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Transcript:

GE Healthcare Technical Publications 2-1 English Rev.1 LOGIQ S Expert Advanced Reference Manual Operating Documentation Copyright 2 By General Electric Co.

Regulatory Requirement LOGIQ S Expert complies with regulatory requirements of the following European Directive 93/2/EEC concerning medical devices. This manual is a reference for the LOGIQ S Expert. GE Healthcare P.O. Box 1, Milwaukee, Wisconsin 3 U.S.A. (Asia, Pacific, Latin America, North America) GE Ultraschall Deutschland GmbH & Co. KG Beethovenstrasse 2 Postfach D-2 Solingen Germany TEL: 9 2.2.2.2; FAX: 9 2.2.2.

Revision History Reason for Change REV DATE REASON FOR CHANGE Rev. 1 2//1 (YYYY/MM/DD) Initial release List of Effective Pages PAGE NUMBER REVISION NUMBER PAGE NUMBER REVISION NUMBER Title Page Rev.1 Chapter 1 Rev.1 Revision History Rev.1 Chapter 2 Rev.1 Regulatory Requirements Rev.1 Chapter 3 Rev.1 Please verify that you are using the latest revision of this document. Information pertaining to this document is maintained on epdm (GE Healthcare 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 2 or 1 2 9. LOGIQ S Expert Advanced Reference Manual i-1 2-1 English Rev.1

This page intentionally left blank. i-2 LOGIQ S Expert Advanced Reference Manual 2-1 English Rev.1

Regulatory Requirements Conformance Standards The following classifications are in accordance with the IEC/ EN 1-1:..1: According to 93/2/EEC Medical Device Directive, this is Class IIa Medical Device. According to IEC/EN 1-1, Equipment is Class I, Type BF or CF Applied Parts. According to CISPR, Equipment is Group 1, Class B ISM Equipment. According to IEC, the footswitch rate IPx is suitable for use in surgical rooms. Probe head (immersible portion) and cable are IPX Probe connector is not waterproof. This product complies with the regulatory requirement of the following: Council Directive 93/2/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 Information Technologies GmbH Munzinger Strasse D-91 Freiburg, Germany Tel: +9 () 1 3 -; Fax: +9 () 1 3-233 LOGIQ S Expert Advanced Reference Manual i-3 2-1 English Rev.1

Conformance Standards (continued) International Electrotechnical Commission (IEC). IEC/EN 1-1 Medical Electrical Equipment, Part 1 General Requirements for Safety. IEC/EN 1-1-1 Safety requirements for medical electrical systems. IEC/EN 1-1-2 Electromagnetic compatibility - Requirements and tests. IEC/EN 1-1- Programmable electrical medical systems. IEC/EN 1-1- (Usability), EN (Information supplied with medical devices) IEC/EN 1-2-3 Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment. IEC Declaration of acoustic output parameters. International Organization of Standards (ISO) ISO 93-1 Biological evaluation of medical devices. Underwriters Laboratories, Inc. (UL), an independent testing laboratory. UL 1-1 Medical Electrical Equipment, Part 1 General Requirements for Safety. Canadian Standards Association (CSA). CSA.2, 1.1 Medical Electrical Equipment, Part 1 General Requirements for Safety. NEMA/AIUM Acoustic Output Display Standard (NEMA UD-3, 2). Medical Device Good Manufacturing Practice Manual issued by the FDA (Food and Drug Administration, Department of Health, USA). i- LOGIQ S Expert Advanced Reference Manual 2-1 English Rev.1

Certifications General Electric Medical Systems is ISO 91 and ISO certified. Original Documentation The original document was written in English. LOGIQ S Expert Advanced Reference Manual i- 2-1 English Rev.1

i- LOGIQ S Expert Advanced Reference Manual 2-1 English Rev.1

Conformance Standards - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-3 Certifications - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i- Original Documentation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i- Chapter 1 Acoustic Output Bioeffects Concerns Surrounding the Use of Diagnostic Ultrasound - - - - - - - - - - - 1-2 Measurement Precision and Uncertainty - - - - - - - - - - - - - - - - - - - - - - - 1-3 Acoustic Output Data Maximum output summary- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1- Acoustic Output Probe Application - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1- Table Key - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1- C1--D Probe - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-9 9L-D Probe - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1- L-D Probe- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-1 ML-1 Probe - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1- IC-9-D Probe - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-2 3CRF-D Probe - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1- L-1i-D Probe - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-33 S-1-D Probe - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-3 P2D Probe - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-2 PD Probe - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-3 RAB--D Probe- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-3Sp-D Probe - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1- C Probe - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-3 Chapter 2 System Formulas Measurement Abbreviations Cardiac measurement abbreviation list - - - - - - - - - - - - - - - - - - - - - - - - 2-2 Measurement Formulas Formulas Generic - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-1 Formulas OB - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-1 Formulas GYN - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-23 Formulas Vascular - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-2 Formulas-Cardiac - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-2 DICOM SR Measurements Structured Reporting - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-3 Chapter 3 OB Tables OB Tables ASUM - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-2 Berkowitz - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3- Bertagnoli - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-12 Brenner - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3- Campbell - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3- Chitty- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-1 Eriksen - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-2 Eik-Nes - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3- French College of Fetal Ultrasound (CFEF)- - - - - - - - - - - - - - - - - - - - 3-23 LOGIQ S Expert Advanced Reference Manual i- 2-1 English Rev.1

Goldstein - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-2 Hadlock - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3- Hansmann - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-3 Hellman - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3- Hill - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3- Hohler - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3- Jeanty - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3- JSUM - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3- Kurtz - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-2 Mayden - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-3 Mercer - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3- Merz - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3- Moore - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3- Nelson - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3- Osaka - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3- Paris - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3- Rempen- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-3 Robinson - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3- Tokyo - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-9 Tokyo Shinozuka - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-92 Williams - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-9 Yarkoni - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-9 Estimated Fetal Body Weight (EFBW) Hadlock - EFBW - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-99 Brenner - EFBW - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-99 Williams - EFBW- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-1 Estimated Fetal Body Weight Tables - - - - - - - - - - - - - - - - - - - - - - - 3- What is the difference between "AUA" and "CUA"? AUA - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-1 CUA - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-1 Variability between CUA and AUA - - - - - - - - - - - - - - - - - - - - - - - - - 3-1 Index i- LOGIQ S Expert Advanced Reference Manual 2-1 English Rev.1

Chapter 1 Acoustic Output Provides Acoustic Output information and tables, as well as possible bioeffects and prudent use. LOGIQ S Expert Advanced Reference Manual 1-1 2-1 English Rev.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 2-1). To contact the AIUM concerning their publications: In the USA, by telephone at 1--3-. To write them, use the following address: AIUM 1 Sweitzer Lane Suite 1 Laurel, MD, USA 2-9 1-2 LOGIQ S Expert Advanced Reference Manual 2-1 English Rev.1

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. of the Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment, rev 2 AIUM/NEMA 2, and the Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment, rev 3 NEMA 2. Table 1-1: Measurement Precision and Uncertainty Center Frequency Acoustic Power Peak Rarefactional Pressure Acoustic Intensity Thermal (external use) Thermal (internal use) Measurement Uncertainty ± 1% ± % ± % ± % ± 1.12 C ±.9 C LOGIQ S Expert Advanced Reference Manual 1-3 2-1 English Rev.1

Acoustic Output Acoustic Output Data Maximum output summary The following tables list the typical maximum acoustic output levels achievable with LOGIQ S Expert 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 intensity for LOGIQ S Expert is limited to 2 mw/cm 2 and MI is limited to 1.9. Modes for which TI does not exceed.1 are indicated by <.1. 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 Transducer Model Operating Mode 9L-D ML-1 RAB--D S-1-D C1--D L-D 3CRF-D IC-9-D L-1i-D P2D PD 3Sp-D C B-Mode 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 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 Color M-Mode (includes B-Mode) Continuous Wave Mode X X X X 1- LOGIQ S Expert Advanced Reference Manual 2-1 English Rev.1

Acoustic Output Data Maximum Probe Temperature Table 1-3: Maximum Probe Temperature (Degrees C) Probe Max Temp With Phantom In Air Mode Probe Max Temp With Phantom In Air Mode 9L-D 2.. CF 3CRF-D 3.2 3. M ML-1. 33. B IC-9-D 2.2. B RAB--D.9 3 M L-1i-D 33.3 3. PW S-1-D. 3. B P2D. 23. CW C1--D 33. 3. B PD.2. CW L-D 2. 2 B 3Sp-D 3.2. CF C 2..1 PW NOTE: Lens temperature was measured under conditions per IEC 1-2-3 and Amendment 1. 1. Thermocouple was placed at the geometric center of the lens. 2. a: Thermal phantom at 3 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 1-2-3 Amd 1: Annex II.2 3. Probe placed upright in contact with above thermal phantom.. Auto-freeze capability is disabled.. Lens temperature is monitored for 3 minutes.. a: Measurement uncertainty for probes with temperature sensor:.3 C. b: Measurement uncertainty and probe variation for other probes: 2 CC. LOGIQ S Expert Advanced Reference Manual 1-2-1 English Rev.1

Acoustic Output Acoustic Output Probe Application Table 1-: Probe Application Probe C1--D 9L-D L-D ML-1 IC-9-D 3CRF-D L-1i-D S-1-D P2D PD RAB--D 3Sp-D C Application Abdomen, Vascular, OB/GYN, Urology Abdomen, Small Parts, Vascular, Pediatric Small Parts, Vascular, Pediatric, Neonatal Small Parts, Vascular, Pediatric, Neonatal OB/GYN, Urology, Transvaginal, Transrectal Abdomen, OB/GYN, Urology Small Pars, Vascular, Neonatal, Pediatrics Pediatrics, Neonatal, Abdomen Cardiac, Vascular Cardiac, Vascular Abdomen, OB/GYN, Urology Cardiac, Abdomen, Transcranial Pediatrics, Neonatal 1- LOGIQ S Expert Advanced Reference Manual 2-1 English Rev.1

Acoustic Output Table Key Table 1-: Table Key FDA IEC Meaning IEC 1-2-3 / FDA & NEMA UD2, UD3 a α Acoustic Attenuation Coefficient / Derating factor (usually.3 db/cm-mhz) A aprt A arpt -12db Output Beam Area / Active aperture area C MI Normalizing Coefficient D eq D eq Equivalent Aperture Diameter / (same) d - d - Pulse Beam Width / Beam diameter at db d eq d eq Equivalent Beam Diameter f c ƒ awf Acoustic Working Frequency / Center frequency I pa I pa Pulse-Average Intensity I pa.3 I pa,α Attenuated Pulse-Average Intensity PII I pi Pulse-Intensity Integral PII.3 I pi,α Attenuated Pulse-Intensity Integral I TA I ta (z) Temporal-Average Intensity I TA.3 (Z) I ta,α (z) Attenuated Temporal-Average Intensity / (at depth z) I SPTA (Z) I zpta (z) Spatial-Peak Temporal-Average Intensity I SPTA.3 (Z) I zpta,α (z) Attenuated Spatial-Peak Temporal-Average Intensity MI MI Mechanical Index W o P Output Power / Time average acoustic power at the source W.3 (Z) P α Attenuated Output Power / Time average acoustic power derated to depth z W o1 P 1 Bounded Output Power / Power emitted from the central 1cm of aperture PII p i Pulse Pressure Squared Integral / Pulse intensity integral pr p r Peak-Rarefactional Acoustic Pressure / (same) p r.3 p rα 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) LOGIQ S Expert Advanced Reference Manual 1-2-1 English Rev.1

Acoustic Output Table 1-: Table Key FDA IEC Meaning IEC 1-2-3 / FDA & NEMA UD2, UD3 TIS TIS Soft-Tissue Thermal Index / (same) PD t d 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) Z sp Z b Depth for TIB / Depth at which the relevant index is maximum Z bp Z bp Break-Point Depth / (same) Z sp Z s Depth for TIS / Depth at which the relevant index is maximum - - This parameter is not applicable to the specified probe/mode combination. 1- LOGIQ S Expert Advanced Reference Manual 2-1 English Rev.1

Acoustic Output C1--D Probe Transducer Mode: C1--D Operating Mode: B-Mode Acoustic Output Reporting Table for IEC1-2-3 (acc. to Table ) Transducer Model: 'C1--D' SW-Release: Operating Mode: B-Mode MI TIS TIB TIC Index Label scan non-scan non- A aprt 1 cm² A aprt >1 cm² scan Global Maximum Index Value 1.3.3 - - - 1. IEC FDA Units p r p r.3 (MPa) 1.1 P W o (mw) 2. - - 3. min of [P (z s), I ta, (z s)] [W.3(z 1), I TA.3(z 1)] (mw) - Assoc. z s z 1 (cm) - Acoustic z bp z bp (cm) - Parameter z b z sp (cm) - z at max. I pi, z sp (cm). d eq (z b ) d eq (z sp ) (cm) - f awf f c (MHz) 2. 2. - - - 2. Dim of A aprt X (cm). - - -. Y (cm) 1.1 - - - 1.1 t d PD (µsec). prr PRF (Hz). p r at max. I pi p r @PII max (MPa) 1. Other d eq at max. I pi d eq @PII max (cm) - Information Focal Length FL x (cm).1 - -.1 FL y (cm). - -. I pa, at max. MI I PA.3 @MI max (W/cm²) 9. Operating Displayed Frequency (MHz) 3. 3. - - - 3. Control Image Depth (cm) 33. 33. - - - 33. Conditions Focal Zone (cm).1.1 - - -.1 Frame Rate (Hz).1.1 - - -.1 Type B B - - - B LOGIQ S Expert Advanced Reference Manual 1-9 2-1 English Rev.1

Acoustic Output C1--D Probe (continued) Transducer Mode: C1--D Operating Mode: Color Flow mode Acoustic Output Reporting Table for IEC1-2-3 (acc. to Table ) Transducer Model: 'C1--D' SW-Release: Operating Mode: Color Flow MI TIS TIB TIC Index Label scan non-scan non- A aprt 1 cm² A aprt >1 cm² scan Global Maximum Index Value..3 - - - 1. IEC FDA Units p r p r.3 (MPa). P W o (mw). - -. min of [P (z s), I ta, (z s)] [W.3(z 1), I TA.3(z 1)] (mw) - Assoc. z s z 1 (cm) - Acoustic z bp z bp (cm) - Parameter z b z sp (cm) - z at max. I pi, z sp (cm).1 d eq (z b ) d eq (z sp ) (cm) - f awf f c (MHz) 2. 2. - - - 2. Dim of A aprt X (cm).3 - - -.3 Y (cm) 1.1 - - - 1.1 t d PD (µsec) 2.3 prr PRF (Hz) 2.2 p r at max. I pi p r @PII max (MPa).9 Other d eq at max. I pi d eq @PII max (cm) - Information Focal Length FL x (cm) 1. - - 1. FL y (cm). - -. I pa, at max. MI I PA.3 @MI max (W/cm²) 12. Operating Displayed Frequency (MHz) 2. 2. - - - 2. Control PRF (khz) 2.2 2.2 - - - 2.2 Conditions ROI span (cm) 1. 1. - - - 1. ROI center (cm) 9. 9. - - - 9. Focal Zone (cm) 1. 1. - - - 1. Type CF CF - - - CF 1-1 LOGIQ S Expert Advanced Reference Manual 2-1 English Rev.1

Acoustic Output C1--D Probe (continued) Transducer Mode: C1--D Operating Mode: M mode Acoustic Output Reporting Table for IEC1-2-3 (acc. to Table ) Transducer Model: 'C1--D' SW-Release: Operating Mode: M Mode MI TIS TIB TIC Index Label scan non-scan non- A aprt 1 cm² A aprt >1 cm² scan Global Maximum Index Value 1.3. -.1.3. IEC FDA Units p r p r.3 (MPa) 1. P W o (mw) 1.1 - - 3. min of [P (z s), I ta, (z s)] [W.3(z 1), I TA.3(z 1)] (mw).3 Assoc. z s z 1 (cm) 2.1 Acoustic z bp z bp (cm) 2.1 Parameter z b z sp (cm). z at max. I pi, z sp (cm) 1. d eq (z b ) d eq (z sp ) (cm). f awf f c (MHz) 2. 2. - - 2.1 2.1 Dim of A aprt X (cm) 1.9-1.9 1.9 1.9 Y (cm) 1.1-1.1 1.1 1.1 t d PD (µsec). prr PRF (Hz) 1. p r at max. I pi p r @PII max (MPa) 1.91 Other d eq at max. I pi d eq @PII max (cm) 1.91 Information Focal Length FL x (cm).1 -.1.1 FL y (cm). -.. I pa, at max. MI I PA.3 @MI max (W/cm²) 3. Operating Displayed Frequency (MHz).. -... Control Image Depth (cm).. -... Conditions Focal Zone (cm).. -... Frame Rate (Hz) 33.3 33.3 -... Type CHI CHI - M M M LOGIQ S Expert Advanced Reference Manual 1-2-1 English Rev.1

Acoustic Output C1--D Probe (continued) Transducer Mode: C1--D mode Operating Mode: Pulsed Doppler Acoustic Output Reporting Table for IEC1-2-3 (acc. to Table ) Transducer Model: 'C1--D' SW-Release: Operating Mode: Pulsed Doppler MI TIS TIB TIC Index Label scan non-scan non- A aprt 1 cm² A aprt >1 cm² scan Global Maximum Index Value 1.1.9 -..9 1.2 IEC FDA Units p r p r.3 (MPa) 1. P W o (mw). - 2. 2. min of [P (z s), I ta, (z s)] [W.3(z 1), I TA.3(z 1)] (mw) 2. Assoc. z s z 1 (cm). Acoustic z bp z bp (cm). Parameter z b z sp (cm). z at max. I pi, z sp (cm). d eq (z b ) d eq (z sp ) (cm).1 f awf f c (MHz) 2.2 2.2-2.9 2.9 2.9 Dim of A aprt X (cm) 2.3 -... Y (cm) 1.1-1.1 1.1 1.1 t d PD (µsec). prr PRF (Hz) 3. p r at max. I pi p r @PII max (MPa) 2. Other d eq at max. I pi d eq @PII max (cm).1 Information Focal Length FL x (cm) 12. - 1. 1. FL y (cm). -.. I pa, at max. MI I PA.3 @MI max (W/cm²).2 Operating Displayed Frequency (MHz).. - 2.1 2.1 2.1 Control PRF (khz).. - 1. 1. 1. Conditions Sample Volume (mm) - - - 1. 1. 1. Sample Volume Depth (cm) - - - 1. 1. 1. Type CHI CHI - PW PW PW 1-12 LOGIQ S Expert Advanced Reference Manual 2-1 English Rev.1

Acoustic Output 9L-D Probe Transducer Mode: 9L-D Operating Mode: B-Mode Acoustic Output Reporting Table for IEC1-2-3 (acc. to Table ) Transducer Model: '9L-D' SW-Release: R1..1 Operating Mode: B-Mode MI TIS TIB TIC Index Label scan non-scan non- A aprt 1 cm² A aprt >1 cm² scan Global Maximum Index Value 1.2. - - - 1. IEC FDA Units p r p r.3 (MPa) 2. P W o (mw) 3. - - 3. min of [P (z s), I ta, (z s)] [W.3(z 1), I TA.3(z 1)] (mw) - Assoc. z s z 1 (cm) - Acoustic z bp z bp (cm) - Parameter z b z sp (cm) - z at max. I pi, z sp (cm) 2. d eq (z b ) d eq (z sp ) (cm) - f awf f c (MHz) 3.3 3.3 - - - 3.3 Dim of A aprt X (cm) 2.9 - - - 2.9 Y (cm). - - -. t d PD (µsec).9 prr PRF (Hz).2 p r at max. I pi p r @PII max (MPa) 3.2 Other d eq at max. I pi d eq @PII max (cm) - Information Focal Length FL x (cm). - -. FL y (cm) 3. - - 3. I pa, at max. MI I PA.3 @MI max (W/cm²) 1. Operating Frequency (MHz) 1.. - - -. Control Image Depth (cm) 1. 1. - - - 1. Conditions Focal Zone (cm).. - - -. Frame Rate (Hz).3.3 - - - 2.9 Type CHI CHI - - - CHI LOGIQ S Expert Advanced Reference Manual 1-2-1 English Rev.1

Acoustic Output 9L-D Probe (continued) Transducer Mode: 9L-D Operating Mode: Color Flow mode Acoustic Output Reporting Table for IEC1-2-3 (acc. to Table ) Transducer Model: '9L-D' SW-Release: R1..1 Operating Mode: Color Flow MI TIS TIB TIC Index Label scan non-scan non- A aprt 1 cm² A aprt >1 cm² scan Global Maximum Index Value 1. 2. - - - 3. IEC FDA Units p r p r.3 (MPa) 2.23 P W o (mw) 3.2 - - 3.2 min of [P (z s), I ta, (z s)] [W.3(z 1), I TA.3(z 1)] (mw) - Assoc. z s z 1 (cm) - Acoustic z bp z bp (cm) - Parameter z b z sp (cm) - z at max. I pi, z sp (cm) 2.1 d eq (z b ) d eq (z sp ) (cm) - f awf f c (MHz) 3.3 3. - - - 3. Dim of A aprt X (cm).1 - - -.1 Y (cm). - - -. t d PD (µsec).9 prr PRF (Hz) 99.2 p r at max. I pi p r @PII max (MPa) 2. Other d eq at max. I pi d eq @PII max (cm) - Information Focal Length FL x (cm). - -. FL y (cm) 3. - - 3. I pa, at max. MI I PA.3 @MI max (W/cm²). Operating Frequency (MHz). 3. - - - 3. Control PRF (khz).9. - - -. Conditions ROI span (cm) -. - - -. ROI center (cm) - 2. - - - 2. Focal Zone (cm) 1. 2. - - - 2. Type HB CF - - - CF 1-1 LOGIQ S Expert Advanced Reference Manual 2-1 English Rev.1

Acoustic Output 9L-D Probe (continued) Transducer Mode: 9L-D Operating Mode: M mode Acoustic Output Reporting Table for IEC1-2-3 (acc. to Table ) Transducer Model: '9L-D' SW-Release: R1..1 Operating Mode: B+M Mode MI TIS TIB TIC Index Label scan non-scan non- A aprt 1 cm² A aprt >1 cm² scan Global Maximum Index Value 1..3 -.. 1. IEC FDA Units p r p r.3 (MPa) 2.1 P W o (mw).3-2.3.3 min of [P (z s), I ta, (z s)] [W.3(z 1), I TA.3(z 1)] (mw) 1. Assoc. z s z 1 (cm) 2.9 Acoustic z bp z bp (cm) 2.9 Parameter z b z sp (cm) 2.9 z at max. I pi, z sp (cm) 2.9 d eq (z b ) d eq (z sp ) (cm). f awf f c (MHz) 3. 3.3-3.3 3.3 3.3 Dim of A aprt X (cm) 2.1-2.1 2.1 2.1 Y (cm). -... t d PD (µsec). prr PRF (Hz) 1. p r at max. I pi p r @PII max (MPa) 2.9 Other d eq at max. I pi d eq @PII max (cm).3 Information Focal Length FL x (cm).1 -.1.1 FL y (cm) 3. - 3. 3. I pa, at max. MI I PA.3 @MI max (W/cm²) 123.92 Operating Frequency (MHz) 1. 1. -.. 1. Control Image Depth (cm) 9. 9. - 1. 1. 9. Conditions Focal Zone (cm). 1. - 1. 1. 1. Frame Rate (Hz). 1.9 -.. 1.9 Type M CHI - M M CHI LOGIQ S Expert Advanced Reference Manual 1-1 2-1 English Rev.1

Acoustic Output 9L-D Probe (continued) Transducer Mode: 9L-D Operating Mode: Pulsed Doppler mode Acoustic Output Reporting Table for IEC1-2-3 (acc. to Table ) Transducer Model: '9L-D' SW-Release: R1..1 Operating Mode: Pulsed Doppler MI TIS TIB TIC Index Label scan non-scan non- A aprt 1 cm² A aprt >1 cm² scan Global Maximum Index Value 1.23. - 1.9 2.3 2.3 IEC FDA Units p r p r.3 (MPa) 2.2 P W o (mw). - 3.33.3 min of [P (z s), I ta, (z s)] [W.3(z 1), I TA.3(z 1)] (mw).3 Assoc. z s z 1 (cm) 2.1 Acoustic z bp z bp (cm) 2.1 Parameter z b z sp (cm) 2.1 z at max. I pi, z sp (cm) 2.1 d eq (z b ) d eq (z sp ) (cm).9 f awf f c (MHz) 3.3 3.3-3.3 3.3 3.3 Dim of A aprt X (cm) 2.9-2.9 2.9 2.9 Y (cm). -... t d PD (µsec).9 prr PRF (Hz) 3. p r at max. I pi p r @PII max (MPa) 2.91 Other d eq at max. I pi d eq @PII max (cm). Information Focal Length FL x (cm) 1. - 1. 1. FL y (cm) 3. -.. I pa, at max. MI I PA.3 @MI max (W/cm²) 9. Operating Frequency (MHz). 1. - 3. 3. 3. Control PRF (khz) 3. 3.2-3.23 3.23 3.23 Conditions Sample Volume (mm) - - - 1. 1. 1. Sample Volume Depth (cm) - - - 1. 1. 1. Type CHI CHI - PW PW PW 1-1 LOGIQ S Expert Advanced Reference Manual 2-1 English Rev.1

Acoustic Output L-D Probe Transducer Mode: L-D Operating Mode: B-Mode Acoustic Output Reporting Table for IEC1-2-3 (acc. to Table ) Transducer Model: 'L-D' SW-Release: R1..C Operating Mode: B-Mode MI TIS TIB TIC Index Label scan non-scan non- A aprt 1 cm² A aprt >1 cm² scan Global Maximum Index Value 1.1. - - - 1.9 IEC FDA Units p r p r.3 (MPa) 2.3 P W o (mw). - -. min of [P (z s), I ta, (z s)] [W.3(z 1), I TA.3(z 1)] (mw) - Assoc. z s z 1 (cm) - Acoustic z bp z bp (cm) - Parameter z b z sp (cm) - z at max. I pi, z sp (cm) 1.3 d eq (z b ) d eq (z sp ) (cm) - f awf f c (MHz).3.2 - - -.2 Dim of A aprt X (cm) 2.1 - - - 2.1 Y (cm). - - -. t d PD (µsec).2 prr PRF (Hz) 2.9 p r at max. I pi p r @PII max (MPa) 3. Other d eq at max. I pi d eq @PII max (cm) - Information Focal Length FL x (cm) 9. - - 9. FL y (cm) 1.3 - - 1.3 I pa, at max. MI I PA.3 @MI max (W/cm²).2 Operating Displayed Frequency (MHz) 9.. - - -. Control Image Depth (cm). 1. - - - 1. Conditions Focal Zone (cm). 9. - - - 9. Frame Rate (Hz). 3. - - - 3. Type B B - - - B LOGIQ S Expert Advanced Reference Manual 1-1 2-1 English Rev.1

Acoustic Output L-D Probe (continued) Transducer Mode: L-D Operating Mode: Color Flow mode Acoustic Output Reporting Table for IEC1-2-3 (acc. to Table ) Transducer Model: 'L-D' SW-Release: R1..C Operating Mode: Color Flow MI TIS TIB TIC Index Label scan non-scan non- A aprt 1 cm² A aprt >1 cm² scan Global Maximum Index Value 1.9 1.3 - - - 1. IEC FDA Units p r p r.3 (MPa) 2. P W o (mw). - -. min of [P (z s), I ta, (z s)] [W.3(z 1), I TA.3(z 1)] (mw) - Assoc. z s z 1 (cm) - Acoustic z bp z bp (cm) - Parameter z b z sp (cm) - z at max. I pi, z sp (cm) 2. d eq (z b ) d eq (z sp ) (cm) - f awf f c (MHz).2.2 - - -.2 Dim of A aprt X (cm) 1.2 - - - 1.2 Y (cm). - - -. t d PD (µsec).2 prr PRF (Hz) 2. p r at max. I pi p r @PII max (MPa) 3.3 Other d eq at max. I pi d eq @PII max (cm) - Information Focal Length FL x (cm). - -. FL y (cm) 1.3 - - 1.3 I pa, at max. MI I PA.3 @MI max (W/cm²). Operating Displayed Frequency (MHz)..2 - - -.2 Control PRF (khz).2. - - -. Conditions ROI span (cm) -. - - -. ROI center (cm) -. - - -. Focal Zone (cm).. - - -. Type B CF - - - CF 1-1 LOGIQ S Expert Advanced Reference Manual 2-1 English Rev.1

Acoustic Output L-D Probe (continued) Transducer Mode: L-D Operating Mode: M mode Acoustic Output Reporting Table for IEC1-2-3 (acc. to Table ) Transducer Model: 'L-D' SW-Release: R1..C Operating Mode: M Mode MI TIS TIB TIC Index Label scan non-scan non- A aprt 1 cm² A aprt >1 cm² scan Global Maximum Index Value 1.1..2 -.33 1. IEC FDA Units p r p r.3 (MPa) 2.92 P W o (mw).2 1.3 3.2.2 min of [P (z s), I ta, (z s)] [W.3(z 1), I TA.3(z 1)] (mw) - Assoc. z s z 1 (cm) - Acoustic z bp z bp (cm) - Parameter z b z sp (cm) 3. z at max. I pi, z sp (cm) 1.2 d eq (z b ) d eq (z sp ) (cm).3 f awf f c (MHz)..2 3.1-3.1.2 Dim of A aprt X (cm) 1.2.2 -.2 1.2 Y (cm). 1.3-1.3. t d PD (µsec).2 prr PRF (Hz) 3.3 p r at max. I pi p r @PII max (MPa) 3. Other d eq at max. I pi d eq @PII max (cm).1 Information Focal Length FL x (cm) 9.. - 9. FL y (cm) 1.3 1.3-1.3 I pa, at max. MI I PA.3 @MI max (W/cm²) 23. Operating Displayed Frequency (MHz) 9... -.. Control Image Depth (cm). 1. 1. - 1. 1. Conditions Focal Zone (cm). 9.. -. 9. Frame Rate (Hz) 9.9.9 - - -.9 Type B B M - M B LOGIQ S Expert Advanced Reference Manual 1-2-1 English Rev.1

Acoustic Output L-D Probe (continued) Transducer Mode: L-D Operating Mode: Pulsed Doppler mode Acoustic Output Reporting Table for IEC1-2-3 (acc. to Table ) Transducer Model: 'L-D' SW-Release: R1..C Operating Mode: Pulsed Doppler MI TIS TIB TIC Index Label scan non-scan non- A aprt 1 cm² A aprt >1 cm² scan Global Maximum Index Value 1.. -..1.3 IEC FDA Units p r p r.3 (MPa) 2.9 P W o (mw).3 -.2 1. min of [P (z s), I ta, (z s)] [W.3(z 1), I TA.3(z 1)] (mw) 1. Assoc. z s z 1 (cm) 1.1 Acoustic z bp z bp (cm) 1.1 Parameter z b z sp (cm) 1.1 z at max. I pi, z sp (cm) 1.2 d eq (z b ) d eq (z sp ) (cm).2 f awf f c (MHz).9.2 -.2.2.2 Dim of A aprt X (cm) 2.1-2.2 2.2 2.2 Y (cm). -... t d PD (µsec).2 prr PRF (Hz) 1.9 p r at max. I pi p r @PII max (MPa) 3.3 Other d eq at max. I pi d eq @PII max (cm).3 Information Focal Length FL x (cm) 9. - 1.1 1.1 FL y (cm) 1.3-1.3 1.3 I pa, at max. MI I PA.3 @MI max (W/cm²).3 Operating Displayed Frequency (MHz) 9.. -... Control PRF (khz).1.3 -.3.3.3 Conditions Sample Volume (mm) - - - 1. 1. 1. Sample Volume Depth (cm) - - - 9. 9. 9. Type B B - PW PW PW 1-2 LOGIQ S Expert Advanced Reference Manual 2-1 English Rev.1

Acoustic Output ML-1 Probe Transducer Mode: ML-1 Operating Mode: B-Mode Acoustic Output Reporting Table for IEC1-2-3 (acc. to Table ) Transducer Model: 'ML-1' SW-Release: R1..C Operating Mode: B-Mode MI TIS TIB TIC Index Label scan non-scan non- A aprt 1 cm² A aprt >1 cm² scan Global Maximum Index Value.2.33 - - -.9 IEC FDA Units p r p r.3 (MPa).9 P W o (mw) 1.1 - - 1.1 min of [P (z s), I ta, (z s)] [W.3(z 1), I TA.3(z 1)] (mw) - Assoc. z s z 1 (cm) - Acoustic z bp z bp (cm) - Parameter z b z sp (cm) - z at max. I pi, z sp (cm) 3. d eq (z b ) d eq (z sp ) (cm) - f awf f c (MHz).. - - -. Dim of A aprt X (cm) 1.92 - - - 1.92 Y (cm). - - -. t d PD (µsec). prr PRF (Hz) 3.9 p r at max. I pi p r @PII max (MPa) 1.1 Other d eq at max. I pi d eq @PII max (cm) - Information Focal Length FL x (cm).2 - -.2 FL y (cm) 3.3 - - 3.3 I pa, at max. MI I PA.3 @MI max (W/cm²) 3. Operating Frequency (MHz) 12. 12. - - - 12. Control Image Depth (cm) 9. 9. - - - 9. Conditions Focal Zone (cm).3.3 - - -.3 Frame Rate (Hz) 3. 3. - - - 3. Type CHI CHI - - - CHI LOGIQ S Expert Advanced Reference Manual 1-2-1 English Rev.1

Acoustic Output ML-1 Probe (continued) Transducer Mode: ML-1 Operating Mode: Color Flow mode Acoustic Output Reporting Table for IEC1-2-3 (acc. to Table ) Transducer Model: 'ML-1' SW-Release: R1..C Operating Mode: Color Flow MI TIS TIB TIC Index Label scan non-scan non- A aprt 1 cm² A aprt >1 cm² scan Global Maximum Index Value 1.3.3 - - -. IEC FDA Units p r p r.3 (MPa) 2. P W o (mw) 1.9 - - 1.9 min of [P (z s), I ta, (z s)] [W.3(z 1), I TA.3(z 1)] (mw) - Assoc. z s z 1 (cm) - Acoustic z bp z bp (cm) - Parameter z b z sp (cm) - z at max. I pi, z sp (cm) 2.9 d eq (z b ) d eq (z sp ) (cm) - f awf f c (MHz)..2 - - -.2 Dim of A aprt X (cm) 1.92 - - - 1.92 Y (cm). - - -. t d PD (µsec). prr PRF (Hz) 1. p r at max. I pi p r @PII max (MPa) 3.3 Other d eq at max. I pi d eq @PII max (cm) - Information Focal Length FL x (cm) 9. - - 9. FL y (cm) 3.3 - - 3.3 I pa, at max. MI I PA.3 @MI max (W/cm²) 1. Operating Frequency (MHz).2 3. - - - 3. Control PRF (khz) 1.9.1 - - -.1 Conditions ROI span (cm) 2. 9. - - - 9. ROI center (cm) 3.. - - -. Focal Zone (cm) 33. 2. - - - 2. Type EL CF - - - CF 1- LOGIQ S Expert Advanced Reference Manual 2-1 English Rev.1

Acoustic Output ML-1 Probe (continued) Transducer Mode: ML-1 Operating Mode: M mode Acoustic Output Reporting Table for IEC1-2-3 (acc. to Table ) Transducer Model: 'ML-1' SW-Release: R1..C Operating Mode: B+M Mode MI TIS TIB TIC Index Label scan non-scan non- A aprt 1 cm² A aprt >1 cm² scan Global Maximum Index Value..2 -...3 IEC FDA Units p r p r.3 (MPa) 1.2 P W o (mw). - 2..9 min of [P (z s), I ta, (z s)] [W.3(z 1), I TA.3(z 1)] (mw).9 Assoc. z s z 1 (cm) 1. Acoustic z bp z bp (cm) 1. Parameter z b z sp (cm) 1. z at max. I pi, z sp (cm) 1. d eq (z b ) d eq (z sp ) (cm).1 f awf f c (MHz).2 1.3 -.2.2.2 Dim of A aprt X (cm) 1.2-1.2 1.2 1.2 Y (cm). -... t d PD (µsec).1 prr PRF (Hz) 1. p r at max. I pi p r @PII max (MPa) 2. Other d eq at max. I pi d eq @PII max (cm).9 Information Focal Length FL x (cm).2 -.2.2 FL y (cm) 3.3-3.3 3.3 I pa, at max. MI I PA.3 @MI max (W/cm²) 3.33 Operating Frequency (MHz). 1. -... Control Image Depth (cm) 9. 9. - 9. 9. 9. Conditions Focal Zone (cm).3.3 -.3.3.3 Frame Rate (Hz) -. - - - - Type M B - M M M LOGIQ S Expert Advanced Reference Manual 1-23 2-1 English Rev.1

Acoustic Output ML-1 Probe (continued) Transducer Mode: ML-1 mode Operating Mode: Pulsed Doppler Acoustic Output Reporting Table for IEC1-2-3 (acc. to Table ) Transducer Model: 'ML-1' SW-Release: R1..C Operating Mode: Pulsed Doppler MI TIS TIB TIC Index Label scan non-scan non- A aprt 1 cm² A aprt >1 cm² scan Global Maximum Index Value.3.12.1 -..1 IEC FDA Units p r p r.3 (MPa) 1. P W o (mw). 3.1 3..2 min of [P (z s), I ta, (z s)] [W.3(z 1), I TA.3(z 1)] (mw) - Assoc. z s z 1 (cm) - Acoustic z bp z bp (cm) - Parameter z b z sp (cm). z at max. I pi, z sp (cm) 2. d eq (z b ) d eq (z sp ) (cm). f awf f c (MHz)...2 -.2 2. Dim of A aprt X (cm) 1.91. -. 3.9 Y (cm).. -. 1.3 t d PD (µsec). prr PRF (Hz) 2.1 p r at max. I pi p r @PII max (MPa) 2.2 Other d eq at max. I pi d eq @PII max (cm).23 Information Focal Length FL x (cm).2. - 23. FL y (cm) 3.3 3.3 -.3 I pa, at max. MI I PA.3 @MI max (W/cm²) 1.12 Operating Frequency (MHz) 9. 9..2 -.2 9. Control PRF (khz).3.3.1 -.1.3 Conditions Sample Volume (mm) - - 1. - 1. - Sample Volume Depth (cm) 9. 9. 1. - 1. 9. Type CHI CHI PW - PW CHI 1-2 LOGIQ S Expert Advanced Reference Manual 2-1 English Rev.1

Acoustic Output IC-9-D Probe Transducer Mode: IC-9-D Operating Mode: B mode Acoustic Output Reporting Table for IEC1-2-3 (acc. to Table ) Transducer Model: 'IC-9-D' SW-Release: R1..C Operating Mode: B-Mode MI TIS TIB TIC Index Label scan non-scan non- A aprt 1 cm² A aprt >1 cm² scan Global Maximum Index Value 1.1. - - -.9 IEC FDA Units p r p r.3 (MPa) 1.2 P W o (mw) 1. - - 1. min of [P (z s), I ta, (z s)] [W.3(z 1), I TA.3(z 1)] (mw) - Assoc. z s z 1 (cm) - Acoustic z bp z bp (cm) - Parameter z b z sp (cm) - z at max. I pi, z sp (cm) 1.3 d eq (z b ) d eq (z sp ) (cm) - f awf f c (MHz).. - - -. Dim of A aprt X (cm) 1. - - - 1. Y (cm). - - -. t d PD (µsec).3 prr PRF (Hz) 1. p r at max. I pi p r @PII max (MPa) 2. Other d eq at max. I pi d eq @PII max (cm) - Information Focal Length FL x (cm) 2. - - 2. FL y (cm) 3. - - 3. I pa, at max. MI I PA.3 @MI max (W/cm²).1 Operating Displayed Frequency (MHz). 9. - - - 9. Control Image Depth (cm). 2. - - - 2. Conditions Focal Zone (cm) 3. 2. - - - 2. Frame Rate (Hz) 1.. - - -. Type CHI CHI - - - CHI LOGIQ S Expert Advanced Reference Manual 1-2 2-1 English Rev.1

Acoustic Output IC-9-D Probe (continued) Transducer Mode: IC-9-D Operating Mode: Color Flow mode Acoustic Output Reporting Table for IEC1-2-3 (acc. to Table ) Transducer Model: 'IC-9-D' SW-Release: R1..C Operating Mode: Color Flow MI TIS TIB TIC Index Label scan non-scan non- A aprt 1 cm² A aprt >1 cm² scan Global Maximum Index Value 1.. - - -. IEC FDA Units p r p r.3 (MPa) 1.9 P W o (mw).3 - -.3 min of [P (z s), I ta, (z s)] [W.3(z 1), I TA.3(z 1)] (mw) - Assoc. z s z 1 (cm) - Acoustic z bp z bp (cm) - Parameter z b z sp (cm) - z at max. I pi, z sp (cm) 2. d eq (z b ) d eq (z sp ) (cm) - f awf f c (MHz).. - - -. Dim of A aprt X (cm) 1.33 - - - 1.33 Y (cm). - - -. t d PD (µsec).3 prr PRF (Hz) 2. p r at max. I pi p r @PII max (MPa) 2. Other d eq at max. I pi d eq @PII max (cm) - Information Focal Length FL x (cm).2 - -.2 FL y (cm) 3. - - 3. I pa, at max. MI I PA.3 @MI max (W/cm²).2 Operating Displayed Frequency (MHz).1.1 - - -.1 Control PRF (khz) 2.2 2.2 - - - 2.2 Conditions ROI span (cm).. - - -. ROI center (cm).. - - -. Focal Zone (cm).2.2 - - -.2 Type CF CF - - - CF 1-2 LOGIQ S Expert Advanced Reference Manual 2-1 English Rev.1

Acoustic Output IC-9-D Probe (continued) Transducer Mode: IC-9-D Operating Mode: M mode Acoustic Output Reporting Table for IEC1-2-3 (acc. to Table ) Transducer Model: 'IC-9-D' SW-Release: R1..C Operating Mode: B+M Mode MI TIS TIB TIC Index Label scan non-scan non- A aprt 1 cm² A aprt >1 cm² scan Global Maximum Index Value.9.9.9 -.33.3 IEC FDA Units p r p r.3 (MPa) 1.3 P W o (mw) 2.3 2.3. 2.3 min of [P (z s), I ta, (z s)] [W.3(z 1), I TA.3(z 1)] (mw) - Assoc. z s z 1 (cm) - Acoustic z bp z bp (cm) - Parameter z b z sp (cm) 2. z at max. I pi, z sp (cm) 2.9 d eq (z b ) d eq (z sp ) (cm). f awf f c (MHz) 3. 3. 3. - 3. 3. Dim of A aprt X (cm).. -.. Y (cm).. -.. t d PD (µsec).2 prr PRF (Hz).9 p r at max. I pi p r @PII max (MPa) 1. Other d eq at max. I pi d eq @PII max (cm). Information Focal Length FL x (cm) 3. 3. - 3. FL y (cm) 3. 3. - 3. I pa, at max. MI I PA.3 @MI max (W/cm²) 2.9 Operating Displayed Frequency (MHz)... -.. Control Image Depth (cm) 2. 2. 2. - 2. 2. Conditions Focal Zone (cm) 3. 3. 3. - 3. 3. Frame Rate (Hz) 23. 23. 23. - 23. 23. Type M CHI M - M M LOGIQ S Expert Advanced Reference Manual 1-2 2-1 English Rev.1

Acoustic Output IC-9-D Probe (continued) Transducer Mode: IC-9-D Operating Mode: Pulsed Doppler mode Acoustic Output Reporting Table for IEC1-2-3 (acc. to Table ) Transducer Model: 'IC-9-D' SW-Release: R1..C Operating Mode: Pulsed Doppler MI TIS TIB TIC Index Label scan non-scan non- A aprt 1 cm² A aprt >1 cm² scan Global Maximum Index Value 1.1.1.9.3. IEC FDA Units p r p r.3 (MPa) 2.1 P W o (mw) 9.2..1 9.2 min of [P (z s), I ta, (z s)] [W.3(z 1), I TA.3(z 1)] (mw) - Assoc. z s z 1 (cm) - Acoustic z bp z bp (cm) - Parameter z b z sp (cm) 1.93 z at max. I pi, z sp (cm) 1. d eq (z b ) d eq (z sp ) (cm).1 f awf f c (MHz) 3. 3..1 -.1 3. Dim of A aprt X (cm) 1.1. -. 1.1 Y (cm).. -.. t d PD (µsec).1 prr PRF (Hz).2 p r at max. I pi p r @PII max (MPa) 2. Other d eq at max. I pi d eq @PII max (cm).1 Information Focal Length FL x (cm) 1. 1.1-1. FL y (cm) 3. 3. - 3. I pa, at max. MI I PA.3 @MI max (W/cm²) 1.1 Operating Displayed Frequency (MHz)...1 -.1. Control PRF (khz).. 2.9-2.9. Conditions Sample Volume (mm) - - 1. - 1. - Sample Volume Depth (cm) - - 1. - 1. - Type CHI CHI PW - PW CHI 1-2 LOGIQ S Expert Advanced Reference Manual 2-1 English Rev.1

Acoustic Output 3CRF-D Probe Transducer Mode: 3CRF-D Operating Mode: B-Mode Acoustic Output Reporting Table for IEC1-2-3 (acc. to Table ) Transducer Model: '3CRF-D' SW-Release: R1..C Operating Mode: B-Mode MI TIS TIB TIC Index Label scan non-scan non- A aprt 1 cm² A aprt >1 cm² scan Global Maximum Index Value..1 - - -. IEC FDA Units p r p r.3 (MPa) 1. P W o (mw) 2.3 - - 2.3 min of [P (z s), I ta, (z s)] [W.3(z 1), I TA.3(z 1)] (mw) - Assoc. z s z 1 (cm) - Acoustic z bp z bp (cm) - Parameter z b z sp (cm) - z at max. I pi, z sp (cm) 3. d eq (z b ) d eq (z sp ) (cm) - f awf f c (MHz) 2.3 2.3 - - - 2.3 Dim of A aprt X (cm) 1. - - - 1. Y (cm) 1.2 - - - 1.2 t d PD (µsec). prr PRF (Hz). p r at max. I pi p r @PII max (MPa).9 Other d eq at max. I pi d eq @PII max (cm) - Information Focal Length FL x (cm). - -. FL y (cm). - -. I pa, at max. MI I PA.3 @MI max (W/cm²) 1.3 Operating Displayed Frequency (MHz) 3.. - - -. Control Image Depth (cm) 3.. - - -. Conditions Focal Zone (cm).. - - -. Frame Rate (Hz) 12. 12. - - - 12. Type CHI CHI - - - CHI LOGIQ S Expert Advanced Reference Manual 1-2-1 English Rev.1

Acoustic Output 3CRF-D Probe (continued) Transducer Mode: 3CRF-D Operating Mode: Color Flow mode Acoustic Output Reporting Table for IEC1-2-3 (acc. to Table ) Transducer Model: '3CRF-D' SW-Release: R1..C Operating Mode: Color Flow MI TIS TIB TIC Index Label scan non-scan non- A aprt 1 cm² A aprt >1 cm² scan Global Maximum Index Value 1.. - - - 1. IEC FDA Units p r p r.3 (MPa) 1. P W o (mw).1 - -.1 min of [P (z s), I ta, (z s)] [W.3(z 1), I TA.3(z 1)] (mw) - Assoc. z s z 1 (cm) - Acoustic z bp z bp (cm) - Parameter z b z sp (cm) - z at max. I pi, z sp (cm).1 d eq (z b ) d eq (z sp ) (cm) - f awf f c (MHz) 2. 2.1 - - - 2.1 Dim of A aprt X (cm) 2. - - - 2. Y (cm) 1.2 - - - 1.2 t d PD (µsec). prr PRF (Hz) 3. p r at max. I pi p r @PII max (MPa) 2.3 Other d eq at max. I pi d eq @PII max (cm) - Information Focal Length FL x (cm) 1. - - 1. FL y (cm). - -. I pa, at max. MI I PA.3 @MI max (W/cm²) 9. Operating Displayed Frequency (MHz). 2. - - - 2. Control PRF (khz).3 1. - - - 1. Conditions ROI span (cm) - 1. - - - 1. ROI center (cm) -. - - -. Focal Zone (cm). 1. - - - 1. Type B CF - - - CF 1-3 LOGIQ S Expert Advanced Reference Manual 2-1 English Rev.1

Acoustic Output 3CRF-D Probe (continued) Transducer Mode: 3CRF-D Operating Mode: M mode Acoustic Output Reporting Table for IEC1-2-3 (acc. to Table ) Transducer Model: '3CRF-D' SW-Release: R1..C Operating Mode: B+M Mode MI TIS TIB TIC Index Label scan non-scan non- A aprt 1 cm² A aprt >1 cm² scan Global Maximum Index Value 1.9.3 -..99 1.3 IEC FDA Units p r p r.3 (MPa) 1.1 P W o (mw) 1.1 -.2 1.1 min of [P (z s), I ta, (z s)] [W.3(z 1), I TA.3(z 1)] (mw) 1.1 Assoc. z s z 1 (cm) 1. Acoustic z bp z bp (cm) 1. Parameter z b z sp (cm).1 z at max. I pi, z sp (cm). d eq (z b ) d eq (z sp ) (cm).3 f awf f c (MHz) 2. 2. - 2. 2. 2. Dim of A aprt X (cm) 1.1-1.1 1.1 1.1 Y (cm) 1.2-1.2 1.2 12. t d PD (µsec).92 prr PRF (Hz) 1. p r at max. I pi p r @PII max (MPa) 2.9 Other d eq at max. I pi d eq @PII max (cm).3 Information Focal Length FL x (cm). -.. FL y (cm). -.. I pa, at max. MI I PA.3 @MI max (W/cm²) 3. Operating Displayed Frequency (MHz).. -... Control Image Depth (cm) 1. 1. - 1. 1. 1. Conditions Focal Zone (cm).. -... Frame Rate (Hz).. -... Type CHI CHI - M M M LOGIQ S Expert Advanced Reference Manual 1-2-1 English Rev.1

Acoustic Output 3CRF-D Probe (continued) Transducer Mode: 3CRF-D Operating Mode: Pulsed Doppler mode Acoustic Output Reporting Table for IEC1-2-3 (acc. to Table ) Transducer Model: '3CRF-D' SW-Release: R1..C Operating Mode: Pulsed Doppler MI TIS TIB TIC Index Label scan non-scan non- A aprt 1 cm² A aprt >1 cm² scan Global Maximum Index Value 1..1 -.3 1. 1. IEC FDA Units p r p r.3 (MPa) 1. P W o (mw).3-2.3 9. min of [P (z s), I ta, (z s)] [W.3(z 1), I TA.3(z 1)] (mw) 9. Assoc. z s z 1 (cm).9 Acoustic z bp z bp (cm) 3. Parameter z b z sp (cm) 3. z at max. I pi, z sp (cm). d eq (z b ) d eq (z sp ) (cm).2 f awf f c (MHz) 2. 3. - 2.9 2.9 2.9 Dim of A aprt X (cm) 1. - 2. 2. 2. Y (cm) 1.2-1.2 1.2 1.2 t d PD (µsec). prr PRF (Hz). p r at max. I pi p r @PII max (MPa) 2. Other d eq at max. I pi d eq @PII max (cm). Information Focal Length FL x (cm). - 1.2 1.2 FL y (cm). -.. I pa, at max. MI I PA.3 @MI max (W/cm²). Operating Displayed Frequency (MHz). 3. - 2. 2. 2. Control PRF (khz) 3.2.9-1. 1. 1. Conditions Sample Volume (mm) - - - 1. 1. 1. Sample Volume Depth (cm) - - - 1. 1. 1. Type CHI B - PW PW PW 1- LOGIQ S Expert Advanced Reference Manual 2-1 English Rev.1

Acoustic Output L-1i-D Probe Transducer Mode: L-1i-D Operating Mode: B-Mode Acoustic Output Reporting Table for IEC1-2-3 (acc. to Table ) Transducer Model: 'L-1i-D' SW-Release: Operating Mode: B-Mode MI TIS TIB TIC Index Label scan non-scan non- A aprt 1 cm² A aprt >1 cm² scan Global Maximum Index Value 1.1. - - -. IEC FDA Units p r p r.3 (MPa) 1.9 P W o (mw). - - 1. min of [P (z s), I ta, (z s)] [W.3(z 1), I TA.3(z 1)] (mw) - Assoc. z s z 1 (cm) - Acoustic z bp z bp (cm) - Parameter z b z sp (cm) - z at max. I pi, z sp (cm) 2.1 d eq (z b ) d eq (z sp ) (cm) - f awf f c (MHz).. - - -. Dim of A aprt X (cm).3 - - -.3 Y (cm). - - -. t d PD (µsec). prr PRF (Hz). p r at max. I pi p r @PII max (MPa) 3. Other d eq at max. I pi d eq @PII max (cm) - Information Focal Length FL x (cm) 3.2 - - 3.2 FL y (cm) 1. - - 1. I pa, at max. MI I PA.3 @MI max (W/cm²). Operating Displayed Frequency (MHz) 12. 12. - - - 12. Control Image Depth (cm).. - - -. Conditions Focal Zone (cm) 3.2 3.2 - - - 3.2 Frame Rate (Hz) 2.9 2.9 - - - 2.9 Type B B - - - B LOGIQ S Expert Advanced Reference Manual 1-33 2-1 English Rev.1

Acoustic Output L-1i-D Probe (continued) Transducer Mode: L-1i-D mode Operating Mode: Color Flow Acoustic Output Reporting Table for IEC1-2-3 (acc. to Table ) Transducer Model: 'L-1i-D' SW-Release: Operating Mode: Color Flow MI TIS TIB TIC Index Label scan non-scan non- A aprt 1 cm² A aprt >1 cm² scan Global Maximum Index Value.. - - -.91 IEC FDA Units p r p r.3 (MPa) 1.3 P W o (mw). - -.3 min of [P (z s), I ta, (z s)] [W.3(z 1), I TA.3(z 1)] (mw) - Assoc. z s z 1 (cm) - Acoustic z bp z bp (cm) - Parameter z b z sp (cm) - z at max. I pi, z sp (cm) 1.2 d eq (z b ) d eq (z sp ) (cm) - f awf f c (MHz).. - - -. Dim of A aprt X (cm) 1.2 - - - 1.2 Y (cm). - - -. t d PD (µsec). prr PRF (Hz).1 p r at max. I pi p r @PII max (MPa) 1.9 Other d eq at max. I pi d eq @PII max (cm) - Information Focal Length FL x (cm). - -. FL y (cm) 1. - - 1. I pa, at max. MI I PA.3 @MI max (W/cm²) 3. Operating Displayed Frequency (MHz) 1..9 - - -.9 Control PRF (khz) 1..2 - - -.2 Conditions ROI span (cm) -. - - -. ROI center (cm) - 2. - - - 2. Focal Zone (cm) 3.2. - - -. Type CHI CF - - - CF 1-3 LOGIQ S Expert Advanced Reference Manual 2-1 English Rev.1

Acoustic Output L-1i-D Probe (continued) Transducer Mode: L-1i-D Operating Mode: M mode Acoustic Output Reporting Table for IEC1-2-3 (acc. to Table ) Transducer Model: 'L-1i-D' SW-Release: Operating Mode: B+M Mode MI TIS TIB TIC Index Label scan non-scan non- A aprt 1 cm² A aprt >1 cm² scan Global Maximum Index Value... -.. IEC FDA Units p r p r.3 (MPa) 1.9 P W o (mw).3.9.2 3.1 min of [P (z s), I ta, (z s)] [W.3(z 1), I TA.3(z 1)] (mw) - Assoc. z s z 1 (cm) - Acoustic z bp z bp (cm) - Parameter z b z sp (cm). z at max. I pi, z sp (cm) 2.1 d eq (z b ) d eq (z sp ) (cm).1 f awf f c (MHz)... -.. Dim of A aprt X (cm).. -.. Y (cm).. -.. t d PD (µsec). prr PRF (Hz).3 p r at max. I pi p r @PII max (MPa) 2. Other d eq at max. I pi d eq @PII max (cm).1 Information Focal Length FL x (cm) 3.2 3.2-3.2 FL y (cm) 1. 1. - 1. I pa, at max. MI I PA.3 @MI max (W/cm²).9 Operating Displayed Frequency (MHz) 1. 1. 1. - - 1. Control Image Depth (cm)... - -. Conditions Focal Zone (cm) 3.2 3.2 3.2 - - 3.2 Frame Rate (Hz)..2 1. - -. Type M CHI CHI - - M LOGIQ S Expert Advanced Reference Manual 1-3 2-1 English Rev.1

Acoustic Output L-1i-D Probe (continued) Transducer Mode: L-1i-D mode Operating Mode: Pulsed Doppler Acoustic Output Reporting Table for IEC1-2-3 (acc. to Table ) Transducer Model: 'L-1i-D' SW-Release: Operating Mode: Pulsed Doppler MI TIS TIB TIC Index Label scan non-scan non- A aprt 1 cm² A aprt >1 cm² scan Global Maximum Index Value 1.1..9 -.9.9 IEC FDA Units p r p r.3 (MPa) 1.2 P W o (mw) 3..1.1.2 min of [P (z s), I ta, (z s)] [W.3(z 1), I TA.3(z 1)] (mw) - Assoc. z s z 1 (cm) - Acoustic z bp z bp (cm) - Parameter z b z sp (cm).2 z at max. I pi, z sp (cm) 1.9 d eq (z b ) d eq (z sp ) (cm).12 f awf f c (MHz).1..2 -.2.2 Dim of A aprt X (cm).. -.. Y (cm).. -.. t d PD (µsec) 1.3 prr PRF (Hz) 3.3 p r at max. I pi p r @PII max (MPa) 3.1 Other d eq at max. I pi d eq @PII max (cm).12 Information Focal Length FL x (cm) 3.2. -. FL y (cm) 1. 1. - 1. I pa, at max. MI I PA.3 @MI max (W/cm²) 3.2 Operating Displayed Frequency (MHz)...2 -.2.2 Control PRF (khz) 1.3 2. 1.3-1.3 1.3 Conditions Sample Volume (mm) 1. 1. 1. - 1. 1. Sample Volume Depth (cm) 1. 1.. -.. Type PW 2D PW - PW PW 1-3 LOGIQ S Expert Advanced Reference Manual 2-1 English Rev.1

Acoustic Output S-1-D Probe Transducer Mode: S-1-D Operating Mode: B-mode Acoustic Output Reporting Table for IEC1-2-3 (acc. to Table ) Transducer Model: 'S-1-D' SW-Release: R1..C Operating Mode: B-Mode MI TIS TIB TIC Index Label scan non-scan non- A aprt 1 cm² A aprt >1 cm² scan Global Maximum Index Value.93 1. - - - 1.12 IEC FDA Units p r p r.3 (MPa) 2.23 P W o (mw) 3.9 - - 3.9 min of [P (z s), I ta, (z s)] [W.3(z 1), I TA.3(z 1)] (mw) - Assoc. z s z 1 (cm) - Acoustic z bp z bp (cm) - Parameter z b z sp (cm) - z at max. I pi, z sp (cm) 1.9 d eq (z b ) d eq (z sp ) (cm) - f awf f c (MHz).. - - -. Dim of A aprt X (cm) 1. - - - 1. Y (cm). - - -. t d PD (µsec).1 prr PRF (Hz).1 p r at max. I pi p r @PII max (MPa) 3. Other d eq at max. I pi d eq @PII max (cm) - Information Focal Length FL x (cm). - -. FL y (cm) 3. - - 3. I pa, at max. MI I PA.3 @MI max (W/cm²) 3.9 Operating Displayed Frequency (MHz).. - - -. Control Image Depth (cm) 1. 1. - - - 1. Conditions Focal Zone (cm).. - - -. Frame Rate (Hz) 3. 3. - - - 3. Type B B - - - B LOGIQ S Expert Advanced Reference Manual 1-3 2-1 English Rev.1