Sample measurement system and sample measurement device

Abstract

Manage the recycling of sample measurement devices. [Solution] The system includes a measurement unit (2) for measuring a sample and a control unit (7) for analyzing measurement data from the measurement unit (2). The measurement unit (2) includes a first reagent container (230) containing a first reagent containing a substance that binds to a test substance in the sample, 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 a test substance by measuring the measurement sample. The system is arranged on a housing (24) that houses a second reagent container (240). The second reagent container (240) contains a second reagent used to perform at least one of the following: cleaning the flow path in the measurement unit (7), diluting the sample, preparing a measurement sample, and measuring the measurement sample by the detection unit (22). The control unit (7) includes 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).

Description

Technical Field

[0001] The present invention relates to a system for performing specimen measurement and the like.

Background Art

[0002] In recent years, various efforts have been required to reduce environmental burdens. Such efforts include efforts to collect used products, recycle them, and create new products (so-called recycling). Patent Document 1 discloses a technique for discriminating the plastic composition of a beverage bottle, which is a plastic product, and discriminating whether the plastic product is recyclable.

Prior Art Documents

Patent Documents

[0003]

Patent Document 1

Summary of the Invention

Problems to be Solved by the Invention

[0004] Towards the realization of global goals for reducing environmental burdens (for example, SDGs: Sustainable Development Goals), in the field of specimen inspection as well, a mechanism for managing the recycling of products is required. Patent Document 1 discloses a technique related to the recycling of beverage bottles, but there is no disclosure regarding a mechanism for managing the recycling of a specimen measurement device that analyzes a specimen.

Means for Solving the Problems

[0005] A sample measurement system (1) according to one aspect of the present invention includes a measurement unit (2) for measuring a sample and a control unit (7) for analyzing measurement data from the measurement unit (2), wherein the measurement unit (2) includes a first reagent container (230) containing a first reagent containing a substance that binds to a test substance in the sample, a reagent placement section (23) for arranging the first reagent container (230), a sample processing section (21) for mixing the first reagent and the sample to prepare a measurement sample, and a detection section (22) for detecting the test substance by measuring the measurement sample, wherein the measurement unit (2) is arranged on a housing (24) that houses 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 (7), (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 a liquid delivery tube (241). The control unit (7) includes an analysis unit (700) that generates measurement results by analyzing the measurement data acquired 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).

[0006] Another aspect of the present invention relates to a sample measuring device (11), which includes a measuring unit (2) for measuring a sample and a control unit (7) for analyzing measurement data from the measuring unit (2), wherein the measuring unit (2) includes a first reagent container (230) for containing a first reagent containing a substance that binds to a test substance in the sample, a reagent placement unit (23) for arranging 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 test substance by measuring the measurement sample, and the measuring unit (2) is arranged on a housing (24) for 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 a liquid delivery tube (241). The control unit (7) includes an analysis unit (700) that generates measurement results by analyzing the measurement data acquired by the detection unit (22), and a remaining amount management unit (701) that manages the remaining amount of the second reagent container (240) for the purpose of managing the number of times the second reagent container (240) has been replaced. [Effects of the Invention]

[0007] According to the present invention, recycling related to sample measuring devices can be managed. [Brief explanation of the drawing]

[0008] [Figure 1] This diagram shows an overview of reagent container recycling. [Figure 2] This figure shows an example of the configuration of a sample measurement device. [Figure 3] This figure shows an example of the configuration of a sample measurement device. [Figure 4] This figure shows an example of the configuration of a sample measurement system. [Figure 5] This figure shows an example of the configuration of a sample measurement system. [Figure 6]It is a diagram showing a configuration example of a specimen measurement device. [Figure 7] It is a diagram showing a configuration example of a specimen measurement system. [Figure 8] It is a diagram showing a configuration example of a reagent container. [Figure 9] It is a diagram showing a configuration example of a specimen measurement device. [Figure 10] It is a diagram showing a configuration example of a specimen measurement device. [Figure 11] It is a diagram showing a configuration example of a reagent supply unit. [Figure 12] It is a diagram showing a configuration example of a reagent supply unit. [Figure 13] It is a flowchart showing an operation example of a remaining amount management unit. [Figure 14] It is a flowchart showing an operation example of a remaining amount management unit. [Figure 15] It is a diagram showing a configuration example of a specimen measurement device. [Figure 16] It is a diagram showing a configuration example of a reagent container. [Figure 17] It is a flowchart showing an operation example of a reagent management unit. [Figure 18] It is a diagram showing the components of a specimen measurement system. [Figure 19] It is a diagram showing a configuration example of a computer. [Figure 20] It is a diagram showing Configuration Example 1 of a specimen measurement system. [Figure 21] It is a diagram showing Configuration Example 2 of a specimen measurement system. [Figure 22] It is a diagram showing Configuration Example 3 of a specimen measurement system. [Figure 23] It is a diagram showing Configuration Example 4 of a specimen measurement system. [Figure 24] It is a diagram showing Configuration Example 5 of a specimen measurement system. [Figure 25] It is a diagram showing Configuration Example 6 of a specimen measurement system. [Figure 26] It is a diagram showing Configuration Example 7 of a specimen measurement system. [Figure 27] It is a diagram showing a hardware configuration example of a control unit. [Figure 28] This figure shows an example configuration of control software and data management software. [Figure 29] This figure shows a modified example of the control unit configuration. [Figure 30] This figure shows an example configuration when the measurement unit is a blood cell analyzer. [Figure 31] This is a schematic diagram illustrating the sample aspiration unit and sample preparation unit when supplying a measurement sample to the FCM detection unit. [Figure 32] This is a schematic diagram illustrating the sample aspiration and sample preparation sections when supplying a measurement sample to the RBC / PLT detection unit. [Figure 33] This is a schematic diagram illustrating the sample aspiration unit and sample preparation unit when supplying a measurement sample to the HGB detection unit. [Figure 34] This figure shows an example configuration when the measurement unit is a urine sample preparation device. [Figure 35] This figure shows an example of the configuration of the detection unit. [Figure 36] This figure shows an example configuration when the measurement unit is a blood coagulation analyzer. [Figure 37] This figure shows an example of the configuration of the light irradiation section of the detection unit. [Figure 38] This figure shows an example of the configuration of the optical detection unit of the detection section. [Figure 39] This diagram shows an example configuration when the measurement unit is an immunoassay analyzer. [Figure 40] This figure shows an example of the processing flow by the sample preparation unit. [Figure 41] This is a diagram showing an example of an interface configuration. [Figure 42] This is a flowchart illustrating an example of the processing flow through the interface of a sample measurement device. [Figure 43] This figure shows an example of the interface configuration for a data management system. [Figure 44] This figure shows an example of the data structure of an HTTP request body when updating lot information for quality control. [Figure 45]This figure shows examples of requests and responses regarding information about sample measurement devices. [Figure 46] This figure shows examples of requests for information regarding sample measurement and responses to those requests. [Figure 47] This figure shows examples of requests for and responses to information regarding the maintenance of sample measuring devices. [Figure 48] This figure shows examples of requirements regarding the operation of a sample measurement device. [Figure 49] This figure shows an example of a configuration for push notifications from a sample measurement device to a data management system. [Figure 50] This figure shows an example of an event and an example of the information corresponding to that event (information that will be sent as a push notification). [Figure 51] This figure shows an example of the application configuration. [Figure 52] This figure shows an example configuration when the application is a reagent management application. [Figure 53] This figure shows an example of a GUI that displays facilities on a map. [Figure 54] This figure shows an example of a GUI that provides information about reagent management. [Figure 55] This figure shows an example of a GUI that provides information about reagent management. [Figure 56] This diagram shows an example configuration where application functionality is provided as a web service. [Figure 57] This figure shows another example configuration where application functionality is provided as a web service. [Figure 58] This figure shows another configuration example where the functionality of an application is provided as a web service. [Figure 59] This diagram shows an example configuration of an application server that provides applications. [Figure 60] This figure shows an example configuration for providing an application in a secure communication environment. [Figure 61]This figure shows an example configuration for providing applications using MDM or MAM. [Figure 62] This diagram shows an example of a data structure when the database of an MDM / MAM system is a relational database. [Modes for carrying out the invention]

[0009] [First Embodiment] In this embodiment, as shown in the example in Figure 1, containers containing reagents used for measuring samples by the sample measuring device 11 are collected from the facility 13 where the sample measuring device 11 is installed. The collected reagent containers are recycled, and the recycled reagent containers are used in the sample measuring device 11. For example, the collected reagent containers are crushed and made into pellets. Reagent containers are then reshaped from the pellets to be recycled. The reshaped reagent containers are then reused as recycled products.

[0010] The amount of reagent containers, which are consumables, recycled by the facility 13 where the sample measuring device 11 is installed is an important indicator of whether the facility 13, for example a medical institution, has contributed to reducing its environmental impact. In this embodiment, as described later, it is possible to determine the amount of reagent containers recycled based on the number of times the reagent containers are replaced by the sample measuring device 11. In other words, the sample measuring system 1 using the sample measuring device 11 automatically determines the amount of recycling based on the number of times the reagent containers are replaced. By automating the determination of the amount of recycling based on the number of times the reagent containers are replaced, it is possible to reduce the workload on operators required to manage the number of replacements and the amount of recycling.

[0011] Figures 2 and 3 show an example of the sample measuring device 11 of this embodiment.

[0012] As illustrated in Figure 2, the sample measuring device 11 includes a measuring unit 2, a control unit 7, and a housing 24. The housing 24 is capable of accommodating reagent containers. For example, a used reagent container is removed from the housing 24 and replaced with a new one. The used reagent containers removed from the housing 24 are collected for recycling. For example, the reagent manufacturer or a contractor commissioned by the reagent manufacturer collects the used reagent containers. The collected reagent containers are provided, for example, to a manufacturer that produces reagent containers as recycled products. The manufacturer, for example, crushes the collected reagent containers into pellets. The manufacturer, for example, molds the pellets into reagent containers for recycling.

[0013] Figure 3 shows an example of the configuration of the sample measuring device 11.

[0014] The measurement unit 2 includes a sample processing unit 21, a detection unit 22, a reagent placement unit 23, and a first reagent container 230 placed in the reagent placement unit 23. The sample processing unit 21 prepares a measurement sample by mixing the sample with the first reagent contained in the first reagent container 230, for example. The sample is provided to the sample processing unit 21 by being drawn from a container containing the sample using a suction tube. The prepared measurement sample is supplied to the detection unit 22. The detection unit 22 measures the test substance contained in the measurement sample. The reagent placement unit 23 may accommodate multiple types of first reagent containers 230. For example, multiple types of first reagent containers 230 can be placed in the reagent placement unit 23 depending on the multiple types of measurement items that can be measured by the sample measuring device 11.

[0015] A second reagent container 240 is placed in the housing 24. The second reagent contained in the second reagent container 240 is supplied to the measurement unit 2 via the liquid delivery pipe 241. The second reagent contained in the second reagent container 240 is used to perform at least one of the following: (1) cleaning the flow path in the measurement 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 be shared for multiple measurement operations, for example, which correspond to multiple types of first reagent containers 230.

[0016] The control unit 7 is composed of, for example, one or more computers. These computers have a configuration similar to, for example, the computer 900 shown in Figure 19. The control unit 7 includes an analysis unit 700 and a remaining quantity management unit 701. The analysis unit 700 and the remaining quantity management unit 701 are functional blocks realized, for example, by the processor 71 of the computer 900 as the control unit 7, which reads a program from the storage unit 74, expands it into the memory 72, and executes it. The analysis unit 700 analyzes measurement data obtained by the detection unit 22 measuring the sample to be measured and generates measurement results. The remaining quantity management unit 701 manages the remaining quantity of the second reagent container 240, for example. The remaining quantity management unit 701 may also manage the remaining quantity of the first reagent container 230. The remaining reagent quantity managed by the remaining quantity management unit 701 is used, for example, to manage the number of times the second reagent container has been replaced. For example, the second reagent container is presumed to have been replaced when the remaining amount in the second reagent container falls below a predetermined amount (e.g., the amount at which virtually no second reagent remains in the container, the minimum amount required for the operation of the measurement unit 2, etc.). If the second reagent container is presumed to have been replaced, the number of replacements is increased.

[0017] For example, the second reagent container (used reagent container) removed from the housing 24 by replacement is placed in a designated disposal area by an operator at facility 13. A company that collects reagent containers then collects the reagent containers that have been placed in the designated disposal area.

[0018] The number of reagent containers recycled by facility 13 can be estimated from the number of times reagent containers are replaced. For example, if facility 13 follows operational rules that require used reagent containers removed from the housing 24 to be placed in a designated disposal area for recycling, the number of times reagent containers are replaced and the number of reagent containers recycled by facility 13 can be considered substantially the same. The management of the number of reagent replacements can be automated by the function of the sample measuring device 11 to monitor the remaining amount of reagents. By estimating the number of recycled reagent containers from the number of times reagent containers are replaced, the burden on facility 13 operators to manage the number of recycled reagent containers can be reduced. By estimating the number of recycled reagent containers from the number of times reagent containers are replaced, the burden on recycling companies to manage the number of collected reagent containers can be reduced. The method for estimating the number of recycled reagent containers is not limited; it may be estimated based on predetermined rules, or it may be estimated using statistical processing or artificial intelligence. Furthermore, the method for determining the number of recycled reagent containers is not limited to "estimation"; instead of "estimation," it may be "determined" or "calculated," for example.

[0019] Furthermore, the various data managed by the remaining capacity management unit 701 are stored in the memory unit 74 of the computer 900, which acts as the control unit 7.

[0020] Figure 4 shows an example of the sample measurement system 1 of this embodiment.

[0021] 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 information about reagents 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 remaining amount management unit 701 of the sample measurement device 11 transmits remaining amount information indicating the remaining amount of reagent containers to the data management system 15. Along with the remaining amount information, the remaining amount management unit 701 may also transmit a device ID for identifying the sample measurement device 11 and a facility ID for identifying facility 13 to the data management system 15. By transmitting the remaining amount information and the facility ID to the data management system 15, the data management system 15 can manage the remaining amount of reagent containers for each facility 13. By transmitting the remaining amount information and the device ID to the data management system 15, the data management system 15 can manage the remaining amount of reagent containers for each sample measurement device 11. The remaining amount management unit 701 transmits remaining amount information for each reagent container, for example, if the sample measuring device 11 has multiple reagent containers. The remaining amount information for each reagent container is transmitted along with a container ID for identifying the reagent container. By transmitting the remaining amount information and container ID to the data management system 15, the data management system 15 can manage the remaining amount for each reagent container.

[0022] The data management system 15 is composed of, for example, one or more computers. The computers have a configuration similar to, for example, the computer 900 shown in Figure 19. The data management system 15 may include various server devices such as a web server, a cloud server, and a storage server. The data management system 15 includes a reagent management unit 702. The reagent management unit 702 is a functional block realized, for example, by the processor 71 of the computer 900 as the data management system 15, which reads a program from the storage unit 74, expands it into memory 72, and executes it. The reagent management unit 702 manages the number of times reagent containers are replaced, for example, based on the remaining amount information obtained from the sample measuring device 11. For example, the reagent management unit 702 monitors whether the remaining amount in the reagent container has fallen below a predetermined amount (for example, the amount at which it is considered that there is virtually no second reagent remaining in the container, the minimum amount required for the operation of the measurement unit 2, etc.) based on the remaining amount information. The reagent management unit 702 adds the number of times the corresponding reagent container is replaced, for example, in response to the remaining amount falling below the predetermined amount. The reagent management unit 702 may manage the number of reagent container replacements for each facility 13 based on, for example, the facility ID transmitted from the remaining amount management unit 701 of the sample measuring device 11. The reagent management unit 702 may manage the number of reagent container replacements for each sample measuring device 11 based on, for example, the device ID transmitted from the remaining amount management unit 701 of the sample measuring device 11. The reagent management unit 702 may manage the number of replacements for each facility 13 and sample measuring device 11 based on, for example, the facility ID and device ID transmitted from the remaining amount management unit 701 of the sample measuring device 11.

[0023] The reagent management unit 702 estimates the number of recycled reagent containers (hereinafter sometimes referred to as "recycled number") based, for example, on the number of replacements. The reagent management unit 702 may also estimate the recycled number for each facility 13 based, for example, on the facility ID. The reagent management unit 702 may also estimate the recycled number for each sample measuring device 11 based, for example, on the device ID.

[0024] Furthermore, the various data managed by the reagent management unit 702 are stored in the storage unit 74 of the computer 900, which serves as the data management system 15.

[0025] Figure 5 shows another example configuration of the sample measurement system 1.

[0026] In the example shown in Figure 5, the reagent management unit 702 is mounted on the terminal device 101. The sample measuring device 11 transmits remaining amount information to the terminal device 101, for example, via the 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, and specifically includes a PC (personal computer), tablet, smartphone, etc. The terminal device 101 has a configuration similar to the computer 900 shown in Figure 19. When the terminal device 101 is used within the facility 13, for example, the sample measuring device 11 and the terminal device 101 are connected via the communication network 203 as an intranet. The terminal device 101 may also be used outside the facility 13, for example. When the terminal device 101 is used outside the facility 13, for example, the sample measuring device 11 and the terminal device 101 are connected via the communication network 203 as the Internet. The remaining amount management unit 701 of the sample measuring device 11 transmits remaining amount information indicating the remaining amount of reagent in the reagent container to the terminal device 101. The remaining amount management unit 701 may transmit the remaining amount information along with the device ID for identifying the sample measuring device 11 and the facility ID for identifying the facility 13 to the terminal device 101. By transmitting the remaining amount information and the facility ID to the terminal device 101, the terminal device 101 can manage the remaining amount of reagent containers for each facility 13. By transmitting the remaining amount information and the device ID to the terminal device 101, the terminal device 101 can manage the remaining amount of reagent containers for each sample measuring device 11. For example, if the sample measuring device 11 has multiple reagent containers, the remaining amount management unit 701 transmits the remaining amount information for each reagent container. The remaining amount information for each reagent container is transmitted along with, for example, the container ID for identifying the reagent container. By transmitting the remaining amount information and the container ID to the terminal device 101, the terminal device 101 can manage the remaining amount for each reagent container.

[0027] 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 a functional block realized, for example, when the processor 71 of the computer 900, which is the terminal device 101, reads a program from the storage unit 74, expands it into memory 72, and executes it. 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.

[0028] As shown in the example configuration in Figure 6, 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 a functional block realized, for example, by the processor 71 of the computer 900 acting as the control unit 7, which reads a program from the storage unit 74, expands it into the memory 72, and executes it. The reagent management unit 702 of the control unit 7 manages the number of times reagent containers are replaced based on the remaining amount information obtained from the remaining amount management unit 701 of the control unit 7. The reagent management unit 702 of the control unit 7 estimates the number of reagent containers to be recycled based on the number of times reagent containers are replaced. The 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 acting as the control unit 7.

[0029] The reagent management unit 702 of the control unit 7 may, 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 transmits, for example, the number of reagent replacements and / or recyclings to the terminal device 101 and / or the data management system 15. The reagent management unit 702 of the control unit 7 may, for example, transmit at least one of the above-mentioned container ID, facility ID, and device ID, along with the number of replacements and / or recyclings, to the terminal device 101 and / or the data management system 15. By coordinating with the terminal device 101 and / or the data management system 15, the management of the number of replacements and / or recyclings can be shared. For example, the reagent management unit 702 of the control unit 7 manages the number of replacements and / or recyclings at the sample measuring device 11, and the reagent management unit 702 of the data management system 15 manages the number of replacements and / or recyclings for each of the multiple facilities 13.

[0030] Figure 7 shows another example of the configuration of the sample measurement system 1.

[0031] The reagent management unit 702 of the data management system 15 transmits, for example, the number of exchanges for each facility 13 to at least one terminal device 101. The reagent management unit 702 may also manage, for example, the correspondence between facilities 13 and terminal devices 101. The terminal device 101 is, for example, the terminal device 101 of a company that collects used reagent containers, and it is assumed that the company is assigned a facility 13 to collect the reagent containers in advance. In such a case, the reagent management unit 702 manages, for example, the correspondence between the company's terminal device 101 and the facility 13 assigned to the company. Based on the correspondence between the terminal device 101 and the facility 13, the reagent management unit 702 transmits, for example, the number of exchanges for the facility 13 corresponding to the terminal device 101 to the terminal device 101. By transmitting the number of exchanges for the corresponding facility 13 to the terminal device 101, the company using the terminal device 101 can grasp the status of the accumulation of used reagent containers at the facility 13 it is responsible for. The supplier can determine whether or not to collect used reagent containers based on the accumulation status of used reagent containers (for example, if the number of accumulated reagent containers exceeds a predetermined number, the supplier will go to facility 13 to collect them). For example, the reagent management unit 702 may transmit to the terminal device 101 the number of exchanges at facility 13 at predetermined intervals (for example, daily, every three days, every week, etc.) rather than the cumulative number of exchanges. By transmitting the number of exchanges at predetermined intervals to the terminal device 101, the supplier can grasp the latest accumulation status of used reagent containers at facility 13.

[0032] Figure 8 shows an example of a reagent container to be recycled. Figure 8 shows an example of a second reagent container 240 as a container to be recycled.

[0033] The second reagent container 240 is manufactured, for example, by molding a recyclable material. For example, the second reagent container 240 is a monomaterial container. The second reagent container 240 includes, for example, a suction tube insertion port 2401, a main body 2402, and an outer casing member 2403. For example, the main body 2402 may be configured as a monomaterial container and be recyclable. The suction tube insertion port 2401 is, for example, a member for inserting a suction tube into the second reagent container 240 installed in the housing 24 to draw in the second reagent and deliver it to the liquid delivery tube 241. The main body 2402 may be covered with an outer casing member 2403. The outer casing member 2403 is made of, for example, cardboard.

[0034] The second reagent container 240 is molded from, for example, a resin. The second reagent container 240 is molded from, for example, a polyethylene-based resin. For example, the main body 2402 of the second reagent container 240 is molded from a polyethylene-based resin. Polyethylene-based resins include, for example, polyethylene terephthalate (PET) and polyethylene naphthalate (PEN). The main body 2402 of the second reagent container 240 may also be molded from, for example, plastic.

[0035] The first reagent container 230 may be recyclable. For example, the first reagent container 230 may be manufactured by molding a recyclable material. The first reagent container 230 may be, for example, a monomaterial container. The first reagent container 230 is molded from, for example, a polyethylene resin. Polyethylene resins include, for example, polyethylene terephthalate (PET) and polyethylene naphthalate (PEN). The first reagent container 230 may be molded from, for example, plastic.

[0036] The first reagent placed in the measurement unit 2 is used, for example, to measure a predetermined measurement item. For example, the first reagent contains a substance (e.g., an antibody) that specifically binds to a predetermined test substance (i.e., a predetermined measurement item) in the sample. For example, the substance that specifically binds to the test substance is labeled, and the detection unit 22 measures the predetermined test substance in the sample by detecting the labeled substance. For example, the first reagent contains a dye compound for staining the test substance corresponding to the measurement item. The detection unit 22 measures the test substance in the sample by detecting the fluorescence generated from the dye compound that stained the test substance in the sample. The measurement unit 2 is equipped with multiple types of first reagent containers for measuring multiple measurement items, for example. The multiple types of first reagent containers each contain a different first reagent, for example. For example, the second reagent can be shared in each of the multiple measurements using multiple types of first reagents. For example, the first reagent is used only for measurements of the corresponding measurement item, but the second reagent can be used in common for measurements of different measurement items. The first reagent is used, for example, exclusively for preparing the sample for measuring the corresponding parameter.

[0037] 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 a sample. The second reagent is used to clean the aspirated sample each time it is measured, for example, to prevent any sample remaining in the suction tube from being carried over to the measurement of the next sample. For example, in the measurement unit 2, the measurement sample prepared by mixing the sample with the first reagent is delivered to the detection unit 22 via the flow path. For example, the flow path through which the measurement sample is delivered is cleaned with the second reagent.

[0038] The second reagent is used, for example, in the measurement unit 2 to dilute the sample aspirated from the sample container by the suction tube. For example, the sample aspirated by the suction tube is discharged into a chamber provided in the sample processing unit 21. For example, the second reagent is supplied to the chamber from which the sample was discharged, and the sample is diluted.

[0039] The second reagent is used, for example, in the preparation of the measurement sample. For example, the measurement sample is prepared by mixing the sample and the second reagent. Alternatively, the measurement sample may be prepared by mixing the sample, the first reagent, and the second reagent. The second reagent is, for example, a reagent (hemolytic agent) for lysing red blood cells in the sample in the measurement unit 2 that performs the blood cell count test.

[0040] The second reagent is used, for example, when measuring the sample. For example, the detection unit 22 of the measurement unit 2 that performs a blood cell count test includes a flow cytometer. The second reagent is used, for example, as a sheath solution in the measurement of the sample using the flow cytometer.

[0041] 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 used for multiple measurement operations using multiple types of first reagents. Therefore, for example, the capacity of the second reagent container 240 is larger 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.

[0042] Figure 9 shows an example configuration of the enclosure 24.

[0043] For example, the measurement unit 2 is installed on the top surface of the housing 24. The housing 24 includes a second opening / closing section 242. When the second opening / closing section 242 is opened, the second reagent container 240 can be installed in the housing 24 and removed from the housing 24. The second reagent container 240 may be placed on a drawer provided in the housing 24. A suction tube (or tube) for supplying the second reagent to the measurement unit 2 is inserted into the suction tube insertion port 2401 of the second reagent container 240 placed in the housing 24. Even if the second opening / closing section 242 is opened, the sample measuring device 11 can continue to operate as long as the second reagent can be supplied to the measurement unit 2.

[0044] Figure 10 shows an example of the configuration of the first opening / closing section 231 of the measurement unit 2.

[0045] For example, the first opening / closing section 231 is located on the front of the measurement unit 2 (i.e., the side from which the laboratory operator can access the measurement unit 2). The measurement unit 2 is located on the housing 24. That is, the first opening / closing section 231 is located above the second opening / closing section 242. When the first opening / closing section 231 is opened, the operator can access the reagent placement section 23 for placing the first reagent container 230. When the first opening / closing section 231 is open, for example, the operation of the measurement unit 2 is stopped.

[0046] Figure 11 shows an example configuration of the reagent supply unit 2404 for supplying the second reagent from the housing 24 to the measurement unit 2.

[0047] The reagent supply unit 2404 includes a second reagent container 240, a sensor 244, and a liquid delivery tube 241. The second reagent contained in the second reagent container 240 is delivered to the measurement unit 2 via the liquid delivery tube 241, for example, by applying negative pressure from a pneumatic source. The sensor 244 can detect whether or not there is substantially any second reagent remaining in the second reagent container 240. Whether or not there is substantially any second reagent remaining in the second reagent container 240 means whether or not there is enough remaining amount of the second reagent to be drawn from the second reagent container 240 into the liquid delivery tube 241. For example, even if there is some second reagent remaining in the second reagent container 240, if the amount is not sufficient to draw the second reagent with the suction tube, it is determined that there is substantially no second reagent remaining. The sensor 244 is, for example, a sensor that monitors air bubbles. The sensor 244 determines, for example, the presence or absence of the second reagent being delivered in the liquid delivery tube 241 by monitoring the air bubbles in the liquid delivery tube 241. For example, if there is not enough second reagent remaining in the second reagent container 240 to be drawn in by the suction tube, the suction tube will draw in air, causing bubbles to flow into the liquid delivery tube 241. Sensor 244 detects such bubbles. For example, based on the detection of bubbles by sensor 244, the remaining amount management unit 701 determines that the second reagent container 240 is substantially empty.

[0048] The sensor 244 may be provided on the suction tube inserted into the second reagent container 240. For example, the sensor 244 may be provided on the suction tube as a liquid level sensor. The sensor 244 may, for example, have multiple electrodes of different lengths. For example, if there are two electrodes, the length of the electrode shorter than one of the electrodes is made to correspond 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 run out). With this configuration, when the liquid level in the second reagent container 240 falls below the length of the shorter electrode (i.e., when there is no liquid between the two electrodes), the current between the two electrodes is cut off. When the current between the electrodes is cut off, the sensor 244 detects that the liquid level has fallen below a predetermined height, and thereby determines that the remaining amount in the second reagent container 240 has run out.

[0049] Figure 12 shows another example of the configuration of the reagent supply unit 2404.

[0050] The reagent supply unit 2404 includes, for example, a plurality of second reagent containers 240, a sensor 244, and a switching unit 245. The reagent supply unit 2404 can supply the second reagent to the measurement unit 2 from another second reagent container 240 even if one of the plurality of second reagent containers 240 is being replaced. Therefore, the measurement unit 2 can continue measurement operations even if a used second reagent container 240 is being replaced. The switching unit 245 switches the supply source for supplying 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 in response to the remaining amount in one of the plurality of second reagent containers 240 running out. Due to the function of the switching unit 245, even if a used second reagent container 240 is removed from the housing 24 for recycling, the supply of the second reagent to the measurement unit 2 can continue without stopping the operation of the sample measuring device 11.

[0051] Figure 13 shows an example of how the remaining quantity management unit 701 manages the number of times the reagents need to be replaced.

[0052] The remaining amount management unit 701 monitors whether the amount of reagent in the reagent container has fallen below a predetermined amount (S10). For example, the remaining amount management unit 701 monitors whether the sensor 244 has detected that the amount remaining in the second reagent container has fallen below a predetermined amount (i.e., the amount has substantially run out). If the sensor 244 detects that the amount remaining in the second reagent container has fallen below a predetermined amount, the remaining amount management unit 701 determines that the reagent container has been replaced. For example, the remaining amount management unit 701 manages the number of replacements using a variable ("N"). The remaining amount management unit 701 increments the variable N in accordance with the fact that the amount remaining in the second reagent container has run out (S11). The remaining amount management unit 701 may also increment the variable N in accordance with the fact that a used reagent container has been removed and a new reagent container has been installed. For example, in accordance with the installation of a new second reagent container 240, the second reagent is drawn from the installed second reagent container 240 to confirm that the container has been properly installed. For example, when the second reagent is aspirated, the sensor 244 monitors for the presence of air bubbles in the liquid delivery tube 241. If no air bubbles are detected and the sensor 244 determines that the liquid delivery tube 241 is filled with the second reagent, the remaining amount management unit 701 determines, for example, that the second reagent container 240 has been replaced and increments the variable N.

[0053] The remaining quantity management unit 701 may, for example, manage the number of times reagent containers in the sample measuring device 11 are replaced at predetermined intervals (e.g., weekly, monthly, quarterly, yearly, etc.). The remaining quantity management unit 701 may, for example, manage the number of replacements for each device if multiple sample measuring devices 11 are installed in the facility 13. The remaining quantity management unit 701 may, for example, manage the sum of the number of replacements for each device as the total number of replacements for the facility 13. The remaining quantity management unit 701 may, for example, manage the number of replacements for each type of second reagent container if multiple types of second reagent containers subject to recycling are installed in the sample measuring device 11. The remaining quantity management unit 701 may, for example, manage the sum of the number of replacements for each type of second reagent container as the total number of replacements for the sample measuring device 11. The remaining quantity management unit 701 may, for example, manage the number of replacements for the first reagent container and the second reagent container respectively if the first reagent container is subject to recycling. The remaining quantity management unit 701 manages, for example, the sum of the number of times the first reagent container has been replaced and the number of times the second reagent container has been replaced as the number of replacements for the sample measuring device 11.

[0054] Figure 14 shows an example of the operation in which the remaining amount management unit 701 manages the number of times the reagent has been replaced. In the example in Figure 14, the remaining amount management unit 701 manages the remaining amount of the reagent container based on the number of measurements.

[0055] The remaining quantity management unit 701 monitors whether the measurement operation of the sample has been completed (S20). For example, the remaining quantity management unit 701 monitors the measurement operation by the sample measuring device 11 for each sample. The remaining quantity management unit 701 determines, for example, that the measurement operation of the sample has been completed when the measurement result of the sample has been obtained.

[0056] The remaining quantity management unit 701 manages the number of remaining tests in the reagent containers according to the completion of the measurement of the sample (S21). For example, the remaining quantity management unit 701 manages the number of remaining tests in at least one of the first reagent container and the second reagent container. The remaining quantity management unit 701 manages the remaining quantity information of the reagent for each reagent container under management, for example. For example, the initial value of the remaining quantity information is determined based on the capacity of the reagent container. For example, if the capacity of the reagent container is 20 liters, the initial value of the remaining quantity information will be 20 liters. The remaining quantity management unit 701 subtracts the amount of reagent (first reagent and / or second reagent) used in the measurement operation from the remaining quantity information, for example, according to the completion of the measurement operation. The remaining quantity management unit 701 has settings for the amount of reagent (first reagent and / or second reagent) used for each type of measurement operation. The remaining quantity management unit 701 determines the amount to be subtracted from the remaining quantity information according to the type of measurement operation that has been completed, for example. For example, if the amount of the second reagent used by the completed measurement operation is 50 ml, the remaining amount management unit 701 subtracts 50 ml from the remaining amount information.

[0057] The remaining quantity management unit 701 increments the reagent replacement count in accordance with when the reagent container runs out (if the answer is "YES" in S22). For example, the remaining quantity management unit 701 increments the variable N corresponding to the number of reagent container replacements in accordance with when the reagent container runs out (S23). Note that the process in S23 may also be executed if the answer is "YES" in S24, which will be described later.

[0058] The remaining amount management unit 701 resets the remaining amount information to its initial value (S25) in response to the reagent container being replaced (if the answer is "YES" in S24).

[0059] Figure 15 shows another example of the configuration of the sample measuring device 11. In the example in Figure 15, the sample measuring device 11 can read the information on the label 2430 attached to the reagent container using the reader 243.

[0060] As shown in the example in Figure 15, for example, a reader 243 is provided on the housing 24. The reader 243 may be provided on the measurement unit 2 or on the control unit 7. The reader 243 can read information from a label 2430 (e.g., a barcode, QR code®) as illustrated in Figure 16. The label 2430 may include information indicating whether the reagent container is a recycled product or not. The label 2430 may also include other information (e.g., lot information, manufacturing date, etc.).

[0061] Figure 17 shows an example of the operation in which the reagent management unit 702 of the control unit 7 manages whether or not the reagent container used by the sample measuring device 11 is a recycled product.

[0062] The reagent management unit 702 determines, for example, whether a reagent container is a recycled item based on the information read by the reader 243 (S30). The reagent management unit 702 determines, for example, whether a second reagent container is a recycled item based on the information read by the reader 243 when the second reagent container is replaced.

[0063] The reagent management unit 702 manages the number of times a recycled reagent container has been used (S31). For example, the reagent management unit 702 manages the number of times a recycled reagent container has been used based on a variable ("E") corresponding to the number of times a recycled reagent container has been used. For example, if the reagent management unit 702 determines in S30 that the second reagent container installed in the sample measuring device 11 is a recycled item ("YES"), it increments the variable E.

[0064] The reagent management unit 702 may transmit the number of times recycled products have been used to the data management system 15. The reagent management unit 702 of the data management system 15 manages, for example, the number of times recycled products have been used for each facility 13.

[0065] [Second Embodiment] As shown in Figure 18, the sample measurement system 1 according to this embodiment includes, for example, a measurement unit 2, control software 3, data management software 4, and an interface 5 as its components. The measurement unit 2 measures a sample and acquires measurement data. The control software 3 and the data management software 4 may be configured as a single 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.

[0066] 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 interface 5, as well as other devices and other software.

[0067] Measurement unit 2 measures the sample placed inside it and acquires data corresponding to the measurement result. An example of measurement unit 2 is a unit that performs measurements for blood cell analysis. Measurement unit 2 operates based on control by control software 3. Measurement unit 2 provides the acquired data to data management software 4 via control software 3.

[0068] The control software 3 works in conjunction with the data management software 4 to control the operation of the measurement unit 2. The control software 3 instructs the measurement unit 2 to perform measurement operations corresponding to the measurement order for the sample placed in the measurement unit 2. The control software 3 analyzes the data acquired by the measurement unit 2 and obtains measurement data, which is the measurement result.

[0069] The data management software 4 manages data related to the measurement unit 2. The data management software 4 has a function (e.g., UI: User interface) to provide the operator with measurement results acquired by the control software 3. The data management software 4 has functions related to device operation, such as registering and acquiring measurement orders, and functions to provide the control software 3 with information related to measurement orders. The data management software 4 may manage the data based on a classification according to the type of data related to the measurement unit 2. For example, the data management software 4 may classify and manage the data according to the type of measurement unit 2 it is working with. The type of measurement unit 2 is, for example, a unit that performs measurements for blood cell analysis. The control software 3 and the data management software 4 may be independent software. Software having equivalent functions to the control software 3 and equivalent functions to the data management software 4 may perform the control of the measurement unit 2 and the management of data related to the measurement unit 2.

[0070] The measurement unit 2, control software 3, and data management software 4 described above may require certification by a certification body as, for example, a medical device. Medical devices requiring certification include, for example, in vitro diagnostic medical devices. 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 a medical device is, for example, to measure a sample and provide measurement results. If the medical device is a blood cell analyzer, for example, to measure a blood sample and provide measurement results related to blood cells (e.g., red blood cell count, white blood cell count, white blood cell classification, etc.).

[0071] Application software (hereinafter simply referred to as "Application") 6 is software independent of control software 3 and data management software 4. Application 6 has functions that were incorporated into, for example, prior art software for devices for measuring samples. That is, Application 6 has functions that are separated from prior art software for devices for measuring samples. Application 6 may have new functions that were not incorporated into, for example, prior art software for devices for measuring samples. Application 6 can have the functions of the above-mentioned remaining amount management unit 701 and reagent management unit 702, and can provide functions for managing the number of times reagent containers are replaced, the amount of reagent containers recycled, and the amount of recycled reagent containers used. Application 6 provides functions that are different from, for example, functions corresponding to "Intended Use" of medical devices. Examples of Application 6 are software for non-medical healthcare applications (hereinafter referred to as "non-medical device software") and software that is not for healthcare applications (hereinafter referred to as "non-health software"). Non-medical device software and non-health software are software that does not require or requires limited certification as a medical device. However, Application 6 may be an application that requires certification as a medical device.

[0072] Application 6 can be added to the sample measurement system 1. In other words, Application 6 can be added on to the sample measurement system 1. Once added to the sample measurement system 1, Application 6 becomes a component of the sample measurement system 1. Application 6 added to the sample measurement system 1 provides, for example, functions that utilize information managed by the data management software 4 (e.g., data related to the measurement unit 2), and functions that utilize the functions of the data management software 4. The functions provided by Application 6 are, for example, functions that the data management software 4 does not have, and functions that extend the functions that the data management software 4 has. The functions provided by Application 6 are, for example, new functions that are different from the functions corresponding to the intended use as a medical device ("Intended Use"). In this way, Application 6 added to the sample measurement system 1 provides functions to extend the sample measurement system 1. In other words, it can be said that Application 6 added to the sample measurement system 1 provides functions that complement the data management software 4.

[0073] Since Application 6 is separate from the data management software 4 and the control software 3, Application 6 can be easily added to the sample measurement system 1 without modifying the data management software 4 or the control software 3. Moreover, if, for example, Application 6 is non-medical device software or non-health software that does not require certification as a medical device, there is no need to obtain certification from a certification body when adding Application 6. Similarly, there is no need to modify the data management software 4 or the control software 3 when removing Application 6 from the sample measurement system 1.

[0074] Application 6, which is separate from the data management software 4, can interact with the data management software 4 via interface 5. Interface 5 is, for example, a software interface. Interface 5 is, for example, an API (Application Programming Interface). Interface 5 allows application 6 to use information managed by the data management software 4 (for example, data related to the measurement unit 2, such as measurement data) and the functions of the data management software 4. Specifically, interface 5 receives requests from application 6 and provides a response to application 6 corresponding to those requests, thereby allowing application 6 to use, for example, data corresponding to the request or functions corresponding to the request. Requests from application 6 include, for example, requests to use data managed by the data management software 4 and requests to use functions of the data management software 4. Responses to application 6 include, for example, providing data corresponding to the request and providing functions corresponding to the request.

[0075] Application 6 interacts with Interface 5 according to predetermined rules (hereinafter referred to as "Rule R"). Based on Rule R, Interface 5 allows Application 6 to use information and functions related to the data management software 4. If Interface 5 is configured as a Web API, for example, Rule R is defined as a combination of a URI (Uniform Resource Identifier) ​​for specifying the processing target in a predetermined syntax and a predetermined HTTP (Hyper Text Transfer Protocol) method indicating an operation on the processing target. Based on Rule R, Application 6 creates a combination of a URI and an HTTP method that specifically identifies the processing target and the operation on the processing target as a request to Interface 5. Hereinafter, this request will also be referred to as "Command C". Application 6 sends Command C, created based on Rule R, to Interface 5. Interface 5 provides Application 6 with a response corresponding to Command C sent from Application 6. For example, based on a command C sent from application 6, interface 5 allows application 6 to use at least one of the following: data related to the measurement unit 2, data related to the measurement operation of the measurement unit 2, data related to the maintenance of the measurement unit 2, and data related to the operation of the measurement unit 2. Also, for example, based on a command C sent from application 6, interface 5 allows application 6 to perform at least one of the following actions: acquiring data related to the measurement unit 2, registering the data, updating the data, or deleting the data. For example, there may be multiple types of rules R depending on the type of sample measuring device 11. For example, the information management style of the data management software 4 and the data management system 15 may differ depending on the type of sample measuring device 11. In such a case, for example, by having interface 5 and application 6 cooperate based on multiple types of rules R corresponding to the information management style, application 6 can utilize multiple types of information, each with a different information management style.

[0076] Interface 5 may allow multiple types of applications 6 to utilize data related to the measurement unit 2 based on rules R commonly defined for multiple types of applications 6 that provide different functions from each other. Interface 5 may allow multiple types of applications 6 to utilize data related to the measurement unit 2 based on rules R commonly defined for multiple types of applications 6 that have been created for multiple types of operating systems.

[0077] Interface 5 may be incorporated into the data management software 4, or it may be incorporated into a separate software program. Interface 5 may be software independent of the data management software 4, the control software 3, and other software programs. Furthermore, the data management software 4 may consist of one software (e.g., one executable file) or multiple software (e.g., multiple executable files). For example, the software responsible for interface 5 and the software responsible for the data management software 4 may consist of multiple different executable files.

[0078] [Examples of software operating environments] The control software 3, data management software 4, interface 5, and application 6 are executed on, for example, one or more computers 900. Computers 900 are, for example, smartphones (iPhone, Android devices), tablets (iPad, Android tablets, Windows tablets), Windows PCs with Windows OS installed, and Macs with Mac OS installed (iPhone, iPad, Android, Windows, and Mac OS are registered trademarks). Furthermore, application 6 may be created for multiple types of operating systems. For example, a single application 6 may have separate versions for Windows OS and iOS.

[0079] Figure 19 shows an example configuration of computer 900. Computer 900, as an example, includes a processor 71, memory 72, bus 73, storage unit 74, display unit 75, interface 751, operation unit 76, interface 761, and communication unit 78. The terminal device 101 and control unit 7 have a similar configuration to computer 900 shown in Figure 19.

[0080] The storage unit 74 is a non-volatile memory such as an SSD (Solid State Drive), flash memory, HDD (Hard Disk Drive), or a combination thereof. The storage unit 74 stores various programs, including control software 3, data management software 4, interface 5, and application 6, as well as various data.

[0081] The processor 71 may be, for example, an IPU (Infrastructure Processing Unit), a CPU (Central Processing Unit), a GPU (Graphic Processing Unit), a DSP (Digital Signal Processor), an MPU (Micro Processing Unit), or a combination thereof. The processor 71 may also be implemented by, for example, a logic circuit. The processor 71 reads various programs from the storage unit 74, loads them into memory 72, and executes them. Memory 72 may be volatile memory such as RAM (Random Access Memory) or DRAM (Dynamic Random Access Memory).

[0082] Interface 751 connects bus 73 to display unit 75, such as a display. Interface 761 connects bus 73 to control unit 76, such as a keyboard or mouse. Communication unit 78 is responsible for communication with external devices.

[0083] In the following sections, in order to simplify the explanation of the operation of the control software 3, data management software 4, interface 5, or application 6, components corresponding to the processor 71, storage unit 74, and memory 72 for executing these may be omitted.

[0084] Furthermore, the computer 900 may be further equipped with communication interfaces for communicating with other devices. The computer 900 may also be further equipped with input / output interfaces for connecting input / output devices such as keyboards, mice, displays, and printers.

[0085] [Example of a sample measurement system configuration] [Configuration Example 1] Figure 20 shows an example configuration of the sample measurement system 1. In the example configuration shown in the figure, the sample measurement system 1 is configured as a sample measurement device 11 that includes a measurement unit 2, control software 3, data management software 4, interface 5, and a control unit 7 that executes application 6. In this example configuration, application 6 is executed on the sample measurement device 11 and utilizes the information and functions of the data management software 4 managed by the data management software 4 via interface 5.

[0086] [Configuration Example 2] Application 6 may be installed on a device different from the sample measuring device 11. In the example configuration shown in Figure 21, the sample measuring system 1 includes a sample measuring device 11 installed in a laboratory and a terminal device 101 connected to the sample measuring device 11 via a communication network 201. The terminal device 101 is used, for example, within the laboratory. The communication network 201 is, for example, an intranet.

[0087] The sample measurement device 11 includes a measurement unit 2, control software 3, data management software 4, and a control unit 7 that executes interface 5. The terminal device 101 is a computer used by users of the sample measurement system 1, and is, for example, a PC, smartphone, or tablet. The terminal device 101 is equipped with and executes application 6.

[0088] In this configuration example, application 6, which runs on terminal device 101, accesses interface 5 of sample measuring device 11 via communication network 201. Interface 5, via communication network 201, allows application 6 on terminal device 101 to use the information and functions of data management software 4.

[0089] [Configuration Example 3] The terminal device 101, which is equipped with application 6, may be used in a location different from the facility where the sample measuring device 11 is installed (for example, outside the laboratory, or in a different room within the same facility as the laboratory). In the configuration example shown in Figure 22, the sample measuring system 1 includes a sample measuring device 11 installed in the laboratory and a terminal device 101 used in a facility different from the laboratory and connected to the sample measuring device 11 via a communication network 202. The communication network 202 is, for example, the internet or an intranet. The sample measuring device 11 includes a measuring unit 2, control software 3, data management software 4, and a control unit 7 that executes interface 5. The terminal device 101 is equipped with application 6 and executes application 6.

[0090] In this configuration example, the application 6 executed on the terminal device 101 accesses the interface 5 of the sample measurement device 11 via the communication network 202. Interface 5, via the communication network 202, allows the application 6 on the terminal device 101 to use the information and functions of the data management software 4 managed by the data management software 4.

[0091] [Configuration Example 4] When a sample measuring device 11 is equipped with application 6, the application 6 installed on the sample measuring device 11 may access other sample measuring devices 11 and utilize the information managed by the data management software 4 of those other sample measuring devices 11 and the functions of said data management software 4. In the configuration example shown in Figure 23, the sample measuring system 1 is configured such that sample measuring devices 11, each comprising a measuring unit 2, control software 3, data management software 4, interface 5, and a control unit 7 that executes application 6, are connected to each other via a communication network 203. The communication network 203 is, for example, an intranet or the internet.

[0092] In this configuration example, an application 6 executed on a sample measuring device 11 can utilize the information and functions of the data management software 4 of the sample measuring device 11 via the interface 5 of the sample measuring device 11, and can also access the interface 5 of other sample measuring devices 11 connected via the communication network 203 and utilize the information and functions of the data management software 4 of those sample measuring devices 11.

[0093] [Configuration Example 5] The information managed by the data management software 4 (e.g., measurement data) may be managed by a device other than the sample measuring device 11. In the example configuration shown in Figure 24, the sample measuring system 1 includes a sample measuring device 11 and a data management system 15 connected to the sample measuring device 11 via a communication network 204. The communication network 204 is, for example, an intranet or the internet. The information managed by the data management software 4 (e.g., measurement data) may be managed by both the sample measuring 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 measuring device 11 may be managed by the data management system 15.

[0094] As shown in Figure 24, the sample measurement device 11 includes a measurement unit 2, control software 3, data management software 4, interface 5, and a control unit 7 that executes application 6. The sample measurement device 11 has a function for providing information managed by the data management software 4 to the data management system 15. As will be described in detail later, as an example of this function, interface 5 may, in response to a predetermined event, provide information corresponding to that event (such as measurement data) to the data management system 15 via push notification over the communication network 204. Push notifications may also be executed by entities other than interface 5 (for example, data management software 4, other software installed on the control unit 7). Instead of push notifications, the sample measurement device 11 may provide information managed by the data management software 4 to the data management system 15 as a response to an inquiry from the data management system 15. The provision of information to the data management system 15 is the same as in configuration examples 6 and 7 described later.

[0095] The data management system 15 includes, for example, data management software 4A, an interface 5A, and a control unit 17 that executes the communication control unit 16. The control unit 17 is equivalent to the processor 902 shown in Figure 2. The data management system 15 includes a data storage 18, which is a memory device. The data management software 4A stores and manages information pushed from the sample measuring device 11 in the data storage 18. The communication control unit 16 has the function of controlling communication related to push notifications from the sample measuring device 11.

[0096] Application 6 can communicate with data management software 4A via interface 5A. Data management software 4A retrieves data from data storage 18 corresponding to requests from application 6 received by interface 5A and provides it to the requesting application 6. Interface 5A has the function of allowing application 6, which is executed on the sample measuring device 11, to use information managed by data storage 18 via data management software 4A. Interface 5A is equivalent to interface 5, and is, for example, a software interface, typically an API. Interface 5A allows application 6 to use information managed by data management software 4A. Application 6 communicates with interface 5A based on rule R, and interface 5A, based on rule R, allows application 6 to use information and functions related to data management software 4A.

[0097] In this configuration example, as shown in Figure 24, the application 6 executed on the sample measuring device 11 accesses the interface 5A of the data management system 15 via the communication network 204 and requests the use of information stored in the data storage 18 of the data management system 15. The data management system 15 may be installed in a laboratory or medical facility, in which case the application 6 of the sample measuring device 11 accesses the interface 5A via the communication network 204, for example, as an intranet.

[0098] [Configuration Example 6] The information stored in the data storage 18 of the data management system 15 may be used by the application 6 executed on the terminal device 101. In the example configuration shown in Figure 25, the sample measurement system 1 consists of a sample measurement device 11, a data management system 15, and a terminal device 101 connected via a communication network 204.

[0099] In this configuration example, application 6, which runs on terminal device 101, accesses interface 5A of data management system 15 via communication network 204 and requests the use of information stored in data storage 18 of data management system 15. Application 6, which runs on terminal device 101, interacts with interface 5A based on rule R.

[0100] [Configuration Example 7] As a variation of Configuration Example 6, the sample measuring device 11 does not need to be equipped with data management software 4 and interface 5. The configuration example shown in Figure 26 is the same as Configuration Example 6, except that the sample measuring device 11 and imaging device 12 do not have data management software 4 and interface 5.

[0101] In this configuration example, the control software 3 controls the measurement unit 2, and the acquired measurement data and other information are transmitted to the data management system 15 via the communication network 204. The data management software 4A of the data management system 15 is then stored in the data storage 18. The application 6 executed on the terminal device 101 accesses the interface 5A of the data management system 15 via the communication network 204, similar to configuration example 6, and requests the use of the information stored in the data storage 18 of the data management system 15.

[0102] The control unit 7 is, for example, a computer. An example of the hardware configuration of the control unit 7 is shown in Figure 27. The control unit 7 includes, as an example, a processor 71, memory 72, bus 73, storage unit 74, display unit 75, interface 751, operation unit 76, interface 761, interface 77, and communication unit 78.

[0103] The processor 71 is a control unit that comprehensively controls the functions of the control unit 7. The processor 71 is equivalent to the processor 71 shown in Figure 2. The processor 71 reads, for example, the control software 3 and the data management software 4 from the storage unit 74, loads them into the memory 72, and executes them. The storage unit 74 is equivalent to the storage unit 74 shown in Figure 19. The memory 72 is equivalent to the memory 72 shown in Figure 19.

[0104] Interface 751 connects bus 73 to display unit 75, such as a display. Interface 761 connects bus 73 to operation unit 76, such as a keyboard or mouse. Interface 77 connects bus 73 to measurement unit 2. Communication unit 78 is responsible for communication with external devices.

[0105] [Example configuration of control software and data management software] Figure 28 shows an example 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 an analysis unit 32. The unit control unit 31 commands the measurement unit 2 to perform an operation corresponding to the measurement order of the sample to be measured. The analysis unit 32 analyzes the data acquired by the measurement unit 2, which has operated according to the command of the unit control unit 31, generates measurement data as a measurement result, and stores the generated measurement data in the storage unit 74.

[0106] The data management software 4 includes, for example, a results provision unit 41 and an operation unit 42. The results provision unit 41 has the function of acquiring measurement data generated by the analysis unit 32 from the storage unit 74 and providing the acquired measurement data to the operator (e.g., GUI: Graphical User Interface). The operation unit 42 has operational functions such as a function (UI) for the operator to register measurement orders / sample information, a function to acquire measurement orders and sample information from a clinical laboratory information system (LIS) and / or a hospital information system (HIS), a function to register measurement instructions based on measurement orders, various setting functions for the device and system, and registration of reagent information and consumable information. The information set and registered by the operation unit 42 is stored in the storage unit 74. The operational functions provided by the data management software 4 are, for example, the functions required for the intended use of the sample measuring device 11 approved as a medical device (e.g., the minimum functions required to measure a sample and provide measurement results specified for the intended use). The operational functions of the data management software 4 include, for example, the functions required for the intended use of the specimen measuring device 11 approved as a medical device, and additional functions to enhance user convenience. The operational functions of the data management software 4 can be expanded, for example, by adding applications 6.

[0107] As a variation, as shown in Figure 29, the control unit 7 of the sample measuring device 11 does not need to include data management software 4. The control unit 7 illustrated in Figure 29 is used, for example, in the system illustrated in Figure 26. In this example, the unit control unit 31 instructs the measurement unit 2 to perform an operation corresponding to a measurement order obtained from LIS / HIS, ​​for example. The analysis unit 32 analyzes the data obtained by the measurement unit 2, which operated according to the instructions of the unit control unit 31, generates measurement data as a measurement result, and transmits the generated measurement data to the data management system 15, for example via the communication unit 78.

[0108] [Measurement Unit] As described above, the measurement unit 2 includes, for example, a sample processing unit 21 and a detection unit 22. The sample processing unit 21 prepares a measurement sample based on the sample and reagent. 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 controls the operation of the sample processing unit 21 and the detection unit 22 in cooperation with the operation unit 42 of the data management software 4 (according to instructions from the operation unit 42). The unit control unit 31 controls the operation of the mechanisms and fluid circuits that constitute the sample processing unit 21 and the detection unit 22, for example. This operation control may include, for example, control of the aspiration operation of a liquid containing at least one of the sample and reagent, control of mixing the sample and reagent to prepare a measurement sample, control of causing the detection unit 22 to detect the measurement sample, and control of detecting at least one of optical information and electrical signals related to the measurement sample by the detection unit 22 and analyzing the measurement result based on the detected detection result.

[0109] [Hematology analyzer] Figure 30 shows an example configuration when the measurement unit 2 is a blood cell analyzer. 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.

[0110] Figure 31 is a schematic diagram illustrating the sample aspiration unit 211 and sample preparation unit 212 when supplying a measurement sample to the FCM detection unit 221. The sample aspiration unit 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 being moved up and down by a device mechanism (not shown). When the pump 2112 applies negative pressure with the nozzle 2111 inserted into the blood collection tube T, the blood sample is aspirated through the nozzle 2111. The device mechanism may also include a hand member for inverting and agitating the blood collection tube T before aspirating blood from the blood collection tube T.

[0111] The sample preparation unit 212 is equipped with five reaction chambers 212a to 212e. Each reaction chamber 212a to 212e is used in the DIFF, RET, WPC, PLT-F, and WNR measurement channels (also called measurement systems). Each reaction chamber is connected via a flow path to a hemolytic agent container containing a hemolytic agent, which is the reagent corresponding to the measurement channel, and a staining solution container containing a staining solution. A measurement channel is composed of one reaction chamber and the reagents (hemolytic agent and staining solution) connected to it. For example, the DIFF measurement channel corresponds to a measurement item that classifies leukocytes into multiple subgroups (5-part leukocyte classification), and is composed of DIFF hemolytic agent and DIFF staining solution, which are reagents for DIFF measurement, and a DIFF reaction chamber. The RET measurement channel corresponds to the measurement parameters related to reticulocytes, the WPC measurement channel corresponds to the measurement parameters related to abnormal white blood cells, the PLT-F measurement channel corresponds to the measurement parameters related to the optical measurement of platelets, and the WNR measurement channel corresponds to the measurement parameters related to white blood cells and nucleated red blood cells. These measurement channels are configured in the same way as the DIFF measurement channel.

[0112] The nozzle 2111, which has aspirated the blood sample, moves horizontally and vertically by the device mechanism to access from above the reaction chamber 212a to 212e corresponding to the measurement channel corresponding to the order, and discharges the aspirated blood sample. The sample preparation unit 212 supplies the corresponding hemolytic agent and staining solution to the reaction chamber from which the blood sample was discharged, and prepares the measurement sample by mixing the blood sample, hemolytic 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 the flow path, and cell measurement is performed by flow cytometry.

[0113] Figure 32 is a schematic diagram illustrating the sample aspiration unit 211 and sample preparation unit 212 when supplying a measurement sample to the RBC / PLT detection unit 222. The sample aspiration unit 211 is the same as the sample aspiration unit 211 shown in Figure 31. The sample preparation unit 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. The measurement sample is prepared by mixing the blood sample and the diluent in the reaction chamber 212f. The prepared measurement sample is supplied from the reaction chamber to the RBC / PLT detection unit 222 via the flow path.

[0114] Figure 33 is a schematic diagram illustrating the sample aspiration unit 211 and sample preparation unit 212 when supplying a measurement sample to the HGB detection unit 223. The sample aspiration unit 211 is the same as the sample aspiration unit 211 shown in Figure 31. The sample preparation unit 212 includes a reaction chamber 212g. The reaction chamber 212g is connected via a flow path to a hemolytic agent container containing a hemolytic agent, which is a reagent corresponding to HGB. The measurement sample is prepared by mixing the blood sample and the hemolytic agent in the reaction chamber 212g. The prepared measurement sample is supplied from the reaction chamber to the HGB detection unit 223 via the flow path.

[0115] [Urine formed component device] Figure 34 shows an example configuration when the measurement unit 2 is a urine sample preparation device. 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.

[0116] The sample preparation unit 214 aspirates a urine sample from the sample container using the sample aspiration unit 213. The sample aspiration unit 213 consists of a pipe-shaped suction tube. The sample preparation unit 214 prepares a measurement sample by mixing reagents with the urine sample aspirated by the sample aspiration unit 213. The reagents mixed with the urine sample are staining solutions containing dyes that stain the formed elements in the urine sample, or diluents.

[0117] The detection unit 22 measures the sample prepared by the sample preparation unit 214. An example of the configuration of the detection unit 22 is shown in Figure 35. The detection unit 22 comprises 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 flows the sample in one direction while surrounded by a sheath liquid. The light irradiation unit 224 is, for example, 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 224. The optical system 2240 guides the forward scattered light generated from formed elements in the flow cell 2250 to the optical detection unit 225A. The optical system 2240 guides the side scattered light and side fluorescence generated from formed elements to the optical detection units 225B and 225C, respectively.

[0118] The optical system 2240 includes a collimator lens 2241, a cylindrical lens 2242, a condenser lens 2243, a focusing lens 2244, a beam stopper 2245, a pinhole 2246, a focusing lens 2247, a dichroic mirror 2248, and an optical filter 2249.

[0119] The collimator lens 2241 converts the light emitted from the light irradiation unit 224 into parallel light. The cylindrical lens 2242 and the condenser lens 2243 shape the light that has passed through the collimator lens 2241 into a wide shape perpendicular to the flow of the sample being measured, and irradiate the sample flow in the flow cell 2250. As a result, forward scattered light is generated in front of the formed elements flowing in the flow cell 2250, and side scattered light and fluorescence are generated to the sides of the formed elements flowing in the flow cell 2250.

[0120] The focusing lens 2244 focuses the forward scattered light at the position of the pinhole 2246. The beam stopper 2245 blocks the light that has passed through the flow cell 2250 without irradiating the particles in the sample being measured. The optical detection unit 225A receives the forward scattered light that has passed through the pinhole 2246. The optical detection unit 225A includes, for example, a photodiode. The optical detection unit 225A amplifies the detection signal with an amplifier to generate a forward scattered light signal based on the forward scattered light, and outputs the generated forward scattered light signal.

[0121] The focusing lens 2247 focuses the lateral scattered light and fluorescence, respectively. The dichroic mirror 2248 reflects the lateral scattered light that has passed through the focusing lens 2247. The optical detection unit 225B receives the lateral scattered light reflected by the dichroic mirror 2248. The optical detection unit 225B includes, for example, a photodiode or a photomultiplier tube. The optical detection unit 225B amplifies the detection signal with an amplifier to generate a lateral scattered light signal based on the lateral scattered light, and outputs the generated lateral scattered light signal.

[0122] The dichroic mirror 2248 transmits the fluorescence that has passed through the focusing lens 2247. The optical filter 2249 removes light in wavelength bands that would be noise from the fluorescence that has passed through the dichroic mirror 2248. The optical detection unit 225C receives the fluorescence that has passed through the optical filter 2249. The optical detection unit 225C includes, for example, a photomultiplier. The optical detection unit 225C amplifies the detection signal with an amplifier to generate a fluorescence-based fluorescence signal and outputs the generated fluorescence signal.

[0123] The optical detection units 225 (225A, 225B, 225C) can switch between low and high sensitivity for light reception by switching the drive voltage during photoelectric conversion or by using an amplifier. Each of the optical detection units 225 (225A, 225B, 225C) generates and outputs signals for each light when the light reception sensitivity is low and signals for each light when the light reception sensitivity is high, respectively, while the sample to be measured flows through the flow cell 2250.

[0124] [Blood coagulation analyzer] Figure 36 shows an example configuration when the measurement unit 2 is a blood coagulation analyzer. 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.

[0125] The sample aspiration unit 215 aspirates a sample from the sample container. The sample preparation unit 216 mixes reagents with the sample aspirated by the sample aspiration unit 215 to prepare the measurement sample.

[0126] The detection unit 22 measures the sample prepared by the sample preparation unit 216. An example of the configuration of the light irradiation unit 226 of the detection unit 22 is shown in 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 one holding member 2263 for holding each light source 2260 and the incident end 2262 of each optical fiber section 2261. The light sources 2260, optical fiber sections 2261 and holding member 2263 are housed in, for example, a metal housing 2264.

[0127] Each of the multiple optical fiber sections 2261 contains multiple optical fibers 2265. At the exit end 2266, the multiple optical fiber sections 2261 corresponding to each light source 2260 are mixed and bundled together so that they are distributed substantially uniformly. Five optical fiber sections 2261 are twisted together and integrated midway, and are configured to have two exit ends 2266. The two exit ends 2266 are provided to correspond to the optical detection unit 227. The light irradiation unit 226 includes an optical distribution member 2267 for distributing the light from the bundled exit ends 2266.

[0128] Figure 38 shows an example of the configuration of the optical detection unit 227 of the detection unit 22. The optical detection unit 227 includes a container mounting portion 2271 as a hole extending in the vertical direction, and the output end 2268 of the light distribution member 2267 is positioned in a hole 2272 extending laterally from the container mounting portion 2271. A condensing lens 2273 is positioned inside the hole 2272. The light receiving portion 2274 is provided at the end of a hole 2275 that is formed to face the hole 2272 with the container mounting portion 2271 in between. As a result, the output end 2268 of the light distribution member 2267, the condensing lens 2273, the container mounting portion 2271, and the light receiving portion 2274 are arranged in a straight line. Light emitted from the emission end 2268 passes through the focusing lens 2273, through the container C containing the measurement sample in the container mounting section 2271, and through the measurement sample inside the container C, and is detected by the light receiving section 2274.

[0129] [Immunology analyzer] Figure 39 shows an example configuration when the measurement unit 2 is an immunoassay analyzer. 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.

[0130] The sample aspiration unit 217 aspirates a 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. An example of the processing flow by the sample preparation unit 218 will be explained with reference to Figure 40. In the primary reaction unit 2181, magnetic particles (R2 reagent) are bound to the capture antibody (R1 reagent) that is bound to the antigen contained in the sample aspirated by the sample aspiration unit 217. Then, the bound (bound) antigen, capture antibody, and magnetic particles are attracted to the magnet of the primary BF separation unit 2182, thereby removing the R1 reagent containing unreacted (free) capture antibody. Then, in the secondary reaction unit 2183, the antigen to which magnetic particles are bound is bound to the labeled antibody (R3 reagent). After that, the bound magnetic particles, antigen, and labeled antibody are attracted to the magnet in the secondary BF separation unit 2184, thereby removing the R3 reagent containing the unreacted (free) labeled antibody. Furthermore, in the secondary reaction unit 2183, a dispersion (R4 reagent) is added, followed by the addition of a luminescent substrate (R5 reagent) that emits light during the reaction process with the labeled antibody. Then, in the optical detection unit 228, the amount of light emitted during the reaction process between the labeled antibody of reagent R3 and the luminescent substrate of reagent R5 (an amount proportional to the number of photons) is acquired by a photomultiplier tube.

[0131] [Example of interface configuration] Interface 5 receives requests from Application 6 and, in cooperation with the data management software 4 (results provision unit 41 and operation unit 42), provides a response to Application 6 corresponding to the request. Figure 41 shows an example configuration of Interface 5. Interface 5 includes, as an example, a request receiving unit 51, a cooperation unit 52, and a response unit 53. The request receiving unit 51 receives requests from Application 6. The request receiving unit 51 analyzes the content of the request based on rule R and, based on the analyzed request, instructs the cooperation unit 52 to cooperate with the data management software 4 to obtain a response to the request. The cooperation unit 52 cooperates with the data management software 4 according to the instruction and obtains a response corresponding to the request. The response unit 53 provides the response obtained by the cooperation unit 52 to Application 6.

[0132] Figure 42 is a flowchart illustrating an example of the processing flow (cooperation method) by the interface 5 of the sample measuring device 11. First, the interface 5 awaits a request from the application 6 (S1). Upon receiving a request from the application 6 (Yes in S1), the interface 5 analyzes the content of the request based on rule R (S2). The interface 5 instructs the data management software 4 to perform the processing corresponding to the analyzed request (S3). The data management software 4 executes the processing according to the instruction. For example, if the result provision unit 41 of the data management software 4 receives a request from the application 6 for information regarding measurement results (e.g., measurement data measured by the measurement unit 2 of a specific sample measuring device 11, measurement results of quality control substances for a period specified in the request (e.g., daily, weekly, or monthly periods)), it identifies the data corresponding to the request and provides that information to the application 6 via the interface 5. The operation unit 42 of the data management software 4, for example, registers a measurement order in response to a registration request from the application 6 and provides the application 6 with a response via the interface 5 indicating that the registration is complete. Interface 5 returns a response to application 6 (S4) in response to the processing performed by data management software 4. This allows application 6 to utilize the data and functions corresponding to the request.

[0133] Figure 43 shows an example configuration of interface 5A of the data management system 15. Interface 5A includes, as an example, a request receiving unit 51A, a cooperation unit 52A, and a response unit 53A. The request receiving unit 51A receives requests from application 6 via the communication network 204. The request receiving unit 51A analyzes the content of the request and, based on the analyzed request, instructs the cooperation unit 52A to cooperate with the data management software 4A to obtain a response to the request. The cooperation unit 52A cooperates with the data management software 4A in accordance with the instruction and obtains a response corresponding to the request. The response unit 53A provides the response obtained by the cooperation unit 52A to application 6 via the communication network 204.

[0134] When interfaces 5 and 5A are configured as Web APIs, application 6 accesses interfaces 5 and 5A using the URI defined by rule R. An example of the syntax of the URI defined by rule R is shown in Equation 1.

[0135] 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 address and a port number.

[0136] Interfaces 5 and 5A may be configured, for example, according to the type of sample measuring device 11. In this case, the "interface ID" in Equation 1 is specified to identify interfaces 5 and 5A. 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 mandatory; if it is not specified, a wildcard (space, *, etc.) may be used. The interface ID corresponds, for example, to the type of rule R. For example, there are multiple types of rule R depending on the sample measuring device 11. In other words, the interface ID corresponds, for example, to the type of sample measuring device 11. For example, the information management style of the data management software 4 and the data management system 15 may differ depending on the type of sample measuring device 11. In such a case, for example, by having interfaces 5 / 5A and application 6 cooperate based on multiple types of rule R corresponding to the information management style, application 6 can utilize multiple types of information, each with a different information management style.

[0137] In Equation 1, "Device ID" is the ID of the sample measuring device 11 that will be using the information and functions. The Device ID is, for example, the serial number of the sample measuring device 11. Specifying "Device ID" in Equation 1 is not mandatory; if it is not specified, a wildcard (space, *, etc.) may be used.

[0138] In Equation 1, "resource" refers to the resource of the API endpoint. This resource is, for example, a directory in the database corresponding to the information to be used.

[0139] In Equation 1, the "query parameter" is a query used to uniquely identify data and control objects when multiple data and control objects exist on a resource. For example, it is used to identify measurement data from among multiple measurement data that meet the conditions specified by the query parameter (specific period, specific sample, measurement data where a measurement anomaly occurred). Specifying the "resource" in Equation 1 is not mandatory; if it is not specified, a wildcard (blank, *, etc.) can be used. The format for specifying the "resource" and "query parameter" may differ depending on the type of sample measuring device 11. For example, when acquiring "measurement data," the format for specifying the "resource" and / or "query parameter" for acquiring "measurement data" from a blood cell analyzer may differ from the format for specifying the "resource" and / or "query parameter" for acquiring "measurement data" from an immunoassay analyzer. Even for the same type of information, such as "measurement data," the resource as an API endpoint may differ depending on the type of sample measuring device 11, or specific query parameters may be required for each type of sample measuring device 11. In such cases, the format for specifying the "resource" and "query parameter" may differ depending on the type of sample measuring device 11. Since the format for specifying "resources" and "query parameters" is part of Rule R, in other words, "resources" and / or "query parameters" may be set based on multiple types of Rule R depending on the type of sample measuring device 11.

[0140] Operations on a resource specified by a URI are identified, for example, by an HTTP method. Examples of HTTP methods include "GET," "PUT," "DELETE," and "POST." Using "GET" retrieves the information specified by the "resource" and "query parameters" in the URI.

[0141] The "PUT" operation updates or edits the information specified by the "resource" and "query parameters" in the URI. In this case, the HTTP request body includes the new data (the content of the resource to be updated or edited). Figure 44 shows an example of the data structure of the HTTP request body when updating lot information for quality control. This example is written in JSON (JavaScript Object Notation) format (JavaScript is a registered trademark). For example, the URI = "http: / / 127.0.0.1:8080 / qcdata / qcLotsInfo?lotNumber=QC22421101" specifies the "server address" = "127.0.0.1" of the control unit 7 that is the target of the "PUT" operation (update). The QC (Quality Control) data held by the control unit 7 at "server address" = "127.0.0.1" is specified by "resource" = "qcdata". A "PUT" operation (update) is specified for the QC lot information with the "query parameter" = "QC22421101" (QC lot number) among 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 target and content of the "PUT" operation (update) for the specified QC lot information. This combination of URI and HTTP request body updates the specified QC lot information to: 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 for WBC (white blood cell count), RBC (red blood cell count), and HGB (hemoglobin concentration), quality control (QC) can be performed using the updated lower and upper limits. These lower and upper limits are also called control values ​​and are set to guarantee the accuracy of the measurement results and to prove the validity of the measurement method and its control method from the record of the measurement results. Furthermore, if the measurement result falls outside the lower or upper limit, it is also used as an indicator that the measurement result is abnormal or that the measurement was not performed correctly.

[0142] Using "DELETE" deletes the information specified in the "resource" and "query parameters" of the URI.

[0143] When registering or creating new information, use "POST" without specifying "Resource" and "Query Parameters." In this case, include the new data (the content of the resource to be registered or created) in the HTTP request body.

[0144] The request receiving unit 51 of interface 5 receives, for example, a URI and HTTP method from application 6. The cooperation unit 52 of interface 5 cooperates with the data management software 4 based on, for example, the URI and HTTP method received by the request receiving unit 51. For example, the cooperation unit 52 cooperates with the result provision unit 41 to obtain the corresponding measurement result in response to a request to acquire measurement results from the sample measuring device 11 specified by the "device ID" in the URI (HTTP method "GET"). The response unit 53 of interface 5 sends a response to application 6 corresponding to the received URI and HTTP method.

[0145] Similarly, the request receiving unit 51A of interface 5A receives, for example, a URI and HTTP method from application 6. The coordination unit 52A of interface 5A coordinates with data management software 4A based on, for example, the URI and HTTP method received by the request receiving unit 51A. For example, the coordination unit 52A coordinates with data management software 4A in response to a request to acquire measurement results from the sample measuring device 11 specified by the "device ID" in the URI (HTTP method "GET") and acquires the corresponding measurement results. The response unit 53A of interface 5A sends a response to application 6 corresponding to the received URI and HTTP method.

[0146] Examples of requests and responses to interfaces 5 and 5A are shown in Figures 45-48. Figure 45 shows an example of a request / response regarding information about the sample measuring device 11. Figure 45 shows examples of (1) requests and responses to information specific to the sample measuring device 11 or the system including the sample measuring device 11, (2) requests and responses regarding information about the status of the sample measuring device 11, and (3) requests and responses regarding information about the operation of the sample measuring device 11. Examples of various types of information corresponding to requests and responses are shown in the table in Figure 45, but the types of information corresponding to requests and responses are not limited to those shown in the table. Interface 5 can, for example, provide information about multiple sample measuring devices 11 (e.g., serial numbers of multiple sample measuring devices 11 installed in a laboratory, error status of multiple sample measuring devices 11 installed in a laboratory, etc.) to application 6 all at once. Figure 39 shows an example of a request / response regarding information about sample measurement. Figure 46 shows examples of (1) requests and responses regarding information on measurement results, (2) requests and responses regarding quality control measurements, and (3) requests and responses regarding measurement orders. Examples of various types of information corresponding to requests and responses are shown in the table in Figure 46, but the types of information corresponding to requests and responses are not limited to those shown in the table. Interface 5 can provide application 6 with information on multiple sample measuring devices 11 (for example, the results of multiple sample measuring devices 11 installed in a laboratory measuring samples over a predetermined period, the results of multiple sample measuring devices 11 installed in a laboratory measuring quality control samples over a predetermined period, etc.) all at once. Figure 47 shows examples of requests and responses regarding information on the maintenance of the sample measuring device 11. Figure 47 shows examples of (1) requests and responses regarding information on reagents, and (2) requests and responses regarding maintenance. Examples of various types of information corresponding to requests and responses are shown in the table in Figure 47, but the types of information corresponding to requests and responses are not limited to those shown in the table. The "consumables" listed in Figure 47 include, for example, cuvettes used for measurement, cleaning solutions for cleaning the flow paths within the device, pipette tips, etc.Interface 5 can provide application 6 with a collection of information regarding multiple sample measuring devices 11 (for example, reagent remaining amount information for multiple sample measuring devices 11 installed in a laboratory, maintenance schedule information for multiple sample measuring devices 11 installed in a laboratory, etc.). Interface 5 can, for example, provide application 6 with remaining amount information for each of several types of reagents installed in the sample measuring device 11 upon request. Application 6 can, for example, request remaining amount information for a specific reagent container from among several types of reagent containers installed in the sample measuring device 11. Interface 5 can, for example, provide application 6 with remaining amount information for a specified reagent container upon request for remaining amount information for a specified reagent container. Figure 47 shows examples of requests regarding the operation of the sample measuring device 11. Figure 47 shows examples of (1) requests and responses regarding sample measurement operations, (2) requests and responses regarding maintenance operations, and (3) requests and responses regarding the operation of the sample measuring device 11. Examples of various types of information corresponding to requests and responses are shown in the table in Figure 47, but the various types of information corresponding to requests and responses are not limited to the examples shown in the table. Interface 5 allows application 6 to execute a series of operations on multiple sample measuring devices 11 (for example, registering Rerun / Reflex rules for multiple sample measuring devices 11 installed in a laboratory, requesting the start / stop of multiple sample measuring devices 11 installed in a laboratory, etc.). In the example in Figure 48, the response to an operation request includes information indicating whether the operation has been completed or not (for example, an ACK corresponding to completion of the operation and a NACK corresponding to incomplete operation (e.g., an error)).

[0147] [PUSH notification] Figure 49 shows an example of the configuration for push notifications from the data management software 4 of the sample measuring device 11 and the imaging device 12 to the data management system 15. Interface 5 may include a notification unit 54 that has the function of making push notifications. The notification unit 54 provides information corresponding to a predetermined event to the data management system 15 via the communication network 204 by push notification when a predetermined event occurs. Figure 50 shows an example of an event and an example of information corresponding to the event (information that is the subject of push notification). For example, the notification unit 54 provides the measurement result to the data management system 15 when the measurement result of a sample is acquired by the sample measuring device 11. For example, the notification unit 54 provides information related to an operation to the data management system 15 when a predetermined operation (e.g., reagent replacement, maintenance, information setting, etc.) is performed on the sample measuring device 11. For example, the notification unit 54 provides information related to a change in the state of the sample measuring device 11 (e.g., error occurrence, error clearing, etc.) to the data management system 15.

[0148] The notification unit 54 may be provided in the data management software 4 instead of the interface 5. Alternatively, the notification unit 54 may be provided in the control unit 7 as software independent of the interface 5 and the data management software 4.

[0149] 〔application〕 Figure 51 shows an example configuration of application 6. Application 6 includes, for example, a function provisioning unit 61, a requesting unit 62, and a response receiving unit 63.

[0150] The function provision unit 61 provides functions to extend the sample measurement system 1. The function provision unit 61 provides functions according to the type of application 6. For example, depending on the type of application 6, the function provision unit 61 provides functions such as providing QC results (QC charts, etc.), managing the remaining amount of reagents installed in the sample measurement device 11, managing errors that occur in the sample measurement device 11, maintenance of the sample measurement device 11, and operation management of the sample measurement device 11.

[0151] The function provisioning unit 61 may have a function to allow the user to log in with the service provider's account for the services provided by application 6. In this case, application 6 will only provide the services provided by the function provisioning unit 61 when the user is logged in with the service provider's account.

[0152] For example, if information regarding the sample measuring device 11 is needed, the function providing unit 61 requests the requesting unit 62 to acquire such information. The requesting unit 62 requests information from interfaces 5 and 5A in response to the request from the function providing unit 61. The requesting unit 62 requests information using a command C defined by a combination of a URI and an HTTP method, as described above. Also, depending on the operation of the function providing unit 61, if control of the sample measuring device 11 (for example, registration and modification of the setting information of the sample measuring device 11, etc.) is required, the function providing unit 61 makes a request to the requesting unit 62 regarding such control (for example, a request for registration and modification of setting information, etc.). The requesting unit 62 makes a request regarding such control to interfaces 5 and 5A. The requesting unit 62 makes a request regarding such control using a command C defined by a combination of a URI and an HTTP method, as described above. The requesting unit 62 generates a command C including a URI based on the information provided by the function providing unit 61 and sends the request to interfaces 5 and 5A. For example, when requesting information about a sample measuring device 11, the function providing unit 61 notifies the requesting unit 62 of instructions regarding the requested information (for example, the results measured by a sample measuring device 11 with a specific ID during a predetermined period). The requesting unit 62 generates command C based on the notified instructions. Instructions from the function providing unit 61 to the requesting unit 62 are notified, for example, based on operations by the user of application 6. For example, if a user requests measurement results obtained by a sample measuring device 11 with a specific ID on a specific day, the function providing unit 61 notifies the requesting unit 62 of instructions corresponding to that request. When generating command C, the requesting unit 62 refers to, for example, configuration information related to the creation of a URI (for example, the IP address of the server to which the request is made) and generates command C. The configuration information may be the IP address of the server to which the request is made itself, or the server's URL (Uniform Resource Locator) may be set. The IP address of the server to which the request is made is, for example, the IP address of the control unit 7 of the sample measuring device 11 set up in the laboratory, or the IP address of the data management system 15.If the address of the server to which the request is made is set by a URL, the request unit 62 queries the DNS (Domain Name System) for the IP address based on, for example, the domain name included in the URL. The request unit 62 generates a URI based on the IP address notified by the DNS. The IP address or URL may also be entered by the user via the GUI of application 6. The generation of the URI and command C by the request unit 62 is the same in the application example described later.

[0153] The response receiving unit 63 receives responses corresponding to requests from the requesting unit 62 from interfaces 5 and 5A, and passes the response content to the function providing unit 61.

[0154] [Examples of applications] Figure 51 shows an example configuration when application 6 is a reagent management application. The reagent management application includes, for example, the functions of the remaining quantity management unit 701 and / or reagent management unit 702 described above. The reagent management application provides, for example, a function for managing the number of times reagent containers are replaced and recycled. The function providing unit 61 of application 6 in the example configuration includes, for example, an instrument information acquisition unit 611, a reagent information acquisition unit 612, and a reagent information providing unit 613.

[0155] The device information acquisition unit 611 requests the request unit 62 to acquire information about the sample measuring device 11 that is subject to reagent management. For example, in order to acquire reagent information to be managed, the device information acquisition unit 611 requests the request unit 62 to acquire information about the sample measuring device 11 on which the reagent is installed. For example, when application 6 is used in a laboratory, the device information acquisition unit 611 requests the request unit 62 to acquire information about the sample measuring device 11 installed in a facility 13 such as a laboratory (for example, 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 also request the request unit 62 to acquire information about a predetermined type of sample measuring device 11 from among several types of sample measuring devices 11 installed in the laboratory (for example, information about 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 from the device information acquisition unit 611, and requests information acquisition from interfaces 5 and 5A using a command 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 / / 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 an API endpoint corresponding to information about the sample measuring device 11 (for example, information about 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 interface 5A of the data management system 15 that manages information about multiple sample measuring devices 11. If there are multiple "server addresses," multiple URIs (each URI corresponding to one of the multiple addresses) may be generated. The "interface ID," "XR," is set, for example, according to the type of sample measuring device 11 from which information is to be acquired. Multiple URIs may be generated depending on the type of information requested.The response receiving unit 63 receives a response corresponding to the request from the requesting unit 62 and passes the received information to the device information acquisition unit 611.

[0156] The device information acquisition unit 611 requests the request unit 62 to acquire information about a specimen measuring device 11 installed in a facility 13 selected from the GUI illustrated in Figure 53. As shown in the example in Figure 53, the function provision unit 61 displays the facility 13 in correspondence with its location on a map, for example, based on the GPS (Global Positioning System) information of the terminal device 101 on which application 6 is installed. The facility 13 displayed on the map is, for example, a facility set in application 6 as a facility 13 to be managed by the user of the terminal device 101. The function provision unit 61 may also display a list for the user to select a facility 13 based on the facility 13 information set in application 6.

[0157] The reagent information acquisition unit 612 requests the request unit 62 to acquire information about reagents based on the information about the sample measuring device 11 acquired by the device information acquisition unit 611. For example, the reagent information acquisition unit 612 requests the request unit 62 to acquire information about each reagent of the sample measuring device 11. For example, the request unit 62 generates a URI in response to the request and requests information acquisition from interfaces 5 and 5A using command C, which is 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 the "query parameters" are not specified. "YYYY" is the API endpoint corresponding to reagent information. For example, "YYYY" is set to the API endpoint corresponding to the remaining amount information of the reagent. The "device ID", "XR-20^AB123456^11000", is set based on information acquired by the device information acquisition unit 611 (the device ID of the sample measuring device 11), for example.

[0158] The reagent information acquisition unit 612 requests the request unit 62 to acquire information about the reagent at predetermined intervals (e.g., every minute, every 30 minutes, every hour, etc.). The reagent information acquisition unit 612 passes the remaining amount information acquired at predetermined intervals to the reagent information provision unit 613. The reagent information provision unit 613 counts the number of times the reagent container has run out based on the information received from the reagent information provision unit 613. The reagent information provision unit 613 manages the number of times the remaining amount has run out as the number of times the reagent container has been replaced.

[0159] The request unit 62 may 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 request reagent information for multiple sample measuring devices 11 together with a single URI. In this case, the "device ID" of the URI may be, for example, multiple device IDs listed separated by a predetermined delimiter (e.g., [ ], |, etc.). The response receiving unit 63 receives a response corresponding to the request from the request unit 62 and passes the received information to the reagent information acquisition unit 612.

[0160] The reagent information provision unit 613 provides information related to reagent management based on the information acquired by the reagent information acquisition unit 612. The reagent information provision unit 613 provides information related to reagent management, for example, via a GUI. In the example GUI shown in Figure 54, the reagent information provision unit 613 provides the number of times multiple reagents installed in each of the multiple sample measuring devices 11 have been replaced. The reagent information provision unit 613 provides, for example, the cumulative number of replacements for a period set by the user (in the example in Figure 54, "2024 / 11 / 4-11 / 8"). The reagent information provision unit 613 also provides, for example, the cumulative number of replacements at the facility during the set period. For example, the user can switch the displayed content of the number of replacements by setting any period (for example, daily, weekly, monthly, every three months, every six months, every year, etc.) via the GUI provided by the reagent information provision unit 613. The reagent information provision unit 613 counts the number of times the remaining amount of reagent has run out, for example, based on the remaining amount information of the reagent acquired by the reagent information acquisition unit 612. The reagent information unit 613 counts, for example, the number of times the remaining amount of reagent has run out at predetermined intervals (e.g., every hour). For example, the reagent information unit 613 manages the number of replacements, such as "The number of times reagent A in device IDxxx1 was replaced between 9:00 am and 10:00 am on 2024 / 11 / 4 is 2." The reagent information unit 613 sums up the counts managed in this way according to the period set by the user in the example in Figure 54 and displays them on the GUI. For example, if the user sets the period to "2024 / 11 / 4", the reagent information unit 613 will sum up the counts for each predetermined period (e.g., every hour) on 2024 / 11 / 4.

[0161] In the GUI example shown in Figure 55, the reagent information unit 613 displays the number of reagent containers recycled in each of the multiple sample measuring devices 11. The number of reagent containers recycled refers to, for example, the number of reagent containers provided to a recycling company.

[0162] The reagent information unit 613, for example, determines the number of times a reagent has been replaced as the number of recycles and displays it on the GUI. The reagent information unit 613 may also calculate the number of recycles from the number of reagent replacements and display it on the GUI, for example, as shown in the example in Figure 55. For example, the reagent information unit 613 calculates the number of recycles by multiplying the number of reagent replacements by a predetermined coefficient. The predetermined coefficient is set, for example, based on the rate at which replaced reagent containers are provided for recycling (e.g., "0.95"). The reagent information unit 613 can display the number of recycles for a period set by the user.

[0163] [Example configuration for providing application functionality as a web service] The functionality of application 6 is not limited to being provided as standalone software executed on terminal device 101 and sample measuring device 11, but may also be provided as a web service.

[0164] Figure 56 shows an example configuration in which the functions of application 6 are provided as a web service. In the example configuration shown in the figure, the sample measurement system 1 includes a sample measurement device 11 equipped with a web browser 8, and a web service system 301 connected to the sample measurement device 11 via 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 control software 3, data management software 4, an interface 5, and a processor 71 that runs the web browser 8.

[0165] The Web service system 301 includes a control unit 302 having a processor that executes a service function provision unit 6A that functions as a Web service. The service function provision unit 6A has functions equivalent to those of application 6. The service function provision unit 6A includes, for example, a function provision unit 61A, a request unit 62A, and a response receiving unit 63A. The function provision unit 61A, the request unit 62A, and the response receiving unit 63A have functions equivalent to those of function provision unit 61, the request unit 62, and the response receiving unit 63, respectively.

[0166] In this configuration example, by accessing the service function provision unit 6A, which functions as a web service, via the web browser 8 of the sample measurement device 11, information and functions can be used through the interface 5 of the sample measurement device 11.

[0167] Figure 57 shows another configuration example in which the functions of application 6 are provided as a web service. In the configuration example shown in the figure, the sample measurement system 1 consists of a sample measurement device 11, a web service system 301, a data management system 15, and a terminal device 101 equipped with a web browser 8, all connected via a communication network 205.

[0168] In this configuration example, by accessing the service function provision unit 6A, which functions as a web service, using the web browser 8 of the terminal device 101, information managed by the data storage 18 can be used via the interface 5A of the data management system 15.

[0169] Figure 58 shows another configuration example in which the functions of application 6 are provided as a web service. In the configuration example shown in the figure, the sample measurement system 1 consists of a sample measurement device 11, a web service system 301, and a terminal device 101 equipped with a web browser 8, all connected via a communication network 205.

[0170] In this configuration example, by accessing the service function provision unit 6A, which functions as a web service, via the Web browser 8 of the terminal device 101, information and functions can be used through the interface 5 of the sample measurement device 11.

[0171] [Application delivery method] The delivery method for application 6 will now be described. Figure 59 shows an example configuration of an application delivery server 401 that provides application 6. The application delivery server 401 is located, for example, on the cloud and is connected to terminal devices 101 and control units 7 via a communication network. Terminal devices 101 and control units 7 are, for example, smartphones (iPhone, Android devices), tablets (iPad, Android tablets, Windows tablets), Windows PCs with Windows OS installed, and Macs with Mac OS installed. The application delivery server 401 includes a control unit 402 having a processor that executes a download request receiving unit 403 and an application delivery unit 404, and an application storage 405 that stores application 6.

[0172] The operators of the terminal device 101 and the control unit 7 log in to a designated download application (e.g., App Store, Google Play Store, Windows Store) using an account ID managed by an application provider (e.g., Apple ID, Google account, Microsoft account, etc.), and request the application provider server 401 to download the desired application 6 through that download application.

[0173] The download request receiving unit 403 notifies the application providing unit 404 of information regarding the requested application 6. The application providing unit 404 retrieves the notified application 6 from the application storage 405 and sends it to the requesting party (terminal device 101 or control unit 7). The application providing unit 404 may also send, for example, an installer for application 6 to the requesting party (terminal device 101 or control unit 7). The terminal device 101 or control unit 7, upon receiving the installer, installs application 6 based on the installer.

[0174] The application delivery server 401 may be multi-platform compatible (e.g., Windows, MacOS, iOS, Android). Furthermore, there may be multiple application delivery servers 401 depending on the platform. For example, there may be an application delivery server 401 providing applications 6 for iOS (e.g., the App Store), an application delivery server 401 providing applications 6 for Android (e.g., Google Play), and an application delivery server 401 providing applications 6 for Windows (e.g., the Microsoft Store). In this case, the terminal device 101 and the control unit 7 request the provision of applications 6 in a manner appropriate to the platform.

[0175] A terminal device 101 and control unit 7 equipped with iOS can request, for example, an application provision server 401 that provides iOS applications 6 to download a desired application 6 found using a predetermined download application (e.g., the App Store). Similarly, a terminal device 101 and control unit 7 equipped with Android OS can request, for example, an application provision server 401 that provides Android applications 6 to download a desired application 6 found using a predetermined download application (e.g., the Google Play Store). Similarly, a terminal device 101 and control unit 7 equipped with Windows OS can request, for example, an application provision server 401 that provides Windows applications 6 to download a desired application 6 found using a predetermined download application (e.g., the Microsoft Store).

[0176] In some medical facilities, such as laboratories, the terminal device 101 and control unit 7 may not be connected to the internet. In such cases, for example, a maintenance worker may copy the installer for application 6 from a medium containing the installer (e.g., CD / DVD / USB memory / external HDD / SSDD) to the terminal device 101 and control unit 7, and then install application 6 to the terminal device 101 and control unit 7.

[0177] In some medical facilities and laboratories, the terminal device 101 and control unit 7 may only be allowed to communicate with the outside world via a secure communication network (e.g., VPN: Virtual Private Network). In this case, for example, application 6 may be distributed from a server that can be configured to connect to the terminal device 101 and control unit 7 via a secure communication network. Figure 60 shows an example configuration for providing application 6 in a secure communication environment. Note that a secure communication environment includes an environment in which the file distribution server 501 is installed within the facility's intranet and accessible from the terminal device 101 and control unit 7 via the intranet.

[0178] The file distribution server 501 includes a processor that runs the communication unit 502 and the information provision unit 503, and storage 504 that stores data necessary for the installation of application 6 (e.g., installer and application 6 configuration files). The communication unit 502 has, for example, VPN server functionality. The information provision unit 503 has, for example, Web server functionality.

[0179] The terminal device 101 and the control unit 7 have processors that execute a communication client unit 91 and an information acquisition unit 92. The communication client unit 91 has, for example, a VPN client function and establishes a secure communication network 206 with the communication unit 502. The information acquisition unit 92 is, for example, a web browser.

[0180] The terminal device 101 and the information acquisition unit 92 of the control unit 7 access the information provision unit 503 of the file distribution server 501 via the secure communication network 206. The information provision unit 503 provides the information acquisition unit 92 with data that the terminal device 101 and the control unit 7 can download, for example. The information acquisition unit 92 presents this data on a web page. When the operators of the terminal device 101 and the control unit 7 select the data they wish to download from the web page, the information provision unit 503 retrieves the corresponding data from the storage 504 and transmits it to the information acquisition unit 92. The information acquisition unit 92 then installs the application 6 based on the retrieved data.

[0181] The terminal device 101 and the control unit 7 may download the installer for application 6 via the internet and install application 6 using the installer.

[0182] [Web clip] The functionality of application 6 may be provided to terminal device 101 and control unit 7 as a web clip (shortcut to a website). The service provider notifies terminal device 101 and control unit 7, for example, of the URL (Uniform Resource Locator) to which the web clip will be accessed. The operator of terminal device 101 and control unit 7 can, for example, bookmark the notified URL as a web clip on the home screen or desktop of terminal device 101 and control unit 7. The operator of terminal device 101 and control unit 7 can, for example, access the service provider's website using the web browser installed in terminal device 101 and control unit 7, access the menu that provides the desired service from that website, and bookmark the site of that menu as a web clip.

[0183] The system configuration examples for using the functions of application 6 with Web Clip are the same as those shown in Figures 56-58. In the configuration example shown in Figure 56, information and functions can be used via the interface 5 of the sample measuring device 11 by accessing the service function provider 6A, which functions as a Web service at the URL specified by Web Clip, using the Web browser 8 of the control unit 7. Similarly, in the configuration example shown in Figure 57, information managed by the data storage 18 via the interface 5A of the data management system 15 can be used by accessing the service function provider 6A, which functions as a Web service at the URL specified by Web Clip, using the Web browser 8 of the terminal device 101. Similarly, in the configuration example shown in Figure 58, information and functions can be used via the interface 5 of the sample measuring device 11 by accessing the service function provider 6A, which functions as a Web service at the URL specified by Web Clip, using the Web browser 8 of the terminal device 101.

[0184] [Providing applications via MDM / MAM] Application 6 may be provided without going through a designated application provider (e.g., Apple Store, Google Play Store, Microsoft Store). For example, Application 6 may be provided to the terminal device 101 and the control unit 7 without going through a designated application provider by utilizing an MDM (Mobile Device Management) or MAM (Mobile Application Management) mechanism.

[0185] Figure 61 shows an example configuration for providing application 6 using MDM or MAM. The terminal device 101 and the control unit 7 are connected to the MDM / MAM system 601 via a communication network 207. The terminal device 101 and the control unit 7 are registered with the MDM / MAM system 601 and managed by the MDM / MAM system 601 according to a management policy. In order to manage the terminal device 101 and the control unit 7 with the MDM / MAM system 601, for example, a management profile is installed on the terminal device 101 and the control unit 7. For example, information for installing the management profile (for example, a URL to download the installer) is notified to the terminal device 101 and the control unit 7 (for example, by email).

[0186] Once the management profile is installed on the terminal device 101 and the control unit 7, the terminal device 101 and the control unit 7 are registered with the MDM / MAM system 601, and information about the terminal device 101 and the control unit 7 is registered in the database 604 of the MDM / MAM system 601.

[0187] The MDM / MAM execution unit 603 acquires 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 then 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. This allows the application 6 to be provided without going through a predetermined application provider (such as the App Store).

[0188] The management function provider unit 602 provides the MDM / MAM management terminal 710 with management functions for the terminal device 101 and the control unit 7. For example, the management function provider unit 602 provides the MDM / MAM management terminal 710 with a website for managing the terminal device 101 and the control unit 7. Through this website, the operator of the MDM / MAM management terminal 710 can perform tasks such as registering and modifying management policies for the terminal device 101 and the control unit 7, distributing applications 6 to the terminal device 101 and the control unit 7, and managing applications 6 installed on the terminal device 101 and the control unit 7.

[0189] Figure 62 shows an example of the data structure of database 604 when database 604 is a relational database. As shown in the figure, the information managed in database 604 includes, for example, user identification information, affiliated organization, device type, device identification information, policies, and application lists.

[0190] User identification information is information used to identify users of terminal device 101 and control unit 7. For example, it may include an ID assigned to the user by the MDM / MAM system 601, the user's name, or a combination of these.

[0191] The affiliated organization is the identification information of the organization to which the terminal device 101 and the control unit 7 belong. For example, this includes the ID assigned to the organization by the MDM / MAM system 601, the organization name, or a combination thereof.

[0192] The device type is information used to identify the device's platform. For example, iOS, Android, Windows, Mac, etc.

[0193] Device identification information is unique to the terminal devices 101 and control unit 7 managed by the MDM / MAM system 601. Examples include IMEI (International Mobile Equipment Identifier), serial number, SIM (Subscriber Identity Module) card number, telephone number, MAC (Media Access Control) address, or combinations thereof.

[0194] The policy is a management policy provided by the MDM / MAM system 601. For example, it is the configuration information for the management policy.

[0195] The application list contains information about applications 6 installed on terminal device 101 and control unit 7, corresponding to user identification information. For example, it is a list describing the identification information of application 6 (application name, application ID) and the application version.

[0196] The present invention is not limited to the embodiments described above, and various modifications are possible within the scope of the claims. Embodiments obtained by appropriately combining the technical means disclosed in different embodiments are also included in the technical scope of the present invention.

[0197] The functions of each device included in the sample measurement system 1 (in particular, the control unit 7, the data management system 15, and the terminal device 101) can be realized by a program that causes the device to function as a computer, and by a program that causes the control block of the device to function as a computer. This program may be recorded on one or more computer-readable recording media, rather than temporarily. [Explanation of symbols]

[0198] 1 Sample measurement system, 2 Measurement unit, 3 Control software, 4, 4A Data management software, 5, 5A Interface, 6 Application software, 7 Control unit, 11 Sample measurement device, 21 Sample processing unit, 22 Detection unit, 23 Reagent placement unit, 61 Function provision unit, 62 Request unit, 63 Response reception unit, 230 First reagent container, 231 First opening / closing unit, 240 Second reagent container, 242 Second opening / closing unit, 700 Analysis unit, 701 Remaining volume management unit, 702 Reagent management unit, C Command, R Predefined rule

Claims

1. A measuring unit for measuring the sample, The control unit includes a control unit that analyzes the measurement data from the measurement unit, The aforementioned measuring unit is A first reagent container containing a first reagent containing a substance that binds to the test substance in the sample, A reagent placement section for arranging the first reagent container, A sample processing unit that mixes the first reagent and the sample to prepare a measurement sample, It includes a detection unit for detecting the test substance by measuring the measurement sample, The measurement unit is placed on a housing that contains the second reagent container, The second reagent container is, (1) Cleaning of the flow path in the measuring unit, (2) Dilution of the above sample, (3) Preparation of the measurement sample, (4) Measurement of the sample to be measured by the detection unit, It contains a second reagent used to perform at least one of the following: The second reagent container housed in the aforementioned housing is connected to the measurement unit via a liquid delivery tube. The control unit is An analysis unit generates measurement results by analyzing the measurement data acquired by the detection unit, A reagent management unit that manages the number of times the second reagent container is replaced based on the remaining amount in the second reagent container, Sample measurement system.

2. The aforementioned second reagent container is a container molded from recyclable material. The sample measurement system according to claim 1.

3. The aforementioned second reagent container is a container molded from resin. The sample measurement system according to claim 1.

4. The second reagent container is a monomaterial container. The sample measurement system according to claim 1.

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

6. The reagent management unit estimates the number of second reagent containers collected for recycling based on the number of replacements. The sample measurement system according to claim 1.

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

8. The system includes multiple types of the first reagent containers, each corresponding to one of the multiple types of measurement items. The second reagent contained in the second reagent container is used for multiple operations of the measurement unit corresponding to each of the multiple types of measurement items. The sample measurement system according to claim 1.

9. The first reagent contained in the first reagent container is used in the measurement unit exclusively for the preparation of the measurement sample. The sample measurement system according to claim 1.

10. The system includes multiple types of the first reagent containers, each corresponding to one of the multiple types of measurement items. Each of the first reagents contained in the plurality of first reagent containers is used in the measurement unit solely for the preparation of the measurement sample for measuring the corresponding measurement item. The sample measurement system according to claim 1.

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

12. The capacity of the first reagent container is 1 ml or more and 300 ml or less. The sample measurement system according to claim 1.

13. The measurement unit includes a first opening / closing section used for placing the first reagent container into the reagent placement section and removing the first reagent container from the reagent placement section. The housing includes a second opening / closing section used for arranging the second reagent container and removing the second reagent container. The sample measurement system according to claim 1.

14. The measurement unit includes a first opening / closing section used for placing the first reagent container into the reagent placement section and removing the first reagent container from the reagent placement section. The housing includes a second opening / closing section used for arranging the second reagent container and removing the second reagent container. The second opening / closing section is positioned below the first opening / closing section. The sample measurement system according to claim 1.

15. The second reagent container is arranged in multiple locations within the housing. The sample measurement system according to claim 1.

16. Multiple second reagent containers are arranged in the housing, During the replacement of at least one of the multiple second reagent containers, the measurement unit operates using the second reagent supplied from the other second reagent containers. The sample measurement system according to claim 1.

17. The reagent management unit manages the number of replacements for each facility where at least one sample measuring device including the measurement unit and the control unit is installed. The sample measurement system according to claim 1.

18. The reagent management unit manages information indicating whether the second reagent container installed in the housing is a recycled item. The sample measurement system according to claim 1.

19. The reagent management unit manages the number of times the recycled second reagent container has been used, based on information indicating whether or not the second reagent container installed in the housing is a recycled item. The sample measurement system according to claim 1.

20. A specimen measuring device comprising a measuring unit for measuring a specimen and a control unit for analyzing the measurement data from the measuring unit, The aforementioned measuring unit is A first reagent container containing a first reagent containing a substance that binds to the test substance in the sample, A reagent placement section for arranging the first reagent container, A sample processing unit that mixes the first reagent and the sample to prepare a measurement sample, It includes a detection unit for detecting the test substance by measuring the measurement sample, The measurement unit is placed on a housing that contains the second reagent container, The second reagent container is, (1) Cleaning of the flow path in the measuring unit, (2) Dilution of the above sample, (3) Preparation of the measurement sample, (4) Measurement of the sample to be measured by the detection unit, It contains a second reagent used to perform at least one of the following: The second reagent container housed in the aforementioned housing is connected to the measurement unit via a liquid delivery tube. The control unit is An analysis unit generates measurement results by analyzing the measurement data acquired by the detection unit, Includes a remaining amount management unit for managing the remaining amount of the second reagent container in order to manage the number of times the second reagent container has been replaced, Sample measuring device.

21. The aforementioned second reagent container is a container molded from recyclable material. The specimen measuring device according to claim 20.

22. The aforementioned second reagent container is a container molded from resin. The specimen measuring device according to claim 20.

23. The second reagent container is a monomaterial container. The specimen measuring device according to claim 20.

24. The aforementioned second reagent container is a container molded from polyethylene resin. The specimen measuring device according to claim 20.

25. The control unit estimates the number of second reagent containers collected for recycling based on the number of replacements. The specimen measuring device according to claim 20.

26. The capacity of the second reagent container is greater than the capacity of the first reagent container. The specimen measuring device according to claim 20.

27. The system includes multiple types of the first reagent containers, each corresponding to one of the multiple types of measurement items. The second reagent contained in the second reagent container is used for multiple operations of the measurement unit corresponding to each of the multiple types of measurement items. The specimen measuring device according to claim 20.

28. The first reagent contained in the first reagent container is used in the measurement unit exclusively for the preparation of the measurement sample. The specimen measuring device according to claim 20.

29. The system includes multiple types of the first reagent containers, each corresponding to one of the multiple types of measurement items. Each of the first reagents contained in the plurality of first reagent containers is used in the measurement unit solely for the preparation of the measurement sample for measuring the corresponding measurement item. The specimen measuring device according to claim 20.

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

31. The capacity of the first reagent container is 1 ml or more and 300 ml or less. The specimen measuring device according to claim 20.

32. The measurement unit includes a first opening / closing section used for placing the first reagent container into the reagent placement section and removing the first reagent container from the reagent placement section. The housing includes a second opening / closing section used for arranging the second reagent container and removing the second reagent container. The specimen measuring device according to claim 20.

33. The measurement unit includes a first opening / closing section used for placing the first reagent container into the reagent placement section and removing the first reagent container from the reagent placement section. The housing includes a second opening / closing section used for arranging the second reagent container and removing the second reagent container. The second opening / closing section is positioned below the first opening / closing section. The specimen measuring device according to claim 20.

34. The second reagent container is arranged in multiple locations within the housing. The specimen measuring device according to claim 20.

35. Multiple second reagent containers are arranged in the housing, During the replacement of at least one of the multiple second reagent containers, the measurement unit operates using the second reagent supplied from the other second reagent containers. The specimen measuring device according to claim 20.

36. The remaining quantity management unit manages the remaining quantity in order to manage the number of replacements for each facility where the sample measuring device is installed. The specimen measuring device according to claim 20.

37. The control unit manages information indicating whether the second reagent container installed in the housing is a recycled item. The specimen measuring device according to claim 20.

38. The control unit manages the number of times the recycled second reagent container has been used, based on information indicating whether or not the second reagent container installed in the housing is a recycled item. The specimen measuring device according to claim 20.

Images