CN111665368A - Automatic analyzer - Google Patents

Automatic analyzer Download PDF

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Publication number
CN111665368A
CN111665368A CN202010133619.5A CN202010133619A CN111665368A CN 111665368 A CN111665368 A CN 111665368A CN 202010133619 A CN202010133619 A CN 202010133619A CN 111665368 A CN111665368 A CN 111665368A
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CN
China
Prior art keywords
reagent
reagent container
unit
sterilization
disk
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Pending
Application number
CN202010133619.5A
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Chinese (zh)
Inventor
梅木博也
安藤贵洋
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Hitachi High Tech Corp
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Hitachi High Technologies Corp
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Publication of CN111665368A publication Critical patent/CN111665368A/en
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    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/00584Control arrangements for automatic analysers
    • G01N35/00722Communications; Identification
    • G01N35/00732Identification of carriers, materials or components in automatic analysers
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/02Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor using a plurality of sample containers moved by a conveyor system past one or more treatment or analysis stations
    • G01N35/04Details of the conveyor system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/02Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using physical phenomena
    • A61L2/08Radiation
    • A61L2/10Ultraviolet radiation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/24Apparatus using programmed or automatic operation
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/00584Control arrangements for automatic analysers
    • G01N35/00594Quality control, including calibration or testing of components of the analyser
    • G01N35/00613Quality control
    • G01N35/00663Quality control of consumables
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2202/00Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
    • A61L2202/10Apparatus features
    • A61L2202/11Apparatus for generating biocidal substances, e.g. vaporisers, UV lamps
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2202/00Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
    • A61L2202/10Apparatus features
    • A61L2202/14Means for controlling sterilisation processes, data processing, presentation and storage means, e.g. sensors, controllers, programs
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N2035/00178Special arrangements of analysers
    • G01N2035/00277Special precautions to avoid contamination (e.g. enclosures, glove- boxes, sealed sample carriers, disposal of contaminated material)
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/00584Control arrangements for automatic analysers
    • G01N35/00594Quality control, including calibration or testing of components of the analyser
    • G01N35/00613Quality control
    • G01N35/00663Quality control of consumables
    • G01N2035/00673Quality control of consumables of reagents
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/00584Control arrangements for automatic analysers
    • G01N35/00722Communications; Identification
    • G01N35/00732Identification of carriers, materials or components in automatic analysers
    • G01N2035/00792Type of components bearing the codes, other than sample carriers
    • G01N2035/00811Type of components bearing the codes, other than sample carriers consumable or exchangeable components other than sample carriers, e.g. detectors, flow cells
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/02Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor using a plurality of sample containers moved by a conveyor system past one or more treatment or analysis stations
    • G01N35/04Details of the conveyor system
    • G01N2035/0401Sample carriers, cuvettes or reaction vessels
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/02Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor using a plurality of sample containers moved by a conveyor system past one or more treatment or analysis stations
    • G01N35/04Details of the conveyor system
    • G01N2035/0439Rotary sample carriers, i.e. carousels
    • G01N2035/0443Rotary sample carriers, i.e. carousels for reagents

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  • Health & Medical Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Biochemistry (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Physics & Mathematics (AREA)
  • Epidemiology (AREA)
  • Analytical Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Physics & Mathematics (AREA)
  • Immunology (AREA)
  • Pathology (AREA)
  • Engineering & Computer Science (AREA)
  • Quality & Reliability (AREA)
  • Automatic Analysis And Handling Materials Therefor (AREA)
  • Apparatus For Disinfection Or Sterilisation (AREA)

Abstract

The present invention provides an automatic analyzer, which prevents contamination caused by microorganisms from the outside of the analyzer in a reagent container storage box, and comprises a reagent container storage box for holding reagent containers, a reagent disk for accommodating the reagent containers and transporting the reagent containers to a desired position in the reagent container storage box, an irradiation unit (902) for irradiating ultraviolet rays to a filling system of the reagent disk and the reagent containers, a control unit (903) for controlling the irradiation unit, a sterilization unit (901) for driving a battery (904) and a mechanical switch (905), and the like, wherein the sterilization unit (901) is used for preventing contamination in the sample container storage box.

Description

Automatic analyzer
Technical Field
The present invention relates to an automatic analyzer.
Background
In general, in an automatic analyzer that handles consumables such as analytical reagents, the workflow can be made efficient by reducing the frequency of replacement and replenishment of the consumables. For example, the frequency of replacement/replenishment of an analytical reagent can be reduced by improving the "on-machine stabilization period" which is the stability of the reagent during storage in the device. One means for achieving this object is to provide a cooling function to the analytical reagent storage chamber in order to prevent thermal denaturation of the reagent components. In addition to this cold insulation function, it is important to prevent contamination (contamination) by microorganisms such as bacteria and molds from entering from the outside of the apparatus, for example, to improve the machine stationary phase. For example, by providing the analytical reagent storage box with a sterilization function, the inside of the analytical reagent storage box can be kept clean all the time, and contamination by microorganisms can be prevented. These functions contribute to labor-time, time-saving for replacement/replenishment of analytical reagents, particularly for large-scale facilities where the daily sample ratio is large.
Documents of the prior art
Patent document
Patent document 1: japanese patent laid-open publication No. 2017-219452
Patent document 2: japanese patent laid-open publication No. 2018-054292
Disclosure of Invention
Problems to be solved by the invention
Patent documents 1 and 2 disclose reagent sterilization means for improving the stability of a reagent used in an automatic analyzer. All of them are intended to sterilize a "common reagent" commonly used for a cleaning solution, a buffer solution, and the like, regardless of the kind of an analysis item. Specifically, a sterilization unit is directly provided to the common reagent bottle, and sterilization is periodically performed to prevent microorganisms from being mixed into and propagating in the reagent bottle. On the other hand, there has been no technical development or the like relating to a sterilization means for the purpose of sterilizing an analytical reagent storage box.
The purpose of the present invention is to provide an automatic analyzer which is provided with a means for sterilizing a reagent container storage box in order to prevent contamination (contamination) by microorganisms from outside the analyzer.
Means for solving the problems
In order to solve the above problem, the present invention provides an automatic analyzer including: a reagent container storage box for holding a reagent container; a reagent disk for accommodating reagent containers and transporting the reagent containers to a desired position in a reagent container storage box; an irradiation unit that irradiates a filling system of the reagent disk and the reagent container with ultraviolet light; and a control unit for controlling the irradiation unit.
Effects of the invention
According to the present invention, the inside of the reagent container storage box can be kept clean by preventing contamination by microorganisms from the outside of the apparatus.
Drawings
Fig. 1 is a diagram showing a schematic configuration of an automatic analyzer.
Fig. 2 is a schematic perspective view of the reagent container (in a sealed state).
Fig. 3 is a schematic perspective view of the reagent vessel (open state).
Fig. 4 is an external view of the reagent disk.
Fig. 5A is an external view of the reagent disk with the cover removed.
Fig. 5B is a plan view of the reagent disk with the cover removed.
Fig. 5C is a diagram of a reagent disk.
Fig. 6 is a schematic view of a filling system.
FIG. 7 is a schematic diagram showing the relationship between the reagent container loading section and the loading system.
Fig. 8 is an enlarged view of the reagent container loading portion.
Fig. 9 is a diagram showing a structural example of the sterilization unit according to embodiment 1.
Fig. 10A is a diagram of a mechanical switch (OFF state) of the sterilization unit of embodiment 1.
Fig. 10B is a diagram of a mechanical switch (ON state) of the sterilization unit of embodiment 1.
Fig. 11A is a flowchart of the sterilization procedure in the case where the sterilization unit is used as the maintenance work in embodiment 1.
Fig. 11B is a flowchart of the sterilization procedure in the case where the sterilization unit is used as the maintenance work in embodiment 1.
Fig. 12A is a flowchart of the sterilization procedure in the case where the sterilization unit is repeatedly used as the maintenance work in embodiment 1.
Fig. 12B is a flowchart of the sterilization procedure in the case where the sterilization unit is repeatedly used as the maintenance work in embodiment 1.
Fig. 13A is a flowchart of the sterilization procedure in the case where the sterilization unit is used in the preparatory operation before the start of the analysis measurement in embodiment 1.
Fig. 13B is a flowchart showing a sterilization procedure in the case where the sterilization unit is used in the preparatory operation before the start of the analysis measurement in example 1.
Fig. 13C is a flowchart showing a sterilization procedure in the case where the sterilization unit is used in the preparatory operation before the start of the analysis measurement in example 1.
Fig. 13D is a flowchart showing a sterilization procedure in the case where the sterilization unit is used in the preparatory operation before the start of the analysis measurement in example 1.
Fig. 14 is a diagram showing an example of an installation configuration of the sterilization unit according to embodiment 2.
Fig. 15 is a diagram showing another example of the installation structure of the sterilization unit according to embodiment 2.
In the figure:
101-automatic analyzer, 106-sample dispensing tip/reaction vessel transport unit, 108-incubator, 109-reagent dispensing mechanism, 110-reagent vessel, 111-reagent disk, 113-detection unit, 114-sample transfer line, 117, 903-control unit, 203-RFID tag, 301-hinge, 302-protrusion, 303-opening, 304-sealing member, 401-cover, 402-jacket, 403, 506-device, 501-reagent drive disk, 502-reagent drive disk drive unit, 503-fixed disk, 504-filling system, 505-reagent vessel moving unit, 601-reagent setting unit, 602-reagent driver, 701-opening, 704, 802-guide groove, 705-indicator lamp, 706-loading switch, 801-slot, 901, 1401, 1501-sterilization unit, 902-ultraviolet irradiation unit, 904-driving battery, 905-mechanical switch, 906-heat dissipation unit, 907 — battery surplus indicator.
Detailed Description
First, the main technical matters to be examined for obtaining the solution of the present invention described above will be described. In designing a sterilization means for a reagent container storage box, it is particularly necessary to take care of the possibility of space saving and interference with a working part.
First, space saving will be explained. In general, a common reagent bottle is often provided with an installation place outside the apparatus to be easily accessible to an operator. On the other hand, in many cases, the analytical reagent container is provided with an installation site inside the apparatus (referred to as the reagent container storage box). In addition, in the case of an apparatus for automatically loading/unloading an analytical reagent container, the reagent container loading area is often only the minimum size required for space saving. Therefore, it is necessary to take care that (i) the occupied volume of the reagent container storage box is not excessively increased by providing the sterilization means; and (ii) the volume occupied by the reagent container loading area (hereinafter referred to as a reagent loading unit) is not excessively increased on the assumption that the sterilizing means is loaded/unloaded periodically in the reagent container storage box.
Next, a description will be given of a possibility of interference with the operation portion. As will be described later, in most cases, an automatic analyzer includes a reagent drive disk that stores an analysis reagent container in a reagent container storage box and transports the analysis reagent container to a desired position in the reagent container storage box. In this case, it is necessary to take care that the sterilization means and the related components such as the power supply cable do not spatially interfere with the reagent drive disk as the working portion.
Hereinafter, various embodiments for carrying out the present invention will be described in order with reference to the drawings. In the present specification, the expression "kill bacteria" or "kill microorganisms" is used not only for "killing microorganisms" but also for "rendering microorganisms harmless". In addition, in the expression, the term "bacterium" or "microorganism" is used not only to completely eradicate the bacterium or microorganism but also to reduce the bacterium or microorganism. Before describing each embodiment in detail, the overall configuration and the like of an automatic analyzer common to each embodiment will be described.
Fig. 1 is a diagram showing an entire configuration example of an automatic analyzer. A sample transfer line 114 in the automatic analyzer 101 transfers the sample 104 to a sample dispensing mechanism adjacent to the sample dispensing unit 115.
The sample distribution tip/reaction vessel transfer unit 106 moves in the X-axis, Y-axis, and Z-axis directions above the sample distribution tip/reaction vessel discarding well 102, the sample distribution tip holder 103, the reaction solution stirring unit 105, the sample distribution tip/reaction vessel station 107, and a part of the incubator 108. The sample distribution tip/reaction vessel transfer unit 106 moves a reaction vessel from the sample distribution tip/reaction vessel station 107 to the incubator 108. The sample distribution tip/reaction vessel transfer unit 106 also moves the sample distribution tip to the sample distribution tip holder 103.
The sample distribution unit 115 moves to the upper region of the sample distribution tip holder 103 on which the sample distribution tip is placed, and picks up any one of the sample distribution tips. The sample dispensing unit 115 moves to the upper region of the sample, acquires the sample by suction, and then moves to the upper region of the reaction vessel on the incubator 108, thereby discharging the sample into the reaction vessel. Thereafter, the sample dispensing unit 115 moves to the upper region of the sample dispensing tip/reaction vessel waste well, and drops the sample dispensing tip into the well for waste. The incubator 108 has a capability of locking a plurality of reaction vessels, and the reaction vessels are moved to predetermined positions on the circumference of the incubator 108 by rotational movement.
The reagent disk 111 holds a plurality of reagent containers 110, and each reagent container 110 is moved to a predetermined position on the circumferential portion of the reagent disk 111 by a rotational motion. The reagent dispensing mechanism 109 moves to an upper region of a predetermined type of reagent on the reagent disk 111, and then the dispensing mechanism sucks a predetermined amount of reagent, moves to an upper region of a predetermined reaction vessel on the incubator, and discharges the reagent into the reaction vessel.
A magnetic particle stirring arm 116 (also referred to as a stirrer) as a stirring means is attached to the reagent disk 111. The arm 116 moves to an upper region of a reagent container containing a magnetic particle solution to be stirred, and the magnetic particle stirring member of the arm 116 is lowered to rotate the stirring member, thereby stirring the magnetic particle solution. The magnetic particle stirring arm 116 stirs the magnetic particles until the reagent is dispensed, so that the magnetic particles in the solution do not precipitate naturally. After the agitation, the magnetic particle agitating arm 116 moves toward the upper region of the cleaning unit containing the cleaning liquid, and then descends to rotate the magnetic particle agitating member, thereby removing the magnetic particles attached to the agitating member.
The reaction solution suction nozzle 112 sucks a reaction solution formed after a predetermined reaction time has elapsed after dispensing a sample and a predetermined reagent from a reaction vessel, and then supplies the reaction solution to the detection unit 113. The detection unit 113 qualitatively/quantitatively analyzes the measured substance in the reaction solution. The sample distribution tip/reaction vessel transfer unit 106 moves the analyzed reaction vessel to the upper region of the sample distribution tip/reaction vessel waste well, and places the reaction vessel into the waste well for waste.
The sample transfer line 114, the reagent disk 111, the incubator 108, the sample dispensing unit 115, the reagent dispensing mechanism 109, the sample dispensing tip/reaction vessel transport unit 106, and the detection unit 113 described above in the automatic analyzer are referred to as an analysis operation unit. Further, the automatic analyzer includes a control unit 117 and an operation unit 118 for controlling the operation of the entire automatic analyzer, in addition to the analysis operation unit. The control unit 117 is constituted by, for example, a hardware board and a computer, and is connected with a storage device 119 such as a hard disk. The operation unit 118 is constituted by a display device as a display, and an input device such as a mouse or a keyboard. The storage device 119 stores, for example, temperature ranges and the like corresponding to the respective cells.
The control unit 117 may be configured by a dedicated circuit board as hardware, or may be configured by software executed by a computer. In the case of a hardware configuration, a plurality of processors for executing processing can be integrated on a wiring board or in a semiconductor chip or a package. In the case of a software configuration, the software configuration can be realized by mounting a high-speed general-purpose CPU on a computer and executing a program for necessary arithmetic processing. An existing apparatus can also be upgraded by a storage medium in which the program is recorded. These devices, circuits, and computers are connected to each other via a wired or wireless network, and can transmit and receive data as appropriate.
Fig. 2 and 3 are schematic perspective views showing an example of a reagent container used in the automatic analyzer according to each embodiment. The reagent container 110 is composed of a set of three containers, for example, a magnetic particle solution and two reagents. Each container includes a main body portion for storing a reagent, an opening portion 303 accessible to the reagent, and a lid portion 201 capable of closing the opening portion 303. The reagent container 110 has a substantially rectangular parallelepiped shape having a shoulder 202 as a whole, and three openings 303 are arranged above the shoulder and project upward. In order to enable the opening and closing operation of the reagent container lid opening and closing device incorporated in the automatic analyzer, a circular rod-shaped protrusion 302 is provided at one end of the lid portion 201, and the protrusion 302 protrudes in the side surface direction of the reagent container 110 with respect to the lid portion 201. An RFID (Radio frequency identification) tag 203 is attached to an end surface of the reagent container 110. The container ID for specifying the reagent container 110, the type of reagent contained in the reagent container 110, the amount of reagent, the expiration date of the reagent, and other necessary information are stored in the memory built in the RFID tag 203. The reading means for the reagent container information is not limited to RFID, and other information reading means such as a barcode may be used.
Fig. 2 is a perspective view schematically showing a reagent pack in a sealed state. In the initial state, the opening 303 is sealed by the lid 201. In order to reliably seal the opening 303, a sealing member 304 is provided in the lid portion so as to be insertable into and sealable with the opening 303. If the opening 303 is always opened, the internal reagent may evaporate and the reagent concentration may change. In addition, when the reagent container 110 is touched by mistake during the treatment, the reagent in the reagent container 110 may be spilled. These problems can be reduced by sealing the opening 303 with the lid 201 and opening the lid 201 if necessary. Fig. 3 is a schematic perspective view showing the reagent vessel in an open state. The lid 201 is rotated about the hinge 301 as a rotation axis, whereby the lid 201 is opened from the protrusion 302. At this time, the sealing member 304 is completely removed from the opening 303, and the lid 201 is opened at a large angle around the hinge 301.
Fig. 4 is an external view of the reagent disk 111 according to each example. In order to control the reagent vessel 110 to a constant temperature, the reagent disk 111 includes a cover 401 having a heat insulating function and a jacket 402. In addition, an RFID information reading device 403 is provided in a part of the cover 401. As will be described later, the jacket 402 is also provided with an RFID information reading device, and the device 403 is referred to as an RFID information reading device a for the purpose of distinguishing it.
Fig. 5A is an external view of the reagent disk 111 with the cover 401 removed, and fig. 5B is a plan view thereof. The reagent disk 111 includes: a reagent drive disk 501 (also referred to as a first turret partition) for transporting reagent containers 110 to a desired location; a reagent driving disk driving unit 502 that drives the reagent driving disk 501; a fixed tray 503 (also referred to as a second turntable partition wall) having a reagent stirring position 508; a loading system 504 capable of mounting the reagent container 110 in the system even during analysis; a reagent container moving unit 505 (also referred to as a container moving mechanism) for moving the reagent container 110 from the reagent driving disk 501 toward the fixed disk 503 or the loading system 504; an RFID information reading device 506 (referred to as an RFID information reading device B for the sake of distinction from the reading device 403 on the cover 401 described above); and partitions for partitioning spaces between the reagent vessels 110. Each space partitioned by the partition plate is referred to as a reagent container installation slot.
As shown in the plan view of fig. 5B, a reagent dispensing position 509 is present on the operation path of the reagent drive disk 501. The reagent stirring position 508 is adjacent to the reagent dispensing position 509, and is present on the working path of the reagent dispensing pipette. The area of the reagent disk is also referred to as the processing area.
Fig. 5C is a side view of the reagent disk shown in fig. 5A and 5B. At the reagent stirring position 508, while the magnetic particle stirring arm 116 stirs the magnetic particle solution in the reagent container, the reagent dispensing pipette 109 can dispense the same kind of reagent into another reaction container. This makes it possible to secure a sufficient magnetic particle stirring time and to perform dispensing and stirring simultaneously. Therefore, analysis can be performed without reducing the throughput. In fig. 5C, the reagent dispensing position 509 and the reagent stirring position 508 are linearly arranged, and both positions are present at the same position on the operation path of the reagent dispensing pipette. The operation paths of the reagent dispensing pipettes can be said to be substantially the same even when they are located on the circumference.
Fig. 6 is a diagrammatic view of the loading system 504 of fig. 5A. The loading system forms part of a fixture located at the inner circumferential portion of the reagent disk, and the system operates upward and downward. For example, when the fixing means is provided on the outer circumferential portion of the reagent disk, the loading system may be configured so as to be able to be pulled out in the vertical direction or the horizontal direction. Further, since a part of the fixing device is a loading system and the system has a shape that can replace five reagent containers at maximum, two or more reagent containers can be replaced, and only one reagent container can be replaced. The filling system 504 includes: a reagent setting unit 601 on which the reagent container 110 is placed; and a reagent actuator 602 for moving the reagent upward/downward.
Fig. 7 is a schematic diagram showing the relationship between the reagent container loading unit and the loading system of the automatic analyzer according to each embodiment, and shows a state in which the loading system 504 is positioned at the uppermost portion. The reagent container loading unit includes: an opening 701 for introducing a reagent container into the apparatus; and a reagent loading unit including a space between an upper surface 702 and a lower surface 703 of the front of the opening connected to the opening 701. When the charging system is positioned at the lowermost portion, the opening 701 is closed by the shielding member. In this embodiment, a plurality of guide grooves 704 for guiding reagent containers are radially arranged on the lower surface of the front side of the opening connected to the opening 701. The guide grooves 704 are for guiding the lower end portion of the reagent pack 110 to slide therein toward the inside of the opening 701, and in this example, five guide grooves are provided in the insertion direction of the reagent pack. As shown, the five radially disposed guide slots 704 communicate with five slots on the filling system that are likewise radially disposed. That is, the radially arranged slots 801 and the radially arranged guide grooves 704 are completely continuous, and constitute an integrated radial groove.
The operator can insert the reagent container into the slot 801 by placing the bottom of the reagent container into the guide groove 704 and sliding the reagent container along the guide groove 704 toward the depth side of the opening 701 in a state where the reagent container is gripped. An indicator lamp 705 indicating the state is provided above each guide groove. In addition, a loading switch 706 is provided beside the opening 701. As will be described later, the loading switch 706 is a hardware switch for raising and lowering the loading system 504, and is used when discharging and adding a reagent.
FIG. 8 is an enlarged view of the reagent loading unit. As shown in the figure, a guide groove 802 is provided on the upper surface of the reagent loading portion in addition to the guide groove 704 on the lower surface. The guide grooves 802 on the upper surface are also arranged in a radial shape, similarly to the guide grooves on the lower surface. Since the reagent container 110 slides while being fixed at the upper and lower ends thereof by the guide grooves 704 and 802 provided above and below the input area, it can be inserted into the slot 801 with higher accuracy. Further, the guide groove 802 on the upper surface has an opening and closing mechanism for the lid of the reagent container, and is configured such that the lid is in a half-open state (hereinafter, this mechanism is referred to as a half-opener, and this function is referred to as a half-open function) in the process of sliding the reagent container to the innermost side. Thus, the operator does not need to open the lid by his or her hand each time he or she puts in the reagent container.
Hereinafter, an example of the procedure of reagent discharge/addition by the operator in the automatic analyzer according to each embodiment will be described.
First, a flow of the continuous reagent loading operation will be described. The operator selects a reagent discharge/addition request by the host computer. The host computer analyzes the operation state of the apparatus at this time, and then, when it is determined that the reagent replacement can be performed, the host computer turns on the indicator lamp 705 to notify that the reagent replacement can be performed. The operator determines that the reagent is replaceable based on information from both the main unit and the indicator lamp 705.
Upon receiving a reagent discharge request from the operator, the reagent drive disk 501 rotates to move the reagent container to be discharged to a position adjacent to the loading system 504. Then, the reagent container moving unit 505 moves the reagent container from the reagent driving disk 501 to the loading system 504. In this state, when the operator presses the loading switch 706, the loading system 504 is operated upward, and the reagent container can be discharged by the operator.
Here, when a reagent needs to be added, the operator can set a reagent container to be added to the loading system 504. After the reagent container is set, the loading system 504 operates downward when the operator presses the loading switch 706. At this time, the filling system 504 is temporarily stopped at a position adjacent to the RFID information reading device 403 (device a). Here, the RFID information of the additional reagent container is read by the device and then entered into the apparatus. If the reagent information is entered, the reagent container is moved to the reagent drive disk 501 by the reagent container moving unit 505.
Further, when the additional reagent container is inserted in a reverse direction, the RFID information cannot be read normally and the reagent information cannot be recorded. At this time, the apparatus notifies the operator of the failure of the reagent information entry via the display. Further, the loading system 504 is operated upward, and a reagent container with a failed recording can be taken out. In this state, the operator temporarily removes the container from the slot 801 and then reinserts the container into the guide in the correct orientation.
(example 1)
Embodiment 1 is an automatic analyzer having the following configuration, including: a reagent container storage box for holding a reagent container; a reagent tray for accommodating the reagent container and transporting the reagent container to a desired position of the reagent container storage box; an irradiation unit that irradiates a filling system of the reagent disk and the reagent container with ultraviolet light; and a control unit for controlling the irradiation unit. In particular, in the present embodiment, a configuration in which an ultraviolet irradiation unit for sterilization is attached to a reagent container will be described.
Fig. 9 shows a sterilization unit 901 for sterilization of the automatic analyzer of the present embodiment. As shown in the drawing, all the components represented by the ultraviolet irradiation section 902 are housed in the reagent container 110, and the shape of the container itself is the same as that of a normal reagent container. With such a configuration, the reagent container can be loaded into the apparatus by the same method as a general reagent container. That is, a dedicated input unit for the container is not required, and space saving can be achieved.
The components other than the ultraviolet irradiation section 902 include: a control part 903 for controlling the ultraviolet irradiation of the irradiation part, a driving battery 904, a mechanical switch 905 for switching the timing of the ultraviolet irradiation, a heat dissipation part 906 for relieving local heat generation caused by the ultraviolet irradiation, and a remaining battery indicator 907 for displaying the remaining battery capacity. In this way, the reagent container is provided with the irradiation unit, and the reagent container provided with the irradiation unit includes at least a control unit, a drive battery for driving the irradiation unit, and a switch for switching the timing of ultraviolet irradiation.
Here, an ultraviolet LED is used for the ultraviolet irradiation section 902. As described above, in order to ensure the mechanical stability of the reagent, it is necessary to maintain the temperature in the reagent disk 111 constant (for example, 2 to 10 ℃). Accordingly, from the viewpoint of stable storage of the reagent on the device, it is important to provide the heat dissipation portion 906 to the ultraviolet irradiation portion 902 to reduce local heat generation caused by ultraviolet irradiation.
Next, a function of switching the irradiation timing of the mechanical switch 905 will be described. Fig. 10A and 10B show a state in which the switch 905 is OFF and a state in which it is ON, respectively. As shown in fig. 10A, the switch 905 is OFF in a state where the lid 201 is completely closed. ON the other hand, as shown in fig. 10B, when the lid 201 is in the half-open state, the switch 905 is ON (is also ON when fully open). The switch 905 includes a spring 1002 under the convex portion 1001, and in a state where the lid 201 is completely closed, the spring 1002 and the convex portion 1001 are pushed in, and are electrically insulated from the control portion, and ultraviolet rays are not irradiated.
Here, when the lid 201 is in the half-open state, the pushing of the projection 1001 is released with the opening of the spring 1002, and the lid is electrically connected to the control unit, and ultraviolet rays are irradiated. As described below, this function is useful in preventing ultraviolet exposure of the operator due to the sterilization unit 901. When using the sterilization unit 901, the operator first sets the unit in the guide groove 704 of the reagent loading unit with the lid 201 closed.
Then, when a predetermined process before the sterilization unit 901 is loaded is performed, the loading system 504 is raised when the load switch 706 is pressed after the apparatus is instructed to load the sterilization unit 901 via, for example, a User Interface (UI). Then, the operator inserts the installed sterilization unit 901 into the slot 801 by sliding it along the guide groove 704. At this time, when the sterilization unit 901 passes through the guide groove 802 ON the upper surface, the lid 201 is in the half-open state and the switch 905 is in the ON state by the half-open function described above. That is, the sterilization unit 901 starts the ultraviolet irradiation after being inserted into the slot 801. This makes it possible to prevent exposure of the operator to ultraviolet light by the unit. The number of mechanical switches 905 need not be three, but may be one or two.
The switching mechanism of the irradiation timing is not limited to the above, and various switches may be used in combination. For example, a toggle switch, which is one of the same mechanical switches, may be used in addition to the switch 905. The dial switch may be attached to the outer surface of the container so that the operator can freely switch the dial switch, and the ultraviolet light may be irradiated after both conditions of the dial switch being ON and the mechanical switch 905 being ON match.
Instead of the mechanical switch, a switching mechanism using a sensor such as an illuminance sensor, a temperature sensor, or an acceleration sensor may be used. The switch using the illuminance sensor turns ON the switch when the illuminance is lower than a preset threshold value. If the threshold value is lower only when the sterilization unit 901 is present in the reagent disk, ultraviolet exposure of the operator outside the reagent disk can be prevented.
A switch using a temperature sensor turns ON the switch when the temperature is lower than a preset threshold value. As in the case of the illuminance sensor, if the illuminance is lower than the threshold value only when the sterilization unit 901 is present in the reagent disk, the ultraviolet exposure of the operator outside the reagent disk can be prevented. The switch using the acceleration sensor turns ON the switch when a certain acceleration is detected. Here, it is assumed that the reagent disk is irradiated with ultraviolet rays while rotating the reagent disk 501 while holding the sterilization unit. That is, acceleration generated when the reagent driving disk 501 enters the rotating motion from the stopped state is detected, and then ultraviolet rays are irradiated.
In addition to the above, a switching mechanism using wireless communication may be used. For example, after the sterilization unit is loaded ON the reagent disk with the power supply cut off, the switch may be turned ON (ON) by a remote controller corresponding to the sterilization unit. Further, as one of the wireless communication techniques, RFID employed in the automatic analyzer of the present embodiment may be used. For example, when the RFID tag 203 incorporates a circuit for switching a switch of the unit when the tag information is read. Thus, when the RFID information reading device 403 (device a) reads the tag information of the RFID tag 203 at the time of loading the unit, the switch is turned ON. On the other hand, when the unit is unloaded, the RFID information reading device 403 (device a) reads the tag information again, and the switch is turned OFF.
The switching means may also utilize the RFID information reading device 506 (device B). That is, after the unit is loaded, the reagent driving disk 501 rotates and moves to a position adjacent to the reading device 506 (device B). Then, the tag information of the RFID tag 203 is read, and the switch is turned ON. After using the unit, the unit is moved to a position adjacent to the device 506 (device B) again, and the tag information is read, whereby the switch is turned OFF. A great advantage of switches using wireless communication is that the ultraviolet radiation can be switched in areas that are not accessible to an operator, such as inside the reagent container storage box.
In this way, by increasing the number and types of switches and increasing the number of steps up to ultraviolet irradiation, the risk of ultraviolet exposure for the operator can be reduced. In addition to increasing the steps before irradiation, the above-mentioned risk can also be reduced by complicating the logic up to irradiation. The following describes the case where three mechanical switches 905 are provided as an example shown in fig. 9.
As one of the means for complicating the logic, there is a method of setting a certain rule for the switching order of three mechanical switches. For example, when the surface to which the RFID tag 203 is attached is referred to as front/front surface in the reagent container 110, ultraviolet rays may be irradiated only when the switch is ON in order from the container behind. In a case where the sterilization unit 901 is actually slid to the deepest side in the correct orientation (the orientation in which the RFID tag 203 is facing the RFID information reading device 403), the switch is turned ON in the above-described order. By providing such a rule, the risk of ultraviolet irradiation when the operator opens lid 201 by mistake can be reduced.
As described above, in the present embodiment, a case where an ultraviolet LED (Light Emitting Diode) is used as the ultraviolet irradiation section is described. Although a mercury lamp may be used as the ultraviolet light source, the use of an ultraviolet LED is more advantageous in terms of space saving. The central wavelength of the light emitted from the ultraviolet LED is preferably 180nm to 340nm, which is known to be useful for sterilization. Particularly, it is preferably about 260nm, i.e., 230 to 290nm, which is a wavelength having high sterilization efficiency.
The amount of ultraviolet light to be irradiated is controlled by the control unit 903 depending on the current, voltage, and energization time of the LED. The amount of ultraviolet irradiation light per unit area required for sterilization is determined by the combination of the seed to be sterilized and the irradiation wavelength. Thus, the irradiation light amount required for sterilization is determined in advance by actual measurement or calculation for each combination of the seed and the wavelength of the ultraviolet light used. These pieces of information are stored as a table in the storage unit 903A of the control unit 903.
From the viewpoint of the sterilization effect, the larger the irradiation light amount, the better. On the other hand, it is necessary to consider the influence on the reagent components and various components (reagent containers and reagent disks) in the reagent container storage box accompanying the ultraviolet irradiation. That is, it is necessary to control the irradiation wavelength and the irradiation light amount so that they are not denatured by ultraviolet irradiation. The irradiation light amount of the denaturation within the allowable range is determined by the combination of the reagent used and the irradiation wavelength, and therefore, is determined in advance by actual measurement or calculation for each combination. These pieces of information are stored as a table in the storage unit 903A of the control unit 903. The denaturation of the reagent components and the structural members can be defined by changes in chemical bonding and molecular weight evaluated by infrared spectroscopy, mass spectrometry, or the like. Further, the change in mechanical properties of the structural member can be defined by a change in parameters such as hardness and young's modulus evaluated by an indentation test using a nanoindenter or the like.
In addition to the above-described sterilization effect and denaturation of the reagent components and various components, the control of the irradiation light amount is also necessary from the viewpoint of the influence on the temperature environment in the reagent disk. For example, when the temperature in the reagent disk needs to be maintained at 2 to 10 ℃, care must be taken not to cause the temperature around the sterilization unit to exceed 10 ℃ due to the lighting of the LED. In this embodiment, a local temperature rise can be suppressed by mounting the heat dissipation portion 906 to the irradiation portion. Here, a heat sink and a fan are used as the heat dissipation portion 906.
The number of LEDs used need not be limited to one as in the present embodiment, and a plurality of LEDs may be used for the purpose of expanding the irradiation range. In addition, optical members such as lenses and mirrors may be used. The optical component may be attached to the sterilization unit 903, or may be provided in the reagent container storage box. Further, the driver can be used to change the mounting position/angle of the LED, thereby extending the irradiation range.
As described above, a mercury lamp can be used for the ultraviolet irradiation unit in addition to the LED. The amount of irradiation light depends on the current, voltage, and energization time of the mercury lamp. As in the case of the LED, the amount of irradiation light required for sterilization is determined in advance by actual measurement or calculation for each combination of the bacterial species to be sterilized and the emission wavelength of the lamp. These pieces of information are stored as a table in the storage unit 903A of the control unit 903. Further, similarly to the case of the LED, it is necessary to consider the denaturation of the reagent components and various components in the reagent container storage box. That is, the irradiation light amount with which the denaturation is within the allowable range is determined in advance by actual measurement or calculation for each combination of the reagent and the irradiation wavelength used.
These pieces of information are stored as a table in the storage unit 903A of the control unit 903. In addition, since the mercury lamp also contains a wavelength in the visible to infrared region that does not participate in sterilization, it is preferable to control the irradiation wavelength by an optical filter. The irradiation range can be enlarged by increasing the number of lamps and using optical members such as lenses and mirrors. The optical component may be attached to the sterilization unit 903, or may be provided in the reagent container storage box. Further, it is also possible to use a driver to make the mounting position/angle of the lamp variable, thereby achieving enlargement of the irradiation range.
A battery is used for supplying power to each component of the sterilization unit 903 typified by an ultraviolet irradiation unit. From the viewpoint of convenience, the battery is preferably reusable by charging. In the selection of the battery to be used, safety aspects, energy density, mass, and the like need to be considered. In the present embodiment, it is assumed that a general rechargeable battery such as a nickel metal hydride battery, a lithium ion battery, or a lithium ion polymer battery is used. Further, the charging operation is periodically performed outside the apparatus by an operator. That is, after the sterilization unit is used a certain number of times, the unit is unloaded and the battery is taken out. Then, the battery taken out is set in a dedicated charger for charging. The charger may be configured to be chargeable only by providing the sterilization unit without taking out the battery. In addition, the charging mode can also adopt wireless charging.
For the charging outside the apparatus, for example, a charging port may be provided in an apparatus such as a reagent container storage box. For example, a part of fixed disk 503 may be used as a charging port. At this time, the reagent stirring position 508 may be used as a charging port, or a new charging port may be provided. Alternatively, one of the reagent container setting slots in the reagent drive disk 501 may be used as a slot dedicated to the sterilization unit, and charging may be performed here. Here, the sterilization unit exclusively means a slot not shared with the analysis reagent container. In addition, the charging mode can also adopt wireless charging. The charging procedure will be described together with a method of operating the sterilization unit (described later).
Next, a method of managing the remaining battery level will be described. The remaining battery level can be visually confirmed by an operator through the remaining battery level indicator 907. Further, the charging port provided in the above-described device may be configured to allow the remaining battery level to be checked. Thus, the remaining battery level can be automatically checked by the device every time the sterilization unit is moved and installed at the charging port. Further, the remaining battery level can be stored as one of the tag information of the RFID tag 203. Thus, the remaining battery level can be confirmed each time the tag information is read by the RFID information reading device 403/506. Here, the remaining battery level read by the charging port/RFID information reading device is displayed on the device GUI and can be confirmed by the operator.
Hereinafter, a method of operating the sterilization unit of the present embodiment will be described. Here, a case where the operator uses the unit as the apparatus maintenance work is considered. Before this operation is performed, the apparatus is in a so-called standby state in which an analysis operation or the like is not performed. Further, it is assumed that, in a state where the reagent container holding unit is provided with the slit in the reagent drive disk 501, the ultraviolet rays are irradiated while rotating the reagent drive disk. The reagent container-provided slot referred to herein is not a slot dedicated to the above-described sterilization unit, but a slot shared with the analysis reagent container. Further, as the switching mechanism of the ultraviolet irradiation timing, a case where the mechanical switch 905 using the above-described half opener and a switch using wireless communication with the RFID information reading device 506 (device B) are used in combination is exemplified.
Fig. 11A, 11B, 12A, and 12B are flowcharts of the operation sequence, and the operation main bodies thereof are the automatic analyzer and the operator controlled by the control units 117 and 903. Fig. 11A and 11B show a case where the used sterilization unit is unloaded after the job is performed once. On the other hand, fig. 12A and 12B show a case where the sterilization unit used is unloaded after the operation is repeatedly performed until the remaining battery level disappears.
First, the former will be explained. When the sterilization unit is loaded into the apparatus, the operator first instructs the apparatus UI to insert the sterilization unit (S1101). Then, the apparatus confirms whether there is an empty slot on the reagent driving disk for setting the unit (S1102). If it is determined that there is no empty slot, the message is displayed on the GUI as warning information (S1103). The operator who has confirmed this information selects and unloads one appropriate reagent container (the order of reagent discharge has already been described, and therefore S1104 is omitted here). After the reagent is discharged, the unit is instructed to be put in again (S1101).
After the apparatus confirms the presence of the empty slot, the operator presses the load switch 706 (S1105). Then, the loading system 504 operates upward, and the sterilization unit can be loaded by the operator (S1106). In this state, the operator sets the unit in the filling system 504(S1107), and presses the loading switch 706 again (S1108). Then, the loading system 504 operates downward (S1109). In this process, the remaining battery level of the RFID tag stored in the sterilization unit is read by the RFID information reading device 403 (device a) (S1110).
Here, if the RFID information is not read normally due to the sterilization unit being inserted in the forward and backward directions by mistake, the information is displayed on the GUI as warning information (S1111). Then, the loading system 504 is operated upward to discharge the sterilization units (S1112). The operator who has confirmed the warning message temporarily takes out the sterilization unit from the slot 801 and reinserts the guide in the correct orientation (S1113).
When the RFID tag information is read normally (S1110), the remaining battery level is checked as shown in fig. 11B (S1114). If the remaining battery level does not satisfy the necessary sufficient level, the information is displayed on the GUI as warning information (S1115). Then, the loading system 504 is operated upward to discharge the sterilization units (S1116). After the operator who has confirmed the warning message discharges the sterilization unit from the charging system 504 (S1117), the battery is charged (S1118). After the battery is charged, the sterilization unit is again put in (S1101).
When the remaining battery level is a sufficient amount, the storage unit of the information recording device of the sterilization unit represented by the remaining battery level is stored (S1119). After the recording, the sterilization unit is moved to the reagent drive disk 501 by the reagent container moving unit 505 (S1120). Then, the operator instructs execution of the sterilization operation on the UI of the apparatus (S1121). Then, the sterilization unit moves to a position adjacent to the RFID information reading device 506 (device B) (S1122), and the LED is turned on by communication with the device (S1123). After the LEDs are turned on, the reagent driving disk is rotated in a predetermined order to sterilize the inside of the safe (S1124). That is, the control unit controls the sterilization unit to move to a position adjacent to the RFID information reading device 506 (device B) and then irradiate ultraviolet rays.
After the sterilization operation is completed, the sterilization unit moves to the position adjacent to the reading device 506 (device B) again (S1125). Then, the LED is turned off by communication with the device (S1126). After the LED is turned off, the sterilizing unit is moved to a position adjacent to the filling system 504, and further, moved to the filling system 504 by the reagent container moving unit 505 (S1127). Thereafter, the loading system 504 is operated upward (S1128), and the operator can take out the sterilization unit (S1129). And finally, the operator takes out the sterilization unit, and the maintenance operation is completed.
In this way, the control unit moves the sterilization unit to the reagent drive disk after the RFID tag information is recorded, and instructs execution of the sterilization operation. Further, the control unit controls the sterilization unit to be turned on and perform a sterilization operation after moving the sterilization unit to a position adjacent to the RFID information reading device B. Further, the control section controls to move the sterilization unit to a position adjacent to the RFID information reading device B after the execution of the sterilization operation, and then to turn off the irradiation section.
Next, a case where the maintenance operation is repeatedly performed until the remaining battery capacity is not obtained will be described with reference to fig. 12A and 12B. Here, the following is assumed: this maintenance operation is performed before, and the used sterilization unit is directly held in the reagent disk. Further, the LED is set to be turned off first. First, the operator instructs execution of the sterilization operation on the apparatus UI (S1201). Then, the sterilization unit is moved to a position adjacent to the filling system 504, and then moved to the filling system 504 by the reagent container moving unit 505 (S1202). Then, the loading system 504 operates upward and temporarily stops at a position adjacent to the RFID information reading device 403 (device a) (S1203). Then, by the apparatus (apparatus a), the remaining battery level is read (S1204).
If the remaining battery capacity is insufficient by the necessary sufficient amount, the information is displayed on the GUI as warning information (S1205). Then, the loading system 504 is operated upward to discharge the sterilization units (S1206). After the operator who has confirmed the warning information discharges the sterilization unit from the charging system 504 (S1207), the battery is charged (S1208).
When the remaining battery level is the necessary sufficient level, the sterilization unit information such as the remaining battery level is updated (S1209). After the update, the loading system 504 operates downward (S1210), and the sterilization unit is moved to the reagent drive disk 501 by the reagent container moving unit 505 (S1211). Then, the sterilization unit moves to a position adjacent to the RFID information reading device 506 (device B) (S1212), and as shown in fig. 12B, the LED lights up by communication with the device (S1213). After the LEDs are turned on, the reagent driving disk is rotated in a predetermined order to sterilize the inside of the safe (S1214).
After the sterilization operation is completed, the sterilization unit moves to the position adjacent to the reading device 506 (device B) again (S1215), and the LED is turned off by communication with the device (S1216). After the LED is turned off, the sterilization unit is moved to a position adjacent to the loading system 504, and further, moved to the loading system 504 by the reagent container moving unit 505 (S1217). The loading system 504 moves upward and stops at a position adjacent to the RFID information reading device 403 (device a) (S1218). Then, by the apparatus (apparatus a), the remaining battery level is read (S1219).
If the remaining battery capacity is insufficient by the necessary sufficient amount, this is displayed on the GUI as warning information (S1220). Thereafter, the loading system 504 is operated upward to discharge the sterilization units (S1221). The operator who has confirmed the warning message discharges the sterilization unit from the loading system 504 (S1222), and charges the battery (S1223).
When the remaining battery level is a sufficient amount, the sterilization unit information is updated (S1224). After the update, the loading system 504 operates downward (S1225), and the sterilization unit is moved to the reagent drive disk 501 by the reagent container moving unit 505 (S1226). Up to this point, the maintenance operation is completed. Finally, the updated information on the sterilization unit is stored in the storage device 119, and the operator can confirm the loading state of the sterilization unit and the remaining battery capacity in advance at the time of the next maintenance operation.
When the maintenance work is completed, the work date may be stored in the storage device 119. This can provide, for example, the following functions: when a constant period is left from the date of the last execution of the maintenance work, information for urging the execution of the work is displayed on the GUI. In addition to the information display, the apparatus may automatically perform the operation when there is no measurement request. When the charging port is located in the reagent container storage box (in the fixed disk 503 or the reagent drive disk 501), the battery can be charged until the next operation is performed by moving the sterilization unit to the charging port after the completion of the operation. Further, by instructing the discharge of the sterilization unit on the apparatus UI, for example, even when the remaining battery capacity is a sufficient amount, the sterilization unit can be discharged at an arbitrary timing. As described above, the operator may use the sterilization unit as the maintenance work of the apparatus.
Next, a case where this operation is performed in a preparatory operation before the start of the analysis measurement will be described. Here, the following is exemplified: this maintenance operation is performed before, and the used sterilization unit is directly held in the reagent disk or the charging port in the safe (in the case of being installed). Fig. 13A, 13B, 13C, and 13D are flowcharts showing the operation sequence, and the operation main bodies of the automatic analyzer and the operator are controlled by the control units 117 and 903.
First, as shown in fig. 13A, when the operator requests the analysis measurement, a preparatory operation before the analysis measurement is started (S1301). The sterilization unit is moved to a position adjacent to the filling system 504 and then moved to the filling system 504 by the reagent container moving unit 505 (S1302). After that, the loading system 504 operates upward and temporarily stops at a position adjacent to the RFID information reading device 403 (device a) (S1303). Then, by the device (device a), the remaining battery level is read (S1304). If the remaining battery level is insufficient by the necessary sufficient amount, this is displayed on the GUI as warning information (S1305). Then, the loading system 504 is operated upward to discharge the sterilization units (S1306). After the operator who has confirmed the warning message has discharged the sterilization unit from the charging system 504 (S1307), the battery-charged sterilization unit is set (S1310), as shown in fig. 13B.
If there is no battery-charged sterilization unit, the operator presses the load switch 706 (S1308). The loading system 504 then operates downward (S1309), and then proceeds to the analysis operation after the preparation operation is completed before the analysis is started without performing the sterilization operation. When the sterilization unit with the charged battery is newly provided, the operator presses the loading switch 706(S1311), and the loading system moves downward (S1312). In this process, the remaining battery level is read by the above-described reading device (device a) (S1313).
If the RFID information is not read normally by inserting the sterilization unit in the forward and backward directions by mistake, the result is displayed on the GUI as warning information (S1314). Then, the loading system 504 is operated upward to discharge the sterilization units (S1315). The operator who has confirmed the warning message temporarily takes out the sterilization unit from the slot 801 and reinserts the guide in the correct orientation (S1316). When the RFID information is read normally (S1313), the remaining battery level is checked next (S1317). If the remaining battery level is insufficient by the necessary sufficient amount, this is displayed on the GUI as warning information (S1318). Thereafter, the sterilization operation is not performed, and the analysis operation is performed after the preparation operation is completed before the analysis is started.
On the other hand, as shown in fig. 13C, when the remaining battery level is a sufficient amount, the sterilization unit information such as the remaining battery level is updated (S1319). Then, the loading system 504 operates downward (S1320), and the sterilization unit is moved to the reagent drive disk 501 by the reagent container moving unit 505 (S1321). Then, the sterilization unit moves to a position adjacent to the RFID information reading device 506 (device B) (S1322), and the LED is turned on by communication with the device (S1323). After the LEDs are turned on, the reagent driving disk is rotated in a predetermined order to sterilize the inside of the safe (S1324).
After the sterilization operation is completed, the sterilization unit moves to the position adjacent to the reading device 506 (device B) again (S1325), and the LED is turned off by communication with the device (S1326). After the LED is turned off, the sterilizing unit is moved to a position adjacent to the filling system 504 and then moved to the filling system 504 by the reagent container moving unit 505 (S1327). The loading system 504 operates upward and temporarily stops at a position adjacent to the RFID information reading device 403 (device a) (S1328). Then, the remaining battery level is read by the apparatus (apparatus a) (S1329). Here, when the remaining battery capacity is insufficient by the necessary sufficient amount, as shown in fig. 13D, this is displayed on the GUI as warning information (S1330). Thereafter, the sterilization operation is not performed, and the analysis operation is performed after the preparation operation is completed before the analysis is started.
When the remaining battery level is a sufficient amount, the sterilization unit information such as the remaining battery level is updated (S1331). After the update, the loading system 504 operates downward (S1332), and the sterilization unit is moved to the reagent drive disk 501 by the reagent container moving unit 505 (S1333). Thus, the maintenance work is completed. Finally, the updated information on the sterilization unit is stored in the storage device 119, and the operator can confirm the loading state of the sterilization unit and the remaining battery capacity in advance at the time of the next maintenance operation.
When the maintenance work is completed, the work date may be stored in the storage device 119. This can provide, for example, the following functions: when a constant period is left from the date of the last execution of the maintenance work, information for urging the execution of the work is displayed on the GUI. In addition to the information display, the apparatus may automatically perform the operation when there is no measurement request. When the battery is placed in the reagent container storage box, that is, in the fixed disk 503 or the reagent drive disk 501, the battery can be charged until the next operation is performed by moving the sterilization unit to the charging port after the completion of the operation. Further, by instructing the discharge of the sterilization unit on the apparatus UI, for example, even when the remaining battery capacity is a sufficient amount, the sterilization unit can be discharged at an arbitrary timing.
This is performed in the preparatory operation before the analysis is started. The present invention is not limited to this, and may be implemented when the apparatus is started or when the apparatus is shut down. Alternatively, the device may be automatically executed after a certain constant period of time has elapsed after the device is turned off. The operation steps are the same as those in the flowcharts of fig. 13A, 13B, 13C, and 13D described above.
Next, the procedure of the sterilization operation will be described. This operation is based on the principle that the reagent drive disk 501 holding the sterilization unit is rotated at a constant interval in a state where the LED is turned on. Preferably, the reagent drive disk 501 and the like are rotated while changing the irradiation angle, so that the light is irradiated into the storage box as uniformly as possible. As described above, the irradiation range may be enlarged by providing optical members (such as a mirror and a lens) in the reagent container storage box. It is also possible to investigate a place where contamination is likely to occur (a place communicating with the outside of the apparatus, etc.) in advance and intensively irradiate the place with ultraviolet rays. In addition, a plurality of sequences may be prepared so that the operator can freely select. In a place where the light is hard to reach in the structure, for example, a gap between the bottom surface of the loading system 504 and the bottom surface of the jacket 402, the loading system 504 is operated slightly upward, and ultraviolet rays are irradiated to sterilize the space.
As described above in detail, according to the configuration of the present embodiment, it is possible to provide an automatic analyzer capable of ensuring the cleanness inside a reagent container storage box by reducing the space of the reagent container storage box, avoiding interference with a reagent drive disk, and preventing contamination by microorganisms from the outside of the analyzer.
(example 2)
Embodiment 2 is an embodiment of an automatic analyzer having a configuration in which an irradiation unit for irradiating ultraviolet rays is provided in a part of the automatic analyzer, the automatic analyzer including: a reagent container storage box for holding a reagent container; a reagent disk for accommodating reagent containers and transporting the reagent containers to a desired position in the reagent container storage box; an irradiation unit that irradiates a filling system of the reagent disk and the reagent container with ultraviolet light; and a control unit for controlling the irradiation unit. In this embodiment, the case where the irradiation part is provided in the jacket 402 of the reagent disk or in the loading system 504 is exemplified.
Fig. 14 shows a case where the sterilization unit 1401 is fitted in the jacket 402. In this figure, two sterilization units 1401 are mounted, but the number is not limited to this, and may be one, or three or more. That is, at least one irradiation part is provided inside the jacket 402 of the reagent disk. On the other hand, fig. 15 shows a case where the sterilization unit 1501 is installed in the charging system 504. In this case, the number of the sterilization units to be mounted is not limited, and may be one or more. I.e. at least one irradiation part is fitted to the filling system.
First, the irradiation unit for irradiating ultraviolet rays according to the present embodiment will be described. As in example 1, an LED was used as the ultraviolet irradiation part. A mercury lamp can also be used as the ultraviolet light source, but the use of an ultraviolet LED is more advantageous in terms of space saving. The central wavelength of the light emitted from the ultraviolet LED is preferably 180nm to 340nm, which is known to be useful for sterilization. Particularly, it is preferably about 260nm, i.e., 230 to 290nm, which is a wavelength having high sterilization efficiency.
In embodiment 1, the control of the irradiation light amount is performed by the control unit 903 in the sterilization unit. On the other hand, in the present embodiment, the control unit 117 on the apparatus side shown in fig. 1 performs the above operation. The irradiation light amount required for sterilization is determined in advance by actual measurement or calculation for each combination of the seed and the wavelength of the ultraviolet ray used, as in example 1. In embodiment 1, these pieces of information are stored as a table in the storage unit 903A of the control unit 903, and in contrast, in this embodiment, they are stored in the storage device 119 on the device side.
The irradiation light amount in which the denaturation of the reagent components by ultraviolet rays and various components in the reagent container storage box, for example, the reagent container and the reagent disk is within an allowable range is determined in advance by actual measurement or calculation for each combination of the reagent to be used and the irradiation wavelength. These pieces of information are stored as a table in the storage device 119. Further, the denaturation of the reagent components and the structural members can be defined by changes in chemical bonding and molecular weight evaluated by infrared spectroscopy, mass spectrometry, or the like. Further, the change in mechanical properties of the structural member can be defined by a change in parameters such as hardness and young's modulus evaluated by an indentation test using a nanoindenter or the like.
In addition to the above-described sterilization effect and denaturation of the reagent components and various components, the control of the irradiation light amount is also necessary from the viewpoint of the influence on the temperature environment in the reagent disk. For example, when the temperature in the reagent disk needs to be maintained at 2 to 10 ℃, care must be taken not to cause the temperature around the sterilization unit to exceed 10 ℃ due to the lighting of the LED. By mounting a heat dissipating unit such as a heat sink on the irradiation portion, local temperature rise can be suppressed.
The number of LEDs used is not limited to one, and a plurality of LEDs may be used for the purpose of expanding the irradiation range. Further, optical members such as lenses and mirrors may be used. The optical component may be attached to the sterilization unit or may be attached to an arbitrary place in the reagent container storage box. Further, the use of the driver allows the mounting position/angle of the LED to be variable, thereby enabling an expansion of the irradiation range. Further, a place where contamination is likely to occur (the same place as the outside of the apparatus, etc.) may be investigated in advance and may be intensively provided around the place.
A mercury lamp can be used for the ultraviolet irradiation unit in addition to the LED, which is the same as in example 1. As in the case of the LED, the amount of irradiation light required for sterilization is determined in advance by actual measurement or calculation for each combination of the bacterial species to be sterilized and the emission wavelength of the lamp. These pieces of information are stored as a table in the storage device 119. Further, the denaturation of the reagent components and various components in the reagent container storage box also needs to be considered in the same manner as in the case of the LED. That is, the irradiation light amount in which the denaturation is within the allowable range is determined in advance by actual measurement or calculation for each combination of the reagent and the irradiation wavelength used. These pieces of information are stored as a table in the storage device 119. In addition, since the mercury lamp contains wavelengths in the visible to infrared regions that do not contribute to sterilization, it is necessary to control the irradiation wavelength by an optical filter. The irradiation range can be expanded by increasing the number of lamps and using optical members such as lenses and mirrors. The optical component may be attached to the sterilization unit 9, or may be provided at any place in the reagent container storage box. Further, the driver can be used to change the mounting position/angle of the lamp, thereby extending the irradiation range.
Next, a power supply means to the sterilization unit of the present embodiment will be described. Unlike embodiment 1, power supply to the sterilization unit does not use a battery, but power supply may be directly from the apparatus. The power supply can be wired or wireless charging can be utilized. Since no battery is used, it is not necessary to check the remaining battery level before the sterilization maintenance work is performed.
The irradiation timing is switched by the control unit 117 without using the various switches described in embodiment 1. However, in order to minimize the risk of ultraviolet exposure for the operator, it is preferable to provide an interlock mechanism. For example, when the sterilization unit is provided in the reagent container storage box, the cover 401 of the storage box is provided with an interlock mechanism, so that the risk of exposure to ultraviolet rays when an operator opens the cover 401 in the apparatus maintenance work or the like can be reduced. In addition, even when the unit is provided in the loading system 504, the risk can be reduced by providing an interlock mechanism in the cover 401. That is, the ultraviolet rays may be irradiated only when the loading system is operated downward and the jacket 402 is completely shielded.
The operation procedure of the sterilization unit was the same as in example 1. That is, the operator may perform the sterilization operation as one of the device maintenance operations. The present invention can be carried out at the time of a preparatory operation before the start of the analysis measurement, at the time of startup of the apparatus, at the time of shutdown of the apparatus, and after shutdown of the apparatus. Further, the device may automatically perform the operation when a certain constant period has elapsed since the previous operation.
Next, the procedure of the sterilization operation will be described. When the sterilization unit is provided in the reagent container storage box, the operator cannot access the inside of the reagent container storage box except when the cover 401 of the storage box is opened, and thus the ultraviolet rays can be always irradiated. On the other hand, when the unit is provided in the filling system 504, the filling system 504 is located at the lowermost portion, and the ultraviolet rays are irradiated only when the cover 401 is completely closed.
The present invention is not limited to the above-described embodiments, and includes various modifications. For example, the above-described embodiments are examples explained in detail for better understanding of the present invention, and are not limited to having all the configurations explained.

Claims (12)

1. An automatic analyzer is characterized by comprising:
a reagent container storage box for holding a reagent container;
a reagent disk for storing the reagent container and transporting the reagent container to a desired position of the reagent container storage box;
an irradiation unit that irradiates ultraviolet light to a loading system of the reagent disk and the reagent container; and
and a control unit for controlling the irradiation unit.
2. The automatic analysis device according to claim 1,
the reagent container storage box or the reagent disk includes the irradiation unit.
3. The automatic analysis device according to claim 2,
at least one of the irradiation parts is provided inside the jacket of the reagent disk.
4. The automatic analysis device according to claim 1,
the filling system is provided with at least one irradiation unit.
5. The automatic analysis device according to claim 1,
the reagent container is provided with the irradiation unit.
6. The automatic analysis device according to claim 5,
the reagent container provided with the irradiation unit includes: the control unit; a drive battery for driving the irradiation unit; and a switch for switching the timing of the ultraviolet irradiation.
7. The automatic analysis device according to claim 2,
the control unit switches the illumination and the extinction of the irradiation unit at a specific timing.
8. The automatic analysis device according to claim 6,
the control unit controls the switch to be switched at a specific timing.
9. The automatic analysis device according to claim 8,
the reagent disk is provided with an RFID information reading device A, namely a radio frequency identification information reading device A,
the control unit reads the RFID tag information of the reagent container provided with the irradiation unit by the RFID information reading device a, checks the remaining amount of the drive battery, and records the RFID tag information when the remaining amount is a necessary sufficient amount.
10. The automatic analysis device according to claim 9,
the control unit moves the reagent container provided with the irradiation unit to the reagent disk of the reagent disk after the RFID tag information is recorded, and instructs the reagent container to perform a sterilization operation.
11. The automatic analysis device according to claim 10,
the reagent driving disk is provided with an RFID information reading device B,
the control unit controls the reagent container including the irradiation unit to move to a position adjacent to the RFID information reading device B, and controls the irradiation unit to be turned on to perform a sterilization operation.
12. The automatic analysis device according to claim 11,
the control unit controls the reagent container having the irradiation unit to move to a position adjacent to the RFID information reading device B and to turn off the irradiation unit after the sterilization operation is performed.
CN202010133619.5A 2019-03-05 2020-03-02 Automatic analyzer Pending CN111665368A (en)

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