阅读说明：本技术 血压模拟器性能测试装置及方法 (Blood pressure simulator performance testing device and method ) 是由 王灿 张忠立 林正皓 冯齐斌 刘贝贝 徐煦 秦亭亭 于 2021-08-19 设计创作，主要内容包括：一种血压模拟器性能测试装置,包括：微处理器；动态压力传感器,该传感器的输入端连通所述血压模拟器；数据采集器,该数据采集器的输入端连接所述动态压力传感器的输出端,该数据采集器的输出端连接所述微处理器,所述数据采集器的采样频率至少为100kHz,远高于所述血压模拟器的工作频率。该血压模拟器用于基于示波法的电子血压计的计量。(A blood pressure simulator performance testing device comprising: a microprocessor; the input end of the dynamic pressure sensor is communicated with the blood pressure simulator; the input end of the data acquisition unit is connected with the output end of the dynamic pressure sensor, the output end of the data acquisition unit is connected with the microprocessor, and the sampling frequency of the data acquisition unit is at least 100kHz and is far higher than the working frequency of the blood pressure simulator. The blood pressure simulator is used for measuring an electronic sphygmomanometer based on an oscillometric method.)

1. A blood pressure simulator performance testing device, characterized in that, this testing device includes:

a microprocessor;

the input end of the dynamic pressure sensor is communicated with the blood pressure simulator;

the input end of the data acquisition unit is connected with the output end of the dynamic pressure sensor, the output end of the data acquisition unit is connected with the microprocessor, and the sampling frequency of the data acquisition unit is at least 100kHz and is far higher than the working frequency of the blood pressure simulator.

2. The blood pressure simulator performance testing device of claim 1, wherein the blood pressure simulator is used for oscillometric based electronic sphygmomanometer metering.

3. The device for testing the performance of a blood pressure simulator of claim 1, wherein the dynamic pressure sensor is in communication with the blood pressure simulator using a hose.

4. The blood pressure simulator performance testing device of claim 2, further comprising a static pressure sensor for static pressure testing.

5. The blood pressure simulator performance testing device of claim 2, further comprising,

the display is used for displaying the test result;

and the operation panel is used for setting and controlling parameters of the test process.

6. The blood pressure simulator performance testing device of claim 1, wherein the testing method of the testing device comprises,

comprises a group of systolic pressure, diastolic pressure and average blood pressure points, heart rate and pulse rate,

setting different adjusting step lengths, carrying out continuous signal acquisition and repeatability analysis,

acquiring the corresponding pressure wave amplitude value of the blood pressure point to obtain a corresponding pulse envelope wave,

continuously collecting a plurality of pulse wave curves, evaluating test results point by point, and analyzing the indication repeatability of the blood pressure simulator under the group of blood pressure points.

7. The blood pressure simulator performance testing device of claim 6, wherein the testing method further comprises,

collecting pulse wave curves generated by the blood pressure simulator at different blood pressure points,

calculating the pulse wave amplitude corresponding to the average pressure and the ratio of the systolic pressure/diastolic pressure to the average pressure,

and correlating the pulse wave amplitude corresponding to the average pressure obtained by calculation and the ratio of the systolic pressure/diastolic pressure to the average pressure with the blood pressure point, the heart rate and the pulse volume set by the blood pressure simulator, and establishing a linear regression model, so as to calculate the relationship between the blood pressure simulation mode of the blood pressure simulator and the corresponding pulse wave and the calculation model when the average pressure, the systolic pressure and the diastolic pressure are calculated.

8. A method for testing the performance of a blood pressure simulator is characterized by comprising the following steps,

communicating the dynamic pressure sensor with the blood pressure simulator through a hose;

sampling the output of the dynamic pressure sensor by adopting a data acquisition unit with the sampling frequency of at least 100 kHz;

setting the blood pressure simulator, wherein the blood pressure simulator comprises a group of systolic pressure, diastolic pressure and average blood pressure points, heart rate and pulse rate;

setting different adjusting step lengths, and carrying out continuous signal acquisition;

acquiring the corresponding pressure wave amplitude value of the blood pressure point to obtain a corresponding pulse envelope wave,

continuously collecting a plurality of pulse wave curves, evaluating test results point by point, and analyzing the indication repeatability of the blood pressure simulator under the group of blood pressure points.

9. The method for testing the performance of a blood pressure simulator according to claim 8, further comprising,

collecting pulse wave curves generated by the blood pressure simulator at different blood pressure points,

calculating the pulse wave amplitude corresponding to the average pressure and the ratio of the systolic pressure/diastolic pressure to the average pressure,

and correlating the pulse wave amplitude corresponding to the average pressure obtained by calculation and the ratio of the systolic pressure/diastolic pressure to the average pressure with the blood pressure point, the heart rate and the pulse volume set by the blood pressure simulator, and establishing a linear regression model, so as to calculate the relationship between the blood pressure simulation mode of the blood pressure simulator and the corresponding pulse wave and the calculation model when the average pressure, the systolic pressure and the diastolic pressure are calculated.

Technical Field

The invention belongs to the technical field of metering test, and particularly relates to a device and a method for testing the performance of a blood pressure simulator.

Background

The electronic sphygmomanometer based on oscillography is a human sphygmomanometer which is the most widely used, and is an important measuring instrument for national folk life and medical safety. The blood pressure simulator is the most widely used and most important measuring standard instrument for evaluating the oscillometric sphygmomanometer. Therefore, the measurement performance testing technology of the blood pressure simulator plays a significant role in the magnitude traceability chain of the blood pressure meter.

Disclosure of Invention

In one embodiment of the present invention, a performance testing apparatus for a blood pressure simulator is used for measuring an electronic sphygmomanometer based on an oscillometric method. The test device includes:

a microprocessor;

the input end of the dynamic pressure sensor is communicated with the blood pressure simulator;

the input end of the data acquisition unit is connected with the output end of the dynamic pressure sensor, the output end of the data acquisition unit is connected with the microprocessor, and the sampling frequency of the data acquisition unit is at least 100kHz and is far higher than the working frequency of the blood pressure simulator.

Drawings

The above and other objects, features and advantages of exemplary embodiments of the present invention will become readily apparent from the following detailed description read in conjunction with the accompanying drawings. Several embodiments of the invention are illustrated by way of example, and not by way of limitation, in the figures of the accompanying drawings and in which:

FIG. 1 is a schematic diagram of a test apparatus according to an embodiment of the present invention.

FIG. 2 is a schematic diagram of a testing apparatus according to an embodiment of the present invention.

FIG. 3 is a schematic diagram illustrating the effect of a testing device on pulse envelope analysis according to an embodiment of the present invention.

Detailed Description

The blood pressure simulator is generally composed of an input/output unit, a data processing unit, a pressure generating unit and the like, when in use, the simulator is connected with a sphygmomanometer through an internal or external cuff, a group of pulse waves are generated according to the corresponding relation of pulse waves, cuff pressure and blood pressure values preset in the simulator, and the connected sphygmomanometer is used for capturing the generated pressure pulsation, so that the blood pressure of a human body is simulated.

With the development of the sphygmomanometer measurement technology, the indication error requirement of the noninvasive sphygmomanometer is improved to +/-3 mmHg by the existing international suggestion OIML R149-1. Therefore, the measurement performance requirement of the blood pressure simulator is correspondingly improved, the requirement of the repeatability of the indication value of the blood pressure simulator needs to be improved to +/-1 mmHg so as to detect the noninvasive sphygmomanometer which meets the international recommendation, and the blood pressure simulator with the precision can not be detected by the existing detection technology and device.

Based on the situation, the invention discloses a portable and integrated performance testing device aiming at parameters such as static pressure range and error of a blood pressure simulator, simulated blood pressure range, simulated blood pressure indicating value repeatability and the like, so as to ensure that the value tracing of the blood pressure simulator is accurate and reliable, and further maintain the value tracing chain of the noninvasive automatic measuring sphygmomanometer based on the oscillography.

In accordance with one or more embodiments, as shown in fig. 1, a blood pressure simulator performance testing apparatus includes: a microprocessor; the input end of the dynamic pressure sensor is communicated with the blood pressure simulator through a hose; the input end of the data collector is connected with the output end of the dynamic pressure sensor, the output end of the data collector is connected with the microprocessor, and the sampling frequency of the data collector is at least 100kHz and is far higher than the working frequency of the blood pressure simulator; the display is used for displaying the test result; and the operation panel is used for setting and controlling parameters of the test process. The blood pressure simulator is used for measuring an electronic sphygmomanometer based on an oscillometric method.

The test apparatus may further comprise a static pressure sensor for static pressure testing. As shown in fig. 2. During static pressure detection, the blood pressure simulator needs to be connected with a static pressure sensor or a standard pressure gauge and a static pressure test container through a connecting tee joint, and the static pressure test container is provided with a fixed internal volume (500mL) and used for simulating an inflatable cuff portion of the sphygmomanometer. The hydrostatic test vessel may be mounted directly within the test apparatus.

According to one or more embodiments, a blood pressure simulator performance testing device comprises a plurality of modules.

1. And the dynamic pressure detection module. The testing device is based on the dynamic pressure sensor with high accuracy, and is matched with a data acquisition and processing system to directly measure the pressure oscillation waveform when the blood pressure simulator simulates the blood pressure indication value, the natural frequency of the developed dynamic pressure sensor is far higher than the working condition frequency of the blood pressure simulator, the dynamic amplitude sensitivity error is better than 1%, the dynamic performance is ensured to be excellent, and the pressure data of the dynamic change of the blood pressure simulator can be accurately acquired.

2. And a data acquisition module. The error of the data acquisition and processing system of the testing device is better than that of the data acquisition and processing system

+/-0.05% FS, sampling frequency of 100kHz, and about 80000 data points can be sampled in each pulse period, so that the sampling data of the device can reproduce a complete and smooth dynamic pressure curve in the running process of the blood pressure simulator.

The data processing part of the test device comprises:

3. and a data post-processing module. After the data is acquired, the acquired data can be automatically subjected to post-processing operations such as filtering and the like by a data processing program compiled by a programming language (Python/C + +/MATLAB), interference signals such as environmental noise, clutter, higher harmonics and the like when the blood pressure display value is simulated by the sampling blood pressure simulator are eliminated, and the original waveform is further restored by a curve of the sampling data.

4. And a pulse envelope analysis module. Aiming at each blood pressure simulation mode of different models of blood pressure simulators, the device can set different adjustment step lengths by setting blood pressure points (a group of systolic pressure, diastolic pressure and average pressure), heart rate and pulse volume, and continuous signal acquisition and repeatability analysis are carried out. The step size adjustment here refers to the adjustment of the sampling time/sampling frequency. By collecting the pressure wave amplitude corresponding to a certain blood pressure point, a corresponding pulse envelope wave (pressure waveform) can be obtained. Continuously acquiring a plurality of pulse wave curves, and evaluating the test result point by point through a built-in program so as to analyze the indication value repeatability condition of the blood pressure simulator under the group of blood pressure points. As shown in fig. 3.

Meanwhile, through collecting pulse wave curves generated by a certain blood pressure simulation mode of a certain type of blood pressure simulator under different blood pressure point settings for multiple times, the device can calculate parameters such as the amplitude of the pulse wave corresponding to the average pressure, the ratio of the amplitude of the systolic pressure/diastolic pressure to the average pressure and the like from collected data, and through a self-programming program, the parameters are associated with influence factors (blood pressure points, heart rate, pulse quantity and the like) of the blood pressure simulator to establish a linear regression model, so that the relation between the blood pressure simulation mode of the blood pressure simulator of the type and the corresponding pulse wave and a calculation model when the average pressure, the systolic pressure and the diastolic pressure are calculated are obtained through calculation.

The calculation process of the pulse envelope analysis module is further described below.

Each set of parameters (blood pressure point, heart rate, pulse volume) set by the blood pressure simulator generates a pulse wave corresponding to the set of parameters.

Therefore, the pulse waveforms generated by the blood pressure simulator under the same parameter setting are continuously and repeatedly acquired, and after errors caused by repeatability are eliminated, the pulse waveforms corresponding to the blood pressure simulator under the group of parameters are obtained.

And modifying the parameters one by controlling the variables, repeating the steps to obtain pulse waveforms corresponding to a plurality of groups of parameters, and searching the relation between the parameters and the pulse wave change to obtain the calculation model of the simulated blood pressure of the blood pressure simulator of the model.

Taking the maximum oscillation amplitude of the pulse wave as an example, the maximum oscillation amplitude of the waveform can be obtained from the pulse wave waveforms corresponding to different parameters, and a functional relation between the changed parameters and the pulse wave amplitude is established. The functional relationship can be established by a calculation mode such as linear regression.

Therefore, the technical effects of the present invention can be summarized as follows:

1. the testing device is based on a high-accuracy dynamic pressure sensor, and is matched with a data acquisition and processing system to detect the repeatability of the indicating value of the blood pressure simulator, so that the pressure oscillation waveform of the blood pressure simulator during the blood pressure indicating value simulation can be directly obtained, the natural frequency of the developed dynamic pressure sensor is far higher than the working condition frequency of the blood pressure simulator, the sensitivity error of the dynamic amplitude is less than 1%, and the dynamic performance is excellent;

2. the error of a high-accuracy data acquisition and processing system in the testing device is better than +/-0.05% FS and far higher than the maximum allowable error +/-3% of a digital oscilloscope in an oscilloscope method, so that the performance detection of the repeatability index +/-1 mmHg of the simulated blood pressure indication of the high-accuracy blood pressure simulator can be realized, and the international suggested level is reached;

3. the sampling frequency of the data acquisition and processing system is far higher than the working condition frequency of the blood pressure simulator, so that the smoothness and the integrity of a sampling data curve in the dynamic pressure process are effectively realized; the signal collection post-device can realize post-processing of data through self-programming, eliminate interference signals such as environmental noise, clutter, higher harmonics and the like when sampling the analog blood pressure indication value, and further ensure the accuracy and reliability of the data in the test process.

4. The device can calculate the acquired data in real time so as to analyze the repeatability of the pulse curve reproduced by the blood pressure simulator under the specific blood pressure point setting. Meanwhile, the device can calculate parameters such as the pulse wave amplitude corresponding to the average pressure, the ratio of the systolic pressure/diastolic pressure to the average pressure and the like in repeated tests of a certain blood pressure simulation mode of the blood pressure simulator to be detected, and establishes a linear regression model by the parameters and the influence factors of the blood pressure simulator through a self-programming program, so that a calculation model of the blood pressure simulation mode of the blood pressure simulator in the model is obtained when the blood pressure is calculated.

It should be noted that while the foregoing has described the spirit and principles of the invention with reference to several specific embodiments, it is to be understood that the invention is not limited to the disclosed embodiments, nor is the division of aspects, which is for convenience only as the features in these aspects cannot be combined. The invention is intended to cover various modifications and equivalent arrangements included within the spirit and scope of the appended claims.