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YY 0781-2010

Chinese Standard: 'YY 0781-2010'
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BASIC DATA
Standard ID YY 0781-2010 (YY0781-2010)
Description (Translated English) Blood pressure transducers
Sector / Industry Medical Device & Pharmaceutical Industry Standard
Classification of Chinese Standard C39
Classification of International Standard 11.040.55
Word Count Estimation 23,266
Date of Issue 2010-12-27
Date of Implementation 2012-06-01
Quoted Standard GB 9706.1-2007; GB/T 1962.1-2001; GB/T 1962.2-2001
Adopted Standard ANSI/AAMI BP22-1994, MOD
Drafting Organization Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Administrative Organization National Standardization Technical Committee of Medical electrical equipment
Regulation (derived from) State Food and Drug Administration Notice 2010 No. 97
Issuing agency(ies) China Food and Drug Administration
Summary This standard applies to direct vascular catheter or puncture to measure blood pressure sensors, including cable. Although the requirements of this standard and the test is designed around the expected use of blood pressure measurement devices for research and design, but the blood pressure measurement of physiological parameters than can also use this sensor. Even though this standard focuses on blood pressure measurement sensors safety and efficacy, attention should also ensure that special sensors and blood pressure monitoring equipment compatibility. Scope of this standard is designed to measure blood pressure include indwelling catheter or by direct puncture of the sensor, cable safety and performance requirements, but also to the user to decide between the sensor and blood pressure monitoring device compatibility reference. Scope of this standard does not include the other is designed for measuring physiological parameters of the sensor, this standard does not elaborate sensors or monitoring equipment for the operation of the program, therefore, refer to the appropriate instruction manual for proper installation, balancing and calibration of the system is absolutely necessary The.

YY 0781-2010
Blood pressure transducers
ICS 11.040.55
C39
People's Republic of China Pharmaceutical Industry Standard
Blood pressure sensor
Released on.2010-12-27
2012-06-01 implementation
Issued by the State Food and Drug Administration
Table of contents
Foreword Ⅰ
1 Scope 1
2 Normative references 1
3 Definition 1
4 Requirements 3
5 test 5
Appendix A (informative appendix) The principle explanation of the development and proposal of this standard 14
Figure 1 The relationship between the standard accuracy error band of the blood pressure sensor and the applied pressure 5
Figure 2 Synchronous demodulator 6
Figure 3 Time course of combined test of drift, zero pressure temperature error band and sensitivity temperature error band 7
Figure 4 Circuit test connection 8
Figure 5 Frequency response parameter test 9
Figure 6 Oscilloscope common mode test 10
Figure 7 Oscilloscope phase shift test (the accuracy of all resistors is 1%) 10
Figure 8 Phase shift measurement Figure 11
Figure 9 Leakage current test 12
Figure 10 Defibrillator tolerance test 13
Preface
This standard uses the translation method to modify the American National Standard ANSI/AAMIBP22.1994 "Blood Pressure Sensor".
The main difference between this standard and ANSI/AAMIBP22.1994.Leakage current limit This standard is based on GB 9706.1-2007, ANSI/
The AAMIBP22.1994 standard is based on ANSI/AAMIBS1-1.
This standard has also made the following editorial changes. For other international standards cited in the standard, if they have been converted into Chinese standards accordingly, then
Subject to the quoted Chinese standards.
This standard is organized by the National Medical Electrical Appliance Standardization Technical Committee Medical Electronic Instrument Standardization Subcommittee (SAC/TC10/SC5)
Focus.
Drafting organizations of this standard. Shenzhen Mindray Biomedical Electronics Co., Ltd., Shanghai Medical Device Testing Institute.
The main drafters of this standard. Ye Jilun, Shi Daifeng.
Blood pressure sensor
1 Scope
This standard applies to pressure sensors that measure blood pressure via catheter or direct vascular puncture, including cables. Despite the requirements of this standard
And the test is developed and designed around the equipment with blood pressure measurement as its intended use, but the measurement of physiological parameters other than blood pressure
This sensor can also be used. Even if this standard focuses on the safety and efficacy of sensors for blood pressure measurement, it should also focus on ensuring dedicated sensors.
Compatibility of monitor and blood pressure monitoring equipment.
The scope of this standard covers the safety and performance of indwelling catheters or directly punctured sensors and cables designed to measure blood pressure.
At the same time, it also provides a reference for users to decide the compatibility between sensors and blood pressure monitoring equipment.
The scope of this standard does not include sensors that are designed to measure other physiological parameters. This standard does not elaborate on sensors or monitoring
The operating procedures of the equipment, therefore, referring to the appropriate instruction manual is absolutely necessary for the correct installation, balancing and calibration of the system.
Note. Please refer to Appendix A for the principle explanation of the formulation of the clauses and requirements of this standard.
2 Normative references
The clauses in the following documents become clauses of this standard after being quoted in this standard. For dated reference documents, all subsequent
The amendments (not including errata content) or revisions do not apply to this standard. However, all parties who have reached an agreement based on this standard are encouraged to study
Is the latest version of these files available? For undated references, the latest version is applicable to this standard.
GB 9706.1-2007 Medical electrical equipment Part 1.General requirements for safety (IEC 60601-1.1988, IDT)
GB/T 1962.1-2001 Syringes, injection needles and other medical devices 6% (Luer) tapered joints Part 1.General requirements
(ISO 594-1.1986, IDT)
GB/T 1962.2-2001 Syringes, injection needles and other medical devices 6% (Luer) tapered joints Part 2.Locking joints
(ISO 594-2.1998, IDT)
3 definition
The following terms and definitions apply to this standard.
3.1
Accuracy
The ratio of error (measured value minus true value) to true value (or theoretical value), expressed as a percentage.
3.2
Balance
When properly excited, the symmetry of the Wheatstone bridge or the zero condition of the output from the bridge.
3.3
Critical damping
The damping value required for the minimum settling time of a step input without overshoot.
3.4
Damping
An energy dissipation characteristic that determines the upper limit of the frequency response and response time of the sensor together with the natural frequency.
3.5
Damping coefficient
The ratio of the actual damping value to the critical damping value.
3.6
Force-sensitive membrane diaphragm
The sensing element is composed of a thin film between two volumes. The pressure difference between the two sides of the film will cause its deformation.
3.7
Electricalcalibration
Attached equipment calibration. In this process, through a calibration resistor placed on a bridge arm of the bridge, or placed in the excitation circuit
Press a proportional voltage divider to deliberately generate the electrical imbalance of the sensor to simulate a known pressure.
3.8
Incentive
The external voltage or current applied to make the sensor work normally.
3.9
Excitationimpedance
input resistance
The excitation source impedance measured from the sensor excitation terminal.
3.10
Frequency response frequencyresponse
When a sinusoidal pressure is input, the output amplitude ratio changes. For a two-order system, the frequency response is composed of the undamped natural frequency and
The damping coefficient is jointly determined.
3.11
15% passband 15 ndwidth
The frequency response amplitude corresponding to this frequency band is within ±15% of the flat low-pass frequency amplitude.
3.12
Hysteresis
The pressure input of a given value in a range, and when the positive stroke and the reverse stroke are close to the pressure value, a pressure measurement
The maximum difference output by the measuring device.
3.13
Point-based linearity
Non-linearity is expressed as the degree of deviation from a certain straight line passing through a given point or multiple points.
3.14
Resistive bridge sensor resistivebridgetransducer
The sensor can accept DC or AC current excitation, and its output is directly proportional to the product of applied pressure and excitation.
3.15
Resonantfrequency
Undamped natural frequency
When the damping coefficient of an electrical or mechanical system (second-order) is zero, the system will oscillate at a frequency.
3.16
Sensitivity
Under a given excitation voltage, the ratio of the change in sensor output to the change in pressure.
3.17
Signal impedance signalimpedance
Output impedance
The effective impedance that is connected across the output of the sensor and presented to the associated external circuit.
3.18
Symmetry
In the center of the sensor common-mode signal output between the excitation voltages.
4 requirements
4.1 Labeling requirements
The term "identification" refers to the printed text or marks that appear on the equipment, accessories or packaging, and all accompanying documents. In addition to regulations
In addition to the requirements applicable to the identification of all medical devices, the requirements contained in this article also apply to the equipment included in the scope of this standard.
4.1.1 Equipment marking
The equipment (or packaging, such as the outer packaging of disposable equipment) should be permanently and conspicuously marked with the following information.
a) Model;
b) manufacturer's name;
c) Serial number or other manufacturing control identification code;
d) Reusable electronic components should be marked with serial numbers or other control identification codes.
4.1.2 Manual
An instruction manual should be provided for each sensor or reusable cable, or in the case of multiple pieces, the instruction manual should be configured according to the order.
The instruction manual should include at least the following information.
a) Excitation voltage (or voltage range);
b) Excitation frequency (or frequency range);
c) The excitation impedance or the characteristics of the components at the excitation voltage and frequency specified in a) and b);
d) Sensor signal output impedance with certain tolerance;
e) If applicable, the maximum phase deviation or phase frequency characteristics within the excitation frequency range specified in b);
f) The nominal sensitivity of the ideal sensor output;
g) The sensor cable connected to the monitor connector and the corresponding monitor manufacturer, including a wiring board, makes the sensor connection
To the monitor to ensure convenient operation and safety;
h) Precautions and warnings about the storage, use, operation and sterilization of sensor components;
i) A list of accessories recommended for use with the sensor, including pressure transmission diaphragm, mounting brackets and other devices;
j) Recommended operating procedures for connecting the sensor to the hydraulic system;
k) If applicable, detailed instructions for the cleaning and sterilization of sensors, pressure transmission diaphragms and other related components;
l) In order to ensure the functional integrity of the equipment, instructions for the use, attention, storage, operation and maintenance of the sensor;
m) The name and address of the organization that can accept customer service;
n) The acceleration of the half-sine shock that the sensor can withstand on each axis, and still meet the requirements of 4.2, 4.2.3.7
The zero calibration range given may be increased to 150mmHg;
o) Under the condition of 25℃±1℃, within 4h after the recommended warm-up time, deviation from the maximum value of the initial sensor zero output,
Expressed in mmHg;
p) After the recommended warm-up time, the error of zero drift when the temperature changes from 25℃~15℃ and from 25℃~40℃
Range, expressed in mmHg;
q) The error range of sensitivity when the temperature changes from 25°C to 15°C and from 25°C to 40°C, relative to the sensitivity at 25°C
Expressed as a percentage;
r) Sensitivity of the sensor under the conditions of zero pressure (mmHg) input and 3300lx from a 3400K tungsten light source
The maximum error within the nominal excitation voltage range should be nominal.
4.2 Sensor performance requirements
4.2.1 Environmental performance
Unless otherwise specified, when the storage temperature is -25℃~70℃, the sensor should meet the performance requirements of 4.2 and its work
The conditions are as follows.
a) Working temperature. 15℃~40℃;
b) Humidity. 10%~90%, under non-condensing conditions;
c) Atmospheric pressure. 567kPa~1130kPa.
4.2.2 Mechanical requirements
When used together with the accessories or pressure transmission diaphragm recommended by the sensor manufacturer, and apply these accessories or
When transmitting pressure diaphragm, the following requirements cover the entire structure of this pressure sensor.
4.2.2.1 Pressure range
The sensor should work normally within the entire range of -30mmHg~300mmHg, and within -400mmHg~4000mmHg
It should not be damaged under the range of overvoltage conditions.
4.2.2.2 Installation requirements
When installed on any axis, the sensor should meet the performance requirements of 4.2.
4.2.2.3 Requirements for accessories
Luer connector or Linden connector meets the requirements of standards GB/T 1962.1-2001 and GB/T 1962.2-2001.
The adapter should enable the sensor to be connected to the needle or catheter.
4.2.2.4 Frequency response
All the integrated, reusable or disposable pressure transmission diaphragms recommended by the manufacturer are based on standards when operating in accordance with the manufacturer’s recommended procedures
"Evaluation of invasive blood pressure monitoring clinical systems" (AAMITIR9, Evaluation of clinical systems for invasive blood pres-
The frequency response of the 15% passband specified in suremonitoring) shall not be less than.200Hz.
4.2.3 Electrical performance
This article describes the electrical performance requirements of the functional monitoring system when the sensor or interface is coupled to a blood pressure monitoring device.
4.2.3.1 Sensor excitation
When the excitation is from direct current (DC) to 5000Hz and is in the range of 4V~8V (rms); or as noted in the instruction manual
Given the excitation voltage and frequency (range), the sensor should meet the requirements of 4.2.
4.2.3.2 Phase shift
In the case of sinusoidal excitation, within the excitation frequency range, the phase offset between the sensor's excitation and the signal (including cable) should be less than 5°, or
The relevant phase offset or phase characteristics should be indicated in the instruction manual.
Warning. The capacitive imbalance should be compensated to avoid affecting the phase shift measurement.
4.2.3.3 Sensor excitation impedance
For the excitation source from DC to 5000Hz, the excitation impedance of the sensor should be greater than.200Ω, or the needle should be indicated in the instruction manual.
The excitation impedance for the frequency range used.
4.2.3.4 Sensor signal (output) impedance
For the excitation source from DC to 5000Hz, the sensor signal output impedance should be less than 3000Ω, or the user manual should indicate the pin
The signal output impedance for the frequency range used.
4.2.3.5 Sensor symmetry
The increased impedance of any calibration or compensation bridge should be separated and maintain the common mode symmetry of the signal output terminal and the excitation terminal within ±5%
Internally, symmetry does not require a non-resistive sensor.
4.2.3.6 Sensitivity
Use the nominal sensitivity of 5μV/V/mmHg or use the sensitivity specified in the instruction manual to determine the accuracy of 4.2.3.8
Ideal output.
4.2.3.7 Maladjustment
For the sensor installed on any axis, its offset should be able to be adjusted internally within the range of ±75mmHg.
Note. The manufacturer of monitoring equipment should provide an adjustment range from 150mmHg to -150mmHg for pressure imbalance.
4.2.3.8 Accuracy (sexuality)
The total error of sensitivity, repeatability, nonlinearity and hysteresis should be less than ±1% of the reading of ±1mmHg (pressure range. -30mmHg~
50mmHg) or ±3% of the reading (pressure range. 50mmHg~300mmHg), the above error is taken into account in 4.2.3.6
The ideal output calculated from the nominal sensitivity should be measured afterwards (see Figure 1).
Figure 1 The relationship between the standard accuracy error band of the blood pressure sensor and the applied pressure
4.2.4 Safety requirements
4.2.4.1 Liquid isolation
The sensor (without isolation pressure diaphragm) should maintain electrical isolation between the liquid column and the container and all electrical terminals connected together.
Note. If the amplifier and sensor are provided by the sensor manufacturer as a system, the considerations are as in 4.2.4.1, 4.2.4.2 and 4.2.4.3
The liquid isolation requirements described are met by an isolation amplifier. Complete the test on the designated connector that can be connected to the monitor.
4.2.4.2 Leakage current
Add 110% of the grid power rating between the liquid column, the housing (bare metal, or any other) and the connected terminals
The limit of voltage and leakage current should meet the limit requirements of patient leakage current (applied part of the grid power supply voltage) specified in GB 9706.1-2007.
4.2.4.3 Defibrillation prevention
The sensor should withstand the discharge of a damped sine wave with an energy of 360J repeated 5 times within 5 minutes. When the fluid surface of the sensor is connected
When connected to one side, the cardiac defibrillation device is released to 50Ω, and at the same time the liquid column of the sensor is connected to one end of the 50Ω load, and the shell (bare metal)
Connect the other end of the load.
If there is a significant warning label on the sensor assembly that contains the following content, this requirement can be exempted.
Note. This pressure sensor does not have anti-defibrillation function, it must only be used for monitoring with patient interface marked as having anti-defibrillation function
equipment.
4.3 Cable requirements
The connecting cable assembly between the sensor and the cable connector should meet the following requirements.
a) The manufacturer shall announce the length of the cable;
b) The cable assembly should provide a vent for the sensor, so that the sensor measures the pressure relative to the atmospheric pressure;
c) The cable assembly should withstand (if there is no breakdown) within 5 minutes a damped sine wave discharge with an energy of 360J repeated 5 times. core
The wires are connected together at one end of the 50Ω load, and the cable sheath is wrapped with a 15cm-long metal foil to connect to the other end of the load.
5 test
This chapter will introduce the test methods and test procedures that can verify the sensor's compliance with the performance requirements of Chapter 4.These test routines
(Or equivalent test) can be suitable for design verification, but it is not necessary for quality assurance purposes or for testing in this field.
Required. Most of these tests are applicable to resistance strain type sensors and alternating current (AC) bridge type sensors. The manufacturer can use
Alternative technology to perform equivalent tests on test sensors. Except for the first number, the serial numbers of the articles in this chapter will correspond to those in Chapter 4.
The required serial number. For example. the test of 5.2.3 will determine the compliance with the standard of 4.2.3.For certain requirements, the compliance test can pass the visual
These will be explained in appropriate places. The conventional instruments and procedures for implementing these tests will be described next.
Test conditions. Unless otherwise specified, all measurements and tests should be within the rated temperature range of 20℃~25℃ and maintained
Within ±1℃ of the rated temperature (measurement accuracy is 0.25℃), 40%±20% relative humidity and 425mmHg~850mmHg
It is done under air pressure.
Combined test. Since the temperature characteristics of the sensor are included in the requirements, several tests need to be performed at different temperatures to confirm this
Some requirements. It should be noted that during each temperature operation in these combined tests, it is allowed to determine the temperature characteristics of the sensor and the entire
Operating characteristics of temperature range.
Test equipment. The following test equipment is required.
a) A differential input amplifier with a common-mode rejection ratio of at least 60dB in the 5kHz range, with a minimum input impedance of 1MΩ.
A dual-channel oscilloscope with a phase shift of less than 1° at 5kHz.
b) One can measure AC/DC voltage from 1mV to 10V, and has an input impedance greater than 10MΩ, 1μV resolution
Rate, and 0.1% reading accuracy of the digital voltmeter.
c) A signal generator capable of generating sine waves with a frequency range of 5000Hz. This signal generator should have a negative
Under load, the adjustable voltage output rises to a minimum of 10V (rms). Relative to the earth, the output voltage is floating, and
There is a minimum insulation resistance of 2MΩ to the earth at 5kHz.
d) A defibrillator that can apply a 360J damped sine wave to a 50Ω load.
e) A pressure source with an accurate range that can provide and read up to 300mmHg and accurate to ±0.2% at 100mmHg.
f) A vacuum pump that can provide up to -400mmHg and an accuracy of ±0.2% at -30mmHg.
g) A pressure waveform generator capable of generating a 25mmHg square wave pressure signal at 2Hz.
h) A can work beyond the excitation voltage and frequency range mentioned in 4.2.3.1, and the additional effect is less than
For a synchronous demodulator with ±0.5mmHg and a reading error of less than 0.2%, this test circuit is shown in Figure 2.
Note 1.Beckman resistor network 692-3-R1K-B.
Note 2.The cutoff frequency (-3dB) formed by R5, R6 and C6 is a low-pass filter at 338Hz.
Note 3.The input of the multimeter must be floating.
Note 4.All resistors are of type RN55D and expressed in ohms, and all capacitances are expressed in microfarads.
Figure 2 Synchronous demodulator
5.1 Marking requirements
Compliance with many labeling requirements of 4.1 can be determined by visual inspection. In order to verify the disclosure required in 4.1.2
Technical information, test procedures are necessary.
5.1.1 Equipment marking
The compliance verification required by 4.1.1 can be obtained through visual inspection.
5.1.2 Manual
The compliance of parts h) to m) in 4.1.2 can be verified by checking the instruction manual. Performance indicators from b) to g)
It is taken from the results obtained in the test procedures 5.2.3.1~5.2.3.4 and 5.2.3.6.
n) The sensor needs to withstand a half-sine shock on each axis. The magnitude of the acceleration should be equal to the nominal value. Experiencing
After these continuous shocks, test the imbalance (5.2.3.7), accuracy (5.2.3.8) and safety (5.2.4) of this sensor
Etc., the performance of the sensor should be consistent with the requirements in 4.2.3.7, 4.2.3.8 and 4.2.4.
o), p) and q) The following program combines the temperature error range for drift, zero pressure and sensitivity temperature error range
Test (see Figure 3).
Figure 3 Time course of combined test of drift, zero pressure temperature error band and sensitivity temperature error band
1) Equilibrate all parts at 25℃±1℃ for 2h.
2) Connect the pressure transmission diaphragm and other necessary parts of the measuring system, and fill them with distilled water.
3) Connect this sensor to the excitation source and digital multimeter (DMM) as shown in Figure 4, and set the digital multimeter to DC
20V range. Set switch S3 to the excitation (EXC) end, adjust the excitation source to output DC 6V voltage or frequency as
2.5kHz 6V AC sinusoidal signal (6.664rms), or set according to the manufacturer's instructions.
Note. The output of the synchronous demodulator circuit at V3 is equivalent to a full-wave rectified signal. For sinusoidal excitation, the reading is equivalent to a
The average value of the half period. The average sine value of one half cycle of the excitation voltage (hereinafter referred to as the AC average value) can also be used for any follower
No. output voltage to the conversion of equivalent mmHg readings. The synchronous demodulator circuit is also used for DC excitation, but it can be used in the special measurement for DC.
Try to get rid of. The conversion formula from RMS to AC average sine is.
AC average = effective value × 0.9003
4) Set DMM to DC 20mV range, turn switch S3 to TEST terminal, and measure the output signal.
5) Record the initial non-equilibrium reading (Z1), and start a 4h test cycle at 25℃±1℃. Plot under zero pressure
Output trend graph, and record the maximum value (unit. mmHg) that deviates from the initial reading during this time period.
6) Record the output readings of zero pressure and 100mmHg pressure changes as Z2 and S1 (refer to 5.2.3.6). Set up an environmental temperature control room
The temperature is 15°C. After waiting for 1h, the room temperature is constant within 15℃±1℃, and then record zero pressure and 100mmHg
Output readings of pressure changes (Z3 and S2). Following the same operation, change the temperature to 25°C, then to 40°C, and then back to
25℃, measure the output readings (Z4, Z5 and Z6) at each point under zero pressure, and measure at 100mmHg pressure change
40°C output reading (S3).
The zero-point drift error (expressed in mmHg) is the maximum value that deviates from the Z1 data point in more than 4 hours of measurement. Zero drift corresponding to temperature
The shift error band (expressed in mmHg) is the larger value among (Z3-Z2), (Z4-Z2), (Z5-Z2), (Z6-Z2). Corresponding to temperature
The sensitivity changes are.
(S2-S1)
S1 ×
100 or ±
(S3-S1)
S1 ×
100%
The larger of the two.
Figure 4 Circuit test connection
r) Prepare the sensor and a 3400K tungsten light source that can emit 914lx. Use the recommended excitation level to excite the sensor,
Cover the sensor with a black fabric, and insert a metal plate between the sensor and the light source. Adjust the output reading
Zero, remove the cover, and expose the sensor to this light source. Rotate the sensor to get the change in reading compared to when it is dark
For the maximum output, observe the change in output in mmHg units. Repeat this test within the incentive range claimed by the manufacturer,
In order to find the maximum response, report this maximum reading in mmHg.
5.2 Sensor performance requirements
5.2.1 Environmental performance
As environmental changes may affect performance requirements, procedures are described within the required range to ensure successful testing. Here some test
Test regulations. The temperature should be set to 15℃±1℃, Ts (see the test conditions in Chapter 5) and within 40℃±1℃, to verify 4.2.1
Performance within the specified entire environmental range. The sensor and cable assembly should be stored at -25°C for 24h, and then returned to room temperature to protect
Hold for 24h, then store at 70℃ for 24h, and finally put it back to room temperature before testing to evaluate the impact on performance requirements.
5.2.2 Mechanical requirements
5.2.2.1 Pressure range
The operating range characteristics will be tested during the accuracy test in 5.2.3.8.To test over-range performance, this sensor can be connected
Connect to appropriate test equipment, which has adequate protection for test equipment and personnel. The pressure should be able to increase to 4000mmHg
And keep it for 1s. After this pressure acts on the sensor, the sensor should also withstand a negative pressure of 400mmHg for 1s. Then again
The sensors are tested for deviation (5.2.3.7), accuracy (5.2.3.8) and safety (5.2.4).
5.2.2.2 Installation requirements
The sensor should be installed by a clamp in each of its three different positions. the upper part of the pressure-sensitive diaphragm, the lower part of the pressure-sensitive diaphragm, and the pressure-sensitive diaphragm.
For the vertical part of the membrane, the sensitivity (5.2.3.6), offset (5.2.3.7) and accuracy (5.2.3.8) of the sensor should be measured at each position.
Test.
5.2.2.3 Configuration requirements
Accessories should be tested in accordance with the procedures described in GB/T 1962.1-2001 and GB/T 1962.2-2001.
5.2.2.4 Frequency response
The following step response test procedure is used to measure the natural frequency Fn and damping coefficient of the sensor. These two values are used to calculate the transmission
15% passband of the sensor.
a) Connect the sensor to the excitation source as shown in Figure 4.Use an oscilloscope instead of DMM. Set the excitation voltage to 8.0V±0.5V
The DC voltage or AC sine wave with a frequency of 2.5kHz (effective value), or in accordance with the excitation method recommended by the manufacturer.
b) Turn on the power of the oscilloscope, set the sensitivity to 1mV/div, and the sweep time to 10ms/div.
c) Set the pressure generator according to the manufacturer's instructions, and fill the pressure chamber with water (just boiled) without air.
d) Connect the sensor to the pressure chamber and remove all bubbles in the pressure transmission diaphragm. Close the valve to close the fluid path.
e) Set the pressure generator to output a square wave signal with a frequency of 2 Hz.
f) Measure and record the interval time (tp) between the peak and peak values of the damped oscillation.
g) Measure the amplitude of the first peak (Mp) and the amplitude of the last peak (Mf).
h) Calculate overshoot (Mo) and damped resonance frequency (Fd) using the following formula (see Figure 5)
Mo=(Mp-Mf)/Mf=(Mp/Mf)-1
Fd=1/tp
i) Calculate the damping coefficient (D) and eigenfrequency (Fn) according to the following formula.
D= -InMo(π2 (InMo)2)0.5
Fn=Fd/(1-D2)0.5
j) Calculate 15% passband according to the following formula
F15=(0.208514)(Fn)(2(529D4-529D2 100)0.5-46D2 23)0.5
Figure 5 Frequency response parameter test
5.2.3 Electrical performance
Note. The phase shift (5.2.3.2), sensor excitation impedance (5.2.3.3) and sensor signal output impedance (5.2.3.4) are all for the resistance bridge sensor, and
Not suitable for AC type sensors.
5.2.3.1 Sensor excitation
Excitation frequency range and voltage range capability tests are included in other tests. such as phase shift (5.2.3.2), excitation impedance
(5.2.3.3), signal impedance (5.2.3.4) and accuracy (5.2.3.8) are being tested.
5.2.3.2 Phase shift
In order to ensure the accuracy of the measurement, a confirmation test for the common mode rejection and phase shift of the measurement system is recommended. This test uses
Lissajous plot to obtain a measurement of phase shift.
Common mode test. As shown in Figure 6, set the oscilloscope to scan mode and set the Y2 sensitivity to 2mV/div. Increase the output of the generator,
Until the deviation of Y1 is equal to 2V (peak-peak). The deviation of Y2 should be less than 2mV (peak-peak).
Figure 6 Oscilloscope common mode test
Phase shift test. As shown in Figure 7, set the oscilloscope to display in XY mode, and set the sensitivity of Y1 to 2V/div. Set the spirit of Y2
The sensitivity is 2mV/div. The measured phase shift should be less than 1°. The phase shift is the arc sine value of A/B, where A refers to the ring across the vertical axis
Curve width, B refers to the maximum value of vertical deflection.
Figure 7 Oscilloscope phase shift test (the accuracy of all resistors is 1%)
In order to measure the phase shift of the sensor, set the sensor as shown in Figure 8 and set the oscilloscope to XY mode. then.
a) Set the sensitivity of Y1 to 2V/div.
b) Set the sensitivity of Y2 to 2mV/div.
c) When no pressure is applied to the sensor, adjust CBAL and RBAL to balance the electric bridge in the sensor. This is on the oscilloscope
Shown as a closed loop similar to a straight vertical line.
d) Apply (approximately.200mmHg) pressure to the sensor to obtain a full-scale deflection on the oscilloscope.
e) The measured phase shift should be less than 5°, or the phase characteristics of the frequency range used should be indicated in the instruction manual.
5.2.3.3 Sensor excitation impedance
Connect the sensor as shown in Figure 4 and use a DC power supply. With S1 and S2 open, set V2 to 6V DC
Pressure, and measure V1.Under the condition that V2 is set to 6V AC average or AC 6.664V (rms), the frequency is 2kHz and
Repeat the above test at 5kHz. The minimum value calculated according to the following formula is the excitation impedance.
Zin=1000 V2V1-V2
(Ω)
Figure 8 Phase shift measurement diagram
5.2.3.4 Sensor signal impedance
Connect the sensor to the circuit shown in Figure 4, keep S1 closed and S2 open, and use a 6V DC power supply to apply about 100mmHg
The pressure to the sensor, and then read the value of V3 when S2 is open (V0) and S2 is closed (Vc). Set V1 to 6V AC
Under the condition of average [or AC 6.664V(rms)], repeat the above test at frequencies of 2kHz and 5kHz respectively. According to the following
The maximum value calculated by the formula is the signal impedance.
Zout=1000V0Vc-
÷1 (Ω)
5.2.3.5 Sensor symmetry
Connect the signal terminal and -signal terminal of the bridge sensor to form a /-signal terminal. Use 6V DC or AC average
Value to excite this sensor, and measure the voltage value from the negative excitation terminal to the /- signal terminal as Vx, and the voltage from the /- signal terminal to the positive excitation terminal
The pressure value is taken as Vy. Calculate the ratio of Vx/Vy. The ratio should be 1.0±0.05.
5.2.3.6 Sensitivity
The nominal sensitivity (Sn) is given in the instruction manual.
5.2.3.7 Offset offset
Connect the sensor as shown in Figure 4, keeping S1 closed and S2 open. Excite the sensor with 6V DC or AC average value,
Measure V3 and calculate the equivalent offset offset according to the following formula.
Un= V3SnVexc
(mmHg)
Sn is the nominal sensitivity (5.2.3.6), and the offset deviation should be within ±75mmHg.
5.2.3.8 Accuracy
Connect the sensor as shown in Figure 4, keeping S1 closed and S2 open. Use a calibrated good voltage source to provide 6V DC or
A sinusoidal signal with an AC average frequency of 2.5kHz excites the sensor, and a pressure source and a pressure gauge are connected to the sensor
The pressure gauge should have non-linearity and hysteresis. The total deviation is less than 0.2% of the reading. After experiencing the warm-up time recommended by the manufacturer
After that, apply pressure to the sensor in the following pressure sequence (mmHg (serial number). 0(1), 25(2), 50(3), 100(4),.200(5),
300(6),.200(7), 100(8), 50(9), 25(10), 0(11), -10(12), -30(13), -10(14), 0(15)]. (see picture 1)
The pressure values from 2 to 6 in the sequence all gradually increase from the lower pressure, and the pressure values from 7 to 13 are gradually reduced from the higher pressure.
The pressure values of 14 and 15 are lower, the pressure gradually rises. Therefore, this pressure source should meet the requirements. this pressure source is
The transition from pressure to the next should maintain a smooth transition without pressure overshoot or spikes. In order to avoid the reversal of the applied pressure,
The actual applied pressure can be ±10% deviation of the given value. Test the equipment in the given order and record the actual output measured.
The input pressure and the corresponding microvolt output voltage are used in explicit calculations. The voltage output at each required pressure value will be marked
Denoted as Vx, where X is the sequence count number corresponding to the data point. Similarly, Px is defined as the pressure reading of the reference pressure gauge at each data point
The unit is mmHg. Follow the steps below to analyze this data.
a) Subtract V1 from V1~V15.It is assumed that the pressure gauge used as a reference has no zero offset.
b) Calculate the error of each point (from 1 to 15) converted to mmHg according to the following formula.
Ex=Vx-V1SnVexc-
Px(mmHg)
Here Sn is the nominal sensitivity specified in the instruction manual, and the unit is μV/V/mmHg. For most sensors, the standard
The said sensitivity is 5μV/V/mmHg or 40μV/V/mmHg;
c) For points 1~3 and points 9~15, the maximum allowable error is ±1mmHg plus ±1% of the corresponding Px value.
d) For points 4~8, the maximum allowable error is ±3% of the corresponding Px value.
e) The test here should be based on the use of DC 4V and 8V or 2.5kHz AC RMS (3.6 and 7.2 AC average sine
Wave). The error band of accuracy is illustrated in Figure 1.
5.2.4 Safety requirements
5.2.4.1 Liquid isolation
The leakage current measurement in 5.2.4.2 describes the isolation of the liquid column, and the measurement will be performed at the connector connected to the monitor. This department
The system shall include any intermediate amplifiers provided by the sensor manufacturer as part of the sensor system.
5.2.4.2 Leakage current
As shown in Figure 9, a physiological saline column with an inner diameter of 1 mm and a length of 30 cm forms an electrical connection with the pressure-sensitive diaphragm of the sensor.
Pick up. Before testing, make sure that there are no air bubbles in the hydraulic system. Any exposed metal or intermediate amplifier (such as
If it is part of the sensor system) to the connector pin, and ground. 110% of the rated voltage of the grid power supply is applied to the normal saline column
Signal, and measure the patient leakage current specified in GB 9706.1-2007 (applied part of the grid power supply voltage).
Figure 9 Leakage current test
5.2.4.3 Anti-defibrillation ability
In the leakage current test device, a defibrillator with a damped attenuated sine wave is used to replace the 110% grid power supply, as shown in Figure 9.
Its output load is 50Ω. Connect a saline column to one end of the defibrillator load, and connect the electrical terminal and any bare metal
Connect to the other end of the defibrillator load. The defibrillator is charged so that it can output 360J of energy to a 50Ω load, and then through the load and transmission
The sensor discharges. This test is repeated every minute during the 5-min interval. By testing the sensor's offset offset (5.2.3.7), accurate
Confirmation (5.2.3.8) and leakage current (5.2.4.2) to verify that the sensor is functioning normally.
5.3 Cable requirements
The compliance verification required by a) and b) in 4.3 can be obtained through inspection.
c) Use conductive metal foil to wrap the cable with a length of 15cm. Connect the A terminal and B terminal of the defibrillator (with load) to the sensor
Between all the terminals (as shown in Figure 10) and the metal foil surrounding the cable. The defibrillator discharges within 5 minutes
This test is repeated every minute during the period. Check the cable for signs of breakdown, and then test the leakage current. Use a 110%
The signal source of the rated voltage of the network power supply replaces the defibrillator, and the leakage current is tested. The limit of this leakage current should comply with GB 9706.1-
2007 requirements.
Figure 10 Defibrillator tolerance test
Appendix A
(Informative appendix)
The principle explanation of the development and proposal of this standard
A.1 Introduction
Continuous monitoring of blood pressure using an indwelling needle or direct puncture has been widely used. These measurements are made by blood pressure sensors and monitoring
The combination of equipment to complete. About 95% of the pressure sensors that are mainly used to measure blood pressure are bridge-type, they can pass DC (AC)
To supply power, and these sensors are packaged with wire strain gauge bridges or silicon piezoresistive components. In addition, from the sensor's excitation characteristics, output
In terms of impedance range, excitation voltage requirements, sensitivity, zero adjustment range and other parameters, sensors are usually interchangeable and compatible with most monitors.
护设备. Except as otherwise stated in the sensor manual, these specific parameters all have a given index value.
Due to the limitation of excitation characteristics or the use of non-bridge imbalance balance of other technologies, the remaining 5% of the sensors used for blood pressure measurement are not
Meet all functional requirements of resistive bridge sensors, so unless a switching circuit is provided, their applications are limited to specific
Monitors, such as piezomagnetic sensors, differential transformer sensors, fiber optic sensors and capacitive bridge sensors. This part of the sensor
It has not been excluded from the requirements of this standard, but some modifications need to be made to the test procedures to evaluate the requirements of this standard.
Standardization of performance and safety alone is not enough to solve the interchangeability of pressure sensors. Although the same sensor can be used for different
Same as the manufacturer's monitor, but the configuration of the cable connector used does not form a uniform. Even if the configuration of the cable connector can fit a certain
For a given monitor, there is still no guarantee for the matching of the connection terminal distribution or the normal operation of the system.
Various monitors use reusable cables with disposable sensors. The industry has adapted to the lack of interchangeability between them.
All are specified by the monitor, but allow disposable sensors and catheter systems to be transferable.
Although pressure sensors are the most common for blood pressure measurement, these sensors can also be used for many other fluid-coupled physiological pressures.
Force measurement, such as the pressure in organs such as the brain, stomach, uterus and bladder. Therefore, the focus of this standard is blood pressure measurement, but as long as it
We have common components, and these sensors for other measurements cannot be excluded from this standard.
This standard only includes those sensors that are isolated and meet the recognized safe current range specified in the previous section, using conduits and direct sensors.
The puncture will introduce a conduction path directly to the heart.Even if the conductivity of this path is significantly lower than that of the intra-heart electrode, it is generally believed that this
Non-isolated sensors pose unacceptable risks to patients. Sensors that do not meet the anti-defibrillation requirements must have a warning label.
The label requires that this sensor can only be used with an isolated defibrillation-proof amplifier.
This standard cannot answer all questions about pressure monitoring systems. It focuses more on sensors and cable connector interfaces, and recognizes
Other new standards should be developed to work on pressure monitors, catheters, manifolds, valves, etc. The standard developed here only serves the present
And the technology in the near future, innovations for sensors and monitoring systems will no longer be adapted to this standard, and it will be necessary to develop other new standards at that time.
Pay attention to the performance of the new structure.
A.2 The necessity of formulating this standard
In 1974, the FDA established a classification group in the form of an advisory committee to determine how to best regulate
Cardiovascular medical equipment in the cloth. for example, it is classified into Class I equipment (general control), Class II equipment (performance standards), or Class III (pre-sale approval). This
This behavior also paved the way for the subsequent draft medical equipment amendments to the American Food, Drug, and Cosmetic Act (issued on 1976-5-18).
On February 5, 1980, the FDA finalized the decision to determine the blood pressure sensor as a Class II device, which was based on the cardiovascular equipment and anesthesia equipment classification group
On the final proposal.
The team recommends that the blood pressure sensor be identified as Category II, because this electronic device is neither life support nor life support
Even if it is used correctly, it still poses a potential hazard to life or health. If the equipment cannot properly provide accurate and precise
The misdiagnosis caused by blood pressure measurement can have a significant negative impact on the health of patients. This device is connected to a conduit system through internal pipelines
The blood in the system is in contact with the human body and is used in the clinical environment. Excessive leakage current will cause serious harm. because
Therefore, the electrical characteristics of this device, such as leakage current, need to meet certain requirements. Performance characteristics, including accuracy, repeatability, and
Any restriction on the function of blood pressure equipment should be maintained within a basically acceptable level of satisfaction, and users should be notified through special stickers.
If the equipment is used with other equipment in a system, if it cannot be assembled, used and maintained reasonably, it may also cause harm.
The group believes that a performance standard will provide a reasonable guarantee for the safety and effectiveness of the equipment, and that there is sufficient information to establish a standard.
Come to provide such a guarantee.
The final regulations can be found in 21CFR870.2850, the common name is the blood pressure sensor of peripheral blood vessels, in addition, in 21CFR870.2870
In, the catheter tip pressure sensor is also classified as Category II, therefore, both sensors need a performance standard.
A.3 Definition
A.4 The basic principles of the special clauses in this standard
A.4.1 Identification...
Related standard: YY 0782-2010    YY 0783-2010
Related PDF sample: YY 0896-2013    YY/T 1519-2017