Sample measurement system and sample measurement device

Abstract

A sample measurement system and a sample measurement apparatus are provided. The sample measurement system includes a measurement unit (2) for measuring a sample, and a control unit (7) for analyzing measurement data of the measurement unit (2), the measurement unit including: a first reagent container (230) that contains a first reagent containing a substance that binds to a substance to be measured in the sample; a sample processing section (21) that mixes the first reagent and the sample to prepare a measurement sample; and a detection section (22) for detecting the substance to be measured by measurement of the measurement sample; the measurement unit is disposed on a housing (24) that contains a second reagent container (240), the second reagent container containing a second reagent used for at least one of cleaning of a flow path within the measurement unit, dilution of the sample, preparation of the measurement sample, measurement of the measurement sample by the detection section, the control unit including a reagent management section (702) that manages a number of replacements of the second reagent container based on a remaining amount of the second reagent container.

Description

[Technical Field] This invention relates to a system for performing sample measurements, etc. [Background Technology] In recent years, there has been a demand for various measures to reduce environmental impact. These measures include recycling used products and turning them into resources to manufacture new products (so-called recycling). Patent Document 1 discloses a technology that identifies the plastic composition of beverage bottles, which are plastic products, and determines whether the plastic product can be recycled.

[0003] [Existing Technical Documents] [Patent Literature] [Patent Document 1] Japanese Patent Publication No. 2022-525396 [Summary of the Invention] [The problem the invention aims to solve] To achieve global goals of reducing environmental impact (e.g., the SDGs: Sustainable Development Goals), mechanisms for managing product recycling are needed, even in the field of sample testing. Patent Document 1 discloses technology related to the recycling of beverage bottles, but does not disclose mechanisms for managing recycling related to sample measuring devices used for analyzing samples.

[0004] [Problem-solving methods] A sample measurement system (1) of the present invention includes a measurement unit (2) for measuring a sample and a control unit (7) for analyzing the measurement data of the measurement unit (2). The measurement unit (2) includes: a first reagent container (230) for containing a first reagent containing a substance that binds to the analyte in the sample; a reagent preparation unit (23) for preparing the first reagent container (230); a sample processing unit (21) for mixing the first reagent and the sample to prepare a measurement sample; and a detection unit (22) for detecting the analyte by measuring the measurement sample. The measurement unit (2) is disposed on a housing (24) containing a second reagent container (240). The reagent container (240) contains a second reagent used to perform at least one of the following: (1) cleaning the flow path in the measurement unit (2), (2) diluting the sample, (3) preparing the measurement sample, and (4) measuring the measurement sample by the detection unit (22). The second reagent container (240), housed in the housing (24), is connected to the measurement unit (2) via an infusion tube (241). The control unit (7) includes: an analysis unit (700) that generates a measurement result by analyzing the measurement data obtained by the detection unit (22); and a reagent management unit (702) that manages the number of times the second reagent container (240) is replaced based on the remaining amount in the second reagent container (240).

[0005] Another aspect of the present invention is a sample measuring device (11) comprising a measuring unit (2) for measuring a sample and a control unit (7) for analyzing the measurement data of the measuring unit (2). The measuring unit (2) comprises: a first reagent container (230) containing a first reagent containing a substance that binds to the analyte in the sample; a reagent preparation unit (23) for preparing the first reagent container (230); a sample processing unit (21) for mixing the first reagent and the sample to prepare a measurement sample; and a detection unit (22) for detecting the analyte by measuring the measurement sample. The measuring unit (2) is disposed on a housing (24) containing a second reagent container (240). The second reagent container (240) contains a second reagent used to perform at least one of the following: (1) cleaning the flow path in the measurement unit (2), (2) diluting the sample, (3) preparing the measurement sample, and (4) measuring the measurement sample by the detection unit (22). The second reagent container (240) housed in the housing (24) is connected to the measurement unit (2) via an infusion tube (241). The control unit (7) includes: an analysis unit (700) that generates a measurement result by analyzing the measurement data obtained by the detection unit (22); and a balance management unit (701) that manages the balance of the second reagent container (240) in order to manage the number of times the second reagent container (240) is replaced.

[0006] [The effects of the invention] According to the present invention, it is possible to manage the recycling of the sample measurement device. [Image Description] Figure 1 This is a diagram illustrating the general outline of reagent container recycling.

[0008] Figure 2 This is a diagram illustrating an example of the configuration of a sample measuring device.

[0009] Figure 3 This is a diagram illustrating an example of the configuration of a sample measuring device.

[0010] Figure 4 This is a diagram illustrating an example of the configuration of a sample measurement system.

[0011] Figure 5 This is a diagram illustrating an example of the configuration of a sample measurement system.

[0012] Figure 6 This is a diagram illustrating an example of the configuration of a sample measuring device.

[0013] Figure 7 This is a diagram illustrating an example of the configuration of a sample measurement system.

[0014] Figure 8This is a diagram showing an example of the structure of a reagent container.

[0015] Figure 9 This is a diagram illustrating an example of the configuration of a sample measuring device.

[0016] Figure 10 This is a diagram illustrating an example of the configuration of a sample measuring device.

[0017] Figure 11 This is a diagram showing an example of the structure of a reagent supply department.

[0018] Figure 12 This is a diagram showing an example of the structure of a reagent supply department.

[0019] Figure 13 This is a flowchart illustrating an example of the actions taken by the margin management department.

[0020] Figure 14 This is a flowchart illustrating an example of the actions taken by the margin management department.

[0021] Figure 15 This is a diagram illustrating an example of the configuration of a sample measuring device.

[0022] Figure 16 This is a diagram showing an example of the structure of a reagent container.

[0023] Figure 17 This is a flowchart illustrating an example of the actions taken by the reagent management department.

[0024] Figure 18 It is a diagram showing the components of a sample measurement system.

[0025] Figure 19 This is a diagram illustrating an example of computer configuration.

[0026] Figure 20 This is a diagram illustrating the configuration of a sample measurement system, as shown in Example 1.

[0027] Figure 21 This is a diagram illustrating the configuration of a sample measurement system, as shown in Example 2.

[0028] Figure 22 This is a diagram illustrating the configuration of a sample measurement system, as shown in Example 3.

[0029] Figure 23 This is a diagram illustrating the configuration of a sample measurement system, as shown in Example 4.

[0030] Figure 24 This is a diagram illustrating the configuration of a sample measurement system, as shown in Example 5.

[0031] Figure 25 This is a diagram illustrating the configuration of a sample measurement system, as shown in Example 6.

[0032] Figure 26This is a diagram illustrating the configuration of a sample measurement system, as shown in Example 7.

[0033] Figure 27 This is a diagram illustrating an example of the hardware configuration of a control unit.

[0034] Figure 28 This is a diagram illustrating an example of the structure of control software and data management software.

[0035] Figure 29 This is a diagram showing a modified example of the configuration of a control unit.

[0036] Figure 30 This is a diagram illustrating an example configuration when the measuring unit is a blood cell analyzer.

[0037] Figure 31 This is a schematic diagram illustrating the sample aspiration section and sample preparation section when supplying measurement samples to the FCM (flow cytometry) detection unit.

[0038] Figure 32 This is a schematic diagram illustrating the sample aspiration section and sample preparation section when supplying measurement samples to the RBC (red blood cell) / PLT (platelet) detection unit.

[0039] Figure 33 This is a schematic diagram illustrating the sample aspiration section and sample preparation section when supplying measurement samples to the HGB (hemoglobin) detection unit.

[0040] Figure 34 This diagram illustrates an example of a device for measuring formed elements in urine.

[0041] Figure 35 This is a diagram showing an example of the structure of the detection unit.

[0042] Figure 36 This is a diagram illustrating an example configuration when the measuring unit is a blood coagulation analysis device.

[0043] Figure 37 This is a diagram showing an example of the configuration of the light irradiation section of the detection section.

[0044] Figure 38 This is a diagram showing an example of the configuration of an optical detection unit.

[0045] Figure 39 This is a diagram illustrating a configuration example where the measurement unit is an immunoassay device.

[0046] Figure 40 This is a diagram illustrating an example of the processing flow in the sample preparation section.

[0047] Figure 41 This is a diagram illustrating an example of interface construction.

[0048] Figure 42 This is a flowchart illustrating an example of the processing flow of the interface of a sample measurement device.

[0049] Figure 43 This is a diagram illustrating an example of the interface structure of a data management system.

[0050] Figure 44 This is a diagram illustrating an example of the data structure of an HTTP (Hypertext Transport Protocol) request body when updating batch information for precision management.

[0051] Figure 45 This is a diagram illustrating an example of a request for / response to a request for information related to a sample measurement device.

[0052] Figure 46 This is a diagram illustrating an example of a request for / response to a request for information related to sample measurement.

[0053] Figure 47 This is a diagram illustrating an example of a request for / response to a request for information related to the maintenance of a sample measuring device.

[0054] Figure 48 This is a diagram illustrating an example of a request related to the operation of a sample measuring device.

[0055] Figure 49 This diagram illustrates an example of the structure of a push notification from a sample measurement device to a data management system.

[0056] Figure 50 This is a diagram representing an example of an event and an example of the information corresponding to the event (the information that becomes the object of the PUSH notification).

[0057] Figure 51 This is a diagram illustrating an example of the application's structure.

[0058] Figure 52 This is a diagram illustrating a configuration example when used for reagent management applications.

[0059] Figure 53 This is a diagram illustrating an example of a GUI (Graphical User Interface) for displaying facilities on a map.

[0060] Figure 54 This is a diagram illustrating an example of a GUI that provides information related to reagent management.

[0061] Figure 55This is a diagram illustrating an example of a GUI that provides information related to reagent management.

[0062] Figure 56 This is a diagram illustrating how the functionality of an application is provided as a component of a web service.

[0063] Figure 57 This diagram illustrates how providing application functionality serves as another example of a network service.

[0064] Figure 58 This is another example of a network service that provides the functionality of an application.

[0065] Figure 59 This is a diagram illustrating the structure of an application server that provides applications.

[0066] Figure 60 This is a diagram illustrating an example of how applications can be provided in a secure communication environment.

[0067] Figure 61 This is a diagram illustrating an example of how applications can be provided using MDM (Mobile Device Management) or MAM (Mobile Application Management).

[0068] Figure 62 This is a diagram illustrating an example of the data structure when the database in an MDM / MAM system is a relational database. [Detailed Implementation] [First Implementation Method] In this embodiment, such as Figure 1 As shown in the example, containers containing reagents used by the sample measuring device 11 to measure samples are recovered from the facility 13 equipped with the sample measuring device 11. The recovered reagent containers are reused, and the reused reagent containers are used in the sample measuring device 11. For example, the recovered reagent containers are first crushed into granules. The granules are then reshaped into reagent containers as a recycled product. The reshaped reagent containers are reused as a recycled product.

[0070] The amount of reagent containers used as consumables in a facility 13 equipped with a sample measuring device 11 is important as an indicator of whether the facility 13, for example, in a medical institution, helps reduce environmental impact. In this embodiment, as described below, the amount of reagent containers reused can be determined based on the number of times the reagent containers of the sample measuring device 11 are replaced. That is, the amount of reused reagent containers is automatically determined based on the number of times they are replaced using the sample measuring system 1 of the sample measuring device 11. By automating the determination of reused reagent containers based on the number of replacements, the workload required for operators to manage the number of replacements or the amount of reused reagent containers can be reduced.

[0071] Figure 2 and Figure 3 An example of the sample measuring device 11 of this embodiment is shown.

[0072] like Figure 2 As illustrated, the sample measuring device 11 includes a measuring unit 2, a control unit 7, and a housing 24. The housing 24 can accommodate reagent containers. For example, a used reagent container is removed from the housing 24 and replaced with a new one. The used reagent container removed from the housing 24 is recycled for reuse. For example, the reagent manufacturer or a contractor commissioned by the reagent manufacturer may recycle the used reagent containers. The recycled reagent containers may be provided, for example, to a manufacturer that manufactures reagent containers as recycled products. The manufacturer may, for example, pulverize the recycled reagent containers and make them into granules. The manufacturer may, for example, shape the granules into reagent containers as recycled products.

[0073] Figure 3 The diagram shows an example of the configuration of the sample measuring device 11.

[0074] The measurement unit 2 includes a sample processing unit 21, a detection unit 22, a reagent preparation unit 23, and a first reagent container 230 disposed in the reagent preparation unit 23. The sample processing unit 21 prepares a measurement sample, for example, by mixing a first reagent contained in the first reagent container 230 with a sample. For example, a sample is drawn from the container containing the sample using a suction tube and provided to the sample processing unit 21. The prepared measurement sample is supplied to the detection unit 22. The detection unit 22 measures the analyte contained in the measurement sample. The reagent preparation unit 23 can be configured with multiple types of first reagent containers 230. For example, multiple types of first reagent containers 230 can be configured in the reagent preparation unit 23 according to the multiple types of measurement items that the sample measurement device 11 can measure.

[0075] A second reagent container 240 is disposed in the housing 24. The second reagent contained in the second reagent container 240 is supplied to the measuring unit 2 via an infusion tube 241. The second reagent contained in the second reagent container 240 is used, for example, to perform at least one of the following: (1) cleaning the flow path within the measuring unit, (2) diluting the sample, (3) preparing the measurement sample, and (4) measuring the measurement sample by the detection unit. The use of the second reagent is not limited to (1) to (4) above. The second reagent may, for example, be shared by multiple measuring operations corresponding to multiple types of first reagent containers 230.

[0076] The control unit 7 may consist of, for example, one or more computers. This computer may be, for example, connected to... Figure 19 The computer 900 shown has the same configuration. The control unit 7 includes an analysis unit 700 and a balance management unit 701. The analysis unit 700 and the balance management unit 701 are, for example, functional blocks implemented by the processor 71 of the computer 900, which is the control unit 7, expanding the program read from the storage unit 74 into the memory 72 and executing it. The analysis unit 700, for example, analyzes the measurement data obtained by the detection unit 22 measuring the measurement sample and generates a measurement result. The balance management unit 701, for example, manages the balance of the second reagent container 240. The balance management unit 701 may also manage the balance of the first reagent container 230. The reagent balance managed by the balance management unit 701 is used, for example, to manage the number of times the second reagent container is replaced. For example, if the balance of the second reagent container becomes a predetermined balance (e.g., the amount considered to be the amount of second reagent that is substantially not left in the container, the minimum amount required for the operation of the measuring unit 2, etc.), it is presumed that the second reagent container has been replaced. When it is presumed that the second reagent container has been replaced, the number of replacements is added up.

[0077] For example, the second reagent container (used reagent container) removed from housing 24 by replacement is placed in a designated waste disposal area by the operator of facility 13. Reagent container recycling companies, for example, recycle reagent containers placed in the designated waste disposal area.

[0078] The number of reagent containers recycled by facility 13 is estimated based on the number of times the reagent containers are replaced. For example, if facility 13 follows the operating rules of placing used reagent containers removed from housing 24 in a designated waste disposal site for recycling, then the number of reagent container replacements can be considered substantially the same as the number of reagent containers supplied for recycling by facility 13. The management of reagent replacement frequency can be automated through the function of the sample measuring device 11 to monitor reagent balance. By estimating the number of recycled reagent containers based on the number of reagent container replacements, the workload of facility 13 operators in managing the number of recycled reagent containers can be reduced, for example. By estimating the number of recycled reagent containers based on the number of reagent container replacements, the workload of recycling operators in managing the number of recycled reagent containers can be reduced, for example. The method for estimating the number of recycled reagent containers is not limited; it can be based on pre-set rules or estimated using statistical processing or artificial intelligence. Furthermore, the method for determining the number of recycled reagent containers is not limited to "estimation"; for example, "determining" or "calculating" can be used instead of "estimation".

[0079] Furthermore, the various data managed by the surplus management department 701 are stored in the storage unit 74 of the computer 900, which serves as the control unit 7.

[0080] Figure 4 An example of the sample measurement system 1 of this embodiment is shown.

[0081] The sample measurement system 1 includes the sample measurement device 11 and the data management system 15 described above. The sample measurement device 11 is installed in facility 13. The sample measurement device 11 transmits reagent-related information to the data management system 15, for example, via a communication network 203. The communication network 203 is, for example, the Internet. For example, the balance management unit 701 of the sample measurement device 11 transmits balance information indicating the remaining amount of reagent containers to the data management system 15. The balance management unit 701 can transmit the device ID (identifier) ​​used to identify the sample measurement device 11, the facility ID used to identify facility 13, and the balance information together to the data management system 15. By transmitting the balance information and facility ID to the data management system 15, the data management system 15 can manage the remaining amount of reagent containers according to facility 13. By transmitting the balance information and device ID to the data management system 15, the data management system 15 can manage the remaining amount of reagent containers according to the sample measurement device 11. For example, if the sample measurement device 11 has multiple reagent containers, the balance management unit 701 transmits the balance information for each reagent container. The remaining quantity information for each reagent container is sent along with a container ID used to identify the reagent container. By sending the remaining quantity information and container ID to the data management system 15, the data management system 15 can manage the remaining quantity by reagent container.

[0082] The data management system 15, for example, comprises one or more computers. The computers, for example, are connected to... Figure 19 The computer 900 shown has the same configuration. The data management system 15 may include various server devices such as network servers, cloud servers, and storage servers. The data management system 15 includes a reagent management unit 702. The reagent management unit 702 is a functional block implemented, for example, by the processor 71 of the computer 900, which is the data management system 15, expanding the program read from the storage unit 74 into the memory 72 and executing it. The reagent management unit 702 manages the number of times the reagent container is replaced, for example, based on the balance information obtained from the sample measuring device 11. For example, the reagent management unit 702 monitors whether the balance of the reagent container is below a specified balance (e.g., the amount considered to be substantially free of second reagent residue in the container, the minimum amount required for the operation of the measuring unit 2, etc.) based on the balance information. The reagent management unit 702 calculates the corresponding number of times the reagent container is replaced, for example, based on the balance being below the specified balance. The reagent management unit 702 may manage the number of times the reagent container is replaced, for example, based on the facility ID sent from the balance management unit 701 of the sample measuring device 11, according to facility 13. The reagent management unit 702 can, for example, manage the number of reagent container replacements based on the device ID sent from the balance management unit 701 of the sample measuring device 11. The reagent management unit 702 can, for example, manage the number of replacements based on the facility ID and device ID sent from the balance management unit 701 of the sample measuring device 11, and by facility 13 and sample measuring device 11.

[0083] The reagent management department 702 estimates the number of reagent containers that can be reused (hereinafter sometimes referred to as "reuse count") based on, for example, the number of reuses based on the number of replacements. The reagent management department 702 may, for example, estimate the reuse count based on facility ID, for facility 13. The reagent management department 702 may, for example, estimate the reuse count based on device ID, for sample measuring device 11.

[0084] In addition, the various data managed by the reagent management department 702 are stored in the storage unit 74 of the computer 900, which is a data management system 15.

[0085] Figure 5 This represents another example of the configuration of sample measurement system 1.

[0086] exist Figure 5 In this example, the reagent management unit 702 is mounted on the terminal device 101. The sample measuring device 11, for example, transmits remaining information to the terminal device 101 via a communication network 203. The terminal device 101 is, for example, a computer used within the facility 13 where the sample measuring device 11 is installed; specifically, it is a personal computer (PC), tablet, smartphone, etc. The terminal device 101 is, for example, connected to... Figure 19The computer 900 shown has the same configuration. When the terminal device 101 is used within facility 13, for example, the sample measuring device 11 and the terminal device 101 are connected via a communication network 203, which is an intranet. The terminal device 101 can also be used outside facility 13, for example. When the terminal device 101 is used outside facility 13, for example, the sample measuring device 11 and the terminal device 101 are connected via a communication network 203, which is the Internet. The balance management unit 701 of the sample measuring device 11 sends balance information indicating the remaining amount of the reagent containers to the terminal device 101. The balance management unit 701 can send the device ID used to identify the sample measuring device 11, the facility ID used to identify facility 13, and the balance information together to the terminal device 101. By sending the balance information and the facility ID to the terminal device 101, the terminal device 101 can manage the remaining amount of the reagent containers according to facility 13. By sending the balance information and the device ID to the terminal device 101, the terminal device 101 can manage the remaining amount of the reagent containers according to the sample measuring device 11. The balance management unit 701, for example, sends balance information for each reagent container when the sample measuring device 11 has multiple reagent containers. The balance information for each reagent container is sent together with a container ID used to identify the reagent container. By sending the balance information and container ID to the terminal device 101, the terminal device 101 can manage the balance by reagent container.

[0087] The reagent management unit 702 of the terminal device 101 has the same functions as the reagent management unit 702 of the data management system 15 described above. The reagent management unit 702 of the terminal device 101 is implemented, for example, by a function block that expands a program read from the storage unit 74 into the memory 72 and executes it via the processor 71 of the computer 900, which is the terminal device 101. Furthermore, the various data managed by the reagent management unit 702 of the terminal device 101 are stored in the storage unit 74 of the computer 900, which is the terminal device 101.

[0088] like Figure 6 As shown in the configuration example, the control unit 7 of the sample measuring device 11 may include a reagent management unit 702. The reagent management unit 702 of the control unit 7 has the same functions as the reagent management unit 702 of the data management system 15 described above. The reagent management unit 702 of the control unit 7 is, for example, a function block implemented by the processor 71 of the computer 900, which is the control unit 7, expanding a program read from the storage unit 74 into the memory 72 and executing it. Based on the remaining quantity information obtained from the remaining quantity management unit 701 of the control unit 7, the reagent management unit 702 of the control unit 7 manages the number of times the reagent containers are replaced. Based on the number of times the reagent containers are replaced, the reagent management unit 702 of the control unit 7 estimates the number of times the reagent containers can be reused. Furthermore, various data managed by the reagent management unit 702 of the control unit 7 are stored in the storage unit 74 of the computer 900, which is the control unit 7.

[0089] The reagent management unit 702 of the control unit 7 can, for example, cooperate with the reagent management unit 702 of the data management system 15 and the reagent management unit 702 of the terminal device 101. The reagent management unit 702 of the control unit 7 can, for example, send the number of reagent replacements and / or reuses to the terminal device 101 and / or the data management system 15. The reagent management unit 702 of the control unit 7 can, for example, send at least one of the container ID, facility ID, and device ID, as well as the number of replacements and / or reuses, to the terminal device 101 and / or the data management system 15. Through the cooperation between the reagent management unit 702 of the control unit 7 and the terminal device 101 and / or the data management system 15, the management of the number of replacements and / or reuses can be shared. For example, the reagent management unit 702 of the control unit 7 manages the number of replacements and / or reuses in the sample measuring device 11, and the reagent management unit 702 of the data management system 15 manages the number of replacements and / or reuses of each of the multiple facilities 13.

[0090] Figure 7 This represents another example of the configuration of sample measurement system 1.

[0091] The reagent management unit 702 of the data management system 15, for example, sends the number of replacements for each facility 13 to at least one terminal device 101. The reagent management unit 702 can, for example, manage the correspondence between facilities 13 and terminal devices 101. A terminal device 101 is, for example, the terminal device 101 of a company that recycles used reagent containers, assuming the company has been pre-assigned facilities 13 to recycle reagent containers. In this case, the reagent management unit 702 manages, for example, the correspondence between the company's terminal device 101 and the facilities 13 assigned to the company. The reagent management unit 702, for example, based on the correspondence between terminal devices 101 and facilities 13, sends the number of replacements for the facility 13 corresponding to the terminal device 101 to that terminal device 101. By sending the corresponding number of replacements for the facility 13 to the terminal device 101, the company using the terminal device 101 can monitor the retention status of used reagent containers in the facilities 13 under its responsibility. Based on the retention status of used reagent containers, operators can determine whether to recycle them (e.g., if the number of retained reagent containers exceeds a certain limit, the operator can go to facility 13 for recycling). For example, reagent management department 702 can send the number of replacements in facility 13 at regular intervals (e.g., daily, every three days, weekly, etc.) instead of sending the cumulative number of replacements to terminal device 101. By sending the number of replacements for each regular interval to terminal device 101, operators can keep track of the latest retention status of used reagent containers in facility 13.

[0092] Figure 8 Examples of reagent containers representing objects to be recycled. Figure 8An example of a second reagent container 240, which is intended for recycling, is shown.

[0093] The second reagent container 240 is, for example, a container manufactured by molding recyclable raw materials. For example, the second reagent container 240 is a single-material container. The second reagent container 240 includes, for example, a suction tube insertion port 2401, a main body 2402, and an outer casing 2403. For example, the main body 2402 can be configured as a single-material container, and the main body 2402 can be recycled. The suction tube insertion port 2401 is, for example, a component for inserting a suction tube used to draw up the second reagent and deliver it to the infusion tube 241 into the second reagent container 240 disposed in the housing 24. The main body 2402 may be covered by the outer casing 2403. The outer casing 2403 is, for example, made of cardboard.

[0094] The second reagent container 240 is, for example, molded from resin. The second reagent container 240 is, for example, molded from a polyethylene-based resin. For example, the main body 2402 of the second reagent container 240 is molded from a polyethylene-based resin. The polyethylene-based resin is, for example, polyethylene terephthalate (PET) or polyethylene naphthalate (PEN). The main body 2402 of the second reagent container 240 may, for example, be molded from plastic.

[0095] The first reagent container 230 can be recyclable. For example, the first reagent container 230 can be manufactured by molding recyclable raw materials. The first reagent container 230 can be, for example, a single-material container. The first reagent container 230 can be molded from, for example, a polyethylene resin. The polyethylene resin can be, for example, polyethylene terephthalate (PET) or polyethylene naphthalate (PEN). The first reagent container 230 can be molded from, for example, plastic.

[0096] The first reagent configured in the measurement unit 2 is used, for example, to measure a specified measurement item. For example, the first reagent contains a substance (e.g., an antibody) that specifically binds to a specified analyte (i.e., a specified measurement item) in the sample. For example, a labeling substance is applied to the substance that specifically binds to the analyte, and the detection unit 22 measures the specified analyte in the sample by detecting the labeling substance. For example, the first reagent contains a pigment compound for staining the analyte corresponding to the measurement item. The detection unit 22 measures the analyte in the sample, for example, by detecting the fluorescence generated by the pigment compound that stains the analyte in the sample. The measurement unit 2 may, for example, be provided with multiple types of first reagent containers to measure multiple measurement items. The multiple types of first reagent containers may, for example, each contain a different first reagent. For example, a second reagent may be shared among multiple measurements using multiple types of first reagents. For example, the first reagent may be used only for the measurement of a corresponding measurement item, while the second reagent may be used universally among measurements of different measurement items. The first reagent may, for example, be used to specifically prepare a measurement sample for measuring the corresponding measurement item.

[0097] The second reagent contained in the second reagent container 240 is used, for example, to clean the flow path within the measurement unit 2. For example, the measurement unit 2 has a suction tube for aspirating samples. For example, the second reagent is used to clean the tube each time a sample is aspirated, in order to prevent residual sample in the suction tube from being carried over to the next sample measurement. For example, in the measurement unit 2, the measurement sample prepared by mixing the sample and the first reagent is transported to the detection unit 22 via the flow path. For example, the flow path for transporting the measurement sample is cleaned by the second reagent.

[0098] The second reagent is used, for example, in the measuring unit 2 to dilute the sample aspirated from the sample container by the aspirator. For example, the sample aspirated by the aspirator is ejected into a chamber provided in the sample processing unit 21. For example, the second reagent is supplied to the chamber where the sample is ejected to dilute the sample.

[0099] The second reagent is used, for example, to prepare the measurement sample. For instance, the measurement sample is prepared by mixing the sample and the second reagent. Alternatively, the measurement sample can be prepared by mixing the sample, the first reagent, and the second reagent. The second reagent is, for example, a reagent (hemolysin) used to dissolve red blood cells in the sample in the measurement unit 2 for performing a blood cell count test.

[0100] The second reagent is used, for example, when measuring the sample. For example, the detection unit 22 of the measurement unit 2 for performing a blood cell count includes a flow cytometer. The second reagent is used, for example, as a sheath fluid when measuring the sample using a flow cytometer.

[0101] The capacity of the second reagent container 240 is, for example, 2 liters or more and 25 liters or less. As described above, the second reagent contained in the second reagent container 240 can be shared by multiple measurement operations using multiple types of first reagents. Therefore, for example, the capacity of the second reagent container 240 is greater than the capacity of the first reagent container 230. The capacity of the first reagent container 230 is, for example, 1 ml or more and 300 ml or less.

[0102] Figure 9 This shows an example of the structure of the housing 24.

[0103] For example, a measuring unit 2 is provided on the upper surface of the housing 24. The housing 24 includes a second opening / closing part 242. When the second opening / closing part 242 is opened, the second reagent container 240 can be placed in the housing 24 and removed from the housing 24. The second reagent container 240 can be disposed on a drawer provided in the housing 24. A suction tube (or tube) for delivering the second reagent to the measuring unit 2 is inserted into the suction tube insertion port 2401 of the second reagent container 240 disposed in the housing 24. Even when the second opening / closing part 242 is open, the sample measuring device 11 can continue to operate as long as the second reagent can be supplied to the measuring unit 2.

[0104] Figure 10 This section shows an example of the configuration of the first opening / closing part 231 of the measuring unit 2.

[0105] For example, a first opening / closing part 231 is provided on the front of the measuring unit 2 (i.e., the side of the measuring unit 2 that can be accessed by the operator in the testing room). The measuring unit 2 is disposed on the housing 24. That is, the first opening / closing part 231 is disposed higher than the second opening / closing part 242. When the first opening / closing part 231 is opened, the operator can access the reagent preparation section 23 for setting the first reagent container 230. When the first opening / closing part 231 is open, for example, the operation of the measuring unit 2 stops.

[0106] Figure 11 This section illustrates a configuration example of a reagent supply unit 2404 used to supply a second reagent from the housing 24 to the measuring unit 2.

[0107] The reagent supply unit 2404 includes a second reagent container 240, a sensor 244, and an infusion tube 241. The second reagent contained in the second reagent container 240 is delivered to the measuring unit 2 via the infusion tube 241, for example, by applying negative pressure from an air source. The sensor 244 can detect whether there is substantial residue of the second reagent in the second reagent container 240. Whether there is substantial residue of the second reagent in the second reagent container 240 means whether there is a sufficient amount of the second reagent to be drawn from the second reagent container 240 into the infusion tube 241. For example, even if there is residual second reagent in the second reagent container 240, but not enough to be drawn through the suction tube, it is determined that there is substantially no residue of the second reagent. The sensor 244 is, for example, a bubble monitoring sensor. The sensor 244 determines the presence or absence of the second reagent being delivered in the infusion tube 241, for example, by monitoring for bubbles within the infusion tube 241. For example, when there is no remaining amount of second reagent in the second reagent container 240 sufficient to be drawn up by the suction tube, air is drawn up by the suction tube, causing air bubbles to flow into the infusion tube 241. The sensor 244 detects these air bubbles. For example, based on the detection of air bubbles by the sensor 244, the balance management unit 701 determines that the second reagent container 240 is substantially empty.

[0108] Sensor 244 can be provided in a suction tube inserted into the second reagent container 240. For example, sensor 244 as a liquid level sensor can be provided in the suction tube. Sensor 244 may have multiple electrodes of different lengths. For example, when there are two electrodes, the length of the electrode shorter than one of the electrodes corresponds to the liquid level height to be detected (i.e., the liquid level height at which it can be determined that the remaining amount of the second reagent has been used up). With this configuration, when the liquid level in the second reagent container 240 becomes lower than that of the shorter electrode (i.e., when there is no liquid between the two electrodes), the power supply between the two electrodes is cut off. By cutting off the power supply between the electrodes, sensor 244 detects that the liquid level has fallen below a predetermined height, thereby determining that the remaining amount in the second reagent container 240 has been used up.

[0109] Figure 12 This represents another example of the composition of the reagent supply unit 2404.

[0110] The reagent supply unit 2404 includes, for example, a plurality of second reagent containers 240, a sensor 244, and a switching unit 245. For example, even if one of the plurality of second reagent containers 240 is being replaced, the reagent supply unit 2404 can supply the second reagent to the measurement unit 2 from other second reagent containers 240. Therefore, the measurement unit 2 can continue to perform measurement operations even while replacing a used second reagent container 240. The switching unit 245 switches the supply source of the second reagent to the measurement unit 2, for example. For example, the switching unit 245 switches the supply source of the second reagent to another second reagent container 240 when the remaining amount of the plurality of second reagent containers 240 is depleted. Through the function of the switching unit 245, even if a used second reagent container 240 is removed from the housing 24 for reuse, the second reagent can continue to be supplied to the measurement unit 2 without stopping the operation of the sample measurement device 11.

[0111] Figure 13 This is an example of an action that indicates the number of times reagents in the Balance Management Department 701 are replaced.

[0112] The remaining reagent management unit 701 monitors whether the reagent in the reagent container is below a specified amount (S10). For example, the remaining reagent management unit 701 monitors whether the sensor 244 detects that the remaining amount in the second reagent container is below a specified amount (i.e., the remaining amount is substantially used up). When the sensor 244 detects that the remaining amount in the second reagent container is below a specified amount, the remaining reagent management unit 701 determines that the reagent container has been replaced. For example, the remaining reagent management unit 701 manages the number of replacements through a variable (“N”). The remaining reagent management unit 701 increments the variable N, for example, based on the fact that the remaining amount in the second reagent container has been used up (S11). The remaining reagent management unit 701 may also increment the variable N, for example, based on the removal of a used reagent container and the setting of a new reagent container. For example, based on the setting of a new second reagent container 240, a second reagent is drawn from the set second reagent container 240 to confirm whether the container is set up properly. For example, based on the drawing of the second reagent, the sensor 244 monitors the presence or absence of air bubbles in the infusion tube 241. When sensor 244 determines that no air bubbles are detected and the infusion tube 241 is filled with the second reagent, the balance management unit 701, for example, determines that the second reagent container 240 has been replaced and increments the variable N.

[0113] The inventory management unit 701 can manage the number of times reagent containers in the sample measuring device 11 are replaced at specified intervals (e.g., weekly, monthly, every three months, annually, etc.). For example, when multiple sample measuring devices 11 are provided in the facility 13, the inventory management unit 701 can manage the number of replacements per device. The inventory management unit 701 manages the total number of replacements for each device as the total number of replacements for the facility 13. For example, when multiple types of second reagent containers for reuse are provided in the sample measuring device 11, the inventory management unit 701 can manage the number of replacements per type of second reagent container. The inventory management unit 701 manages the total number of replacements for each type of second reagent container as the total number of replacements for the sample measuring device 11. For example, when the first reagent container is for reuse, the inventory management unit 701 manages the number of replacements for both the first and second reagent containers. The inventory management unit 701 manages the total number of replacements for the first and second reagent containers as the total number of replacements for the sample measuring device 11.

[0114] Figure 14 This is an example of an action that indicates the number of times reagents in the 701 inventory management department have been replaced. Figure 14 In the example, the balance management department 701 manages the balance of reagent containers based on the number of measurements.

[0115] The margin management unit 701 monitors whether the sample measurement operation is completed (S20). For example, the margin management unit 701 monitors the measurement operation of the sample measuring device 11 according to the sample. The margin management unit 701 determines, for example, that the sample measurement operation has been completed based on the measurement results of the acquired sample.

[0116] The remaining test count management unit 701 manages the remaining test counts of reagent containers based on the completion of sample measurement (S21). For example, the remaining test count management unit 701 manages the remaining test counts of at least one of the first reagent container and the second reagent container. The remaining test count management unit 701 manages the remaining reagent information for each managed reagent container. For example, the initial value of the remaining test count information is determined based on the capacity of the reagent container. For example, when the capacity of the reagent container is 20 liters, the initial value of the remaining test count information is 20 liters. The remaining test count management unit 701 subtracts the amount of reagent (first reagent and / or second reagent) used in the measurement action from the remaining test count information based on the completion of the measurement action. In the remaining test count management unit 701, for example, the amount of reagent (first reagent and / or second reagent) to be used is set according to the type of measurement action. The remaining test count management unit 701 determines the amount to be subtracted from the remaining test count information based on the type of measurement action completed. For example, when the amount of second reagent used in the completed measurement action is 50 ml, the remaining test count management unit 701 subtracts 50 ml from the remaining test count information.

[0117] The remaining quantity management unit 701 increments the reagent replacement count based on the reagent container's remaining quantity being used up (when "Yes" is set in S22). For example, the remaining quantity management unit 701 increments the variable N corresponding to the number of reagent container replacements based on the reagent container's remaining quantity being used up (S23). Furthermore, the processing in S23 can also be performed when "Yes" is set in S24 below.

[0118] When the reagent container has been replaced (S24 is "Yes"), the remaining balance management unit 701 resets the remaining balance information to the initial value (S25).

[0119] Figure 15 This illustrates another configuration example of the sample measuring device 11. Figure 15 In this example, the sample measuring device 11 can read the information of the label 2430 attached to the reagent container via the reader 243.

[0120] like Figure 15 As shown in the example, for instance, a reader 243 is provided in the housing 24. The reader 243 can be located in the measuring unit 2 or in the control unit 7. The reader 243, for example, can read... Figure 16 The illustrated label 2430 (e.g., a barcode, QR code (quick response code) (registered trademark)) contains information, for example, indicating whether the reagent container is a recyclable product. Label 2430 may also contain other information (e.g., batch information, manufacturing date, etc.).

[0121] Figure 17 This refers to an example of the reagent management unit 702 of the control unit 7 managing whether the reagent container used by the sample measuring device 11 is a recycled product.

[0122] The reagent management unit 702, for example, determines whether a reagent container is a recyclable product based on information read by the reader 243 (S30). The reagent management unit 702, for example, determines whether a second reagent container is a recyclable product based on information read by the reader 243 when the second reagent container is replaced.

[0123] The reagent management unit 702 manages the number of times the reagent container, which is a recycled product, is used (S31). For example, the reagent management unit 702 manages the number of times the recycled product is used based on a variable ("E") corresponding to the number of times the reagent container, which is a recycled product, is used. For example, when it is determined in S30 that the second reagent container provided in the sample measuring device 11 is a recycled product ("yes"), the reagent management unit 702 increments the variable E.

[0124] The reagent management department 702 can send the number of times the recycled products have been used to the data management system 15. The reagent management department 702 of the data management system 15, for example, manages the number of times the recycled products have been used in each facility 13.

[0125] [Second Implementation] like Figure 18 As shown, as an example, the sample measurement system 1 of this embodiment includes a measurement unit 2, control software 3, data management software 4, and an interface 5 as its constituent elements. The measurement unit 2 measures a sample, for example, and acquires measurement data. Furthermore, the control software 3 and the data management software 4 can be integrated into one unit. The sample measurement system 1 is, for example, a sample measurement device including the measurement unit 2, control software 3, data management software 4, and interface 5.

[0126] The sample measurement system 1 is a system that includes, for example, a sample measurement device including a measurement unit 2, control software 3, data management software 4 and an interface 5, as well as other devices or other software.

[0127] Measurement unit 2 measures the sample fed into it and acquires data corresponding to the measurement results. An example of measurement unit 2 is a unit that performs measurements for blood cell analysis. Measurement unit 2 operates under the control of control software 3. Measurement unit 2 provides the acquired data to data management software 4 via control software 3.

[0128] Control software 3 and data management software 4 collaborate to control the actions of measurement unit 2. Control software 3 commands measurement unit 2 to perform measurement actions corresponding to the measurement sequence of the samples input into measurement unit 2. Control software 3 analyzes the data acquired by measurement unit 2 to obtain measurement data as the measurement result.

[0129] Data management software 4 manages data related to measurement unit 2. Data management software 4 has the function of providing the measurement results acquired by control software 3 to the operator (e.g., a user interface). Data management software 4 has functions related to device operation, such as registering and acquiring measurement sequences, and providing information related to the measurement sequence to control software 3. Data management software 4 can manage the data based on the classification of the types of data related to measurement unit 2. For example, data management software 4 can classify and manage the data according to the type of the cooperating measurement unit 2. The type of measurement unit 2 is, for example, a unit that performs measurements for blood cell analysis. Control software 3 and data management software 4 can be independent software. Software with the same functions as control software 3 and data management software 4 can perform control of measurement unit 2 and management of data related to measurement unit 2.

[0130] The measurement unit 2, control software 3, and data management software 4 described above may require certification from a certification body as medical devices. The medical device requiring certification is, for example, an in vitro diagnostic medical device. In this case, the measurement unit 2, control software 3, and data management software 4 provide functions corresponding to the intended use of the certified medical device. The intended use of the medical device is, for example, measuring samples and providing measurement results. When the medical device is a blood cell analysis device, it may measure blood samples and provide blood cell-related measurement results (e.g., red blood cell count, white blood cell count, white blood cell differential, etc.).

[0131] Application software (hereinafter referred to as "application") 6 is software independent of control software 3 and data management software 4. Application 6, for example, has functions embedded in existing software related to the device for measuring samples. That is, application 6 has functions separate from existing software related to the device for measuring samples. Application 6, for example, may have new functions not embedded in existing software related to the device for measuring samples. Application 6, for example, possesses the functions of the aforementioned balance management unit 701 and reagent management unit 702, and can provide functions for managing the number of reagent container replacements, the amount of reagent container reused, and the amount of reagent containers used as reused products. Application 6, for example, provides functions different from those corresponding to the "purpose of use" of a medical device. Examples of application 6 are software for healthcare purposes other than medical use (hereinafter referred to as "non-medical device software") and software for non-healthcare purposes (hereinafter referred to as "non-medical software"). Non-medical device software and non-medical software are software that does not require or has limited requirements for certification as a medical device. Furthermore, application 6 may be an application that requires certification as a medical device.

[0132] Application 6 can be added to sample measurement system 1. In other words, application 6 can be attached to sample measurement system 1. Application 6, added to sample measurement system 1, becomes a component of sample measurement system 1. Application 6, added to sample measurement system 1, provides, for example, the following functions: utilizing information managed by data management software 4 (e.g., data related to measurement unit 2); and utilizing the functions of data management software 4. The functions provided by application 6 may be functions not possessed by data management software 4, or functions that extend the functions possessed by data management software 4. The functions provided by application 6 may be new functions different from those corresponding to the purpose of use as a medical device. Thus, application 6, added to sample measurement system 1, provides functions for expanding sample measurement system 1. In other words, it can be said that application 6, added to sample measurement system 1, provides functions that supplement data management software 4.

[0133] Application 6 is separate from data management software 4 and control software 3, therefore, application 6 can be easily added to sample measurement system 1 without changing data management software 4 and control software 3. Furthermore, for example, if application 6 is non-medical device software or non-medical software that does not require certification as a medical device, certification from a certification body is not required when adding application 6. Similarly, removing application 6 from sample measurement system 1 does not require changing data management software 4 and control software 3.

[0134] Application 6, separate from data management software 4, can collaborate with data management software 4 via interface 5. Interface 5 is, for example, a software interface, such as an API (Application Programming Interface). Interface 5 enables application 6 to utilize information managed by data management software 4 (e.g., measurement data and other data related to measurement unit 2) and the functions of data management software 4. Specifically, interface 5 accepts requests from application 6 and responds accordingly, enabling application 6 to utilize, for example, the data or functions corresponding to the request. Requests from application 6 may be, for example, requests to utilize data managed by data management software 4 or requests to utilize the functions of data management software 4. Responses to application 6 may include, for example, providing the requested data or providing the requested functions.

[0135] Application 6 collaborates with Interface 5 according to pre-agreed rules (hereinafter referred to as "Rule R"). Interface 5, based on Rule R, enables Application 6 to utilize information and functions related to Data Management Software 4. For example, when Interface 5 is configured as a Web API, Rule R is defined as a combination of a URI (Uniform Resource Identifier) ​​specifying the processing object in a defined syntax and a defined Hypertext Transfer Protocol (HTTP) method representing an operation on the processing object. Application 6, based on Rule R, creates a request to Interface 5 that specifically identifies the processing object and the combination of the URI and HTTP method for the operation on the processing object. This request will also be referred to as "Instruction C". Application 6 sends Instruction C, created based on Rule R, to Interface 5. Interface 5 provides Application 6 with a response corresponding to Instruction C sent from Application 6. For example, based on Instruction C sent from Application 6, Interface 5 enables Application 6 to utilize at least one of the following: data related to Measurement Unit 2, data related to the measurement actions of Measurement Unit 2, data related to the maintenance of Measurement Unit 2, and data related to the operation of Measurement Unit 2. Additionally, for example, interface 5, based on instruction C sent from application 6, causes application 6 to perform at least one of the following: acquiring data related to measurement unit 2, registering the data, updating the data, or deleting the data. For example, depending on the type of sample measurement device 11, multiple types of rules R may exist. For example, depending on the type of sample measurement device 11, the information management methods of data management software 4 or data management system 15 may sometimes differ. In this case, for example, by collaborating between interface 5 and application 6 based on multiple types of rules R corresponding to the information management methods, application 6 can utilize different types of information for different purposes.

[0136] Interface 5 can enable multiple types of applications 6 to utilize data related to measurement unit 2 based on a rule R commonly defined for multiple types of applications 6 that provide different functionalities. Interface 5 can also enable applications 6 to utilize data related to measurement unit 2 based on a rule R commonly defined for multiple types of applications 6 created separately for multiple types of operating systems.

[0137] Interface 5 can be embedded in data management software 4, or it can be embedded in a different software program. Interface 5 can be software independent of data management software 4, control software 3, and other software programs. Furthermore, data management software 4 can consist of a single software program (e.g., an executable file) or multiple software programs (e.g., multiple executable files). For example, the software responsible for interface 5 and the software responsible for data management software 4 can consist of multiple different executable files.

[0138] [Example of software operating environment] Control software 3, data management software 4, interface 5, and application 6, for example, execute on one or more computers 900. Computer 900 is, for example, a smartphone (iPhone, Android terminal), a tablet (iPad, Android tablet, Windows tablet), a Windows PC running Windows OS, or a Mac running Mac OS (iPhone, iPad, Android, Windows, and Mac OS are registered trademarks). Furthermore, application 6 can be created separately for multiple operating systems. For example, for a given application 6, separate applications can be created for Windows OS and for iOS.

[0139] The structure of computer 900 is illustrated in the following example. Figure 19 As an example, computer 900 includes a processor 71, a memory 72, a bus 73, a storage unit 74, a display unit 75, an interface 751, an operation unit 76, an interface 761, and a communication unit 78. Terminal device 101 and control unit 7 are... Figure 19 The computer shown has the same configuration as the 900.

[0140] Storage unit 74 is, for example, a non-volatile memory such as an SSD (Solid State Drive), flash memory, an HDD (Hard Disk Drive), or a combination thereof. Storage unit 74 stores, for example, various programs including control software 3, data management software 4, interface 5, and application 6, as well as various data.

[0141] The processor 71 is, for example, an IPU (Infrastructure Processing Unit), a CPU (Central Processing Unit), a GPU (Graphics Processing Unit), a DSP (Digital Signal Processor), an MPU (Micro Processing Unit), or a combination thereof. The processor 71 may be implemented using logic circuitry. The processor 71 reads various programs from the storage unit 74, expands them into the memory 72, and executes them. The memory 72 is, for example, a volatile memory such as RAM (Random Access Memory) or DRAM (Dynamic Random Access Memory).

[0142] Interface 751 connects to bus 73 and display unit 75 such as a monitor. Interface 761 connects to bus 73 and operation unit 76 such as a keyboard or mouse. Communication unit 78 is responsible for communication with external devices.

[0143] In order to simplify the description of the operation of the control software 3, data management software 4, interface 5, or application 6, the description of the components corresponding to the processor 71, storage unit 74, and memory 72 used to execute them will sometimes be omitted.

[0144] Furthermore, the computer 900 may also have a communication interface for communicating with other devices. Additionally, the computer 900 may further have an input / output interface for connecting input / output devices such as a keyboard, mouse, monitor, and printer.

[0145] [Example of a sample measurement system] [Example 1] Figure 20 An example configuration of sample measurement system 1 is shown. In this configuration example, sample measurement system 1 is configured as a sample measurement device 11 including a measurement unit 2, execution control software 3, data management software 4, interface 5, and application 6. In this configuration example, application 6 is executed by sample measurement device 11, utilizing information managed by data management software 4 and the functions of data management software 4 via interface 5.

[0146] [Example 2] Application 6 can be mounted on a device different from the sample measurement device 11. Figure 21 In the illustrated configuration example, the sample measurement system 1 includes a sample measurement device 11 installed in a testing laboratory, and a terminal device 101 connected to the sample measurement device 11 via a communication network 201. The terminal device 101 is used, for example, in the testing laboratory. The communication network 201 is, for example, an internal network.

[0147] The sample measurement device 11 includes a measurement unit 2, and a control unit 7 comprising execution control software 3, data management software 4, and an interface 5. The terminal device 101 is a computer used by the user of the sample measurement system 1, such as a PC, smartphone, or tablet. The terminal device 101 carries and executes application 6.

[0148] In this configuration example, application 6 running on terminal device 101 accesses interface 5 of sample measurement device 11 via communication network 201. Interface 5 enables application 6 of terminal device 101 to utilize information managed by data management software 4 and the functions of data management software 4 via communication network 201.

[0149] [Example 3] The terminal device 101 equipped with application 6 can also be used in locations different from the facility where the sample measurement device 11 is located (e.g., outside the testing room, or in another room within the same facility as the testing room). Figure 22 In the illustrated configuration example, the sample measurement system 1 includes a sample measurement device 11 installed in a testing laboratory, and a terminal device 101 used in a facility different from the testing laboratory and connected to the sample measurement device 11 via a communication network 202. The communication network 202 is, for example, the Internet or an intranet. The sample measurement device 11 includes a measurement unit 2, and a control unit 7 that executes control software 3, data management software 4, and an interface 5. The terminal device 101 carries and executes an application 6.

[0150] In this configuration example, application 6 running on terminal device 101 accesses interface 5 of sample measurement device 11 via communication network 202. Interface 5 enables application 6 of terminal device 101 to utilize information managed by data management software 4 and the functions of data management software 4 via communication network 202.

[0151] [Example 4] When the sample measurement device 11 is equipped with application 6, application 6 itself can access another sample measurement device 11 and utilize the information managed by the data management software 4 of that other sample measurement device 11 and the functions of that data management software 4. Figure 23 In the illustrated configuration example, the sample measurement system 1 is configured as a sample measurement device 11 comprising a measurement unit 2, execution control software 3, data management software 4, interface 5, and application 6, which are communicatively connected to each other via a communication network 203. The communication network 203 may be, for example, an internal network or the Internet.

[0152] In this configuration example, the application 6 running in a sample measurement device 11 can utilize the information managed by the data management software 4 of the sample measurement device 11 and the functions of the data management software 4 via the interface 5 of the sample measurement device 11, and can also access the interface 5 of another sample measurement device 11 connected via the communication network 203, and utilize the information managed by the data management software 4 of the sample measurement device 11 and the functions of the data management software 4.

[0153] [Example 5] The information managed by the data management software 4 (e.g., measurement data) can be managed by a device different from the sample measurement device 11. Figure 24In the illustrated configuration example, the sample measurement system 1 includes a sample measurement device 11 and a data management system 15 connected to the sample measurement device 11 via a communication network 204. The communication network 204 may be, for example, an intranet or the Internet. Information managed by the data management software 4 (e.g., measurement data) may also be managed by both the sample measurement device 11 and the data management system 15. For example, a copy of all or part of the information managed by the data management software 4 of the sample measurement device 11 may be managed by the data management system 15.

[0154] like Figure 24 As shown, the sample measurement device 11 includes a measurement unit 2, execution control software 3, data management software 4, interface 5, and application 6, and a control unit 7. The sample measurement device 11 has the function of providing information managed by the data management software 4 to the data management system 15. Details will be described below. As an example of this function, the interface 5 can provide information (measurement data, etc.) corresponding to a predetermined event to the data management system 15 via a push notification through the communication network 204. The push notification can also be executed by software other than the interface 5 (e.g., other software installed in the data management software 4 and control unit 7). In response to inquiries from the data management system 15, the sample measurement device 11 can provide information managed by the data management software 4 to the data management system 15 instead of a push notification. The configuration examples 6 and 7 described below are also the same regarding providing information to the data management system 15.

[0155] The data management system 15 includes, for example, a control unit 17 that executes data management software 4A, an interface 5A, and a communication control unit 16. The control unit 17 and... Figure 2 The processor 902 shown is the same. The data management system 15 includes a data storage unit 18 as a storage device. The data management software 4A stores and manages the information from the sample measurement device 11 via PUSH notifications in the data storage unit 18. The communication control unit 16 has the function of controlling communication related to PUSH notifications from the sample measurement device 11.

[0156] Application 6 can collaborate with data management software 4A via interface 5A. Data management software 4A retrieves data from data storage 18 corresponding to the request received from application 6 via interface 5A and provides it to the requesting application 6. Interface 5A enables application 6, executing in sample measurement device 11, to utilize information managed in data storage 18 via data management software 4A. Interface 5A is the same as interface 5, for example, a software interface, typically an API. Interface 5A enables application 6 to utilize information managed by data management software 4A. Application 6 collaborates with interface 5A based on rule R, and interface 5A, based on rule R, enables application 6 to utilize information and functions related to data management software 4A.

[0157] In the case of this configuration example, such as Figure 24 As shown, application 6, executed in sample measuring device 11, accesses interface 5A of data management system 15 via communication network 204, requesting access to information stored in data storage 18 of data management system 15. Data management system 15 may be located in a laboratory or medical facility, in which case application 6 of sample measuring device 11 accesses interface 5A, for example, via communication network 204, which serves as an intranet.

[0158] [Example 6] The information stored in the data storage 18 of the data management system 15 can be utilized by the application 6 running in the terminal device 101. Figure 25 In the example configuration shown, the sample measurement system 1 is configured to connect the sample measurement device 11, the data management system 15, and the terminal device 101 via the communication network 204.

[0159] In this configuration example, application 6, running on terminal device 101, accesses interface 5A of data management system 15 via communication network 204 and requests information stored in data storage 18 of data management system 15. Application 6, running on terminal device 101, collaborates with interface 5A based on rule R.

[0160] [Example 7] As a variation of Example 6, the sample measuring device 11 may not have data management software 4 and interface 5. Figure 26 In the configuration example shown, except that the sample measuring device 11 and the camera device 12 do not have data management software 4 and interface 5, it is the same as configuration example 6.

[0161] In this configuration example, measurement data and other information acquired by controlling the measurement unit 2 via the control software 3 are transmitted to the data management system 15 via the communication network 204, and stored in the data storage 18 by the data management software 4A of the data management system 15. Similarly to configuration example 6, the application 6 running on the terminal device 101 accesses the interface 5A of the data management system 15 via the communication network 204, requesting access to the information stored in the data storage 18 of the data management system 15.

[0162] The control unit 7 is, for example, a computer. The hardware configuration of the control unit 7 is illustrated below. Figure 27 As an example, the control unit 7 includes a processor 71, a memory 72, a bus 73, a storage unit 74, a display unit 75, an interface 751, an operation unit 76, an interface 761, an interface 77, and a communication unit 78.

[0163] The processor 71 is a control unit that provides overall control over the functions of the control unit 7. The processor 71 and... Figure 2 The processor 71 shown is the same. For example, the processor 71 reads the control software 3 and data management software 4 from the storage unit 74, expands them to the memory 72, and executes them. The storage unit 74 is the same as... Figure 19 The storage unit 74 shown is the same. The memory 72 is the same as... Figure 19 The memory 72 shown is the same.

[0164] Interface 751 connects to bus 73 and display unit 75 such as a monitor. Interface 761 connects to bus 73 and operation unit 76 such as a keyboard or mouse. Interface 77 connects to bus 73 and measurement unit 2. Communication unit 78 is responsible for communication with external devices.

[0165] [Example of the composition of control software and data management software] Figure 28 This describes an example of the configuration of the control software 3 and data management software 4 executed in the control unit 7. The control software 3 includes, for example, a unit control unit 31 and a parsing unit 32. The unit control unit 31, for example, commands the measurement unit 2 to perform actions corresponding to the measurement sequence of the sample being measured. The parsing unit 32, for example, parses the data acquired by the measurement unit 2, which operates according to the commands of the unit control unit 31, generates measurement data as measurement results, and stores the generated measurement data in the storage unit 74.

[0166] The data management software 4 includes, for example, a result provision unit 41 and an operation unit 42. The result provision unit 41 has the function (e.g., a GUI) to retrieve measurement data generated by the parsing unit 32 from the storage unit 74 and provide the retrieved measurement data to the operator. The operation unit 42 has the function (UI) for the operator to register measurement sequence / sample information, the function to retrieve measurement sequence and sample information from the Laboratory Information System (LIS) and / or the Hospital Information System (HIS), the function to register measurement instructions based on the measurement sequence, various setting functions related to the device and system, and the operation functions for registering reagent information and consumable information. The setting and registration information of the operation unit 42 is stored in the storage unit 74. The operation functions of the data management software 4 are, for example, the functions required for the intended use of the sample measurement device 11 approved as a medical device (e.g., the function of measuring samples and providing the minimum measurement results specified by the intended use). The operational functions of the data management software 4 include those required for the intended use of the sample measurement device 11, which is approved as a medical device, as well as additional functions to improve user convenience. The operational functions of the data management software 4 can be expanded, for example, by adding an application 6.

[0167] As a variation, such as Figure 29 As shown, the control unit 7 of the sample measurement device 11 may not have data management software 4. Figure 29 The illustrated control unit 7 is used, for example, for... Figure 26 An example system. In this example, the unit control unit 31 commands the measurement unit 2 to perform actions corresponding to the measurement sequence obtained from the LIS / HIS. The parsing unit 32 parses the data acquired by the measurement unit 2, which operates according to the command of the unit control unit 31, generates measurement data as a measurement result, and sends the generated measurement data to the data management system 15, for example, via the communication unit 78.

[0168] [Measurement Unit] As described above, as an example, the measurement unit 2 includes a sample processing unit 21 and a detection unit 22. The sample processing unit 21 prepares a measurement sample based on a sample and reagents. The detection unit 22 measures the measurement sample prepared by the sample processing unit 21. The unit control unit 31 of the control software 3 cooperates with the operation unit 42 of the data management software 4 (according to instructions from the operation unit 42) to control the operation of the sample processing unit 21 and the detection unit 22. The unit control unit 31, for example, performs operation control on the mechanisms and fluid circuits constituting the sample processing unit 21 and the detection unit 22. This operation control may include, for example, at least one of the following: control of the aspiration of liquid including at least one of the sample and reagents; control of mixing the sample and reagents to prepare the measurement sample; control of detecting the measurement sample using the detection unit 22; and control of detecting at least one of the optical information and electrical signals related to the measurement sample using the detection unit 22 and analyzing the measurement result based on the detection result.

[0169] [Blood cell analysis device] An example of the configuration when the measurement unit 2 is a blood cell analyzer is shown below. Figure 30 In this case, the sample processing unit 21 includes, for example, a sample aspiration unit 211 and a sample preparation unit 212, and the detection unit 22 includes, for example, an FCM detection unit 221, an RBC / PLT detection unit 222 and an HGB detection unit 223.

[0170] Figure 31 This is a schematic diagram illustrating the sample aspiration section 211 and the sample preparation section 212 when supplying a measurement sample to the FCM detection unit 221. The sample aspiration section 211 includes a nozzle 2111 for aspirating a blood sample (whole blood) from a blood collection tube T, and a pump 2112 for applying negative / positive pressure to the nozzle. The nozzle 2111 is inserted into the blood collection tube T by moving up and down via a device mechanism (not shown). When negative pressure is applied by the pump 2112 while the nozzle 2111 is inserted into the blood collection tube T, a blood sample is aspirated through the nozzle 2111. Furthermore, the device mechanism may include a handheld component for inverting and stirring the blood collection tube T before aspirating blood from it.

[0171] The sample preparation unit 212 has five reaction chambers 212a to 212e. These chambers are used in measurement channels (also called measurement systems) for DIFF (Differential Count), RET (Reticulocyte Count), WPC (White Blood Cell Precursor Count), PLT-F (Platelet Fluorescence), and WNR (White Blood Cell and Nucleated Red Blood Cell Count). Each reaction chamber is connected via a flow path to a hemolysin container containing a hemolysin that corresponds to the reagent for that measurement channel, and a staining solution container containing a staining solution. One reaction chamber and the reagents (hemolysin and staining solution) connected to it constitute a measurement channel. For example, the DIFF measurement channel corresponds to measurements that classify white blood cells into multiple subgroups (5-part differential), and consists of a DIFF hemolysin, DIFF staining solution, and a DIFF reaction chamber, which are used as reagents for DIFF measurement. The RET measurement channel corresponds to measurements related to reticulocytes, the WPC measurement channel corresponds to measurements related to abnormal white blood cells, the PLT-F measurement channel corresponds to measurements related to optical platelet measurements, and the WNR measurement channel corresponds to measurements related to white blood cells and nucleated red blood cells. These measurement channels are also constructed in the same manner as the DIFF measurement channel.

[0172] The nozzle 2111, which has drawn a blood sample, moves horizontally and vertically through the device mechanism to access the reaction chambers 212a-212e, which correspond to the measurement channels in sequence, and ejects the drawn blood sample. The sample preparation unit 212 supplies the corresponding hemolysing agent and staining solution to the reaction chamber that has ejected the blood sample, and prepares the measurement sample by mixing the blood sample, hemolysing agent, and staining solution in the reaction chamber. The prepared measurement sample is supplied from the reaction chamber to the FCM detection unit 221 via a flow path, and the cells are measured using flow cytometry.

[0173] Figure 32 This is a schematic diagram illustrating the sample suction unit 211 and the sample preparation unit 212 when supplying measurement samples to the RBC / PLT detection unit 222. The sample suction unit 211 and... Figure 31The sample aspiration section 211 shown is identical. The sample preparation section 212 includes a reaction chamber 212f. The reaction chamber 212f is connected via a flow path to a diluent container containing a diluent corresponding to RBC / PLT. A measurement sample is prepared by mixing the blood sample and the diluent within the reaction chamber 212f. The prepared measurement sample is supplied from the reaction chamber to the RBC / PLT detection section 222 via the flow path.

[0174] Figure 33 This is a schematic diagram illustrating the sample suction unit 211 and the sample preparation unit 212 used to explain the supply of measurement samples to the HGB detection unit 223. The sample suction unit 211 and... Figure 31 The sample aspiration section 211 shown is identical. The sample preparation section 212 includes a reaction chamber 212g. The reaction chamber 212g is connected via a flow path to a hemolysin container containing a reagent corresponding to HGB, namely a hemolysin. A measurement sample is prepared by mixing a blood sample and a hemolysin in the reaction chamber 212g. The prepared measurement sample is supplied from the reaction chamber to the HGB detection section 223 via a flow path.

[0175] [Formed elements in urine] The configuration of measuring unit 2 as a device for detecting formed elements in urine is illustrated below. Figure 34 In this case, the sample processing unit 21 includes, for example, a sample aspiration unit 213 and a sample preparation unit 214, and the detection unit 22 includes, for example, a light irradiation unit 224 and an optical detection unit 225.

[0176] The sample preparation unit 214 draws urine samples from the sample container via the sample aspiration unit 213. The sample aspiration unit 213 is composed of a tubular aspiration tube. The sample preparation unit 214 prepares a measurement sample by mixing reagents into the urine sample drawn by the sample aspiration unit 213. The reagents mixed into the urine sample are staining solutions or diluents containing pigments that stain the formed elements in the urine sample.

[0177] The detection unit 22 measures the measurement sample prepared by the sample preparation unit 214. The configuration of the detection unit 22 is illustrated below. Figure 35 The detection unit 22 includes a flow cell 2250, a light irradiation unit 224, an optical system 2240, and optical detection units 225 (225A, 225B, 225C). The flow cell 2250 allows the sample to flow unidirectionally while surrounded by a sheath fluid. The light irradiation unit 224, for example, is composed of a laser diode and emits light of a predetermined wavelength. The optical system 2240 irradiates the sample flow in the flow cell 2250 with the light emitted from the light irradiation unit 2240. The optical system 2240 guides forward-scattered light generated by formed elements in the flow cell 2250 to the optical detection unit 225A. The optical system 2240 guides side-scattered light and side fluorescence generated by formed elements to the optical detection units 225B and 225C, respectively.

[0178] The optical system 2240 includes a collimating lens 2241, a cylindrical lens 2242, a condenser lens 2243, a light-collecting lens 2244, a beam blocker 2245, a pinhole 2246, a light-collecting lens 2247, a dichroic mirror 2248, and a filter 2249.

[0179] Collimating lens 2241 converts the light emitted from illumination section 224 into parallel light. Cylindrical lens 2242 and condenser lens 2243 shape the light transmitted through collimating lens 2241 into a shape with a wider width in the direction perpendicular to the sample flow being measured, and then illuminate the sample flow in flow cell 2250. As a result, forward-scattered light is generated in front of the formed elements flowing through flow cell 2250, and lateral-scattered light and fluorescence are generated laterally to the formed elements flowing through flow cell 2250.

[0180] A focusing lens 2244 converges the forward-scattered light to the pinhole 2246. A beam blocker 2245 blocks light that passes through the flow cell 2250 but does not reach particles in the measurement sample. An optical detection unit 225A receives the forward-scattered light passing through the pinhole 2246. The optical detection unit 225A includes, for example, a photodiode. The optical detection unit 225A amplifies the detection signal using an amplifier, generates a forward-scattered light signal based on the forward-scattered light, and outputs the generated forward-scattered light signal.

[0181] The light-collecting lens 2247 collects both side-scattered light and fluorescence. The dichroic mirror 2248 reflects the side-scattered light transmitted through the light-collecting lens 2247. The optical detection unit 225B receives the side-scattered light reflected by the dichroic mirror 2248. The optical detection unit 225B may include, for example, a photodiode or a photomultiplier tube. The optical detection unit 225B amplifies the detection signal using an amplifier, generates a side-scattered light signal based on the side-scattered light, and outputs the generated side-scattered light signal.

[0182] Dichroic mirror 2248 allows fluorescence passing through light-collecting lens 2247 to pass through. Filter 2249 removes light of the wavelength band that becomes noise from the fluorescence passing through dichroic mirror 2248. Optical detection unit 225C receives the fluorescence passing through filter 2249. Optical detection unit 225C includes, for example, a photomultiplier tube. Optical detection unit 225C amplifies the detection signal using an amplifier, generates a fluorescence-based fluorescence signal, and outputs the generated fluorescence signal.

[0183] The optical detection units 225 (225A, 225B, 225C) can switch between low and high sensitivity by switching the driving voltage during photoelectric conversion or by using an amplifier. The optical detection units 225 (225A, 225B, 225C) generate and output signals for each light source when the light sensitivity is low, and signals for each light source when the light sensitivity is high, respectively, during the flow of the measurement sample through the flow cell 2250.

[0184] [Blood coagulation analysis device] An example of the configuration when the measuring unit 2 is a blood coagulation analysis device is shown below. Figure 36 In this case, the sample processing unit 21 includes, for example, a sample aspiration unit 215 and a sample preparation unit 216, and the detection unit 22 includes, for example, a light irradiation unit 226 and an optical detection unit 227.

[0185] The sample aspiration section 215 aspirates a sample from the sample container. The sample preparation section 216 mixes reagents into the sample aspirated by the sample aspiration section 215 to prepare a measurement sample.

[0186] The detection unit 22 measures the measurement sample prepared by the sample preparation unit 216. The configuration of the light irradiation unit 226 of the detection unit 22 is illustrated below. Figure 37 The light irradiation unit 226 includes five light sources 2260, five optical fiber sections 2261 corresponding to the five light sources 2260, and a holding member 2263 for holding the incident ends 2262 of each light source 2260 and each optical fiber section 2261. The light sources 2260, optical fiber sections 2261, and holding member 2263 are, for example, housed in a metal housing 2264.

[0187] Each of the multiple fiber optic sections 2261 includes multiple optical fibers 2265. Furthermore, the multiple fiber optic sections 2261 are mixed and bundled at their emission ends 2266 in a manner that is substantially uniformly distributed with respect to each light source 2260. Five fiber optic sections 2261 are twisted together midway to form a single unit, thus having two emission ends 2266. The two emission ends 2266 are arranged in a manner corresponding to the optical detection unit 227. The light irradiation unit 226 includes a light distribution member 2267 for distributing light from the bundled emission ends 2266.

[0188] The configuration of the optical detection unit 227 of the detection unit 22 is illustrated in the figure. Figure 38The optical detection unit 227 includes a container mounting section 2271, which is a hole extending in the vertical direction. An exit end 2268 of a light distribution member 2267 is disposed in a hole 2272 extending laterally from the container mounting section 2271. A light-collecting lens 2273 is disposed inside the hole 2272. A light-receiving section 2274 is provided at the end of a hole 2275 formed so as to face the hole 2272 across the container mounting section 2271. Thus, the exit end 2268 of the light distribution member 2267, the light-collecting lens 2273, the container mounting section 2271, and the light-receiving section 2274 are arranged in a straight line. Light emitted from the exit end 2268 passes through the light-collecting lens 2273 through the container C containing the measurement sample in the container mounting section 2271 and the measurement sample inside the container C, and is detected by the light-receiving section 2274.

[0189] [Immunoassay Device] An example of the configuration when measurement unit 2 is an immunoassay device is shown below. Figure 39 In this case, the sample processing unit 21 includes, for example, a sample aspiration unit 217 and a sample preparation unit 218, and the detection unit 22 includes, for example, an optical detection unit 228.

[0190] The sample aspiration unit 217 aspirates the sample from the sample container. The sample preparation unit 218 includes, for example, a primary reaction unit 2181, a primary BF (Bound-Free) separation unit 2182, a secondary reaction unit 2183, and a secondary BF separation unit 2184. (See reference...) Figure 40 Here is an example of the processing flow of the sample preparation unit 218. In the primary reaction unit 2181, a capture antibody (R1 reagent) bound to an antigen contained in the sample aspirated by the sample aspiration unit 217 is bound to magnetic particles (R2 reagent). The bound antigen, capture antibody, and magnetic particles are then attracted to a magnet in the primary BF separation unit 2182, thereby removing the R1 reagent containing unreacted capture antibody. Then, in the secondary reaction unit 2183, an antigen bound to magnetic particles is bound to a labeled antibody (R3 reagent). The bound magnetic particles, antigen, and labeled antibody are then attracted to a magnet in the secondary BF separation unit 2184, thereby removing the R3 reagent containing unreacted labeled antibody. Then, in the secondary reaction section 2183, a dispersion (R4 reagent) is added, followed by the addition of a luminescent matrix (R5 reagent) that emits light during the reaction with the labeled antibody. In the optical detection section 228, a photomultiplier tube is used to obtain the amount of light emitted during the reaction between the labeled antibody of R3 reagent and the luminescent matrix of R5 reagent (an amount proportional to the number of photons).

[0191] [Example of interface construction] Interface 5 receives requests from application 6 and collaborates with data management software 4 (results provision unit 41 and operations unit 42) to respond to application 6 in accordance with the request. Figure 41 This section describes an example of the configuration of interface 5. As an example, interface 5 includes a request receiving unit 51, a collaboration unit 52, and a response unit 53. The request receiving unit 51 receives requests from application 6. The request receiving unit 51 parses the content of the request based on rule R, and based on the parsed request, instructs the collaboration unit 52 to collaborate with the data management software 4 to obtain a response to the request. The collaboration unit 52 collaborates with the data management software 4 according to this instruction to obtain a response corresponding to the request. The response unit 53 provides the response obtained by the collaboration unit 52 to application 6.

[0192] Figure 42 This is a flowchart illustrating an example of the processing flow (cooperative method) of interface 5 of sample measuring device 11. First, interface 5 waits for a request from application 6 (S1). Interface 5 parses the content of the request based on rule R, according to the request received from application 6 ("Yes" in S1). Interface 5 instructs data management software 4 on the processing corresponding to the parsed request (S3). Data management software 4 executes the processing corresponding to the instruction. For example, when application 6 requests information related to measurement results (e.g., measurement data measured in measurement unit 2 of a specific sample measuring device 11, or measurement results of a precision-managed substance for a specified period (e.g., in days, weeks, or months), the result providing unit 41 of data management software 4 specifies the data corresponding to the request and provides this information to application 6 via interface 5. The operation unit 42 of data management software 4, for example, registers the measurement sequence according to a registration request for the measurement sequence from application 6 and provides a response indicating registration completion to application 6 via interface 5. Interface 5 returns a response to application 6 based on the processing performed by data management software 4 (S4). Therefore, interface 5 enables application 6 to utilize the data or functions corresponding to the request.

[0193] Figure 43 This section illustrates an example of the configuration of interface 5A in the data management system 15. As an example, interface 5A includes a request receiving unit 51A, a collaboration unit 52A, and a response unit 53A. The request receiving unit 51A receives a request from application 6 via communication network 204. The request receiving unit 51A parses the content of the request and, based on the parsed request, instructs the collaboration unit 52A to collaborate with the data management software 4A to obtain a response to the request. The collaboration unit 52A collaborates with the data management software 4A according to the instruction to obtain a response corresponding to the request. The response unit 53A provides the response obtained by the collaboration unit 52A to application 6 via communication network 204.

[0194] When interfaces 5 and 5A constitute a Web API, application 6 accesses interfaces 5 and 5A using the URIs specified in rule R. The syntax of the URIs specified in rule R is illustrated in Equation 1.

[0195] http: / / [server address] / [interface ID] / [device ID]{ / [resource] / [query parameters]} (Equation 1) In Equation 1, the "server address" is the communication address corresponding to interfaces 5 and 5A. The server address is specified, for example, by an IP (Internet Protocol) address and a port number.

[0196] Interfaces 5 and 5A can be configured, for example, according to the type of sample measuring device 11. In this case, to identify interfaces 5 and 5A, the "interface ID" in Equation 1 is specified. The interface ID is, for example, an ID corresponding to the type of sample measuring device 11. Specifying the "interface ID" in Equation 1 is not required; if not specified, wildcards (blank, empty, etc.) can be used. The interface ID, for example, corresponds to a type of rule R. For instance, based on the sample measurement device 11, there are multiple types of rules R. In other words, the interface ID, for example, corresponds to a type of sample measurement device 11. For instance, depending on the type of sample measurement device 11, the information management methods of the data management software 4 or the data management system 15 may differ. In this case, for example, by collaborating with the application 6 through interface 5 / 5A based on multiple types of rules R corresponding to the information management methods, the application 6 can utilize multiple types of information, each with its own distinct information management method.

[0197] In Equation 1, "Device ID" refers to the ID of the sample measuring device 11, which is the object of information and function utilization. The Device ID is, for example, the serial number of the sample measuring device 11. Specifying the "Device ID" in Equation 1 is not mandatory; if not specified, wildcards (blank, empty, etc.) can be used. ).

[0198] In Equation 1, "resource" refers to the resource of the API endpoint. This resource is, for example, a directory on a database corresponding to the information of the utilized object.

[0199] In Equation 1, the "query parameter" is used to uniquely specify multiple data and control objects on a resource. For example, it's used to identify measurement data from multiple measurement data sets based on conditions specified by the query parameter (specific period, specific sample, measurement data where measurement anomalies occurred). Specifying the "resource" in Equation 1 is not mandatory; if not specified, wildcards (blank, empty, etc.) can be used. The way "resources" and "query parameters" are specified may vary depending on the type of sample measurement device 11. For example, in acquiring "measurement data," the way "resources" and / or "query parameters" are specified for acquiring "measurement data" from a hematology analyzer may differ from the way "resources" and / or "query parameters" are specified for acquiring "measurement data" from an immunoassay analyzer. Even for "measurement data" which is the same type of information, the resources may differ depending on the type of sample measurement device 11, for example, as an API endpoint, or specific query parameters may be required for each type of sample measurement device 11. In this case, the way "resources" and "query parameters" are specified may vary depending on the type of sample measurement device 11. Since the way "resources" and "query parameters" are specified is part of rule R, in other words, "resources" and / or "query parameters" can be set based on multiple types of rule R depending on the type of sample measurement device 11.

[0200] Operations on the resource specified in the URI are, for example, specific to the HTTP method. Examples of HTTP methods include "GET", "PUT", "DELETE", and "POST". Using "GET", information specified by the "resource" and "query parameters" of the URI is retrieved.

[0201] The "PUT" command is used to update or edit information specified by the "resource" and "query parameters" of the URI. In this case, the HTTP request body contains the new data (the content of the resource that should be updated or edited). The data structure of the HTTP request body when updating batch information for precision management is illustrated below. Figure 44This example is described in JSON (JavaScript Object Notation) format (JavaScript is a registered trademark). For example, the "Server Address" of Control Unit 7, specified as the object of "PUT" processing (update), is "127.0.0.1", via URI=http: / / 127.0.0.1:8080 / qcdata / qcLotsInfo?lotNumber=QC22421101. The QC (Quality Control) data held by Control Unit 7, with "Server Address"="127.0.0.1", is specified by "Resource"="qcdata". "PUT" processing (update) is specified for the QC batch information with "Query Parameter"="QC22421101" (QC batch number) in the QC data held by Control Unit 7, with "Server Address"="127.0.0.1". The HTTP request body="{"Limits":[{"parameter":"WBC","lowerLimit":10.0,"upperLimit":100.0},{"parameter":"RBC","lowerLimit":20.0,"upperLimit":200.0},{"parameter":"HGB","lowerLimit":30.0,"upperLimit":300.0},]}" specifies the object and content to be updated using the "PUT" process for the specified QC batch information. Through this combination of URI and HTTP request body, the specified QC batch information is updated with the following values: WBC (white blood cell count) lower limit = 10.0 / upper limit = 100.0, RBC (red blood cell count) lower limit = 20.0 / upper limit = 200.0, and HGB (hemoglobin concentration) lower limit = 30.0 / upper limit = 300.0. Here, by updating the lower and upper limits of WBC (white blood cell count), RBC (red blood cell count), and HGB (hemoglobin concentration), QC can be implemented using the updated lower and upper limits. These lower and upper limits, also known as management values, are set to ensure the accuracy of measurement results and to demonstrate the appropriateness of the measurement and management methods through the recording of measurement results. Furthermore, deviations from the lower or upper limits are also used as indicators of abnormal or incorrect measurement results.

[0202] The information specified by the "resource" and "query parameters" of the URI is deleted by using "DELETE".

[0203] When registering or creating new information, use "POST" instead of specifying "resource" and "query parameters". In this case, the HTTP request body contains the new data (the content of the resource to be registered or created).

[0204] The request receiving unit 51 of interface 5, for example, accepts a URI and HTTP method received from application 6. The cooperation unit 52 of interface 5, for example, cooperates with the data management software 4 based on the URI and HTTP method accepted by the request receiving unit 51. For example, the cooperation unit 52 cooperates with the result providing unit 41 to obtain the corresponding measurement result based on the request (HTTP method "GET") for obtaining the measurement result from the sample measuring device 11 specified by the "Device ID" of the URI. The response unit 53 of interface 5 sends a response corresponding to the received URI and HTTP method to application 6.

[0205] Similarly, the request receiving unit 51A of interface 5A, for example, accepts the URI and HTTP method received from application 6. The cooperation unit 52A of interface 5A, for example, cooperates with the data management software 4A based on the URI and HTTP method accepted by the request receiving unit 51A. For example, the cooperation unit 52A cooperates with the data management software 4A to obtain the corresponding measurement result based on the request (HTTP method "GET") for obtaining the measurement result from the sample measuring device 11 specified by the "Device ID" of the URI. The response unit 53A of interface 5A sends a response corresponding to the received URI and HTTP method to application 6.

[0206] Examples of requests and responses to interfaces 5 and 5A are shown below. Figures 45-48 . Figure 45 An example of a request for / response to a request regarding information related to the sample measurement device 11. Figure 45 Examples are shown, for example, of (1) requests and responses to information inherent to the sample measuring device 11 or the system containing the sample measuring device 11, (2) requests and responses to information related to the state of the sample measuring device 11, and (3) requests and responses to information related to the operation of the sample measuring device 11. Examples of various types of information corresponding to the requests and responses are shown in Figure 45 The table contains various information related to requests and responses, but is not limited to the examples shown in the table. Interface 5, for example, can provide application 6 with information related to multiple sample measuring devices 11 (e.g., serial numbers of multiple sample measuring devices 11 installed in the testing room, error states of multiple sample measuring devices 11 installed in the testing room, etc.). Figure 46 An example of a request for / response to a request for information related to sample measurement. Figure 46Examples are shown, for example, of (1) requests and responses to information related to measurement results, (2) requests and responses to accuracy management measurements, and (3) requests and responses to information related to measurement sequence. Examples of various types of information corresponding to requests and responses are shown in Figure 46 The table contains various information related to requests and responses, but is not limited to the examples shown in the table. Interface 5, for example, can provide application 6 with information related to multiple sample measuring devices 11 (e.g., the results of multiple sample measuring devices 11 in the testing laboratory measuring samples during a specified period, the results of multiple sample measuring devices 11 in the testing laboratory measuring samples for accuracy management during a specified period, etc.). Figure 47 An example of a request for / response to a request for information related to the maintenance of the sample measuring device 11. Figure 47 Examples are shown, for example, of (1) requests and responses to information related to reagents, and (2) requests and responses to information related to maintenance and upkeep. Examples of various types of information corresponding to the requests and responses are shown in Figure 47 The table contains information related to requests and responses, but is not limited to the examples shown in the table. Figure 47 The "consumables" described in the documentation include, for example, cuvettes used in the measurement, cleaning solutions for cleaning the flow paths within the apparatus, and pipette tips. Interface 5 can, for example, aggregate information related to multiple sample measuring devices 11 (e.g., reagent balance information for multiple sample measuring devices 11 installed in the laboratory, maintenance schedule information for multiple sample measuring devices 11 installed in the laboratory, etc.) and provide it to application 6. Interface 5 can, for example, provide application 6 with the balance information for each of multiple types of reagents mounted on the sample measuring device 11 upon request. Application 6 can, for example, specify a particular reagent container among the multiple types of reagent containers mounted on the sample measuring device 11 and request its balance information. Interface 5 can, for example, provide application 6 with the balance information for the specified reagent container upon request. Figure 47 Examples of requests related to the operation of the sample measurement device 11. Figure 47 Examples of requests and responses related to (1) sample measurement operations, (2) maintenance and upkeep operations, and (3) operation of the sample measurement device 11 are shown. Examples of various information corresponding to the requests and responses are shown in Figure 47 The table contains various information corresponding to requests and responses, but is not limited to the examples shown in the table. Interface 5, for example, allows application 6 to aggregate operations performed on multiple sample measuring devices 11 (e.g., registering rerun / reflex rules for multiple sample measuring devices 11 located in the testing room, requesting start / stop for multiple sample measuring devices 11 located in the testing room, etc.). Figure 48In the example, as a response to an operation request, information indicating whether the operation has been completed is shown (e.g., ACK (Acknowledgement) for operation completion, and NACK (Negative Acknowledgement) for operation failure (e.g., error).

[0207] [PUSH Notification] Figure 49 This diagram illustrates an example of the configuration of a push notification from the data management software 4 of the sample measurement device 11 and the camera device 12 to the data management system 15. The interface 5 may include a notification unit 54 with push notification functionality. For example, when a specified event occurs, the notification unit 54 provides information corresponding to the event to the data management system 15 via the communication network 204 through a push notification. Figure 50 An example of an event and an example of the corresponding information (information that becomes the object of the PUSH notification) are shown. For example, the notification unit 54 provides the measurement result obtained by the sample measuring device 11 to the data management system 15. For example, the notification unit 54 provides information related to the operation performed on the sample measuring device 11 (e.g., reagent replacement, maintenance, information setting, etc.). For example, the notification unit 54 provides information related to the state change of the sample measuring device 11 (error occurrence, error resolution, etc.) to the data management system 15.

[0208] The notification unit 54 can replace interface 5 in the data management software 4. Alternatively, the notification unit 54 can be installed as independent software in the control unit 7, separate from interface 5 and data management software 4.

[0209] 〔application〕 Figure 51 This illustrates an example of the structure of application 6. Application 6 includes, for example, a function providing unit 61, a request unit 62, and a response receiving unit 63.

[0210] The function providing unit 61 provides functions for expanding the sample measurement system 1. The function providing unit 61 provides functions corresponding to the type of application 6. For example, depending on the type of application 6, the function providing unit 61 provides functions such as providing QC results (QC charts, etc.), managing the reagent balance mounted on the sample measurement device 11, managing errors generated in the sample measurement device 11, maintaining the sample measurement device 11, and managing the operation of the sample measurement device 11.

[0211] The function providing unit 61 may have the function of allowing users to log in using the account of the service provider provided by application 6. In this case, application 6 only provides the services of function providing unit 61 when the user logs in using the service provider's account.

[0212] For example, when information related to the sample measuring device 11 is needed, the function providing unit 61 requests the information from the requesting unit 62. The requesting unit 62 requests information from interfaces 5 and 5A based on the request from the function providing unit 61. As described above, the requesting unit 62 requests information, for example, through instruction C defined by a combination of URI and HTTP method. Furthermore, depending on the action of the function providing unit 61, for example, when control of the sample measuring device 11 is needed (e.g., registration and modification of setting information of the sample measuring device 11), the function providing unit 61 makes a request related to this control (e.g., a request for registration and modification of setting information) to the requesting unit 62. The requesting unit 62 makes this control-related request to interfaces 5 and 5A. As described above, the requesting unit 62 makes this control-related request, for example, through instruction C defined by a combination of URI and HTTP method. The requesting unit 62 generates instruction C including the URI based on the information provided by the function providing unit 61 and sends the request to interfaces 5 / 5A. For example, when a request is made for information related to the sample measuring device 11, the function providing unit 61 notifies the requesting unit 62 of an instruction related to the requested information (e.g., the measurement results of the sample measuring device 11 with a specific ID during a specified period). The requesting unit 62 generates an instruction C based on the notified instruction. The instruction from the function providing unit 61 to the requesting unit 62 is, for example, based on the user's operation in application 6. For example, when a user requests the measurement results obtained by the sample measuring device 11 with a specific ID on a specific date, the function providing unit 61 notifies the requesting unit 62 of an instruction corresponding to that request. When generating the instruction C, the requesting unit 62 generates the instruction C, for example, by referring to setting information related to the creation of the URI (e.g., the IP address of the server at the request destination). As setting information, the IP address of the server at the request destination can be set itself, or the URL (Uniform Resource Locator) of the server can be set. The IP address of the server at the request destination is, for example, the IP address of the control unit 7 of the sample measuring device 11 set in the testing laboratory, or the IP address of the data management system 15. When the address of the server to which the request is made is set by the URL, the request unit 62 queries the DNS (Domain Name System) for the IP address, for example, based on the domain name contained in the URL. The request unit 62 generates a URI based on the IP address notified from the DNS. The IP address or URL can be entered by the user via the GUI of application 6. The same applies to generating a URI or instruction C using the request unit 62 in the examples of the following applications.

[0213] The response receiving unit 63 receives the response corresponding to the request from the request unit 62 from the interfaces 5 and 5A, and passes the response content to the function providing unit 61.

[0214] [Examples of application] Figure 51 This illustrates an example configuration for application 6 as a reagent management application. The reagent management application, for example, possesses the functions of the aforementioned balance management unit 701 and / or reagent management unit 702. The reagent management application, for example, provides functions for managing the number of times reagent containers are replaced and the number of times they are reused. The function providing unit 61 of application 6 in this configuration example includes, for example, a device information acquisition unit 611, a reagent information acquisition unit 612, and a reagent information providing unit 613.

[0215] The device information acquisition unit 611 requests the request unit 62 to obtain information related to the sample measuring device 11, which is a reagent management object. For example, in order to obtain reagent information of the management object, the device information acquisition unit 611 requests the request unit 62 to obtain information related to the sample measuring device 11 on which the reagent is installed. For example, when application 6 is used in the laboratory, the device information acquisition unit 611 requests the request unit 62 to obtain information related to the sample measuring device 11 installed in the laboratory or other facilities 13 (e.g., the device ID of the sample measuring device 11, the name of the sample measuring device 11, etc.). The device information acquisition unit 611 may, for example, request the request unit 62 to obtain information related to a specific type of sample measuring device 11 among the multiple types of sample measuring devices 11 installed in the laboratory (e.g., information related to the type of sample measuring device 11, the device ID of the sample measuring device 11, the name of the sample measuring device 11, etc.). The request unit 62 generates a URI based on the request content from the device information acquisition unit 611, and requests information acquisition from interfaces 5 and 5A by using instruction C generated by combining the generated URI with the HTTP method "GET". The URI generated by request unit 62 is, for example, “http: / / 127.0.0.1:8080 / XR / / XXXX”. In this example URI, the “server address” is specified as “127.0.0.1:8080”, the “interface ID” is specified as “XR”, the “device ID” is not specified, the “resource” is specified as “XXXX”, and the “query parameters” are not specified. “XXXX” is the API endpoint corresponding to information related to the sample measuring device 11 (e.g., information related to the type of sample measuring device 11, the device ID of the sample measuring device 11, the name of the sample measuring device 11, etc.). The “server address” “127.0.0.1:8080” is, for example, the address corresponding to the interface 5A of the data management system 15 that manages information about multiple sample measuring devices 11. When there are multiple “server addresses”, multiple URIs can be generated (each URI corresponds to multiple addresses). The “interface ID” “XR” is set, for example, according to the type of sample measuring device 11 that is the object of information acquisition. Multiple URIs can be generated depending on the type of information requested. The response receiving unit 63 accepts the response corresponding to the request of the request unit 62 and transmits the accepted information to the device information acquisition unit 611.

[0216] The device information acquisition unit 611, for example, entrusts the request unit 62 to acquire and obtain information from... Figure 53 Information related to the sample measurement device 11 installed within the facility 13 selected by the illustrated GUI. For example... Figure 53As shown in the example, the function providing unit 61, for example, establishes a correspondence between the GPS (Global Positioning System) information of the terminal device 101 on which the application 6 is installed and the location on the map to display facility 13. The facility 13 displayed on the map is, for example, a facility that is set in the application 6 to be managed by the user of the terminal device 101. The function providing unit 61 may, for example, display a list for the user to select facilities 13 based on the information of the facilities 13 set in the application 6.

[0217] The reagent information acquisition unit 612, based on the information of the sample measuring device 11 acquired by the device information acquisition unit 611, requests the request unit 62 to acquire reagent-related information. For example, the reagent information acquisition unit 612 requests the request unit 62 to acquire reagent information for each sample measuring device 11. For example, the request unit 62 generates a URI based on the request and requests information acquisition from interfaces 5 and 5A using instruction C generated by combining the generated URI with the HTTP method "GET". The URI generated by the request unit 62 is, for example, "http: / / 127.0.0.1:8080 / XR / XR-20^AB123456^11000 / YYYY". In this URI, the "server address" is specified as "127.0.0.1:8080", the "interface ID" is specified as "XR", the "device ID" is specified as "XR-20^AB123456^11000", the "resource" is specified as "YYYY", and no "query parameters" are specified. "YYYY" is the API endpoint corresponding to the reagent information. For example, “YYYY” sets the API endpoint corresponding to the reagent balance information. “XR-20^AB123456^11000” as “Device ID” is set based on the information (Device ID of sample measuring device 11) obtained by the device information acquisition unit 611.

[0218] The reagent information acquisition unit 612 requests reagent-related information from the request unit 62 at a predetermined period (e.g., every minute, every 30 minutes, every hour, etc.). The reagent information acquisition unit 612 transmits the remaining reagent information acquired at the predetermined period to the reagent information providing unit 613. The reagent information providing unit 613 counts the number of times the remaining reagent in the container has been used up, for example, based on the information received from the reagent information providing unit 613. The reagent information providing unit 613 manages the number of times the remaining reagent has been used up as the number of times the reagent container needs to be replaced, for example.

[0219] The request unit 62 can generate multiple URIs corresponding to each of the multiple sample measuring devices 11. In this case, the request unit 62 generates a URI with a different "device ID" for each sample measuring device 11. Alternatively, for example, the request unit 62 can also request reagent information for multiple sample measuring devices 11 through a single URI. In this case, the "device ID" of the URI is enumerated, for example, by separating multiple device IDs with a prescribed separator (e.g., [ ], |, etc.). The response receiving unit 63 accepts the response corresponding to the request from the request unit 62 and transmits the accepted information to the reagent information acquisition unit 612.

[0220] The reagent information providing unit 613 provides reagent management-related information based on the information acquired by the reagent information acquisition unit 612. For example, the reagent information providing unit 613 provides reagent management-related information via a GUI. Figure 54 In the example of the GUI shown, the reagent information providing unit 613 provides the number of times each of the multiple reagents mounted in the multiple sample measuring devices 11 can be replaced. The reagent information providing unit 613, for example, provides a period set by the user (…). Figure 54 In the example, this refers to the cumulative number of replacements within the period "2024 / 11 / 4-11 / 8". The reagent information providing unit 613 provides, for example, the cumulative number of replacements in the facility during a set period. For example, the user can switch the display content of the replacement count by setting any period (e.g., daily, weekly, monthly, every 3 months, every half year, annually, etc.) via the GUI provided by the reagent information providing unit 613. The reagent information providing unit 613 counts the number of times the remaining reagent is used up, for example, based on the remaining reagent information obtained by the reagent information acquisition unit 612. The reagent information providing unit 613 counts the number of times the remaining reagent is used up, for example, according to a specified time (e.g., 1 hour). For example, the reagent information providing unit 613 manages the replacement count in a manner such as "the number of times reagent A in device IDxxx1 was replaced was twice between 9:00 am and 10:00 am on 2024 / 11 / 4". The reagent information providing unit 613 calculates the replacement count based on the user's... Figure 54 In the example, the number of counts managed in this way is totaled for the specified period and displayed in the GUI. For example, when the user sets the period to "2024 / 11 / 4", the reagent information providing unit 613 totals the number of counts for each specified period (e.g., 1 hour) of 2024 / 11 / 4.

[0221] exist Figure 55 In the example GUI shown, the reagent information providing unit 613 displays the number of reagent containers reused in each of the multiple sample measuring devices 11. The number of reagent containers reused is, for example, the number of reagent containers supplied to recycling companies.

[0222] The reagent information providing unit 613, for example, determines the number of reagent replacements as the number of reuses and displays it in the GUI. For example, such as... Figure 55 As shown in the example, the reagent information providing unit 613 can calculate the number of reuses based on the number of reagent replacements and display it in the GUI. For example, the reagent information providing unit 613 calculates the number of reuses by multiplying the number of reagent replacements by a predetermined coefficient. The predetermined coefficient is set, for example, based on the ratio of replaced reagent containers provided for reuse (e.g., "0.95"). The reagent information providing unit 613 can display the number of reuses within a period set by the user.

[0223] [Example of providing application functionality as a component of network services] Application 6 is not limited to being provided as standalone software executed on terminal device 101 and sample measurement device 11, but can also be provided as a network service.

[0224] Figure 56 This diagram illustrates an example of a network service that provides the functionality of application 6. In this example, the sample measurement system 1 includes a sample measurement device 11 equipped with a web browser 8, and a network service system 301 connected to the sample measurement device 11 and a communication network 205. The communication network 205 is, for example, the Internet. The sample measurement device 11 includes a measurement unit 2 and a control unit 7 having execution control software 3, data management software 4, an interface 5, and a processor 71 with a web browser 8.

[0225] The network service system 301 includes a control unit 302, which has a processor that executes a service function providing unit 6A that performs network service functions. The service function providing unit 6A has the same functions as application 6. The service function providing unit 6A includes, for example, a function providing unit 61A, a request unit 62A, and a response receiving unit 63A. The function providing unit 61A, request unit 62A, and response receiving unit 63A each have the same functions as the function providing unit 61, request unit 62, and response receiving unit 63.

[0226] In this configuration example, by accessing the service function provisioning unit 6A, which functions as a network service, in the web browser 8 of the sample measuring device 11, information and functions can be utilized via the interface 5 of the sample measuring device 11.

[0227] Figure 57 This figure illustrates another configuration example that provides the functionality of application 6 as a network service. In this configuration example, the sample measurement system 1 is configured to connect the sample measurement device 11, the network service system 301, the data management system 15, and the terminal device 101 equipped with a web browser 8 via the communication network 205.

[0228] In this configuration example, by accessing the service function provisioning unit 6A, which functions as a network service, in the web browser 8 of the terminal device 101, the information managed in the data storage 18 can be utilized via the interface 5A of the data management system 15.

[0229] Figure 58 This illustrates another configuration example that provides the functionality of application 6 as a network service. In the configuration example shown in this figure, the sample measurement system 1 is configured to connect the sample measurement device 11, the network service system 301, and the terminal device 101 equipped with a web browser 8 via a communication network 205.

[0230] In this configuration example, by accessing the service function provisioning unit 6A, which functions as a network service, in the web browser 8 of the terminal device 101, information and functions can be utilized via the interface 5 of the sample measurement device 11.

[0231] [Application delivery format] The provision format of application 6 is explained. Figure 59 This describes an example of the configuration of an application providing server 401 that provides application 6. The application providing server 401 is configured, for example, in the cloud and communicatively connected to the terminal device 101 and the control unit 7 via a communication network. The terminal device 101 and the control unit 7 are, for example, smartphones (iPhones, Android devices), tablets (iPads, Android tablets, Windows tablets), Windows PCs running Windows OS, and Macs running Mac OS. The application providing server 401 includes a control unit 402 with a processor that executes a download request receiving unit 403 and an application providing unit 404, and an application storage unit 405 that stores application 6.

[0232] The operator of the terminal device 101 and the control unit 7 logs into the designated download application (e.g., App Store, Google Play Store, Windows Store) using an account ID managed by the application provider (e.g., Apple ID, Google account, Microsoft account, etc.) and requests the required application 6 from the application provider server 401 through the download application.

[0233] The download request receiving unit 403, for example, notifies the application providing unit 404 of information related to the requested application 6. The application providing unit 404 retrieves and obtains the notified application 6 from the application storage 405 and sends it to the requesting source (terminal device 101 or control unit 7). The application providing unit 404 may, for example, send the installation program of application 6 to the requesting source (terminal device 101 or control unit 7). The terminal device 101 or control unit 7, upon receiving the installation program, installs application 6 based on the installation program.

[0234] Application provider server 401 can support multiple platforms (e.g., Windows, macOS, iOS, Android). Furthermore, multiple application provider servers 401 may exist depending on the platform. For example, there may be an application provider server 401 providing application 6 for iOS (e.g., an app store), an application provider server 401 providing application 6 for Android (e.g., Google Play Store), an application provider server 401 providing application 6 for Windows (e.g., Microsoft Store), etc. In this case, terminal device 101 and control unit 7 request application 6 in a method appropriate to the platform.

[0235] A terminal device 101 running iOS and a control unit 7, for example, request an application server 401 providing an application 6 for iOS to download the desired application 6 retrieved from a specified downloadable application (e.g., an app store). Similarly, a terminal device 101 running Android OS and a control unit 7, for example, request an application server 401 providing an application 6 for Android to download the desired application 6 retrieved from a specified downloadable application (e.g., the Google Play Store). Likewise, a terminal device 101 running Windows OS and a control unit 7, for example, request an application server 401 providing an application 6 for Windows to download the desired application 6 retrieved from a specified downloadable application (e.g., the Microsoft Store).

[0236] Depending on the medical facility, laboratory, etc., it is conceivable that the terminal device 101 and control unit 7 may not be connected to the Internet. In this case, for example, maintenance personnel can copy the installation program of application 6 to the terminal device 101 and control unit 7 from a medium containing the installation program of application 6 (e.g., CD (Compact Disc) / DVD (Digital Video Disk) / USB (Universal Serial Bus) storage / external HDD (Hard Disk Drives) / SSD), and install application 6 to the terminal device 101 and control unit 7.

[0237] Depending on the medical facility or laboratory, terminal device 101 and control unit 7 may only allow communication with the outside world within a secure communication network (e.g., VPN: Virtual Private Network). In this case, for example, application 6 may be distributed from a server capable of establishing a secure communication network with terminal device 101 and control unit 7. Figure 60 This illustrates a configuration example of providing application 6 in a secure communication environment. Furthermore, the secure communication environment includes an environment where the file distribution server 501 is located within the facility's intranet and can be accessed from the terminal device 101 and the control unit 7 via the intranet.

[0238] The file distribution server 501 includes a processor that executes the communication unit 502 and the information providing unit 503, and a storage unit 504 that stores data required for installing the application 6 (e.g., the installation program or the configuration file of the application 6). The communication unit 502 has, for example, VPN server functionality. The information providing unit 503 has, for example, network server functionality.

[0239] The terminal device 101 and the control unit 7 include processors that execute the communication client unit 91 and the information acquisition unit 92. The communication client unit 91, for example, has a VPN client function, establishing a secure communication network 206 between itself and the communication unit 502. The information acquisition unit 92 is, for example, a web browser.

[0240] The information acquisition unit 92 of terminal device 101 and control unit 7 accesses the information provision unit 503 of file distribution server 501 via secure communication network 206. The information provision unit 503 provides, for example, downloadable data to terminal device 101 and control unit 7 to the information acquisition unit 92. The information acquisition unit 92 displays this data on a webpage. The operator of terminal device 101 and control unit 7 selects the data they wish to download from the webpage, whereby the information provision unit 503 retrieves the corresponding data from storage 504 and sends it to the information acquisition unit 92. The information acquisition unit 92 installs application 6 based on the retrieved data.

[0241] Terminal device 101 and control unit 7 can download the installation program of application 6 via the Internet and use the installation program to install application 6.

[0242] [Web page clipping] Application 6 can provide the functionality of a web clip (a shortcut to a website) to terminal device 101 and control unit 7. The service provider, for example, notifies terminal device 101 and control unit 7 of the URL of the destination accessed as the web clip. The operator of terminal device 101 and control unit 7, for example, registers the notified URL as a web clip as a bookmark on the main screen or desktop of terminal device 101 and control unit 7. The operator of terminal device 101 and control unit 7, for example, can access the service provider's website through a web browser integrated in terminal device 101 and control unit 7, and access a menu offering the required services from that website, registering the site in that menu as a web clip as a bookmark.

[0243] System configuration example for using the functionality of application 6 for web page clipping and Figures 56-58 same. Figure 56 In the illustrated configuration example, by accessing a web service provided by a web service specified by a web clipping URL through the web browser 8 of the control unit 7, information and functions can be utilized via the interface 5 of the sample measurement device 11. Similarly, in Figure 57 In the illustrated configuration example, by accessing the service function provisioning unit 6A, which functions as a web service based on a URL specified by a web clip, through the web browser 8 of the terminal device 101, information managed in the data storage unit 18 can be utilized via the interface 5A of the data management system 15. Similarly, in Figure 58 In the configuration example shown, by accessing the service function providing unit 6A, which functions as a web service specified by a web clip, in the web browser 8 of the terminal device 101, information and functions can be utilized via the interface 5 of the sample measuring device 11.

[0244] [Provide applications via MDM / MAM] Application 6 may be provided without going through a designated application provider (e.g., app store, Google Play Store, Microsoft Store). For example, application 6 may be provided to terminal device 101 and control unit 7 without going through a designated application provider by using MDM or MAM mechanisms.

[0245] Figure 61This illustrates a configuration example of application 6 provided using an MDM or MAM. Terminal device 101 and control unit 7 are communicatively connected to MDM / MAM system 601 via communication network 207. Terminal device 101 and control unit 7 are registered with MDM / MAM system 601 and managed by MDM / MAM system 601 according to a management policy. For MDM / MAM system 601 to manage terminal device 101 and control unit 7, a management configuration file is installed on terminal device 101 and control unit 7, for example. For example, information for installing the management configuration file (e.g., a URL for downloading the installation program) is notified to terminal device 101 and control unit 7 (e.g., via email, etc.).

[0246] When the management configuration file is installed on the terminal device 101 and the control unit 7, the terminal device 101 and the control unit 7 are registered to the MDM / MAM system 601, and information related to the terminal device 101 and the control unit 7 is registered in the database 604 of the MDM / MAM system 601.

[0247] The MDM / MAM execution unit 603 obtains information about the application 6 installed on the terminal device 101 and the control unit 7, and registers it in the application list of the database 604. The MDM / MAM execution unit 603 can distribute the application 6 to the terminal device 101 and the control unit 7. The terminal device 101 and the control unit 7 install the distributed application 6. Thus, the application 6 can be provided without going through a designated application provider (application store, etc.).

[0248] The management function providing unit 602 provides management functions for the terminal device 101 and control unit 7 to the MDM / MAM management terminal 710. For example, the management function providing unit 602 provides the MDM / MAM management terminal 710 with a website for managing the terminal device 101 and control unit 7. Through this website, the operator of the MDM / MAM management terminal 710 can, for example, register and change management policies for the terminal device 101 and control unit 7, distribute application 6 to the terminal device 101 and control unit 7, and manage the application 6 installed on the terminal device 101 and control unit 7.

[0249] Figure 62 This is a diagram illustrating the data structure of database 604 when it is a relational database. As shown in the diagram, the information managed in database 604 includes, for example, user identification information, affiliated organization, device type, device identification information, policies, and application lists.

[0250] User identification information is information used to identify the user of the terminal device 101 and the control unit 7. For example, the ID assigned to the user from the MDM / MAM system 601, the user's name, and combinations thereof.

[0251] The organization to which the terminal device 101 and control unit 7 belong is the identification information of the organization to which they belong. For example, the ID assigned to the organization from the MDM / MAM system 601, the organization name, and combinations thereof.

[0252] Device type is information used to identify the device platform. For example, iOS, Android, Windows, Mac, etc.

[0253] Device identification information is the inherent identification information of the terminal device 101 and control unit 7, which are managed objects in the MDM / MAM system 601. For example, IMEI (International Mobile Equipment Identifier), serial number, SIM (Subscriber Identity Module) card number, telephone number, MAC (Media Access Control) address, and combinations thereof.

[0254] The policy is the management policy of the MDM / MAM system 601. For example, the configuration information of the management policy.

[0255] The application list contains information related to application 6 installed in the terminal device 101 and control unit 7 corresponding to user identification information. For example, it includes a list describing the identification information (application name, application ID) and application version of application 6.

[0256] This invention is not limited to the above-described embodiments, and various modifications can be made within the scope of the claims. Embodiments obtained by appropriately combining the technical means disclosed in different embodiments are also included within the technical scope of this invention.

[0257] The functions of the devices included in the sample measurement system 1 (especially the control unit 7, the data management system 15, and the terminal device 101) are programs that enable the computer to function as the device, and can be implemented through programs that enable the computer to function as the control blocks of the device. These programs are recorded in one or more computer-readable recording media, rather than being temporary.

[0258] [Symbol Explanation] 1 Sample Measurement System 2 Measurement Units 3 Control Software 4. 4A Data Management Software 5. 5A interface 6 Application Software 7 control units 11 Sample Measurement Device 21 Sample Processing Department 22 Testing Department 23 Reagent Preparation Department 61 Functional Provision Department Request Department 62 63 Response Receiving Department 230 First Reagent Container 231 First Opening and Closing Section 240 Second Reagent Container 242 Second Opening and Closing Section 700 Analysis Department 701 Balance Management Department 702 Reagent Management Department C commands R Rules

Claims

1. A sample measurement system, comprising: Measurement unit, used to measure samples; as well as The control unit analyzes the measurement data from the measurement unit; The measurement unit includes: The first reagent container holds a first reagent containing a substance that binds to the analyte in the sample; The reagent preparation unit is used to prepare the first reagent container; The sample processing unit mixes the first reagent and the sample to prepare a measurement sample; and The detection unit is used to detect the analyte by measuring the measurement sample; The measuring unit is mounted on the housing that contains the second reagent container. The second reagent container contains a second reagent, which is used to perform at least one of the following: (1) Cleaning of the flow path within the measurement unit; (2) Dilution of the sample (3) Preparation of the measured sample, (4) The measurement of the test sample by the detection unit. The second reagent container, housed within the housing, is connected to the measuring unit via an infusion tube. The control unit includes: The analysis unit generates measurement results by analyzing the measurement data acquired by the detection unit; and The Reagent Management Department manages the number of times the second reagent container is replaced, based on the remaining quantity in the second reagent container.

2. The sample measurement system according to claim 1, wherein The second reagent container is a container formed from recyclable materials.

3. The sample measurement system according to claim 1, wherein... The second reagent container is a resin-molded container.

4. The sample measurement system according to claim 1, wherein The second reagent container is a single-material container.

5. The sample measurement system according to claim 1, wherein The second reagent container is a container molded from polyethylene resin.

6. The sample measurement system according to claim 1, wherein Based on the number of replacements, the reagent management department estimates the number of second reagent containers that are recycled for reuse.

7. The sample measurement system according to claim 1, wherein The capacity of the second reagent container is greater than that of the first reagent container.

8. The sample measurement system according to claim 1, wherein... This includes multiple types of the first reagent containers corresponding to various types of measurement items. The second reagent contained in the second reagent container is shared by multiple actions of the measuring unit corresponding to each of the plurality of measuring items.

9. The sample measurement system according to claim 1, wherein The first reagent, contained in the first reagent container, is specifically used in the measurement unit to prepare the measurement sample.

10. The sample measurement system according to claim 1, wherein... This includes multiple types of the first reagent containers corresponding to various types of measurement items. Each of the first reagents contained in the plurality of first reagent containers is specifically used in the measuring unit to prepare the measurement sample for measuring the corresponding measurement item.

11. The sample measurement system according to claim 1, wherein The capacity of the second reagent container is between 2 liters and 25 liters.

12. The sample measurement system according to claim 1, wherein The capacity of the first reagent container is between 1 ml and 300 ml.

13. The sample measurement system according to claim 1, wherein The measurement unit includes: A first opening / closing part is used to place the first reagent container into the reagent placement part and to remove the first reagent container from the reagent placement part. The housing includes a second opening / closing portion for configuring the second reagent container and for removing the second reagent container.

14. The sample measurement system according to claim 1, wherein The measurement unit includes: A first opening / closing part is used to place the first reagent container into the reagent placement part and to remove the first reagent container from the reagent placement part. The housing includes: a second opening and closing part for configuring the second reagent container and removing the second reagent container; The second opening and closing part is positioned lower than the first opening and closing part.

15. The sample measurement system according to claim 1, wherein The second reagent container is provided in multiples in the housing.

16. The sample measurement system according to claim 1, wherein The second reagent container is provided in multiple forms in the housing. During the replacement of at least one of the plurality of second reagent containers, the measuring unit operates using the second reagent supplied from the other second reagent containers.

17. The sample measurement system according to claim 1, wherein The reagent management department manages the number of replacements for each facility equipped with at least one sample measuring device including the measuring unit and the control unit.

18. The sample measurement system according to claim 1, wherein The reagent management department manages information indicating whether the second reagent container disposed in the housing is a recycled product.

19. The sample measurement system according to claim 1, wherein The reagent management department manages the number of times the second reagent container, which is a recycled product, is used based on information indicating whether the second reagent container disposed in the housing is a recycled product.

20. A sample measuring device, comprising a measuring unit for measuring a sample and a control unit for analyzing measurement data from the measuring unit, and The measurement unit includes: The first reagent container holds a first reagent containing a substance that binds to the analyte in the sample; The reagent preparation unit is used to prepare the first reagent container; The sample processing unit mixes the first reagent and the sample to prepare a measurement sample; and The detection unit is used to detect the analyte by measuring the measurement sample; The measuring unit is mounted on the housing that contains the second reagent container. The second reagent container contains a second reagent, which is used to perform at least one of the following: (1) Cleaning of the flow path within the measurement unit; (2) Dilution of the sample (3) Preparation of the measured sample, (4) The measurement of the test sample by the detection unit. The second reagent container, housed within the housing, is connected to the measuring unit via an infusion tube. The control unit includes: The analysis unit generates measurement results by analyzing the measurement data acquired by the detection unit; as well as The Balance Management Department manages the balance of the second reagent container in order to manage the number of times the second reagent container is replaced.

21. The sample measuring device according to claim 20, wherein... The second reagent container is a container formed from recyclable materials.

22. The sample measuring device according to claim 20, wherein... The second reagent container is a resin-molded container.

23. The sample measuring device according to claim 20, wherein... The second reagent container is a single-material container.

24. The sample measuring apparatus according to claim 20, wherein The second reagent container is a container molded from polyethylene resin.

25. The sample measuring apparatus according to claim 20, wherein... The control unit estimates the number of the second reagent containers to be recycled for reuse based on the number of replacements.

26. The sample measuring device according to claim 20, wherein... The capacity of the second reagent container is greater than that of the first reagent container.

27. The sample measuring device according to claim 20, wherein... This includes multiple types of the first reagent containers corresponding to various types of measurement items. The second reagent contained in the second reagent container is shared by multiple actions of the measuring unit corresponding to each of the plurality of measuring items.

28. The sample measuring device according to claim 20, wherein... The first reagent, contained in the first reagent container, is specifically used in the measurement unit to prepare the measurement sample.

29. The sample measuring device according to claim 20, wherein... This includes multiple types of the first reagent containers corresponding to various types of measurement items. Each of the first reagents contained in the plurality of first reagent containers is specifically used in the measuring unit to prepare the measurement sample for measuring the corresponding measurement item.

30. The sample measuring device according to claim 20, wherein... The capacity of the second reagent container is between 2 liters and 25 liters.

31. The sample measuring device according to claim 20, wherein... The capacity of the first reagent container is between 1 ml and 300 ml.

32. The sample measuring device according to claim 20, wherein... The measurement unit includes: A first opening / closing part is used to place the first reagent container into the reagent placement part and to remove the first reagent container from the reagent placement part. The housing includes a second opening / closing portion for configuring the second reagent container and for removing the second reagent container.

33. The sample measuring device according to claim 20, wherein... The measurement unit includes: A first opening / closing part is used to place the first reagent container into the reagent placement part and to remove the first reagent container from the reagent placement part. The housing includes: a second opening and closing part for configuring the second reagent container and removing the second reagent container; The second opening and closing part is positioned lower than the first opening and closing part.

34. The sample measuring device according to claim 20, wherein... The second reagent container is provided in multiples in the housing.

35. The sample measuring device according to claim 20, wherein... The second reagent container is provided in multiple forms in the housing. During the replacement of at least one of the plurality of second reagent containers, the measuring unit operates using the second reagent supplied from the other second reagent containers.

36. The sample measuring device according to claim 20, wherein... The margin management department manages the margin in order to manage the number of replacements for each facility equipped with the sample measuring device.

37. The sample measuring device according to claim 20, wherein... The control unit manages information indicating whether the second reagent container disposed in the housing is a recycled product.

38. The sample measuring device according to claim 20, wherein... The control unit manages the number of times the second reagent container, which is a recycled product, is used based on information indicating whether the second reagent container disposed in the housing is a recycled product.

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