WO2019198345A1 - Dispositif d'analyse automatique - Google Patents

Dispositif d'analyse automatique Download PDF

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Publication number
WO2019198345A1
WO2019198345A1 PCT/JP2019/006211 JP2019006211W WO2019198345A1 WO 2019198345 A1 WO2019198345 A1 WO 2019198345A1 JP 2019006211 W JP2019006211 W JP 2019006211W WO 2019198345 A1 WO2019198345 A1 WO 2019198345A1
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WO
WIPO (PCT)
Prior art keywords
unit
analysis
identification information
automatic analyzer
replacement
Prior art date
Application number
PCT/JP2019/006211
Other languages
English (en)
Japanese (ja)
Inventor
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 (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 株式会社日立ハイテクノロジーズ filed Critical 株式会社日立ハイテクノロジーズ
Priority to JP2020513098A priority Critical patent/JP6965440B2/ja
Priority to CN201980020519.7A priority patent/CN111886502A/zh
Publication of WO2019198345A1 publication Critical patent/WO2019198345A1/fr

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    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor

Definitions

  • the present invention relates to an automatic analyzer that performs qualitative and quantitative analysis of biological samples such as blood and urine.
  • specimens biological samples such as blood and urine
  • analyzers that perform qualitative and quantitative analysis of biological samples such as blood and urine
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • samples or samples 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.
  • samples or samples 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.
  • 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
  • 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.
  • 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.
  • 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.
  • 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.
  • dispensing to the measurement unit 10 is performed, and measurement is started.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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. .
  • 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.
  • this replacement part is used, it is used in the form of updating the remaining usable number of times (S208, 209).
  • 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).
  • 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.
  • the stop state of the analysis performed using the replacement part is canceled, and the measurement can be started (S215).
  • maintenance guidance is started, and maintenance is performed according to the guidance (S212, S213).
  • 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.
  • 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.
  • FIGS. 3 and 4 show replacement of the ion selective electrode 17 used for electrolyte concentration measurement.
  • the ion selective electrode 17 is used for the detection unit of 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.
  • 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.
  • 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.
  • 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).
  • 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).
  • 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.
  • 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.
  • this replacement part When this replacement part is used, it is used in the form of updating the remaining usable number of times (S409, 410).
  • the part displayed as replaceable is replaced with a part registration button displayed on the display unit, registration of the consumable is completed (S411).
  • the replacement part registration is completed, the lock of the ion selective electrode 17 is released (S412).
  • 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.
  • quality check measurement is instructed and quality check measurement is performed (S417).
  • 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).
  • 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.
  • the exchange guidance is performed so that the exchange is performed in an appropriate order at an appropriate position at the time of exchange.
  • the “Next” button cannot be pressed.
  • 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.
  • 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.
  • the positional relationship such as electrode combination and arrangement order is also displayed.
  • 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.
  • 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.
  • the control unit 15 conveys the rack to each analyzer that requires a calibrator.
  • 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.
  • the two-dimensional barcode can be read.
  • 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.

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  • Physics & Mathematics (AREA)
  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Analytical Chemistry (AREA)
  • Biochemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • General Physics & Mathematics (AREA)
  • Immunology (AREA)
  • Pathology (AREA)
  • Automatic Analysis And Handling Materials Therefor (AREA)

Abstract

La présente invention permet la gestion/le remplacement approprié d'articles consommables et permet d'éviter une réduction de la précision de mesure. Ce dispositif d'analyse automatique comprend : une unité d'analyse qui analyse un échantillon à analyser ; une unité de transport qui transporte un portoir d'échantillons sur lequel est monté un récipient à échantillon contenant l'échantillon ; une unité de commande qui commande l'unité d'analyse et l'unité de transport ; une partie remplaçable comportant des informations d'identification comprenant des informations relatives au moment de remplacement et une référence produit ; une unité d'identification qui lit les informations d'identification et qui est située au niveau d'une section périphérique externe du dispositif ; et une unité de stockage qui stocke les informations d'identification lues par l'unité d'identification.
PCT/JP2019/006211 2018-04-12 2019-02-20 Dispositif d'analyse automatique WO2019198345A1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
JP2020513098A JP6965440B2 (ja) 2018-04-12 2019-02-20 自動分析装置
CN201980020519.7A CN111886502A (zh) 2018-04-12 2019-02-20 自动分析装置

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JP2018-076504 2018-04-12
JP2018076504 2018-04-12

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR20230124332A (ko) * 2022-02-18 2023-08-25 최광진 영상 데이터 공유를 통한 재생 캐필러리 관리 시스템 및 방법
EP4160215A4 (fr) * 2020-05-29 2024-05-15 Hitachi High-Tech Corporation Dispositif d'analyse automatique et procédé de maintenance pour dispositif d'analyse automatique

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Publication number Priority date Publication date Assignee Title
JP2002350451A (ja) * 2001-05-24 2002-12-04 A & T:Kk 自動分析装置、自動分析システム、自動分析装置管理方法および消耗品管理方法
JP2015068758A (ja) * 2013-09-30 2015-04-13 シスメックス株式会社 検体分析装置管理システム、検体分析装置用管理装置、検体分析装置、検体分析装置の管理方法、及びコンピュータプログラム
WO2017221313A1 (fr) * 2016-06-20 2017-12-28 株式会社テクノメデイカ Système de maintenance pour dispositif d'analyse chimique clinique

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Publication number Priority date Publication date Assignee Title
JP2004219352A (ja) * 2003-01-17 2004-08-05 Toshiba Corp 分析装置及び管理システム
JP4152351B2 (ja) * 2004-06-17 2008-09-17 シスメックス株式会社 臨床検体処理装置および臨床検体処理システム
CN102597757A (zh) * 2009-09-18 2012-07-18 日立化成工业株式会社 自动分析装置
CN203031079U (zh) * 2013-01-15 2013-07-03 湖州剑力金属制品有限公司 一种电极寿命检测控制装置

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2002350451A (ja) * 2001-05-24 2002-12-04 A & T:Kk 自動分析装置、自動分析システム、自動分析装置管理方法および消耗品管理方法
JP2015068758A (ja) * 2013-09-30 2015-04-13 シスメックス株式会社 検体分析装置管理システム、検体分析装置用管理装置、検体分析装置、検体分析装置の管理方法、及びコンピュータプログラム
WO2017221313A1 (fr) * 2016-06-20 2017-12-28 株式会社テクノメデイカ Système de maintenance pour dispositif d'analyse chimique clinique

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP4160215A4 (fr) * 2020-05-29 2024-05-15 Hitachi High-Tech Corporation Dispositif d'analyse automatique et procédé de maintenance pour dispositif d'analyse automatique
KR20230124332A (ko) * 2022-02-18 2023-08-25 최광진 영상 데이터 공유를 통한 재생 캐필러리 관리 시스템 및 방법
KR102682915B1 (ko) 2022-02-18 2024-07-05 최광진 영상 데이터 공유를 통한 재생 캐필러리 관리 시스템 및 방법

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CN111886502A (zh) 2020-11-03
JP6965440B2 (ja) 2021-11-10
JPWO2019198345A1 (ja) 2021-02-12

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