WO2019198345A1

WO2019198345A1 - Automatic analysis device

Info

Publication number: WO2019198345A1
Application number: PCT/JP2019/006211
Authority: WO
Inventors: 三島　弘之; 沙耶佳朝田; 賢史島田; 雅文三宅
Original assignee: 株式会社日立ハイテクノロジーズ
Priority date: 2018-04-12
Filing date: 2019-02-20
Publication date: 2019-10-17
Also published as: JP6965440B2; JPWO2019198345A1; CN111886502A

Abstract

The present invention allows for the suitable management/replacement of consumable articles and makes it possible to suppress a reduction in measurement accuracy. This automatic analysis device comprises: an analysis unit that analyzes a sample to be analyzed; a transport unit that transports a sample rack on which a sample container housing the sample is mounted; a control unit that controls the analysis unit and the transport unit; a replaceable part provided with identification information including replacement time information and a product number; an identification unit that reads the identification information and is provided to an outer peripheral section of the device; and a storage unit that stores the identification information read by the identification unit.

Description

Automatic analyzer

The present invention relates to an automatic analyzer that performs qualitative and quantitative analysis of biological samples such as blood and urine.

At present, automatic analyzers that perform qualitative and quantitative analysis of biological samples such as blood and urine (hereinafter referred to as specimens) are widely used mainly in large hospitals and clinical laboratory centers that handle many patient specimens.

In Patent Document 1, when a part is replaced, a part-specific code is read from the barcode of the part. If the code is not registered in the part replacement history, the part is a new part. In the case of a used product, the sample analyzer displays that the part is a used product, and in the case of a new product, a sample analyzer that reproduces a video explaining the replacement of the component in the sample analyzer is displayed. It is disclosed.

Japanese Patent Laid-Open No. 2015-68758

In order to maintain the measurement accuracy of the automatic analyzer, it is necessary to appropriately manage and replace measurement parts that affect analysis performance. Conventionally, one-dimensional barcodes and RFID tags are attached to reagents and detergents, and consumables are registered and managed. However, with regard to the measurement parts, the user periodically confirms the performance, and exchanges are performed with reference to the recommended expiration date and the number of times that the measurement parts can be used. In the invention described in Patent Document 1, there is provided a sample analyzer that allows a user to easily replace parts for maintenance, and to suppress malfunctions and a decrease in analysis accuracy after parts replacement. It is disclosed. However, in Patent Document 1, the management and replacement timing of parts is determined by the operator, and the bar code described in the part only determines whether or not the part is appropriate, and cannot be managed by the expiration date or the number of times of use. It was.

An object of the present invention is to provide an automatic analyzer that solves the above-described problems and can suppress a decrease in measurement accuracy.

An analysis unit for analyzing a sample to be analyzed, a transport unit for transporting a sample rack carrying a sample container containing a sample, a control unit for controlling the analysis unit and the transport unit, replacement time information and a product number. Including a replaceable part to which identification information is included, an identification unit that reads the identification information and is provided on an outer peripheral portion of the apparatus, and a storage unit that stores the identification information read by the identification unit. A featured automatic analyzer is provided.

Consumables can be appropriately managed and exchanged, and measurement accuracy can be prevented from decreasing.

It is the schematic of an automatic analyzer. It is a flowchart which shows the replacement | exchange procedure of consumables. It is a figure which shows reading of the identification information of an ion selective electrode. It is a flowchart which shows the exchange procedure of an ion selective electrode. It is the figure which showed the exchange guidance function. It is the figure which showed the example which displayed each usage condition screen shown in FIG. 6 on one screen. It is a figure which shows the installation / registration method of a calibrator.

Hereinafter, embodiments of the present invention will be described with reference to the drawings.

FIG. 1 shows a schematic diagram of an automatic analyzer. The automatic analyzer 1 controls the operation of the analysis unit 2 for analyzing the sample, the transport unit 3 for loading and collecting the sample rack 5 on which the sample container 6 is mounted, and transporting it to the analysis unit 2, and the automatic analyzer 1. The control device 4 is configured roughly, and the identification device 16 such as a two-dimensional barcode reader or RFID that reads identification information attached to components, reagents, and the like.

In the sample rack 5 handled by the automatic analyzer 1, biological samples such as blood, plasma, serum, urine, and other body fluids (hereinafter, referred to as samples or samples) to be subjected to qualitative / quantitative analysis in the automatic analyzer 1 are stored. One or more sample containers 6 accommodated are mounted.

The analysis unit 2 performs qualitative / quantitative analysis by sampling (dispensing) the sample stored in the sample container 6 mounted on the sample rack 5. The analysis unit 2 uses identification media such as RFIDs and barcodes provided in the sample rack 5 and the sample container 6 in order to collate analysis request information for the sample accommodated in the sample rack 5 carried in by the transport unit 3. A sample identification device (not shown) for reading and identifying, a sample dispensing mechanism 7 for dispensing a sample from the sample container 6 of the sample rack 5 conveyed to the dispensing position to the measurement unit, and a reagent in the reagent storage unit 8 A reagent dispensing mechanism 9 for dispensing the reagent contained in the container into the reaction container, and a measurement unit for performing a qualitative / quantitative analysis by measuring a mixed solution (reaction liquid) of the sample and the reagent dispensed in the reaction container 10.

The transport unit 3 transports the sample rack 5 put into the automatic analyzer 1 to the analysis system. The transport unit 3 includes a transport line 11 for transporting the sample rack 5 to the analysis unit 2 and a storage area 12 for waiting the sample rack 5 before measurement and storing the sample rack 5 after measurement. Yes.

The control device 4 controls the operation of the automatic analyzer 1. The control device 4 is equipped with an input screen for various parameters and settings, a display unit 13 for displaying analysis test data and measurement results for the initial test or retest, and various parameters, settings, measurement results, and each sample rack 5. A storage unit 14 that stores analysis request information and the like of the sample stored in the sample container 6 and a control unit 15 that controls the operation of the automatic analyzer 1 including the control device 4 are provided.

The identification device 16 reads identification information attached to a part or reagent when the part or reagent is exchanged. Based on this identification information, it is determined whether the part is to be replaced or whether it is a replaceable part. In FIG. 1, the identification device 16 is provided on the transport unit, but it may be provided at a position accessible by the user, such as an outer peripheral surface of the device that is easily accessible when the user operates the automatic analyzer. Is preferably provided.

When the control is requested, the control unit 15 starts various operations related to the analysis. One of the sample racks 5 in the storage area 12 is moved to the transport line 11 and transported to the analysis unit 2. Subsequently, the identification information attached to the sample rack 5 moved to the analysis unit 2 is collated by the sample identification device, and the dispensing probe of the sample dispensing mechanism 7 is inserted into the sample container 6 where the analysis is instructed. Then, dispensing to the measurement unit 10 is performed, and measurement is started. When two or more test items are instructed for the same sample container 6 and when test items are instructed for another sample container 6 on the same sample rack 5, the sample dispensing operation is repeated. It is. The sample rack 5 in which the dispensing of the samples related to all the analysis items instructed has been completed is moved to the storage area 12 via the conveyance line 11, and the sample conveyance process is completed.

The automatic analyzer 1 includes a plurality of consumables such as a reagent, a lamp used for measurement, an ion selective electrode, and a reaction vessel. In order to maintain the analysis performance of the automatic analyzer 1, it is necessary to replace these consumables at an appropriate timing and to perform maintenance incidental thereto. Conventionally, identification information such as one-dimensional barcodes and RFID tags is pasted on reagents and detergents, and the information is read by an identification device installed inside the automatic analyzer 1 to register consumables and expiration dates. Management was done. However, with regard to consumable parts used for measurement of ion-selective electrodes, reaction vessels, and the like, the user periodically checks the performance and replaces them with reference to the recommended expiration date and the number of times that they can be used. In addition, parts replacement for maintenance with a replacement period of several years can be collectively managed from a service, but a user has to manage consumables having a short replacement period.

Therefore, in the present invention, in order to clarify the replacement time, identification information is given not only to the reagent, but also to consumables such as lamps, ion-selective electrodes (ISE) and reaction containers, or packaging of consumables. Further, an identification device 16 that reads identification information is provided at a position accessible by the user. The identification information is read by the identification device 16 and registered in the storage unit 14.
This identification information includes management information such as the date of manufacture, the part unique number, and replacement time information. The replacement time of consumables is managed based on replacement time information. This replacement time information includes the expiry date, which is the expiry date when the consumables are not in use, the usable period that is usable from the start of use of the consumables (part registration date), and the test that allows the consumables to be used The number of usable times is a number of times. Necessary replacement time information varies depending on the type of consumables, and it is sufficient to include any one of the expiry date, the number of times that the product can be used, and the usable period. Also good. Based on the replacement time information, if the expiration date has been exceeded, or if it has been used beyond the usable number of times or usable period, an alarm will be given to warn that the measurement result has been used beyond the expiration date or number of times. Is done. An alarm is displayed on the display unit informing that it is necessary to replace the part. Furthermore, an analysis using a part that needs to be replaced cannot be performed until the part is replaced. Thereby, it is possible to manage the expiry date, the number of times of use, and the use period of the measurement component, and to perform replacement at an appropriate timing, and to maintain measurement accuracy. In addition, because the status of the parts can be monitored, guidance is provided to replace multiple measurement parts and perform maintenance (cleaning, calibration, etc.) in order, ensuring reliable measurement accuracy. Maintenance can be carried out.

In addition, it is possible to prevent re-measurement due to a decrease in the user's analytical performance and maintenance misoperation by managing the replacement time and maintenance guidance.

Explain the details of replacement of consumables.

Fig. 2 explains the flow for exchanging consumables. The flow in FIG. 2 shows a flow in the case where management is performed based on the expiration date, the number of usable times, and the usable period, but the flow related to replacement time information that is not used depending on consumables is skipped. When the expiry date of the consumable item arrives, the number of uses reaches the usable number of times, or the usable period elapses, the analysis performed using the consumable item is stopped by the control unit 15. If the expiration date or the upper limit of the number of usable times is reached during measurement, an expired data alarm is added to the measurement result. Analysis performed using consumables after measurement is stopped by the control unit 15 and cannot be performed. Furthermore, parts that need to be replaced are locked, and operations other than replacement cannot be performed (S201). An alarm notifying that replacement is necessary is displayed on the display unit 13 (S202). Identification information is attached to the consumable or the packaging of the consumable, and the identification information attached to the replacement part or the replacement part packaging is held over the identification device 16 to read the identification information (S203). The read information is analyzed by the control unit 15. When the expiry date of the read identification information of the replacement part has expired, an alarm indicating that the replacement is necessary is displayed, and the replacement part identification information is requested to be read. In the storage unit 14, identification information of consumables used so far and a registration date when the consumables are registered are registered. If the replacement part is within the expiration date, it is determined whether the read identification information has been registered before or has not been registered (S204, S205). If the read identification information is not registered, the replacement part is recognized as a new part, and the expiration date and the number of usable times described in the part identification information are displayed on the display unit, so that replacement is possible. (S206, S207). When the read identification information is registered, it is confirmed whether the usable period and the usable number remain based on the information registered in the storage unit. When the usable period or the number of usable times does not remain, an alarm is displayed to notify that replacement is necessary, and reading of replacement part identification information is requested. Whether or not the usable period remains is determined based on whether the period from the registration date when the parts registered in the storage unit are registered for the first time to the date when the identification information is read is shorter than the usable period read by the identification information. . When the usable period and the usable number remain, the expiration date registered in the storage unit, the part registration date, and the usable number are displayed on the display unit, indicating that the replacement is possible. When this replacement part is used, it is used in the form of updating the remaining usable number of times (S208, 209). When a part registration button displayed on the display unit is replaced with a part displayed as being replaceable and replaced with the registered part, registration of the replacement part is completed (S210). When the replacement part registration is completed, the replacement part is unlocked (S211). Some types of replacement parts require maintenance such as cleaning and calibration as well as replacement of consumables, and the necessity and procedure of maintenance are registered in the control device 4. For those that do not require maintenance, the stop state of the analysis performed using the replacement part is canceled, and the measurement can be started (S215). When maintenance is required, maintenance guidance is started, and maintenance is performed according to the guidance (S212, S213). When it is determined that the maintenance has been completed normally, the analysis stop state using the replacement part is canceled, and the measurement can be started (S214, S215). Unless replacement of consumables is completed, analysis using consumables that require replacement cannot be performed. Accordingly, it is possible to prevent the expendable item from being used after the expiration date, the usable period, and the usable number of times, and the measurement accuracy can be maintained. Furthermore, since necessary maintenance can be performed with certainty, it is possible to suppress a decrease in analysis performance. In addition, it is possible to prompt the user for appropriate maintenance, and usability is improved. The identification information provided on the consumable part or the packaging of the part only needs to include the product number and the replacement time information, and the two-dimensional identification number stamped or labeled is used as a two-dimensional identification device 16. Even if it uses a reader, it may be read by RFID using an RF tag. When replacing the consumables, if the user feels an abnormality such as a decrease in analysis performance even before the expiration date or the upper limit of the usable number of times, it is possible to select the maintenance screen and replace the part to be replaced.

As a specific example of consumable replacement, FIGS. 3 and 4 show replacement of the ion selective electrode 17 used for electrolyte concentration measurement. When the electrolyte concentration is measured by the analysis unit, the ion selective electrode 17 is used for the detection unit of the measurement unit 10. When measuring the electrolyte concentration using the ion-selective electrode 17 in the measurement unit 10, the ion-selective electrode 17 is usually used to detect a plurality of ions (for example, sodium ion, potassium ion, chlorine ion, etc.) at the same time. It consists of several types of electrodes corresponding to the items (17a, 17b, 17c, 17d). These electrodes are consumables. For example, they are replaced with new electrodes in a few months, which is a usable period. When the expiration date, the usable period or the upper limit of the usable number is reached during the measurement, an expired data alarm is added to the measurement result. After the measurement is completed, the control unit 15 stops the electrolyte concentration measurement, and the measurement cannot be performed. Furthermore, the ion selective electrode 17 is locked, and operations other than replacement cannot be performed (S401). An alarm notifying that replacement is necessary is displayed on the display unit 13 (S402). Since the ion selective electrode 17 is composed of a plurality of parts, when the ion selective electrode 17 is replaced, replacement guidance for performing replacement in an appropriate place and order is started (S403). Details of the exchange guidance function will be described later. In reading the identification information of the ion selective electrode 17, the identification information 19 attached to the electrode (17a, 17b, 17c, 17d) or the electrode package 18 is held over the identification device 16 and the identification information is read (S404). The read information is analyzed by the control unit 15. When the expiry date of the read identification information of the electrode has expired, an alarm indicating that replacement is necessary is displayed, and reading of the identification information of the replacement part is requested. The storage unit 14 stores identification information of consumables used so far. If it is within the expiration date, it is determined whether the read identification information has been registered before or has not been registered (S405, S406). If the read identification information is not registered, the replacement part is recognized as a new part, and the expiration date and the number of usable times described in the part identification information are displayed on the display unit, so that replacement is possible. (S407, S408). When the read identification information is registered, it is confirmed after the usable period has passed whether the usable number remains based on the information registered in the storage unit. When the usable period has elapsed or the usable number has not remained, an alarm informing that replacement is necessary is displayed, and reading of replacement part identification information is requested. When the usable period and the usable number remain, the registration date, the expiration date, and the usable number of parts registered in the storage unit are displayed on the display unit to indicate that they can be replaced. When this replacement part is used, it is used in the form of updating the remaining usable number of times (S409, 410). When the part displayed as replaceable is replaced with a part registration button displayed on the display unit, registration of the consumable is completed (S411). When the replacement part registration is completed, the lock of the ion selective electrode 17 is released (S412).

When the ion selective electrode 17 is replaced, cleaning and calibration are required as maintenance. Therefore, when the ion selective electrode 17 is normally replaced, a maintenance guide dance is started. First, guidance on cleaning is displayed on the display unit 13 (S413). The user follows the guidance and prepares the cleaning liquid at the designated position of the cleaning rack and installs it in the input area of the analyzer. When the cleaning rack is transported to the reading position of the sample identification device of the analysis unit 2 and is recognized as a cleaning rack, the device automatically executes a cleaning operation necessary for the replacement part. When the cleaning operation is normally completed (S414), calibration guidance is displayed (S415). In accordance with the guidance, the user prepares a sample for calibration at a specified position on the sample rack 5 and installs it in the input area of the analyzer. The rack is transported to the analysis unit 2 for calibration. When the calibration is normally completed (S416), quality check measurement is instructed and quality check measurement is performed (S417). When the quality check measurement is completed normally, it is determined that the replacement and maintenance of the ion selective electrode 17 is completed, and the measurement is possible anytime (S418, S419). In the ion-selective electrode of this example, the expiration date, the usable period, and the number of usable times are described in the identification information as replacement time information for more strict management. It is possible to manage the replacement timing instructions.

The exchange guidance function will be described with reference to FIG. The ion selective electrode 17 is composed of several types of electrodes, and the positions where the respective electrodes are arranged are determined. In addition, since the plurality of types of electrodes are installed in a fitted state, the replacement work can be performed smoothly if the replacement is performed in a fixed order. Therefore, the exchange guidance is performed so that the exchange is performed in an appropriate order at an appropriate position at the time of exchange. When the electrode replacement maintenance is executed, the usage status of the electrode A that needs to be replaced first is displayed on the screen. Since this electrode is ready for use, it can proceed to the next electrode replacement. When the user presses the “Next” button, the usage status of the electrode B is displayed on the screen. Since this electrode can be used 0 times, the “Next” button cannot be pressed. When the user holds the two-dimensional barcode of the electrode over the reader, the expiration date and the number of usable times are updated. The user replaces the electrode and presses the next button to complete registration. Since the electrodes are exchanged in the designated order, it can be prevented from being installed by mistake, and the readjustment time can be reduced. Although only the replacement parts are displayed one by one in FIG. 5, individual usage status screens may be displayed on one screen as shown in FIG. In the case of a plurality of components such as the ion-selective electrode 17, the usage status such as the expiration date and the number of usable times of the plurality of components is displayed on one screen. Further, on this screen, the positional relationship such as electrode combination and arrangement order is also displayed. Thereby, since a use condition and an arrangement | positioning location can be known at a glance, replacement work can be advanced smoothly. When displaying on a single screen, the combination, order, and usage of the electrodes can be seen at a glance, so that a plurality of ID reading operations can be performed together.

Calibration guidance using the identification device 16 will be described with reference to FIG. This calibration includes the calibration at the time of exchanging consumables described in the first embodiment. The calibrator ID installed in the rack is read by a one-dimensional barcode reader installed on the path for transporting from the sample loading unit to the analysis unit. Depending on the read contents, the control unit 15 conveys the rack to each analyzer that requires a calibrator.

Depending on the analyzer, the transport direction of the rack 8 is only one direction. In this case, if the order of the calibrators is not appropriate, the calibrators cannot be dispensed in the intended order, and the rack is returned to the collection unit. Therefore, it is necessary to arrange the calibrators in the rack in an appropriate order. When the calibration of a specific item is selected from the screen or the calibration guidance starts, the two-dimensional barcode can be read. When the user holds the calibrator ID 21 over the identification device 16, a necessary set of calibrators 20 and a read installation position of the calibrator 20 are displayed on the display unit 14. Since the user can install the calibrator 20 at a specified position on the rack, it is possible to prevent remeasurement due to an erroneous operation.

1: Automatic analyzer 2: Analysis unit 3: Transport unit 4: Control device 5: Sample rack 6: Sample container 7: Sample dispensing mechanism 8: Reagent storage unit 9: Reagent dispensing mechanism 10: Measurement unit 11: Conveyance line 12: Storage area 13: Display unit 14: Storage unit 15: Control unit 16: Identification device 17: Ion selective electrode 18: Packaging 19: Identification information 20: Calibrator 21: Calibrator ID

Claims

An analysis unit for analyzing the sample to be analyzed;
A transport unit for transporting a sample rack carrying a sample container containing a sample;
A control unit for controlling the analysis unit and the transport unit;
Replaceable parts with replacement information and identification information including product number,
Read the identification information, an identification unit provided on the outer periphery of the device,
A storage unit for storing identification information read by the identification unit;
An automatic analyzer characterized by comprising:
In claim 1,
An automatic analyzer comprising a display unit that displays identification information read by the identification unit.
In claim 1,
The automatic analysis apparatus according to claim 1, wherein the replacement time information includes at least one of an expiration date, a usable count, and a usable period.
In claim 3,
The automatic analyzer according to claim 1, wherein the replacement time of the component is any one of a time when the expiration date of the component is reached, a time when the number of times of use reaches the number of usable times, and a time when the usable period elapses.
In claim 4,
An automatic analyzer that makes it impossible for the control unit to perform analysis of the analysis unit using the component when it is time to replace the component, and enables analysis of the analysis unit when the component is replaced .
In claim 4,
An automatic analyzer characterized in that when it is time to replace a part, the measurement result using the part is displayed on the display unit with an alarm.
In claim 2,
The automatic analyzer according to claim 1, wherein the display unit displays a mounting order of the components when it is time to replace the components.
In claim 4,
When it ’s time to replace the parts,
An automatic analyzer characterized in that an alarm notifying that a part needs to be replaced is displayed on the display unit.
In claim 5,
When the part is replaced, at least one of cleaning and calibration procedures for the replaced part is displayed on the display unit.
In claim 5,
The control unit disables the analysis of the analysis unit from being executed until at least one of cleaning and calibration of the replaced part is completed after the part is replaced.
In claim 1,
An automatic analyzer characterized in that the component is an ion selective electrode.
In claim 1,
The automatic analyzer according to claim 1, wherein the identification unit is provided on a front side of the apparatus on a side operated by a user of the apparatus.
In claim 1,
The analysis unit and the transport unit are arranged side by side to the left and right as seen from the user who operates,
The automatic analyzer is characterized in that the identification unit is provided in a transport unit.
In claim 1,
The automatic analysis apparatus, wherein the component is a component used in the analysis unit.
In claim 2,
When the product number of the read identification information is not registered in the storage unit, the automatic analysis apparatus displays the expiration date and the usable number of times of the read identification information on the display unit.
In claim 2,
When the product number of the read identification information is already registered in the storage unit, an expiration date corresponding to the product number registered in the storage unit and the number of usable times are displayed on the display unit. An automatic analyzer.