Maintenance method

Abstract

To allow an analyzing device to easily recover from an abnormality even the analyzing device is not communication-connected to a network outside a facility.SOLUTION: A maintenance method for an analyzing device that is not communication-connected to a network outside a facility includes: a presentation step of presenting information regarding processing that the analyzing device is caused to execute on a terminal that is communication-connected to the network outside the facility; a reading step of reading the information presented by the terminal at the analyzing device; and an execution step of executing the processing indicated by the read information at the analyzing device.SELECTED DRAWING: Figure 62

Description

[Technical field]

[0001] The present invention relates to a maintenance method for an analytical device that is not communicatively connected to a network outside a facility. [Background technology]

[0002] Analytical devices are mainly installed in hospital laboratories, and are maintained in a state where tests can be performed with a certain level of accuracy by service staff who periodically visit the laboratories to perform maintenance. When an abnormality occurs in an analytical device, various technologies have been proposed to enable recovery from the abnormality without calling a service staff, so that the device can be restored as quickly as possible. For example, Patent Document 1 discloses an information processing system including an information server 30 communicably connected to an analytical device 20 via a network 4, which stores handling information for device abnormalities in the analytical device 20, and a handling information display unit which acquires handling information corresponding to device abnormalities occurring in the analytical device 20 from the information server 30 and displays the information to an operator of the analytical device 20. According to this system, information on an apparatus abnormality occurring in the analytical device is quickly transmitted to the information server, and a user can obtain handling information corresponding to the abnormality and perform abnormality recovery. [Prior art documents] [Patent documents]

[0003] [Patent Document 1] Patent Publication No. 2007-271334 Summary of the Invention [Problem to be solved by the invention]

[0004] Since the analyzer handles information on the health of patients, a high level of security is required, and in some facilities, the analyzer is not connected to the Internet. In addition, in some facilities, the Internet is not available. In such facilities, it is not possible to obtain the countermeasure information for dealing with abnormalities as in Patent Document 1, and it may be necessary to ask the service staff how to deal with the abnormality over the phone or to wait for the service staff to visit the site. If the operator is inexperienced, even if the countermeasure information is available, it may not be easy to understand the countermeasure information and restore the abnormality of the analyzer.

[0005] An object of the present invention is to enable easy recovery from an abnormality even in an analytical device that is not communicatively connected to a network outside a facility. [Means for solving the problem]

[0006] In order to solve the above problems, the present invention provides a maintenance method for an analytical device (2) that is not communication-connected to a network outside a facility, the maintenance method including: a presentation step of presenting information related to a process to be executed by the analytical device (2) on a terminal (3) communication-connected to the network outside the facility; a reading step of reading the information presented by the terminal (3) by the analytical device (2); and an execution step of executing the process indicated by the read information by the analytical device (2). Effect of the Invention

[0007] According to the present invention, even if an analysis device is not connected to a network outside the facility, the analysis device can easily recover from an abnormality by reading the information presented on the terminal. Furthermore, according to the present invention, the operator only needs to have the analysis device read the information, so that recovery from an abnormality is easy even if the operator is inexperienced. [Brief description of the drawings]

[0008] [Figure 1] FIG. 1 is a schematic diagram showing an overview of a management support system. [Diagram 2]FIG. 2 is a diagram illustrating an example of the configuration of an analysis device. [Diagram 3] FIG. 2 illustrates an example of the configuration of a storage device of the analysis device. [Figure 4] FIG. 13 is a diagram illustrating an example of a data structure of a device attribute database. [Diagram 5] FIG. 2 is a diagram illustrating an example of a data structure of a quality control database. [Figure 6] FIG. 13 is a diagram showing a specific example of a record in the quality control database. [Figure 7] FIG. 2 illustrates an example of the configuration of an application that runs on the analysis device. [Figure 8] 13 is a diagram showing a specific example of data recorded in an information code created in the quality control information extraction process. FIG. [Figure 9] FIG. 13 is a diagram showing an example of a menu screen displayed on the analysis device. [Figure 10] FIG. 13 is a diagram showing an example of a screen displaying an information code in the analysis device. [Figure 11] FIG. 13 is a diagram showing an example of a screen for setting a quality control type in the analyzer. [Figure 12] FIG. 13 is a diagram showing an example of a screen for setting extraction conditions for automatic extraction of quality control information by the analysis device. [Figure 13] FIG. 13 is a diagram showing another example of a screen for setting extraction conditions in the analysis device. [Figure 14] 4 is a flowchart showing an example of a flow of processing executed by the analysis device. [Figure 15] FIG. 13 is a diagram showing an example of a confirmation screen displayed when starting shutdown in the analyzer. [Figure 16] 13 is a flowchart showing an example of the flow of a quality control measurement process. [Figure 17] 13 is a flowchart showing an example of the flow of quality control information extraction processing. [Figure 18] 15 is a flowchart showing a variation of the flowchart shown in FIG. [Figure 19] FIG. 13 is a diagram showing an example of a screen for notifying that there are unextracted quality control results. [Figure 20] 13 is an example of a screen for setting an automatic confirmation time for determining whether or not there are unextracted quality control results. [Figure 21] 13 is an example of a confirmation screen output to an analysis device at a set automatic confirmation time. [Figure 22] FIG. 2 is a diagram illustrating an example of the configuration of a terminal. [Diagram 23] FIG. 2 is a diagram illustrating an example of the configuration of a storage device of a terminal. [Figure 24] FIG. 4 is a diagram illustrating an example of a data structure of a user attribute database. [Diagram 25] FIG. 2 is a diagram illustrating an example of the configuration of an application that operates on a terminal. [Figure 26] 13 is an example of a login screen displayed on the terminal. [Figure 27] FIG. 13 is a diagram showing an example of a menu screen displayed on the terminal after login. [Figure 28] 13 is an example of a screen displayed on the terminal after reading of the information code is completed. [Figure 29] 13 is another example of a screen displayed on the terminal after the information code has been read. [Diagram 30] FIG. 2 illustrates an example of the configuration of a management device. [Diagram 31] FIG. 2 illustrates an example of the configuration of a storage device of a management apparatus. [Diagram 32] FIG. 2 illustrates an example of the configuration of an application that operates on a management device. [Diagram 33] 10 is a flowchart showing an example of a flow of processes executed by a terminal and a management device. [Diagram 34] 13 is a diagram showing an example of a data structure of a quality control database when the analytical device is an immunoassay device. FIG. [Diagram 35] 13 is a diagram showing a specific example of a record in the quality control database when the analytical device is an immunoassay device. FIG. [Diagram 36] FIG. 13 is a diagram showing an example of a screen showing the progress when quality control results are transmitted via short-range wireless communication. [Figure 37] FIG. 2 illustrates an example of the configuration of a management device. [Figure 38] FIG. 2 illustrates an example of the configuration of a storage device of a management apparatus. [Figure 39] FIG. 13 illustrates an example of a data structure of an instruction information database. [Diagram 40] FIG. 13 is a diagram showing a specific example of a record in the instruction information database. [Diagram 41] FIG. 4 is a diagram illustrating an example of a data structure of a user attribute database. [Diagram 42] FIG. 2 illustrates an example of the configuration of an application that operates on a management device. [Diagram 43] FIG. 13 is a diagram showing an example of an instruction information creation screen. [Diagram 44] FIG. 2 is a diagram illustrating an example of the configuration of a terminal. [Diagram 45] FIG. 2 is a diagram illustrating an example of the configuration of an application that operates on a terminal. [Figure 46] That is, this is an example of a screen displayed on the terminal when instruction data including removal and continuous blank checks is received. [Figure 47] 13 is another example of a screen displayed on the terminal when instruction data including turning off the blood suction sensor is received. [Figure 48] 13 is another example of a screen displayed on the terminal when instruction data including turning off the screen lock is received. [Figure 49] 13 is another example of a screen displayed on the terminal when instruction data including reading of an error history is received. [Figure 50] 13 is another example of a screen displayed on the terminal when instruction data including the performance of quality control measurements is received. [Figure 51] 13 is an example of a screen of an analyzer that displays an information code in which quality control results are recorded. [Figure 52] FIG. 2 is a diagram illustrating an example of the configuration of an analysis device. [Figure 53] FIG. 2 illustrates an example of the configuration of a storage device of the analysis device. [Figure 54] FIG. 13 is a diagram illustrating an example of a data structure of a command information database. [Figure 55]FIG. 13 is a diagram showing a specific example of a record in a command information database. [Figure 56] FIG. 13 illustrates an example of a data structure of an error history database. [Figure 57] FIG. 13 is a diagram showing a specific example of a record in the error history database. [Figure 58] FIG. 2 illustrates an example of the configuration of an application that runs on the analysis device. [Figure 59] FIG. 13 is a diagram showing an example of a screen displaying an information code relating to quality control history on the analysis device. [Figure 60] FIG. 13 is a diagram showing an example of a screen displaying an information code relating to an error history in the analysis device. [Figure 61] FIG. 13 is a diagram showing an example of a screen displaying information codes related to service data in the analysis device. [Figure 62] 10 is a flowchart showing an example of a process flow in which the management device causes the analysis device to execute a process via the terminal. [Figure 63] 63 is a flowchart showing a variation of the flowchart shown in FIG. 62. [Figure 64] FIG. 2 is a diagram illustrating an example of the configuration of an analysis device. [Figure 65] FIG. 2 illustrates an example of the configuration of an application that runs on the analysis device. [Figure 66] FIG. 13 is a diagram showing an example of a screen displayed on the analyzer when clogging occurs in the RBC detection unit. [Figure 67] FIG. 13 is a diagram showing an example of a screen displaying an information code regarding clogging of an RBC detection unit in the analyzer. [Figure 68] 13 is a diagram showing an example of a screen displayed on the terminal when a receipt notification is received from the management device. FIG. [Figure 69] FIG. 13 is a diagram showing an example of a screen displaying an information code regarding a short sample in the analytical device. [Figure 70] 13 is a flowchart showing an example of a process flow for sending information about an error that has occurred in an analysis device to a management device via a terminal. [Figure 71]71 is a flowchart showing an example of an expansion of the flowchart shown in FIG. 70. [Figure 72] FIG. 13 is a diagram showing an example of a screen for selecting information to be extracted from the analysis device. [Figure 73] 13 is a flowchart showing an example of the flow of an information extraction process. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0009] [Overview of Management Support System 1] An overview of a management support system 1 according to the present invention will be described with reference to Fig. 1. The management support system 1 includes an analysis device 2, a terminal 3, and a management device 4.

[0010] [Overview of Analytical Device 2] The analytical device 2 is installed in a medical facility (e.g., a hospital or a clinic) and used by medical staff at the medical facility. The analytical device 2 operates in an offline environment (i.e., operates standalone) or is connected only to a LAN (Local Area Network) installed in the medical facility. In other words, the analytical device 2 is not connected to a communication network 5 such as the Internet installed outside the medical facility, and is operated in an environment where it is not connected to devices outside the medical facility. This operating form is often applied in medical facilities that require high-level security measures to handle information about patients. In addition, the above operating form is often applied in countries or regions where it is not common to connect the analytical device 2 to the Internet, or where a communication network environment is not well developed.

[0011] The analyzer 2 analyzes a specimen. Examples of specimens that the analyzer 2 analyzes include, but are not limited to, biological samples such as blood and urine, human or animal bodies, foods and beverages, etc. A typical example of the analyzer 2 is a clinical testing device. A typical example of a clinical testing device is a blood cell counter. In addition to a blood cell counter, the analyzer 2 may also be, for example, an immunoassay device, a blood coagulation measurement device, a biochemical analyzer, or a urine analyzer.

[0012] The blood cell counter counts blood cell components such as red blood cells, white blood cells, and platelets contained in a blood sample, for example, by an electrical resistance detection method. The electrical resistance detection method involves flowing a blood sample between a pair of electrodes, and measuring the number of blood cells and blood cell volume based on the change in electrical resistance that occurs when blood cells pass between the electrodes. The blood cell counter can also measure the amount of hemoglobin in blood by a non-cyanide hemoglobin method. An example of such a blood cell counter is the XQ-320 (manufactured by Sysmex Corporation). In addition to the electrical resistance detection method, the blood cell counter may also count blood cell components by a flow cytometry method.

[0013] A blood cell counter performs measurements on samples (hereinafter referred to as "sample measurements"), for example, tens to hundreds of times per day. In addition, in a blood cell counter, reproducibility is required for the measurement results when the same sample is measured, and therefore quality control (QC) of the measurements is necessary. For this purpose, the blood cell counter performs measurements on quality control samples (hereinafter referred to as "quality control measurements"). The blood cell counter performs quality control measurements, for example, several times per day. Typical examples of the timing for performing quality control measurements are before performing the first sample measurement in a day (for example, early in the morning) and after performing the last sample measurement in a day (for example, in the evening). Another example of the above timing is after performing the first sample measurement in a day and before performing the last sample measurement (i.e., during the period in which the sample measurements are performed). The reason for performing quality control measurements at these times is that quality control measurements may be performed, for example, when a reagent is changed in the middle of a day or an error is recovered.

[0014] In quality control measurements, the measurement values ​​of quality control samples are analyzed to see whether they are within a specified normal range (whether the deviation from the reference value is within a specified value). Specifically, the measurement values ​​of quality control samples include 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), and mean corpuscular hemoglobin concentration (MCHC). Hereinafter, the measurement values ​​of quality control samples are also referred to as quality control results. Measurement values ​​within the normal range are normal quality control results. Measurement values ​​outside the normal range are abnormal quality control results.

[0015] Quality control is broadly divided into internal quality control and external quality control. Internal quality control is to reduce the variation in measurement results when the same quality control sample is measured in the same facility. The quality control sample of the same lot is repeatedly measured by the same analyzer, and the accuracy of the analyzer is maintained and controlled by confirming that the intraday variation and day-to-day variation are within the allowable range. In general, the analyzer is judged to be normal or abnormal based on whether the measurement value obtained by measuring the quality control sample by the analyzer is within a predetermined normal range determined for each lot of the quality control sample. For example, if the normal range of HGB is set to 9.6 to 11.4, an HGB measurement value of, for example, 10.9 is a normal quality control result.

[0016] External quality control is to reduce the variation in the measurement results when the same quality control sample is measured among multiple facilities. The quality control results of the same lot of quality control samples are collected from multiple facilities, and the quality control results of the analyzer are maintained and managed by confirming that the difference between the measurement results of the facility and the statistical data of the population (for example, the average value or the median value) is within an acceptable range. In this embodiment, the management device 4 receives quality control results from multiple facilities, collects them, calculates statistical data, and judges whether each analyzer is normal or abnormal based on the calculated statistical data. The type of external quality control varies depending on the method of external quality control in which the facility participates, and includes, for example, intra-day quality control for managing intra-day fluctuations in quality control results, daily quality control for managing daily fluctuations in quality control results, and monthly quality control for managing monthly fluctuations in quality control results. In intra-day quality control, each quality control result obtained on a target day (for example, the current day) is transmitted to the management device 4 as a quality control target. In daily quality control, statistical values ​​obtained by performing statistical processing on quality control results obtained on a target day (e.g., the current day) for each lot of quality control samples are transmitted to the management device 4 as the subject of quality control. Typical examples of statistical values ​​are the mean, median, standard deviation, deviation, etc. Daily quality control is usually performed once a day. In monthly quality control, statistical values ​​obtained by performing statistical processing on quality control results obtained in a target month (e.g., the current month) for each lot of quality control samples are transmitted to the management device 4 as the subject of quality control. Typical examples of statistical values ​​are the mean, median, standard deviation, deviation, etc. Monthly quality control is usually performed once a month.

[0017] The quality control specimen is also called quality control material or control sample. The quality control specimen includes, for example, whole blood components adjusted to have known concentrations. Examples of such quality control specimens include XN-CHECK (registered trademark), e-CHECK (registered trademark), and EIGHTCHECK (registered trademark) (manufactured by Sysmex Corporation). The quality control specimen may include three types of quality control specimens adjusted to three concentration levels: low concentration, standard concentration, and high concentration. In the following, the quality control specimen with low concentration is referred to as level 1, the quality control specimen with standard concentration is referred to as level 2, and the quality control specimen with high concentration is referred to as level 3. Level 1, level 2, and level 3 are abbreviated as L1, L2, and L3, respectively.

[0018] [Terminal 3 Overview] The terminal 3 is a computer used by medical staff in a medical facility, such as a smartphone, a tablet terminal, or a personal computer. The terminal 3 serves as an intermediary for the exchange of information between the analysis device 2 and the management device 4.

[0019] Typically, information is exchanged between the terminal 3 and the analysis device 2 using an information code that can be optically read. Either the terminal 3 or the analysis device 2 creates and displays an information code, which is then read by the other device, thereby transferring the information. A typical example of an information code is a two-dimensional code. Two-dimensional codes are excellent in terms of information density, reading performance, and information capacity, and can accurately transmit complex information in a small area. A specific example of a two-dimensional code is a QR code (registered trademark), but is not limited to this. Information may be exchanged between the analysis device 2 and the terminal 3 using short-range wireless communication instead of using an information code. Typical examples of short-range wireless communication are Bluetooth (registered trademark) and Wi-Fi (registered trademark), but are not limited to these.

[0020] The terminal 3 is connected to the communication network 5 directly or via a mobile communication network, and is capable of bidirectional communication 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 (such as a VPN network) and an open network (such as the Internet).

[0021] [Overview of management device 4] The management device 4 is a computer installed in a facility (a facility located remotely from the medical facility) different from the medical facility where the analysis device 2 is installed. The management device 4 may be realized by one computer, or may be realized by distributing functions among multiple computers. The management device 4 is communicatively connected to a communication network 5 and can communicate bidirectionally with a terminal 3 via the communication network 5. The management device 4 transmits information to be sent to the analysis device 2 to the terminal 3, and also receives information stored in the analysis device 2 from the terminal 3. As shown in FIG. 1, 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, and can perform large-scale data aggregation required for external quality control, for example.

[0022] A typical example of a facility in which the management device 4 is installed is a support center. When the management device 4 is installed in a support center, the management device 4 is used by the service staff of the support center. In the following description, the user of the management device 4 is assumed to be the service staff. The service staff uses the management device 4 to perform, for example, (1) external quality control, (2) maintenance and operation support of the analysis device 2 (hereinafter abbreviated as "maintenance operation"), etc.

[0023] External quality control is quality control that performs statistical analysis to determine whether or not the measurement value of a quality control sample is within a predetermined tolerance range, by comparing it with a statistical value (e.g., average value) of a total population composed of multiple medical facilities. External quality control is performed by the management device 4 executing an external quality control program. The external quality control results are provided to the medical facility from the management device 4. As a form of provision, for example, the results may be posted on a web page accessible to terminal 3 used by medical personnel at the medical facility, or may be notified to terminal 3 by email or a dedicated application.

[0024] During maintenance operations, the service staff deals with abnormalities and the like that occur in the analytical device 2. Specifically, the service staff performs tasks such as collecting and analyzing information related to the status of the analytical device 2 (e.g., error history, service data, and the like) and selecting commands to be executed by the analytical device 2.

[0025] [Example of information code format] The information recorded in the information code used for transferring information 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 the CSV (Comma Separated Values) format, but is not limited to this. (D01) First code type: This is the main type for identifying the information recorded in the information code. (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 does not need to be used. (D03) Date and time information: When the analysis device 2 creates the information code, this is the creation date and time of the information code and / or the expiration date. When the terminal 3 creates the information code, this is the issuance date and time of the instruction data (described later) issued by the management device 4 and / or the expiration date. (D04) Model name: The model name of the analytical device 2 to which information is to be transferred. (D05) Device ID: This is the identifier of the analytical device 2 to which information is to be transferred. (D06) Data body: This is the body of the information to be transferred. When the analysis device 2 creates the information code, this is one or more pieces of information read out from the analysis device 2. When the terminal 3 creates the information code, this is one or more instruction identifiers included in the instruction data.

[0026] When the analysis device 2 creates the information code, in addition to the above information (D01) to (D06), information indicating the destination from the terminal 3 may be recorded in the information code. This information is, for example, a URL (Uniform Resource Locator), an email address, a communication address, etc.

[0027] [Embodiment 1] In this embodiment, information stored in the analysis device 2 is sent to the management device 4 via the terminal 3. The following description takes quality control results as an example of information stored in the analysis device 2. According to this embodiment, quality control results stored in the analysis device 2, which operates in an environment where communication with devices outside the medical facility is not possible, can be sent to the management device 4. Moreover, this can be done simply by reading the information code, without any operational errors, so that even medical personnel who are not familiar with the use of the analysis device 2 can easily do this.

[0028] [Configuration example of analysis device 2] 2, the analysis device 2 according to this embodiment includes, for example, an aspirator 21, a sample preparation unit 22, a detector 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 transmitting information 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.

[0029] The aspirating section 21 includes an aspirating pipette, a sampling valve, etc. The aspirating pipette aspirates a sample from a sample container and delivers the sample to the sampling valve. The sampling valve measures a predetermined amount of the introduced sample and flows it out to the sample preparation section 22.

[0030] The sample preparation section 22 includes a fluid circuit made up of a chamber, a valve, etc. for diluting the sample flowing in from the suction section 21 and preparing it as a measurement sample.

[0031] Detection unit 23 is equipped with an electrical resistance detector for measuring red blood cells, white blood cells, platelets, etc. in the measurement sample prepared by sample preparation unit 22. Detection unit 23 detects electrical information measured by the electrical resistance detector as sample data.

[0032] The display / operation device 24 is, for example, a touch panel display. The display / operation device 24 displays quality control results, specimen measurement results, various menus, etc. The display / operation device 24 also accepts input operations of specimen numbers and selection operations of various menus, etc. The display / operation device 24 may include a mouse and a keyboard as devices for accepting user operations.

[0033] 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. As shown in Fig. 3, the storage device 25A stores, for example, an apparatus attribute database 251 and a quality control database 252.

[0034] 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). Fig. 4 is a diagram showing an example of a data structure when the device attribute database 251 is an RDB. As shown in the figure, the device attribute database 251 stores, for example, the following information (D11) to (D12) in association with each other. (D11) Device ID: An identifier of the analysis device 2. (D12) Model name: The model name of the analytical device 2. An example is "XQ-320."

[0035] The quality control database 252 is a database that stores information related to quality control measurements, and is, for example, an RDB. Fig. 5 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. (D21) Measurement ID: An identifier for the quality control measurement. (D22) Measurement item name: The name of the quality control measurement. An example is "CBC" (Complete Blood Count). (D23) Quality control sample type: The concentration level of the quality control sample used in the quality control measurement. Examples include "Control L1" (level 1), "Control L2" (level 2), and "Control L3" (level 3). (D24) Lot: The lot number of the quality control sample used in the quality control measurement. (D25) Expiration date: The expiration date of the quality control sample used in the quality control measurement. (D26) Measurement date: The date on which the quality control measurement was carried out. (D27) Measurement time: The time when the quality control measurement was performed. The measurement date and the measurement time may be integrated. (D28) WBC: The measured value of the white blood cell count, which is one of the quality control results. (D29) RBC: A measurement of the number of red blood cells, which is one of the quality control results. (D30) HGB: A measured value of hemoglobin concentration, which is one of the quality control results. (D31) HCT: The measured hematocrit value, which is one of the quality control results. (D32) MCV: A measured value of mean corpuscular volume, which is one of the quality control results. (D33) MCH: A measured value of mean corpuscular hemoglobin, which is one of the quality control results. (D34) MCHC: A measured value of mean corpuscular hemoglobin concentration, which is one of the quality control results. (D35) PLT: The measured platelet count, which is one of the quality control results. (D36) Flag: A flag indicating whether or not the quality control results have been extracted.

[0036] FIG. 6 shows a specific example of a record in the quality control database 252. Four records are shown in the figure. The two records on the top side show the quality control results of a quality control sample whose quality control sample type is Control L1, whose lot is S3422, and whose expiration date is May 9, 2023. The dates and times of the quality control measurements are 7:53:28 and 19:05:36 on April 11, 2023, respectively. The two records on the bottom side show the quality control results of a quality control sample whose quality control sample type is Control L2, whose lot is M5652, and whose expiration date is May 10, 2023, respectively. The dates and times of the quality control measurements are 7:59:22 and 19:07:39 on April 11, 2023, respectively.

[0037] Returning to FIG. 2, the processor 26A is a control unit that controls the overall functions of the analysis device 2. The processor 26A is, for example, a CPU (Central Processing Unit). The processor 26A may be realized by, for example, a logic circuit. The processor 26A reads out the application 261A from the storage device 25A, expands it in the RAM 27, and executes it. The application 261A is stored, for example, in the storage device 25A as a program for causing a computer to function as a control unit that executes various processes.

[0038] [Example of application 261A configuration] 7 shows an example of the configuration of application 261 A. Application 261 A includes, for example, a quality control measurement section 262, a specimen measurement section 263, and an information extraction section 264.

[0039] When the display / operation device 24 receives an input operation to start a quality control measurement, the processor 26A executes a quality control measurement process in accordance with an instruction from the quality control measurement unit 262. In the quality control measurement process, for example, each unit including the aspirator 21, the sample preparation unit 22, and the detector 23 operates to perform a measurement on the quality control sample.

[0040] When display / operation device 24 receives an input operation to start a specimen measurement, processor 26A executes a specimen measurement process in accordance with an instruction from specimen measurement unit 263. In the specimen measurement process, for example, each unit including aspirator 21, sample preparation unit 22, and detector 23 operates to perform a measurement related to the specimen, and the measurement result is displayed on display / operation device 24 and stored in storage device 25A.

[0041] Moreover, the processor 26A executes the quality control information extraction process according to the instruction of the information extraction unit 264. The quality control information extraction process may be triggered by the reception of an input operation to extract quality control information at the display / operation device 24, or by the arrival of a reserved date and time. In the quality control information extraction process, quality control results that match the extraction conditions are acquired from the quality control database 252, an information code capable of reading each of the acquired quality control results or values ​​(such as statistical values) calculated based on these is created, and the created information code is displayed on the display / operation device 24. This makes it possible to extract only the quality control results that are the target of the external quality control performed by the management device 4. The quality control results that are the target of the external quality control performed by the management device 4 are one of the management information that should be acquired by the management device 4. In the quality control database 252, the fact that the extracted record has been extracted is recorded in the flag 274 of the extracted record. In this specification, "extracting" information from the storage unit is also expressed as "reading" information from the storage unit.

[0042] A first typical example of an extraction condition is to extract only quality control results obtained within a specified time range. If multiple quality control measurements are performed within the specified time range, each of those quality control results will be extracted. Specific examples of the time range are the current day, the current month, etc. A specific time on the current day is, for example, from 11pm the previous day to 9am the next day. The start date and time and end date and time of the time range may be set appropriately.

[0043] In the first typical example, "all" quality control results obtained within a specified time range may be extracted, or "only quality control results that have not been extracted in the past (i.e., unextracted)" may be extracted from among the quality control results obtained within a specified time range. In the latter case, the amount of information recorded in the information code can be reduced.

[0044] The second typical example of extraction conditions is to extract quality control results according to the quality control operation defined by the medical facility. In the case of an operation in which intra-day quality control is performed, each quality control result obtained on the target day is the subject of quality control. All quality control results obtained on the target day may be extracted, or only quality control results obtained on the target day that have not yet been selected as extraction subjects may be extracted, or extraction subjects may be individually selected from the quality control results obtained on the target day.

[0045] In the case of daily quality control, each quality control result obtained on the target day is extracted. In the case of monthly quality control, each quality control result obtained in the target month is extracted.

[0046] In addition, in the case of an operation in which the timing for performing quality control in a day is determined, for example, as (T1) to (T3) shown below, each of the quality control results obtained at the determined timing may be subject to quality control. (T1) Before the first sample measurement of the day. (T2) After the first sample measurement and before the last sample measurement of the day. (T3) After the last sample measurement of the day.

[0047] Incidentally, the above (T2) is often an irregular timing due to, for example, reagent replacement, error recovery, etc. Therefore, in medical facilities that basically perform external quality control only for the above (T1) and (T3), by not selecting the above (T2), the quality control results obtained at the timing of the above (T2) can be excluded from the external quality control.

[0048] The third typical example of extraction conditions extracts only quality control results that comply with the internal quality control standards of the medical facility. Quality control results that comply with the internal quality control standards are normal quality control results. According to the third typical example, only normal quality control results are extracted, and abnormal quality control results are not extracted, so that the reliability of the population data in the external quality control can be guaranteed, and the reliability of the daily average and monthly average data can also be guaranteed.

[0049] The fourth typical example of the extraction condition is to extract only the quality control results of quality control samples with a specified concentration level. As a specific example, only L1 and L2 may be extracted, or only L1 may be extracted.

[0050] The extraction conditions may be a combination of a plurality 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 quality control results obtained on the same day, normal, and having concentration levels of L1 and L2 may be extracted.

[0051] The extraction conditions may be set in advance using a setting menu or the like, or may be set when the quality control information extraction process is executed.

[0052] [Information recorded in the information code] The information recorded in the information code created in the quality control information extraction process is, for example, as shown in (D41) to (D46) below. (D41) First code type: "QC" as an example. (D42) Second code type: For intraday quality control, an example is "Intraday". For daily quality control, an example is "Daily". For monthly quality control, an example is "Monthly". (D43) Date and time information: the date and time when the analysis device 2 created the information code. (D44) Model name: the model name of the analytical device 2 that created the information code. This is obtained from the device attribute database 251. (D45) Device ID: the identifier of the analysis device 2 that created the information code. This is obtained from the device attribute database 251. (D46) Data body: the quality control information of (D22) to (D35) above. These are obtained from the quality control database 252. For (D28) to (D35) above, in the case of intra-day quality control, these are the measured values ​​themselves obtained from the quality control database 252. On the other hand, in the case of daily quality control and monthly quality control, these are statistical values ​​(e.g., average values) obtained by performing statistical processing on the measured values ​​obtained from the quality control database 252.

[0053] FIG. 8 shows a specific example of data recorded in an information code created in the quality control information extraction process. In the figure, the first code type "QC", the second code type "Intraday", the date and time information "April 11, 2023 17:59:22", the model name "XQ-320", the device ID "F5659", and the information of the four records shown in FIG. 6 as the quality control results of the intraday quality control are shown in CSV format. Note that the information shown in FIG. 8 is 340 characters in total, but this amount of data can be recorded in one information code. As the information code in this case, for example, a QR code of version 10 with an error correction level of L (restoration ability of 7%) may be used. The maximum number of recordable characters of the QR code is 395 alphanumeric characters, so all of the information shown in FIG. 8 can be recorded. As illustrated in Fig. 8, according to this embodiment, multiple quality control results (four in the example of Fig. 8) are included in one QR code, so the user only needs to take a picture of the QR code once, which is more convenient for the user than converting quality control results into QR codes one by one. In quality control measurements, quality control samples with different concentration levels are often measured multiple times in one day, so if the quality control results are converted into QR codes one by one, the number of times they are taken increases, and in some cases, it is expected that the user may forget to take a picture. In this regard, the analysis device 2 automatically extracts unsent quality control results and converts them into a single QR code, preventing the user from forgetting to take a picture.

[0054] The processor 26A may be capable of changing the version (size of the QR code) according to the amount of data of the information code created in the quality control information extraction process. For example, if the amount of data is smaller than the information shown in FIG. 8, a QR code of version 9 or lower may be generated, and if the amount of data is larger than the information shown in FIG. 8, a QR code of version 11 or higher may be generated. However, since the display area of ​​the display / operation device 24 of the analysis device 2 is limited, if the amount of data included in the information code exceeds a predetermined amount of data, the QR code may be divided into two or more information codes and displayed sequentially instead of increasing the version. When dividing into two or more information codes, for example, the first information code is displayed, and when the user inputs that the photographing of the information code is completed, the next information code is displayed. In this case, each information code may contain information indicating that it is a divided information code. For example, if the information code is divided into three information codes, each information code contains a character string such as "1 / 3", "2 / 3", and "3 / 3 (END)". If the read information code contains information indicating that it is a divided information code, the terminal 3 may display a screen prompting the user to read all of the divided information codes. By dividing the information code in this way, even if the display area is limited, large data can be converted into an information code and transferred to the terminal 3. Also, even if the information code is divided, it is possible to prevent data from being missed when the user forgets to take a picture.

[0055] The information code illustrated in Fig. 8 has a data structure in which information common to each of multiple quality control results, i.e., the first code type (D41), the second code type (D42), the date and time information (D43), the model name (D44), and the device ID (D45), are described as common items. Furthermore, in the information code illustrated in Fig. 8, of the four records illustrated in Fig. 6, the common information between two records, measurement ID: 001 and measurement ID: 002, i.e., the measurement item, quality control sample type, lot, and expiration date, is made common. This data structure makes it possible to reduce the amount of information stored in the information code.

[0056] [Example of the analyzer 2 screen] An example of a screen displayed on the display / operation device 24 will be described. FIG. 9 is a diagram showing an example of a menu screen. The menu screen is a screen that displays a list of 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 on the menu screen. When the user touches the icon 700, the processor 26A executes quality control information extraction processing according to an instruction from the information extraction unit 264, and causes the display / operation device 24 to display the created information code. FIG. 10 is a diagram showing an example of a screen that displays the created information code. As shown in FIG. 10, the screen displays a message urging the user to take a picture of the information code, such as "Please take a picture of the information code with the camera of the terminal." together with the created information code.

[0057] 11 is a diagram showing an example of a screen for setting a quality control type. The screen may be accessible from a menu screen. In the example shown in the figure, a field 701 is provided with radio buttons for selecting one of "intra-day quality control", "daily quality control", and "monthly quality control". When a user selects one of the radio buttons and touches a button 702, the processor 26A stores the quality control type selected in the field 701 in the storage device 25A according to an instruction from the information extraction unit 264.

[0058] 12 is a diagram showing an example of a screen for setting extraction conditions for automatic extraction of quality control information by the analysis device 2. The screen may be accessible from a menu screen, or may be displayed when the quality control information extraction process is executed.

[0059] Field 703 is provided with radio buttons for selecting either "Target all" or "Specify target". When the user touches the radio button corresponding to "Target all" on the touch panel, all quality control results obtained on the target date or month are set to be subject to quality control. In this case, the check boxes in fields 704 and 705 are locked so that they cannot be operated. When the user selects the radio button corresponding to "Specify target", fields 704 and 705 become selectable.

[0060] Field 704 is provided with check boxes for selecting the timing of performing quality control measurements. "Pre-sample measurement QC" is a quality control result obtained before the first sample measurement is performed on the target date, "during sample measurement QC" is a quality control result obtained after the first sample measurement is performed and before the last sample measurement is performed on the target date, and "post-sample measurement QC" is a quality control result obtained after the last sample measurement is performed on the target date.

[0061] Field 705 includes check boxes for selecting the concentration levels (L1, L2, L3) of the quality control samples.

[0062] When the user sets the 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 in accordance with an instruction from information extraction unit 264. The extraction conditions stored in storage device 25A or RAM 27 are used in the quality control information extraction process (FIG. 17) described later. Therefore, the user can set the extraction conditions in advance via the screen in FIG. 11 or FIG. 12, and does not need to set the quality control information to be transmitted to management device 4 for external quality control every time.

[0063] FIG. 13 is a diagram showing another example of a screen for setting extraction conditions. The screen may be accessible from a quality control result confirmation screen displayed by selecting the quality control icon 710 in FIG. 9, for example, or may be displayed when the quality control information extraction process is executed. When the screen is accessible from a quality control result confirmation screen, for example, a button such as "Create information code" can be provided on the quality control result confirmation screen. The screen in FIG. 13 is displayed when the user selects the button. The screen in FIG. 13 is suitable for individually specifying the quality control results to be sent externally, rather than the user setting the extraction conditions in advance as exemplified in FIG. 11 and FIG. 12.

[0064] Field 707 displays each of the measurement values ​​that are the quality control results as a time series graph, and is a field for selecting a measurement value. Measurement values ​​indicated by black circles plotted on the time series graph are selectable. On the other hand, measurement values ​​indicated by white circles plotted on the time series graph cannot be selected because the collection period has passed. In the time series graph of FIG. 13, one quality control result, that is, the measurement values ​​of multiple measurement items corresponding to one quality control measurement (WBC, RBC, HGB, HCT, etc.), are displayed lined up vertically.

[0065] The slider 708 is used to specify the period to be extracted. The slider 708 can be moved left and right by the user touching and dragging it. In the example shown in the figure, the start time and end time of the period to be extracted can each be set by moving the slider 708 left and right. Although three quality control results are specified in the example screen of FIG. 13, it is also possible to specify only one as the extraction target. Note that the specification of the period to be extracted is not limited to moving the slider 708, and may be specified by the user touching a black circle plotted on a time series graph, for example.

[0066] When the user operates the button 709, the processor 26A stores the extraction conditions selected in the field 707 and the slider 708 in the storage device 25A or the RAM 27 in accordance with an instruction from the information extraction unit 264.

[0067] [Example of process flow executed by the analysis device 2] 14 is a flowchart showing an example of the flow of processing executed by the processor 26A of the analyzer 2. First, when the power of the analyzer 2 is turned on, the processor 26A executes a startup process (S11). In the startup process, for example, initialization of the mechanical part and the fluid part of the analyzer 2, cleaning of the fluid part, waiting for the temperature stabilization of the measurement module, and a background check are performed.

[0068] When the processor 26A receives an input operation after the startup process is completed (YES in S12), the processor 26A executes a process according to the input operation (S13 to S17). If the input operation is an operation to start "quality control measurement", the processor 26A executes quality control measurement process (S14). If the input operation is an operation to start "specimen measurement", the processor 26A executes specimen measurement process (S15). If the input operation is an operation to start "quality control information extraction", the processor 26A executes quality control information extraction process (S16, extraction step). If the input operation is an operation to start "shutdown", the processor 26A displays a confirmation screen shown in FIG. 15 on the display / operation device 24, executes shutdown process (S17), and turns off the power. The shutdown process includes, for example, draining waste liquid, cleaning the flow path, etc.

[0069] Step S16 (extraction step) is part of a step (preparation step) of preparing management information to be acquired by the management device 4 from among the information stored in the analysis device 2. The preparation step 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 by short-range wireless communication.

[0070] 16 is a flowchart showing an example of the flow of the quality control measurement process. The processor 26A performs measurement on the quality control sample by operating each unit including the aspirator 21, the sample preparation unit 22, and the detector 23 (S141), stores the quality control result in the quality control database 252, and also displays it on the display / operation device 24 (S142). If the quality control result is abnormal (NO in S143), the processor 26A may output information prompting remeasurement to the display / operation device 24 (S144). On the other hand, if the quality control result is normal (YES in S143), the processor 26A ends the quality control measurement process.

[0071] 17 is a flowchart showing an example of the flow of the quality control information extraction process. The processor 26A acquires quality control results that match the extraction conditions from the quality control database 252 (S161). The processor 26A creates an information code that can read each of the acquired quality control results or a value calculated based on these (S162). The processor 26A causes the display / operation device 24 to display the created information code (S163). When an input operation to end the quality control information extraction process is accepted (YES in S164), the processor 26A ends the quality control information extraction process.

[0072] FIG. 18 is a flowchart showing a modified example of the flowchart shown in FIG. 14. In this modified example, S171 to S174 are added to the flowchart shown in FIG. 14. When the input operation received in S12 is an operation to start "shutdown", the processor 26A first determines whether or not unextracted quality control results exist in the quality control database 252 before performing the shutdown process (S171), and if unextracted quality control results exist (YES in S171), outputs a screen inquiring whether or not to extract the unextracted quality control results to the display / operation device 24 (S172). An example of this screen is shown in FIG. 19. In FIG. 19, "Yes" and "No" buttons are displayed together with a message notifying the user that there are unextracted quality control results (QC files) and inquiring the user whether or not to send them to the management device. When an input operation to extract information about unextracted quality control results is received, that is, when "Yes" is selected on the screen of Fig. 19 (YES in S173), quality control information extraction processing is executed (S174), and then shutdown processing is executed (S17). Note that S171 to S174 and S17 may be executed in parallel. By executing them in parallel, the processing time can be shortened compared to when they are executed in series.

[0073] Since the analysis device 2 is always shut down at the end of each day's sample measurement work, in this modified example, by automatically checking whether there are any unextracted quality control results when the device is shut down, it is possible to prevent forgetting to send the quality control results to the management device 4.

[0074] Automatic confirmation of the presence or absence of unextracted quality control results is not limited to at shutdown. For example, the automatic confirmation time may be set arbitrarily. FIG. 20 is an example of a screen for setting the automatic confirmation time. In the example shown in the figure, 13:30 is set as the automatic confirmation time. FIG. 21 is an example of a confirmation screen output to the display / operation device 24 at the set automatic confirmation time. In the example shown in the figure, the confirmation screen is output at 13:30, which is the automatic confirmation time set on the screen shown in FIG. 20.

[0075] [Example of terminal 3 configuration] As shown in FIG. 22, the terminal 3 according to this 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-range wireless communication unit 30.

[0076] The communication device 31 is an interface that communicates with the management device 4 via the communication network 5 under the control of the processor 36A. The imaging device 32 is a camera equipped with an image sensor such as a CCD (Charge Coupled Device). The main imaging target of the imaging device 32 is information codes. The operation device 33 accepts operations for various data on the terminal 3. The operation 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.

[0077] 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. The storage device 35A stores, for example, a user attribute database 351, as shown in FIG.

[0078] The user attribute database 351 is a database, for example an RDB, that stores information on medical personnel who are users of the terminal 3. Fig. 24 is a diagram showing an example of a data structure when the user attribute database 351 is an RDB. As shown in the figure, the user attribute database 351 stores, for example, the following information (D51) to (D56) in association with each other. (D51) User ID: An identifier for a medical professional. (D52) User name: The name of a medical professional. (D53) Password: This is the password that the medical staff uses to log in to terminal 3. (D54) Device ID: An identifier of the analysis device 2 associated with the medical professional. (D55) Model name: The model name of the analysis device 2 associated with the medical professional. (D56) Destination: A destination associated with a healthcare professional. For example, a URL, an email address, a communication address, etc.

[0079] The processor 36A is a control unit that controls the functions of the terminal 3. The processor 36A is, for example, a CPU. The processor 36A may be realized by, for example, a logic circuit. The processor 36A reads out the application 361A from the storage device 35A, expands it in the RAM 37, and executes it. The application 361A is stored, for example, in the storage device 35A as a program for causing the computer to function as a control unit that executes various processes.

[0080] [Example of application 361A configuration] 25 shows an example of the configuration of an application 361 A. The application 361 A includes a reading / transmitting unit 362 and an external quality control result acquiring unit 363, for example.

[0081] When an input operation to start reading an information code is accepted by the operation device 33, the processor 36A executes an information code reading process in accordance with an instruction from the reading / transmitting unit 362. In the information code reading process, the imaging device 32 captures an image of the information code, and reads information from the captured information code.

[0082] After the reading is completed, the processor 36A may display the read information on the output device 34 so that the medical staff can confirm it. After the reading is completed, the processor 36A may determine whether the read information is appropriate or not according to an instruction from the reading / transmission unit 362. Specifically, the processor 36A determines whether the model name and device ID included in the read information match the model name and device ID stored in the user attribute database 351. If they match, the processor 36A transmits the read information to the management device 4. As a result, the quality control result is transmitted to the management device 4. The transmission destination may be included in the read information or may be preset in the terminal 3. The transmission timing may be automatic transmission or may be the timing of receiving an input operation. On the other hand, if at least one of the model name and device ID does not match, the processor 36A may display a screen on the output device 34 that prompts the medical staff to confirm. This makes it possible to prevent the wrong pick-up of the analysis device 2, the reading of a counterfeit code, impersonation, and the like.

[0083] Furthermore, processor 36A acquires external quality control results from management device 4 in accordance with instructions from external quality control result acquisition unit 363. Processor 36A may acquire external quality control results of analysis device 2 identified by a device ID stored in user attribute database 351 in association with the user ID of a medical professional logged in to terminal 3. The external quality control results may be acquired from, for example, a web page provided by management device 4, or from an email sent from management device 4. The trigger for acquiring the external quality control results may be receipt of an input operation on operation device 33, or may be automatic acquisition at a predetermined timing.

[0084] [Example of Terminal 3 screen] 26 is an example of a login screen displayed on the output device 34. A field 800 accepts a user ID and a password.

[0085] 27 is a diagram showing an example of a menu screen displayed on the output device 34 after login. A field 801 displays, for example, 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 worker are displayed.

[0086] When an operation is accepted by the button 802, the processor 36A acquires the external quality control results according to an instruction from the external quality control result acquisition unit 363.

[0087] When an operation is accepted by button 803, processor 36A executes an information code reading process in accordance with an instruction from reading / transmitting unit 362. Figures 28 and 29 are examples of screens displayed on output device 34 after reading is complete. The example shown in Figure 28 is an example of a screen when the model name and device ID match. Field 804 displays the read information. This allows the medical professional to check whether there is anything missing in the information to be sent. The example shown in Figure 29 is an example of a screen when the model name and device ID do not match. Field 805 displays a message urging the medical professional to check. Field 806 displays the read information.

[0088] [Example of configuration of management device 4] As shown in FIG. 30, the management device 4 according to this embodiment includes, for example, a communication device 41, an operation 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 that communicates with the terminal 3 via the communication network 5 according to the control of the processor 46A. The operation device 43 accepts operations of various data for the management device 4. The operation device 43 is, for example, a touch panel and 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, and 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. As shown in FIG. 31, the storage device 45A stores, for example, an external quality control database 451. The external quality control database 451 manages information required for external quality control and external quality control results for each model of the analysis device 2 and each type of quality control sample.

[0089] The processor 46A is a control unit that controls the functions of the management device 4. The processor 46A is, for example, a CPU. The processor 46A may be realized by, for example, a logic circuit. The processor 46A reads out the application 461A from the storage device 45A, expands it in the RAM 47, and executes it. 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.

[0090] [Example of application 461A configuration] 32 shows a configuration example of the application 461A. The application 461A includes, for example, an external quality control unit 462. The processor 46A executes external quality control processing in accordance with an instruction from the external quality control unit 462. In the external quality control processing, information transmitted from the terminal 3 is received and stored in an external quality control database 451, external quality control is performed when a predetermined set time is reached or in response to an input operation, and the external quality control result is provided to a medical facility.

[0091] [Example of flow of processing executed by terminal 3 and management device 4] FIG. 33 is a flowchart showing an example of the flow of the process executed by the terminal 3 and the management device 4. In a state where the information code is displayed on the analysis device 2 in S163 described in FIG. 17, the processor 36A of the terminal 3 executes an information code reading process, whereby the imaging device 32 of the terminal 3 reads the information code (S21, acquisition step), and transmits the read information to the management device 4 (S22, transmission step). The processor 46A of the management device 4 receives the information transmitted from the terminal 3 and stores it in the external quality control database 451 (S31). In addition, the processor 46A of the management device 4 performs data collection and judgment of the external quality control, for example, when a predetermined set time is reached (YES in S32) (S33). Data collection of the external quality control is performed, for example, by calculating a statistical value (for example, an average value or a median value) as a population of measurement results related to quality control samples of the same lot based on external quality control data transmitted to the management device 4 from multiple facilities during a collection period. The processor 46A of the management device 4 judges whether the external quality control results of each analysis device are normal based on the calculated statistical values. For example, if an individual quality control result is within 2SD of the overall average value, it is judged to be normal, and if it is outside 2SD, it is judged to be abnormal. The processor 46A of the management device 4 transmits the aggregation results and judgment results thus obtained to the terminal 3 as the external quality control results (S34). The processor 36A of the terminal 3 receives the external quality control results (S23) and displays them, for example, on the output device 34.

[0092] [In the case of an immunoassay device] As another example of the analyzer 2, an immunoassay device will be described. An example of the immunoassay device is HISCL-5000 (manufactured by Sysmex Corporation). In immunoassay, the amount of data on quality control results is greater than that of a blood cell counter, and therefore the quality control results may not be recorded in the information code. Therefore, it is preferable to use short-distance wireless communication such as Bluetooth between the short-distance wireless communication unit 20 and the short-distance wireless communication 30 instead of the information code to exchange information between the analyzer 2 and the terminal 3. Note that, when short-distance wireless communication is used, the capacity and types of data to be transmitted can be increased compared to when information codes are used. Therefore, for example, various information stored in the analyzer 2, such as calibration curve data, various logs, error information, and status information, can be used as the data to be transmitted.

[0093] 34 is a diagram showing an example of the data structure of the quality control database 252 when the analyzer 2 is an immunoassay apparatus. The quality control database 252 shown in the figure associates and stores, for example, the following information (D61) to (D73). Note that since the types of measurement items shown in (D62) below are, for example, a maximum of 24, the amount of data of the quality control results increases compared to blood cell counting. For example, when there are a maximum of 24 types of measurement items, there are two concentration levels of the quality control specimen, and two quality control measurements are performed in one day, 96 (=24×2×2) records are stored in the quality control database 252 as the quality control results for one day. (D61) Measurement ID: An identifier for the quality control measurement. (D62) Measurement item: The name of the quality control measurement item. Examples of measurement items are "FLUA" (influenza type A) and "FLUB" (influenza type B). (D63) Quality control specimen type: A type indicating the concentration level of the quality control specimen used in the quality control measurement. Examples of quality control specimen types are "FLU-L1" (level 1), "FLU-L2" (level 2), and "FLU-L3" (level 3). (D64) Lot: The lot number of the quality control sample used in the quality control measurement. (D65) Expiration date: The expiration date of the quality control sample used in the quality control measurement. (D66) Measurement date: The date on which the quality control measurement was carried out. (D67) Measurement time: The time when the quality control measurement was performed. The measurement date and measurement time may be combined into one item. (D68) Concentration: This is the concentration of the quality control sample, which is one of the quality control results. It is converted by applying the count value described later to the calibration curve. (D69) Count: A count value, which is one of the quality control results. The count value is an optical characteristic value detected by an optical detector (e.g., a photomultiplier tube) included in the immunoassay device, and is proportional to the amount of the test substance contained in the quality control sample. In the case of a photomultiplier tube, it is the number of detected photons. (D70) Curve ID: An identifier indicating the calibration curve. (D71) Reagent 1: The type of reagent used. (D72) Reagent 2: The type of reagent used. (D73) Flag: A flag indicating whether or not the quality control results have been extracted.

[0094] FIG. 35 shows a specific example of a record in the quality control database 252 when the analyzer 2 is an immunoassay device. Four records are shown in the figure. The upper two records show quality control results using quality control samples whose quality control sample type is FLU-L1, whose lot is J337, and whose expiration date is April 17, 2023. The dates and times of quality control measurements are 7:53:28 and 19:43:36 on April 11, 2023, respectively. The lower two records show quality control results using quality control samples whose quality control sample type is FLU-L2, whose lot is J882, and whose expiration date is April 17, 2023, respectively. The dates and times of quality control measurements are 7:54:33 and 19:44:22 on April 11, 2023, respectively.

[0095] In the quality control information extraction process executed by processor 26A, quality control results that match the extraction conditions are obtained from quality control database 252, and one or more pieces of transmission data are created (preparation step) including each of the obtained quality control results or values ​​(such as statistical values) calculated based on these. Then, the created transmission data is transmitted to terminal 3 via short-range wireless communication unit 20. Processor 36A of terminal 3 receives the transmission data via short-range wireless communication unit 30 (acquisition step).

[0096] During the period in which quality control results are transmitted by short-range wireless communication, it is desirable to display a screen showing the progress of the transmission on the display / operation device 24. An example of a screen showing the progress is shown in Fig. 36. In this figure, the progress is displayed with a gauge, the progress rate is displayed, and the time required until transmission is completed is displayed. By displaying such progress, medical personnel can perform other tasks while understanding the progress.

[0097] [Embodiment 2] The same configurations and processes as those described in the first embodiment are denoted by the same reference numerals, and the description thereof will be omitted.

[0098] In this embodiment, an embodiment will be described in which an instruction input by a service staff using a management device 4 is sent to the analysis device 2 via a terminal 3. According to this embodiment, the service staff can make the analysis device 2 execute processing without communicating with a medical professional by phone or visiting a medical facility, and therefore, maintenance operations can be efficiently and quickly performed. Furthermore, the medical professional who mediates the instruction can make the analysis device 2 execute processing only by a simple operation of reading an information code, and without operating it erroneously. In other words, even if the service staff does not visit a medical facility, and even if the medical professional is not familiar with the operation of the analysis device 2, it is possible to easily take measures for the analysis device 2 (for example, error recovery, various settings, etc.).

[0099] [Example of configuration of management device 4] As shown in FIG. 37, the management device 4 according to this embodiment has the same configuration as the management device 4 of the first embodiment, except that the management device 4 includes a storage device 45B and a processor 46B instead of the storage device 45A and the processor 46A.

[0100] 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. As shown in Fig. 38, the storage device 45B stores, for example, an instruction information database 452 and a user attribute database 453.

[0101] The instruction information database 452 is a database, for example an RDB, that stores information about instructions to the analyzer 2 and medical personnel who use the analyzer 2. The instructions are (IN1) and (IN2) shown below.

[0102] (IN1) Command for analyzer 2 The commands stored in the instruction information database 452 are all commands executable in the user mode and service mode (a mode in which only service staff can log in) of the analyzer 2. By having the analyzer 2 execute commands executable in the service mode via the terminal 3, it becomes possible for the service staff to take action on the analyzer 2 without visiting the medical facility. Examples of commands are removal, continuous blank check, turning off the blood suction sensor, shutting down, shutting down and restarting, reading error history, reading quality control history, reading service data, setting service data (for example, turning on and off screen lock, turning on and off notification function (for example, reagent remaining amount notification function), setting automatic wake-up, setting automatic shutdown, etc.), and resetting service settings. For example, a command executable only in the service mode is the continuous blank check. In other words, removal and continuous blank check are commands for dealing with clogging of the RBC detector, and turning off the blood suction sensor is a command for dealing with a short sample (insufficient blood volume). Note that the continuous blank check is a function for repeating blank checks until the blank value falls below a threshold value. The screen lock is a function that prevents another operator from operating the analysis device 2 when the operator leaves the device.

[0103] (IN2) Instructions for medical personnel These are instructions regarding tasks that medical professionals should perform, etc. One example of such instructions is an instruction to perform quality control measurements.

[0104] 39 is a diagram showing an example of a data structure in the case where the instruction information database 452 is an RDB. As shown in the figure, the instruction information database 452 stores, for example, the following pieces of information (D81) to (D83) in association with each other. (D81) Device ID: An identifier of the analysis device 2. (D82) Instruction ID: An instruction identifier. Specifically, it is either an identifier of a command or an identifier of an instruction to a medical professional. It is desirable for the instruction ID to be an ID system capable of identifying both of these. It is desirable for the instruction ID to be composed of a combination of letters or numbers, and for the number of digits to be small. (D83) Content of instructions: The content of the instructions.

[0105] Fig. 40 shows a specific example of a record in the instruction information database 452. In this figure, an instruction for the analysis device 2 with the device ID "F5659" is shown as an example.

[0106] The user attribute database 453 is a database, for example an RDB, that stores information about the service staff who are users of the management device 4. Fig. 41 is a diagram showing an example of a data structure when the user attribute database 453 is an RDB. As shown in the figure, the user attribute database 453 stores, for example, the following information (D91) to (D97) in association with each other. (D91) User ID: An identifier for the service staff. (D92) User name: The name of the service staff. (D93) Password: This is the password used by the service staff to log in to the management device 4. (D94) Medical facility: The name of the medical facility in which the analysis device 2 to be associated with the service staff is installed. (D95) Destination: Information indicating the destination of data sent from the service staff to the medical staff. For example, the communication address of the terminal 3. (D96) Device ID: An identifier of the analysis device 2 to be associated with the service staff. (D97) Model name: The model name of the analytical device 2 to be associated with the service staff.

[0107] Returning to FIG. 37, the processor 46B is a control unit that controls the functions of the management device 4. The processor 46B is, for example, a CPU. The processor 46B may be realized by, for example, a logic circuit. The processor 46B reads out the application 461B from the storage device 45B, expands it in the RAM 47, and executes it. The application 461B is stored in, for example, the storage device 45B as a program for causing the computer to function as a control unit that executes various processes.

[0108] [Example of application 461B configuration] 42 shows an example of the configuration of the application 461B. The application 461B includes, for example, an instruction information generating unit 463.

[0109] The processor 46B generates an instruction information creation screen 4631 in accordance with an instruction from 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 is a diagram showing an example of the instruction information creation screen 4631. As shown in FIG. 43, the instruction information creation screen 4631 includes, for example, fields 901 to 904 and a button 905.

[0110] The field 901 displays, for example, information about a user who is logged in to the management device 4. The information displayed in the field 901 is obtained from the user attribute database 453.

[0111] The field 902 displays, for example, the status of the analyzer 2. In the illustrated example, "RBC detection unit clogged" is displayed as the status of the analyzer 2. The displayed status may be transmitted from the terminal 3 that reads the information code in which the status of the analyzer 2 is recorded (see the third embodiment described later), or may be a status heard by a service staff member from a medical professional and input from the operation device 43.

[0112] The field 903 accepts the selection of an instruction and the execution order of the selected instruction. The instruction candidates are obtained from the instruction information database 452. In the example shown in the figure, two commands, "remove clog" and "continuous blank check", are selected as instructions, and the execution order of "remove clog" is set to be the first (primary response) and the execution order of "continuous blank check" is set to be the second (secondary response). In this way, the service staff can select a desired instruction on the instruction information creation screen 4631. Furthermore, when the service staff wants to execute multiple commands consecutively as instructions to the analyzer 2, the service staff can select multiple desired commands collectively on the instruction information creation screen 4631 and specify the execution order of the commands. Therefore, the service staff can collectively instruct the analyzer 2 to execute each command in order, which a medical professional would have to execute, and can perform effective troubleshooting, etc.

[0113] The field 904 accepts input of a message related to the selected instruction. Examples of messages include matters related to the process to be executed by the analysis device 2, matters to be notified to medical personnel, matters to be performed by medical personnel, etc. A message predetermined for each instruction may be displayed in an editable manner in the field 904.

[0114] When an operation is accepted by the button 905, the processor 46B creates data (hereinafter referred to as instruction data) including the information input in the fields 903 to 904 in accordance with an instruction from the instruction information creation unit 463, and transmits the created instruction data to the terminal 3. The destination is obtained from the user attribute database 443.

[0115] An example of information included in the instruction data is shown below in (D101) to (D104). (D101) is a required item, and (D102) to (D104) are optional items. (D101) The instruction ID of the instruction selected in field 903, and sequence information indicating the execution sequence of the instructions. Note that the order of the instruction IDs in the instruction data may be regarded as the sequence information, or data indicating the sequence information may be included. (D102) The message entered in field 904. (D103) The device ID and / or model name of the analytical device 2 to be instructed. This information can be used to prevent the wrong analytical device 2 from being selected as the instructed device. (D104) Issue date and / or expiration date of the instruction data. The issue date and time is the creation date and time of the instruction data, and the expiration date is a predetermined time after the issue date and time (e.g., 30 minutes). This information can be used to prevent the reuse and unauthorized use of the instruction data.

[0116] [Example of terminal 3 configuration] As shown in FIG. 44, the terminal 3 according to this embodiment has the same configuration as the terminal 3 according to the first embodiment, except that the terminal 3 includes a processor 36B instead of the processor 36A.

[0117] The processor 36B is a control unit that controls the functions of the terminal 3. The processor 36B is, for example, a CPU. The processor 36B may be realized by, for example, a logic circuit. The processor 36B reads out the application 361B from the storage device 35A, expands it in the RAM 37, and executes it. The application 361B is stored, for example, in the storage device 35A as a program for causing the computer to function as a control unit that executes various processes.

[0118] [Example of application 361B configuration] 45 shows an example of the configuration of the application 361B. The application 361B includes, for example, a reading / transmitting unit 362 and a display control unit 364.

[0119] When receiving the instruction data from the management device 4, the processor 36B executes a display control process in accordance with an instruction from the display control unit 364. In the display control process, the following (display control process 1) and (display control process 2) are performed.

[0120] (Display control process 1) If 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 .

[0121] (Display control process 2) If the instruction ID included in the instruction data is an identifier of an instruction to a medical worker, a screen corresponding to the instruction ID is displayed on the output device 34.

[0122] [Example of screen and information code] FIG. 46 is an example of a screen displayed by the display control process 1 when instruction data including the instruction IDs "B1002" (ie, removal) and "B1003" (continuous blank check) is received.

[0123] Field 911 displays a message. This message is a message input on instruction information creation screen 4631 shown in Fig. 43. By displaying a message in this manner, for example, it is possible to inform a medical professional of the instruction content, or to contact the medical professional about matters to be carried out other than having the analysis device 2 read the information code, thereby enabling reliable troubleshooting, etc.

[0124] Field 912 displays an information code. This information code is an information code for executing "removal of insufficient space" and "continuous blank check" selected in this order on instruction information creation screen 4631 shown in Fig. 43. Information recorded in this information code is, for example, as shown in (D111) to (D116) below. Data of this information in CSV format is recorded in the information code. (D111) First code type: One example is "Instruction". (D112) Secondary code type: Not used. An example is a NULL value. (D113) Date and time information: Date and time information included in the instruction data (issue date and time and / or expiration date). (D114) Model name: The model name included in the instruction data. (D115) Apparatus ID: An identifier of the analysis apparatus 2 included in the instruction data. (D116) Data body: One or more instruction IDs included in the instruction data.

[0125] Specific examples of data recorded in the information code are shown below. "Instruction,,2023 / 04 / 11 17:59:22,XQ-320,F5659,B1002,B1003".

[0126] 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 IDs "B1002" and "B1003" are shown in CSV format. Since the character string "Instruction" is stored in the first code type, the analysis device 2 recognizes that this information code contains an instruction. The model name and the device ID are used to confirm that the analysis device 2 is the target of the instruction. If the model name and the device ID included in the read information code do not match 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 IDs indicates the execution order. Since "B1002" (i.e. removal) and "B1003" (continuous blank check) are recorded in this order, the analysis device 2 that reads the information code executes the commands in this order. In the example of Fig. 46, the analyzer 2 that reads the illustrated information code performs a continuous blank check after performing removal. Even when the analyzer 2 is made to perform multiple processes in this way, it is sufficient to read the information code only once. In other words, there is no need to make the analyzer 2 read the information code multiple times, which simplifies the operation of medical personnel.

[0127] 47 is another example of a screen displayed by the display control process 1 when command data including the command ID "S4099" (turn off the blood suction sensor) is received. Field 914 displays an information code for turning off the blood suction sensor of the analyzer 2. A specific example of the data recorded in this information code is shown below. "Instruction,,2023 / 04 / 11 17:59:22,XQ-320,F5659,S4099" 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" (turn off the blood suction sensor) are shown in CSV format. When the analyzer 2 reads this information code, it turns off the blood suction sensor.

[0128] 48 is another example of a screen displayed by the display control process 1 when command data including the command ID "S1181" (turn off screen lock) is received. Field 916 displays an information code for turning off the screen lock of the analysis device 2. A specific example of the data recorded in this information code is shown below. "Instruction,,2023 / 04 / 11 17:59:22,XQ-320,F5659,S1181" 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 displayed in CSV format. When the analysis device 2 reads this information code, it switches the screen lock function off.

[0129] 49 is another example of a screen displayed by the display control process 1 when command data including the command ID "X882" (read error history) is received. Field 918 displays an information code for executing a process to extract the most recent error history from the analysis device 2. A specific example of the data recorded in this information code is shown below. "Instruction,,2023 / 04 / 11 17:59:22,XQ-320,F5659,X882" 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" (reading error history) are shown in CSV format. When the analysis device 2 reads this information code, it reads the most recent error history stored in the analysis device 2, creates and displays an information code based on the information of the read error history (see FIG. 60 for a screen example). After the user has the analysis device 2 read the information code of FIG. 49, the user operates the "camera start" button displayed on the screen of the terminal 3. When the camera is started, the user can take an image of the information code based on the information of the error history by the terminal 3 and transmit it to the management device 4.

[0130] FIG. 50 is an example of a screen displayed by the display control process 2 when instruction data including instruction ID "Q220" (perform quality control measurement) is received. In this example screen, instructions for the medical staff are displayed to perform quality control measurement and to read the information code displayed on the analysis device 2 as the quality control result. The medical staff operates the analysis device 2 in accordance with these instructions. FIG. 51 shows an example of a screen of the analysis device 2 that displays the information code in which the quality control result is recorded after the analysis device 2 performs quality control measurement. The medical staff reads the information code with the imaging device 32 of the terminal 3.

[0131] [Configuration example of analysis device 2] As shown in FIG. 52, the analysis device 2 of this embodiment has the same configuration as the analysis device 2 of embodiment 1, except that it has a memory device 25B (memory unit) and a processor 26B instead of the memory device 25A and the processor 26A, and further has a reading unit 29 or can be attached.

[0132] The reading unit 29 is a reader for optically reading the information code displayed on the output device 34 of the terminal 3. The reading unit 29 may be a handheld type to facilitate the reading operation of medical staff.

[0133] 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. As shown in Fig. 53, the storage device 25B stores, for example, an apparatus attribute database 251, a quality control database 252, a command information database 253, an error history database 254, and a service data information database 255.

[0134] The command information database 253 is a database, for example an RDB, that stores commands executable by the analysis device 2. Fig. 54 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 association with each other. (D121) Command ID: This is an identifier of a command. This corresponds to the identifier of a command among the command IDs stored in the command information database 452 of the management device 4. (D122) Process: One process or a set of multiple processes corresponding to the command ID.

[0135] FIG. 55 shows a specific example of a record in the command information database 253.

[0136] The error history database 254 is a database, for example an RDB, that stores history of errors that have occurred in the analyzer 2. Errors include, for example, abnormalities and warnings related to pressure, temperature, reagents, motors, specimen measurement, covers, maintenance, sampler measurement operations, etc. A specific example of an error is an RBC detector, i.e., an abnormal drop in pressure, etc. FIG. 56 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 association with each other. (D131) Error ID: An identifier given to each error. (D132) Date and time of occurrence: The date and time when the error occurred. (D133) Error code: An identifier indicating the type of error. The error code is displayed on the display / operation device 24, for example, when an error occurs. (D134) Error message: A message showing an outline of the error. The error message is displayed on the display / operation device 24, for example, when an error occurs.

[0137] Figure 57 shows a specific example of a record in the error history database 254. Two records are shown in the figure. The record at the top of the figure shows the history of occurrences of "RBC detector clogging." The record at the bottom of the figure shows the history of occurrences of "abnormal pressure drop."

[0138] The service data information database 255 is a database, for example an RDB, that stores various information collected by the analysis device 2 or various parameters set in the analysis device 2 (hereinafter, these are referred to as "service data"). An example of hardware-related service data stored in the service data information database 255 is shown below. Number of unit operations (e.g., total, periodic wash, piercer, whole blood aspiration motor, air pump, pinch valve, etc.) -Various pressure data (positive pressure, negative pressure) ·Environmental temperature Data from sensors used to monitor each part (e.g., blood suction sensor, WBC / HGB detection sensor, RBC detection sensor, MIX chamber detection sensor) An example of the blood cell count measurement-related service data stored in the service data information database 255 is shown below. Sampling data to monitor noise (e.g., particle counts in the RBC / PLT channels at regular intervals) Reference data (e.g., red blood cell volume mode, platelet volume mode, mean large red blood cell volume of RBC bimodal distribution, mean small red blood cell volume of RBC bimodal distribution, large red blood cell count with RBC bimodal distribution, small red blood cell count with RBC bimodal distribution) Position of the discriminator in the RBC size distribution (e.g., the lower limit of the red blood cell region in the RBC size distribution, the valley between two peaks in the RBC size distribution, the upper limit of the red blood cell region in the RBC size distribution) Position of the discriminator in the PLT size distribution (e.g., the lower limit of the red blood cell region in the PLT size distribution, the upper limit of the red blood cell region in the RBC size distribution) Hemoglobin measurements (e.g. A / D converted optical density of sample, A / D converted optical density of blank) Particle size distribution anomaly flag Values ​​related to RBC measurement (e.g., the value electrically detecting the degree of clogging of the RBC detector, the number of bubbles in the RBC detector) Returning to FIG. 52, the processor 26B is a control unit that controls the overall functions of the analysis device 2. The processor 26B is, for example, a CPU. The processor 26B may be realized by, for example, a logic circuit. The processor 26B reads out the application 261B from the storage device 25B, expands it in the RAM 27, and executes it. The application 261B is stored, for example, in the storage device 25B as a program for causing a computer to function as a control unit that executes various processes.

[0139] [Example of application 261B configuration] 58 shows an example of the configuration of application 261B. Application 261B includes quality control measurement section 262, specimen measurement section 263, and information extraction section 264, as well as reading execution section 265, for example.

[0140] Processor 26B executes (Process P1) shown below based on the information read from the information code by reading unit 29 in accordance with an instruction from reading execution unit 265. Before executing (Process P1), (Process P2) and / or (Process P3) may be executed.

[0141] (Process P1) The processor 26B determines the type of information recorded in the information code based on the "first code type" and "second code type" included in the read information. If the first code type is "Instruction", the processor 26B identifies the process corresponding to the instruction ID included in the read information by referring to the command information database 253, and controls each part of the analysis device 2 to execute the identified process.

[0142] If the identified process is to read out quality control history, processor 26B executes quality control information extraction process in accordance with instructions from information extraction unit 264. In quality control information extraction process, quality control results that match predetermined extraction conditions (for example, quality control results obtained in the most recent week) are obtained from quality control database 252, an information code is created that can read each of the obtained quality control results or values ​​calculated based on these (such as statistical values), and the created information code is displayed on display / operation device 24. An example of the screen displayed in this case is shown in FIG. 59. The quality control results that match the predetermined extraction conditions are one piece of management information that should be obtained by management device 4.

[0143] If the identified process is reading out an error history, processor 26B executes an error history extraction process in accordance with an instruction from information extraction unit 264. In the error history extraction process, error histories that match a predetermined extraction condition are obtained from error history database 254 (for example, error histories obtained in the past week, error histories that are permitted to be output by user settings, etc.), an information code capable of reading each of the obtained error histories is created, and the created information code is displayed on display / operation device 24. An example of a screen displayed in this case is shown in FIG. 60. The error histories that match the predetermined extraction condition are management information that should be obtained by management device 4.

[0144] If the identified process is reading of service data, processor 26B executes service data extraction process according to an instruction from information extraction unit 264. In the service data extraction process, service data that matches a predetermined extraction condition (e.g., predetermined service data, service data that is permitted to be output by user settings, etc.) is obtained from service data information database 255, an information code capable of reading each of the obtained service data is created, and the created information code is displayed on display / operation device 24. An example of a screen displayed in this case is shown in Fig. 61. The service data that matches the predetermined extraction condition is one of the management information that should be obtained by management device 4.

[0145] (Process P2) The processor 26B may determine whether the device ID included in the read information matches the device ID stored in the device attribute database 251. If the device IDs match, the processor 26B may execute the reading process, and if the device IDs do not match, the processor 26B may cancel the reading process. This makes it possible to avoid a situation in which, for example, when multiple analysis devices 2 are installed in a medical facility, an information code that should be read by an original analysis device is mistakenly read by another analysis device, causing the other analysis device to execute a process that should not be executed. In other words, it is possible to prevent the wrong analysis device 2 from being selected to execute the process, making it possible to perform, for example, reliable troubleshooting. When canceling the reading process, the processor 26B may display a message indicating that the device IDs do not match on the display / operation device 24.

[0146] (Process P3) The processor 26B may determine whether the information code is valid based on the date and time information (issue date and time and / or expiration date) included in the read information. For example, if the difference between the issue date and time included in the read information and the current time is a predetermined time (e.g., 30 minutes) or more, the information code may be determined to be invalid. Also, for example, if the expiration date included in the read information has passed, the information code may be determined to be invalid. If the information code is determined to be valid, the processor 26B may execute the read process, and if the information code is determined to be invalid, the processor 26B may stop the read process. This makes it possible to prevent the reuse of information codes used in the past. Therefore, for example, it is possible to prevent a user from obtaining information that can only be obtained in the service mode for fraudulent purposes, or from having the analysis device 2 execute a process that can only be executed in the service mode without the permission of the service staff. When the read process is stopped, the processor 26B may display a message indicating that the information code is invalid on the display / operation device 24.

[0147] [Example of processing flow] FIG. 62 is a flowchart showing an example of a process flow in which the management device 4 causes the analysis device 2 to execute a process via the terminal 3. The processor 46A of the management device 4 accepts an instruction, for example, on the instruction information creation screen 4631 (S41), and transmits instruction data to the terminal 3 (S42). The processor 36A of the terminal 3 receives the instruction data (S43), creates, for example, an information code capable of reading the instruction data, and displays it on the output device 34 (S44, display step). In other words, in step S44, the processor 36A presents information on the process to be executed by the analysis device 2 on the output device 34 (presentation step). The processor 26A of the analysis device 2 reads the information code (S45, reading step), and executes a process according to the instruction included in the read information (S46, execution step). In this way, the medical staff can cause the analysis device 2 to execute a process based on an instruction from the service staff, simply by performing a simple operation of causing the analysis device 2 to read the information code displayed on the terminal 3. In addition, service staff can have the analysis device 2 execute processing without having to communicate with medical personnel over the phone or visiting the medical facility, thereby enabling maintenance operations to be carried out efficiently and quickly.

[0148] FIG. 63 shows a modified example of the flowchart shown in FIG. 62. In this modified example, S47 to S50 are added. After executing the process in S46, the processor 26A of the analysis device 2 causes the display / operation device 24 to display, for example, a readable information code showing the quality control result (S47, preparation step). The processor 36A of the terminal 3 reads the information code with the imaging device 32 (S48) and transmits 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 staff can receive, for example, the quality control result in S50 as a result of the instruction given in S41, and thus can carry out flexible maintenance operations, such as giving further instructions while checking the state of the analysis device 2 after the instruction. Note that, when the amount of data to be sent from the analysis device 2 to the terminal 3 is large, instead of reading the information code in S47 to S48, information may be transmitted from the analysis device 2 to the terminal 3 by short-range wireless communication such as Bluetooth as described in the first embodiment.

[0149] [Embodiment 3] The same configurations and processes as those described in the above-mentioned embodiment are denoted by the same reference numerals, and the description thereof will be omitted.

[0150] In this embodiment, information on an error that has occurred in the analyzer 2 (hereinafter referred to as "error information") is sent to the management device 4 via the terminal 3. As described in the second embodiment, an error is, for example, an abnormality or warning related to pressure, temperature, reagent, motor, specimen measurement, cover, maintenance, sampler measurement operation, etc. A specific example of an error is an RBC detector, i.e., an abnormal drop in pressure, etc. According to this embodiment, error information stored in the analyzer 2 that operates in an environment in which communication with devices outside the medical facility cannot be performed can be sent to the management device 4. Moreover, this can be performed by a simple operation of reading the information code without any erroneous operation, so that even medical personnel who are not familiar with the handling of the analyzer 2 can easily perform it. In addition, even if a medical personnel does not tell the service staff about the error information of the analyzer 2 by phone or the like, the service staff can accurately know the error information and can perform reliable troubleshooting, etc.

[0151] [Configuration example of analysis device 2] As shown in FIG. 64, the analysis device 2 according to this embodiment has the same configuration as the analysis device 2 according to the second embodiment, except that the analysis device 2 according to this embodiment includes a processor 26C instead of the processor 26B.

[0152] The processor 26C is a control unit that controls the functions of the analysis device 2. The processor 26C is, for example, a CPU. The processor 26C may be realized by, for example, a logic circuit. The processor 26C reads out the application 261C from the storage device 25B, expands it in the RAM 27, and executes it. The application 261C is stored, for example, in the storage device 25B as a program for causing a computer to function as a control unit that executes various processes.

[0153] [Example of application 261C configuration] 65 shows an example of the configuration of application 261C. Application 261C includes quality control measurement section 262, specimen measurement section 263, information extraction section 264, and reading execution section 265, as well as error information notification section 266, for example.

[0154] Processor 26C executes error information extraction processing in accordance with an instruction from error information notification unit 266. A typical example of a trigger for executing error information extraction processing is when an error occurs, but may be when a predetermined input operation is received by display / operation device 24.

[0155] A typical example of the error information extraction process is to obtain error histories (for example, one or more most recently occurred errors) that meet predetermined extraction conditions from the error history database 254, create an information code capable of reading the obtained error history, and display the created information code on the display / operation device 24. Information recorded in the information code created by the error information extraction process is, for example, as shown in (D141) to (D146) below. Data in CSV format of this information is recorded in the information code. (D141) First code type: "Error" as an example. (D142) Secondary code type: Not used. An example is a NULL value. (D143) Date and time information: The date and time when the information code was created. (D144) Model name: the model name of the analytical device 2 that created the information code. This is obtained from the device attribute database 251. (D145) Device ID: the identifier of the analysis device 2 that created the information code. This is obtained from the device attribute database 251. (D146) Data body: Information about the error. Specifically, the data includes the date and time the error occurred, the error code, and the error message. The data is obtained from the error history database 254.

[0156] [Screen example] FIG. 66 shows an example of a screen that the error information notification unit 266 causes the display / operation device 24 to display when an "RBC detection unit blockage" occurs.

[0157] When an operation is accepted by the button 1001, the processor 26C controls each part of the analyzer 2 to execute a preset operation for clearing the blockage of the RBC detection part. This allows a medical professional to first try to clear the error by himself / herself without assistance from a service staff, for example, when the blockage of the RBC detection part occurs for the first time on the day.

[0158] When an operation is accepted by the button 1002, the processor 26C executes an error information extraction process according to an instruction from the error information notification unit 266, and causes the display / operation device 24 to display the created information code. Fig. 67 is a diagram showing an example of a screen displaying the created information code. This allows the medical staff to be notified of the error information via the terminal 3 in cases where the medical staff needs support from a service staff member, such as when the medical staff member is unable to clear a clogged RBC detection unit by himself / herself.

[0159] Specific examples of data recorded in this information code are shown below. "Error,,2023 / 04 / 11 17:59:22,XQ-320,F5659,2023 / 03 / 30 16:28:00,311240" In this specific example, the first code type "Error", 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", the date and time the error occurred "March 30, 2023, 16:28:00", and the error code "311240" (RBC detection section) are displayed in CSV format.

[0160] After the terminal 3 reads the information code and transmits the read information to the management device 4, it is desirable for the terminal 3 to receive a receipt notice from the management device 4 as a response. This allows the medical staff to recognize that they have been able to notify the service staff of the error information. Figure 68 is an example of a screen displaying the receipt notice on the terminal 3.

[0161] Figure 69 is a diagram showing an example of a screen displaying an information code that is created when a "short sample (insufficient blood volume)" occurs. Specific examples of data recorded in this information code are shown below. "Error,,2023 / 04 / 11 17:59:22,XQ-320,F5659,2023 / 03 / 30 16:28:00,228239" In this specific example, the first code type "Error", 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", the date and time the error occurred "March 30, 2023, 16:28:00", and the error code "228239" (short sample) are shown in CSV format.

[0162] [Processing flow] 70 is a flow chart showing an example of the flow of a process for sending information about an error that has occurred 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 executes an error information extraction process and causes the display / operation device 24 to display an information code from which the error information can be read (S52, preparation step). The terminal 3 reads the information code with the imaging device 32 (S53) and transmits the read information to the management device 4 (S54). The management device 4 receives the information (S55), and the service staff takes action based on the information.

[0163] Fig. 71 shows an example in which the flowchart shown in Fig. 70 is expanded. In this example, after S55, S41 to S46 shown in Fig. 62 and described in the second embodiment are carried out. As an example of the action taken by the service staff, an instruction for dealing with the error is received in the management device 4, for example, on the instruction information creation screen 4631 shown in Fig. 43 (S41), and the instruction data is transmitted to the terminal 3 (S42).

[0164] As an example of how to deal with the case where error information regarding a clog in the RBC detection unit is received in S55, in S41, input of instructions to execute "clogging removal" and "continuous blank check" in the analyzer 2 is accepted using the instruction information creation screen 4631. Note that in this case, it is desirable that the field 902 on the instruction information creation screen 4631 displays "RBC detection unit clogged" as the status of the analyzer 2, as shown in FIG.

[0165] As another example of how to deal with the case where error information related to a short sample is received in S55, in S41, input of an instruction to cause the analyzer 2 to execute "turn off the blood suction sensor" is accepted using the instruction information creation screen 4631. Note that in this case, it is desirable that the field 902 on the instruction information creation screen 4631 displays "short sample" as the status of the analyzer 2.

[0166] The terminal 3 receives the instruction data (S43) and causes the output device 34 to display an information code from which the instruction data can be read (S44). The processor 26C of the analysis device 2 reads the information code (S45) and executes processing according to the read information (S46). Through the above process, the service staff who received the error information can cause the analysis device 2 to execute a command for dealing with the error.

[0167] [Variation 1] 71, instead of receiving instructions for dealing with the error from the service staff, the management device 4 may automatically determine the instructions. Specifically, the management device 4 may store a database in which error information and instructions are associated with each other in the storage device 25B, and automatically determine instructions corresponding to the information received in S55 by referring to the database.

[0168] [Variation 2] In the case of performing the automation described in the above modified example 1, the operating subject that determines the instruction may be the terminal 3. Specifically, the storage device 35A of the terminal 3 may store a database in which error information and instructions are associated with each other, and the terminal 3 may determine an instruction corresponding to the information read in S53 by referring to the database.

[0169] [Embodiment 4] The same configurations and processes as those described in the above-mentioned embodiment are denoted by the same reference numerals, and the description thereof will be omitted.

[0170] In this embodiment, information stored in the analysis device 2 is extracted and sent to the management device 4 via the terminal 3. The trigger for executing the process of extracting 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. This allows a medical professional to cause the analysis device 2 to execute the information extraction process voluntarily or when requested by a service staff member over the phone or the like.

[0171] For example, when a predetermined input operation is received by the display / operation device 24, the processor 26B executes an information extraction process according to an instruction from the information extraction unit 264, and causes the display / operation device 24 to display the created information code. Fig. 72 is a diagram showing an example of a screen for selecting information to be extracted. The screen may be transitionable from a menu screen. In the example shown in the figure, buttons 1101 to 1103 are provided as a menu for selecting one of quality control history, error history, and service data.

[0172] When an operation is accepted by button 1101, processor 26B acquires quality control results that meet predetermined extraction conditions from quality control database 252, creates an information code that can read each of the acquired quality control results or values ​​calculated based on these (such as statistical values), and displays the created information code on display / operation device 24. An example of the screen displayed in this case is similar to that shown in FIG.

[0173] When an operation is accepted by the button 1102, the processor 26B acquires error histories that meet a predetermined extraction condition from the error history database 254, creates a readable information code for each of the acquired error histories, and displays the created information code on the display / operation device 24. An example of the screen displayed in this case is the same as that shown in FIG.

[0174] When an operation is accepted by the button 1103, the processor 26B acquires service data that meets a predetermined extraction condition from the service data information database 255, creates a readable information code for each of the 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 similar to that shown in FIG.

[0175] FIG. 73 is a flowchart showing an example of the flow of the information extraction process. When the processor 26B of the analysis device 2 accepts an input operation for creating an information code (S61), it displays an information code capable of reading information corresponding to the input operation on the display / operation device 24 (S62, preparation step). The terminal 3 reads the information code with the imaging device 32 (S63) and transmits the read information to the management device 4 (S64). The management device 4 receives the information (S65), and the service staff performs maintenance operations and the like based on the information. Note that when the amount of data to be sent from the analysis device 2 to the terminal 3 is large, instead of reading the information code in S62 to S63, information may be transmitted from the analysis device 2 to the terminal 3 by short-range wireless communication such as Bluetooth as described in the first embodiment.

[0176] The present invention is not limited to the above-described embodiments, and various modifications are possible within the scope of the claims. Embodiments obtained by appropriately combining the technical means disclosed in different embodiments are also included in the technical scope of the present invention. [Explanation of symbols]

[0177] 1 Management Support System 2 Analyzer 3. Terminal 4 Management Devices

Claims

1. A maintenance method for an analytical device that is not communicatively connected to a network outside a facility, comprising the steps of: a presentation step of presenting information regarding the process to be executed by the analysis device on a terminal communicatively connected to a network outside the facility; a reading step of reading the information presented by the terminal with the analysis device; an execution step of executing the process indicated by the read information in the analysis device; (c) a method of maintenance.

2. The maintenance method according to claim 1 , wherein the presenting step includes displaying an optically readable information code including the information.

3. The maintenance method according to claim 1 , wherein the information includes a set of a plurality of the processes.

4. the information includes sequence information indicating an execution sequence of the plurality of processes; The maintenance method according to claim 1 , wherein the execution step includes executing the plurality of processes in the analyzer according to an execution order indicated by the read order information.

5. The maintenance method according to claim 1 , wherein the process includes a process that cannot be executed in a user mode of the analytical device but can be executed in a service mode of the analytical device.

6. the information includes an ID for identifying a command corresponding to the process; The maintenance method according to claim 1 , wherein the execution step executes the process corresponding to the read ID in the analyzer.

7. The information includes an ID of the analysis device, The execution step includes: The analysis device determines whether the read ID matches an ID stored in the analysis device; The maintenance method according to claim 1 , further comprising the step of: executing the process in the analysis device when the two match.

8. the information code includes date and time information indicating at least one of an issue date and an expiration date of the information code, The execution step includes: determining whether the information code is valid based on the date and time information read from the information code by the analysis device; The maintenance method according to claim 2 , further comprising the step of: executing the process in the analysis device if the information code is valid.

9. The execution step includes:

9. The maintenance method according to claim 8, further comprising the steps of: if the information code is invalid, the process is not executed by the analysis device, and a message indicating that the information code is invalid is displayed by the analysis device.

10. displaying, on the analysis device, an information code capable of reading the information stored in the analysis device; reading the information code at the terminal; transmitting information read from the information code from the terminal to a management device that is not communicatively connected to the analysis device but is communicatively connected to the terminal; receiving, by the management device, input of one or more of the processes corresponding to the transmitted information; The maintenance method of claim 1 , comprising:

11. The method further includes a step of transmitting information indicating a process for which the input has been received from the management device to the terminal; The maintenance method according to claim 10 , wherein the presenting step displays, on the terminal, the information code from which information indicating the process for which the input has been accepted can be read.

12. The execution step includes, after the process is executed by the analysis device, displaying, on the analysis device, a readable information code indicating information on quality control obtained by the analysis device; reading the information code at the terminal; The maintenance method according to claim 10, further comprising the step of: transmitting the information read from the information code to the management device.

13. The maintenance method according to claim 1 , wherein the analytical device is not connected to the Internet.

14. 2. The maintenance method according to claim 1, wherein the terminal is connected to the Internet via a mobile communication network.

15. The maintenance method according to claim 1 , wherein the terminal is a smartphone or a tablet terminal.

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