JP7720979B2 - Physiological testing device - Google Patents

Description

The present invention relates to a physiological testing device.

Traditionally, physiological tests include electrocardiograms, electroencephalograms, pulmonary function tests, and ultrasound tests. 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 information about cardiac activity can be obtained. Physiological testing devices that perform these physiological tests include electrocardiographs, electroencephalographs, pulmonary function test devices, and ultrasound diagnostic devices.

In addition, 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).

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.

Japanese Patent Application Laid-Open No. 2006-116207

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

However, with conventional physiological testing equipment, sufficient consideration was not given to quality control. For example, quality control for electrocardiographs was carried out by checking them according to inspection items such as daily inspections and periodic inspections, and the results were then applied to quality control. Specific inspections of electrocardiographs included checking whether the test waveform's wave height was 10mm/1mV (±10%) and whether the time constant was 3.2 seconds or longer. Furthermore, test result data, such as the test result screen and result report, were displayed in the same way as when performing regular tests (outpatient tests, inpatient tests, etc.), and test technicians and other users would take notes and evaluate the accuracy while looking at them.

As a result, when there is a large amount of test result data required for accuracy evaluation, there is the problem of it being time-consuming to write it down in notes. Furthermore, if there are any mistakes in writing the test result data, there is also the problem of the reliability of quality control being reduced.

The present invention was made in consideration of the above points and provides a physiological testing device that allows for easy and highly reliable quality control.

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.

According to the present invention, quality control mode can be set, and test result data obtained in quality control mode is stored so that it can be distinguished from that obtained in normal test mode, making quality control easy and highly reliable.

1 is a block diagram showing the main configuration of an electrocardiograph according to an embodiment; A diagram showing the electrocardiogram test selection screen 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. FIG. 10 is a diagram showing an example of quality control data output by an output unit. FIG. 10 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, using 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 includes a measurement unit 11, a mode setting unit 12, a data classification unit 13, a memory unit 14, and an output unit 15.

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.

The mode setting unit 12 can be operated by the user to set a quality control mode that is separate from the normal inspection mode. In this embodiment, the mode setting unit 12 is embodied as 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," or "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 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.

The technical accuracy of the electrocardiograph 10 refers to the variability in test results when different technicians are used; the lower 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 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, the lower the variability in the test results, the higher the technical accuracy. Generally, 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 values relative to the input, and specifically indicates the degree of variability 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 malfunction in the electrocardiograph 10, the measurement output of the electrocardiograph 10 will vary, but if there is no malfunction, there will be no variability, so the variability in the measurement output can be used as an indicator of device accuracy. In practice, as shown in Figure 1, 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.

The data classification unit 13 distinguishes 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 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.).

Here, the data sorting unit 13 can separate test result data for normal testing from test result data for quality control mode, for example, by separating files for normal testing and files for quality control mode into separate files. However, the method of separation 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 quality control mode by the output unit 15. By operating the operation screen in Figure 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.

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

In addition, test result data for 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 communication means (not shown), as shown in Figure 6. Figure 6 shows an example in which a CSV file of test result data brought to the terminal 40 via the SD card 30 is copied to a master file managed by the facility.

As described above, according to this embodiment, the electrocardiograph 10 comprises a measurement unit 11 that performs predetermined measurement processing on input electrocardiogram signals to obtain test result data; a mode setting unit 12 that can be operated by the user to set a quality control mode separate from the normal test mode; 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 quality control mode so that it can be distinguished from that obtained in 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 implementation of the present invention, and the technical scope of the present invention should not be interpreted as being limited by these embodiments. In other words, the present invention can be implemented in various forms without departing from its gist or main features.

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. Furthermore, in terms of procedural accuracy control, in the case of electroencephalographs, electrode placement and the amount of paste used affect test results; in the case of pulmonary function testing devices, treatment of the subject (speaking to them and easing their anxiety), and in the case of ultrasound diagnostic devices, the way the ultrasound probe is applied and the amount of ultrasound gel used affect test results; and it can be said that the smaller the variance in 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 testing in quality control mode. The notification unit prompts the user to perform testing 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 can prevent situations where quality control is not performed for long periods of time.

Furthermore, when the notification unit prompts the user to perform an examination in quality control mode, it is preferable to encourage the user to perform the examination in equipment quality control mode first rather than 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 note quality control mode based on the results or after ensuring accuracy, the reliability of the examination results in procedure quality control mode can be increased.

This invention is useful as technology to support quality control operations 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 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: 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 . 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. 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 .