Automatic analysis device and determination method

Abstract

Provided is a technology for suppressing a degradation in analysis accuracy and device contamination due to abnormalities of a stirring device.　An automatic analysis device according to the present disclosure comprises: a stirring device having a rod-like member that stirs a liquid to be stirred and a power source that applies power to the rod-like member; a sensor that detects vibration of the stirring device; and a processor that determines the state of the stirring device on the basis of a detection signal of the vibration from the sensor, wherein the processor calculates the characteristic amount of the vibration on the basis of the detection signal of the vibration, and determines that the rod-like member is in a bent state when the characteristic amount of the vibration is no less than a first predetermined value.

Description

[Technical field]

[0001] The present disclosure relates to an automated analyzer and an analysis method. [Background technology]

[0002] The stirring mechanism of an automatic analyzer is used to stir reagents, specimens, and their reaction liquids, and plays an important role in the analysis process. The stirring mechanism of an automatic analyzer generally stirs the liquid by immersing a rod-shaped stirring member in the liquid to be stirred and rotating it. Here, a technology has been developed to suppress the decrease in analytical accuracy caused by the stirring process performed by the automatic analyzer (see Patent Document 1). [Prior art documents] [Patent documents]

[0003] [Patent Document 1] JP 2016-24044 A Summary of the Invention [Problem to be solved by the invention]

[0004] Patent Document 1 describes that vibrations that may affect the analysis results of an automatic analyzer include those caused by earthquakes, the movement of large vehicles or trains, the operation of construction machinery, etc. However, Patent Document 1 does not take into consideration equipment defects such as misalignment, loosening, bending, etc. that occur due to the installation of parts of the stirring device.

[0005] Therefore, the present disclosure provides a technique for suppressing deterioration in analytical accuracy and contamination of the device due to an abnormality in the stirring device. [Means for solving the problem]

[0006] In order to solve the above problems, the automatic analysis apparatus of the present disclosure comprises a stirring device having a rod-shaped member for stirring the stirred liquid and a power source for applying power to the rod-shaped member, a sensor for detecting vibration of the stirring device, and a processor for determining the state of the stirring device based on a detection signal of the vibration from the sensor, wherein the processor calculates a characteristic amount of the vibration based on the detection signal of the vibration, and determines that the rod-shaped member is in a bent state if the characteristic amount of the vibration is greater than or equal to a first predetermined value.

[0007] Further features related to the present disclosure will become apparent from the description of the present specification and the accompanying drawings. Also, the aspects of the present disclosure are achieved and realized by the elements and combinations of various elements and the following detailed description and the appended claims. The description of the present specification is merely exemplary and is not intended to limit the scope or application of the present disclosure in any way. This specification includes the disclosures of Japanese Patent Application No. 2021-070642, which is the priority basis of this application. Effect of the Invention

[0008] According to the technique of the present disclosure, it is possible to suppress deterioration of analytical accuracy and contamination of the device caused by an abnormality in the stirring device. Problems, configurations, and effects other than those described above will become apparent from the description of the following embodiments. [Brief description of the drawings]

[0009] [Figure 1] FIG. 1 is a top view illustrating a schematic overall configuration of an automatic analyzer according to a first embodiment. [Diagram 2] FIG. 4 is a side view showing a configuration example of a stirring mechanism and a container holding unit. [Diagram 3] 10 is a flowchart showing an overview of a process for determining whether or not there is an abnormality in the stirring mechanism, which is executed by an operation control unit. [Figure 4] FIG. 4 is a functional block diagram of components related to determining whether or not an abnormality occurs in the stirring mechanism. [Diagram 5] 6 is a flowchart showing an abnormality identifying process executed by an operation control unit. [Figure 6] FIG. 13 is a diagram showing the state of the stirring mechanism when the rod-shaped member is bent. [Figure 7] 13 is a diagram showing the state of the stirring mechanism when there is an abnormality in the connection between the connection portion and the rod-shaped member. FIG. [Figure 8] 13 is a diagram showing the state of the stirring mechanism when there is an abnormality in the connection between the protection part and the base part. FIG. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0010] [First embodiment] <Example of automatic analyzer configuration> Fig. 1 is a top view showing a schematic overall configuration of an automatic analyzer 1 according to a first embodiment. As shown in Fig. 1, the automatic analyzer 1 includes a housing 100, a sample rack 101, a sample container 102, a sample probe 103, a sample tip 104, a first reaction container transport unit 105, a horizontal movement mechanism 106, a vertical movement mechanism 107, a reaction container 108, a reaction container rack 109, a sample transport unit 110, a sample tip mounting unit 111, a disposal unit 112, a reagent probe 113, a reagent disk 114, a reagent bottle 115, a liquid holder for the reagent probe 117, a reaction container installation unit 118, a second reaction container transport unit 124, a liquid holder for the reaction container 125, a second horizontal movement mechanism 128, a cleaning reagent probe 129, an analysis unit 130, a reaction liquid suction probe 132, a stirring mechanism 136, a container holder 138, and a control device 200.

[0011] The housing 100 has a substantially rectangular parallelepiped shape and houses therein a substrate, a flow path, etc. (not shown). In the following description of Fig. 1, the direction parallel to the longitudinal direction of the upper surface of the housing 100 may be referred to as the horizontal direction, and the direction parallel to the short side direction of the upper surface of the housing 100 may be referred to as the vertical direction.

[0012] The sample transport unit 110 transports a sample rack 101 that holds a sample container 102. The sample container 102 contains a sample. The sample container 102 may be transported using, for example, a disk instead of the sample rack 101.

[0013] The reaction container rack 109 holds unused specimen tips 104 and reaction containers 108. Unused specimen tips 104 and reaction containers 108 can be placed in the reaction container rack 109 by a user of the automated analyzer 1. The specimen tips 104 and reaction containers 108 can be disposable.

[0014] The first reaction vessel transport unit 105 has a horizontal movement mechanism 106 and a vertical movement mechanism 107. The horizontal movement mechanism 106 holds the reaction vessel 108 and moves the reaction vessel 108 in the horizontal direction. The horizontal movement mechanism 106 can be moved vertically by the vertical movement mechanism 107. The first reaction vessel transport unit 105 transports the reaction vessel 108 from the reaction vessel rack 109 to a first reaction vessel installation position 119 of the reaction vessel installation unit 118 by driving the horizontal movement mechanism 106 and the vertical movement mechanism 107. In addition, the first reaction vessel transport unit 105 transports the specimen tip 104 from the reaction vessel rack 109 to the specimen tip installation unit 111. The specimen tip installation unit 111 is a place where the specimen tip 104 is temporarily held.

[0015] The reaction vessel setting section 118 is disk-shaped and holds a plurality of reaction vessels 108 along the circumferential direction. The reaction vessel setting section 118 is configured to be rotatable, and by rotation, the reaction vessel 108 placed at the first reaction vessel setting position 119 is moved to a predetermined position (a sample dispensing position 120, a second reaction vessel setting position 121, a reagent dispensing position 122, or a reaction liquid aspirating position 123). The reaction vessel setting section 118 functions as an incubator, and is temperature-controlled to a constant temperature such as 37°C.

[0016] The sample probe 103 has an arm that rotates with the rotation of a rotating shaft provided at one end of the arm, and a pipette (not shown in FIG. 1) provided at the other end of the arm. The sample probe 103 attaches a sample tip 104 to the tip of a pipette (rod-shaped member) at a sample tip attachment section 111. The sample probe 103 aspirates the sample in the sample container 102 into the sample tip 104, and dispenses it into a reaction container 108 at a sample dispensing position 120. The sample probe 103 then discards the used sample tip 104 at a disposal section 112.

[0017] The waste section 112 has a waste hole provided on the top surface of the housing 100 and a waste box located below the waste hole, and accumulates discarded specimen tips 104 and reaction containers 108. When the waste box becomes full, the user can pull out the waste box and discard the contents.

[0018] The reagent disk 114 is substantially circular in top view, and stores a plurality of reagent bottles 115 radially along the diameter direction. The reagent disk 114 is configured to be rotatable, and the reagent bottles 115 are moved to predetermined positions (reagent aspirating position 116 or mixing position 137) by the rotation.

[0019] The reagent probe 113 has an arm that rotates with the rotation of a rotary shaft provided at one end of the arm, and a pipette (not shown in FIG. 1) provided at the other end of the arm. The reagent probe 113 aspirates a reagent from a reagent bottle 115 at a reagent aspirating position 116 into a pipette (rod-shaped member), and dispenses the reagent into a reaction vessel 108 at a reagent dispensing position 122.

[0020] The reagent probe liquid holder 117 contains a cleaning liquid for cleaning the pipette of the reagent probe 113 .

[0021] The stirring mechanism 136 has an arm that rotates with the rotation of a rotating shaft provided at one end of the arm (a base portion described later), and a rod-shaped member (not shown in FIG. 1) provided at the other end of the arm. The rod-shaped member may be, for example, paddle-shaped or spiral-shaped. The stirring mechanism 136 stirs the reagent at the stirring position 137 with the rod-shaped member. The stirring mechanism 136 has a sensor 139 such as a vibration sensor. The sensor 139 detects vibration of the stirring mechanism 136. The sensor 139 may be a sensor other than a vibration sensor, such as an image sensor or an acoustic sensor. The container holder 138 contains a cleaning liquid for cleaning the rod-shaped member of the stirring mechanism 136.

[0022] The second reaction vessel transport unit 124 grips the reaction vessel 108 and moves it laterally by a second lateral movement mechanism 128. The second reaction vessel installation position 121, the reaction vessel liquid holder 125, and the reaction vessel washing position 126 are arranged in a straight line along the longitudinal direction (lateral direction) of the automatic analyzer 1. The second reaction vessel transport unit 124 transports the reaction vessel 108 from the second reaction vessel installation position 121 to the second reaction vessel installation position 121, the reaction vessel liquid holder 125, or the reaction vessel washing position 126. The reaction vessel liquid holder 125 contains a buffer liquid for washing the reaction vessel 108.

[0023] The cleaning reagent probe 129 has an arm that rotates with the rotation of a rotary shaft provided at one end of the arm, and a pipette (not shown in FIG. 1) provided at the other end of the arm. The cleaning reagent probe 129 sucks the buffer liquid in the reaction vessel liquid holder 125 into the pipette (rod-shaped member) and dispenses it at the reaction vessel cleaning position 126.

[0024] The reaction liquid aspirating probe 132 has an arm that rotates with the rotation of a rotary shaft provided at one end of the arm, and a pipette (not shown in FIG. 1) provided at the other end of the arm. The reaction liquid aspirating probe 132 aspirates the reaction liquid from the reaction container 108 at the reaction liquid aspirating position 123 into a pipette (rod-shaped member) and delivers the reaction liquid to the analysis unit 130.

[0025] The analysis unit 130 detects the physical properties of the reaction liquid. Examples of the physical properties include, but are not limited to, the amount of light emitted, the amount of scattered light, the amount of transmitted light, the current value, and the voltage value. The analysis unit 130 may perform the analysis while the reaction liquid is held in the reaction vessel 108.

[0026] The control device 200 includes an operation control unit 201, an analysis control unit 202, a user interface 203, and a data storage unit 204. The control device 200 is a computer device, and the operation control unit 201 and the analysis control unit 202 can be realized as processing modules executed by a processor of the control device 200.

[0027] The operation control unit 201 controls the operation of each component of the automatic analyzer 1. Although details will be described later, the operation control unit 201 receives an input of a detection signal from a sensor 139 provided in the stirring mechanism 136, and determines an abnormality in the stirring mechanism 136 based on the detection signal. The analysis control unit 202 receives an input of a detection signal of a physical property of the reaction liquid from the analysis unit 130, and performs a qualitative analysis or a quantitative analysis of the substance to be measured in the sample based on the detection signal.

[0028] The user interface 203 can be realized by input devices such as a mouse, keyboard, microphone, and touch panel, and output devices such as a display, touch panel, and speaker.

[0029] The data storage unit 204 can be realized by a storage device such as an internal memory such as a ROM or a RAM, or an external storage. The data storage unit 204 stores various data used in the processing of the control device 200.

[0030] <Example of automatic analyzer operation> Next, an example of the operation of the automatic analyzer 1 when two types of reagents are used to analyze a substance to be measured in a sample through an antigen-antibody reaction will be described. The operation of each component of the automatic analyzer 1 is controlled by the control device 200, but for the sake of simplicity, the following description will be given with each component acting as the subject of the operation.

[0031] First, first reaction container transport unit 105 transports reaction container 108 in reaction container rack 109 to first reaction container installation position 119 in reaction container installation unit 118. In addition, first reaction container transport unit 105 transports specimen tip 104 in reaction container rack 109 to specimen tip installation unit 111.

[0032] Next, the sample probe 103 rotates, and the sample tip 104 is attached to the tip of the probe at the sample tip attachment section 111. The sample transport section 110 transports the sample rack 101 to the aspirating position of the sample probe 103. The sample probe 103 aspirates the sample in the sample container 102.

[0033] The reaction container installation section 118 rotates, and moves the reaction container 108 installed at the first reaction container installation position 119 to the sample dispensing position 120. The sample probe 103 rotates after aspirating the sample, and dispenses a specified amount of the sample into the reaction container 108 at the sample dispensing position 120. After dispensing the sample, the sample probe 103 rotates further, moves the pipette to above the disposal section 112, and drops the sample tip 104 into the inside of the disposal section 112.

[0034] Next, the stirring mechanism 136 rotates and stirs the second reagent in the reagent bottle 115 at the stirring position 137. After stirring, the stirring mechanism 136 rotates from the stirring position 137 and moves the rotation shaft up and down in the container holding part 138 to wash the rod-shaped member.

[0035] The reagent disk 114 rotates and moves the reagent bottle 115 containing the first reagent to the reagent aspirating position 116. The reagent probe 113 aspirates the first reagent from the reagent bottle 115 at the reagent aspirating position 116. Next, the reaction container setting unit 118 rotates and moves the reaction container 108 into which the sample has been dispensed from the sample dispensing position 120 to the reagent dispensing position 122.

[0036] Next, the reagent probe 113 rotates and dispenses a specified amount of the first reagent at the reagent dispensing position 122. The first reagent contains an antibody that specifically binds only to a specific antigen in the specimen. An antigen-antibody reaction occurs between the specimen and the first reagent in the reaction vessel 108 placed in the reaction vessel setting section 118. The antibody in the first reagent is in a state of being bound to a fluorescent substance. After a certain period of time has passed and the antigen-antibody reaction has progressed sufficiently, the operation of dispensing another specimen into a new reaction vessel is performed in the same manner as above. After the antigen-antibody reaction has progressed sufficiently, the reaction vessel setting section 118 moves the reaction vessel 108 to the reagent dispensing position 122 again.

[0037] Next, the reagent probe 113 aspirates the second reagent from the reagent bottle 115, and dispenses the second reagent into the reaction vessel 108 at the reagent dispensing position 122. Here, the reagent bottle for the first reagent and the reagent bottle for the second reagent may be provided separately.

[0038] The second reagent contains an antibody that specifically binds only to the antigen in the specimen. The antibody in the second reagent is already bound to the magnetic particles. After a certain amount of time has passed and the antigen-antibody reaction has progressed to a certain extent, a sufficient amount of final reaction product is generated in which the antigen present in the specimen is bound to the magnetic particles and the fluorescent emitter.

[0039] Next, the reaction container setting unit 118 rotates, and moves the reaction container 108 into which the sample, the first reagent, and the second reagent have been dispensed, to a second reaction container setting position 121. The second reaction container transport unit 124 moves the reaction container 108 from the second reaction container setting position 121 to a reaction container washing position 126.

[0040] At the reaction vessel washing position 126, the magnetic properties of the magnetic particles bound to the antibodies in the reaction solution in the reaction vessel 108 are utilized, and the reaction solution is discarded while being captured in the vessel by a magnet installed outside the reaction vessel 108. This washes away and removes substances derived from the specimen other than the antigens, and performs B / F separation, leaving only the final reaction product in the reaction solution.

[0041] The cleaning reagent probe 129 aspirates the buffer liquid from the reaction vessel liquid holder 125 and dispenses it at the reaction vessel cleaning position 126. Next, the second reaction vessel transport unit 124 moves the reaction vessel 108 to the second reaction vessel installation position 121 of the reaction vessel installation unit 118.

[0042] Next, the reaction container setting unit 118 rotates to move the reaction container 108 to the reaction liquid suction position 123. The reaction liquid suction probe 132 suctions the reaction liquid from the reaction container 108 at the reaction liquid suction position 123. Next, the reaction liquid suction probe 132 delivers the reaction liquid to the analysis unit 130.

[0043] The analysis unit 130 detects the amount of light emitted by the fluorescent substance in the reaction liquid, and outputs a detection signal to the analysis control unit 202. The analysis control unit 202 performs analysis based on the amount of light emitted by the fluorescent substance, and outputs the analysis result to an output device of the user interface 203. The analysis control unit 202 performs analysis, for example, by utilizing information indicating the amount of specimen (prescribed liquid volume information) and the principle that the amount of light emitted by the fluorescent substance is proportional to the number of antigens.

[0044] The above is an example of a unit of one analytical operation for measuring a sample. The automatic analyzer 1 can perform multiple analytical operations at once. Furthermore, the automatic analyzer 1 can have the operation control unit 201 control the operation in a pipeline manner so that multiple analytical operations can be performed simultaneously. This configuration enables the analysis processing of multiple samples without delay.

[0045] Here, the time required for an analysis operation will be described. One analysis operation includes five steps, namely, a sample dispensing step, a first reagent dispensing step, a second reagent dispensing step, a washing step, and an analysis step, and requires a considerable amount of time. For example, if one analysis operation requires 10 minutes, then when multiple analysis operations are performed sequentially, 30 minutes are required to perform three analysis operations.

[0046] <Example of mixing mechanism configuration> 2 is a side view showing a configuration example of the stirring mechanism 136 and the container holding unit 138. The stirring mechanism 136 includes a sensor 139, a connection unit 140, a rod-shaped member 141, a moving mechanism 142 (power source), a base unit 143 (arm), a protective unit 144, a connection part 145, a movable unit 154 (power source), and a detector 156.

[0047] The connecting portion 140 grips the rod-shaped member 141 and is connected to the base portion 143. The connecting portion 140 is configured to be rotatable by application of a rotational force from a rotation drive source (such as a motor) provided inside the base portion 143. The connecting part 145 fixes the rod-shaped member 141 to the connecting portion 140.

[0048] A paddle is provided at the tip of the rod-shaped member 141. The tip of the rod-shaped member 141 may be screw-shaped. The rod-shaped member 141 is immersed in the liquid to be stirred and stirs the liquid.

[0049] The sensor 139 is provided inside the base 143. The sensor 139 detects vibrations caused by the operation of the stirring mechanism 136. The vibrations are not easily affected by changes in the environment (usage conditions) such as changes in air pressure and temperature, and therefore the detection accuracy varies little regardless of the use conditions. Therefore, the detection of vibrations can be achieved with stable detection accuracy even under various use conditions. The mounting position of the sensor 139 may be any position that can detect the vibrations of the stirring mechanism 136, and is not limited to the position shown in FIG. 2. For example, the sensor 139 may be disposed near the container holding part 138. In this case, for example, vibrations caused by the rod-shaped member 141 slightly contacting the inner wall surface of the container holding part 138 due to bending of the rod-shaped member 141 can be detected. Alternatively, a change in the water flow of the liquid in the container holding part 138 can be detected as vibrations. However, by positioning the sensor 139 near the rod-shaped member 141 of the stirring mechanism 136, vibrations caused by the stirring operation can be detected more accurately.

[0050] The protective portion 144 functions as a cover that protects the upper part of the base portion 143 .

[0051] The upper surface of container holder 138 is flush with the upper surface of housing 100, and the liquid (cleaning liquid) held by container holder 138 is located inside housing 100. However, the upper surface of container holder 138 may be located above or below the upper surface of housing 100.

[0052] The movement mechanism 142 has a rotating shaft 1421, a bearing 1422, and a fixed part 1423. The rotating shaft 1421 is fixed to the base part 143 by the fixed part 1423, and the base part 143 also rotates when the rotating shaft 1421 rotates. The bearing 1422 is fixed to the upper surface of the housing 100, has a hole through which the rotating shaft 1421 passes, and supports the rotating shaft 1421 so that it can move up and down.

[0053] The movable part 154 controls the driving of the moving mechanism 142 and the driving of the rotation drive source of the connection part 140. The movable part 154 is composed of, for example, an actuator or a motor, and rotates the rotation shaft 1421 and moves it up and down. The detector 156 detects the state of the movable part 154. The movable part 154 and the detector 156 are provided inside the housing 100.

[0054] <How to determine if the stirring mechanism is malfunctioning> Fig. 3 is a flowchart showing an outline of the process for determining whether or not there is an abnormality in the stirring mechanism, which is executed by the operation control unit 201. The process in Fig. 3 is executed as a reset operation of the stirring mechanism 136 when a reset operation is performed in the automatic analyzer 1 after maintenance such as replacement or cleaning of the rod-shaped member 141 has been performed, for example.

[0055] (Step S301) The sensor 139 starts measuring the vibration of the stirring mechanism 136 , and the operation control unit 201 receives an input of a detection signal of the vibration of the sensor 139 .

[0056] (Step S302) The operation control unit 201 drives the movable unit 154 to move the rod-shaped member 141 from a predetermined position to above the container holding unit 138. Thereafter, the operation control unit 201 moves the rotating shaft 1421 downward to move the rod-shaped member 141 into the inside of the container holding unit 138. At this time, the operation control unit 201 may simultaneously perform an operation such as washing or drying the rod-shaped member 141 while the rod-shaped member 141 is moving.

[0057] (Step S303) The operation control unit 201 drives the movable unit 154 to rotate the connection unit 140, thereby rotating the rod-shaped member 141 inside the container holding unit 138. At this time, a cleaning liquid may be stored in the container holding unit 138, and cleaning may be performed by rotating the rod-shaped member 141. Alternatively, drying may be performed by rotating the rod-shaped member 141.

[0058] (Step S304) The operation control unit 201 drives the movable unit 154 to raise and then rotate the rotating shaft 1421, thereby moving the rod-shaped member 141 to a predetermined position. The operation control unit 201 may simultaneously perform operations such as washing and drying the rod-shaped member 141 while the rod-shaped member 141 is moving.

[0059] (Step S305) The sensor 139 ends the measurement of the vibration, and the operation control unit 201 stops receiving the detection signal from the sensor 139. As described above, if vibration occurs due to an abnormality such as a mechanical failure of the stirring mechanism 136 during the rotational operation of the rod-shaped member 141, this is reflected in the detection signal of the sensor 139.

[0060] (Step S306) The operation control unit 201 judges whether or not there is an abnormality in the stirring mechanism 136 based on the acquired vibration detection signal. The method of judging the abnormality will be described in detail later, but in summary, the abnormality is judged based on whether or not the magnitude of the power spectrum in the occurrence region of each vibration frequency is equal to or greater than a predetermined threshold. If it is judged that there is an abnormality (YES), the process proceeds to step S307. If it is judged that there is no abnormality (NO), the process ends.

[0061] (Step S307) If there is an abnormality in the stirring mechanism 136, the operation control unit 201 stops the operation of the automatic analyzer 1.

[0062] (Step S308) The operation control unit 201 generates an alarm according to the type of abnormality, and outputs it to the output device of the user interface 203. Examples of the alarm include a warning indication shown on a display and a warning sound issued from a speaker.

[0063] <How to identify anomalies> 4 is a functional block diagram of components related to determining an abnormality in the stirring mechanism 136. As shown in FIG. 4, the operation control unit 201 has an electric signal conversion unit 150, a comparison unit 151, a determination unit 152, and a control unit 153.

[0064] The electric signal conversion unit 150 receives an input of a detection signal of vibration detected by the sensor 139, and performs frequency analysis such as fast Fourier transform (FFT). Specifically, the electric signal conversion unit 150 acquires vibration feature quantities such as the vibration frequency, acceleration, vibration time, and power spectrum. The vibration power spectrum can be acquired by converting the magnitude of the vibration frequency. The electric signal conversion unit 150 outputs the result of the frequency analysis to the comparison unit 151.

[0065] The comparison unit 151 determines (specifies) the cause of the abnormal vibration based on the result of the frequency analysis in the electric signal conversion unit 150. Specifically, the comparison unit 151 compares the feature amount of the vibration with a predetermined threshold, and determines the cause of the abnormality when the feature amount is equal to or greater than the predetermined threshold. A plurality of predetermined thresholds are set according to the type of abnormality, and are stored in the data storage unit 204. The comparison unit 151 outputs the determination result of the cause of the abnormality to the control unit 153.

[0066] The determination unit 152 receives a detection signal from the detector 156 that detects the state (e.g., the number of rotations) of the movable part 154, and determines whether the state of the movable part 154 is normal or not. The determination unit 152 outputs information indicating the determined state of the movable part 154 to the control unit 153.

[0067] The control unit 153 acquires the determination result of the cause of the abnormal vibration from the comparison unit 151, determines the state transition of the automatic analyzer 1 based on the determination result, and transmits an operation instruction to the movable unit 154. The control unit 153 also stores the determination result received from the comparison unit 151 and the determination result received from the determination unit 152 in the data storage unit 204.

[0068] <How to identify abnormalities in the mixing mechanism> FIG. 5 is a flowchart showing the abnormality identification process executed by the operation control unit 201.

[0069] (Step S501) The electric signal conversion unit 150 receives an input of a detection signal of the vibration detected by the sensor 139 .

[0070] (Step S502) The electric signal conversion section 150 performs frequency analysis processing on the vibration detection signal.

[0071] (Step S503) The comparison unit 151 determines whether the vibration frequency is in the low frequency band (for example, 500 Hz or less) or in the medium to high frequency band (greater than 500 Hz). If it is in the low frequency band, the process proceeds to step S504. If it is in the medium to high frequency band, the process proceeds to steps S509 and S514.

[0072] (Step S504) If it is determined that the vibration is in the low frequency band, it is known that there is a possibility that the rod-shaped member 141 is in an abnormal state of being bent. Note that bending of the rod-shaped member 141 refers to a state in which the longitudinal direction of the rod-shaped member 141 is not perpendicular to the longitudinal direction of the base portion 143, or a state in which the rod-shaped member 141 is bent midway. The comparison unit 151 determines whether the magnitude of the vibration in the low frequency band (for example, the power spectrum) is equal to or greater than a first predetermined value.

[0073] The magnitude of vibration depends on the number of rotations and the degree of bending of the rod-shaped member 141, and since the number of rotations is a preset fixed value, it can be determined that the rod-shaped member 141 is in a bent state when the vibration is large. The first predetermined value can be set, for example, to a value according to the bending angle of the rod-shaped member 141 at which the analysis accuracy begins to be affected. In other words, when the bending of the rod-shaped member 141 is negligible and does not affect the analysis accuracy, the magnitude of vibration is less than the first predetermined value. If the magnitude of vibration is equal to or greater than the first predetermined value (YES), the process proceeds to step S506. If the magnitude of vibration is less than the first predetermined value (NO), the process proceeds to step S505.

[0074] (Step S505) When the magnitude of the vibration in the low frequency band is less than the first predetermined value, the comparison section 151 determines that there is no abnormality, and outputs the determination result to the control section 153. The control section 153 maintains the automatic analyzer 1 in an operating state.

[0075] (Step S506) When the magnitude of the vibration in the low frequency band is equal to or greater than the first predetermined value, the comparison section 151 determines that the rod-shaped member 141 is in a bent state and is abnormal, and outputs the determination result to the control section 153.

[0076] (Step S507) The control unit 153 performs state transition of the automatic analyzer 1 so as to stop the operation of the automatic analyzer 1.

[0077] (Step S508) The control unit 153 generates an alarm notifying the user that the rod-shaped member 141 is bent, and outputs the alarm to the user interface 203. The alarm notifying the user that the rod-shaped member 141 is bent may be a notification screen including text urging the user to correct the bend in the rod-shaped member 141 or to check the condition of the rod-shaped member 141.

[0078] (Step S509) The comparison unit 151 determines whether the magnitude of vibration in the mid-high frequency band (e.g., power spectrum) is equal to or greater than a second predetermined value. The second predetermined value can be set to a value according to the state of assembly of the connection unit 140 at which the analysis accuracy begins to be affected, for example. If the magnitude of vibration is equal to or greater than the second predetermined value (YES), the process proceeds to step S510. If the magnitude of vibration is less than the second predetermined value (NO), the process proceeds to step S513.

[0079] (Step S510) If the magnitude of the vibration in the mid-high frequency band is equal to or greater than a second predetermined value, the comparison unit 151 determines that the condition of the connection portion 140 between the rod-shaped member 141 and the base portion 143 is abnormal (for example, the connection is insufficient), and outputs the determination result to the control unit 153.

[0080] (Step S511) The control unit 153 performs state transition of the automatic analyzer 1 so as to stop the operation of the automatic analyzer 1.

[0081] (Step S512) The control unit 153 generates an alarm notifying the user that there is an abnormality in the connection unit 140, and outputs the alarm to the user interface 203. The alarm notifying the user of the abnormality in the connection unit 140 may be a notification screen including text that prompts the user to check the status of the connection unit 140.

[0082] (Step S513) When the magnitude of the vibration in the mid-high frequency band is less than the second predetermined value, the comparison section 151 determines that there is no abnormality, and outputs the determination result to the control section 153. The control section 153 maintains the automatic analyzer 1 in an operating state.

[0083] (Step S514) The comparison unit 151 determines whether the magnitude of vibration in the mid-high frequency band (e.g., power spectrum) is equal to or greater than a third predetermined value. The third predetermined value can be set, for example, to a value according to the installation state of the protection unit 144 at which the analysis accuracy begins to be affected. If the magnitude of vibration is equal to or greater than the third predetermined value (YES), the process proceeds to step S515. If the magnitude of vibration is less than the third predetermined value (NO), the process proceeds to step S518.

[0084] (Step S515) If the magnitude of the vibration in the mid-high frequency band is equal to or greater than the third predetermined value, the comparison unit 151 determines that the state of the protection unit 144 is abnormal (for example, the assembly is insufficient) and outputs the determination result to the control unit 153.

[0085] (Step S516) The control unit 153 performs state transition of the automatic analyzer 1 so as to stop the operation of the automatic analyzer 1.

[0086] (Step S517) The control unit 153 generates an alarm notifying the user that there is an abnormality in the protection unit 144, and outputs the alarm to the user interface 203. The alarm notifying the user of the abnormality in the protection unit 144 may be a notification screen including text that prompts the user to check the status of the protection unit 144.

[0087] (Step S518) When the magnitude of the vibration in the mid-high frequency band is less than the third predetermined value, the comparison section 151 determines that there is no abnormality, and outputs the determination result to the control section 153. The control section 153 maintains the automatic analyzer 1 in an operating state.

[0088] As described above, an abnormality in the stirring mechanism 136 can be determined based on the frequency band and the magnitude of the vibration. In the above process, if the magnitude of the vibration is less than the first predetermined value, that is, if the bending does not affect the analytical accuracy, it is ignored, and only when the magnitude of the vibration in the low frequency band is equal to or greater than the first predetermined value, that is, when it is considered that the analytical accuracy will be affected, is the device stopped and an alarm output taken. The first predetermined value is the criterion for this determination. By doing so, a technical effect can be expected that the device is stopped even though there is no effect on the analytical accuracy, and time loss can be prevented. The same applies to the second and third predetermined values.

[0089] Here, it has been found from experiments by the present inventors that the first predetermined value is greater than the second and third predetermined values. The relationship between the magnitude of the second and third predetermined values ​​varies depending on the individual automated analyzer and the state of assembly of the stirring mechanism 136, and the second predetermined value may be greater than the third predetermined value, or vice versa.

[0090] <Examples of abnormalities in the stirring mechanism> FIG. 6 is a diagram showing the state of the stirring mechanism 136 when the rod-shaped member 141 is bent. For example, when the magnitude of vibration in the low frequency band is equal to or greater than the first predetermined value, the rod-shaped member 141 is bent as shown in FIG. 6. In this case, there is a risk that the analysis accuracy will decrease or the automatic analyzer 1 will be contaminated due to an increase in the amount of cleaning water carried from the container holder 138 to other locations by the rod-shaped member 141 or an increase in the amount of splashing when the rod-shaped member 141 rotates. Therefore, by stopping the operation of the automatic analyzer 1 and notifying the user of the state of the rod-shaped member 141 by an alarm, it is possible to encourage confirmation or repair, and to suppress the impact on the device, the user, the analysis results, etc.

[0091] 7 is a diagram showing the state of the stirring mechanism 136 when there is an abnormality in the connection between the connection part 140 and the rod-shaped member 141. For example, when the magnitude of vibration in the mid-high frequency band is equal to or greater than the second predetermined value, there is an abnormality in the connection between the connection part 140 and the rod-shaped member 141 as shown in FIG. 7. In this case, there is a risk that the automatic analyzer 1 will break down due to the dropping of the rod-shaped member 141 or the connecting part 145. Therefore, by stopping the operation of the automatic analyzer 1 and informing the user of the connection abnormality of the connection part 140 by an alarm, it is possible to encourage the user to check or repair the connection, and to suppress the impact on the device, the user, the analysis results, etc.

[0092] 8 is a diagram showing the state of the stirring mechanism 136 when there is an abnormality in the connection between the protection unit 144 and the base unit 143. For example, when the magnitude of vibration in the mid-high frequency band is equal to or greater than the third predetermined value, there is an abnormality in the connection between the protection unit 144 and the base unit 143, as shown in FIG. 8. In this case, there is a risk of the automatic analyzer 1 breaking down due to the protection unit 144 falling or the inside of the base unit 143 becoming exposed. Therefore, by stopping the operation of the automatic analyzer 1 and informing the user of the connection abnormality of the protection unit 144 by an alarm, it is possible to encourage checking or repair, and to suppress the impact on the device, the user, the analysis results, etc.

[0093] As described above, by determining whether or not there is an abnormality in the stirring mechanism 136 when the automatic analyzer 1 is reset, the abnormal state can be corrected before the analysis operation is performed, thereby preventing a decrease in analysis accuracy during the analysis operation.

[0094] <Modification of the first embodiment> In the first embodiment, the sensor 139 is provided in the stirring mechanism 136 to determine whether there is an abnormality in the stirring mechanism 136. Alternatively, the sensor 139 may be provided in a dispensing probe such as the sample probe 103 or the reagent probe 113, and an abnormality in the dispensing probe may be determined in a manner similar to that described above.

[0095] In the first embodiment, it has been described that the timing for determining whether or not there is an abnormality in the stirring mechanism 136 is within the reset operation time of the automatic analyzer 1. Alternatively, the determination for whether or not there is an abnormality in the stirring mechanism 136 may be performed during any other operation. However, by determining whether or not there is an abnormality at a timing other than during the analysis operation, the impact on the analysis accuracy can be reduced.

[0096] Since the usage method of the automatic analyzer 1 varies depending on the user, a plurality of values ​​for each of the first, second, and third predetermined values ​​may be stored in advance in the data storage unit 204, and the user may be allowed to selectively set each threshold value from the GUI screen of the user interface 203. Furthermore, when there are a plurality of vibration frequency bands that affect the analysis results, the user may be allowed to set threshold values ​​for the magnitude and time of vibration in each frequency band from the GUI screen.

[0097] Each mechanism of the automatic analyzer 1 has individual variations (manufacturing variations, assembly variations, etc.). Therefore, the control unit 153 may perform control to determine the target amplitude value of the rod-shaped member 141 of the stirring mechanism 136, i.e., the allowable vibration width of the tip portion of the rod-shaped member 141, according to the variations inherent to the device.

[0098] In the first embodiment, a single sensor 139 is provided in the stirring mechanism 136. Alternatively, a plurality of sensors may be provided in the stirring mechanism 136, and an abnormality may be determined based on a combination of detection signals from the plurality of sensors.

[0099] Although the method for determining whether or not there is an abnormality in the stirring mechanism 136 in the automatic analyzer 1 has been described above, the technology of this embodiment can also be applied to analyzers other than the automatic analyzer (for example, clinical testing devices).

[0100] <Summary of the First Embodiment> As described above, the automatic analyzer 1 of this embodiment includes the stirring mechanism 136 having the rod-shaped member 141 for stirring the liquid to be stirred, the moving mechanism 142 for applying power to the rod-shaped member, and the movable part 154 (power source), the sensor 139 provided in the stirring mechanism 136 for detecting the vibration of the stirring mechanism 136, and the operation control unit 201 (processor) for determining the state of the stirring mechanism 136 based on the vibration detection signal from the sensor 139. The operation control unit 201 calculates a characteristic amount of the vibration based on the vibration detection signal, and determines that the rod-shaped member 141 is in a bent state when the characteristic amount of the vibration is equal to or greater than a first predetermined value. In this way, by determining the bending of the stirring mechanism 136 based on the vibration of the stirring mechanism 136, it is possible to prevent a decrease in analysis accuracy and contamination of the device due to the splashing of the liquid to be stirred. In addition, according to the technology of this embodiment, the user does not need to check for abnormalities in the stirring mechanism 136 himself, so that abnormalities are not overlooked and the user is not required to do anything. As a result, the sample analysis operation will not be performed while the sample is in an abnormal state, and a decrease in analytical accuracy can be prevented.

[0101] [Variations] The present disclosure is not limited to the above-described embodiments, and includes various modified examples. For example, the above-described embodiments have been described in detail to clearly explain the present disclosure, and it is not necessary to include all of the configurations described. In addition, a part of an embodiment can be replaced with a configuration of another embodiment. In addition, a configuration of another embodiment can be added to a configuration of an embodiment. In addition, a part of the configuration of each embodiment can be added to, deleted from, or replaced with a part of the configuration of another embodiment. [Explanation of symbols]

[0102] 1…Automatic analyzer 100…Housing 136...Stirring mechanism (stirring device) 138...Container holding part 139…Sensor 140…Connection 141... Rod-shaped member 142...Movement mechanism (power source) 143…Base 144...Protection Department 145…Connecting parts 200...Control device (processor) All publications, patents, and patent applications cited herein are hereby incorporated by reference in their entirety.

Claims

1. An automated analyzer for performing an analysis of a sample, comprising: A stirring device having a rod-shaped member for stirring the liquid to be stirred and a power source for applying power to the rod-shaped member; A sensor for detecting vibration of the stirring device; a processor that determines a state of the stirring device based on the vibration detection signal from the sensor; The processor, An automatic analyzer that calculates the frequency and magnitude of the vibration based on the detection signal of the vibration, and determines that the rod-shaped member is in a bent state if the magnitude of the vibration in the low frequency band is equal to or greater than a first predetermined value that is set according to the bending angle of the rod-shaped member at which the analysis accuracy begins to be affected.

2. A base portion supporting the power source and to which the rod-shaped member is connected; A connection portion between the rod-shaped member and the base portion is further provided, The processor, The automatic analyzer according to claim 1 , wherein when the magnitude of the vibration in the medium to high frequency band is equal to or greater than a second predetermined value set according to the assembly condition of the connection at which the analysis accuracy begins to be affected, the connection is determined to be abnormal.

3. a base portion supporting the power source and to which the rod-shaped member is connected; A protective part attached to the base part and protecting the base part, The processor, 2. The automatic analyzer according to claim 1, wherein when the magnitude of the vibration in the medium to high frequency band is equal to or greater than a third predetermined value that is set according to the state of assembly of the protection unit at which the analysis accuracy begins to be affected, the protection unit is determined to have an abnormality.

4. The processor, The automatic analyzer according to claim 1 , further comprising: a frequency analysis of the detection signal of the vibration to calculate a power spectrum of the vibration.

5. The processor, When it is determined that the rod-shaped member is in a bent state, the operation of the automatic analyzer is stopped, 2. The automatic analyzer according to claim 1, wherein when it is determined that the magnitude of the vibration in the low frequency band is less than the first predetermined value and the rod-shaped member is not bent, the operation of the automatic analyzer is continued.

6. an output device coupled to the processor; The processor, 2. The automatic analyzer according to claim 1, wherein when it is determined that the rod-shaped member is in a bent state, an alarm is output by the output device.

7. The processor, The automatic analyzer according to claim 1 , wherein the determination is performed when the automatic analyzer is reset.

8. 2. The automated analyzer according to claim 1, wherein the sensor is provided in the stirring device.

9. A method for determining whether a sample is to be analyzed by a processor of an automatic analyzer, comprising: The automated analyzer comprises: A stirring device having a rod-shaped member for stirring the liquid to be stirred and a power source for applying power to the rod-shaped member; a sensor provided in the stirring device and configured to detect vibration of the stirring device; The method comprises: receiving a detection signal of the vibration of the stirring device from the sensor; Calculating a frequency and a magnitude of the vibration based on the detection signal of the vibration; A determination method comprising: determining that the rod-shaped member is in a bent state if the magnitude of the vibration in the low frequency band is equal to or greater than a first predetermined value set according to the bending angle of the rod-shaped member at which the analysis accuracy begins to be affected.

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