Physiological testing device

The device addresses inefficiencies in conventional quality control by enabling separate data handling for quality control modes, ensuring reliable and efficient accuracy evaluations in physiological testing devices.

JP7720979B2Active Publication Date: 2025-08-08FUKUDA DENSHI CO LTD
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Patent Information

Application Number
JP2024191588
Authority / Receiving Office
JP · JP
Patent Type
Patents
Current Assignee / Owner
Filing Date
2024-10-31
Publication Date
2025-08-08
Estimated Expiration
2039-07-31

AI Technical Summary

Technical Problem

Conventional physiological testing devices lack effective quality control mechanisms, leading to inefficiencies and reduced reliability due to time-consuming manual data recording and potential errors in accuracy evaluations.

Method used

A physiological testing device equipped with a measurement unit, mode setting unit, data classification unit, storage unit, and output unit that allows for easy and reliable quality control by distinguishing between normal and quality control modes, enabling separate data storage and output for accurate evaluation.

Benefits of technology

Facilitates easy and highly reliable quality control by allowing distinct handling of quality control data, enhancing the reliability and efficiency of accuracy assessments.

✦ Generated by Eureka AI based on patent content.

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Abstract

To provide a physiological inspection apparatus that makes it possible to perform accuracy management easily and with high reliability.SOLUTION: An electrocardiograph 10 includes: a measurement unit 11 for performing predetermined measurement processing on an input electrocardiographic signal to acquire inspection result data; a mode setting unit 12 capable of setting an accuracy management mode differing from a normal inspection mode, via user operation; a data classification unit 13 that when the accuracy management mode is set, classifies inspection result data acquired by the measurement unit 11 so that the data can be discriminated from inspection result data acquired by the measurement unit 11 when the normal inspection mode is set; a storage unit 14 for storing the data classified by the data classification unit 13; and an output unit 15 for outputting the data stored in the storage unit 14.SELECTED DRAWING: Figure 1
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Description

[Technical Field]

[0001] The present invention relates to a physiological testing device. [Background technology]

[0002] Physiological tests such as electrocardiograms, electroencephalograms, pulmonary function tests, and ultrasound tests have been available for some time. For example, electrocardiograms are widely used to diagnose heart disease. An electrocardiogram detects the electrical activity of the heart on the body's surface and displays it as an electrocardiographic waveform. By analyzing this electrocardiographic waveform (electrocardiogram), various pieces of information about the activity of the heart can be obtained. Devices used to perform such physiological tests include electrocardiographs, electroencephalographs, pulmonary function test devices, and ultrasound diagnostic devices.

[0003] Furthermore, with the development of digital electrocardiographs that record electrocardiograms as digital data, it has become possible to automatically analyze electrocardiograms using a computer (see, for example, Patent Document 1).

[0004] In recent years, hospitals and other medical institutions have placed increasing importance on quality control of medical equipment, and this has expanded to include physiological testing devices such as electrocardiographs. [Prior art documents] [Patent documents]

[0005] [Patent Document 1] Japanese Patent Application Laid-Open No. 2006-116207 Summary of the Invention [Problem to be solved by the invention]

[0006] Thus, there is a demand for managing the accuracy of electrocardiographs in medical institutions.

[0007] However, in conventional physiological testing devices, quality control has not been sufficiently considered. For example, quality control of electrocardiographs has been carried out according to inspection items such as daily inspections and periodic inspections, and the results have been applied mutatis mutandis to quality control. Specific inspections of electrocardiographs include checking whether the test waveform has a peak of 10 mm / 1 mV (±10%) and whether the time constant is 3.2 seconds or longer. Furthermore, test result data, such as the test result screen and result report, displayed in the same way as when conducting regular tests (outpatient tests, inpatient tests, etc.), are displayed, and users such as laboratory technicians write notes on them and evaluate the accuracy while looking at them.

[0008] Therefore, when there is a large amount of test result data required for accuracy evaluation, there is a problem that it takes time to write it down in memos. Also, if there are any mistakes in writing the test result data, there is a problem that the reliability of quality control decreases.

[0009] The present invention has been made in consideration of the above points, and provides a physiological testing device that allows for easy and highly reliable quality control. [Means for solving the problem]

[0010] One aspect of the physiological testing device of the present invention is a measurement unit that performs predetermined measurement processing on input biological information to obtain test result data; a mode setting unit that allows a user to set a quality control mode different from a normal inspection mode; a data classification unit that classifies the test result data obtained by the measurement unit when the quality control mode is set to be different data from the test result data obtained by the measurement unit when the normal test mode is set to be, so that the data is identifiable as different data; a storage unit that stores the data sorted by the data sorting unit; an output unit that outputs the data stored in the storage unit; Equipped with. [Effects of the Invention]

[0011] According to the present invention, the quality control mode can be set, and the test result data obtained in the quality control mode is stored so that it can be distinguished from the normal test mode, thereby enabling quality control to be performed easily and with high reliability. [Brief explanation of the drawings]

[0012] [Figure 1] 1 is a block diagram showing the main configuration of an electrocardiograph according to an embodiment; [Figure 2] A diagram showing the electrocardiogram test selection screen [Figure 3] FIG. 10 is a diagram showing an example of an operation screen for outputting test result data obtained in the quality control mode by an output unit. [Figure 4] FIG. 10 is a diagram showing an example of quality control data output by an output unit. [Figure 5] FIG. 10 is a diagram showing an example of a graph for quality control output by an output unit. [Figure 6] A diagram showing an example of copying test result data for quality control mode to another terminal DETAILED DESCRIPTION OF THE INVENTION

[0013] DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Hereinafter, an embodiment of the present invention will be described in detail with reference to the drawings, taking an electrocardiograph as an example.

[0014] 1 is a block diagram showing the main configuration of an electrocardiograph according to an embodiment. The electrocardiograph 10 includes a measurement unit 11, a mode setting unit 12, a data classification unit 13, a storage unit 14, and an output unit 15.

[0015] The measurement unit 11 obtains test result data by performing predetermined measurement processing on the electrocardiogram signals input from the electrocardiogram electrodes 21 attached to the subject. Specifically, the measurement unit 11 is composed of an amplifier that amplifies the electrocardiogram signals, an analog-to-digital conversion circuit, a calculation unit that performs electrocardiogram analysis, and the like.

[0016] The mode setting unit 12 can be operated by a user to set a quality control mode that is different from the normal inspection mode. In this embodiment, the mode setting unit 12 is embodied by a liquid crystal display with a touch panel.

[0017] 2 shows the test selection screen of the electrocardiograph 10 according to this embodiment. When the user touches any of the buttons "12-lead test," "Arrhythmia test," "Rhythm measurement test," "Master test test," "Additionally registered 12-lead test," and "Additionally registered arrhythmia," the electrocardiograph 10 executes the normal test mode corresponding to the button.

[0018] In response to this, the electrocardiograph 10 executes the technique accuracy control mode when the user touches the "procedure accuracy control" button, and executes the equipment accuracy control mode when the user touches the "equipment accuracy control" button.

[0019] The procedural accuracy of the electrocardiograph 10 refers to the variability in test results when different technicians are used, and the smaller the variability, the higher the procedural accuracy. In other words, the test results of the electrocardiograph 10 are affected by factors such as the positioning of the electrocardiographic electrodes 21 on the subject, the amount and method of application of electrolyte cream applied before attaching the electrodes to these positions, and noise interference caused by the routing of the lead cords that connect the electrodes to the measuring unit and transmit electrocardiographic signals. Therefore, the smaller the variability in the test results, the higher the procedural accuracy. Generally, procedural accuracy is measured by having different technicians perform tests on the same subject.

[0020] The device accuracy of the electrocardiograph 10 refers to the accuracy of the measurement value relative to the input, and specifically indicates the degree of variation in the test result data that can be output when the same electrocardiographic signal is input. In other words, if there is some kind of internal defect in the electrocardiograph 10, the measurement output of the electrocardiograph 10 will vary, but if there is no defect, there will be no variation, so the variation in the measurement output can be used as an index of device accuracy. In practice, as shown in Figure 1, the device accuracy is evaluated by inputting a standard electrocardiographic signal from a simulator into the measurement unit 11 and evaluating the test result data output from the measurement unit 11 at that time.

[0021] The data classification unit 13 classifies the test result data obtained by the measurement unit 11 when set to a quality control mode (procedure quality control mode, equipment quality control mode) as separate data from the test result data obtained by the measurement unit 11 when set to a normal test mode (12-lead test mode, arrhythmia test mode, rhythm measurement test mode, master test mode, additionally registered 12-lead test mode, additionally registered arrhythmia test mode, etc.).

[0022] Here, the data classification unit 13 can classify the test result data of the normal test and the test result data of the quality control mode by, for example, dividing the files of the normal test and the files of the quality control mode into different files. Note that the classification method is not limited to this.

[0023] The storage unit 14 stores the data separated by the data separation unit.

[0024] The output unit 15 outputs the data stored in the storage unit 14. The output unit 15 is realized by, for example, a display unit (not shown) of the electrocardiograph 10 or a printing device.

[0025] 3 shows an example of an operation screen for outputting test result data obtained in the quality control mode by the output unit 15. By operating the operation screen in FIG. 3, the user can cause the output unit 15 to output test result data for technique quality control or test result data for equipment quality control stored in the memory unit 14.

[0026] 4 shows an example of data for quality control output by the output unit 15. FIG. 5 shows an example of a graph for quality control output by the output unit 15.

[0027] The test result data for the quality control modes (procedure quality control mode, equipment quality control mode) stored in the memory unit 14 of the electrocardiograph 10 may be copied to another terminal 40 via an SD card 30 or a communication means (not shown) as shown in Fig. 6. Fig. 6 shows an example in which a CSV file of the test result data brought into the terminal 40 by the SD card 30 is copied to a master file managed by the facility.

[0028] As described above, according to this embodiment, the electrocardiograph 10 has a measurement unit 11 that performs a predetermined measurement process on the input electrocardiogram signal to obtain test result data, a mode setting unit 12 that can set a quality control mode different from the normal test mode by user operation, a data classification unit 13 that classifies the test result data obtained by the measurement unit 11 when the quality control mode is set so that the data is identifiable as different data from the test result data obtained by the measurement unit 11 when the normal test mode is set, a memory unit 14 that stores the data classified by the data classification unit 13, and an output unit 15 that outputs the data stored in the memory unit 14.

[0029] In this way, by making it possible to set the quality control mode and storing the test result data obtained in the quality control mode so that it can be distinguished from the normal test mode, quality control can be performed easily and with high reliability.

[0030] The above-described embodiment merely illustrates an electrocardiograph as an example of a specific embodiment of the present invention, and the technical scope of the present invention should not be construed as being limited by these embodiments. In other words, the present invention can be embodied in various forms without departing from the gist or main features thereof.

[0031] Specifically, in addition to electrocardiographs, the simulator can also be applied to physiological testing devices such as electroencephalographs, pulmonary function testing devices, and ultrasound diagnostic devices. Equipment accuracy control using simulators is also possible for electroencephalographs, pulmonary function testing devices, and ultrasound diagnostic devices. Regarding procedural accuracy control, electrode placement and the amount of paste used in the case of electroencephalographs, treatment of the subject (speaking to them and easing their anxiety) in the case of pulmonary function testing devices, and the way the ultrasound probe is applied and the amount of ultrasound gel used in the case of ultrasound diagnostic devices all affect test results, and the smaller the variance in test results, the higher the procedural accuracy can be said to be.

[0032] In addition to the above-described embodiment, a notification unit may be provided that prompts the user by voice or display to perform an inspection in quality control mode. The notification unit prompts the user to perform an inspection in quality control mode, for example, periodically (e.g., every few months) or every predetermined operating time (e.g., every few hundred operating hours). This prevents situations where quality control is not performed for a long period of time.

[0033] Furthermore, when the notification unit prompts the user to perform an examination in quality control mode, it is preferable to prompt the user to perform the examination in equipment quality control mode first rather than in procedure quality control mode. This is because the reliability of the examination results in procedure quality control mode is significantly affected by the accuracy of the equipment. In other words, by first performing the equipment quality control mode and then performing the notes management mode based on the results or after ensuring accuracy, the reliability of the examination results in procedure quality control mode can be increased. [Industrial Applicability]

[0034] The present invention is useful as a technique for supporting quality control of physiological testing devices in hospitals and the like. [Explanation of symbols]

[0035] 10 Electrocardiograph 11 Measurement section 12 Mode setting section 13 Data Sorting Department 14 Storage section 15 Output section 21 Electrocardiogram electrode 22 Simulator

Claims

1. a measurement unit that obtains test result data in each of a normal test mode and a quality control mode including a procedure quality control mode; a storage unit that stores the test result data obtained in the quality control mode and the test result data obtained in the normal test mode in a separately readable manner; A physiological testing device comprising:

2. The quality control mode further includes an equipment quality control mode, the storage unit stores the test result data obtained in the normal test mode, the test data obtained in the technique quality control mode, and the test result data obtained in the equipment quality control mode in a separately readable manner. The physiological testing device according to claim 1 .

3. Further, a notification unit is provided to prompt a user to perform the test in the quality control mode. The physiological examination device according to claim 1 or 2.

4. a notification unit that prompts a user to perform an inspection in the quality control mode; the notification unit prompts the user to prioritize the device accuracy control mode over the technique accuracy control mode. The physiological testing device according to claim 2 .

Citation Information

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