JP2025010344A - Physiological examination device - Google Patents

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

Description

The present invention relates to a physiological testing device.

Conventionally, there have been physiological tests such as electrocardiograms, electroencephalograms, pulmonary function tests, and ultrasound tests. For example, electrocardiograms are widely used to diagnose heart diseases. An electrocardiogram detects the electrical activity of the heart on the body's surface and displays it as an electrocardiogram waveform. By analyzing this electrocardiogram waveform (electrocardiogram), various information about the activity of the heart can be obtained. Devices that perform such physiological tests include physiological testing devices such as electrocardiographs, electroencephalographs, pulmonary function test devices, and ultrasound diagnostic devices.

In addition, with the development of digital electrocardiographs that digitize and record electrocardiograms, it has become possible to automatically analyze electrocardiograms using a computer (see, for example, Patent Document 1).

In recent years, hospitals and other medical institutions have placed great importance on quality control of medical equipment, and the scope of this has expanded to include physiological testing devices such as electrocardiographs.

JP 2006-116207 A

As such, there is a demand for medical institutions to manage the accuracy of electrocardiographs.

However, in conventional physiological testing devices, quality control was not given sufficient consideration. For example, quality control of electrocardiographs was actually performed by inspecting them according to inspection items such as daily inspections and regular inspections, and the results were applied mutatis mutandis to quality control. Specifically, electrocardiograph inspections included checking whether the test waveform's wave height was 10 mm/1 mV (±10%) and whether the time constant was 3.2 sec or more. In addition, test result data such as the test result screen and result report, which were displayed in the same way as when performing normal tests (outpatient tests, inpatient tests, etc.), were written in memos by users such as laboratory technicians, and the accuracy was evaluated while looking at them.

Therefore, when a large amount of test result data is required for accuracy evaluation, there is a problem that it is time-consuming to write it down in notes. In addition, if there are mistakes in writing the test result data, there is also the problem that the reliability of quality control decreases.

The present invention was made in consideration of the above points, and provides a physiological testing device that can perform quality control easily and with high reliability.

One aspect of the physiological testing device of the present invention includes:
a measurement unit that performs a predetermined measurement process on the 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 sorting unit that sorts the test result data obtained by the measurement unit when the quality control mode is set to the normal test mode so as to be identifiable as different data from the test result data obtained by the measurement unit when the quality control mode is set to the normal test mode;
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.

According to the present invention, by making it possible to set a 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 reliably.

FIG. 1 is a block diagram showing a configuration of a main part of an electrocardiograph according to an embodiment of the present invention; A diagram showing the electrocardiogram test selection screen FIG. 13 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. FIG. 13 is a diagram showing an example of data for quality control output by an output unit. FIG. 13 is a diagram showing an example of a graph for quality control output by an output unit. A diagram showing an example of copying test result data for quality control mode to another terminal.

The following describes in detail an embodiment of the present invention, taking an electrocardiograph as an example, with reference to the drawings.

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

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

The mode setting unit 12 can be operated by the 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.

Figure 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 that button.

In response to this, the electrocardiograph 10 executes the procedure quality control mode when the user touches the "Procedure Quality Control" button, and executes the equipment quality control mode when the user touches the "Equipment Quality Control" button.

The technical 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 technical accuracy. In other words, since the test results of the electrocardiograph 10 are affected by factors such as the position at which the electrocardiogram electrodes 21 are attached to the subject, the amount and method of application of electrolyte cream applied before attaching the electrodes to this position, and noise interference caused by the routing of the induction cord that connects the electrodes and the measuring unit to transmit the electrocardiogram signal, the smaller the variability in the test results, the higher the technical accuracy. In general, technical accuracy is measured by having different technicians perform tests on the same subject.

The device accuracy of the electrocardiograph 10 refers to the accuracy of the measurement value for the input, and specifically indicates the degree to which test result data with no variation can be output when the same electrocardiograph signal is input. In other words, if there is some 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, a standard electrocardiograph signal from a simulator is input into the measurement unit 11, and the device accuracy is evaluated by evaluating the test result data output from the measurement unit 11 at that time.

The data sorting unit 13 distinguishes the test result data obtained by the measurement unit 11 when the quality control mode (procedure quality control mode, equipment quality control mode) is set as separate data from the test result data obtained by the measurement unit 11 when the 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.) is set.

Here, the data sorting unit 13 can sort the test result data of the normal test from the test result data of the quality control mode, for example, by dividing the files of the normal test and the files of the quality control mode into separate files. Note that the sorting method is not limited to this.

The memory unit 14 stores the data sorted by the data sorting unit.

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

Figure 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 Figure 3, the user can output test result data for technique quality control or test result data for equipment quality control stored in the memory unit 14 from the output unit 15.

Figure 4 shows an example of data for quality control output by the output unit 15. Figure 5 shows an example of a graph for quality control output by the output unit 15.

The test result data for the quality control mode (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 the 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 to the terminal 40 by the SD card 30 is copied to a master file managed by the facility.

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 a user operation, a data sorting unit 13 that sorts the test result data obtained by the measurement unit 11 when the quality control mode is set so that it can be identified 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 sorted by the data sorting unit 13, and an output unit 15 that outputs the data stored in the memory unit 14.

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.

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 interpreted in a limiting manner based on the embodiment. In other words, the present invention can be embodied in various forms without departing from the gist or main features of the present invention.

Specifically, in addition to electrocardiographs, it can also be applied to physiological testing devices such as electroencephalographs, pulmonary function testing devices, and ultrasound diagnostic devices. Equipment quality control using a simulator is also possible for electroencephalographs, pulmonary function testing devices, and ultrasound diagnostic devices. As for procedural quality control, in the case of electroencephalographs, electrode placement and the amount of paste, in the case of pulmonary function testing devices, treatment of the subject (talking to them, removing anxiety), and in the case of ultrasound diagnostic devices, the way the ultrasound probe is applied and the amount of ultrasound gel, affect the test results, and it can be said that the smaller the variance in the test results, the higher the procedural accuracy.

In addition to the above-described embodiment, a notification unit may be provided that prompts the user by voice or display to perform an examination in quality control mode. The notification unit prompts the user to perform an examination in quality control mode, for example, periodically (e.g., every few months) or every specified operating time (e.g., every few hundred operating hours). This makes it possible to prevent a situation in which quality control is not performed for a long period of time.

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

This invention is useful as a technology that supports quality control work for physiological testing devices in hospitals and other facilities.

REFERENCE SIGNS LIST 10 electrocardiograph 11 measurement unit 12 mode setting unit 13 data classification unit 14 storage unit 15 output unit 21 electrocardiogram electrode 22 simulator

Claims (4)

a measurement unit that obtains test result data in each of a normal test mode and a quality control mode including a technique 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: The quality control mode further includes an equipment quality control mode,
The storage unit stores the examination result data obtained in the normal examination mode, the examination data obtained in the technique quality control mode, and the examination result data obtained in the equipment quality control mode in a manner that allows them to be read out separately.
The physiological testing device according to claim 1 . A notification unit that prompts a user to perform an inspection in the quality control mode is further provided.
The physiological testing device according to claim 1 or 2. A notification unit that prompts a user to perform an inspection in the quality control mode,
the notification unit prompts the user to preferentially perform the equipment quality control mode over the technique quality control mode.
The physiological testing device according to claim 2 .

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