Electrocardiograph and control method thereof

Abstract

The invention discloses an electrocardiograph and a control method thereof, which can reduce the burden of related medical personnel on electrocardiograph inspection and evaluation for evaluating the possibility of ACS. An electrocardiograph continuously acquires an electrocardiogram of a subject, and automatically applies an analysis process to the electrocardiogram in parallel therewith. The electrocardiograph executes extended inspection when the information obtained by the analysis process satisfies a predetermined condition relating to the possibility of acute coronary syndrome (ACS). The electrocardiograph changes the screen displayed on the display device to the expanded inspection screen when executing the expanded inspection. The extended examination screen has a first display area for displaying an electrocardiogram, a second display area for displaying a composite lead waveform generated by the composite processing, and a third display area for displaying the ST level of each lead.

Description

Technical Field

[0001] The invention relates to an electrocardiograph and a control method thereof. Background Art

[0002] Acute Coronary Syndromes (ACS) are acute myocardial ischemia caused by severe stenosis or occlusion of the coronary arteries. In the Acute Coronary Syndrome Guidelines (2018 Revised Edition) (Non-Patent Document 1, hereinafter referred to as the Guidelines), as an electrocardiogram examination for subjects suspected of ACS, it is recommended that:

[0003] ·Evaluate a 12-lead ECG (initial ECG) within 10 minutes;

[0004] If the diagnosis cannot be made by the initial ECG, record a 12-lead ECG every 5 to 10 minutes based on symptoms, etc.; record a 12-lead ECG over time; record V4R leads in addition to the 12 leads; consider recording leads V7 to V9, etc.

[0005] [Prior technical literature]

[0006]

Non-patent literature

[0007] [Non-patent document 1] Kimura et al., “Acute Coronary Syndrome Guidelines (2018 Revised Edition)”, [online], published on March 29, 2019, Japan Society of Cardiovascular Medicine, [retrieved on October 5, 2019], Internet<URL:https: / / www.j-circ.or.jp / cms / wp-content / uploads / 2020 / 02 / JCS2018_kim ura.pdf> Summary of the invention

[0008] [Summary of the Invention]

[0009] [Problems to be solved by the invention]

[0010] However, in an emergency room where various treatments are performed in parallel for a patient who complains of chest pain and is transported by emergency medical services, it is difficult to perform the electrocardiogram recommended in the guidelines, especially when the initial electrocardiogram cannot provide a diagnosis. Moreover, even if an electrocardiogram is measured, there may not be a doctor in the emergency room who can evaluate the electrocardiogram. In addition, when multiple electrocardiograms are measured, it is necessary to compare multiple reports output from each measurement to make a diagnosis, which is troublesome.

[0011] For such reasons, there is a problem that the possibility of ACS may not be adequately evaluated, particularly for subjects who cannot be diagnosed by the initial electrocardiogram.

[0012] The present invention has been made in view of the above problems in the prior art, and in one aspect thereof, provides an electrocardiograph and a control method thereof, which can reduce the burden on medical personnel in performing electrocardiogram examination and evaluation for evaluating the possibility of ACS.

[0013]

Solutions to Solve the Problem

[0014] According to one aspect of the present invention, an electrocardiograph is provided, comprising: an acquisition unit for continuously acquiring an electrocardiogram of a subject; a display unit for continuously displaying the electrocardiogram on a display device; an analysis unit for automatically applying analysis processing to the electrocardiogram; a determination unit for determining whether information obtained through the analysis processing satisfies a predetermined condition regarding the possibility of acute coronary syndrome (ACS); and a control unit for performing an extended examination when the determination unit determines that the information obtained through the analysis processing satisfies the condition regarding the possibility of ACS. When performing the extended examination, the control unit changes a screen displayed on the display device to an extended examination screen, the extended examination screen having a first display area for displaying the electrocardiogram, a second display area for displaying a synthesized lead waveform generated through synthesis processing, and a third display area for displaying the ST level of each lead.

[0015] [Effects of the invention]

[0016] According to the present invention, it is possible to provide an electrocardiograph and a control method thereof, which can reduce the burden on medical personnel in performing electrocardiogram examination and evaluation for evaluating the possibility of ACS. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] The accompanying drawings are included in the specification and constitute a part of the specification, illustrate embodiments of the present invention, and together with the description of the specification, serve to explain the principles of the present invention.

[0018] Figure 1 It is a block diagram showing an example of the functional configuration of the electrocardiograph according to the embodiment.

[0019] Figure 2A This is a flowchart regarding the operation of the electrocardiograph according to the embodiment.

[0020] Figure 2B This is a flowchart regarding the operation of the electrocardiograph according to the embodiment.

[0021] Figure 3 It is a diagram showing an example of a screen presented by the electrocardiograph according to the embodiment.

[0022] Figure 4It is a diagram showing an example of a screen presented by the electrocardiograph according to the embodiment.

[0023] Figure 5 It is a diagram showing an example of a screen presented by the electrocardiograph according to the embodiment.

[0024] Figure 6 It is a diagram showing an example of a screen presented by the electrocardiograph according to the embodiment.

[0025] Figure 7 It is a diagram showing an example of a screen presented by the electrocardiograph according to the embodiment.

[0026] Figure 8 It is a diagram showing an example of a screen presented by the electrocardiograph according to the embodiment.

[0027] Fig. 9 It is a diagram showing an example of a screen presented by the electrocardiograph according to the embodiment.

[0028] Fig.10 It is a diagram showing an example of a screen presented by the electrocardiograph according to the embodiment.

[0029] Fig.11A It is a diagram showing an example of a summary report output by the electrocardiograph according to the embodiment.

[0030] Fig. 11B It is a diagram showing an example of a summary report output by the electrocardiograph according to the embodiment.

[0031] Fig. 12A It is a diagram showing an example of a summary report output by the electrocardiograph according to the embodiment.

[0032] Fig. 12B It is a diagram showing an example of a summary report output by the electrocardiograph according to the embodiment.

[0033] Fig.13 It is a diagram showing an example of a summary report output by the electrocardiograph according to the embodiment. DETAILED DESCRIPTION

[0034] Hereinafter, the present invention will be described in detail based on the exemplary embodiments of the present invention with reference to the accompanying drawings. It should be noted that the following embodiments do not limit the invention of the claims. Moreover, although the embodiments describe a plurality of features, not all of them are essential to the invention, and a plurality of features may be combined arbitrarily. In addition, in the accompanying drawings, the same reference numerals are given to the same or similar structures, and repeated descriptions are omitted.

[0035] Hereinafter, the mode of implementing the present invention is described by using an electrocardiograph, but the present invention can be applied to any other electronic device that can measure and analyze a standard 12-lead electrocardiogram. Such an electronic device is not limited to a medical device such as a monitoring device, but also includes an interface that can connect electrocardiogram electrodes and a general-purpose computer device (personal computer, tablet terminal, smart phone, etc.) that can execute an application program that can measure and analyze a standard 12-lead electrocardiogram.

[0036] (Structure of an electrocardiograph)

[0037] Figure 1 It is a block diagram showing a configuration example of the electrocardiograph 1 according to the embodiment of the present invention.

[0038] The electrode group 110 has a structure that connects a plurality of electrodes worn on the body surface of the subject to a connector installed in the input part 111 of the electrocardiograph through a lead wire. In the present embodiment, the electrocardiograph 1 uses the electrode group 110 to measure a standard 12-lead electrocardiogram. The electrode group 110 used in the measurement of the standard 12-lead electrocardiogram usually has limb electrodes (4) and chest electrodes (6). It should be noted that wireless communication can also be used instead of the lead wire to input signals from the electrodes to the electrocardiograph.

[0039] The input unit 111 has a connector that fits into the connector of the electrode group 110. The input unit 111 also has, for example, a protection circuit, a lead selector, an amplifier circuit, etc., and outputs a preset type of electrocardiogram signal (here, a standard 12-lead electrocardiogram signal).

[0040] The A / D converter 112 performs A / D conversion on the analog electrocardiogram signal output from the input unit 111 and outputs the signal as electrocardiogram data. The input unit 111 and the A / D converter 112 are also referred to as an analog front end (AFE).

[0041] The filter processing unit 113 applies a noise removal filter to the electrocardiogram data input from the A / D conversion unit 112 according to the setting of the control unit 120. In the present embodiment, as an example, the filter processing unit 113 can selectively apply an electromyographic noise removal filter, an AC noise removal filter, and a drift noise removal filter, but the type and number of filter processing are not limited thereto.

[0042] The speaker 114 is used to output, for example, a warning sound or a voice message from the control unit 120 .

[0043] The control unit 120 (control unit) is a processor such as a CPU capable of executing a program. The control unit 120 loads the program stored in the ROM 125 into the RAM 124 and executes the program through the processor, thereby controlling the components of the electrocardiograph 1 and realizing the operation of the electrocardiograph 1 including the operation of the extended mode described later.

[0044] In addition to the program, the ROM 125 also stores unique information and setting values ​​of the electrocardiograph 1, data of a graphical user interface (GUI) displayed on the display unit 118, and the like. The information and data stored in the ROM 125 are appropriately used during the execution of the program. It should be noted that at least a portion of the ROM 125 may be electrically rewritable.

[0045] The RAM 124 is used to load programs or store variables during the execution of programs, etc. The RAM 124 may also be used as a buffer memory or an image memory of the display unit 118 .

[0046] It should be noted that at least one of the A / D conversion unit 112 and the filter processing unit 113 may be implemented by the control unit 120 executing a program, or may be implemented by a dedicated or existing hardware circuit.

[0047] The analysis unit 1201 (analysis means) applies a pre-set analysis process to the electrocardiogram data. The analysis unit 1201 is a functional module for representing the analysis function of the electrocardiogram data realized by the control unit 120 executing the program. Therefore, the operation of the analysis unit 1201 is actually performed by the control unit 120. It should be noted that the analysis unit 1201 can be executed using the same processor as the control unit 120.

[0048] The analysis process performed by the analysis unit 1201 can be roughly divided into a classification process, a feature quantity acquisition process, and an observation result classification process.

[0049] The classification process is a process of obtaining electrocardiogram data of a predetermined unit (for example, a predetermined number of heartbeats, a predetermined amount of time, etc.) from the measured electrocardiogram data.

[0050] The feature acquisition process is to detect the waveform of the electrocardiogram that constitutes one heartbeat (such as P wave, QRS group, T wave) and its distinction points, and calculate the pre-set feature quantities (RR interval, ST level, PQ or PR interval, QRS width, QT interval, etc.).

[0051] The observation result classification process is a process of determining a plurality of observation results including an observation result that is suspicious of ACS based on a feature amount and a determination condition determined in advance.

[0052] It should be noted that the characteristic quantities listed here are only examples, and other characteristic quantities can also be obtained. Moreover, there is no particular limitation on the observation results to be determined. The analysis processing performed by the analysis unit 1201 is the same as the processing implemented as an automatic analysis function in a known electrocardiograph or electrocardiogram analysis device, so further detailed description is omitted.

[0053] The recording medium 116 may be a removable medium such as a memory card or a USB memory. The control unit 120 may record the electrocardiogram data on the recording medium 116, or read the electrocardiogram data recorded on the recording medium 116. It should be noted that the electrocardiogram data includes various data obtained along with the electrocardiogram measurement, such as the subject information, the electrocardiogram data, and the analysis processing results. The electrocardiogram data is generated in a predetermined data format for each examination. It should be noted that the electrocardiogram data may be recorded as a plurality of data files associated with each other, or may be recorded as one data file.

[0054] The operation unit 117 is an input device for the user (medical personnel) to input various settings and instructions to the electrocardiograph 1. In the present embodiment, the operation unit 117 is a physical switch, button, or key provided on the housing of the electrocardiograph 1. The operation unit 117 has a recording button for giving a start instruction / end instruction for manual recording.

[0055] The display unit 118 is a touch display including an LCD and a touch panel. The display unit 118 displays an electrocardiogram during measurement, subject information, analysis processing results, various GUIs, and the like in real time under the control of the control unit 120 .

[0056] The printer 119 is, for example, a thermal printer having a paper conveying mechanism, a print head and a drive circuit thereof. The printer 119 outputs the electrocardiogram in the measurement process in real time, or outputs a report of the measured electrocardiogram and its analytical processing results, in accordance with the control of the control unit 120. It should be noted that the built-in printer 119 is not necessary in the present invention. The printer 119 can be an external printer connected to the electrocardiograph 1 so as to be able to communicate. That is, the electrocardiograph 1 can be used as long as it can use a built-in or external printer.

[0057] The power supply unit 121 is, for example, a secondary battery or a commercial power supply (AC adapter), and supplies power to the components of the electrocardiograph 1 .

[0058] External I / F 123 is a communication interface with an external device, and has a structure that complies with one or more standards in known wired or wireless communication standards. For example, external I / F 123 can comply with one or more standards such as USB, 100BASE-T, wireless LAN, and Bluetooth (registered trademark).

[0059] Here, the electrocardiograph 1 is connected to the in-hospital information system 2 via the in-hospital LAN 160 using the external I / F 123. Therefore, the electrocardiograph 1 can communicate with the in-hospital information system 2 via the external I / F 123. The in-hospital information system 2 manages medical information such as personal information, past examination results, and diagnosis results in association with the subject ID.

[0060] The electrocardiograph 1 of this embodiment has, as an operation mode, a normal mode in which a conventional fixed electrocardiograph operates, and an extended mode that provides a function of reducing the burden on medical personnel who perform electrocardiograms for evaluating the possibility of ACS and evaluate the results of electrocardiograms. The operation mode at startup can be selected, for example, by user settings based on a setting screen. The operation of the normal mode is omitted, and the operation of the extended mode is described below.

[0061] (Extended mode action)

[0062] Figure 2A and Figure 2B This is a flowchart about the extended mode operation of the electrocardiograph 1. The operation of the flowchart is implemented by the control unit 120 reading the program stored in the ROM 125 into the RAM 124 and executing it. It should be noted that in the following description, "electrocardiogram" and "lead" refer to the state in which the waveform can be observed (displayed or printed state), and "electrocardiogram (data)" and "lead (data)" refer to data representing the electrocardiogram and the lead, respectively. Moreover, the "electrocardiogram" includes more than one "lead".

[0063] The control unit 120 (acquisition unit) continuously acquires the electrocardiogram of the subject based on the signal input by the input unit 111 through the electrodes of the electrode group 110. Furthermore, the control unit 120 (display unit) continuously displays the acquired electrocardiogram on the display unit 118 in real time. The control unit 120 starts the real-time display sequentially from the leads that can be displayed. Furthermore, while executing the acquisition and real-time display of the electrocardiogram, the control unit 120 concurrently executes the actions described below.

[0064] Furthermore, when the control unit 120 detects an operation on the operation unit 117 or a touch operation on the display unit 118, it executes the processing corresponding to the detected operation in parallel with the operation described below. For example, when the record button is operated, the control unit 120 outputs the electrocardiogram from the printer 119 in real time as in the normal mode operation.

[0065] In S201, the control unit 120 determines whether the electrodes of the electrode group 110 are completely worn by the subject. If it is determined that the wearing is complete, S203 is executed. If it is determined that the wearing is not complete, S201 is executed again. The control unit 120 can determine that the wearing of the electrodes is complete when it can confirm that the data of all the leads (here, leads I to III, aVR, aVL, aVF, and leads V1 to V6) constituting the electrocardiogram to be recorded can be obtained.

[0066] In S203, the control unit 120 starts to save the electrocardiogram data to the RAM 124. The control unit 120 uses a predetermined area of ​​the RAM 124 as a buffer (FIFO) that always holds the electrocardiogram data of the most recent predetermined time (e.g., 30 seconds). In addition, the control unit 120 starts to perform periodic analysis processing on the electrocardiogram data. These processes are automatically performed without the need for user instructions, so even if the operation unit 117 is not instructed to record (output) the initial electrocardiogram, the electrocardiogram evaluation can be performed in the background.

[0067] The control unit 120 (analysis unit 1201) periodically (for example, every 30 seconds) performs analysis processing on the electrocardiogram data of a predetermined time (for example, 10 seconds). It should be noted that when the analysis processing can be performed in real time, the analysis processing can be performed on the electrocardiogram data of the most recent predetermined time.

[0068] Figure 3 The following is an example of an initial screen of the extended mode displayed by the control unit 120 on the display unit 118 when the electrodes are worn and the periodic analysis process is executed. The user may be able to change at least a part of the layout of the display screen and the displayed items.

[0069] The initial screen 100 has a waveform display area 20 for displaying a standard 12-lead electrocardiogram and one lead (here, lead II) predetermined as a rhythm waveform in the standard 12-lead in real time. Furthermore, a function key area 30 is provided below the waveform display area 20. In the function key area 30, eight function keys can be switched and displayed, and these function keys are GUI components that can be operated by touch by the user.

[0070] A first information display area 10 is provided above the waveform display area 20 (the uppermost portion of the initial screen 100 ), and a second information display area 40 is provided below the function key area 30 (the lowermost portion of the initial screen 100 ).

[0071] The first information display area 10 includes a heart rate area 11 , a subject information area 12 , an examination type area 13 , a filter type area 14 , and a record type area 15 .

[0072] The heart rate area 11 displays the instantaneous heart rate (bpm) calculated based on the time difference (e.g., RR interval) between the characteristic points of the electrocardiogram of the two most recent heartbeats. The subject information area 12 displays subject information such as identification information (subject ID), name, and age. The subject information area 12 can be touched, and subject information can be input through the displayed sub-screen by touch operation (details will be described later).

[0073] The test category area 13 displays the current test category. The electrocardiograph 1 of this embodiment can perform 12-lead test and 18-lead test in the extended mode, and the 12-lead test is shown here in the initial state. When the operation starts in the extended mode, the user can set which of the 12-lead test and the 18-lead test is to be performed. In addition, the test category can be changed by touching the test category area 13.

[0074] The filter type area 14 displays the type of filter applied to the electrocardiogram data by the filter processing unit 113. As described above, the filter processing unit 113 can selectively apply the myoelectric noise removal filter, the AC noise removal filter, and the drift noise removal filter. The user can change the type of filter applied by the filter processing unit 113 by touching the filter type area 14.

[0075] The recording type area 15 displays whether automatic recording or manual recording is to be performed when a recording instruction is given by the recording button of the operation unit 117, and displays recording settings such as the number of leads to be recorded. The switching between automatic recording and manual recording can be changed by touching the automatic recording / manual recording switching key 36 described later. The recording setting can be set by the user through the menu screen.

[0076] The waveform display area 20 includes an area 21 for displaying limb leads (leads I to III and aVR, aVL, and aVF), an area 22 for displaying chest leads (leads V1 to V6), and an area 23 for displaying a cardiac rhythm waveform (lead II in this case). The leads displayed in the waveform display area 20 are updated in real time, and the leads of the most recent predetermined amount of time are always displayed. The display of the cardiac rhythm waveform is for evaluating the regularity of the heartbeat, and the waveform is compressed in the time direction in order to display a waveform longer than that in areas 21 and 22.

[0077] The types of function keys displayed in the function key area 30 are determined according to the display screen. Furthermore, the user can set at least a part of the displayed function keys.

[0078] The last examination result call key 34 is a key for reading information of the electrocardiogram examination performed in the past for the subject during the electrocardiogram measurement. When the last examination result call key 34 is operated, the control unit 120 inquires the in-hospital information system 2 about the past electrocardiogram examination result through the external I / F 123 based on the subject ID input to the subject information area 12. When there are corresponding examination results, the control unit 120 receives a list of examination results from the in-hospital information system 2. The control unit 120 displays a selection screen of the examination result on the display unit 118 based on the list. Then, the control unit 120 obtains the examination result selected from the selection screen from the in-hospital information system 2 and displays it on the display unit 118.

[0079] When the automatic recording / manual recording switching key 36 is operated, the control unit 120 switches whether to perform an automatic recording operation or a manual recording operation when the recording button provided in the operation unit 117 is operated. The currently set recording operation is displayed in the recording type area 15.

[0080] In the case of automatic recording, the control unit 120 outputs the electrocardiogram for a certain period of time from the time when the record button is pressed as a report in a predetermined format from the printer 119 together with the analysis result of the analysis unit 1201. On the other hand, in the case of manual recording, when the record button is pressed, the control unit 120 continues to output the measured electrocardiogram from the printer 119 in real time until the record button is pressed again.

[0081] When the interval recording start key 37 is operated, the control unit 120 switches the interval recording on and off. When the interval recording is enabled, the control unit 120 outputs an electrocardiogram for a certain period of time from the printer 119 every time a predetermined time elapses.

[0082] When the menu key 38 is operated, the control unit 120 displays a menu screen on the display unit 118. It should be noted that the menu screen may be displayed as a sub-window overlapping the initial screen 100, or the initial screen 100 may be replaced by the menu screen.

[0083] When the page switching key 39 is operated, the control unit 120 switches the group of function keys displayed in the function key area 30. Here, a case where two groups of function keys can be switched is shown.

[0084] The second information display area 40 is an area for displaying the current date and time, the settings and status of the electrocardiograph 1 , and the like.

[0085] return Figure 2AThe control unit 120 performs periodic analysis processing while determining in S205 whether an information input instruction is detected. The information input instruction is, for example, a touch operation on the subject information area 12. If the control unit 120 determines that an information input instruction is detected, it executes S207, and if it determines that an information input instruction is not detected, it executes S213.

[0086] In S207 , the control unit 120 displays the information input screen on the display unit 118 , and executes S209 . Figure 4 FIG. 4 is a diagram showing an example of an input screen displayed in S207. Figure 4 , there is shown an example in which the control unit 120 displays a setting screen 200 for inputting subject information as a sub-window overlapping the initial screen 100 , because the control unit 120 determines that a touch operation on the subject information area 12 is detected.

[0087] The setting screen 200 has buttons that can be touched according to each input item. When the button is operated, the control unit 120 activates the corresponding input area and displays a soft keyboard, a further input screen, etc. according to the item. When the all-delete button 211 is operated, the control unit 120 puts the setting screen 200 into an initial state. And, when the end button 212 is operated, the control unit 120 closes the setting screen 200. The control unit 120 saves the information input to the setting screen 200 at the time when the end button 212 is operated, for example, in the ROM 125 or the recording medium 116. It should be noted that the subject information only needs to be input for the items that can be input, and additional input and changes can be made later.

[0088] "TIMI" among the input items of the setting screen 200 is the TIMI (Thrombolysis In Myocardial Infarction) risk score. The TIMI risk score is a numerical value indicating the risk of non-ST elevation ACS (NSTE-ACS), and corresponds to the number of corresponding items among the following 7 items.

[0089] (1) Over 65 years old

[0090] (2) There is an increase in myocardial biomarkers

[0091] (3) Having angina symptoms more than twice within 24 hours

[0092] (4) Have taken aspirin within 7 days

[0093] (5) Those who have had coronary artery disease with a stenosis of more than 50% in the past

[0094] (6) Meet three or more of the following risk factors for coronary disease (family history, hypertension, hypercholesterolemia, diabetes, current smoking)

[0095] (7) ST deviation of more than 0.5 mm in the electrocardiogram

[0096] When the TIMI button 210 of the setting screen 200 is operated, the control unit 120 further displays a TIMI score input screen 220 for inputting items (2) to (6) of the above-mentioned seven items. It should be noted that item (1) is input in the age item of the setting screen 200. In addition, item (7) requires analysis or evaluation of the electrocardiogram and is therefore not input here.

[0097] The TIMI score input screen 220 is configured so that items (2) to (6) can be input by touching buttons. It should be noted that the item names are simpler than the items of the TIMI risk score due to the number of characters. Figure 4 In the example, the input of item (3) is selected from the three items of "none", "once", and "twice or more". However, since the TIMI risk score does not distinguish between "none" and "once", it can be selected from "less than twice" or "twice or more". It should be noted that for the TIMI score, only the items that can be input need to be input, and additional input and changes can be made later.

[0098] When the end button 227 of the TIMI score input screen 220 is operated, the control unit 120 closes the TIMI score input screen 220. The control unit 120 calculates the TIMI score based on the state of the button of the TIMI score input screen 220 when the end button 227 is operated, and inputs the TIMI score into the TIMI score area of ​​the setting screen 200.

[0099] The button status of the TIMI score input screen 220 when the end button 227 is pressed is stored in, for example, the ROM 125 or the recording medium 116 by the control unit 120 , similarly to other subject information when the end button 212 of the setting screen 200 is pressed.

[0100] It should be noted that the TIMI risk score is an example of a risk score for ACS, and other known ACS risk scores such as the Global Registry of Acute Coronary Events (GRACE) risk score may also be used.

[0101] In S209, the control unit 120 determines whether the information input is completed. Figure 4In the example shown, the control unit 120 may determine that the information input is completed when the operation of the end button 212 of the setting screen 200 is detected. If the control unit 120 determines that the information input is completed, it executes S211 after saving the input subject information. If it determines that the information input is not completed, it repeats S209.

[0102] In S211, the control unit 120 (determination unit) refers to the input subject information to determine whether the risk score is above the threshold. Here, the TIMI risk score is used as the ACS risk score, and the threshold is set to 1 point. That is, as long as there is one item that meets the requirements among the above items (1) to (6), the control unit 120 determines that the risk score is above the threshold. It should be noted that the threshold is determined according to the type of ACS risk score used. Moreover, the threshold can be changed by the user. If the control unit 120 determines that the risk score is above the threshold, it executes S215. If it does not determine that the risk score is above the threshold, it executes S213.

[0103] In S213, the control unit 120 (determination unit) determines whether an observation result indicating suspicious ACS is detected in the analysis process started by the analysis unit 1201 from S209. The observation result indicating suspicious ACS includes, for example, observation results indicating suspicion or possibility of infarction, or observation results such as an increase in ST grade (ST interval is above the baseline), negativity of T wave (change from upward convexity to downward convexity), abnormal Q wave, prolongation of QT interval, and atrioventricular conduction block. These observation results can be detected by a known analysis process, and therefore, their detailed description is omitted.

[0104] During the analysis process, the control unit 120 executes S215 if it is determined that an observation result suspicious of ACS is detected, and executes S214 if it is determined that an observation result suspicious of ACS is not detected. Figure 2A In the description of , the analysis process is executed as a sequential processing step, but the analysis process is executed in parallel with the processes of S205 to S211. Therefore, in reality, each time the analysis process is completed, the control unit 120 executes S213, and if it is determined that a suspicious observation result of ACS is detected, S215 is immediately executed. It should be noted that if the information input screen is displayed, the control unit 120 can force the information input process to end after notifying the user.

[0105] In S214, the control unit 120 determines whether a predetermined time has passed since the analysis process was started in S203. If it is determined that the predetermined time has passed, the extended mode operation is terminated. If it is determined that the predetermined time has not passed, the operation is repeated from S205. It should be noted that even if the extended mode operation is terminated, the measurement and real-time display of the electrocardiogram continue until the electrodes are removed or the power is turned off. The predetermined time is the time for determining that there is no suspicion of ACS, and can be set to, for example, 1 hour.

[0106] It should be noted that, if it is determined in S214 that no suspicious ACS observation result has been detected after a predetermined time, the user may be asked whether to continue the extended mode operation (here, the execution of the periodic analysis process). And, if the user instructs to continue, the control unit 120 returns the elapsed time to 0 and continues the process from S205.

[0107] In S215, the control unit 120 notifies the user that the risk score is equal to or greater than the threshold value or that a suspicious ACS observation result is detected by the analysis process. Furthermore, the control unit 120 determines whether to proceed to an extended examination.

[0108] Figure 5 1 is a diagram showing an example of the display of the initial screen 100 when it is determined through analysis processing that an observation result suspicious of ACS is detected. The control unit 120 displays a message 51 indicating the name of the detected observation result on the initial screen 100 in an overlapping manner. Here, the background color of the message 51 is different depending on the importance (severity) of the observation result. The importance of the observation result is preset. In addition, the control unit 120 notifies the user of which lead the observation result represented by the message 51 is detected by by reversing the index 52 of the lead. It should be noted that in addition to these displays, an alarm sound or voice can also be output from the speaker 114.

[0109] Thus, the electrocardiograph 1 of this embodiment periodically performs analysis processing in parallel with the real-time display of the electrocardiogram, and notifies the user when a suspicious observation result of ACS is detected, even if the user does not give an explicit instruction. Therefore, even if it takes time to record the first electrocardiogram, the suspicion of ACS can be detected in advance. Moreover, by utilizing the automatic analysis function of the electrocardiograph 1, even in the absence of a person or doctor familiar with electrocardiogram interpretation, the suspicion of ACS can be objectively grasped.

[0110] The control unit 120 also changes the function keys displayed in the function key area 30. Here, the TIMI key 32 and the 18-lead key 35 are additionally displayed. The TIMI key 32 is used to input items that have not been input in the TIMI risk score or to change items that have been input. For example, the presence or absence of an increase in myocardial markers is checked from the time the subject is transported, so there is a situation where it is still uncertain when the TIMI risk score is initially input. Therefore, if the test results are determined at this point, the TIMI key 32 can be operated to make additional inputs. It is not limited to the increase in myocardial markers, and other items that have not been input can also be additionally input in the same way. Moreover, even if there are errors in the information that has been input, corrections can be made here. It should be noted that the addition and change of input can be performed through the operation of the subject information area 12 as previously described.

[0111] The 18-lead key 35 is a key for inputting an instruction to execute an extended examination. The control unit 120 waits for the 18-lead key 35 to be operated while performing a real-time display of a standard 12-lead electrocardiogram. Here, the display mode of the 18-lead key 35 is made different from that of other function keys, so that the user can easily grasp the input operation of the instruction to transfer to the extended examination. Here, since the initial state of the extended mode operation is the measurement of the standard 12-lead electrocardiogram, the operation of the 18-lead key 35 is regarded as an instruction to transfer to the extended examination. However, for example, in the case where the 18-lead electrocardiogram is originally measured, a function key such as "Execute extended examination" can be displayed.

[0112] It should be noted that here, the user explicitly instructs whether to execute the extended inspection, but the process may automatically shift to the extended inspection as long as an operation to reject the execution of the extended inspection (for example, a predetermined operation on the operation unit 117) is not detected. For example, the control unit 120 may automatically execute S217 if a user operation instructing not to execute the extended inspection is not detected within a certain period of time after the message 51 is displayed. Alternatively, the user may be notified of the start of the execution of the extended inspection together with the observation results using the message 51 without asking the user whether to execute the extended inspection, and the extended inspection may be automatically executed.

[0113] In S217, the control unit 120 starts the extended check. Specifically, the extended check includes the following processing:

[0114] Generate data for the right chest lead (at least lead V4R) and back lead (leads V7 to V9) by synthesizing data based on a measured standard 12-lead electrocardiogram.

[0115] Periodically perform analysis processing (ECG examination) on the measured standard 12-lead ECG data;

[0116] Periodically check ST level for synthetic lead data;

[0117] For 18 leads, representative waveforms and ST levels are displayed separately;

[0118] ·Summarize the results of multiple analysis processes into a report for output.

[0119] The following describes the operation related to the extended check.

[0120] In S219, the control unit 120 changes the screen display from the initial screen 100 to the extended inspection screen. Figure 6 An example of an extended inspection screen 300 is shown. In the extended inspection screen 300, an area corresponding to the waveform display area 20 in the initial screen 100 includes a measured waveform display area 310 (first display area), a synthesized waveform display area 320 (second display area), and an ST level display area 330 (third display area).

[0121] The measured waveform display area 310 is an area for displaying the standard 12-lead electrocardiogram being measured by the electrocardiograph 1. Unlike the waveform display area 20 of the initial screen 100, the measured waveform display area 310 has a representative waveform display area 311 in addition to the real-time display area 312. Similar to the waveform display area 20 of the initial screen 100, the real-time display area 312 is an area for displaying the standard 12-lead electrocardiogram being measured in real time.

[0122] The representative waveform display area 311 is an area for displaying the representative waveform of each lead. The representative waveform is a waveform corresponding to one heartbeat, which represents an electrocardiogram for a predetermined amount of time (e.g., 10 seconds) to which the analysis process is applied. There is no particular limitation on the method for determining the representative waveform from the waveforms corresponding to multiple heartbeats included in the electrocardiogram for a predetermined amount of time, and any known method can be used. For example, the waveform corresponding to one heartbeat with the smallest difference from the average waveform (with the largest correlation with the average waveform) can be used as the representative waveform.

[0123] It should be noted that in the present embodiment, the representative waveform of the standard 12-lead electrocardiogram for a predetermined amount of time used for the analysis process performed immediately before or after S217 (the start of the execution of the extended test) is set as the control waveform (reference waveform) 311a and is first displayed in the representative waveform display area 311. Then, each time the analysis process is performed in the extended test, the representative waveform 311b of the standard 12-lead electrocardiogram for a predetermined amount of time used for the most recent analysis process is displayed overlapping with the control waveform 311a. By making the display method (for example, color) of the control waveform 311a and the most recent representative waveform 311b displayed overlappingly different, it is possible to easily grasp the change of the waveform at the time of the start of the extended test and the waveform thereafter.

[0124] The synthesized waveform display area 320 is an area for displaying the representative waveform of the lead obtained by the synthesis process. The synthesis process is a process for generating the data of the unmeasured lead based on the data of the lead actually measured. Through the synthesis process, the data of the lead that should be measured at the position on the body surface where the electrodes are not worn (synthesized lead data) can be obtained.

[0125] By synthesizing, data of more types of leads than the standard 12 leads can be obtained, and therefore information related to the leads useful for diagnosing the possibility of ACS can be provided without increasing the number of electrodes to be worn by the subject.

[0126] In this embodiment, electrocardiogram data of V3R to V5R leads and V7 to V9 leads including the right chest lead (V4R lead) and back leads (V7 to V9 leads) recommended by the guidelines are generated by synthesis processing based on the standard 12-lead electrocardiogram data being measured.

[0127] The synthesis process of generating data of V3R to V5R leads and V7 to V9 leads, which are not actually wearing electrodes, based on the standard 12-lead electrocardiogram data can be implemented by a known method. For example, the control unit 120 generates data of X leads, Y leads, and Z leads using the Inverse Lead Matrix based on the measured standard 12-lead electrocardiogram data. Then, the control unit 120 calculates the inner product of the data of X leads, Y leads, and Z leads with the x, y, and z components of the lead vector at the virtual electrode position according to each sample of the lead data, thereby generating the synthesized lead data at the virtual electrode position. For specific examples of the synthesis process, it is desirable to refer to, for example, Japanese Patent No. 4664068 and Japanese Patent No. 4955153.

[0128] The control unit 120 generates data of V3R to V5R leads and V7 to V9 leads for a predetermined amount of time by using the synthesis process of the standard 12-lead electrocardiogram data for a predetermined amount of time to which the analysis process is applied. Furthermore, the control unit 120 determines a representative waveform for each lead obtained by the synthesis process, and displays the determined representative waveform in the synthetic waveform display area 320. The method for determining the representative waveform may be the same as the method for determining the representative waveform of the standard 12 leads. Alternatively, the control unit 120 may use the data of V3R to V5R leads and V7 to V9 leads for one heartbeat generated by applying the synthesis process to the data of the representative waveform of the standard 12-lead electrocardiogram for displaying the representative waveform of the synthetic lead.

[0129] In addition, the control unit 120 displays the representative waveform involved in the initial synthesis process as the control waveform 321 in the synthesis waveform display area 320, and displays the representative waveform 322 involved in the most recent synthesis process in an overlapping manner with the control waveform for the second and subsequent synthesis processes. Here, the control waveform 321 is also displayed differently from the most recent representative waveform 322.

[0130] The ST level display area 330 is an area for displaying the ST level for each of the standard 12 leads and the synthesized leads. Here, the ST level is a relative value with the baseline level set to 0. Figure 6 In the ST level, the maximum ST level corresponding to the maximum amplitude of the ST interval is displayed as the ST level. For example, a straight line connecting the Q wave start point and the T wave end point of the heartbeat including the ST interval of the processing object is used as the baseline, and the ST level at which the absolute value of the difference between each sample value of the ST interval and the corresponding baseline level becomes the largest can be obtained as the maximum ST level. The maximum ST level is an example of a representative value of the ST interval based on the amplitude.

[0131] In this embodiment, the 18 leads are classified into 6 limb leads (I, II, III, aVL, aVR, aVF) and 12 chest leads (V1 to V6, V3R, V4R, V5R, V7 to V9), and the ST level of each lead is displayed according to each classification. Figure 6 In the illustrated example, the maximum ST level is plotted on the respective radar graphs 331 a and 331 b for each category of the lead to display the ST level of each lead.

[0132] Here, the maximum ST level detected by using the electrocardiogram data of 18 leads (measured standard 12 leads and synthesized 6 leads) for a predetermined amount of time to be analyzed is displayed for each lead.

[0133] The maximum ST level (control value) detected in the analysis process immediately before or immediately after the extended check (the beginning of the extended check),

[0134] The maximum ST level detected in the most recent analysis of the extended check

[0135] The comparison is displayed in the ST level display area 330 (plotted on a radar graph). When the electrocardiogram data of the predetermined time period includes electrocardiogram data of two or more heart beats, the maximum ST level for all the heart beats is displayed.

[0136] Radar chart 331a shows the maximum ST level of the 6 leads of the limbs. Radar chart 331a has three concentric circles 332 to 334, and circle 333 represents ST level 0. Moreover, compared with circle 333, the central direction represents a negative ST level, and the peripheral direction represents a positive ST level. With respect to each axis, the distance between the intersection point with circle 333 and the intersection point with circle 334 is equal to the distance between the intersection point with circle 333 and the intersection point with circle 332. Radar chart 331b is the same as radar chart 331a except that the types and numbers of plotted leads are different.

[0137] The scales of the axes of the radar graphs 331a and 331b are dynamically determined according to the absolute value of the maximum ST level of the 18 leads. Specifically, if the maximum ST level is a positive value, the scales of the axes are determined so that the maximum absolute value is plotted on the circle 334. On the other hand, if the maximum ST level is a negative value, the scales of the axes are determined so that the maximum absolute value is plotted on the circle 332. In the radar graphs 331a and 331b, the scales of the axes are the same.

[0138] Labels indicating lead names are attached to the axes of the radar charts 331a and 331b. Furthermore, for the standard 12 leads, the maximum ST level 335 detected in the analysis process just before or after the extended examination is performed is set as the control value (reference value) and plotted on the radar charts 331a and 331b, respectively. On the other hand, for the 6 leads generated by the synthesis process, the maximum ST level 335 detected in the analysis process just after the extended examination is performed (the first in the extended examination) is set as the control value (reference value) and plotted on the radar charts 331a and 331b, respectively. Furthermore, for the analysis process performed after the control value is obtained, for all 18 leads, the maximum ST level 336 (latest value) detected in the most recent analysis process is plotted on the radar charts 331a and 331b, respectively, visually differently from the control value. Figure 6 In the figure, the control value (cont.) is represented by a dotted line, and the latest value (curt.) is represented by a solid line.

[0139] Figure 7 The ST level display area 330 is shown in FIG. Figure 6 Different modifications of the extended inspection screen 300. Figure 6 In the example shown, the axes of the leads are arranged evenly, but in the present modification, the axes are arranged in a positional relationship that imitates the positional relationship of the electrodes corresponding to the leads on the body surface.

[0140] That is, when configuring the axes corresponding to each lead, the radar chart 331a of the 6-lead limb lead simulates the electrode wearing positions on the limbs in a standing posture, while the radar chart 331b of the 12-lead chest lead simulates the electrode wearing positions on the surface of the chest body.

[0141] Regarding the plotting method of the maximum ST level in the radar charts 331a and 331b, due to the Figure 6 The example shown is the same as that shown in FIG. 1 , and therefore the description thereof is omitted. Figure 6 The examples shown are the same and the description thereof is omitted.

[0142] It should be noted that, instead of the maximum ST level, other ST levels may be plotted on the radar chart. Figure 8 300 is another modified example of the extended inspection screen 300, in which a radar chart is used to present the ST level at a specific timing instead of the maximum ST level. Figure 6 and Figure 7 The examples shown are the same. Figure 8 The ST level shown in the example is an example of a representative value of the ST section based on the timing.

[0143] exist Figure 8 In the example shown, as the ST level corresponding to the amplitude of a predetermined specific timing in the ST interval, for example, the ST level corresponding to the amplitude of the timing after a predetermined time has passed from the beginning of the ST interval is displayed. The predetermined time may be an absolute value (fixed value) or a value dynamically determined based on something other than the ST level. As an example of a value dynamically determined based on something other than the ST level, it may be a value determined based on the QT time of the heartbeat including the ST interval of the treatment object (for example, a predetermined ratio such as 1 / 10 or 1 / 5 of the QT time).

[0144] exist Figure 8 In the example shown, the ST level detected in the most recent analysis process is displayed for each lead. It should be noted that when the predetermined amount of time of electrocardiogram data to be the subject of the analysis process includes electrocardiogram data of more than two heartbeats, representative values ​​(such as average values ​​or maximum values) of the detected multiple ST levels are displayed. Figure 6 , Figure 7 Similarly to the example of , it is possible to display so that the ST level detected in the initial analysis process is set as the control value for comparison.

[0145] It should be noted that the ST level can be displayed in a different way from the radar chart. Fig. 9An example of the extended inspection screen 300' having the ST level display area 340 which does not use the radar graph is shown. The ST level display area 340 indicates the ST level using bar graphs 341a to 341c.

[0146] The bar graph 341a shows the ST level of the 6 leads of the limbs. In addition, the bar graphs 341b and 341c divide the ST level of the 12 leads of the chest into the measured 6 leads (V1 to V6) and the synthetic 6 leads (V3R to V5R, V7 to V9) and display them separately. When using the bar graph, the control value 342 and the most recent value 343 are also displayed for each lead so that they can be compared. It should be noted that the displayed ST level can be the maximum ST level or the ST level at a specific timing.

[0147] At least one of the display method (for example, a radar graph or a bar graph) of the ST level display area and the type of ST level to be displayed can be switched by the user at any timing.

[0148] In the extended examination screen 300, the function keys displayed in the function key area 30 are changed. Representative function keys are described below. When the TIMI key 35 is operated, the control unit 120 displays a screen for additional input or correction of a risk score (here, the TIMI risk score) (details will be described later).

[0149] When the report key 41 is operated, the control unit 120 ends the extended inspection at that point in time, and outputs a summary report (described later) based on the results of the analysis process performed so far from the printer 119 .

[0150] When the 12-lead key 42 is operated, the control unit 120 terminates the operation of the extended mode. It should be noted that even if the extended mode operation is terminated, the standard 12-lead electrocardiogram continues to be displayed in real time. It should be noted that when the 12-lead key 42 is operated, the control unit 120 displays a message on the display unit 118 asking the user to confirm whether to terminate the extended examination. The extended examination is terminated only when the user explicitly instructs to terminate the extended examination. In this case, the summary report described later is not output.

[0151] return Figure 2BAs described in S221, the control unit 120 determines whether the implementation conditions of the analysis process (electrocardiogram examination) are met. If it is determined that it is met, S223 is executed, and if it is determined that it is not met, S225 is executed. Here, the implementation conditions of the analysis process can be, for example, the elapsed time since the last execution of the analysis process. In the guidelines, it is recommended to perform an electrocardiogram every 5 to 10 minutes, so the elapsed time can also be set to 5 to 10 minutes. However, the guidelines should have determined a longer examination cycle assuming that medical personnel perform manual recording. Therefore, in this embodiment, the analysis process is performed at a cycle shorter than the cycle recommended by the guidelines (for example, 30 seconds) to achieve a more detailed electrocardiogram examination.

[0152] It should be noted that when the operation of the record button of the operation unit 117 is detected, it can also be determined that the execution condition of the analysis process is satisfied. In this case, the control unit 120 executes the analysis process in response to the operation of the record button in addition to periodically performing the analysis process. It should be noted that the user can set the execution condition of the analysis process in the extended inspection.

[0153] In S223, the control unit 120 (analysis unit 1201) applies the analysis process after copying the latest predetermined time amount (e.g., 10 seconds) of the 12-lead electrocardiogram data cached in the RAM 124 to another area of ​​the RAM 124 or the ROM 125. The electrocardiogram data is copied because the electrocardiogram data to which the analysis process is applied may be used for output of a summary report. In the case where the measured electrocardiogram data is not deleted, such as when the cache of the RAM 124 can hold, for example, several hours of 12-lead electrocardiogram data, the copying of the electrocardiogram data is not necessary.

[0154] The analysis process applied here may be the same as the analysis process started in S203. It should be noted that the analysis process includes detecting the ST level of the displayed type for each lead.

[0155] In addition, the control unit 120 generates synthesized lead data of a predetermined amount of time by synthesizing the 12-lead electrocardiogram data of a predetermined amount of time to which the analytical processing is applicable, and stores it in RAM124. In this way, the synthesized lead data is intermittently generated. The control unit 120 (analyzing unit 1201) also applies analytical processing to the generated synthesized lead data, and detects the ST level of the displayed type for each lead. It should be noted that in the present embodiment, only the analytical processing required for detecting the ST level is applied to the synthesized lead data. However, the same analytical processing as that applied to the standard 12-lead electrocardiogram data can also be applied to the synthesized lead data. In this case, the analytical processing can be applied to the 18-lead electrocardiogram data after the synthetic processing is performed.

[0156] Furthermore, the control unit 120 executes S225 after updating the representative waveform of the standard 12 leads, the representative waveform of the synthesized 6 leads, and the ST level in the extended examination screen 300. In this way, the display of the representative waveform and the magnitude of the ST deviation is updated every time the analysis process is executed.

[0157] In S225 , the control unit 120 determines whether an input instruction of a risk score is detected, and executes S227 if it is detected, and executes S231 if it is not detected. The input instruction of the risk score may be an operation of the TIMI key 35 .

[0158] In S227 , the control unit 120 displays a screen (re-input screen) for additional input or correction of the risk score on the display unit 118 . Fig.10 FIG. 2 shows an example of a TIMI score re-entry screen 230. The TIMI score re-entry screen 230 is the same screen as the TIMI score input screen 220, but for items that have already been input, the input contents are grayed out instead of the selection items. Fig.10 In the example shown, items other than the myocardial marker are shown as having been input.

[0159] When the re-input button 228 is operated, the control unit 120 changes the display of the inputted items to include options other than the inputted content (the same display as the TIMI score input screen 220). The inputted content among the options is displayed as selected.

[0160] In S229 , the control unit 120 determines whether an input of a TIMI score or an instruction to end the correction is detected, and if it is determined that no instruction is detected, S227 is repeated. The instruction to end may be an operation of the end button 227 .

[0161] When it is determined that the operation of the end button 227 is detected, the control unit 120 updates the input content of the TIMI score stored in, for example, the ROM 125 or the recording medium 116 according to the state of the button of the TIMI score re-input screen 230. Then, the control unit 120 ends the display of the TIMI score re-input screen 230 and executes S231.

[0162] In S231, the control unit 120 determines whether the end condition of the extended examination is satisfied, and executes S233 if the end condition is satisfied, and executes S221 again if the end condition is not satisfied. The end condition of the extended examination may be the elapsed time from the start of the extended examination or the operation of the report key 41 described above.

[0163] The guide recommends at least 15 minutes of measurement, so the elapsed time is set to be more than 15 minutes. There is no particular upper limit, and it can be set to 1 hour, for example. It should be noted that when the extended examination is terminated due to the elapsed time, the user can be asked whether to extend the extended examination, so that the user can extend the extended examination.

[0164] It should be noted that in Figure 2A and Figure 2B In the diagram, although each process is recorded in time series, some processes can be executed in parallel. For example, the automatic analysis started in S203 is also executed periodically while waiting for the end of information input in S209, and the judgment of whether the observation result of ACS suspicion is detected (S213) and the processing corresponding to the judgment result (S214, S215) are executed in parallel. Moreover, while the risk score is additionally input or corrected through the loop of S227 and S228, the judgment of whether the implementation conditions of the analysis process (electrocardiogram examination) are met (S221) and the automatic analysis process (S223) corresponding to the judgment result are executed in parallel.

[0165] When the report key 41 is operated, the control unit 120 can determine whether the number of analysis processes performed in the extended examination is less than a predetermined number (e.g., 4 times). If it is determined that the number is less than the predetermined number, the control unit 120 can display a message on the display unit 118 indicating that the electrocardiogram examination has not been performed a sufficient number of times, and ask the user whether the extended examination can be terminated.

[0166] In S233, the control unit 120 outputs the summary report from the printer 119, and ends the operation in the expansion mode. It should be noted that even if the operation in the expansion mode ends, the 12-lead electrocardiogram continues to be displayed in real time.

[0167] Next, the summary report is explained. The summary report is a report that summarizes information useful for diagnosing the possibility of ACS into one page based on the results of multiple electrocardiogram examinations (analysis processing) performed in the extended examination. In the past, in order to diagnose the possibility of ACS based on the results of multiple electrocardiogram examinations, it was necessary to compare different reports output according to each electrocardiogram examination, which was very troublesome. In this embodiment, a summary report that summarizes information useful for diagnosing the possibility of ACS based on the results of multiple electrocardiogram examinations into one page is output, so there is no need to compare and view multiple reports, which improves convenience.

[0168] Fig.11A and Fig. 11BAn example of the summary report 400 outputted in S233 is shown. The summary report 400 includes a subject information area 401, a waveform area 410 (first area), an ST level area 420 (second area), and an observation result area 430 (third area).

[0169] The subject information area 401 is an area where subject information including an ACS risk score (here, TIMI risk score) is presented.

[0170] The waveform area 410 is an area for presenting a list of representative waveforms of each lead of a standard 12-lead electrocardiogram for which analysis processing has been applied for a predetermined amount of time for each of the multiple electrocardiogram tests recorded in the report. In this embodiment, the control unit 120 selects four electrocardiogram tests (analysis processing) that meet the following conditions among the electrocardiogram tests performed in the extended test as the multiple electrocardiogram tests recorded in the report.

[0171] (1) An electrocardiogram (ECG) test performed immediately before or after an extended test

[0172] (2) Electrocardiogram examination in which the maximum maximum ST level is detected after the start of the extended examination

[0173] (3) Electrocardiogram examination in which an abnormal electrocardiogram is detected after the start of the extended examination

[0174] (4) Electrocardiogram (ECG) at the end of the extended examination

[0175] It should be noted that, among the conditions (1) to (4), (1) and (4) are exclusive, and a combination of other conditions may be satisfied in the same electrocardiogram examination. Therefore, the number of electrocardiogram examinations that meet the conditions (1) to (4) may be less than four. In the case where the number of electrocardiogram examinations that meet the conditions (1) to (4) is less than four, two or more electrocardiogram examinations that meet the conditions (2) or (3) may be included in the summary report 400.

[0176] Then, the control unit 120 records, in the waveform area 410 , representative waveforms 411 to 414 of each lead of the standard 12-lead electrocardiogram for which the analysis process has been applied for a predetermined amount of time to each of the selected four electrocardiogram examinations.

[0177] The representative waveform 411 of the electrocardiogram examination of (1) is the above-mentioned control waveform. (1) and (4) are important for understanding the temporal changes of the electrocardiogram at the beginning and end of the extended examination. Both (2) and (3) are important in terms of the possibility of diagnosing ACS. It should be noted that, with respect to (3), when abnormal observation results are detected in two or more electrocardiogram examinations, it is assumed that the electrocardiogram examination that detected the observation result with the highest predetermined importance is the one that detected abnormal observation results.

[0178] It should be noted that, here, the number of electrocardiogram tests for recording waveforms in summary report 400 is set to four times, but it may be set to three times, (1)(2)(4) or (1)(3)(4). Alternatively, it may be set to five or more times, including (3) twice or more. If the number of electrocardiogram tests for recording waveforms is increased, it will be difficult to grasp the subtle changes in the waveforms, so when it is set to five or more times, observability should be considered.

[0179] The control unit 120 allows the generated summary report 400 to fit on one page in order to ensure both visibility and overview of the summary report 400. The size of one page depends on the size of the printer 119, and the control unit 120 may generate the summary report 400 in such a manner that it fits on one A4-size or B4-size page. The control unit 120 generates print data of the summary report 400 corresponding to the size of the printing paper, and provides it to the printer 119, thereby outputting the summary report 400.

[0180] The waveform presented in the waveform area 410 is preferably the same as the electrocardiogram output from the printer 119 in the normal mode operation, or the scale is as similar as possible. On the other hand, in order to eliminate the labor and time of comparing and observing multiple reports and to support effective diagnosis, it is necessary to summarize the results of multiple electrocardiogram examinations on one page. Therefore, the waveform area 410 does not include the waveform of the synthesized 6 leads, and only the standard 12 leads are presented. On the other hand, the maximum ST level is presented including the synthesized 6 leads.

[0181] However, the control unit 120 may output the standard 12-lead and synthesized 6-lead waveforms to be the subject of the above-mentioned electrocardiographic examinations (1) to (4) as a report different from the summary report 400 from the printer 119 in accordance with a user instruction.

[0182] ST level area 420 presents the maximum ST level for each lead. Figure 6Similarly, ST level area 420 uses different radar graphs for the 6 leads of the limbs and the 12 leads of the chest including the synthetic leads to present the maximum ST level of each lead. However, in ST level area 420, the maximum ST level (cont) in the electrocardiogram test (1) used as the control waveform and the maximum ST level (maximum ST level throughout the entire extended test) (MAX-ST) detected by the electrocardiogram test (2) are presented in a comparable manner.

[0183] In the observation result area 430 , a list of observation results of abnormal electrocardiograms detected by the analysis process performed in the extended examination process is presented in order from the observation result with the highest importance.

[0184] It should be noted that, similarly to the modified example of the extended inspection screen 300, at least one of the form of the radar graph of the ST level area and the type of ST level plotted may be changed in the summary report 400. Fig. 12A and Fig. 12B In the ST level area 420 ′ of the modified example of the summary report 400 shown, the form of the radar chart and the type of ST level to be plotted are changed.

[0185] exist Fig. 12A and Fig. 12B In the variation shown, Figure 7 and Figure 8 Similarly, the configuration of the axes of the radar chart is changed so that their positional relationship mimics the positional relationship of the electrodes corresponding to each lead on the body surface. In addition, the types of ST levels plotted are changed to be limited to the maximum ST level detected by the extended examination. It should be noted that only the configuration of the axes may be different, or only the types of ST levels plotted may be different.

[0186] Fig.13 Shown with Fig. 9 An example of summary report 400' using ST level area 425 of bar graphs 341a to 341c. ST level area 425 records ST level in the same manner as bar graphs 341a to 341c of extended examination screen 300'. In ST level area 425, the maximum ST level (cont) of electrocardiogram examination (1) used as a control waveform and the maximum ST level (maximum ST level throughout the entire extended examination) (MAX-ST) detected by electrocardiogram examination (2) are presented in a comparable manner. When using a bar graph, it is also possible to change to present only the maximum ST level detected by the extended examination.

[0187] The user can select the format of the ST level area of ​​the summary report and the type of ST level to be plotted. The control unit 120 outputs the summary report from the printer 119 using the format of the ST level area corresponding to the setting at the time of execution of S233.

[0188] The electrocardiograph of this embodiment has an extended mode for automatically performing an electrocardiogram examination for evaluating the possibility of ACS without explicit instructions from the user. In the extended mode, the electrocardiograph periodically performs an electrocardiogram examination (analysis processing) while continuously performing electrocardiogram measurement and real-time display, and performs a more detailed extended examination when suspicious observation results of ACS are detected. In addition, the electrocardiograph also performs an extended examination when the ACS risk score of the subject input is greater than a predetermined value.

[0189] Thus, the electrocardiograph of this embodiment can determine whether a subject is suspected of ACS based on the analysis process or risk score even without special instructions from the user. Therefore, the user can know whether a subject should be subjected to a more detailed electrocardiogram examination without instructing the electrocardiograph to perform an examination at every predetermined time or asking a doctor to interpret the report of the examination result output by the electrocardiograph.

[0190] The electrocardiograph also performs electrocardiogram examination (analysis processing) periodically while continuously performing electrocardiogram measurement and real-time display in the extended examination. In the extended examination, the electrocardiograph generates the right chest lead and back lead recorded as recommended by the guidelines through synthesis processing, and detects the ST level for each lead including the standard 12 leads. Furthermore, when the extended examination is completed, the electrocardiograph outputs a summary report that summarizes the results of multiple electrocardiogram examinations that are useful for diagnosing the possibility of ACS in the electrocardiogram examinations that are periodically performed in the extended examination into one page.

[0191] For patients who complain of chest pain and are transported by emergency medical services, various treatments need to be carried out in parallel, so the shortage of personnel for electrocardiogram examinations must be fully considered. Therefore, there is a situation where additional electrocardiogram examinations and evaluations recommended by the guidelines are not fully performed for patients who cannot be diagnosed with ACS by initial electrocardiograms. The possibility of failing to correctly diagnose the ACS of the patient due to insufficient electrocardiogram examinations over time should be avoided for both the patient and the medical personnel.

[0192] The electrocardiograph of this embodiment automatically evaluates the risk of ACS without user participation, and automatically performs a detailed electrocardiogram examination recommended by the guidelines for subjects for whom the possibility of ACS cannot be denied. Furthermore, a summary report that summarizes the results of multiple electrocardiogram examinations is ultimately output, which is useful for doctors to diagnose the possibility of ACS. This saves the user the effort and time of managing or comparing multiple reports, and helps doctors make appropriate diagnoses. In this way, the electrocardiograph of this embodiment can reduce the burden on medical staff and perform appropriate electrocardiogram examinations, especially for subjects for whom ACS cannot be diagnosed by the initial electrocardiogram but the possibility of ACS cannot be denied.

[0193] (Other Embodiments)

[0194] The present invention may also be implemented as a program that enables a computer to function as the electrocardiogram analysis device described in the above-mentioned embodiment. Moreover, the present invention is not limited to the contents of the above-mentioned embodiment, and various changes and modifications may be made without departing from the spirit and scope of the invention. Therefore, claims are attached to disclose the scope of the invention.

[0195] This application claims priority based on Japanese patent application No. 2022-70087 filed on April 21, 2022, and all the contents described therein are incorporated herein by reference.

Claims

1. An electrocardiograph having: An acquisition unit is used to continuously acquire an electrocardiogram of the subject; A display unit, which continuously displays the electrocardiogram on a display device; an analysis unit that automatically applies analysis processing to the electrocardiogram in parallel with display of the electrocardiogram by the display unit; as well as a determination unit for determining whether the information obtained by the analysis process satisfies a predetermined condition regarding the possibility of acute coronary syndrome (ACS), The electrocardiograph also has a control unit. Before a predetermined termination condition is satisfied, when the determination unit determines that the information obtained through the analysis process satisfies the condition regarding the possibility of ACS, the control unit controls the electrocardiograph to perform an extended examination in which an electrocardiogram is periodically performed.

2. The electrocardiograph according to claim 1, wherein: The determination unit further determines whether the ACS risk score of the subject is above a predetermined threshold value. Before the end condition is satisfied, when the determination unit determines that the ACS risk score of the subject is equal to or higher than a predetermined threshold, the control unit controls the electrocardiograph to execute the extended examination.

3. The electrocardiograph according to claim 2, wherein: The ACS risk score is a TIMI risk score or a GRACE risk score.

4. The electrocardiograph according to any one of claims 1 to 3, wherein: The analyzing unit periodically applies the analyzing process to the electrocardiogram until the termination condition is satisfied or the determining unit determines that the information obtained by the analyzing process satisfies the condition regarding the possibility of ACS.

5. The electrocardiograph according to any one of claims 1 to 3, wherein: The control unit waits for execution of the extended check until an execution instruction of the extended check by a user is detected.

6. The electrocardiograph according to any one of claims 1 to 3, wherein: The information obtained through the analysis process is the observation result. The control unit displays, on the display device, the observation result determined by the determination unit to satisfy the condition.

7. The electrocardiograph according to any one of claims 1 to 3, wherein: In the extended examination, in parallel with the display unit continuously displaying the electrocardiogram, the analysis unit periodically applies analysis processing to the electrocardiogram. In parallel with the continuous display, the control unit generates data of leads not included in the electrocardiogram by synthesis processing based on the electrocardiogram, In parallel with the continuous display, the control unit detects ST levels for each of the leads of the electrocardiogram and the leads generated by the synthesis process.

8. The electrocardiograph according to claim 7, wherein: The electrocardiogram is a standard 12-lead electrocardiogram, and the leads not included in the electrocardiogram include right chest leads and back leads.

9. The electrocardiograph according to claim 7, wherein: Leads not included in the electrocardiogram include lead V4R and leads V7 to V9.

10. The electrocardiograph according to claim 7, wherein: The ST level is a representative value of the ST level based on amplitude or timing.

11. The electrocardiograph according to claim 10, wherein: The representative value of the amplitude-based ST level is the maximum ST level.

12. The electrocardiograph according to claim 10, wherein: The representative value of the ST level based on the timing is the ST level at the timing when a predetermined time has passed from the start of the ST interval.

13. The electrocardiograph according to any one of claims 1 to 3, wherein: The control unit outputs, from an output device, a report summarizing a predetermined number of analysis processing results among the analysis processing results executed in the extended inspection when an end condition of the extended inspection is satisfied.

14. The electrocardiograph according to claim 13, wherein: The predetermined plurality of analysis processes include analysis processes performed immediately before or after the extended check is started, and analysis processes performed at the end of the extended check.

15. The electrocardiograph according to claim 13, wherein: The predetermined plurality of analysis processes include at least one of an analysis process for detecting a maximum ST level in the extended examination and an analysis process for detecting an abnormal observation result.

16. The electrocardiograph according to claim 13, wherein: The result of the analysis process includes a representative waveform of each lead and a maximum ST level.

17. A method for controlling an electrocardiograph, comprising: Steps for continuously obtaining an electrocardiogram of the subject; The step of continuously displaying the electrocardiogram on a display device; In parallel with the continued display of the electrocardiogram, a step of automatically applying an analysis process to the electrocardiogram; In parallel with the continuous display of the electrocardiogram, a step of determining whether the information obtained by the analysis process satisfies a predetermined condition regarding the possibility of acute coronary syndrome (ACS); When it is determined that the information obtained by the analysis process satisfies the condition regarding the possibility of ACS before a predetermined termination condition is satisfied, a step of performing an extended examination including periodically performing an electrocardiogram examination is executed. 18 . A program for causing a computer included in an electrocardiograph to function as each unit included in the electrocardiograph according to claim 1 .

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