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YY/T 0644-2008: Ultrasonics-surgical systems. Measurement and declaration of the basic output characteristics
YY/T 0644-2008
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 range
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 di...