This standard applies to medical ultrasonic diagnostic equipment. GB 16846-1997 Announcement of requirements for acoustic output of medical ultrasonic diagnostic equipment GB16846-1997 Standard download decompression password: www.bzxz.net

GB16846—1997
Foreword
This standard is equivalent to the International Electrotechnical Commission standard IEC1157:1992 "Requirements for the publication of acoustic output of medical ultrasonic diagnostic equipment". IEC1157:1992 has four referenced standards: IEC469.1:1987 "Pulse technology and equipment Part 1: Pulse terms and definitions"; IEC854:1986 "Performance measurement methods of ultrasonic pulse echo diagnostic equipment"; IEC1102:1991 "Measurement and description of ultrasonic fields in the frequency range of 0.5 to 15 MHz using hydrophones"; IEC1161:1992 "Measurement of ultrasonic power in liquids in the frequency range of 0.5 to 25 MHz". Among them, IEC469.1 and IEC854 are only related to 3.29, 3.33, 3.36 and 3.37 of this standard, so the relevant contents are directly added to this standard, and IEC469.1 and IEC854 in the original referenced standards are deleted. IEC1102:1991 "Characteristics of ultrasonic fields in the frequency range of 0.5~15MHz and their measurement - hydrophone method" has been equivalent to GB/T16540--1996, and the current national standard GB7966-87 "Acoustics Measurement of ultrasonic sound power in the frequency range of 0.5~10MHz" is similar to IEC1161, so these two national standards are directly quoted. In order to facilitate the calculation of measurement results, Appendix D is added, and its content is taken from Appendix E of US FDA510 (K). Appendix A of this standard is the appendix of the standard; Appendix B, Appendix C, and Appendix D of this standard are the appendices of the prompt. This standard is proposed by the State Administration of Medicine. This standard is under the jurisdiction of the National Medical Ultrasonic Equipment Standardization Technical Committee. This standard is drafted by the National Medical Ultrasonic Equipment Quality Supervision and Inspection Center. The main organizers of this standard are: Wang Zhijian, Guan Guojie, and Mang Anshi. 80
GB16846-1997
IEC Foreword
1) Formal decisions or agreements on technical matters are made by technical committees, and all national committees with special interests may present and express their opinions and try their best to achieve international consensus on the subjects involved. 2) It has the form of recommendations that are generally used internationally and, in this sense, are recognized by national committees. 3) In order to promote international consensus, IEC hopes that all national committees will adopt the texts recommended by IEC as their national standards as long as their national conditions permit. Any differences between IEC recommendations and corresponding national standards should be clearly stated in their national standards as far as possible. This standard was prepared by IEC Technical Committee No: 87 "Ultrasound". The content of this standard is based on the following documents:
Draft International Standard
87(CO)11
Voting Report
87(CO)19
All voting information for the approval of this standard can be found in the voting report specified in the table above. Appendix A of this standard is the annex to the standard.
Appendix B and Appendix C of this standard are informative appendices. 81
GB16846—1997
This standard specifies the requirements for the declaration of the acoustic output of medical ultrasonic diagnostic equipment by the manufacturer. The values ​​in the technical specifications represent the maximum output level under a given single or combined operating mode, and the values ​​are derived from measurements in water. Equipment that produces low acoustic output levels may be exempted from the full declaration requirements of this standard. 82
National Standard of the People's Republic of China
Requirements for the declaration of the acoustic output of medical diagnostic ultrasonic equipment This standard is equivalent to IEC1157:1992 "Requirements for the declaration of the acoustic output of medical diagnostic ultrasonic equipment". 1 Scope
This standard applies to medical ultrasonic diagnostic equipment. The requirements for the disclosure of acoustic output information determined in this standard apply to: the information introduced by the manufacturer to potential purchasers of the equipment in the technical data sheet, the information published by the manufacturer in the accompanying documents/manuals; and the applicable background information provided by the manufacturer at the request of relevant units. This standard provides conditions for exemption from publication for equipment that produces low-value acoustic output levels. 2 Referenced standards
GB 16846—1997
idtIEC1157:1992
The provisions contained in the following standards constitute the provisions of this standard through reference in this standard. When this standard is published, the versions shown are valid. All standards will be revised, and parties using this standard should explore the possibility of using the latest versions of the following standards. GB7966—87 Acoustics Measurement of ultrasonic sound power in the frequency range of 0.5 to 10 MHz GB/T16540-1996 Acoustics Characteristics of ultrasonic fields in the frequency range of 0.5 to 15 MHz and their measurement by hydrophone method (idt IEC 1102:1991)
3 Definitions and symbols
This standard adopts the following definitions.
Figures 1 to 4 are diagrams of some of the following defined parameters. 3.1 Accompanying literature The operating and instruction manual provided by the manufacturer with the medical ultrasound diagnostic equipment. 3.2 Acoustic initialization fraction The ratio of the negative peak sound pressure when the system is in the initialization mode to the maximum negative peak sound pressure set by the system in some specific operating mode. The ratio is determined by measuring the position where the maximum square integral of the pulse sound pressure (or the maximum square value of the average sound pressure for continuous wave systems) is produced. The ratio is usually expressed as a percentage.
Note: The initial mode of the system may be different from the specific operating mode. 3.3 Acoustic output freeze The system is in a state where there is no actual update of the ultrasound echo information and the system is in an acoustic output disabled state. 3.4 Acoustic power-up fraction The ratio of the negative peak sound pressure when the system is in the power-up mode to the maximum negative peak sound pressure set by the system in some specific operating mode. The ratio is determined by measuring at the position where the maximum square integral of the pulse sound pressure (or the maximum square average sound pressure for a continuous wave system) is generated. The ratio is usually expressed in percentage form.
GB16846-1997
Note: The system power-on mode may be different from the specific operating mode. 3.5 Bandwidthbandwidth
On the spectrum diagram of the sound pressure, the difference between the frequencies fi and f where the amplitude is 3dB lower than the peak amplitude. 3.6 Combined-operating mode combined-operating mode System operating mode composed of more than one single-operating mode. Note: Examples of composite operation modes: real-time B-mode combined with M-mode (B+M), real-time B-mode combined with pulsed Doppler (B+D) color M-mode (cM), real-time B-mode combined with M-mode and pulsed Doppler (B+M+D), real-time B-mode combined with real-time blood flow Doppler (B+rD), i.e., in blood flow imaging, different types of acoustic pulses are used to generate Doppler information and imaging information. 3.7 discrete-operating mode The operating mode determined by the excitation method of the ultrasonic transducer or ultrasonic transducer array element in medical diagnostic equipment is only applicable to a diagnostic method.
Note: Examples of discrete-operating modes: A-mode (A), M-mode (M), static B-mode (sB), real-time B-mode (B), continuous wave Doppler (cwD), pulsed Doppler (D), static blood flow imaging (sD), real-time blood flow Doppler imaging with only one type of acoustic pulse (rD). 3.8 Inclusive mode
The acoustic output level (p_ and Ipta) of the composite operating mode is less than that of its corresponding specific single operating mode. 3.9 Initialization mode The system-specified state corresponding to the operating mode and system settings when starting a new patient diagnosis. 3.10 Manufacturer manufacturer
A company that manufactures, sells or acts as an agent for medical diagnostic ultrasonic equipment. 3.11 Medical diagnostic ultrasonic equipment (or system) The combination of the main unit and transducer components of the ultrasonic equipment constitutes a complete diagnostic system. 3.12 Non-scanning mode An operating mode of the system in which a set of acoustic pulse sequences excites ultrasonic scanning lines along the same acoustic path. Note: The pulse series does not have to be composed of identical pulses, such as a multi-segment focusing system. 3.13 Output beam area output beam area The area of ​​the ultrasonic beam derived from the output beam size. Unit: square centimeters, cm2.
3.14 Output beam dimensions output beam dimensions The size of the ultrasonic beam in a specific direction perpendicular to the beam calibration axis at the output end face of the transducer (-6 dB pulse beam width). Unit: millimeters, mm.
3.15 Output beam intensity
output beam intensity
The time-averaged output power divided by the output beam area. Symbol: 1ab, unit: milliwatts per square centimeter, mW/cm. 3.16 Patient entry plane The plane perpendicular to the beam alignment axis or, for automatic scanners, the axis of symmetry of the scanning plane, and the intersection of this plane and the above axis is the point where the ultrasound enters the patient's body, see Figure 1. 3.17 Power-up mode
When the system power is turned on, it corresponds to the automatically determined operating mode and a specified state of the system settings. If the specified state is determined by the operator, the power-up mode is called "not applicable" (abbreviated as n/a). Note: The specified state is usually a single or composite operating mode. 3.18 Pulse beam width pulsebeamwidth On a specific surface and in a specific direction passing through the point of maximum pulse sound pressure square integral (p) on the surface, p: the maximum value multiplied by a specific coefficient The distance between two points of force value, the two points are located on both sides of the maximum force value and are farthest apart. If the location of the specific surface is not given, it passes through the spatial peak time peak sound pressure point in the entire sound field. The corresponding specific coefficients for -6dB and -20dB pulse beamwidths are 0.25 and 0.01, respectively. Notes
1 For continuous wave systems, the term pulse pressure square integral (p:) in the above definition is replaced by the average square sound pressure value. 2 The specific surface is usually a plane perpendicular to the beam calibration axis. The ultrasonic transducer with cylindrical sensitive elements is a cylindrical surface, and the ultrasonic transducer with spherical sensitive elements is a spherical surface.
Symbol: Wpb6, Wpb20; Unit: millimeter, mm. 3.19 Reference direction For systems with scanning mode, this direction is perpendicular to the beam calibration axis of the ultrasonic scanning line and lies in the scanning plane. For systems with only non-scanning mode, this direction is perpendicular to the beam calibration axis and parallel to the direction of the maximum -6dB pulse beamwidth. 3.20 Scan direction scan direction
For systems with scanning mode, this direction is located in the scanning plane and perpendicular to a specific ultrasonic scanning line. 3.21 Scanning mode
An operating mode of the system in which a set of ultrasonic pulse sequences excites ultrasonic scan lines along different acoustic paths. Note: The pulse sequence does not have to be composed of identical pulses, such as a multi-segment focusing system. 3.22 Transducer assembly The component of the medical diagnostic ultrasound equipment consisting of the ultrasonic transducer and/or ultrasonic transducer array element group and indispensable parts such as acoustic lenses, supports, etc. The transducer assembly can usually be separated from the main body of the ultrasound equipment. 3.23 Transducer output face The outer surface of the transducer component that directly contacts the patient, or the outer surface that contacts the patient through a water or liquid path, see Figures 1 and 2.
3.24 Transducer stand-off distance The shortest distance between the transducer output face and the patient input face. The term "contact" means that the transducer output face is in direct contact with the patient, at which time the stand-off distance is zero. Symbol: L., unit: millimeter, mm, see Figure 1. Patient input surface
Transducer
Output surface
Transducer sensitive array element
Lna-transducer projection distance, Lt-distance between transducer and transducer output surface Figure 1 Schematic diagram of the relationship between various defined surfaces and distances in a mechanical fan-scan scanner with water path projection distance when applied to a patient, patient surface
GB16846--1997
3.25 Transducer to transducer output-face distance transducer to transducer-output-face distance The distance between the sensitive surface of the ultrasonic transducer or ultrasonic transducer array element group and the transducer output surface along the beam calibration axis.
Symbol: L; Unit: millimeter, mm, see Figures 1 and 2. TransducerwwW.bzxz.Net
Output face
Transducer sensitive element
Lp - distance from the transducer output face to the point of maximum pulse pressure square integration; Lt - distance from the transducer to the transducer output face Maximum pulse pressure
square integration point
Figure 2 Schematic diagram of the relationship between various defined surfaces and distances in a mechanical fan-scan scanner during acoustic output measurement 3.26 Typical test data typetesting values ​​Acoustic output parameter at the maximum possible acoustic output level in a specific system. 3.27 Ultrasonic scan line The beam alignment axis of a specific ultrasonic transducer array element group in an automatic scanning system, or the beam alignment axis of a single or composite excitation of an ultrasonic transducer or ultrasonic transducer array element group, see Figure 3. Note: In this context, ultrasonic scan line refers to the path of the acoustic pulse, not a line in the image on the system display screen. 86
Linear array scanning
instrument transducer
ultrasonic scanning line,
ultrasonic scanning line
mechanical sector scanning
instrument transducer
GB16846—1997
a specific plane
(measurement plane)
ultrasonic scanning line spacing, S.
center scanning line
scanning direction
ultrasonic scanning line spacing, S
center scanning line
specific plane
(measurement plane)
Figure 3 Schematic diagram of various defined parameters and scanning line distribution in linear array scanner and mechanical sector scanning scanner. The specific pattern is the plane corresponding to the square integral of the maximum pulse pressure (or the plane of the maximum average square sound pressure for continuous wave system) 3.28 Ultrasonic instrument console An electronic device unit connected to the transducer assembly. The following definitions are the same or consistent with those in GB/T16540 (idtIEC1102): 3.29 Acoustic pulse waveformacoustic pulsewaveformThe waveform of instantaneous sound pressure relative to time at a specific position in the sound field should be long enough to include all effective information in one or more cycles of a single pulse or burst pulse or continuous wave. 3.30 Arithmetic-mean acoustic-working frequencyarithmetic-mean acoustic-working frequencyThe arithmetic mean of the frequencies, f, at a specific amplitude in the spectrum diagram of the acoustic signal, that is, the amplitude at which the output of the hydrophone at a specific position in the sound field is 3dB lower than the peak amplitude.
Symbol: fawl; Unit: megahertz, MHz. 87
3.31 Beam-alignment axis beam-alignment axis GB16846-1997
For directional purposes only, the beam-alignment axis is a straight line connecting two spatial peak and temporal peak sound pressure points on two hemispherical surfaces, the centers of which are approximately located at the geometric center of the ultrasonic transducer or ultrasonic transducer array element group. The radius of curvature of the first hemispherical surface is approximately A./πλ, where A. is the geometric area of ​​the ultrasonic transducer or ultrasonic transducer array element group, λ is the ultrasonic wave length corresponding to the nominal frequency, and the radius of curvature of the second hemispherical surface is 2A./πλ or A./3λ, whichever is more suitable. For calibration purposes, this line can be extended to the end face of the ultrasonic transducer or ultrasonic transducer array element group.
In most practical applications, two planes perpendicular to the direction of ultrasonic propagation are used. In the case where a single-valued peak is not located on the surface of the hemisphere, a different radius of curvature that can produce a single-valued peak is selected. 3.32 Central scan line For an automatic scanning system, the ultrasonic scanning line closest to the symmetry axis of the scanning plane. 3.33 Nominal frequency The ultrasonic operating frequency of an ultrasonic transducer or ultrasonic transducer array element given by the designer or manufacturer.34 Peak negative (or peak-rarefactional) acoustic pressure The maximum value of the negative instantaneous acoustic pressure in the sound field or at a specific plane during the sound wave repetition period. The peak negative acoustic pressure is represented by a positive number. Symbol: p= (or p.), unit: Pa; see Figure 4. Time
Figure 4 Schematic diagram of peak negative acoustic pressure during an acoustic pulse 3.35 Pulse-pressure-squared integral The time integral of the square of the instantaneous acoustic pressure at a specific point in the sound field within the entire acoustic pulse waveform. Symbol: pi, unit: Pascal squared second, Pa2·S. 3.36 Pulse repetition period pulserepetitionperiod The time interval between two consecutive pulses or burst pulses, which is applicable to single-element non-scanning systems and automatic scanning systems. Unit: second, s.
3.37 Pulse repetition frequency pulse repetition rate The reciprocal of the pulse repetition period.
Symbol: prr; Unit: Hz.
3.38 Scan plane scanplane
For automatic scanning system, it includes the plane of all ultrasonic scanning lines. 3.39 Scan repetition period scan repetition period The time interval between two consecutive frames, sectors or the same point during scanning, only applicable to automatic scanning system. Unit: second, s.
3.40 Scan repetition rate scan repetition rate88
The reciprocal of the scan repetition period.
Symbol: srt; Unit: Hz.
GB 16846--1997
3.41 Spatial-peak temporal-average derived intensity spatial-peak temporal-average derived intensity The maximum value of the time-averaged derived intensity in the sound field or a specific plane. When the system is in the composite operation mode, the time interval of the time average is long enough to include the period when scanning may not occur. Note: "derived" is used to limit the definition of sound intensity. Symbol: I.pa; Unit: milliwatt per square centimeter, mW/cm2. 3.42 Ultrasonic scan line separation Ultrasonic scan line separation In an automatic scanning system, the distance between two specific continuous ultrasonic scan lines of the same type and two intersection points of a specific plane. Symbol: S, Unit: millimeter, mm, see Figure 3. 4 Requirements
4.1 General
The report of acoustic output shall comply with the requirements of Chapter 5. The information presented in the random documents shall comply with the requirements of Chapter 8. To simplify the presentation of acoustic parameters, the following symbols are used to represent the various operating modes of medical diagnostic ultrasound equipment. A
A-type mode
Real-time B-type mode
Static B-type mode
M-type mode
Static pulsed Doppler mode
Continuous wave Doppler mode (continuous wave Doppler) Real-time blood flow imaging Doppler mode (color Doppler) Static blood flow imaging Doppler mode
Color M-mode mode
B-type and M-mode combined mode
B-type and pulsed Doppler combined mode
B-type and real-time blood flow imaging Doppler combined mode Combined mode of B-type, pulsed Doppler and M-mode Any single operating mode or combined operating mode different from the above should be explained by a concise note. If the above items are involved but the meaning is unclear, a definition should be given.
For all single operation modes, the general requirements of the technical content are: the acoustic output data shall be given in accordance with the requirements of 4.2, and the included modes shall be described (the acoustic output parameters (p- and Ic) of the composite operation mode do not exceed the levels of the specific single operation mode).
Note: The specific single operation mode does not have to be included in the modes that constitute the composite operation mode. For composite operation modes, the general requirements of the technical content are: if the system can only operate in one composite operation mode, the acoustic output data shall be provided in detail. If the composite operation mode has a larger (or maximum) (p- and I.p) value than the corresponding single operation mode of the system, the acoustic output data shall be provided in detail.
If the composite operation mode has a smaller (or minimum) acoustic output level (p- and Iapta) than the corresponding single operation mode of the system, the composite operation mode shall be called the included mode of the specific single operation mode. When specifying the acoustic output data of the composite operation mode, this purpose can also be achieved by specifying one or more single operation modes that play a major role.
GB16846—1997
The relevant pulses of one or more single operation modes that constitute the composite operation mode determine the acoustic output parameters (p_ and I.pta), and the composite operation mode is composed of the acoustic pulse sequence. Then the composite operation mode is composed of the above-mentioned single operation mode that plays a dominant role. In this case, the technical content of the acoustic output of the composite operation mode should be based on the single operation mode that plays a dominant role. Some systems can only work in the composite operation mode during diagnostic applications, but their internal test options allow them to work in the single operation mode for measurement purposes. For such systems, the acoustic output data of various types of acoustic pulses or single operation modes can be determined. For the composite operation mode, the correct application of pulse sequence theory can conveniently and reliably evaluate the results in the composite operation mode. When it is necessary to determine the output in the composite operation mode, this calculation method can be used. Single or composite operation modes may be composed of different types of acoustic pulse sequences that excite an acoustic scan line, such as a system working in a multi-segment focusing mode. In this case, the sound pressure parameter should be derived from the maximum sound output parameter value produced by a specific sound pulse sequence, such as: it should be determined from the excitation pulse of a specific focal area. However, Ipra should include the excitation pulses of all focal areas and take into account the superposition of adjacent ultrasound scan lines.
If the system settings when producing the maximum negative sound pressure (p_) are different from the settings when producing the maximum derived sound intensity (Ipt), the sound output of such equipment may need to be detailed with two sets of sound pressure and derived sound intensity parameters. When two sets of sound output parameters are required to specify the output of a certain operating mode, they should be distinguished by adding a superscript to the symbols used to represent the two sets of values ​​in accordance with 4.2. For example, for some Doppler systems, the symbol D. is used to represent the parameters and settings produced at the maximum sound pressure (p-), while D, is used to represent the parameters and settings produced at the maximum sound intensity (Ispt).
4.2 Requirements for the publication of sound output information
The information should be provided by the manufacturer in the following three ways: technical data sheets, accompanying documents/manuals, and background information provided upon request.
4.2.1 Information published in the technical data sheet The following information shall be included in the technical data sheet presented by the manufacturer to the potential purchaser of the equipment: A set of data for the following five parameters a) to e) shall be given for each transducer component and the main ultrasonic equipment. The maximum values ​​of the parameters a) to d) shall be selected from all the data for all modes in accordance with 4.2.2. The published data shall include the mode in which the maximum value is produced.
a) Maximum time-averaged sound power output (maximum power) For scanning mode, it shall be the total power of all sound pulse outputs, and it shall also be stated whether the power output can be controlled by the user; b) Peak negative sound pressure located in the plane perpendicular to the beam correction axis in the whole sound field and containing the point of maximum pulse sound pressure square integration (or the point of maximum average square sound pressure for continuous wave systems), c) Output beam strength,
d) Spatial peak time-averaged derived sound intensity For the whole sound field, e) Nominal frequency.
4.2.2 Information published in the random documents/manuals The following information shall be published in the random documents of the equipment. Data for all single operating modes shall be given. If the system can only work in the combined operating mode, refer to 4.1. In case of a request from a third party, all contents in this clause shall be subject to 4.2.3 Provide more detailed information. The acoustic parameters a) to d) shown should be the maximum values ​​of the specific transducer components and ultrasonic equipment host. If not specified, the working conditions involved in the remaining parameters should produce these maximum acoustic parameters. Note: Appendix A gives an example of the disclosure of the acoustic output of the automatic scanning system. The following information must be disclosed:
a) Maximum spatial average sound power output (maximum power) For scanning mode, it should be the total power of all acoustic pulse outputs; b) Peak negative sound pressure (p_) - located in the entire sound field perpendicular to the beam calibration axis and containing the square integral point of the maximum pulse sound pressure (or the maximum average square sound pressure point for continuous wave systems), c) Output beam sound intensity lob,
d) Spatial peak time-averaged derived sound intensity (Ip) - For the entire sound field, the scanning system should be for the central scanning line (the superposition effect of 90
scanning lines should be considered),
GB 16846—1997
e) Settings of the ultrasound equipment host (system settings) - System settings corresponding to the specific data in a) to d) above. If the system settings are different under a), b), c), and d), the system settings should be specified separately for different parameters; f) Distance between the output end face of the transducer and the point of maximum square integration of pulse sound pressure (for continuous wave systems, the maximum average square sound pressure) (Lp)
If the position of the spatial peak time-averaged derived sound intensity point in the ultrasound field is different from the position of the maximum square integration point of pulse pressure (for continuous wave systems, the maximum average square sound pressure), the distance between the output end face of the transducer and the Ispta point should also be given; Note: The above situation may occur in multi-segment focusing and/or sector scanning systems. g) 6dB pulse beam width (Wpb6) - Located at the point of maximum square integration of pulse pressure (for continuous wave systems, the maximum average square sound pressure). If the difference in beam width in different directions is greater than 10% of the maximum beam width, the beam width values ​​in two orthogonal directions should be given. The directions should be parallel to (II) and perpendicular to (I) reference directions. For scanning mode, it is the beam width of the center scanning line; h) Pulse repetition frequency (PRR) - for non-scanning mode, it is the scanning repetition frequency (SRR); i) Output beam size - the size parallel to () and perpendicular to (U) reference directions. In scanning mode, only the center scanning line is involved. In many cases, especially in contact systems, the geometric dimensions of the ultrasonic transducer or ultrasonic transducer array element group can be used; i) Arithmetic mean acoustic Working frequency (f) - measured when the hydrophone is placed at the point of maximum square integral of pulse sound pressure (maximum average square sound pressure point for continuous wave system),
k) Acoustic start-up coefficient;
1) Start-up mode - in the system where the start-up mode is defined by the user, "user defined" or "not applicable" (n/α) should be stated; m) Acoustic initial coefficient - if applicable, n) Initial mode - if applicable, in the system where the initial mode is defined by the user, "user defined" or "not applicable" (n/a) should be stated;
o) Acoustic output freeze - if the system has an acoustic output freeze function, "yes" should be stated, otherwise "no" should be stated. The following information is recommended to be published:
p) Distance from transducer to transducer output end face (Lt) if applicable; q) Transducer projection distance (L) - take its typical value, if the transducer component is in direct contact with the patient during normal use, it should be specified as a "contact" system.
If the maximum sound pressure (item b) above) produced by the system (front panel) settings of the equipment (such as sampling depth and sampling volume length in a Doppler system) is different from the system settings that produce the maximum spatial peak time-averaged derived sound intensity (item d) above), then two sets of data should be detailed for parameters b), d) to k) and m), one set should include the maximum sound pressure p- and the system settings or system parameters, and the second set should include the maximum spatial peak time-averaged derived sound intensity and the corresponding system settings or system parameters, and all required values ​​should be given in each set. This means that the two sets of data have the same form for parameters a), c), 1) and n) to q), which will ensure that one set of sound parameter data corresponds to the specific operating conditions of the equipment setting. From the current level of understanding, this set of data should be as complete as possible. For example, the sound pressure in the set corresponding to the system settings that produce the maximum Iap will be lower than the sound pressure in the second set of data corresponding to the system settings that produce the maximum sound pressure. The system settings for the above parameters a) and c) may be different from the system settings for parameters b) or d). In this case, the maximum power and Io may be given after the acoustic initial coefficient, as shown in Table A1 of Appendix A. The system settings corresponding to the maximum power and Io may be given in a footnote or on a separate line.
4.2.3 Background information
Any of the background information listed may be requested from the manufacturer. When providing background information, the relevant information for each mode shall be provided in accordance with 4.2.2.
If applicable, the operating conditions involved in the parameters shall correspond to the system settings that produce the maximum acoustic output level in 4.2.2. For automatic scanners that can only operate in a composite operating mode, the relevant information for each type of acoustic pulse that constitutes the composite operating mode shall be provided in accordance with 4.2.3.1 and 4.2.3.2.
When a mode consists of four or more different types of acoustic pulses, the background information shall be limited to 91% of the system settings that produce the maximum axial sound pressure square integral.If the transducer components are in direct contact with the patient during normal use, then the system should be specified as a "contact" system.
If the maximum sound pressure (item b) above) produced by the system (front panel) settings of the equipment (such as sampling depth and sampling volume length in a Doppler system) is different from the system settings that produce the maximum spatial peak time-averaged derived sound intensity (item d) above), then two sets of data should be provided in detail for parameters b), d) to k) and m), one set should include the maximum sound pressure p- and the system settings or system parameters, and the second set should include the maximum spatial peak time-averaged derived sound intensity and the corresponding system settings or system parameters, and all required values ​​should be given in each set. This means that the two sets of data have the same form for parameters a), c), l) and n) to q), which will ensure that one set of acoustic parameter data corresponds to the specific operating conditions of the equipment setting. From the current level of understanding, this set of data should be as complete as possible. For example, the sound pressure in the set corresponding to the system settings that produce the maximum Iap will be lower than the sound pressure in the second set of data corresponding to the system settings that produce the maximum sound pressure. The system settings for the above parameters a) and c) may be different from the system settings for parameters b) or d). In this case, the maximum power and Io may be given after the acoustic initial coefficient, as shown in Table A1 of Appendix A. The system settings corresponding to the maximum power and Io may be given in a footnote or on a separate line.
4.2.3 Background information
Any of the background information listed may be requested from the manufacturer. When providing background information, the relevant information for each mode shall be provided in accordance with 4.2.2.
If applicable, the operating conditions involved in the parameters shall correspond to the system settings that produce the maximum acoustic output level in 4.2.2. For automatic scanners that can only operate in a composite operating mode, the relevant information for each type of acoustic pulse that constitutes the composite operating mode shall be provided in accordance with 4.2.3.1 and 4.2.3.2.
When a mode consists of four or more different types of acoustic pulses, the background information shall be limited to 91% of the system settings that produce the maximum axial sound pressure square integral.If the transducer components are in direct contact with the patient during normal use, then the system should be specified as a "contact" system.
If the maximum sound pressure (item b) above) produced by the system (front panel) settings of the equipment (such as sampling depth and sampling volume length in a Doppler system) is different from the system settings that produce the maximum spatial peak time-averaged derived sound intensity (item d) above), then two sets of data should be provided in detail for parameters b), d) to k) and m), one set should include the maximum sound pressure p- and the system settings or system parameters, and the second set should include the maximum spatial peak time-averaged derived sound intensity and the corresponding system settings or system parameters, and all required values ​​should be given in each set. This means that the two sets of data have the same form for parameters a), c), l) and n) to q), which will ensure that one set of acoustic parameter data corresponds to the specific operating conditions of the equipment setting. From the current level of understanding, this set of data should be as complete as possible. For example, the sound pressure in the set corresponding to the system settings that produce the maximum Iap will be lower than the sound pressure in the second set of data corresponding to the system settings that produce the maximum sound pressure. The system settings for the above parameters a) and c) may be different from the system settings for parameters b) or d). In this case, the maximum power and Io may be given after the acoustic initial coefficient, as shown in Table A1 of Appendix A. The system settings corresponding to the maximum power and Io may be given in a footnote or on a separate line.
4.2.3 Background information
Any of the background information listed may be requested from the manufacturer. When providing background information, the relevant information for each mode shall be provided in accordance with 4.2.2.
If applicable, the operating conditions involved in the parameters shall correspond to the system settings that produce the maximum acoustic output level in 4.2.2. For automatic scanners that can only operate in a composite operating mode, the relevant information for each type of acoustic pulse that constitutes the composite operating mode shall be provided in accordance with 4.2.3.1 and 4.2.3.2.
When a mode consists of four or more different types of acoustic pulses, the background information shall be limited to 91% of the system settings that produce the maximum axial sound pressure square integral.
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