Automatic analysis device
The automated analyzer restricts maintenance software activation by user authority, preventing malfunctions and wear, ensuring reliable operation and accuracy.
Patent Information
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- HITACHI HIGH TECH CORP
- Filing Date
- 2025-07-18
- Publication Date
- 2026-07-02
Smart Images

Figure JP2025025763_02072026_PF_FP_ABST
Abstract
Description
Automated analyzer
[0001] The present invention relates to an automated analyzer.
[0002] An automated analyzer that analyzes specimens such as blood and urine provided by patients may be operated by users in various positions. If all users are permitted to perform various operations on the automated analyzer, problems such as equipment failure and excessive wear may occur.
[0003] Here, Patent Document 1 discloses restricting the operable range according to the operation authority set for each user position and displaying a screen for allowing the user to confirm whether the operation authority is granted for a specific operation.
[0004] Japanese Patent No. 4765295
[0005] In Patent Document 1, consideration for restricting the activation of other software from the software that executes the analysis operation is insufficient. Regular maintenance is required to maintain the analysis accuracy of the automated analyzer, and software that executes the maintenance operation is used. If the software that executes the maintenance operation is activated by a general user, the automated analyzer may malfunction, so it is preferable to restrict the activation as necessary.
[0006] Therefore, an object of the present invention is to provide an automated analyzer capable of restricting the activation of other software from the software that executes the analysis operation.
[0007] An automated analyzer according to an aspect of the present invention includes a storage unit that stores a first software that is software for executing an analysis operation, a second software that is software for executing a maintenance operation, and an authority table in which a user ID and an authority level are associated, and a control unit that restricts the activation of the second software from the first software based on a collation result obtained by collating the user ID of the user logged in to the first software with the authority table.
[0008] According to the present invention, it is possible to provide an automated analyzer capable of restricting the activation of other software from the software that executes the analysis operation.
[0009] A schematic diagram showing an example of the configuration of an automated analyzer. A diagram showing an example of the configuration of a control device. A diagram showing an example of the process flow for restricting the startup of the SSW. A diagram showing an example of a user table, a privilege table, and a startup software table. A diagram showing an example of a settings screen for each privilege level. A diagram showing an example of a system configuration screen. A diagram showing an example of the process flow after the startup of the SSW. A diagram showing an example of a user table for the SSW.
[0010] A preferred embodiment of the automated analyzer according to the present invention will be described below with reference to the attached drawings. In the following description and attached drawings, components having the same functional configuration will be denoted by the same reference numerals to avoid redundant explanations.
[0011] An example of the overall configuration of the automated analyzer 100 will be explained using Figure 1. The automated analyzer 100 is a device that analyzes samples such as blood and urine provided by patients, and comprises an incubator 1, an SR disk 3, a dispensing unit 9, a washing tank 13, a reagent stirring unit 14, a spectrophotometer 15, a detection unit 16, a transport unit 17, a water supply tank 24, a waste liquid tank 25, and a control device 30. Each part will be described below.
[0012] The incubator 1, which is a reaction disk, has reaction vessels 2 arranged around its circumference, into which samples and reagents are dispensed. The incubator 1 rotates to move the reaction vessels 2 to positions accessible by the dispensing unit 9 and the transport unit 17, as well as to the position of the spectrophotometer 15. The incubator 1 is also maintained at a predetermined temperature. Unused reaction vessels 2 are held in a container tray 20 and transported from the container tray 20 to the incubator 1 by the transport unit 17.
[0013] The SR disk 3 stores the sample container 5 and the reagent bottle 4. The sample container 5 contains the sample provided by the patient, and the reagent bottle 4 contains multiple reagents to be reacted with the sample. The SR disk 3 rotates to move the sample container 5 to the sample aspiration port 7, which is the position accessed by the dispensing unit 9, and the reagent bottle 4 to the reagent aspiration port 6. The reagents in the reagent bottle 4 are also stirred by the reagent stirring unit 14 as needed.
[0014] The dispensing unit 9 has a dispensing nozzle used for dispensing samples and reagents, and moves between the SR disk 3 and the incubator 1 along an arc-shaped trajectory indicated by a dotted line. A dispensing pump 11 is connected to the dispensing nozzle, and the dispensing pump 11 drives the dispensing nozzle to draw up samples from the sample container 5 and reagents from the reagent bottle 4, respectively, and dispenses the drawn-up samples and reagents into the reaction vessel 2. After dispensing the samples and reagents, the dispensing nozzle is washed in a washing tank 13 located on the arc-shaped trajectory. Pure water used to wash the dispensing nozzle is supplied from a water supply tank 24, and the waste liquid generated by washing is stored in a waste liquid tank 25. Multiple dispensing units 9 may be provided.
[0015] In the reaction vessel 2 from which the sample and reagents are dispensed, the reaction between the sample and reagents is promoted by maintaining the incubator 1 at a predetermined temperature, thereby generating a reaction solution.
[0016] The spectrophotometer 15 includes, for example, a light source that irradiates the reaction solution with light and a detector that detects the light transmitted through the reaction solution, and measures the absorbance of the reaction solution in the reaction vessel 2. The measurement results from the spectrophotometer 15 are transmitted to the control device 30.
[0017] The detection unit 16 has a photodetector such as a photomultiplier tube and performs optical measurements to detect the labeled substance contained in the reaction solution. The reaction vessel 2 is transported from the incubator 1 by the transport unit 17 to the detection unit 16, and the first liquid is supplied from the first liquid bottle 26 by the drive of the first liquid pump 28. By mixing the first liquid with the reaction solution, electrochemiluminescence or chemiluminescence occurs, and the labeled substance is detected by measuring the amount of these emissions with the photodetector. The detection results from the detection unit 16 are transmitted to the control device 30. After the optical measurement, the detection unit 16 is supplied with cleaning solution from the cleaning solution bottle 27 by the drive of the cleaning solution pump 29.
[0018] A dispensing tip 18 may be attached to the tip of the dispensing nozzle to suppress contamination during dispensing. Unused dispensing tips 18 are held in a tip tray 19 and transported from the tip tray 19 to the tip mounting position 22 by the transport unit 17. Dispensing tips 18 used for dispensing are discarded into the waste box 21 through the tip waste port 23. The reaction vessel 2 used for analysis is also discarded into the waste box 21.
[0019] The control device 30 is a computer that controls the operation of units such as the incubator 1 and the dispensing unit 9, and also stores and displays the detection results from the detection unit 16 as analysis results.
[0020] The configuration of the control device 30 will be explained using Figure 2. The control device 30 has an input / output unit 31, a control unit 32, and a storage unit 33.
[0021] The input / output unit 31 includes a keyboard, mouse, liquid crystal display, touch panel, etc., and is used to input instructions related to the operation of the automatic analyzer 100, and to display operation screens and analysis results.
[0022] The control unit 32 is a computing unit such as a CPU (Central Processing Unit) and executes operation programs that operate each unit of the automatic analysis device 100.
[0023] The storage unit 33 is a storage device such as an HDD (Hard Disk Drive) or SSD (Solid State Drive), and stores the operation program executed by the control unit 32. The operation program includes product applications (first software), which are software that performs analysis operations, and service software (hereinafter referred to as SSW), which is separate software from the product applications and performs maintenance operations (second software). The storage unit 33 also stores an authority table, which associates user IDs with authority levels.
[0024] The product application automatically starts when the automated analyzer 100 is powered on, and operates each unit according to instructions input by the user via the input / output unit 31.
[0025] The SSW also operates each unit in response to instructions input by the user via the input / output unit 31. However, if it is activated by a general user, such as a medical professional performing sample analysis, it may cause the automated analyzer 100 to malfunction. Therefore, it is preferable to restrict its activation according to the attributes of the logged-in user. Specifically, service personnel, who possess knowledge and skills related to maintenance operations, are permitted to activate the SSW, while general users, who have different attributes from service personnel, are not permitted to activate it.
[0026] Using Figure 3, we will explain step by step an example of the process flow for restricting the activation of the SSW.
[0027] (S301) When the automatic analyzer 100 is powered on, the control unit 32 starts the product application read from the storage unit 33. When the product application starts, the login screen is displayed.
[0028] (S302) The control unit 32 receives the user ID and password entered by the user as a login operation for the login screen displayed in S301.
[0029] (S303) The control unit 32 checks the user ID and password entered in S302 against the user table to confirm that the user is registered, and then checks the user ID against the authority table to determine whether the logged-in user has an authority level of High. If the authority level is not High, the process proceeds to S304; if it is High, the process proceeds to S305. If the user ID and password entered in S302 are not included in the user table, the process returns to S302, and if the number of times the process returns to S302 exceeds a predetermined number, the process may be terminated.
[0030] An example of a user table, a privilege table, and a startup software table will be explained using Figure 4. Figure 4(a) shows the user table. The user table is a table in which user IDs and passwords are associated, and Figure 4(a) shows examples of N user IDs and the passwords associated with each user ID.
[0031] Figure 4(b) shows the authorization table. The authorization table is a table that associates user IDs with authorization levels. Figure 4(b) illustrates N user IDs and the authorization levels associated with each user ID, with ID-1 and ID-N being assigned a Low authorization level, and ID-2 being assigned a High authorization level. The authorization level associated with each user ID may be assigned according to the user's attributes. For example, if the user's attribute is a service technician, a High authorization level may be assigned, and if it is a general user, a Low authorization level may be assigned. Note that the authorization levels that can be assigned are not limited to two levels, High and Low, but may be three or more levels.
[0032] Figure 4(c) shows the bootable software table. The bootable software table is a table that associates permission levels with the software that can be booted. Figure 4(c) shows that when the permission level is Low, only the product application can be booted, and when the permission level is High, both the product application and the SSW can be booted. Note that the software that can be booted is not limited to the product application and the SSW. Return to the explanation of Figure 3.
[0033] (S304) The control unit 32 displays the settings screen for when the authorization level is High on the input / output unit 31. Figure 5(a) shows an example of the settings screen when the authorization level is High. The settings screen when the authorization level is High displays a system configuration button 500 along with buttons to transition to screens for setting various items. The system configuration button 500 is a button to transition to the system configuration screen. If any button other than the system configuration button 500 is pressed, the user transitions to the setting screen for each item, and the product application operates each unit according to the measurement conditions etc. set on the destination setting screen.
[0034] (S305) The control unit 32 displays the settings screen for when the authorization level is Low on the input / output unit 31. Figure 5(b) shows an example of the settings screen when the authorization level is Low. The settings screen when the authorization level is Low only displays buttons for transitioning to screens for setting various items. In other words, the system configuration button 500 is not displayed.
[0035] Furthermore, when the permission level is Low, the inactive System Configuration button 500 may be displayed on the settings screen. Even if the inactive System Configuration button 500 is pressed, the user will not be redirected to the System Configuration screen.
[0036] (S306) The control unit 32 determines whether the system configuration button 500 has been pressed on the settings screen shown in Figure 5(a). If the system configuration button 500 is pressed, the process proceeds to S307; otherwise, the process ends.
[0037] (S307) The control unit 32 displays the system configuration screen on the input / output unit 31. Figure 6 shows an example of the system configuration screen. The system configuration screen displays buttons for operating various items, as well as the SSW button 601, which is the SSW activation button. A mode change button 602 may also be displayed on the system configuration screen.
[0038] The mode change button 602 is used to switch between the normal mode, which allows for analytical operations, and the verification mode, which is a special mode for verifying the device. In verification mode, in addition to the operations that can be performed in normal mode, it is possible to verify the operation of various detectors without using calibration data. It is preferable that switching from normal mode to verification mode is restricted according to the attributes of the logged-in user, similar to the activation of the SSW. By displaying the mode change button 602 on the system configuration screen, switching from normal mode to verification mode will also be restricted according to the attributes of the logged-in user.
[0039] (S308) The control unit 32 determines whether the SSW button 601 has been pressed on the system configuration screen illustrated in FIG. 6. If the SSW button 601 is pressed, the process proceeds to S309 and the SSW is started. If it is not pressed, the process flow ends.
[0040] (S309) The control unit 32 starts the SSW read from the storage unit 33. After the SSW is started, the process flow illustrated in FIG. 7 is executed.
[0041] According to the process flow illustrated in FIG. 3, it is possible to restrict the start of the SSW, which is other software, from the product application, which is software that executes the analysis operation. That is, since the start of the SSW is permitted for a serviceman who has knowledge and technology regarding maintenance operations and not permitted for a general user, malfunctions of the automatic analyzer 100 can be suppressed.
[0042] An example of the process flow after starting the SSW using FIG. 7 will be described step by step.
[0043] (S701) The control unit 32 displays a login screen in accordance with the start of the SSW and requests the user to perform a login operation. The user inputs a user ID and a password on the login screen. Note that since it is a login operation to the SSW, which is software different from the product application, it is preferable to use a different user ID and password from those at the time of the login operation in S302. By doing so, it is possible to prevent a general user from accidentally logging in to the SSW.
[0044] (S702) The control unit 32 collates the user ID and password input in S701 with the user table to determine whether the login data is correct. If the login data is correct, the process proceeds to S703. If it is incorrect, the process returns to S701.
[0045] Note that in S701, when a user ID and password different from those at the time of the login operation in S302 are used, a user table different from that in (a) of FIG. 4, for example, the user table shown in FIG. 8, is used in S702. Also, when the number of times of returning to S701 exceeds a predetermined number, the process flow may be terminated.
[0046] (S703) The control unit 32 causes the maintenance menu to be displayed on the input / output unit 31. The maintenance menu includes a plurality of executable maintenance operations. The user selects a specific maintenance operation from the displayed maintenance menu. Note that when the time from when the maintenance menu is displayed until a maintenance operation is selected exceeds a predetermined time, the process may return to S701. By doing so, it is possible to prevent a general user from accidentally selecting a maintenance operation while the service technician is away.
[0047] (S704) The control unit 32 executes the maintenance operation selected in S703. When each unit of the automatic analyzer 100 is being operated by the product application, the control unit 32 starts executing the maintenance operation after the operation by the product application is completed. Also, when the maintenance operation is being executed, the control unit 32 starts the operation by the product application after the maintenance operation is completed. By such control, simultaneous execution of a plurality of software is avoided, and problems such as the units of the automatic analyzer 100 colliding with each other can be suppressed.
[0048] According to the process flow illustrated in FIG. 7, a maintenance operation by SSW is executed.
[0049] The present invention is not limited to the above embodiments, and components may be modified without departing from the gist of the invention. Also, a plurality of components disclosed in the above embodiments may be appropriately combined. Furthermore, some components may be deleted from all the components shown in the above embodiments.
[0050] Incubator 1, reaction vessel 2, SR disk 3, reagent bottle 4, sample container 5, reagent suction port 6, sample suction port 7, dispensing unit 9, dispensing pump 11, washing tank 13, reagent stirring unit 14, spectrophotometer 15, detection unit 16, transport unit 17, dispensing tip 18, tip tray 19, container tray 20, waste box 21, tip mounting position 22, tip waste port 23, water supply tank 24, waste liquid tank 25, first liquid bottle 26, washing liquid bottle 27, first liquid pump 28, washing liquid pump 29, control device 30, input / output unit 31, control unit 32, memory unit 33, automatic analyzer 100, system configuration button 500, SSW button 601, mode change button 602.
Claims
1. An automated analyzer for analyzing a sample, comprising: first software which is software that performs analysis operations; second software which is software that performs maintenance operations; a storage unit that stores an authority table in which user IDs and authority levels are associated; and a control unit that restricts the startup of the second software from the first software based on a matching result obtained by comparing the user ID of a user who has logged into the first software with the authority table.
2. An automatic analyzer according to claim 1, wherein the control unit determines, based on the comparison result, whether or not to display a button to transition to a second screen on the first screen displayed by the first software, which displays the launch button for the second software.
3. An automatic analyzer according to claim 2, wherein the control unit displays a mode change button used for switching between normal mode and verification mode on the second screen.
4. An automatic analyzer according to claim 1, wherein the control unit causes a button to transition to a second screen on the first screen displayed by the first software, where the launch button for the second software is displayed, and determines whether or not to deactivate the transition button based on the comparison result.
5. An automatic analyzer according to claim 1, wherein the control unit displays a login screen after starting the second software and requests a login operation to the second software.
6. An automatic analyzer according to claim 5, wherein the control unit displays a maintenance menu after a login operation to the second software, and if the time until a specific maintenance operation is selected from the maintenance menu exceeds a predetermined time, the login screen is redisplayed.
7. An automatic analyzer according to claim 1, characterized in that the control unit does not start the operation of the second software while the operation of the first software is being performed, and does not start the operation of the first software while the operation of the second software is being performed.
8. An automated analyzer according to claim 1, wherein the control unit permits the startup of the second software when the logged-in user is a service technician, and does not permit the startup of the second software when the user is not a service technician.