53

B

9L-RS

37.4

27.8

PW

3Sc-RS

40.93

32.72

B

C1-5-RS

40.20

32.80

PW

4C-RS

45.70

37.50

CF

E8C-RS

40.73

28.93

CF

6S-RS

42.2

35.58

PW

L6-12-RS

41.53

34.03

CF

8C-RS

39.3

31.73

B

ML6-15-RS

42.2

35.81

M

RAB2-6-RS

42.2

35.19

B

P8D

35.5

26.3

CW

L8-18i-RS

38.63

29.73

B

12S-RS

39.94

31.73

PW

BE9CS-RS

42.60

33.60

PW

E8CS-RS

41.63

31.33

M

L3-9i-RS

36.43

29.13

CF

L4-12T-RS

39.80

33.50

B

L10-22-RS

41.88

35.03

CF

RIC5-9A-RS

42.30

34.80

PW

L12n-RS

39.7

32.8

PW

P6D

35

27

CW

L3-12-RS

41.90

37.50

PW

6Tc-RS

42.10

32.00

CF

IC9-RS

42.20

31.90

REF

P2D

34.60

24.60

CW

M+

33.20

23.80

M

XL+

33.40

24.50

M

1-6

Mode

Mode

LOGIQ P7/P9 Advanced Reference Manual 5791625-100 English Rev. 4

FDA Acoustic Output Data Maximum Probe Temperature (continued) NOTE:

Lens temperature was measured under conditions per IEC 60601-2-37 and Amendment 1. 1. Thermocouple was placed at the geometric center of the lens. 2. a: Thermal phantom at 37 °C for non-external probes. b: Thermal phantom at 33 °C (or 23 °C) for external probes. (Temperature rise is measured and added to 33 °C if the phantom is at 23 °C). NOTE: Thermal phantom made with tissue-mimicking material as referenced in IEC 60601-2-37 Amd 1: Annex II.2 3. Probe placed upright in contact with above thermal phantom. 4. Auto-freeze capability is disabled. 5. Lens temperature is monitored for 30 minutes. 6. a: Measurement uncertainty for probes with temperature sensor: 0.3°C. b: Measurement uncertainty and probe variation for other probes: 2°C.

LOGIQ P7/P9 Advanced Reference Manual 5791625-100 English Rev. 4

1-7

Acoustic Output

Acoustic Output

Table Key Table 1-5: 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

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

ƒawf

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

pr

pr

Peak-Rarefactional Acoustic Pressure / (same)

1-8

LOGIQ P7/P9 Advanced Reference Manual 5791625-100 English Rev. 4