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YY/T 0644-2008: Ultrasonics-surgical systems. Measurement and declaration of the basic output characteristics
---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/YYT0644-2008
Ultrasonics-surgical systems.Measurement and declaration of the basic output characteristics
ICS 11.040.01; 17.140.50
C41
People's Republic of China Pharmaceutical Industry Standard
YY/T 0644-2008/IEC 61847.1998
Basic output characteristics of ultrasound surgical systems
Measurement and publication
(IEC 61847.1998, IDT)
Released on.2008-04-25
2009-06-01 implementation
State Food and Drug Administration released
Foreword
This standard is equivalent to the use of IEC 61847.1998 "Measurement and publication of the basic output characteristics of ultrasonic surgical systems."
This standard changes the "this international standard" in the original text to "this standard" and makes a very small amount of editorial changes, which does not affect the degree of consistency.
Appendix A and Appendix B of this standard are informative annexes.
This standard is under the jurisdiction of the National Technical Committee for Standardization of Medical Ultrasound Equipment.
This standard was drafted. National Wuhan Medical Ultrasonic Instrument Quality Supervision and Testing Center.
The main drafters of this standard. Busan Anshi, Wang Zhiwei.
YY/T 0644-2008/IEC 61847.1998
Basic output characteristics of ultrasound surgical systems
Measurement and publication
1 Scope
This standard specifies.
--- The main non-thermal output characteristics of the ultrasound surgical system;
Note 1. One specific parameter involved is the output sound power. This standard only considers the low frequency component (below 100 kHz) of the total released energy, which may be related to
The cavitation-related high frequency components produced by the tip are not taken into account.
---Measurement method of output characteristics;
--- The characteristic parameters that the equipment manufacturer should publish.
Note 2. For the sake of simplicity, this standard does not consider all possible complex appearances and shapes of the tip of the treatment head. Explain the parameters and measurements in a straight line
The tip of the tube shape is taken as an example. If required, users of this standard apply more complex designs using the basic methods described in the standard.
The equipment to which this standard applies shall also meet the requirements of a), b) and c) below.
a) operate in the frequency range of 20kHz to 60kHz;
b) for the breaking or cutting of human tissue (regardless of whether these effects are related to the removal or solidification of the tissue);
c) Sound waves transmit energy to the surgical site through specially designed waveguides.
Note 3. Examples of this type of system are surgical aspirator, internal lithotripter, end cutting device, and the like.
This standard does not apply to.
--- A gravel device that introduces a pressure pulse in vitro and focuses through a liquid medium and human soft tissue;
---Surgical device (thermotherapeutic system) as part of the treatment process;
--- The surgical application where the acoustic application site is not at the tip of the longitudinal vibrating treatment tip and therefore does not conform to the unipolar model used in this standard.
Note 4. In this standard, the term “accuracy” refers to the total uncertainty at the 95% confidence level.
2 Normative references
The terms in the following documents become the terms of this standard by reference to this standard. All dated references, followed by all
Modifications (not including errata content) or revisions do not apply to this standard, however, parties to agreements based on this standard are encouraged to study
Is it possible to use the latest version of these files? For undated references, the latest edition applies to this standard.
IEC 60500.1974 IEC standard hydrophone
IEC 61205.1993 Measurement and publication of output characteristics of ultrasonic dental descaling systems
3 Terms and definitions
The following terms and definitions apply to this standard.
3.1
The part of the surgical system that is in direct contact with human tissue.
3.2
At a constant distance from the tip of the treatment tip, the sound pressure varies with the normalization of the angle.
Note. This parameter is important when working near the inner wall cells in stress- and motion-sensitive human structures such as the cornea and auditory nerves.
YY/T 0644-2008/IEC 61847.1998
Unit. dimensionless
3.3
The average frequency of the excitation voltage or current.
Note. Combining this parameter with the tip vibration displacement allows the user to estimate the vibration velocity at the tip of the treatment tip.
Unit. kilohertz (kHz)
3.4
For systems that modulate the type of electrical excitation power, the duration of the voltage or current pulse is consistent with the duration of the device's operation.
The ratio of continued time.
Symbol. Dcy
Unit. dimensionless
3.5
When the load at the tip of the treatment head is gradually increased from static (ie, no-load state, the same below), the peak input of the ultrasonic hand-held component
power.
Note. Peak electrical power occurs when the tip primary amplitude begins to decrease from its value corresponding to static (no-load) electrical power (see 6.9 and 6.10).
Symbol. Pmax
Unit. tile (W)
3.6
The acoustic power measured by the calorimetry method to the tip of the treatment head to the water (see 6.5).
Note. Measurement of the sound power emitted by the tip of the treatment head with different output areas and/or amplitudes contributes to the application of the ALARA principle (ie in a reasonable range)
Use as low a radiation level as possible).
Symbol. Pa
Unit. milliwatt (mW)
3.7
The sound power emitted by the tip of the treatment head to the water derived from the measurement of the hydrophone method (see 6.5).
Note. Measurement of the sound power emitted by the tip of the treatment head with different output areas and/or amplitudes contributes to the application of the ALARA principle (ie in a reasonable range)
Use as low a radiation level as possible).
Symbol. Pad
Unit. milliwatt (mW)
3.8
The ratio of the maximum electrical power to the static (no-load) electrical power.
Note 1. The power reserve index allows the user to understand how much (extra) backup is required to maintain a constant tip amplitude under varying load conditions.
Power margin.
Symbol. Pi
Unit. dimensionless
Note 2. Only for devices using the same working mode, can directly compare the power reserve index of different devices, and perform piezoelectric and magnetostrictive devices.
Comparison is meaningless.
YY/T 0644-2008/IEC 61847.1998
3.9
The projected area of the solid portion of the tip of the tip is treated in the direction of the major amplitude of the tip.
Note. For different tips operating at the same amplitude and frequency, the primary acoustic output area is used to determine the energy radiated by the treatment tip (tip) end face.
Symbol. Aap
Unit. square millimeter (mm2)
3.10
The peak-to-peak displacement of the tip of the treatment head in the direction of maximum amplitude, the measurement point is located at the tip of the treatment tip at a free end (end) not exceeding
1mm (see 3.2 of IEC 61205.1993).
Note. The ability to break tissue is related to the dominant amplitude of the tip.
Symbol. 狊p
Unit. micron (μm)
3.11
For systems that modulate the type of electro-active power, the percentage change in tip main amplitude from maximum to minimum.
Symbol. Msp
Unit. dimensionless
3.12
For systems that modulate the electric excitation power class, the excitation voltage or current first exceeds the reference value and the excitation voltage or current finally
The time interval before returning to the reference value once. The reference value is equal to the minimum excitation voltage or current plus the maximum and minimum excitation voltage or current
10% difference.
Unit. millisecond (ms)
3.13
The (peak) electrical power input to the ultrasonic handpiece for a given tip primary amplitude when the tip of the treatment tip is unloaded.
Symbol. Pq
Unit. tile (W)
3.14
For the combination of measured treatment tip and hand held components, the maximum tip primary amplitude.
Note. The reference tip main amplitude is used in order to obtain the static (no-load) electrical power and maximum electrical power values required for the power reserve index of the computing device.
Symbol. 狊pr
Unit. micron (μm)
3.15
The projected area of the exposed portion of the tip of the treatment tip in a direction perpendicular to the major amplitude of the tip and corresponding to the submaximal motion component.
Symbol. Aas
Unit. square millimeter (mm2)
Note. The definitions of 3.9 and 3.15 are used to simplify the shape of the tip of the treatment head to the basic area given when the tube is straight. They cannot fully include a specific device.
A complex tip shape that can be found.
YY/T 0644-2008/IEC 61847.1998
3.16
In the direction perpendicular to the main amplitude of the tip and corresponding to the submaximal motion component, the peak-to-peak displacement of the tip of the treatment head, the measurement point is located in the treatment
The tip of the head is no more than 1 mm near its free end (end).
Symbol. 狊s
Unit. micron (μm)
3.17
The fundamental frequency of the tip of the treatment head is oscillated (see 3.3 of IEC 61205.1993).
Unit. kilohertz (kHz)
4 symbol table
Aas infrasound output area
Aap main sound output area
犮 media sound speed
Dcy work cycle
Msp tip main amplitude modulation
Pa output sound power
Pad derived output sound power
Pi Power Reserve Index
Pq static (no load) electric power
Pmax maximum electric power
狊p tip main amplitude
狊pr reference tip main amplitude
狊s tip lateral amplitude
ρ measure the density of the medium
5 General measurement requirements
5.1 Working conditions
The parameters to be measured should be set under the conditions recommended by the manufacturer. The parameters considered are.
--- Ambient temperature;
--- tip injection flow rate;
--- tip amplitude;
--- Tip inhalation flow rate.
In practical surgical applications, the parameters listed above are not independently set. Therefore, when studying a specific surgical environment, it should be specified
YY/T 0644-2008/IEC 61847.1998
The above parameters are used to make a meaningful comparison of performance (see Chapter B.5).
5.2 Load conditions
5.2.1 Measurement of the derived output sound power
When deriving the output sound power or output sound power measurement, degassing water should be used (see Chapter A.6 for the principle and method of degassing technology).
The sink is lined with sound absorbing material, and the size of the sink should be suitable for the frequency of the tip vibration involved, so that there is substantially no echo, ie free field conditions.
In addition, for a surgical system with an attractive function, the tip is minimized by a sufficient flow of fluid from the front surface of the tip.
5.2.2 Measurement of static (no-load) electrical power
When measuring the static (no-load) electrical power of an ultrasonic handpiece, all flow systems should be actuated and the tip of the treatment head placed empty
In the air.
5.2.3 Measurement of maximum electric power
When measuring the maximum electrical power of the ultrasonic hand-held component (this power just before its maximum offset value begins to decrease), it shall be measured according to 5.2.2.
Said, but the tip of the tip of the treatment head is located in the sound absorbing material, so that the treatment head is subjected to the load without being damaged.
5.3 Preparation for measurement
5.3.1 Preparation of treatment head
All surfaces and components of the treatment head should be clean before any measurements are taken, and the tip of the treatment head in contact with water and detergent should be super
The acoustic hand-held parts and measuring devices are washed with detergent and rinsed with warm water.
5.3.2 Preparation of water
Deaerated water should be used.
5.3.3 System Preparation
The device under test is preheated at the time specified by the manufacturer. If the manufacturer does not specify a warm-up time, the warm-up time should be long enough for the equipment
A stable working condition is reached, but no more than 15 minutes.
6 Measurement steps
6.1 Tip main amplitude
The tip main amplitude is measured using one of the following methods, and the accuracy of the vibration offset measurement should be within ±10%.
6.1.1 Optical microscopy
The microscope was focused on one end within 1.0 mm of the tip of the treatment tip and illuminated with a light beam. When the device is working, this point
The trajectory is a straight line. Changing the relative orientation of the tip of the treatment head and the microscope makes the straight line the longest. The length of the line is equal to the tip of the main vibration
The frame should be measured with an eyepiece or micrometer with an accuracy better than ±10% and calibrated over the scale. If there is lateral vibration at the same time, the treatment head
The point is the trajectory of the ellipse, at which point the long axis length of the ellipse should be measured (see Figure 1).
6.1.2 Laser Vibration Meter Method
The output beam spot size of the laser vibrometer should be small enough to focus on the end of the tip of the treatment tip, and the beam should be directly parallel to
The longitudinal axis of the tip vibration is in line with the direction of the measured tip amplitude. The output of the vibrometer control unit is in the manufacturer of the laser vibrometer
Display and record on the instrument.
6.1.3 Feedback Voltage Method
For devices having a feedback system that is directly coupled to the amplitude of the mechanical tip, the feedback voltage is proportional to the leading amplitude of the tip. For a specific group
For the combined ultrasound handpiece and treatment head, the feedback voltage should be calibrated according to the amplitude of the tip using optical microscopy of 6.1.1.
An oscilloscope display with an accuracy of ±2% for time base and ±2% accuracy for vertical deflection amplifier for optical measurement according to 6.1.1
Feedback voltage. Once the calibration is complete, the amplitude of the tip is obtained by simply observing the feedback voltage.
YY/T 0644-2008/IEC 61847.1998
Figure 1 Measurement of tip main vibration offset and secondary vibration offset
6.2 Tip lateral amplitude
The lateral amplitude of the tip is measured by optical microscopy and the accuracy of the amplitude measurement should be better than ±10%.
The method is as described in 6.1.1, but when monitoring the length of the elliptical short axis, the tip of the treatment head should first rotate around its main axis of vibration, the measured ellipse
The maximum length of the short axis of the circle is taken as the lateral amplitude of the tip (see Figure 1).
6.3 Excitation frequency
The excitation frequency measurement uses one of the following methods, and the accuracy of the excitation frequency measurement should be better than ±2%.
6.3.1 Frequency meter method
A frequency meter should be used to determine the frequency of the excitation voltage or current acting on the ultrasonic handpiece. There are two kinds of signal acquisition available.
Choice. one is to connect the appropriate shielded cable directly to the circuit load specified by the manufacturer, and the other is to wrap the ultrasonic hand-held component
Winding the coil and feeding the sensing signal to the frequency meter.
6.3.2 Spectrum Analyzer Method
A spectrum analyzer with a frequency range of not less than 10 kHz to 100 kHz should be used to determine the frequency of the excitation voltage or current. Signal
The acquisition method should be connected to the circuit according to the load specified by the manufacturer.
YY/T 0644-2008/IEC 61847.1998
6.4 Tip vibration frequency
The measurement of the tip vibration frequency is performed by one of the following methods, and the accuracy of the tip vibration frequency measurement should be better than ±2%.
6.4.1 Vibration meter method
A non-contact vibrometer should be used to obtain the frequency of the tip of the treatment head, using an electronic frequency meter, spectrum analyzer or calibration time base
The waver measures the output signal of the vibrometer.
6.4.2 Hydrophone method
The frequency of the sound pressure at the tip of the treatment head is measured with a hydrophone according to IEC 60500. The hydrophone should be placed at the tip of the treatment head
A range of 30mm to 100mm distance to reduce the effects of nonlinear propagation. Use an electronic frequency meter, spectrum analyzer or calibrated time base
The waver measures the frequency of the hydrophone output.
6.5 Outputted output sound power and output sound power
The derived output sound power and output sound power shall be determined by the methods specified in 6.5.1 and 6.5.2, respectively.
6.5.1 Exported output sound power - hydrophone method
The method is based on the use of a calibrated hydrophone, and the uncertainty of the measured output sound power should be within 20%. Due to the method
As a unit-based hydrophone, and a method of measuring at a single distance from the tip of the treatment tip, you have to choose the ideal to exclude the integral sound pressure field.
The possibility of cavitation occlusion is required and avoided (see Chapter A.4). Hydrophones according to IEC 60500 at known distances from the tip of the treatment head
The measured sound pressure is measured and then the derived output acoustic power value is calculated for any tip amplitude using a monopole or dipole model (see below). rule
The head is positioned such that the axis of symmetry of the main amplitude of the tip coincides with the plane geometric axis of the hydrophone guide.
For the tip of the treatment head that acts as a sound source that reciprocates in the direction of the main amplitude of the tip (which is smaller than the wavelength in the acoustic medium),
Considered as a unipolar sound source. In general, the ultrasonic surgical device is deeply immersed in the water tank, and the derived output sound power is calculated by the formula (1) (see
Section A. Chapter 8).
(1)
In the formula.
ρ---measure the density of the medium;
犮---The speed of sound in the medium.
However, many devices are designed with the tip of the treatment head in contact with the tissue while the other parts of the treatment head are located outside the body. For such devices
The tip of the treatment tip should be positioned so that it is immersed in water approximately 1/4 wavelength in water. For this special case (whether for measurement
The convenience is also to reflect the unipolar source from the water/air interface in order not to superimpose the energy radiated by the hand-held component that is not in contact with the tissue. This
The resulting effective auxiliary monopole source is exactly 180° out of phase with the monopole tip source, so this combination just forms the dipole source.
In this case, the immersed water at the tip of the treatment tip is approximately 1/4 wavelength long, and the derived output sound power is given by equation (2).
2ρ犮
(2)
In the formula.
The hydrophone shall comply with the requirements of IEC 60500 and measure the sound pressure from a defined distance between the tip axis and the water surface (see Figure A.2).
The derived output sound power of any tip amplitude required can then be calculated using the dipole source model described above.
YY/T 0644-2008/IEC 61847.1998
Figure 2 Example of the main sound output area
6.5.2 Output sound power---calorimeter method
The repeatability of this alternative measurement method is much worse than the hydrophone based method specified in 6.5.1. However, it can still be used as a
An approximate means of use.
The tip of the tip of the treatment tip should be inserted into a calorimeter containing a sound absorbing liquid to determine the rate of temperature rise of the fluid and used to calculate the treatment head.
The power delivered. It is important to note that the depth of insertion of the tip of the treatment head will affect the results obtained by this method (see [1] and [3]).
6.6 Directional pattern
The directional pattern (distribution of the sound field) should be measured by measuring the angular distribution of the amplitude of the sound pressure around a certain center of rotation at a specific distance.
determine. The hydrophone shall comply with the requirements of IEC 60500 and install the hydrophone on a circular orbit. It moves 180° in the sink in the sink
move. The treatment head is positioned such that the axis of symmetry of the main amplitude of the tip coincides with the geometric axis of the hydrophone track.
Note. For a linearly symmetric treatment tip, the direction of maximum amplitude coincides with the axis of symmetry of the treatment head. However, for curved or meandering tips,
The tip end of the tip is at an angle to the axis of the ultrasonic handpiece (therapeutic head).
For devices designed to be in contact with tissue at the tip of the treatment head while the rest of the treatment head is located outside the body. The tip of the treatment head
The position should be such that it is immersed in water below the surface of the measuring vessel by a length of approximately 1/4 wavelength in the water. In this case, the center of rotation should be in the water
The intersection of the surface and the axis of rotation of the tip of the treatment head (see Figure 3).
For percutaneous puncture, the elongate treatment head tip is mostly located in the body. The tip of the treatment head can be deeply immersed in the measurement volume
In the water. In this case, the center of rotation should be the end of the tip of the treatment tip.
For each of the above cases, the installed hydrophone should have the same sensitivity in all directions of the tip of the treatment head, hydrophone and treatment tip.
YY/T 0644-2008/IEC 61847.1998
The spacing of the ends and the depth of the tip of the treatment tip immersed in water should be recorded. The distance between the tip of the treatment head and the hydrophone during the measurement
The change should be in the range of 2mm.
Figure 3 Measurement of the sound field
6.7 Tip main amplitude modulation
The tip amplitude modulation is measured using a laser vibrometer method, and the accuracy of the measurement should be within ±15%.
The method described in 6.1.2 is used to determine the change in amplitude during the modulation period. The tip main amplitude modulation Msp is expressed as a percentage.
(3) Given.
Msp = {(狊pon-狊poff)/狊pon}×100(%) (3)
In the formula.
狊pon---the peak amplitude of the tip during work;
狊poff---the main amplitude of the tip during the stop.
6.8 duty cycle
For systems that modulate the electrical excitation power, the duty cycle is determined by the method described below.
An oscilloscope with a time base accuracy of ±2% and a vertical deflection amplifier accuracy of ±2% displays the excitation voltage or current. Determine maximum
And the minimum peak-to-peak excitation level.
Note. It is assumed here that the peak-to-peak voltage or current is measured and its minimum peak-to-peak level can be zero or not zero.
The minimum excitation voltage or current plus 10% of the difference between the maximum and minimum excitation voltages or currents is used as the reference level. Scope sweep
Dcy =
(5)
YY/T 0644-2008/IEC 61847.1998
Figure 4 Example of a method for determining the duty cycle from the oscilloscope scan trace
The level indicated by the dashed line is equal to the minimum peak-to-peak level plus 10% of the difference between the maximum and minimum peak-to-peak values.
6.9 Static (no-load) electric power
Set the tip main amplitude to its maximum level and then measure directly using a wattmeter with phase correction designed for ultrasound applications
Enter the electrical power of the ultrasonic handheld component, requiring an accuracy of ±10%.
6.10 Maximum electric power
Set the tip main amplitude to the maximum value, then directly measure and lose using the phase-corrected electric power meter designed for ultrasonic applications.
The electrical power of the ultrasonic hand-held component is required to be ±10% accurate. In the water tank shown in Figure 5, the simulation is added to the main amplitude direction of the tip.
Surgical tip load, loading should use materials that do not damage the tip of the treatment tip, such as open cell foam or other aqueous media. Loading material
The density of the material should be sufficient to drive the electrical power of the input ultrasonic handpiece to a maximum and reduce the primary amplitude of the reference tip. As the load increases
The electrical excitation power is measured and it is noted that the maximum power value occurs just before the tip main amplitude begins to decrease from its maximum amplitude.
Note. The tip primary amplitude can be monitored using the method described in 6.1.3.
YY/T 0644-2008/IEC 61847.1998
6.11 main sound output area
For a specific hollow cylindrical treatment tip, the main sound input can be calculated by measuring the inner and outer diameters of the tip of the hollow tubular treatment tip.
Out of area. The main sound output area is the projected area of the ring formed by two diameters, and the formula is (6) (see Figure 2).
Aap = π4
In the formula.
6.12 Secondary transverse vibration output area
For a particular hollow cylindrical treatment tip, the secondary transverse vibration output area can be calculated. In the direction of the lateral amplitude of the tip,
(7) is the formula for calculating the output area of the secondary transverse vibration from the projected rectangle (see Figure 6).
In the formula.
Figure 6 Example of secondary transverse vibration output area
6.13 Power reserve index
The power reserve index is used to indicate the maximum effective input power Pmax and to maintain the vibration of the surgical handpiece when there is no external (tissue) load.
The relationship between the required electric power Pq, the power reserve index is given by equation (8).
Pi=PmaxPq
(8)
See note 4 of Chapter 7.
7 Announcement of output characteristics
The following characteristics should be published in a random file of the ultrasound surgical system.
YY/T 0644-2008/IEC 61847.1998
Note 1. See Section B for the rationality of using these parameters. Chapter 4.
--- the reference tip main amplitude of each type of treatment tip (ie, the maximum tip main amplitude);
--- The main s...
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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