Management method

Abstract

The invention provides a management method. The purpose of the present invention is to more easily manage an analysis device operating in an environment in which the analysis device is not online connected to a remote management device. The method for managing an analysis device uses a management device, a terminal communicatively connected to the management device, and the analysis device not communicatively connected to the management device, the method comprising: a preparation step for preparing the terminal; preparing, in the analysis device, management information to be acquired by the management device among the information stored in the analysis device; an acquisition step for acquiring the prepared management information by means of the terminal; and a transmission step for transmitting the acquired management information from the terminal to the management device.

Description

Technical Field

[0001] The present invention relates to a management method of an analysis device. Background Art

[0002] Provide a service that connects an analysis device to a management device located at a remote location via the Internet or a dedicated line, collects precision management results and device information online in the management device, performs statistical analysis on the measurement results of precision management specimens to implement external precision management, or provides rapid troubleshooting when errors occur.

[0003] Prior art literature

[0004] Patent Literature

[0005] Patent Document 1: Japanese Patent Application Laid-Open No. 2001-229291 Summary of the invention

[0006] Since the analysis device handles information related to the health of the patient, high security is required. However, in some facilities, the analysis device is not connected to the Internet. In such facilities, it is not possible to send the accuracy management results and device information to the server online as in Patent Document 1. In addition, the same problem also exists in the analysis device used in an environment without an Internet environment.

[0007] In such an offline environment, for example, in order to participate in external quality control, it is necessary to print the quality control results of the analysis device, manually input the quality control results into another computer connected to the Internet, and send them to the server, which is a complicated task. In addition, when an error occurs, it is necessary to provide the service personnel with the status of the device by phone for troubleshooting.

[0008] An object of the present invention is to provide a management method for more easily managing an analysis device operating in an environment where there is no online connection with a management device installed at a remote location.

[0009] In order to solve the above-mentioned problems, the present invention provides a management method for an analysis device (2), using a management device (4), a terminal (3) connected to the management device (4) for communication, and an analysis device (2) not connected to the management device (4) for communication, wherein the management method includes: a preparation step, preparing in the analysis device (2) management information stored in the analysis device (2) that should be obtained by the management device (4); an acquisition step, using the terminal (3) to obtain the prepared management information; and a sending step, sending the obtained management information from the terminal (3) to the management device (4).

[0010] In another aspect, the present invention provides a management method, comprising: an extraction step, using an analysis device (2) to extract information that satisfies predetermined conditions from information stored in an analysis device (2) that is not communicatively connected to a management device (4); an acquisition step, using a terminal (3) that is communicatively connected to the management device (4) to acquire the extracted information or information generated based on the extracted information; and a sending step, sending the acquired information from the terminal (3) to the management device (4).

[0011] According to the present invention, it is possible to more easily manage an analysis device operating in an environment where there is no online connection with a management device installed in a remote location. BRIEF DESCRIPTION OF THE DRAWINGS

[0012] Figure 1 It is a schematic diagram showing the outline of the management support system.

[0013] Figure 2 It is a diagram showing a configuration example of an analysis device.

[0014] Figure 3 It is a diagram showing a configuration example of a storage device of an analysis device.

[0015] Figure 4 This is a diagram showing an example of the data structure of the device attribute database.

[0016] Figure 5 It is a diagram showing an example of the data structure of the quality control database.

[0017] Figure 6 It is a diagram showing a specific example of a record item of the quality control database.

[0018] Figure 7 This is a diagram showing a configuration example of an application that operates on the analysis device.

[0019] Figure 8 This is a diagram showing a specific example of data recorded in the information code created in the accuracy management information extraction process.

[0020] Fig. 9 This is a diagram showing an example of a menu screen displayed by the analysis device.

[0021] Fig.10 This is a diagram showing an example of a screen on which an information code is displayed by the analysis device.

[0022] Fig.11 This is a diagram showing an example of a screen for setting the quality control type in the analysis device.

[0023] Fig.12This is a diagram showing an example of a screen for setting extraction conditions for automatically extracting quality management information by the analysis device.

[0024] Fig.13 This is a diagram showing another example of a screen for setting extraction conditions using the analysis device.

[0025] Fig.14 This is a flowchart showing an example of the flow of processing executed by the analysis device.

[0026] Fig.15 This is a diagram showing an example of a confirmation screen displayed when the analysis device starts shutdown.

[0027] Fig.16 This is a flowchart showing an example of the flow of the quality control measurement process.

[0028] Fig.17 This is a flowchart showing an example of the flow of the accuracy management information extraction process.

[0029] Fig.18 It is shown Fig.14 A flowchart of a modified example of the flowchart shown.

[0030] Fig.19 This is a diagram showing an example of a screen for notifying that there are quality control results that have not been extracted.

[0031] Fig. 20 This is an example of a screen for setting the automatic confirmation time for whether there are quality control results that have not been extracted.

[0032] Fig.21 This is an example of a confirmation screen that is input to the analysis device at the set automatic confirmation time.

[0033] Fig. 22 It is a diagram showing a configuration example of a terminal.

[0034] Fig.23 This is a diagram showing a configuration example of a storage device of a terminal.

[0035] Fig.24 It is a diagram showing an example of the data structure of the user attribute database.

[0036] Fig.25 This is a diagram showing a configuration example of an application running on a terminal.

[0037] Fig.26 This is an example of a login screen displayed by a terminal.

[0038] Fig. 27 This is a diagram showing an example of a menu screen displayed on the terminal after login.

[0039] Fig.28 This is an example of the screen displayed on the terminal after the information code is read.

[0040] Fig.29 This is another example of the screen displayed on the terminal after the information code is read.

[0041] Fig.30 It is a diagram showing a configuration example of a management device.

[0042] Fig.31 It is a diagram showing a configuration example of a storage device of a management device.

[0043] Fig.32 This is a diagram showing a configuration example of an application running on the management device.

[0044] Fig.33 This is a flowchart showing an example of the flow of processing executed by the terminal and the management device.

[0045] Fig.34 This is a diagram showing an example of the data structure of the quality control database when the analyzing device is an immunoassay device.

[0046] Fig.35 This is a diagram showing a specific example of a record item of the quality control database when the analyzing device is an immunoassay device.

[0047] Fig.36 This is a diagram showing an example of a screen indicating the progress status when the accuracy management result is transmitted by short-distance wireless communication.

[0048] Fig.37 It is a diagram showing a configuration example of a management device.

[0049] Fig.38 It is a diagram showing a configuration example of a storage device of a management device.

[0050] Fig.39 It is a diagram showing an example of the data structure of the instruction information database.

[0051] Fig.40 It is a diagram showing a specific example of a record item of the instruction information database.

[0052] Fig.41 It is a diagram showing an example of the data structure of the user attribute database.

[0053] Fig.42 This is a diagram showing a configuration example of an application running on the management device.

[0054] Fig.43 This is a diagram showing an example of an instruction information creation screen.

[0055] Fig.44 It is a diagram showing a configuration example of a terminal.

[0056] Fig.45 This is a diagram showing a configuration example of an application running on a terminal.

[0057] Fig.46 This is an example of a screen displayed on the terminal when instruction data including jam removal and continuous blank check are received.

[0058] Fig.47 This is another example of a screen displayed on the terminal when receiving instruction data including deactivation of the blood suction sensor.

[0059] Fig.48 This is another example of a screen displayed on the terminal when receiving instruction data including closing the screen lock.

[0060] Fig.49 This is another example of a screen displayed on the terminal when receiving instruction data including reading of the error history.

[0061] Fig.50 This is another example of a screen displayed on the terminal when receiving instruction data including the execution of the quality control measurement.

[0062] Fig.51 This is an example of a screen of an analyzer displaying information codes recording quality control results.

[0063] Fig.52 It is a diagram showing a configuration example of an analysis device.

[0064] Fig.53 It is a diagram showing a configuration example of a storage device of an analysis device.

[0065] Fig.54 It is a diagram showing an example of the data structure of the command information database.

[0066] Fig.55 It is a diagram showing a specific example of a record item of the command information database.

[0067] Fig.56 It is a diagram showing an example of the data structure of the error history database.

[0068] Fig.57 It is a diagram showing a specific example of a record item of the error history database.

[0069] Fig.58 This is a diagram showing a configuration example of an application that operates on the analysis device.

[0070] Fig.59This is a diagram showing an example of a screen displaying information codes related to the quality control history using the analysis device.

[0071] Fig.60 This is a diagram showing an example of a screen displaying information codes related to error history using an analysis device.

[0072] Fig.61 This is a diagram showing an example of a screen displaying information codes related to service data using an analysis device.

[0073] Fig.62 This is a flowchart showing an example of the flow of a process in which the management device causes the analysis device to execute a process via the terminal.

[0074] Fig.63 It is shown Fig.62 A flowchart of a modified example of the flowchart shown.

[0075] Fig.64 It is a diagram showing a configuration example of an analysis device.

[0076] Fig.65 This is a diagram showing a configuration example of an application that operates on the analysis device.

[0077] Fig.66 This is a diagram showing an example of a screen displayed on the analyzer when clogging of the RBC detection unit occurs.

[0078] Fig.67 This is a diagram showing an example of a screen displaying an information code related to clogging of the RBC detection unit by the analyzing device.

[0079] Fig.68 This is a diagram showing an example of a screen displayed on a terminal when a receipt notification is received from a management device.

[0080] Fig.69 This is a diagram showing an example of a screen displaying information codes related to short samples using an analysis device.

[0081] Fig.70 This is a flowchart showing an example of the flow of a process of transmitting information on an error occurring in the analysis device to the management device via the terminal.

[0082] Fig.71 It shows that Fig.70 The flowchart shown is an expanded example flowchart.

[0083] Fig.72 This is a diagram showing an example of a screen for selecting information to be extracted from the analysis device.

[0084] Fig.73This is a flowchart showing an example of the flow of information extraction processing.

[0085] (Explanation of symbols)

[0086] 1: Management support system; 2: Analysis device; 3: Terminal; 4: Management device; 24: Display / operation device (display unit); 25A, 25B: Storage device (storage unit). DETAILED DESCRIPTION

[0087] [Overview of Management Support System 1]

[0088] Reference Figure 1 The following describes an overview of a management support system 1 according to the present invention. The management support system 1 includes an analysis device 2, a terminal 3, and a management device 4.

[0089] [Overview of Analytical Device 2]

[0090] The analysis device 2 is installed in a medical facility (e.g., a hospital or a clinic) and is used by medical practitioners in the medical facility. The analysis device 2 operates in an offline environment (i.e., operates independently) or is only connected to a LAN (Local Area Network) installed in the medical facility. That is, the analysis device 2 is used in an environment where it is not connected to a communication network 5 such as the Internet installed outside the medical facility and is not connected to a device outside the medical facility for communication. This mode of operation is often used in medical facilities that require higher security measures in order to handle information related to patients. In addition, the above-mentioned mode of operation is often used in countries or regions where the analysis device 2 is not generally connected to the Internet, or in countries or regions where a communication network environment is not provided.

[0091] The analyzer 2 analyzes the specimen. The specimen analyzed by the analyzer 2 may be, for example, biological samples such as blood and urine, human and animal bodies, food, and beverages, but is not limited thereto. A typical example of the analyzer 2 is a clinical examination device. A typical example of a clinical examination device is a blood cell counting device. In addition to the blood cell counting device, the analyzer 2 may also be, for example, an immunoassay device, a blood coagulation assay device, a biochemical analysis device, or a urine analysis device.

[0092] The blood cell counting device counts the blood cell components such as red blood cells, white blood cells, platelets, etc. contained in the blood sample by, for example, a resistance detection method. The resistance detection method refers to making the blood sample flow between a pair of electrodes, and measuring the number of blood cells and the blood volume based on the resistance change generated when the blood cells pass between the electrodes. In addition, the blood cell counting device can measure the amount of hemoglobin in the blood by the non-cyanide hemoglobin method. As such a blood cell counting device, for example, there is XQ-320 (manufactured by Sysmex Corporation). In addition to the resistance detection method, the blood cell counting device can also count the blood cell components by flow cytometry.

[0093] The blood cell counting device, for example, performs measurements related to the specimen (hereinafter referred to as "specimen measurements") tens to hundreds of times a day. In addition, in the blood cell counting device, reproducibility is required in the measurement results when measuring the same specimen, so precision management (QC: Quality Control) of the measurement is necessary. For this reason, the blood cell counting device performs measurements related to the precision management specimen (hereinafter referred to as "precision management measurements"). The blood cell counting device, for example, performs precision management measurements several times a day. Typical examples of the timing for performing precision management measurements are before the first specimen measurement of the day (for example, in the morning) and after the last specimen measurement of the day (for example, in the evening). Other examples of the above timing are after the first specimen measurement of the day and before the last specimen measurement (that is, during the specimen measurement). The reason for this timing is that, for example, precision management measurements are sometimes performed when reagents are changed or errors are recovered during the day.

[0094] In the precision management measurement, it is analyzed whether the measured value of the precision management specimen is within the predetermined normal range (whether the deviation from the reference value is within the predetermined value). The measured value of the precision management specimen refers to, specifically, the red blood cell count (RBC), white blood cell count (WBC), platelet count (PLT), hemoglobin concentration (HGB), hematocrit value (HCT), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), etc. Hereinafter, the measured value of the precision management specimen is also referred to as the precision management result. The measured value within the normal range is a normal precision management result. The measured value outside the normal range is an abnormal precision management result.

[0095] Precision management is roughly divided into internal precision management and external precision management. Internal precision management reduces the deviation of measurement results when the same precision management specimen is measured in the same facility. The same batch of precision management specimens are repeatedly measured using the same analysis device to confirm that the intra-day variation and the daily variation are within the allowable range, thereby maintaining the precision of the management analysis device. In general, whether the analysis device is normal or abnormal is determined based on whether the measurement value obtained by measuring the precision management specimen using the analysis device is within the predetermined normal range determined for each batch of the precision management specimen. For example, when the normal range of HGB is determined to be 9.6 to 11.4, if the measurement value of HGB is, for example, 10.9, it is a normal precision management result.

[0096] External quality management reduces the deviation of measurement results when the same quality management sample is measured between multiple facilities. The measurement results of the same batch of quality management samples from multiple facilities are summed up, and the difference between the measurement results of the facility and the statistical data (such as the average value or the median value) of the whole is confirmed to be within the allowable range, thereby maintaining the accuracy of the management analysis device. In this embodiment, the management device 4 receives the quality management results from multiple facilities and sums them up, calculates the statistical data, and determines the normality / abnormality of each analysis device based on the calculated statistical data. The types of external quality management vary depending on the method of external quality management in which the facility participates. For example, there are intra-day quality management for managing the intra-day variation of quality management results, daily quality management for managing the daily variation of quality management results, and monthly quality management for managing the monthly variation of quality management results. In intra-day quality management, each quality management result obtained on the target day (such as the current day) is sent to the management device 4 as the object of quality management. In daily quality management, statistical processing is performed on the quality management results obtained on the target day (such as the current day) for each batch of quality management samples, and the obtained statistical value is sent to the management device 4 as the object of quality management. Typical examples of statistical values ​​are average value, median value, standard deviation, deviation, etc. Daily precision management is usually implemented once a day. In monthly precision management, regarding the precision management results obtained in the target month (for example, the current month), statistical processing is performed for each batch of precision management specimens, and the obtained statistical values ​​are sent to the management device 4 as the object of precision management. Typical examples of statistical values ​​are average value, median value, standard deviation, deviation, etc. Monthly precision management is usually implemented once a month.

[0097] Precision management specimens are also referred to as precision management substances or control samples. Precision management specimens include, for example, whole blood components adjusted to a known concentration. As such precision management specimens, for example, there are XN-CHECK (registered trademark), e-CHECK (registered trademark), and EIGHTCHECK (registered trademark) (manufactured by Sysmex Corporation). Precision management specimens may also include three types of precision management specimens adjusted to three concentration levels: low concentration, standard concentration, and high concentration. Hereinafter, the precision management specimen with a low concentration is referred to as level 1, the precision management specimen with a standard concentration is referred to as level 2, and the precision management specimen with a high concentration is referred to as level 3. Level 1, Level 2, and Level 3 are abbreviated as L1, L2, and L3, respectively.

[0098] [Outline of Terminal 3]

[0099] The terminal 3 is a computer used by medical personnel in a medical facility, and is, for example, a smartphone, a tablet terminal, or a personal computer. The terminal 3 plays a role in relaying information between the analysis device 2 and the management device 4 .

[0100] In the information exchange between the terminal 3 and the analysis device 2, typically, an information code that can optically read the information is used. The information code is made and displayed by one party of the terminal 3 and the analysis device 2, and the other party reads it for exchange. A typical example of an information code is a QR code. The QR code has advantages in terms of information density, reading performance, information capacity, etc., and can correctly transmit complex information in a small area. A specific example of a QR code is a QR code (registered trademark), but is not limited to this. The information exchange between the analysis device 2 and the terminal 3 can also be carried out using short-range wireless communication instead of using an information code. Typical examples of short-range wireless communication are Bluetooth (Bluetooth (registered trademark)), Wi-Fi (registered trademark), but are not limited to this.

[0101] The terminal 3 is connected to the communication network 5 via a mobile communication network or directly, and can communicate bidirectionally with the management device 4 via the communication network 5. The terminal 3 may be authenticated when communicating with the management device 4. The communication network 5 includes a closed network (VPN network, etc.) and an open network (Internet, etc.).

[0102] [Overview of Management Device 4]

[0103] The management device 4 is a computer installed in a facility different from the medical facility where the analysis device 2 is installed (a facility located remotely from the medical facility). The management device 4 may be implemented by a single computer or by distributing its functions among a plurality of computers. The management device 4 is connected to the communication network 5 so as to be communicable, and can communicate with the terminal 3 in both directions via the communication network 5. The management device 4 sends information sent to the analysis device 2 to the terminal 3, and receives information stored in the analysis device 2 from the terminal 3. The management device 4 is configured as follows: Figure 1 As shown, the management device 4 is also connected to analysis devices in other facilities different from the medical facility where the analysis device 2 is installed, and terminals in other facilities via the communication network 5. In this way, the management device 4 can collect data from analysis devices or terminals in multiple facilities, for example, and can aggregate large-scale data required for external accuracy management.

[0104] A typical example of a facility where the management device 4 is installed is a support center. When the management device 4 is installed in the support center, the management device 4 is used by the service personnel of the support center. Hereinafter, the user of the management device 4 is assumed to be the service personnel. The service personnel use the management device 4 to perform, for example, (1) external accuracy management, (2) maintenance and operation support (hereinafter referred to as "maintenance operation") of the analysis device 2, etc.

[0105] External quality management is a quality management that statistically analyzes whether the measured value of the quality management specimen is within a predetermined allowable range by comparing it with the statistical value (e.g., average value) of the total population composed of multiple medical facilities. The external quality management is performed by executing the external quality management program by the management device 4. The external quality management result is provided to the medical facility from the management device 4. As a provision method, for example, it can be posted on a web page accessible by the terminal 3 used by the medical practitioners of the medical facility, or it can be notified to the terminal 3 using an email or a dedicated application.

[0106] During maintenance operations, the service personnel handle abnormalities that occur in the analyzer 2. Specifically, the service personnel collect and analyze information related to the current status of the analyzer 2 (such as error history, service data, etc.), select commands for the analyzer 2 to execute, and so on.

[0107] [Example of information code format]

[0108] The information recorded in the information code used for information exchange between the terminal 3 and the analysis device 2 includes, for example, (D01) to (D06) shown below. A typical example of the data format of the recorded information is CSV (Comma Separated Values), but the present invention is not limited thereto.

[0109] (D01) 1st code type: a main type for identifying information recorded in the information code.

[0110] (D02) Second code type: A sub-type for identifying information recorded in the information code. If only the first code type is sufficient, the second code type may not be used.

[0111] (D03) Date and time information: When the information code is generated by the analysis device 2, it is the date and time of generation of the information code and / or the expiration date. When the information code is generated by the terminal 3, it is the date and time of issuance of the instruction data (described later) issued by the management device 4 or the expiration date.

[0112] (D04) Model name: the model name of the analysis device 2 to which the information is transferred.

[0113] (D05) Device ID: an identifier of the analysis device 2 to which the information is transferred.

[0114] (D06) Data body: The body of the transferred information. When the information code is generated by the analysis device 2, it is one or more information read from the analysis device 2. When the information code is generated by the terminal 3, it is one or more instruction identifiers included in the instruction data.

[0115] When the analysis device 2 creates the information code, in addition to the information (D01) to (D06) described above, information indicating the destination from the terminal 3 may be recorded in the information code. This information may be, for example, a URL (Uniform Resource Locator), an email address, a communication address, or the like.

[0116] [Implementation method 1]

[0117] This embodiment is a method of sending the information stored in the analysis device 2 to the management device 4 via the terminal 3. The information stored in the analysis device 2 is described by taking the accuracy management result as an example. According to this embodiment, the accuracy management result stored in the analysis device 2 operating in an environment where it cannot communicate with devices outside the medical facility can be sent to the management device 4. Moreover, since it is only a simple operation such as reading an information code, and it can be implemented without misoperation, even medical practitioners who are not proficient in operating the analysis device 2 can easily implement it.

[0118] [Configuration Example of Analyzer 2]

[0119] like Figure 2As shown, the analysis device 2 involved in this embodiment includes, for example, a suction unit 21, a sample preparation unit 22, a detection unit 23, a display / operation device 24 (display unit), a storage device 25A (storage unit), a processor 26A, a RAM (Random Access Memory) 27, and a ROM (Read Only Memory) 28. When short-range wireless communication is used for information exchange between the analysis device 2 and the terminal 3, the analysis device 2 further includes a short-range wireless communication unit 20. The short-range wireless communication unit 20 performs short-range wireless communication with a short-range wireless communication unit 30 (described later) of the terminal 3.

[0120] The suction unit 21 includes a suction pipette and a sampling valve, etc. The suction pipette sucks a sample from a sample container and delivers the sample to the sampling valve. The sampling valve quantitatively measures the introduced sample to a predetermined amount and makes it flow to the sample preparation unit 22.

[0121] The sample preparation section 22 includes a fluid circuit composed of a chamber, a valve, etc. for diluting the sample flowing in from the suction section 21 and preparing it into a measurement sample.

[0122] The detection unit 23 includes a resistance type detector for measuring red blood cells, white blood cells, platelets, etc. in the measurement sample prepared by the sample preparation unit 22. The detection unit 23 detects electrical information measured by the resistance type detector as sample data.

[0123] The display / operation device 24 is, for example, a touch panel display. The display / operation device 24 displays the accuracy management results, the specimen measurement results, various menus, etc. In addition, the display / operation device 24 accepts the input operation of the specimen number and the selection operation of various menus, etc. The display / operation device 24 may also be equipped with a mouse and a keyboard as a device for accepting user operations.

[0124] The storage device 25A stores various data and various programs used by the analysis device 2, and is, for example, a semiconductor drive such as a solid-state drive or a magnetic disk such as a hard disk. Figure 3 As shown, the storage device 25A stores, for example, a storage device attribute database 251 and a precision management database 252 .

[0125] The device attribute database 251 is a database that stores attribute information of the analysis device 2, and is, for example, a relational database (RDB). Figure 4 2 is a diagram showing an example of a data structure when the device attribute database 251 is an RDB. As shown in the diagram, the device attribute database 251 stores, for example, the following information (D11) to (D12) in association with each other.

[0126] (D11) Device ID: an identifier of the analysis device 2 .

[0127] (D12) Model name: The model name of the analyzing device 2. As an example, "XQ-320".

[0128] The quality control database 252 is a database that stores information related to quality control measurement, and is, for example, RDB. Figure 5 2 is a diagram showing an example of a data structure when the quality control database 252 is an RDB. As shown in the figure, the quality control database 252 stores, for example, the following information (D21) to (D36) in association with each other.

[0129] (D21) Measurement ID: Identifier of the quality control measurement.

[0130] (D22) Measurement item name: the name of the quality control measurement. As an example, "CBC" (Complete Blood Count).

[0131] (D23) Quality control sample type: The concentration level of the quality control sample used in the quality control measurement. As an example, "Control L1" (level 1), "Control L2" (level 2), and "Control L3" (level 3).

[0132] (D24) Batch: The batch number of the quality control sample used in the quality control measurement.

[0133] (D25) Expiration date: The expiration date of the quality control sample used in the quality control measurement.

[0134] (D26) Measurement date: the date on which the quality control measurement is carried out.

[0135] (D27) Measurement time: The time when the quality control measurement was performed. The measurement date and measurement time can also be combined.

[0136] (D28) WBC: The measured value of the white blood cell count as one of the quality control results.

[0137] (D29) RBC: The measured value of the red blood cell count as one of the quality control results.

[0138] (D30) HGB: The measured value of hemoglobin concentration as one of the results of quality control.

[0139] (D31) HCT: The measured value of the hematocrit value which is one of the results of the precision management.

[0140] (D32) MCV: The measured value of mean corpuscular volume, which is one of the results of quality management.

[0141] (D33) MCH: A measured value of mean corpuscular hemoglobin as one of the results of quality control.

[0142] (D34) MCHC: A measured value of mean corpuscular hemoglobin concentration as one of the results of precision management.

[0143] (D35)PLT: The measured value of the platelet count as one of the quality control results.

[0144] (D36) Flag: A flag indicating whether the precision management results have been extracted.

[0145] Figure 6 A specific example of the record items of the precision management database 252 is shown. Four record items are shown in the figure. The two record items on the upper side represent the precision management results of the precision management specimens whose category is Control L1, batch is S3422, and expiration date is May 9, 2023. The implementation date and time of the precision management measurement are 7:53:28 on April 11, 2023 and 19:05:36 on the same day. The two record items on the lower side represent the precision management results of the precision management specimens whose category is Control L2, batch is M5652, and expiration date is May 10, 2023. The implementation date and time of the precision management measurement are 7:59:22 on April 11, 2023 and 19:07:39 on the same day.

[0146] Return to Figure 2 The processor 26A is a control unit that performs overall control of the functions of the analysis device 2. The processor 26A is, for example, a CPU (Central Processing Unit). The processor 26A may also be implemented by, for example, a logic circuit. The processor 26A reads the application 261A from the storage device 25A and expands it into the RAM 27 for execution. The application 261A is a program for causing the computer to function as a control unit that performs various processes, and is stored in, for example, the storage device 25A.

[0147] [Structural example of application 261A]

[0148] Figure 7 The following is a configuration example of the application 261A. The application 261A includes, for example, a quality control measurement unit 262, a sample measurement unit 263, and an information extraction unit 264.

[0149] When the input operation for starting the quality control measurement is received by the display / operation device 24, the processor 26A executes the quality control measurement process according to the instruction of the quality control measurement unit 262. In the quality control measurement process, for example, the measurement related to the quality control specimen is performed by the operation of each unit including the suction unit 21, the sample preparation unit 22, and the detection unit 23, and the quality control result is displayed on the display / operation device 24 and stored in the quality control database 252.

[0150] When the display / operation device 24 receives an input operation for starting sample measurement, the processor 26A executes the sample measurement process according to the instruction of the sample measurement unit 263. In the sample measurement process, for example, each unit including the suction unit 21, the sample preparation unit 22, and the detection unit 23 operates to perform the measurement related to the sample, and the measurement result is displayed on the display / operation device 24 and stored in the storage device 25A.

[0151] In addition, the processor 26A executes the precision management information extraction process according to the instruction of the information extraction unit 264. The opportunity for executing the precision management information extraction process may be the input operation of extracting the precision management information received by the display / operation device 24, or the arrival of the date and time set by the reservation. In the precision management information extraction process, the precision management results that meet the extraction conditions are obtained from the precision management database 252, and information codes that can read the obtained precision management results or the values ​​(statistical values, etc.) calculated based on these are produced, and the produced information codes are displayed on the display / operation device 24. In this way, only the precision management results that are the objects of external precision management implemented by the management device 4 can be extracted. The precision management results that are the objects of external precision management implemented by the management device 4 are one of the management information that the management device 4 should obtain. In addition, in the precision management database 252, it is recorded that it has been extracted in the flag 274 of the extracted record item. In addition, in this specification, "extracting" information from the storage unit is also expressed as "reading" information from the storage unit.

[0152] In the first typical example of the extraction condition, only the accuracy management results obtained within the specified time range are taken as the extraction objects. When multiple accuracy management measurements are performed within the specified time range, these accuracy management results are respectively taken as the extraction objects. Specific examples of the time range are the day, the month, etc. The specific time of the day is, for example, 23:00 the previous day to 9:00 the next day. The start date and time and the end date and time of the time range can also be set appropriately.

[0153] In the first typical example, "all" of the accuracy management results obtained within a specified time range can be used as the extraction object, or "only the accuracy management results that have not been extracted in the past (i.e., not extracted)" among the accuracy management results obtained within a specified time range can be used as the extraction object. In the latter case, the capacity of the information recorded in the information code can be reduced.

[0154] In the second typical example of the extraction condition, the accuracy management results corresponding to the operation of the accuracy management determined by the medical facility are used as the extraction object. In the case of the operation of intra-day accuracy management, each accuracy management result obtained on the target day is used as the accuracy management object. All the accuracy management results obtained on the target day can be used as the extraction object, only the results that have not been used as the extraction object can be used as the extraction object among the accuracy management results obtained on the target day, and the extraction objects can be selected individually from the accuracy management results obtained on the target day.

[0155] When the operation is to perform daily quality management, the quality management results obtained on the target day are used as the extraction object. When the operation is to perform monthly quality management, the quality management results obtained on the target month are used as the extraction object.

[0156] Furthermore, when the following operations (T1) to (T3), for example, are determined as the execution timing of quality management in a day, each quality management result obtained at the determined timing may be the target of quality management.

[0157] (T1) Before the first sample measurement of the day.

[0158] (T2) After the first sample measurement is performed and before the last sample measurement is performed in a day.

[0159] (T3) After the last sample measurement of the day.

[0160] In addition, (T2) is often an irregular timing caused by, for example, reagent exchange or error recovery. Therefore, in a medical facility that performs external quality management only on (T1) and (T3), by not selecting (T2), the quality management result obtained at the timing of (T2) can be excluded from the external quality management.

[0161] In the third typical example of the extraction condition, only the accuracy management results that meet the internal accuracy management benchmark in the medical facility are used as the extraction objects. The accuracy management results that meet the internal accuracy management benchmark are normal accuracy management results. According to the third typical example, only the normal accuracy management results are used as the extraction objects, and the abnormal accuracy management results are excluded from the extraction objects, so the reliability of the overall data in the external accuracy management can be guaranteed, and the reliability of the daily average and monthly average data can be guaranteed.

[0162] In the fourth typical example of the extraction condition, only the quality control results of the quality control specimens at a designated concentration level are selected as extraction targets. As a specific example, only L1 and L2 may be selected as extraction targets, or only L1 may be selected as extraction targets.

[0163] The extraction condition may also be a combination of different conditions. For example, at least one of the first typical example, the second typical example, the third typical example, and the fourth typical example may be combined. For example, only the accuracy management results obtained on the same day and normal and with concentration levels of L1 and L2 may be used as extraction objects.

[0164] The extraction conditions may be set in advance using a setting menu or the like, or may be set when the accuracy management information extraction process is executed.

[0165] [Information recorded in the information code]

[0166] The information recorded in the information code created in the accuracy management information extraction process is as shown in (D41) to (D46) shown below, for example.

[0167] (D41) Code 1 category: "QC" as an example.

[0168] (D42) Second code category: In the case of intraday precision management, an example is "Intraday". In the case of daily precision management, an example is "Daily". In the case of monthly precision management, an example is "Monthly".

[0169] (D43) Date and time information: the date and time when the analysis device 2 generates the information code.

[0170] (D44) Model name: the model name of the analysis device 2 that created the information code. Acquired from the device attribute database 251.

[0171] (D45) Device ID: Identifier of the analysis device 2 that created the information code. Acquired from the device attribute database 251.

[0172] (D46) Data body: The accuracy management information of (D22) to (D35) above. These are obtained from the accuracy management database 252. Regarding (D28) to (D35) above, in the case of intra-day accuracy management, the data are the measured values ​​themselves obtained from the accuracy management database 252. On the other hand, in the case of daily accuracy management and monthly accuracy management, the data are statistical values ​​(e.g., average values) obtained by statistically processing the measured values ​​obtained from the accuracy management database 252.

[0173] Figure 8 This figure shows a specific example of data recorded in the information code created in the precision management information extraction process. In this figure, the first code category "QC", the second code category "Intraday", the date and time information "April 11, 2023 17:59:22", the model name "XQ-320", the device ID "F5659", and the precision management result as intraday precision management are shown in CSV format. Figure 6 The information of the 4 records shown. In addition, Figure 8 The information shown is 340 characters in total, but this amount of data can be recorded in one information code. In this case, for example, a QR code of version 10 with an error correction level of L (7% recovery capability) can be used. The maximum number of characters that can be recorded in this QR code is 395 characters in English and numbers, so Figure 8 All the information shown is recorded. Figure 8 For example, according to this embodiment, a plurality of (in Figure 8 In the example of 4) precision management results, the user only needs to take a picture of the QR code once, which is more convenient for the user than converting the precision management results into QR codes one by one. In the precision management measurement, there are many cases where precision management specimens with different concentration levels are measured multiple times a day, so when the precision management results are converted into QR codes one by one, the number of photographs increases, and it is also conceivable that the user forgets to take pictures depending on the situation. In this regard, the analysis device 2 automatically extracts the unsent precision management results and converts them into one QR code, which can prevent the user from forgetting to take pictures.

[0174] The processor 26A may also be able to change the version (size of the QR code) according to the amount of data of the information code generated in the precision management information extraction process. For example, if the amount of data is less than Figure 8 The information shown generates a QR code below version 9. If the amount of data is greater than Figure 8The information shown generates a QR code of version 11 or higher. However, there is a limit in the display area of ​​the display / operation device 24 of the analysis device 2, so when the amount of data included in the information code exceeds the predetermined amount of data, the QR code may be divided into two or more information codes instead of increasing the version and displayed in sequence. In the case of dividing into two or more information codes, for example, the first information code is displayed, and when the user inputs that the information code has been completed, the next information code is displayed. In this case, information indicating that it is a divided information code may also be included in each information code. For example, when the information code is divided into three information codes, each information code includes a character string such as "1 / 3", "2 / 3", and "3 / 3 (END)". When the terminal 3 includes information indicating that it is a divided information code in the read information code, a screen that prompts the user to read all the divided information codes may also be displayed. If the information code is divided in this way, even if the display area is limited, large data can be converted into information codes and handed over to the terminal 3. In addition, when the information code is divided, it is also possible to prevent data transmission omissions caused by the user forgetting to take pictures.

[0175] Figure 8 The illustrated information code has a data structure that records common information for each of the multiple accuracy management results, namely, the first code category (D41), the second code category (D42), the date and time information (D43), the model name (D44), and the device ID (D45) as common items. Figure 8 In the example information code, Figure 6 Of the four records shown, the information common to the two records of measurement ID: 001 and measurement ID: 002, namely, the measurement item, quality control specimen type, lot, and expiration date, is made common. This data structure can reduce the amount of data stored in the information code.

[0176] [Screen example of analysis device 2]

[0177] An example of a screen displayed on the display / operation device 24 will be described. Fig. 9 2 is a diagram showing an example of a menu screen. The menu screen is a screen that displays various processes that can be executed by the analysis device 2 in a selectable manner. In the example shown in the figure, an icon 700 is provided as one of the menus in the menu screen. When the user touches the icon 700, the processor 26A executes the precision management information extraction process according to the instruction of the information extraction unit 264, and displays the generated information code on the display / operation device 24. Fig.10 FIG. 1 is a diagram showing an example of a screen displaying the information code created. Fig.10As shown, on the screen, together with the created information code, a message prompting the user to take a photo of the information code, such as “Please take a photo of the information code using the camera of the terminal”, is displayed.

[0178] Fig.11 702 is a diagram showing an example of a screen for setting the accuracy management category. This screen can also be migrated from the menu screen. In the example shown in the figure, in field 701, a radio button for selecting any of "intraday accuracy management", "daily accuracy management", and "monthly accuracy management" is provided. When the user selects any radio button and touches button 702, processor 26A stores the accuracy management category selected in field 701 in storage device 25A according to the instruction of information extraction unit 264.

[0179] Fig.12 1 is a diagram showing an example of a screen for setting extraction conditions for automatically extracting quality control information using the analyzer 2. This screen may be able to be transferred from a menu screen, or may be displayed when the quality control information extraction process is executed.

[0180] In field 703, a radio button for selecting either "Use all as objects" or "Specify objects" is provided. When the user touches the radio button corresponding to "Use all as objects" on the touch panel, all the accuracy management results obtained on the target day or target month are set as objects of accuracy management. In this case, the check boxes of field 704 and field 705 are locked and cannot be operated. When the user selects the radio button corresponding to "Specify objects", field 704 and field 705 become selectable.

[0181] A check box for selecting the timing of performing the quality control measurement is provided in field 704. "QC before sample measurement" is the quality control result obtained before the first sample measurement is performed on the target day, "QC during sample measurement" is the quality control result obtained after the first sample measurement is performed on the target day and before the last sample measurement is performed, and "QC after sample measurement" is the quality control result obtained after the last sample measurement is performed on the target day.

[0182] In the field 705, check boxes for selecting the concentration levels (L1, L2, L3) of the quality control specimens are provided.

[0183] When the user sets extraction conditions in fields 703, 704, and 705 and touches button 706, processor 26A stores the extraction conditions selected in fields 703 to 706 in storage device 25A or RAM 27 according to the instruction of information extraction unit 264. The extraction conditions stored in storage device 25A or RAM 27 are used in the accuracy management information extraction process described later ( Fig.17 ). Therefore, users can Fig.11 or Fig.12 The extraction conditions are preset on the screen, and there is no need to set the accuracy management information sent to the management device 4 for external accuracy management each time.

[0184] Fig.13 is a diagram showing another example of a screen for setting extraction conditions. Fig. 9 The accuracy management icon 710 can be displayed when the accuracy management information extraction process is executed. In the case where the accuracy management result confirmation screen can be transferred, for example, a button such as "Information code creation" can be pre-set in the accuracy management result confirmation screen. When the user selects the button, the accuracy management result confirmation screen is displayed. Fig.13 In the picture. Fig.13 In the picture, it is not as Fig.11 as well as Fig.12 The example in which the user sets the extraction conditions in advance is suitable for individually specifying the quality control results that the user wishes to send externally.

[0185] Field 707 is a field for displaying each measurement value as a result of the quality management as a time series graph and for selecting the measurement value. The measurement values ​​represented by the black circles drawn in the time series graph can be selected. On the other hand, the measurement values ​​represented by the white circles drawn in the time series graph cannot be selected because they exceed the total period. Fig.13 In the time series graph, measurement values ​​(WBC, RBC, HGB, HCT, . . . ) of a plurality of measurement items corresponding to one quality management result, that is, one quality management measurement, are displayed side by side in the vertical direction.

[0186] Slider 708 specifies the extraction target period. Slider 708 can be moved left and right by dragging it while being touched by the user. In the example shown in the figure, by moving slider 708 left and right, the start time and end time of the extraction target period can be set. Fig.13 In the example of the screen, three precision management results are specified, but only one can be specified as the extraction object. In addition, the designation of the extraction object period is not limited to moving the slider 708, and for example, it can also be specified by the user touching a black circle drawn in the timing chart.

[0187] When the button 709 is operated by the user, the processor 26A stores the extraction condition selected by the field 707 and the slider 708 in the storage device 25A or the RAM 27 according to the instruction of the information extraction unit 264 .

[0188] [Example of the flow of processing executed by the analysis device 2]

[0189] Fig.14 2 is a flowchart showing an example of the flow of processing executed by the processor 26A of the analysis device 2. First, when the power of the analysis device 2 is turned on, the processor 26A executes a startup process (S11). In the startup process, for example, the mechanism unit and the fluid unit of the analysis device 2 are initialized, the fluid unit is cleaned, the temperature stabilization wait of the measurement module is performed, and a background check is performed.

[0190] When the processor 26A receives an input operation after the startup process is completed ("Yes" in S12), it executes the processing corresponding to the input operation (S13 to S17). In the case where the input operation is an operation to start "precision management measurement", the processor 26A executes the precision management measurement processing (S14). In the case where the input operation is an operation to start "specimen measurement", the processor 26A executes the specimen measurement processing (S15). In the case where the input operation is an operation to start "precision management information extraction", the processor 26A executes the precision management information extraction processing (S16, extraction process). In the case where the input operation is an operation to start "shutdown", the processor 26A, for example, causes the display / operation device 24 to display Fig.15 After the confirmation screen is displayed, shutdown processing is performed (S17) to turn off the power supply. The shutdown processing includes, for example, discharge of waste liquid, cleaning of the flow path, etc.

[0191] Step S16 (extraction process) is a part of the process (preparation process) of preparing the management information to be acquired by the management device 4 from among the information stored in the analysis device 2. The preparation process includes converting the management information into an information code that can be optically read by the terminal 3 and displaying it on the display / operation device 24, or creating transmission data for transmitting the management information from the analysis device 2 to the terminal 3 via short-range wireless communication.

[0192] Fig.16 14 is a flowchart showing an example of the process of the precision management measurement process. The processor 26A performs the measurement related to the precision management specimen by operating the various parts including the suction part 21, the sample preparation part 22, and the detection part 23 (S141), and stores the precision management result in the precision management database 252 and displays it on the display / operation device 24 (S142). When the precision management result is abnormal ("No" in S143), the processor 26A may also output information prompting re-measurement to the display / operation device 24 (S144). On the other hand, when the precision management result is normal ("Yes" in S143), the processor 26A ends the precision management measurement process.

[0193] Fig.172 is a flowchart showing an example of the process of the precision management information extraction process. The processor 26A obtains the precision management results that meet the extraction conditions from the precision management database 252 (S161). The processor 26A creates an information code that can read each of the obtained precision management results or the values ​​calculated based on these (S162). The processor 26A displays the created information code on the display / operation device 24 (S163). When the input operation to end the precision management information extraction process is accepted ("Yes" in S164), the processor 26A ends the precision management information extraction process.

[0194] Fig.18 It is shown Fig.14 In this variation, except Fig.14 In addition to the flowchart shown, S171 to S174 are added. When the input operation accepted in S12 is an operation to start "shutdown", the processor 26A first determines whether there are unextracted quality management results in the quality management database 252 before performing the shutdown process (S171), and when there are unextracted quality management results ("Yes" in S171), the display / operation device 24 outputs a screen asking whether to extract the unextracted quality management results (S172). Fig.19 An example of this screen is shown. Fig.19 In the information processing, the user is informed that there are unextracted quality control results (QC files), and a "Yes" and "No" buttons are displayed along with a message asking the user whether to send the information to the management device. Fig.19 When "Yes" is selected on the screen ("Yes" in S173), the precision management information extraction process (S174) is executed, and then the shutdown process (S17) is executed. In addition, S171 to S174 and S17 can also be executed in parallel. By executing in parallel, the processing time can be shortened compared to the case of serial execution.

[0195] The analyzer 2 is shut down at the end of the daily sample measurement work. Therefore, by automatically checking whether there are any unextracted quality control results when the analyzer 2 is shut down as in this modification, it is possible to prevent forgetting to send the quality control results to the management device 4.

[0196] The automatic confirmation of the existence of the unextracted quality control results is not limited to the shutdown time. For example, the automatic confirmation time may be set arbitrarily. Fig. 20 13:30 is set as the automatic confirmation time. Fig.212 is an example of a confirmation screen output to the display / operation device 24 at the set automatic confirmation time. Fig. 20 The confirmation screen is output at 13:30, which is the automatic confirmation time set in the screen shown.

[0197] [Configuration example of terminal 3]

[0198] like Fig. 22 As shown, the terminal 3 according to the present embodiment includes, for example, a communication device 31 , an imaging device 32 , an operation device 33 , an output device 34 , a storage device 35A, a processor 36A, a RAM 37 , a ROM 38 , and a short-distance wireless communication unit 30 .

[0199] The communication device 31 is an interface for communicating with the management device 4 via the communication network 5 according to the control executed by the processor 36A. The camera device 32 is, for example, a camera having an image sensor such as a CCD (Charge Coupled Device). The main imaging object of the camera device 32 is the information code. The operating device 33 accepts operations on various data of the terminal 3. The operating device 33 is, for example, a touch panel or a microphone. The output device 34 outputs various data processed by the terminal 3. The output device 34 is, for example, a touch panel. The short-range wireless communication unit 30 performs short-range wireless communication with the short-range wireless communication unit 20 of the analysis device 2.

[0200] The storage device 35A stores various data and various programs used by the terminal 3, and is, for example, a semiconductor drive such as a solid-state drive or a magnetic disk such as a hard disk. Fig.23 As shown, for example, a user attribute database 351 is stored.

[0201] The user attribute database 351 is a database that stores information on medical practitioners who are users of the terminal 3 , and is, for example, an RDB. Fig.24 3 is a diagram showing an example of a data structure when the user attribute database 351 is an RDB. As shown in the figure, in the user attribute database 351, for example, the following information (D51) to (D56) are stored in association.

[0202] (D51) User ID: Identifier of the medical practitioner.

[0203] (D52) Username: The name of the medical practitioner.

[0204] (D53) Password: Password used by medical personnel to log into terminal 3.

[0205] (D54) Device ID: Identifier of the analysis device 2 associated with the medical practitioner.

[0206] (D55) Model name: the model name of the analysis device 2 associated with the medical professional.

[0207] (D56) Destination: The destination associated with the medical practitioner, for example, a URL, an email address, a mailing address, etc.

[0208] The processor 36A is a control unit that performs overall control of the functions of the terminal 3. The processor 36A is, for example, a CPU. The processor 36A may also be implemented by, for example, a logic circuit. The processor 36A reads the application 361A from the storage device 35A and expands and executes it in the RAM 37. The application 361A is stored in the storage device 35A, for example, as a program for causing the computer to function as a control unit that performs various processes.

[0209] [Structural example of applying 361A]

[0210] Fig.25 The following is a configuration example of an application 361A. The application 361A includes, for example, a reading / transmitting unit 362 and an external quality control result acquiring unit 363 .

[0211] When the operation device 33 receives an input operation to start reading the information code, the processor 36A executes the information code reading process according to the instruction of the reading / transmitting unit 362. In the information code reading process, the image pickup device 32 captures the information code and reads information from the captured information code.

[0212] After the reading is completed, the processor 36A may also display the read information on the output device 34 for the medical practitioner to confirm. In addition, after the reading is completed, the processor 36A may also determine whether the read information is appropriate according to the instruction of the reading / transmitting unit 362. Specifically, the processor 36A determines whether the model name and device ID included in the read information are consistent with the model name and device ID stored in the user attribute database 351. In the case of consistency, the processor 36A sends the read information to the management device 4. Thus, the accuracy management result is sent to the management device 4. The sending destination may be included in the read information or may be pre-set in the terminal 3. The sending timing may be automatic sending or the timing of receiving the input operation. On the other hand, in the case where at least one of the model name and the device ID is inconsistent, the processor 36A may also display a screen prompting the medical practitioner to confirm on the output device 34. Thus, it is possible to prevent the reading error of the analysis device 2, the reading of the forged code, impersonation, etc.

[0213] In addition, the processor 36A obtains the external accuracy management result from the management device 4 according to the instruction of the external accuracy management result acquisition unit 363. The processor 36A may also obtain the external accuracy management result of the analysis device 2 identified by the device ID stored in the user attribute database 351 in association with the user ID of the medical practitioner who logged in to the terminal 3. The acquisition destination of the external accuracy management result may be, for example, a web page provided by the management device 4 or an email sent from the management device 4. The opportunity to obtain the external accuracy management result may be an input operation received by the operation device 33 or may be automatically obtained at a predetermined timing.

[0214] [Screen example of terminal 3]

[0215] Fig.26 This is an example of a login screen displayed on the output device 34. The field 800 accepts a user ID and a password.

[0216] Fig. 27 8 is a diagram showing an example of a menu screen displayed on the output device 34 after logging in. The field 801 displays information related to the user, for example, the user name, model name, and device ID stored in the user attribute database 351 in association with the user ID of the logged-in medical professional.

[0217] When an operation is received using the button 802 , the processor 36A acquires the external quality management result according to the instruction of the external quality management result acquisition unit 363 .

[0218] When an operation is received using the button 803 , the processor 36A executes the information code reading process according to the instruction of the reading / transmitting unit 362 . Fig.28 as well as Fig.29 This is an example of a screen displayed on the output device 34 after the reading is completed. Fig.28 The example shown is an example of a screen when the model name and the device ID match. The read information is displayed in the field 804. Thus, the medical staff can check whether there is any deficiency in the transmitted information. Fig.29 The example shown is an example of a screen when the model name and the device ID do not match. A message prompting the medical professional to confirm is displayed in field 805. The read information is displayed in field 806.

[0219] [Configuration Example of Management Device 4]

[0220] like Fig.30As shown, the management device 4 involved in this embodiment includes, for example, a communication device 41, an operating device 43, an output device 44, a storage device 45A, a processor 46A, a RAM 47, and a ROM 48. The communication device 41 is an interface for communicating with the terminal 3 via the communication network 5 in accordance with the control executed by the processor 46A. The operating device 43 accepts operations on various data of the management device 4. The operating device 43 is, for example, a touch panel or a microphone. The output device 44 outputs various data processed by the management device 4. The output device 44 is, for example, a touch panel, a speaker, or a printer. The storage device 45A stores various data and various programs used by the management device 4, and is, for example, a semiconductor drive such as a solid-state drive or a magnetic disk such as a hard disk. Fig.31 As shown, the storage device 45A stores, for example, an external quality control database 451. The external quality control database 451 manages information necessary for external quality control and external quality control results for each model of the analyzer 2 and each type of quality control specimen.

[0221] The processor 46A is a control unit that performs overall control of the functions of the management device 4. The processor 46A is, for example, a CPU. The processor 46A may also be implemented by, for example, a logic circuit. The processor 46A reads the application 461A from the storage device 45A and expands it into the RAM 47 for execution. The application 461A is stored in, for example, the storage device 45A as a program for causing the computer to function as a control unit that executes various processes.

[0222] [Structural example of applying 461A]

[0223] Fig.32 The following is a structural example of the application 461A. The application 461A includes, for example, an external accuracy management unit 462. The processor 46A executes an external accuracy management process in accordance with the instruction of the external accuracy management unit 462. In the external accuracy management process, information sent from the terminal 3 is received and stored in the external accuracy management database 451, and external accuracy management is implemented according to whether a predetermined set time or input operation is reached, and the external accuracy management result is provided to the medical facility.

[0224] [Example of the flow of processing executed by the terminal 3 and the management device 4]

[0225] Fig.33 4 is a flowchart showing an example of the flow of processing executed by the terminal 3 and the management device 4. Fig.17In S163 described in the description, in the state where the information code is displayed on the analysis device 2, the processor 36A of the terminal 3 performs information code reading processing, and the camera device 32 of the terminal 3 reads the information code (S21, acquisition process), and the read information is sent to the management device 4 (S22, sending process). The processor 46A of the management device 4 receives the information sent from the terminal 3 and stores it in the external quality management database 451 (S31). In addition, the processor 46A of the management device 4 implements the data aggregation and judgment of the external quality management after, for example, reaching a predetermined set time ("Yes" in S32) (S33). For example, based on the external quality management data sent from multiple facilities to the management device 4 during the aggregation period, the measurement results related to the quality management specimens of the same batch are used as a whole to calculate the statistical value (such as the average value or the median value), thereby performing the data aggregation of the external quality management. The processor 46A of the management device 4 determines whether the external quality management results of each analysis device are normal based on the calculated statistical value. For example, when the individual quality management result is within the range of 2SD relative to the overall average value, it is determined to be normal, and if it is outside 2SD, it is determined to be abnormal. The processor 46A of the management device 4 sends the total result and the determination result obtained in this way as an external quality management result to the terminal 3 (S34). The processor 36A of the terminal 3 receives the external quality management result (S23) and displays it on the output device 34, for example.

[0226] [Case of immunoassay device]

[0227] As another example of the analysis device 2, an immunoassay device is described. As an immunoassay device, for example, there is HISCL-5000 (manufactured by Sysmex Corporation). In immunoassay, the amount of data of the precision management result is greater than that of the blood cell counting device, so sometimes it is impossible to record all the precision management results in the information code, so it is preferred to use short-range wireless communication such as Bluetooth between the short-range wireless communication unit 20 and the short-range wireless communication 30 instead of the information code to carry out information exchange between the analysis device 2 and the terminal 3. In addition, when using short-range wireless communication, compared with the case of using information codes, the capacity and type of the data to be sent can be increased, so for example, the data of the calibration curve stored in the analysis device 2, various logs, error information, current status information, and other various information stored in the analysis device 2 can be used as the data to be sent.

[0228] Fig.34This is a diagram showing an example of the data structure of the precision management database 252 when the analyzer 2 is an immunoassay device. The precision management database 252 shown in the figure stores, for example, the information (D61) to (D73) shown below in association. In addition, the types of measurement items shown in (D62) below are, for example, a maximum of 24, so the amount of data of the precision management result increases compared to the blood cell count. For example, when the measurement items are a maximum of 24 types, the concentration levels of the precision management specimens are 2 types, and when the precision management measurement is performed twice a day, 96 (=24×2×2) record items are stored in the precision management database 252 as the daily precision management results.

[0229] (D61) Measurement ID: Identifier of the quality control measurement.

[0230] (D62) Measurement item: The name of the item to be measured for quality control. Examples of measurement items are "FLUA" (influenza A) and "FLUB" (influenza B).

[0231] (D63) Quality control specimen type: indicates the type of concentration level of the quality control specimen used in the quality control measurement. Examples of the quality control specimen type are "FLU-L1" (level 1), "FLU-L2" (level 2), and "FLU-L3" (level 3).

[0232] (D64) Batch: The batch number of the quality control sample used in the quality control measurement.

[0233] (D65) Expiration date: The expiration date of the quality control sample used in the quality control measurement.

[0234] (D66) Measurement date: The date on which the quality control measurement is carried out.

[0235] (D67) Measurement time: The time when the quality control measurement was performed. The measurement date and measurement time can also be combined into one item.

[0236] (D68) Concentration: The concentration of the quality control sample, which is one of the quality control results. It is calculated by applying the count value described later to the calibration curve.

[0237] (D69) Count: A count value that is one of the results of quality control. The count value is an optical characteristic value detected by an optical detector (e.g., a photomultiplier tube) in the immunoassay device and is proportional to the amount of the substance to be tested contained in the quality control specimen. In the case of a photomultiplier tube, it is the number of photons detected.

[0238] (D70)Curve ID: The identifier of the calibration curve.

[0239] (D71) Reagent 1: The type of reagent used.

[0240] (D72) Reagent 2: The type of reagent used.

[0241] (D73) Flag: A flag indicating whether the precision management results have been extracted.

[0242] Fig.35 A specific example of the record items of the precision management database 252 is shown when the analysis device 2 is an immunoassay device. Four record items are shown in the figure. The two record items on the upper side indicate the precision management results of the precision management specimens whose category is FLU-L1, batch is J337 and expiration date is April 17, 2023. The implementation date and time of the precision management measurement are 7:53:28 on April 11, 2023 and 19:43:36 on the same day. The two record items on the lower side indicate the precision management results of the precision management specimens whose category is FLU-L2, batch is J882 and expiration date is April 17, 2023. The implementation date and time of the precision management measurement are 7:54:33 on April 11, 2023 and 19:44:22 on the same day.

[0243] In the precision management information extraction process executed by the processor 26A, the precision management results that meet the extraction conditions are obtained from the precision management database 252, and one or more transmission data including the obtained precision management results or values ​​(statistical values, etc.) calculated based on these are prepared (preparation process). In addition, the prepared transmission data is sent to the terminal 3 via the short-distance wireless communication unit 20. The processor 36A of the terminal 3 receives the transmission data via the short-distance wireless communication unit 30 (acquisition process).

[0244] While the accuracy management results are being transmitted via short-distance wireless communication, it is preferable that a screen showing the progress of the transmission is displayed on the display / operation device 24 . Fig.36 An example of a screen showing the progress status is shown. In this figure, the progress status is displayed with a gauge, the progress ratio is displayed, and the time required until the delivery is completed is displayed. By displaying such a progress status, medical practitioners can perform other tasks while understanding the progress status.

[0245] [Implementation method 2]

[0246] The same reference numerals are given to the same structures and processes as those described in Embodiment 1, and description thereof will be omitted.

[0247] In this embodiment, a method of sending instructions input by a service person using the management device 4 to the analysis device 2 via the terminal 3 is described. According to this embodiment, the service person can make the analysis device 2 perform processing without contacting the medical practitioner by phone or the like and without going to the medical facility, so maintenance operations and the like can be carried out efficiently and quickly. In addition, the medical practitioner who relays the instructions can make the analysis device 2 perform processing by a simple operation such as reading an information code and without making a mistake. That is, even if the service person does not go to the medical facility and even if the medical practitioner is not familiar with the operation of the analysis device 2, it is possible to easily implement the treatment for the analysis device 2 (such as error recovery, various settings, etc.).

[0248] [Configuration Example of Management Device 4]

[0249] like Fig.37 As shown, the configuration of the management device 4 according to the present embodiment is the same as that of the management device 4 according to the first embodiment, except that the storage device 45B and the processor 46B are provided instead of the storage device 45A and the processor 46A.

[0250] The storage device 45B stores various data and various programs used by the management device 4, and is, for example, a semiconductor drive such as a solid-state drive or a magnetic disk such as a hard disk. Fig.38 As shown, the storage device 45B stores, for example, an indication information database 452 and a user attribute database 453 .

[0251] The instruction information database 452 is a database, such as RDB, that stores information related to instructions to the analysis device 2 and the medical staff who operate the analysis device 2. The instructions are (IN1) and (IN2) shown below.

[0252] (IN1) Command to analysis device 2

[0253] Regarding the commands stored in the instruction information database 452, all commands that can be executed in each mode of the user mode and the service mode (a mode that only service personnel can log in) in the analysis device 2 are objects. By making the analysis device 2 execute the commands that can be executed in the service mode through the terminal 3, even if the service personnel do not go to the medical facility, the treatment of the analysis device 2 can be implemented. An example of a command is to remove the blockage, continuous blank check, turn off the blood suction sensor, shut down, shut down and restart, read out the error history, read out the accuracy management history, read out the service data, set the service data (such as the opening and closing of the screen lock, the opening and closing of the notification function (such as the reagent remaining amount notification function), the setting of automatic wake-up, the setting of automatic shutdown, etc.), and reset the service setting. The command that can be executed only in the service mode is, for example, a continuous blank check. Removing the blockage and the continuous blank check are commands for handling the blockage of the RBC detector, and the closing of the blood suction sensor is a command for handling short samples (insufficient blood volume). In addition, the continuous blank check refers to a function of repeating the blank check until the blank value is less than the threshold. The screen lock is a function that prevents other operators from operating the analyzer 2 when the operator leaves the analyzer 2 .

[0254] (IN2) Instructions for medical practitioners

[0255] This is an instruction regarding a task that a medical professional is expected to perform, etc. An example of this instruction is an instruction to perform a quality control measurement.

[0256] Fig.39 4 is a diagram showing an example of a data structure when the instruction information database 452 is an RDB. As shown in the figure, in the instruction information database 452, for example, the following information (D81) to (D83) are stored in association with each other.

[0257] (D81) Device ID: an identifier of the analysis device 2.

[0258] (D82) Instruction ID: an identifier of an instruction. Specifically, it is any one of an identifier of a command and an identifier of an instruction to a medical practitioner. The instruction ID is preferably an ID system that can identify both. The instruction ID is composed of a combination of letters or numbers, and preferably has a small number of digits.

[0259] (D83) Instruction content: the content of the instruction.

[0260] Fig.40 Specific examples of records of the instruction information database 452 are shown. In this figure, instructions related to the analysis device 2 whose device ID is "F5659" are shown as an example.

[0261] The user attribute database 453 is a database that stores information on service personnel who are users of the management device 4, and is, for example, an RDB. Fig.41 4 is a diagram showing an example of a data structure when the user attribute database 453 is an RDB. As shown in the figure, in the user attribute database 453, for example, the following information (D91) to (D97) are stored in association with each other.

[0262] (D91) User ID: Identifier of the agent.

[0263] (D92) Username: The name of the service personnel.

[0264] (D93) Password: The password used by the service personnel to log into the management device 4.

[0265] (D94) Medical facility: the name of the medical facility where the analysis device 2 associated with the service personnel is installed.

[0266] (D95) Destination: Information indicating the destination of data sent from the service personnel to the medical staff, for example, the communication address of the terminal 3.

[0267] (D96) Device ID: Identifier of the analysis device 2 associated with the service person.

[0268] (D97) Model name: the model name of the analysis device 2 associated with the service personnel.

[0269] Return to Fig.37 The processor 46B is a control unit that performs overall control of the functions of the management device 4. The processor 46B is, for example, a CPU. The processor 46B may also be implemented by, for example, a logic circuit. The processor 46B reads the application 461B from the storage device 45B and expands it into the RAM 47 for execution. The application 461B is stored in the storage device 45B as a program for causing the computer to function as a control unit that performs various processes.

[0270] [Structural example of application 461B]

[0271] Fig.42 The following is a configuration example of the application 461B. The application 461B includes, for example, an instruction information generating unit 463 .

[0272] The processor 46B generates an instruction information creation screen 4631 according to the instruction of the instruction information creation unit 463, and displays it on the output device 44. The instruction information creation screen 4631 is a screen for creating instruction information. Fig.43 46 is a diagram showing an example of the instruction information creation screen 4631. Fig.43As shown, the instruction information creation screen 4631 includes, for example, fields 901 to 904 and a button 905 .

[0273] The field 901 displays, for example, information about a user who has logged into the management device 4. The information displayed in the field 901 is acquired from the user attribute database 453.

[0274] Field 902 displays, for example, the current status of the analyzer 2. In the example of the figure, "RBC detection unit is blocked" is displayed as the current status of the analyzer 2. The displayed current status may be sent from the terminal 3 that reads the information code recording the current status of the analyzer 2 (see Embodiment 3 described later), or may be input from the operating device 43 when the service personnel hears the current status from the medical staff.

[0275] Field 903 accepts the selection of instructions and the execution order of the selected instructions. The instructions that become selection candidates are obtained from the instruction information database 452. In the example shown in the figure, the two commands "remove blockage" and "continuous blank check" are selected as instructions, and the execution order of "remove blockage" becomes the first (one-time correspondence), and the execution order of "continuous blank check" becomes the second (secondary correspondence). In this way, the service personnel can select the desired instructions in the instruction information creation screen 4631. In addition, when the service personnel wishes to execute multiple commands continuously as instructions for the analyzer 2, they can select multiple desired commands in the instruction information creation screen 4631 and specify their execution order. Therefore, the service personnel can indicate all the commands that the analyzer 2 must execute one by one in sequence if it is a medical practitioner, and can perform effective troubleshooting, etc.

[0276] Field 904 accepts input of a message related to the selected instruction. The message may be, for example, a matter related to the processing to be executed by the analyzer 2, a matter to be notified to a medical practitioner, a matter to be implemented by a medical practitioner, etc. In field 904, a message predetermined for each instruction may be displayed in an editable manner.

[0277] When receiving an operation using button 905, processor 46B generates data (recorded as instruction data) including information input to fields 903 and 904 according to instructions from instruction information generator 463, and transmits the generated instruction data to terminal 3. A transmission destination is acquired from user attribute database 443.

[0278] An example of information included in the instruction data is shown in (D101) to (D104) below. (D101) is a required item, and (D102) to (D104) are optional items.

[0279] (D101) Instruction ID of the instruction selected in field 903 and sequence information indicating the execution order of the instructions. In addition, the arrangement order of the instruction IDs in the instruction data may be regarded as the sequence information, and data indicating the sequence information may be included.

[0280] (D102) The message entered in the field 904.

[0281] (D103) The device ID and / or model name of the analysis device 2 to be indicated. This information can be used to prevent the wrong analysis device 2 to be indicated.

[0282] (D104) The issuance date and / or validity period of the indication data. The issuance date is the date and time when the indication data is created, and the validity period is a predetermined time after the issuance date (e.g., 30 minutes). This information can be used to prevent the arbitrary use and illegal use of the indication data.

[0283] [Configuration example of terminal 3]

[0284] like Fig.44 As shown, the configuration of the terminal 3 according to the present embodiment is the same as that of the terminal 3 according to the first embodiment, except that the processor 36B is provided instead of the processor 36A.

[0285] The processor 36B is a control unit that performs overall control of the functions of the terminal 3. The processor 36B is, for example, a CPU. The processor 36B may also be implemented by, for example, a logic circuit. The processor 36B reads the application 361B from the storage device 35A and expands and executes it in the RAM 37. The application 361B is stored in the storage device 35A, for example, as a program for causing the computer to function as a control unit that performs various processes.

[0286] [Structural example of applying 361B]

[0287] Fig.45 The following is a configuration example of an application 361B. The application 361B includes, for example, a reading / transmitting unit 362 and a display control unit 364 .

[0288] When receiving the instruction data from the management device 4, the processor 36B executes the display control process according to the instruction of the display control unit 364. In the display control process, the following (display control process 1) and (display control process 2) are performed.

[0289] (Display Control Process 1) When the instruction ID included in the instruction data is an identifier of a command, an information code capable of reading the command is created, and the created information code is displayed on the output device 34.

[0290] (Display Control Process 2) When the instruction ID included in the instruction data is an identifier of an instruction to a medical professional, a screen corresponding to the instruction ID is displayed on the output device 34 .

[0291] [Screen examples and information code examples]

[0292] Fig.46 This is an example of a screen displayed by the display control process 1 when instruction data including instruction IDs “B1002” (remove jam) and “B1003” (continuous blank check) are received.

[0293] Field 911 displays the message. The message is in Fig.43 The message inputted in the instruction information creation screen 4631 is shown. By displaying the message in this way, for example, in addition to notifying the medical staff of the instruction content or contacting the medical staff about the matters that they want to perform other than having the analyzer 2 read the information code, reliable troubleshooting can be performed.

[0294] Field 912 displays the information code. The information code is used to Fig.43 The information code for executing "jam removal" and "continuous blank check" selected in the instruction information creation screen 4631 shown in the figure is executed in this order. The information recorded in the information code is, for example, as shown in (D111) to (D116) below. The data in CSV format is recorded in the information code.

[0295] (D111) Code 1 category: "Instruction" as an example.

[0296] (D112) Code 2 Category: Not used. As an example, NULL value.

[0297] (D113) Date and time information: Date and time information (issuance date and / or validity period) included in the instruction data.

[0298] (D114) Model name: The model name included in the indication data.

[0299] (D115) Device ID: an identifier of the analysis device 2 included in the instruction data.

[0300] (D116) Data body: One or more indication IDs included in the indication data.

[0301] Specific examples of data recorded in the information code are shown below.

[0302] "Instruction,, 2023 / 04 / 11 17:59:22, XQ-320, F5659, B1002, B1003".

[0303] In this specific example, the first code category "Instruction", the second code category "NULL value", the date and time information "April 11, 2023 17:59:22", the model name "XQ-320", the device ID "F5659", and the instruction ID "B1002" and "B1003" are represented in CSV format. By storing the character string "Instruction" in the first code category, the analysis device 2 recognizes that the information code includes instructions. The model name and the device ID are used to confirm that the analysis device 2 is the object of the instruction. When the model name and the device ID included in the read information code are inconsistent with the model name and the device ID stored in the analysis device 2, the analysis device 2 displays an error. The recording order of the instruction ID indicates the execution order. By recording "B1002" (remove jam) and "B1003" (continuous blank check) in this order, the analysis device 2 that reads the information code executes the commands in this order. Fig.46 In the example of FIG. 1 , the analyzer 2 that reads the information code shown in the figure performs a continuous blank check after performing the blockage removal. Even in the case where the analyzer 2 performs multiple processes, it is sufficient to read the information code once. That is, it is not necessary to make the analyzer 2 read the information code multiple times, so the operation of the medical practitioner becomes simple.

[0304] Fig.47 This is another example of a screen displayed by the display control process 1 when instruction data including instruction ID "S4099" (turn off the blood aspiration sensor) is received. In field 914, an information code for executing the turn off of the blood aspiration sensor of the analyzer 2 is displayed. A specific example of the data recorded in the information code is shown below.

[0305] "Instruction,, 2023 / 04 / 11 17:59:22, XQ-320, F5659, S4099"

[0306] In this specific example, the first code type "Instruction", the second code type "NULL value", the date and time information "April 11, 2023 17:59:22", the model name "XQ-320", the device ID "F5659", and the instruction ID "S4099" (blood aspiration sensor off) are shown in CSV format. After reading the information code, the analysis device 2 switches the blood aspiration sensor to off.

[0307] Fig.48This is another example of a screen displayed by the display control process 1 when receiving instruction data including instruction ID "S1181" (disable screen lock). In field 916, an information code for disabling screen lock of the analysis device 2 is displayed. A specific example of data recorded in the information code is shown below.

[0308] "Instruction,,2023 / 04 / 11 17:59:22,XQ-320,F5659,S1181"

[0309] In this specific example, the first code type "Instruction", the second code type "NULL value", the date and time information "April 11, 2023 17:59:22", the model name "XQ-320", the device ID "F5659", and the instruction ID "S1181" (screen lock off) are expressed in CSV format. After reading the information code, the analysis device 2 switches the screen lock function to off.

[0310] Fig.49 This is another example of a screen displayed by the display control process 1 when instruction data including instruction ID "X882" (reading of error history) is received. In field 918, an information code for executing a process of extracting the most recent error history from the analysis device 2 is displayed. A specific example of the data recorded in the information code is shown below.

[0311] "Instruction,,2023 / 04 / 11 17:59:22,XQ-320,F5659,X882"

[0312] In this specific example, the first code type "Instruction", the second code type "NULL value", the date and time information "April 11, 2023 17:59:22", the model name "XQ-320", the device ID "F5659", and the instruction ID "X882" (error history reading) are expressed in CSV format. After reading the information code, the analysis device 2 reads the most recent error history stored in the analysis device 2, and creates and displays the information code based on the information in the read error history (for a screen example, refer to the following description). Fig.60 ). User in Fig.49 After the information code is read by the analysis device 2, the "camera start" button displayed on the screen of the terminal 3 is operated. After the camera is started, the user can use the terminal 3 to take a picture of the information code based on the information of the error history and send it to the management device 4.

[0313] Fig.50This is an example of a screen displayed by the display control processing 2 when receiving instruction data including instruction ID "Q220" (implementation of quality control measurement). In this screen example, the information code displayed as an instruction to the medical staff to measure quality control and as a result of quality control is read from the analyzer 2 is displayed. The medical staff operates the analyzer 2 according to these instructions. Fig.51 The following is an example of a screen of the analyzer 2 showing an information code recording the quality control result after the quality control measurement is performed by the analyzer 2. The medical professional reads the information code using the imaging device 32 of the terminal 3.

[0314] [Configuration Example of Analyzer 2]

[0315] like Fig.52 As shown, the structure of the analysis device 2 involved in this embodiment is the same as that of the analysis device 2 of the embodiment 1, except that it includes a storage device 25B (storage unit) and a processor 26B instead of the storage device 25A and the processor 26A, and further includes a reading unit 29 or can be installed with the reading unit 29.

[0316] The reading unit 29 is a reader for optically reading an information code displayed on the output device 34 of the terminal 3. In order to facilitate the reading operation of the medical staff, the reading unit 29 may be a portable type.

[0317] The storage device 25B stores various data and various programs used by the analysis device 2, and is, for example, a semiconductor drive such as a solid-state drive or a magnetic disk such as a hard disk. Fig.53 As shown, the storage device 25B stores, for example, a command information database 253 , an error history database 254 , and a service data information database 255 in addition to the device attribute database 251 and the accuracy management database 252 .

[0318] The command information database 253 is a database storing commands executable by the analysis device 2 , and is, for example, an RDB. Fig.54 2 is a diagram showing an example of a data structure when the command information database 253 is an RDB. As shown in the figure, the command information database 253 stores, for example, the following information (D121) to (D122) in a linked manner.

[0319] (D121) Command ID: Identifier of a command. Corresponds to the identifier of the command in the instruction ID stored in the instruction information database 452 of the management device 4.

[0320] (D122) Process: One process or a group of multiple processes corresponding to the command ID.

[0321] Fig.55 A specific example of the record items of the command information database 253 is shown.

[0322] The error history database 254 is a database, such as RDB, that stores the history of errors that occurred in the analyzer 2. Errors refer to, for example, abnormalities and warnings related to pressure, temperature, reagents, motors, sample measurement, covers, maintenance, sampler measurement operations, etc. Specific examples of errors are clogging of the RBC detector, abnormal pressure drop, etc. Fig.56 2 is a diagram showing an example of a data structure when the error history database 254 is an RDB. As shown in the figure, the error history database 254 stores, for example, the following information (D31) to (D134) in a linked manner.

[0323] (D131) Error ID: An identifier attached to each error.

[0324] (D132) Occurrence date and time: The date and time when the error occurred.

[0325] (D133) Error code: An identifier indicating the type of error. The error code is displayed on the display / operation device 24 when an error occurs, for example.

[0326] (D134) Error message: A message indicating an outline of an error. The error message is displayed on the display / operation device 24 when an error occurs, for example.

[0327] Fig.57 Specific examples of records in the error history database 254 are shown. Two records are shown in the figure. The record on the upper side of the figure shows the history of "RBC detector clogging". The record on the lower side of the figure shows the history of "abnormal pressure drop".

[0328] The service data information database 255 is a database, such as RDB, that stores various information collected by the analysis device 2 or various parameters set for the analysis device 2 (hereinafter referred to as "service data"). An example of hardware-related service data stored in the service data information database 255 is shown below.

[0329] ·Number of unit actions (e.g. overall, periodic cleaning, punch, whole blood aspiration motor, air pump, clamp valve, etc.)

[0330] Various pressure data (positive pressure, negative pressure)

[0331] Ambient temperature

[0332] Data from sensors used to monitor each part (e.g., blood aspiration sensor, WBC / HGB detection sensor, RBC detection sensor, MIX cavity detection sensor)

[0333] An example of service data related to blood cell count measurement stored in the service data information database 255 is shown below.

[0334] Sample data for monitoring noise (e.g., particle counts of RBC / PLT channels measured at certain intervals)

[0335] Reference data (e.g., red blood cell volume mode, platelet volume mode, average large red blood cell volume of RBC bimodal particle size distribution, average small red blood cell volume of RBC bimodal particle size distribution, number of large red blood cells in RBC bimodal particle size distribution, number of small red blood cells in RBC bimodal particle size distribution)

[0336] The position of the discriminator of the RBC particle size distribution (e.g., the lower limit position of the red blood cell region of the RBC particle size distribution, the position of the valley between two peaks of the RBC particle size distribution, the upper limit position of the red blood cell region of the RBC particle size distribution)

[0337] The position of the discriminator of the PLT particle size distribution (e.g., the lower limit position of the red blood cell region of the PLT particle size distribution, the upper limit position of the red blood cell region of the RBC particle size distribution)

[0338] ·Measured value of hemoglobin (e.g., optical concentration of sample sample after A / D conversion, optical concentration of blank sample after A / D conversion)

[0339] Abnormal particle size distribution signs

[0340] Values ​​related to RBC measurement (e.g., values ​​obtained by electrically detecting the degree of clogging of the RBC detector, the number of bubbles in the RBC detector)

[0341] Return to Fig.52 The processor 26B is a control unit that performs overall control of the functions of the analysis device 2. The processor 26B is, for example, a CPU. The processor 26B may also be implemented by, for example, a logic circuit. The processor 26B reads the application 261B from the storage device 25B and expands it into the RAM 27 for execution. The application 261B is stored in the storage device 25B as a program for causing the computer to function as a control unit that performs various processes.

[0342] [Structural example of application 261B]

[0343] Fig.58 The following is a configuration example of the application 261B. The application 261B includes, for example, a read execution unit 265 in addition to the quality control measurement unit 262, the sample measurement unit 263, and the information extraction unit 264.

[0344] The processor 26B executes the following (process P1) according to the information read from the information code by the reading unit 29 in accordance with the instruction of the reading execution unit 265. Before executing (process P1), (process P2) and / or (process P3) may be executed.

[0345] (Processing P1) The processor 26B determines the type of information recorded in the information code by using the "first code type" and "second code type" included in the read information. When the first code type is "Instruction", the processor 26B controls each part of the analysis device 2 in such a manner that the processing corresponding to the instruction ID included in the read information is determined by referring to the command information database 253 and the determined processing is executed.

[0346] When the determined process is to read the quality management history, the processor 26B executes the quality management information extraction process according to the instruction of the information extraction unit 264. In the quality management information extraction process, the quality management results (for example, the quality management results obtained in the most recent week) that meet the predetermined extraction conditions are obtained from the quality management database 252, and information codes that can read the obtained quality management results or the values ​​(statistical values, etc.) calculated based on these are generated, and the generated information codes are displayed on the display / operation device 24. Fig.59 An example of a screen displayed in this case is shown. The quality management result that meets the predetermined extraction condition is one of the management information that the management device 4 should acquire.

[0347] When the determined process is to read the error history, the processor 26B executes the error history extraction process according to the instruction of the information extraction unit 264. In the error history extraction process, the error history that meets the predetermined extraction conditions (for example, the error history obtained in the last week, the error history that is allowed to be output by the user setting, etc.) is obtained from the error history database 254, and an information code that can read each of the obtained error histories is created, and the created information code is displayed on the display / operation device 24. Fig.60 An example of a screen displayed in this case is shown. The error history that meets the predetermined extraction condition is management information that should be acquired by the management device 4.

[0348] When the determined process is to read the service data, the processor 26B executes the service data extraction process according to the instruction of the information extraction unit 264. In the service data extraction process, the service data that meets the predetermined extraction conditions (for example, predetermined service data, service data that is permitted to be output by user setting, etc.) is obtained from the service data information database 255, and an information code that can read each obtained service data is generated, and the generated information code is displayed on the display / operation device 24. Fig.61An example of a screen displayed in this case is shown. The service data that meets the predetermined extraction condition is one of the management information that the management device 4 should acquire.

[0349] (Processing P2) The processor 26B may determine whether the device ID included in the read information is consistent with the device ID stored in the device attribute database 251. When the device IDs are consistent, the processor 26B may execute the reading process, and when the device IDs are inconsistent, the processor 26B may terminate the reading process. Thus, for example, in a case where a plurality of analysis devices 2 are installed in a medical facility, it is possible to avoid a situation where another analysis device performs a process that should not be performed because the other analysis device 2 mistakenly reads an information code that should be read by the original analysis device. That is, it is possible to prevent the analysis device 2 that performs the process from being wrongly read, so that, for example, reliable troubleshooting can be implemented. In addition, when the reading process is terminated, the processor 26B may display a message indicating that the device ID is inconsistent on the display / operation device 24.

[0350] (Processing P3) The processor 26B may also determine whether the information code is valid based on the date and time information (issue date and / or validity period) included in the read information. For example, the information code may be determined to be invalid when the difference between the issue date and time included in the read information and the current time is more than a predetermined time (for example, 30 minutes). In addition, for example, the information code may be determined to be invalid when the validity period of the information included in the read information is exceeded. The processor 26B may also perform the reading process when it is determined to be valid, and the processor 26B may terminate the reading process when it is determined to be invalid. Thus, it is possible to prevent the arbitrary use of information codes used in the past. Therefore, for example, it is possible to prevent users from obtaining information that can only be obtained in the service mode for the purpose of illegal use or from causing the analysis device 2 to perform processing that can only be performed in the service mode without the permission of the service personnel. In addition, when the reading process is terminated, the processor 26B may also display a message indicating that the information code is invalid on the display / operation device 24.

[0351] [Example of processing flow]

[0352] Fig.624 is a flowchart showing an example of the flow of a process for causing the analysis device 2 to execute a process from the management device 4 via the terminal 3. The processor 46A of the management device 4 receives the instruction (S41) through the instruction information creation screen 4631, for example, and sends the instruction data to the terminal 3 (S42). The processor 36A of the terminal 3 receives the instruction data (S43), for example, creates an information code that can read the instruction data and displays it on the output device 34 (S44, display process). In other words, in step S44, the processor 36A prompts the output device 34 with information related to the process to be executed by the analysis device 2 (prompt process). The processor 26A of the analysis device 2 reads the information code (S45, reading process), and executes the process corresponding to the instruction contained in the read information (S46, execution process). In this way, the medical practitioner can make the analysis device 2 execute the process based on the instruction from the service personnel only by performing a simple operation such as causing the analysis device 2 to read the information code displayed on the terminal 3. Furthermore, since the service personnel can cause the analyzer 2 to execute processing without having to contact a medical professional by phone or the like or go to a medical facility, maintenance operations and the like can be performed efficiently and quickly.

[0353] Fig.63 Show Fig.62 A variation of the flowchart shown in FIG. 1 is shown in FIG. 2. In this variation, S47 to S50 are added. After the processor 26A of the analysis device 2 performs processing in S46, for example, an information code that can read the accuracy management result is displayed on the display / operation device 24 (S47, preparation process). The processor 36A of the terminal 3 uses the camera 32 to read the information code (S48) and sends the read information to the management device 4 (S49). The processor 46A of the management device 4 receives the information (S50). In this way, the service personnel can receive the accuracy management result in S50 as the result indicated in S41, so that flexible maintenance operations such as further other instructions can be performed while confirming the state of the analysis device 2 after the instruction. In addition, in the case where the amount of data sent from the analysis device 2 to the terminal 3 is large, instead of reading the information code in S47 to S48, the information can be sent from the analysis device 2 to the terminal 3 through short-range wireless communication such as Bluetooth as described in the first embodiment.

[0354] [Implementation method 3]

[0355] The same reference numerals are given to the same configurations and processes as those described in the above embodiment, and description thereof will be omitted.

[0356] In the present embodiment, a method of sending information related to an error occurring in the analysis device 2 (hereinafter referred to as "error information") to the management device 4 via the terminal 3 is described. Errors refer to, for example, abnormalities and warnings associated with pressure, temperature, reagents, motors, specimen measurements, covers, maintenance, sampler measurement operations, etc., as described in Embodiment 2. Specific examples of errors are blockage of the RBC detector, abnormal pressure reduction, etc. According to the present embodiment, error information stored in the analysis device 2 that operates in an environment where it cannot communicate with devices outside the medical facility can be sent to the management device 4. Moreover, it can be implemented by simple operations such as reading an information code and without misoperation, so even medical practitioners who are not proficient in operating the analysis device 2 can easily implement it. In addition, even if the medical practitioner does not convey the error information of the analysis device 2 to the service personnel by telephone, etc., the service personnel can correctly know the error information and can implement reliable troubleshooting.

[0357] [Configuration Example of Analyzer 2]

[0358] like Fig.64 As shown in FIG. 1 , the configuration of the analysis device 2 according to the present embodiment is the same as that of the analysis device 2 according to the second embodiment, except that a processor 26C is provided instead of the processor 26B.

[0359] The processor 26C is a control unit that performs overall control of the functions of the analysis device 2. The processor 26C is, for example, a CPU. The processor 26C may also be implemented by, for example, a logic circuit. The processor 26C reads the application 261C from the storage device 25B and expands and executes it in the RAM 27. The application 261C is stored in, for example, the storage device 25B as a program for causing the computer to function as a control unit that performs various processes.

[0360] [Structural example of applying 261C]

[0361] Fig.65 The following is a configuration example of the application 261C. The application 261C includes, in addition to the quality control measurement unit 262, the sample measurement unit 263, the information extraction unit 264, and the reading execution unit 265, for example, an error information notification unit 266.

[0362] Processor 26C executes error information extraction processing according to the instruction of error information notification unit 266. A typical example of a trigger for executing error information extraction processing is when an error occurs, but it may also be when a predetermined input operation is accepted by display / operation device 24.

[0363] A typical example of error information extraction processing is to obtain error history (e.g., one or more errors that occurred recently) that meets the predetermined extraction conditions from the error history database 254, create an information code that can read the acquired error history, and display the created information code on the display / operation device 24. The information recorded in the information code created by the error information extraction processing is shown in (D141) to (D146) below. This information is converted into data in CSV format and recorded in the information code.

[0364] (D141) Code 1 category: "Error" as an example.

[0365] (D142) Code 2 Category: Not used. As an example, NULL value.

[0366] (D143) Date and time information: the date and time when the information code is generated.

[0367] (D144) Model name: the model name of the analysis device 2 that created the information code. Acquired from the device attribute database 251.

[0368] (D145) Device ID: Identifier of the analysis device 2 that created the information code. Acquired from the device attribute database 251.

[0369] (D146) Data body: information related to the error. Specifically, it includes the date and time when the error occurred, the error code, and the error message. It is obtained from the error history database 254.

[0370] [Screen example]

[0371] Fig.66 The following is an example of a screen that the error information notification unit 266 causes the display / operation device 24 to display when “RBC detection unit clogging” occurs.

[0372] When the operation is received by the button 1001, the processor 26C causes the analyzer 2 to execute a preset action for controlling each unit to eliminate the blockage of the RBC detection unit. Thus, for example, when the RBC detection unit is blocked for the first time that day, the medical staff can first try to eliminate the error by themselves without the support of the service staff.

[0373] When an operation is received using the button 1002 , the processor 26C executes error information extraction processing according to the instruction of the error information notification unit 266 , and causes the generated information code to be displayed on the display / operation device 24 . Fig.67 1 is a diagram showing an example of a screen displaying the generated information code. Thus, when a medical professional cannot eliminate the blockage of the RBC detection unit by himself and needs support from a service staff, error information can be notified to the service staff via the terminal 3.

[0374] A specific example of the data recorded in the information code is shown below.

[0375] "Error,,2023 / 04 / 11 17:59:22,XQ-320,F5659,2023 / 03 / 3016:28:00,311240"

[0376] In this specific example, the first code category "Error", the second code category "NULL value", the date and time information "April 11, 2023 17:59:22", the model name "XQ-320", the device ID "F5659", the error occurrence date and time "March 30, 2023 16:28:00", and the error code "311240" (RBC detection unit is blocked) are represented in CSV format.

[0377] Furthermore, after the terminal 3 reads the information code and transmits the read information to the management device 4, the terminal 3 preferably receives a receipt notification from the management device 4 as a response. Thus, the medical staff can recognize that the error information can be notified to the service staff. Fig.68 This is an example of a screen displaying a receipt notification using the terminal 3.

[0378] Fig.69 This is a diagram showing an example of a screen displaying an information code generated when "short sample (insufficient blood volume)" occurs. A specific example of data recorded in the information code is shown below.

[0379] "Error,,2023 / 04 / 11 17:59:22,XQ-320,F5659,2023 / 03 / 3016:28:00,228239"

[0380] In this specific example, the first code category "Error", the second code category "NULL value", the date and time information "April 11, 2023 17:59:22", the model name "XQ-320", the device ID "F5659", the error date and time "March 30, 2023 16:28:00", and the error code "228239" (short sample) are represented in CSV format.

[0381] [Processing Flow]

[0382] Fig.70This is a flowchart showing an example of the process flow of sending information related to an error occurring in the analysis device 2 to the management device 4 via the terminal 3. When the processor 26C of the analysis device 2 detects an error (S51), it performs error information extraction processing and displays an information code that can read the error information on the display / operation device 24 (S52, preparation process). The terminal 3 reads the information code using the camera device 32 (S53) and sends the read information to the management device 4 (S54). The management device 4 receives the information (S55), and the service personnel take measures based on the information.

[0383] Fig.71 Show that Fig.70 This example is an example of extending the flowchart shown in the figure. This example is to implement the method described in the second embodiment after S55. Fig.62 As an example of the treatment performed by the service personnel, in the management device 4, for example, Fig.43 In the instruction information creation screen 4631 shown, an instruction for handling the error is accepted (S41), and instruction data is transmitted to the terminal 3 (S42).

[0384] As an example of a treatment example when an error message related to clogging of the RBC detection unit is received in S55, in S41, the instruction information creation screen 4631 is used to accept input of instructions for executing "removal of clogging" and "continuous blank check" using the analysis device 2. In addition, in the field 902 of the instruction information creation screen 4631 in this case, as shown in FIG. Fig.43 As shown in FIG. 1 , it is preferable to display “RBC detection unit is clogged” as the current status of the analyzer 2 .

[0385] As another example, as a handling example when error information about a short sample is received in S55, in S41, the instruction information creation screen 4631 is used to accept input of an instruction for executing "turning off the blood aspiration sensor" by the analyzer 2. In this case, it is preferable that "short sample" is displayed as the current status of the analyzer 2 in the field 902 of the instruction information creation screen 4631.

[0386] The terminal 3 receives the instruction data (S43), and displays the information code that can read the instruction data on the output device 34 (S44). The processor 26C of the analysis device 2 reads the information code (S45), and executes the processing corresponding to the read information (S46). Through the above process, the service personnel who receive the error information can make the analysis device 2 execute the command for handling the error.

[0387] [Modification 1]

[0388] exist Fig.71In S41 shown, instead of receiving an instruction for handling the error from the service personnel, the management device 4 may automatically determine the instruction. Specifically, the management device 4 may store a database that corresponds error information and instructions in the storage device 25B, and automatically determine the instruction corresponding to the information received in S55 by referring to the database.

[0389] [Modification 2]

[0390] When the automation described in the above modification 1 is performed, the subject of the action of determining the instruction may be the terminal 3. Specifically, the terminal 3 may store a database of correspondence between error information and instructions in the storage device 35A of the terminal 3, and determine the instruction corresponding to the information read in S53 by referring to the database.

[0391] [Implementation method 4]

[0392] The same reference numerals are given to the same configurations and processes as those described in the above embodiment, and description thereof will be omitted.

[0393] This embodiment is a method of extracting information stored in the analysis device 2 and sending it to the management device 4 via the terminal 3. The opportunity to execute the process of extracting the information stored in the analysis device 2 may be, for example, when an input operation is received by the display / operation device 24 of the analysis device 2. Thus, medical practitioners can cause the analysis device 2 to execute the information extraction process voluntarily or when receiving a request from a service staff by telephone or the like.

[0394] For example, when a predetermined input operation is received by the display / operation device 24 , the processor 26B executes information extraction processing according to the instruction of the information extraction unit 264 , and causes the generated information code to be displayed on the display / operation device 24 . Fig.72 11 is a diagram showing an example of a screen for selecting extracted information. This screen may also be able to be transferred from a menu screen. In the example shown in this figure, buttons 1101 to 1103 are provided as menus for selecting any one of the accuracy management history, error history, and service data.

[0395] When the button 1101 is operated, the processor 26B obtains the quality management results that meet the predetermined extraction conditions from the quality management database 252, creates information codes that can read the obtained quality management results or the values ​​(statistical values, etc.) calculated based on them, and displays the created information codes on the display / operation device 24. An example of the screen displayed in this case is as follows Fig.59 same.

[0396] When the operation is received by using the button 1102, the processor 26B obtains the error history that meets the predetermined extraction condition from the error history database 254, creates an information code that can read each error history obtained, and displays the created information code on the display / operation device 24. An example of the screen displayed in this case is as follows Fig.60 same.

[0397] When the operation is received by using the button 1103, the processor 26B obtains the service data that meets the predetermined extraction conditions from the service data information database 255, creates an information code that can read each acquired service data, and displays the created information code on the display / operation device 24. An example of the screen displayed in this case is as follows Fig.61 same.

[0398] Fig.73 1 is a flowchart showing an example of the flow of information extraction processing. When the processor 26B of the analysis device 2 receives an input operation for creating an information code (S61), the information code that can read the information corresponding to the input operation is displayed on the display / operation device 24 (S62, preparation process). The terminal 3 uses the camera device 32 to read the information code (S63) and sends the read information to the management device 4 (S64). The management device 4 receives the information (S65), and the service personnel perform maintenance operations based on the information. In addition, in the case where the amount of data sent from the analysis device 2 to the terminal 3 is large, instead of reading the information code in S62 to S63, the information can be sent from the analysis device 2 to the terminal 3 through short-range wireless communication such as Bluetooth as described in the first embodiment.

[0399] The present invention is not limited to the above-described embodiments, and various modifications can be made within the scope of the claims. Embodiments obtained by appropriately combining technical means disclosed in different embodiments are also included in the technical scope of the present invention.

Claims

1. A method for managing an analysis device, comprising: using a management device, a terminal connected to the management device for communication, and the analysis device not connected to the management device for communication, wherein: The management method comprises: a preparation step of preparing, in the analysis device, management information to be acquired by the management device from among the information stored in the analysis device; an acquisition step of acquiring the prepared management information using the terminal; and A sending step of sending the acquired management information from the terminal to the management device.

2. The management method according to claim 1, wherein: The preparation process includes: The management information is converted into an information code that can be optically read by the terminal and displayed on the display unit of the analysis device, or transmission data for transmitting the management information from the analysis device to the terminal by short-distance wireless communication is prepared.

3. The management method according to claim 1, wherein: The preparation process includes: As the management information, information satisfying a predetermined condition is read from the storage unit of the analysis device.

4. The management method according to claim 3, wherein: The preparation process includes: As the management information, information related to quality management obtained by the analyzing device is read from a storage unit of the analyzing device.

5. The management method according to claim 4, wherein: The preparation process includes: As the management information, information related to the quality management obtained by the analysis device within a predetermined time range is read from the storage unit.

6. The management method according to claim 4, wherein: The preparation process includes: As the management information, a plurality of pieces of information related to the quality management obtained by the analysis device within a predetermined time range are read from the storage unit.

7. The management method according to claim 4, wherein: The preparation process includes: As the management information, the accuracy management result within the normal range is read from the storage unit.

8. The management method according to claim 4, wherein: The preparation process includes: As the management information, one or more pieces of information related to quality management obtained by the analysis device within a time range set according to the operation of quality management are read from the storage unit.

9. The management method according to claim 8, wherein: When intra-day quality management is set as the operation, the information satisfying the predetermined condition includes one or more pieces of information related to quality management obtained by the analysis device within the time range set as the day.

10. The management method according to claim 8, wherein: When intra-day quality management is set as the operation, the information satisfying the predetermined condition is unextracted information from one or more pieces of information related to quality management obtained by the analysis device within the time range set as the day.

11. The management method according to claim 8, wherein: When daily precision management is set as the operation, the information satisfying the predetermined condition is one or more pieces of information related to precision management obtained by the analysis device within the time range set as the daily time. The preparation step includes a step of performing statistical processing on measurement values ​​related to quality management included in the read information.

12. The management method according to claim 4, wherein: The information related to the quality control includes a measurement value of a quality control sample at a first concentration level and a measurement value of a quality control sample at a second concentration level.

13. The management method according to claim 1, wherein: The preparation step is executed by a program for causing a computer to function as the analysis device.

14. The management method according to claim 1, wherein: The preparation process is performed by the analyzing device when the analyzing device is shut down.

15. The management method according to claim 1, wherein: The preparation process includes: As the management information, information on the current status of the analyzing device is read from a storage unit of the analyzing device.

16. The management method according to claim 1, wherein: The preparation process includes: As the management information, information permitted to be output among the information on the current status of the analyzing device is read from the storage unit of the analyzing device.

17. The management method according to claim 1, wherein: The analysis device is not connected to the Internet.

18. The management method according to claim 1, wherein: The terminal is connected to the Internet via a mobile communication network.

19. The management method according to claim 1, wherein: The terminal is a smart phone or a tablet terminal.

20. A management method comprising: an extraction step of extracting, using the analysis device, information satisfying a predetermined condition from information stored in an analysis device that is not communicatively connected to the management device; an acquisition step of acquiring the extracted information or information generated based on the extracted information using a terminal that is communicatively connected to the management device; as well as The sending step is to send the acquired information from the terminal to the management device.

21. The management method according to claim 20, wherein: Also includes: a step of converting the information satisfying the predetermined condition into an information code that can be optically read by the terminal and displaying the information on the display unit of the analysis device; The obtaining step includes reading, using the terminal, an information code displayed on the display unit.

22. The management method according to claim 20, wherein: Also includes: The step of transmitting information satisfying the predetermined condition from the analysis device to the terminal via short-range wireless communication.

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