CN111904410B - Dynamic electrocardiogram accuracy detection system and detection method - Google Patents

Dynamic electrocardiogram accuracy detection system and detection method Download PDF

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CN111904410B
CN111904410B CN202010565532.5A CN202010565532A CN111904410B CN 111904410 B CN111904410 B CN 111904410B CN 202010565532 A CN202010565532 A CN 202010565532A CN 111904410 B CN111904410 B CN 111904410B
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file
data
detected
holter
chip
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CN111904410A (en
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杨晓玲
韩溟
徐军峰
黎金
党琳琳
许文锋
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Shaanxi Medical Device Quality Supervision And Inspection Institute
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Shaanxi Medical Device Quality Supervision And Inspection Institute
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Abstract

The invention discloses a system and a method for detecting the accuracy of a dynamic electrocardiogram, wherein the system comprises an electrocardiosignal analog signal generator, a file automatic separation module and a data consistency analysis module, wherein the file automatic separation module and the data consistency analysis module run in a computer; the electrocardiosignal simulation generator can continuously output a plurality of recorded files to the electrocardio acquisition box of the HOLTER to be detected for acquisition, and the recorded files are separated by the file automatic separation module and then are output to the analysis module of the HOLTER to be detected for comparison analysis, so that the detection efficiency is greatly improved, the accuracy of the detection result is ensured, and meanwhile, the recorded files pass through the electrocardio acquisition box and the analysis module in the HOLTER to be detected, so that two core elements of the HOLTER to be detected are detected at one time, and the detection accuracy is further improved.

Description

Dynamic electrocardiogram accuracy detection system and detection method
Technical Field
The invention relates to the field of dynamic electrocardiogram accuracy detection, in particular to a system and a method for detecting the accuracy of a dynamic electrocardiogram.
Background
With the development of economy and the improvement of living standard of people, the incidence of heart diseases and the rapid increase of sudden death population due to heart diseases in recent years, and the inspection and early diagnosis equipment of heart diseases presents explosive growth, wherein the dynamic electrocardiogram with the most diagnostic value for heart diseases is the most representative. The dynamic electrocardiogram is different from the conventional electrocardiographic examination methods such as the conventional electrocardiograph, electrocardiographic monitor and the like, and is a medical instrument capable of recording and analyzing electrocardiographic signals and all abnormal electric waves of a patient in daily life, work and activity states at 24 hours or 48 hours or 72 hours. Because it can continuously record long-time dynamic electrocardiosignal, it can make up the defect that conventional electrocardiogram can only make short static record. Therefore, the heart disease detection device can capture myocardial ischemia, myocardial infarction, various occasional and short-array arrhythmias, sudden death, different types of ectopic rhythms or conduction blocks, occasional premature beat, palpitation, chest distress, chest pain, dizziness or syncope and other suspected heart diseases which are difficult to find by the conventional electrocardiogram, and the like, and greatly improves the detection rate of the arrhythmias.
The main components of the dynamic electrocardiogram (HOLTER) product comprise an acquisition recording box and analysis software, wherein the acquisition recording box records the electrocardiogram of a patient and stores continuously acquired electrocardiogram data as an ECG file, and the analysis software analyzes the ECG file stored by the recording box. Currently, the national inspection standard mandates that manufacturers of dynamic electrocardiographic products need to analyze 175 special patient electrocardiographic records in total of AHA, MIT, NST and CU standard databases, and the analysis result is compared with the standard result given by the standard database, so that whether the dynamic electrocardiographic products produced by the manufacturers meet the requirements is inspected.
According to the requirements of detection standards, the accuracy detection of the existing dynamic electrocardiographic data is generally realized in two ways:
one is a direct input authentication method, which is divided into two ways:
A. 175 records in the four databases are manually collected one by using an electrocardiograph collection box, and after collection, the data are imported into analysis software for analysis. The collection and analysis of one record took about 1 hour, and the collection and analysis of 175 database records required about 22 days, calculated as 8 hours of operation per day.
B. The 175 database records are directly input into analysis software and analyzed by dynamic electrocardiogram analysis software. Analysis of a single record takes less than three minutes, and takes up to two days to complete the assay. However, the accuracy of the data acquired by the electrocardiograph acquisition box of the manufacturer cannot be detected through digital analysis and verification. Moreover, because the standard database records and results are public and can be identified, the analysis process data can be tampered manually, and therefore, the authenticity of the analysis of the detected product is difficult to ensure.
The other mode is that 175 recorded files in four databases are stored by adopting an electrocardio signal simulation generator and are sent to the dynamic electrocardiogram one by one for detection, so that whether the dynamic electrocardiogram meets the requirements is verified:
however, the use of an electrocardiographic signal analog generator also has the following two problems:
1. sending the record files one by one can result in inefficiency in testing.
2. When the electrocardiosignal stored in the existing electrocardiosignal analog generator is converted into analog quantity, weaker signals cannot be output according to the actual voltage value (for most electrocardiosignal analog generators, the analog converter cannot effectively convert signals with the voltage value smaller than 10 uV), so that the output signals are distorted, and the accuracy of dynamic electrocardiograph performance detection can be affected.
Disclosure of Invention
The invention provides a system and a method for detecting the accuracy of a dynamic electrocardiogram, which are used for solving the problems that the existing direct input mode is low in test efficiency and cannot guarantee the test authenticity and the problem that the test efficiency is low when an electrocardiograph simulation generator is adopted to detect the dynamic electrocardiogram.
The specific technical scheme of the invention is as follows:
in order to achieve the above purpose, the invention adopts the following technical scheme:
the invention provides a dynamic electrocardiogram accuracy detection system, which comprises an electrocardiosignal analog signal generator, a file automatic separation module and a data consistency analysis module, wherein the file automatic separation module and the data consistency analysis module are operated in a computer;
the electrocardiosignal simulation generator is used for storing a standard electrocardiogram database specified by the international standard cardiovascular diseases and adding an inter-file isolator behind the last data of each record file in the standard electrocardiogram database so as to isolate each record file; the electrocardiosignal simulation generator outputs one or more record files to an electrocardio acquisition box of the HOLTER to be detected for storage in an analog signal; the standard electrocardiogram database comprises AHA, MIT, NST and CU data, and N record files are recorded in total, wherein N is more than or equal to 175;
the input end of the file automatic separation module is connected with the output end of the electrocardiograph acquisition box of the HOLTER to be detected, the output end of the file automatic separation module is connected with the input end of the analysis module of the HOLTER to be detected, and the file automatic separation module is used for separating a plurality of record files stored in the electrocardiograph acquisition box of the HOLTER to be detected according to the file-to-file separator and outputting the record files to the analysis module of the HOLTER to be detected for analysis;
the data consistency analysis module is connected with the output end of the analysis module of the HOLTER to be detected, standard results of a standard electrocardiogram database are stored in the data consistency analysis module, and the standard results can be used for carrying out attribute comparison with the analysis results of the analysis module in the HOLTER to be detected.
Further, the electrocardiosignal analog generator comprises a touch display screen, a Flash memory, a processor, a digital-to-analog converter, a digital comparator, a signal amplitude adjusting circuit and a 3.5mm coaxial analog signal output interface;
the processor adopts an STM32F103RX singlechip chip for adding a start identifier and a termination identifier to a record file to be output;
the Flash memory adopts an internal memory space of an STM32F103RX singlechip chip and is used for storing a standard database and customized electrocardiograph data;
the digital comparator adopts an SN74ASA885U6 chip and is used for judging whether the output electrocardiosignal is smaller than a set threshold value, wherein the set threshold value is the minimum convertible digital quantity of the digital-to-analog converter;
the digital-to-analog converter adopts a DAC1220 chip for converting the electrocardiosignal from digital quantity to analog quantity;
the signal amplitude regulating circuit comprises an MCP4012 chip and a resistor and is used for amplifying the converted electrocardiosignal smaller than a set threshold value so as to output the electrocardiosignal with a real voltage value;
the STM32F103RX singlechip chip is connected with the touch display screen through a UART pin;
the SPI pin is electrically connected with a CS pin, an SCLK pin and an SDIO end of the DAC1220 chip;
the circuit is connected with DAT [0:7] pins of the SN74ASA885U6 chip through DAT [0:7] pins;
the circuit is electrically connected with a CS1 pin and a UD pin of the MCP4012 chip through the CS1 pin and the UD pin respectively;
the ADJ_EN pin of the SN74ASA885U6 chip is connected with the CS1 pin of the MCP4012 chip;
the VOUT pin of the DAC1220 chip is connected with the resistor end of the MCP4012 chip through resistors, and the VOUT pin of the DAC1220 chip is connected with a 3.5mm coaxial analog signal output cable.
Further, the digital comparator further comprises a threshold data setting circuit connected with the threshold signal pin REF thereof; the threshold data setting circuit generates one-bit binary digital quantity data through a dial switch on each bit.
Further, the electrocardiograph signal simulation generator further comprises a data update interface for performing data update.
Further, the data update interface is an RS232 interface, a USB interface, an SD card interface, or a network interface.
Further, the DAC1220 chip has 20-bit resolution, the digital power supply DVDD and the analog power supply AVDD of the DAC1220 chip use 5V voltage, and the reference voltage VREF is 2.5V; maximum output voltage of 5V, minimum output voltage of 5V/2 20
Further, the power supply voltage adopted by the touch display screen is 5V, the data interface is UART, wherein TX represents data sent to the touch display screen by the processor, and RX represents data sent to the processor by the touch display screen.
Further, the voltages of the digital power supply VDD and the analog power supply VDDA of the STM32F103RX singlechip chip are both 3.3V.
Based on the description of the detection system, the method for detecting the dynamic electrocardiogram product by adopting the system is introduced, and the specific implementation steps are as follows:
step 1: the electrocardiosignal analog generator generates an electrocardiosignal analog signal;
step 1.1: selecting a record file to be output from a standard electrocardiogram database stored in an electrocardiosignal simulation generator, if the record file to be output is one record file, directly executing the step 1.3, otherwise, executing the step 1.2, and executing the step 1.3;
step 1.2; when the number of the recorded files to be output is multiple, adding a file spacer behind the last data of each recorded file, so as to realize mutual isolation of the multiple recorded files;
step 1.3: performing digital-to-analog conversion on the content in the record file, collecting and storing by an electrocardiograph collection box of the HOLTER to be detected, executing the step 3 if the record file is one, and executing the step 2 and then executing the step 3 if the record file is a plurality of records;
step 2: separation of a plurality of record files;
the electrocardio acquisition box of the HOLTER to be detected outputs a plurality of recorded files to the file automatic separation module, and the file automatic separation module separates according to the file interval sign of each recorded file and transmits the file to the analysis module of the HOLTER to be detected;
step 4; analyzing a record file;
the analysis module of the HOLTER to be detected analyzes the record file and transmits an analysis result to the data consistency analysis module;
step 5: verification of analysis results
And the data consistency analysis module compares the analysis result of the analysis module of the HOLTER to be detected with the standard result stored in the analysis module of the HOLTER to be detected, so as to determine whether the HOLTER to be detected is a qualified product or not.
Further, the specific adding process of the file spacer in the step 1.2 is as follows: when the last data of the current record file is sent, the high level with the amplitude of 5mv is sent for 20ms, then the low level with the amplitude of 0mv is sent for 20ms, so that a periodic square wave is formed and N seconds are continued, and a file spacer consisting of M periodic square waves is obtained; n is more than or equal to 1;
the principle that the file automatic separation module separates according to the file spacer of each recorded file in the step 3 is as follows: when a high-level signal of a first periodic square wave is detected, the last data of the high-level signal is the last data of the last recorded file, after M periodic squares are continuously searched, the next first data is the initial data of the next recorded file, and the data between the first data of the last recorded file and the first data of the next recorded file are saved as separate files, so that one file separation is completed.
The invention has the beneficial effects that:
1. according to the invention, the electrocardio signal simulation generator is adopted to continuously output a plurality of recorded files to the electrocardio acquisition box of the HOLTER to be detected for acquisition, and the recorded files are separated by the file automatic separation module and then are output to the analysis module of the HOLTER to be detected for comparison analysis, so that the detection efficiency is greatly improved, the accuracy of the detection result is ensured, and meanwhile, the recorded files pass through the electrocardio acquisition box and the analysis module in the HOLTER to be detected, so that two core elements of the HOLTER to be detected are detected at one time, and the detection accuracy is further improved.
2. The electrocardiosignal analog generator constructed by the touch display screen, the Flash memory, the processor, the digital comparator, the digital-to-analog converter, the signal amplitude regulating circuit and the 3.5mm coaxial analog signal output interface can output the 1uV-10uV weak electrocardiosignal according to the real voltage value, so that the problem of distortion when the traditional electrocardiosignal analog generator outputs the weak electrocardiosignal is solved, and the accuracy of dynamic electrocardiograph performance detection is ensured.
Drawings
FIG. 1 is a schematic diagram of a detection system according to the present invention.
Fig. 2 is a schematic block diagram of an electrocardiographic simulation generator.
Fig. 3 is a schematic circuit diagram of a touch display screen.
Fig. 4 is a circuit diagram of a processor.
Fig. 5 is a circuit diagram of a digital-to-analog converter.
Fig. 6 is a circuit diagram of a digital comparator.
Fig. 7 is a circuit diagram of a signal amplitude adjustment circuit.
Detailed Description
The following description of the embodiments of the present invention will be made apparent and fully in view of the accompanying drawings, in which some, but not all embodiments of the invention are shown. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without making any inventive effort, are intended to be within the scope of the invention.
As shown in fig. 1, the embodiment provides a system for detecting the accuracy of a dynamic electrocardiogram, wherein the detection object of the system is an electrocardiograph acquisition box and an HOLTER analysis module of HOLTER, and the system itself comprises an electrocardiograph signal simulation generator, a file automatic separation module and a data consistency analysis module which are operated in a computer.
The electrocardiosignal simulation generator is used for storing a standard electrocardiogram database specified by the international standard cardiovascular diseases and adding an inter-file isolator behind the last data of each record file in the standard electrocardiogram database so as to isolate each record file; the electrocardiosignal simulation generator outputs one or more record files to an electrocardio acquisition box of the HOLTER to be detected for storage in an analog signal; the standard electrocardiogram database comprises AHA, MIT, NST and CU data, wherein the total number of the standard electrocardiogram database is N, and the number of the recorded files in the existing standard electrocardiogram database is 175;
the input end of the file automatic separation module is connected with the output end of the electrocardiograph acquisition box of the HOLTER to be detected, the output end of the file automatic separation module is connected with the input end of the analysis module of the HOLTER to be detected, and the file automatic separation module is used for separating a plurality of record files stored in the electrocardiograph acquisition box of the HOLTER to be detected according to the file-to-file separator and outputting the record files to the analysis module of the HOLTER to be detected for analysis;
the data consistency analysis module is connected with the output end of the analysis module of the HOLTER to be detected, standard results of a standard electrocardiogram database are stored in the data consistency analysis module, and the standard results can be used for carrying out attribute comparison with the analysis results of the analysis module in the HOLTER to be detected.
The specific structure of the electrocardiosignal analog generator in the embodiment is shown in fig. 2, and the electrocardiosignal analog generator comprises a touch display screen 1, a data updating interface 2, a Flash memory 3, a processor 4, a digital-to-analog converter 5, a digital comparator 6, a signal amplitude regulating circuit 7 and a 3.5mm coaxial analog signal output interface 8;
the processor 4 is connected with the touch display screen 1, and the touch display screen 1 is used for a user to send out an operation instruction; the operation command comprises start/stop signal output, characteristic electrocardiosignal selection, setting sequence and file separator setting, and external custom characteristic electrocardiosignal data is imported; the output function is used for displaying equipment working state information to a user, wherein the equipment working state information comprises the current output state start/stop of the equipment, the current output characteristic electrocardiosignal number and name, separation identification code parameters and equipment working time;
the processor 4 is connected with the Flash memory 3, and the Flash memory 3 is used for storing the electrocardiosignals of the standard electrocardiogram database and the electrocardiosignals uploaded by the user in a self-definition way;
the processor 4 is connected with the digital-to-analog converter 5, and the digital-to-analog converter 5 is used for converting electrocardiosignals from digital quantity to analog quantity;
the processor 4 is connected with the digital comparator 6; the data comparator 6 judges whether the electrocardiosignal to be output is smaller than a set threshold value (the set threshold value is the digital quantity which can be least converted by the digital-to-analog converter), and then outputs the comparison result to the signal amplitude regulating circuit;
the digital-analog converter 5 is electrically connected with the 3.5mm coaxial analog signal output interface 8 through the signal amplitude regulating circuit 7 and is used for outputting all electrocardiosignals with real voltage values.
A specific circuit of the touch display screen 1 is shown in fig. 3. The circuit power supply voltage is 5V, and the data interface is UART, wherein TX represents data sent to the touch display screen by the processor 4, and RX represents data sent to the processor 4 by the touch display screen. The circuit transmits the content to be displayed to the touch display screen through TX under the control of the processor 4, and the touch display screen transmits the touch position signal of the user to the processor (3) through RX, so that the whole input-output interaction operation is completed.
The data updating interface 2 is used for updating the internal electrocardiographic data by a user, and can be an RS232 interface, a USB interface, an SD card interface or a network interface. In this embodiment, a USB interface is used.
The specific circuitry of the processor 4 is shown in fig. 4. And an STM32F103RX singlechip is used as a core processor, a digital power supply VDD is powered by 3.3V, an analog power supply VDDA is powered by 3.3V, and a filter capacitor is respectively designed for each pin of VDD and VDDA so as to ensure the power supply quality. The circuit is designed with data interfaces with other circuits, and the data interfaces are respectively:
the signal is USB_DM and USB_DP;
UART interface connected with touch display screen 1, signal is TX and RX;
the SPI interface with the digital-to-analog converter 5 is provided with signals CS, SCLK and SDIO;
the parallel data interface DAT [0:7] connected with the digital comparator 6 is signaled by DAT [0:7];
UD and CS interfaces connected to the signal amplitude adjustment circuit 7;
the Flash memory 3 uses a memory space inside the STM32F103RX, so that no additional design is required for an external circuit, and an external memory can be used as required.
A specific circuit of the digital-to-analog converter 5 is shown in fig. 5. The digital-to-analog converter 5 adopts a DAC1220 chip; DVDD is a digital power supply of the circuit, and adopts 5V voltage; AVDD is an analog power supply of the circuit, and adopts 5V voltage; c1 and C4 are power supplies for filtering clutter; VREF is the reference voltage of the digital-to-analog converter, and 2.5V reference voltage is adopted; x1 provides a clock for circuit operation and adopts a crystal oscillator of 2.5 MHz; CS, SCLK, SDIO form the digital signal input interface together, responsible for communicating with processor 4, CS is the chip select signal, the low level is valid, output to this circuit by the processor 4, SCLK is the clock signal, provide the clock reference for this digital communication interface, output to this circuit by the processor 4, SDIO is the serial data signal, in this scheme, need to realize the analog output imitative electrocardio data of analog output, namely transmit this serial data signal to this circuit by the processor 4 after the data conversion is the signal of the corresponding voltage, the analog electrocardio signal output pin is VOUT; the VOUT signal is coupled to a signal amplitude regulation circuit.
In the present embodiment, a 20-bit resolution digital-to-analog converter is usedThe ratio VREF is 2.5V, the minimum output voltage is 0V, the maximum output voltage is 2X Vref, i.e. 5V, so the minimum output voltage of the D/A converter is 5V/2 20 I.e. 4.8uV.
The digital comparator 6 adopts an SN74ASA885U6 chip, and the circuit can automatically identify the data size which needs to be converted and output, compare the data size with a threshold value and then output the comparison result. Specifically, as shown in fig. 6, the DAT [0:7] pins of the SN74ASA885 chip read from the processor 4 to obtain electrocardiograph data or user-defined electrocardiograph data of a standard database in the Flash memory 3; the REF pin provides threshold data for the circuit, which may be a value entered by a user through a touch screen or a value set directly by a set of dial switches; (of course, the threshold data, which is the digital signal that can be converted by the digital-to-analog converter minimum, can also be set in advance), the comparison result is output via P < QOUT, which is connected to the amplitude-adjusting circuit, as signal adj_en.
The working principle of the circuit is as follows: the two groups of input data of the circuit are respectively electrocardiograph data DAT to be converted and set threshold data REF, when DAT < REF, namely when the current electrocardiosignal amplitude to be output is smaller than the minimum signal amplitude which can be converted by the digital-to-analog converter, the ADJ_EN signal activates the signal amplitude regulating circuit to regulate the electrocardiograph data DAT signal which is required to be converted and smaller than the threshold data REF, and when DAT < REF, the signal amplitude regulating circuit does not regulate and directly outputs the converted electrocardiosignal. Specifically, in this example, the REF is set to a value corresponding to 4.8uV, and the circuit can automatically adjust the amplitude of the signal smaller than 4.8uV to ensure that the output signal is not distorted.
The specific circuit of the signal amplitude adjusting circuit 7 is shown in fig. 7, and is realized by adopting a digital potentiometer MCP4012 and a resistor R1, wherein the digital potentiometer MCP4012 changes the resistor (denoted as Ru 4) between a resistor pin 5 and a resistor pin 6 through the control of a CS1 and UD receiving processor and a digital comparator, and the SIG is an electrocardiosignal output port and is used for being connected with a 3.5mm coaxial analog signal output interface so as to output the electrocardiosignal to the outside. The output signal sig=vout×ru4/(r1+ru4) of the signal amplitude adjusting circuit is calculated according to the voltage dividing circuit principle. The user can change the amplitude of the output signal by changing Ru4 according to the needs of the user. When the signal does not need to be adjusted in amplitude (DAT is greater than REF), the ADJ_EN signal turns off its function through the CS pin of the digital potentiometer, at which time the resistive contact between resistor pin 5 and resistor pin 6 is opened and the Ru4 resistance is infinite. At this time sig=vout, i.e., the signal is directly output without amplitude adjustment.
The signal amplitude adjusting circuit R1 selects 40kΩ, and when Ru4 is set to 10kΩ, the output signal amplitude is 4.8/5 uv=0.96 uV.
Based on the above description of the architecture of the detection system, a detailed description will be given of a specific process of performing dynamic electrocardiogram detection by using the detection system:
step 1: the electrocardiosignal analog generator generates an electrocardiosignal analog signal;
step 1.1: selecting a record file to be output from a standard electrocardiogram database stored in an electrocardiosignal simulation generator, if the record file to be output is one record file, directly executing the step 1.3, otherwise, executing the step 1.2, and executing the step 1.3;
step 1.2; when the number of the recorded files to be output is multiple, adding a file spacer behind the last data of each recorded file, so as to realize mutual isolation of the multiple recorded files;
the specific process of adding the file separator is as follows: when the last data of the current recording file is sent, a high level with the amplitude of 5mv is sent for 20ms, then a low level with the amplitude of 0mv is sent for 20ms, so that a periodic square wave is formed and is continued for 10s, a file spacer consisting of 250 periodic square waves is obtained, and the first data of the next recording file starts to be output after the last periodic square wave is received (because the electrocardiosignal amplitude is generally less than 5mv and the electrocardiosignal is mostly a pulse signal, and the square wave is adopted as the file spacer and has obvious distinction from the electrocardiosignal of the recording file).
Step 1.3: performing digital-to-analog conversion on the content in the record file, collecting and storing by an electrocardiograph collection box of the HOLTER to be detected, executing the step 3 if the record file is one, and executing the step 2 and then executing the step 3 if the record file is a plurality of records;
step 2: separation of a plurality of record files;
the electrocardio acquisition box of the HOLTER to be detected outputs a plurality of recorded files to the file automatic separation module, and the file automatic separation module separates according to the file interval sign of each recorded file and transmits the file to the analysis module of the HOLTER to be detected;
the separation process of the file separator specifically comprises the following steps: when the high-level signal of the first periodic square wave is detected, the last data of the high-level signal is the last data of the last recorded file, after 250 periodic square wave signals are continuously searched, the next first data is the initial data of the next file, and the data between the first data (including the data) of the last recorded file and the first data (not including the data) of the next recorded file are saved as single files, so that one file separation is completed.
Step 4; analyzing a record file;
the analysis module of the HOLTER to be detected analyzes the record file and transmits an analysis result to the data consistency analysis module;
step 5: verification of analysis results
And the data consistency analysis module compares the analysis result of the analysis module of the HOLTER to be detected with the standard result stored in the analysis module of the HOLTER to be detected, and outputs a final comparison result, so as to determine whether the HOLTER to be detected is a qualified product.

Claims (10)

1. A system for detecting the accuracy of a dynamic electrocardiogram, which is characterized in that: the system comprises an electrocardiosignal analog signal generator, a file automatic separation module and a data consistency analysis module, wherein the file automatic separation module and the data consistency analysis module are operated in a computer;
the electrocardiosignal simulation generator is used for storing a standard electrocardiogram database specified by the international standard cardiovascular diseases and adding an inter-file isolator behind the last data of each record file in the standard electrocardiogram database so as to isolate each record file; the electrocardiosignal simulation generator outputs one or more record files to an electrocardio acquisition box of the HOLTER to be detected for storage in an analog signal; the standard electrocardiogram database comprises AHA, MIT, NST and CU data, and N record files are recorded in total, wherein N is more than or equal to 175;
the input end of the file automatic separation module is connected with the output end of the electrocardiograph acquisition box of the HOLTER to be detected, the output end of the file automatic separation module is connected with the input end of the analysis module of the HOLTER to be detected, and the file automatic separation module is used for separating a plurality of record files stored in the electrocardiograph acquisition box of the HOLTER to be detected according to the file-to-file separator and outputting the record files to the analysis module of the HOLTER to be detected for analysis;
the data consistency analysis module is connected with the output end of the analysis module of the HOLTER to be detected, standard results of a standard electrocardiogram database are stored in the data consistency analysis module, and the standard results can be used for carrying out attribute comparison with the analysis results of the analysis module in the HOLTER to be detected.
2. The system for detecting accuracy of dynamic electrocardiography according to claim 1, wherein: the electrocardiosignal analog generator comprises a touch display screen, a Flash memory, a processor, a digital-to-analog converter, a digital comparator, a signal amplitude regulating circuit and a 3.5mm coaxial analog signal output interface;
the processor adopts an STM32F103RX singlechip chip for adding a start identifier and a termination identifier to a record file to be output;
the Flash memory adopts an internal memory space of an STM32F103RX singlechip chip and is used for storing a standard database and customized electrocardiograph data;
the digital comparator adopts an SN74ASA885U6 chip and is used for judging whether the output electrocardiosignal is smaller than a set threshold value, wherein the set threshold value is the minimum convertible digital quantity of the digital-to-analog converter;
the digital-to-analog converter adopts a DAC1220 chip for converting the electrocardiosignal from digital quantity to analog quantity;
the signal amplitude regulating circuit comprises an MCP4012 chip and a resistor and is used for amplifying the converted electrocardiosignal smaller than a set threshold value so as to output the electrocardiosignal with a real voltage value;
the STM32F103RX singlechip chip is connected with the touch display screen through a UART pin;
the SPI pin is electrically connected with a CS pin, an SCLK pin and an SDIO end of the DAC1220 chip;
the circuit is connected with DAT [0:7] pins of the SN74ASA885U6 chip through DAT [0:7] pins;
the circuit is electrically connected with a CS1 pin and a UD pin of the MCP4012 chip through the CS1 pin and the UD pin respectively;
the ADJ_EN pin of the SN74ASA885U6 chip is connected with the CS1 pin of the MCP4012 chip;
the VOUT pin of the DAC1220 chip is connected with the resistor end of the MCP4012 chip through resistors, and the VOUT pin of the DAC1220 chip is connected with a 3.5mm coaxial analog signal output cable.
3. The system for detecting accuracy of dynamic electrocardiography according to claim 2, wherein: the digital comparator further comprises a threshold data setting circuit connection connected to its threshold signal pin REF; the threshold data setting circuit generates one-bit binary digital quantity data through a dial switch on each bit.
4. A system for detecting accuracy of a dynamic electrocardiogram according to claim 3 wherein: a data update interface for performing data updates is also included.
5. The system for detecting accuracy of dynamic electrocardiography according to claim 4, wherein: the data updating interface is an RS232 interface or a USB interface or an SD card interface or a network interface.
6. The system for detecting accuracy of dynamic electrocardiography according to claim 5, wherein: the DAC1220 chip has 20-bit resolution, the digital power supply DVDD and the analog power supply AVDD of the DAC1220 chip adopt 5V voltage, and the reference voltage VREF is 2.5V; maximum output voltage of 5V, minimum output voltage of 5V/2 20
7. The system for detecting accuracy of dynamic electrocardiography according to claim 6, wherein: the power supply voltage adopted by the touch display screen is 5V, the data interface is UART, wherein TX represents data sent to the touch display screen by the processor, and RX represents data sent to the processor by the touch display screen.
8. The system for detecting dynamic electrocardiogram accuracy according to claim 7, wherein: the voltages of the digital power supply VDD and the analog power supply VDDA of the STM32F103RX singlechip chip are 3.3V.
9. A method for detecting the accuracy of a dynamic electrocardiogram is characterized by comprising the following steps: the detection system as claimed in claim 1 is used, comprising the following steps:
step 1: the electrocardiosignal analog generator generates an electrocardiosignal analog signal;
step 1.1: selecting a record file to be output from a standard electrocardiogram database stored in an electrocardiosignal simulation generator, if the record file to be output is one record file, directly executing the step 1.3, otherwise, executing the step 1.2, and executing the step 1.3;
step 1.2; when the number of the recorded files to be output is multiple, adding a file spacer behind the last data of each recorded file, so as to realize mutual isolation of the multiple recorded files;
step 1.3: performing digital-to-analog conversion on the content in the record file, collecting and storing by an electrocardiograph collection box of the HOLTER to be detected, executing the step 3 if the record file is one, and executing the step 2 and then executing the step 3 if the record file is a plurality of records;
step 2: separation of a plurality of record files;
the electrocardio acquisition box of the HOLTER to be detected outputs a plurality of recorded files to the file automatic separation module, and the file automatic separation module separates according to the file interval sign of each recorded file and transmits the file to the analysis module of the HOLTER to be detected;
step 3: analyzing a record file;
the analysis module of the HOLTER to be detected analyzes the record file and transmits an analysis result to the data consistency analysis module;
step 4: verification of analysis results
And the data consistency analysis module compares the analysis result of the analysis module of the HOLTER to be detected with the standard result stored in the analysis module of the HOLTER to be detected, so as to determine whether the HOLTER to be detected is a qualified product or not.
10. The method for detecting the accuracy of a dynamic electrocardiogram according to claim 9, wherein:
the specific adding process of the file spacer in the step 1.2 is as follows: when the last data of the current record file is sent, the high level with the amplitude of 5mv is sent for 20ms, then the low level with the amplitude of 0mv is sent for 20ms, so that a periodic square wave is formed and N seconds are continued, and a file spacer consisting of M periodic square waves is obtained; n is more than or equal to 1;
the principle that the file automatic separation module separates according to the file spacer of each recorded file in the step 2 is as follows: when a high-level signal of a first periodic square wave is detected, the last data of the high-level signal is the last data of the last recorded file, after M periodic squares are continuously searched, the next first data is the initial data of the next recorded file, and the data between the first data of the last recorded file and the first data of the next recorded file are stored as separate files to finish one file separation.
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