Diagnostic system, automatic analysis device, and diagnostic method

Abstract

The purpose of the present invention is to more specifically determine the cause of variation in water blank absorbance. To this end, the present invention provides a diagnostic system for diagnosing the state of an automatic analysis device, the diagnostic system having a determination unit that, on the basis of water blank absorbance, which is an absorbance measured by a photometer in a state in which purified water has been dispensed into a reaction container by a dispensing mechanism, distinguishes and determines the cause of variation in the water blank absorbance. The photometer measures a plurality of the water blank absorbances for the same reaction container. The determination unit determines that the amount of air bubbles attached to the inner wall of the reaction container is increasing when the inequality of the water blank absorbances measured a plurality of times tends to increase as the temperature of the purified water in the reaction container increases over time.

Description

Diagnostic system, automatic analyzer and diagnostic method

[0001] The present invention relates to a diagnostic system, an automatic analyzer and a diagnostic method.

[0002] For example, in a biochemical automatic analyzer, in order to perform component analysis of biological samples such as serum and urine, a test sample and a reagent are reacted in a reaction container, and optical measurement is performed with a photometer. Here, the reaction container is immersed in thermostated circulating water in a reaction tank. If air bubbles, dust or the like are mixed into the liquid in the reaction container or the circulating water in the reaction tank, this causes noise during photometry and may cause abnormalities in measurement results. For this reason, a technique has been proposed in which purified water is dispensed into a reaction container, blank absorbance measurement (hereinafter referred to as water blank measurement) is performed before sample measurement, and an increase in air bubbles or dust contained in the reaction tank circulating water is detected based on the measurement result. For example, Patent Document 1 discloses an automatic analyzer that determines an abnormality in the water quality of reaction tank circulating water based on variation in a range calculated by subtracting the minimum value from the maximum value of water blank absorbance data measured a plurality of times in water blank measurement (hereinafter referred to as water blank absorbance range).

[0003] International Publication No. 2023 / 026810

[0004] Variation in the water blank absorbance range may occur not only due to air bubbles and suspended matter contained in the reaction tank circulating water, but also due to air bubbles adhering to the inner wall of the reaction container. However, the technology described in Patent Document 1 cannot distinguish between an increase in air bubbles adhering to the inner wall of the reaction container and an increase in air bubbles or dust contained in the reaction tank circulating water.

[0005] An object of the present invention is to distinguish and determine the cause of variation in water blank absorbance data measured a plurality of times in water blank measurement.

[0006] The present invention has been made in view of the above problems, and one aspect thereof is a diagnostic system for diagnosing the state of an automated analyzer, comprising a determination unit that distinguishes and determines the factors causing the variation in the measured water blank absorbance based on the water blank absorbance and water blank absorbance range, which are the absorbance measured by a photometer when purified water has been dispensed into a reaction vessel by a dispensing mechanism, wherein the photometer measures the water blank absorbance multiple times for the same reaction vessel, and the determination unit determines that the number of bubbles adhering to the inner wall of the reaction vessel is increasing if the water blank absorbance measured multiple times tends to increase as the temperature of the purified water in the reaction vessel rises over time.

[0007] According to the present invention, it is possible to distinguish and determine the factors causing variations in water blank absorbance measured multiple times during water blank measurement. Other problems, configurations, and effects will be clarified by the following description of embodiments.

[0008] Diagram showing the overall configuration of the diagnostic system Diagram showing the circulation path including the constant temperature water supply device of the automatic analyzer Diagram showing an example of the configuration of the degasser Graph showing an example of the water blank absorbance range obtained when there is no effect of bubbles adhering to the inner wall of the reaction vessel or bubbles being mixed into the reaction vessel circulating water Graph showing an example of the water blank absorbance range obtained when there is an effect of bubbles adhering to the inner wall of the reaction vessel or bubbles being mixed into the reaction vessel circulating water Graph showing an example of the results obtained when 400 water blank measurements are performed, in which water blank absorbance is obtained three times, and the difference between the water blank absorbance obtained in the second measurement and the water blank absorbance obtained in the first measurement is plotted (when the amount of bubbles in the reaction vessel circulating water increases) Graph showing an example of the results obtained when 400 water blank measurements are performed, in which water blank absorbance is obtained three times, and the difference between the water blank absorbance obtained in the third measurement and the water blank absorbance obtained in the second measurement is plotted (when the amount of bubbles in the reaction vessel circulating water increases) (When the amount of bubbles increases) 400 water blank measurements were performed, each taking three water blank absorbances. The graph shows an example of the result of plotting the difference between the water blank absorbance obtained in the first measurement and the water blank absorbance obtained in the third measurement for each measurement. (When the amount of bubbles in the circulating water of the reaction vessel increases) 400 water blank measurements were performed, each taking three water blank absorbances. The graph shows an example of the result of plotting the difference between the water blank absorbance obtained in the first measurement and the water blank absorbance obtained in the second measurement for each measurement. (When bubbles adhere to the inner wall of the reaction vessel) 400 water blank measurements were performed, each taking three water blank absorbances.A graph showing an example of the result of plotting the difference between the water blank absorbance obtained in the first measurement and the third measurement in each measurement (when bubbles adhere to the inner wall of the reaction vessel). Functional block diagram of the diagnostic device. Flowchart for determining the factors causing variations in water blank absorbance. Example of GUI for setting measurement conditions for water blank measurement. Example of GUI for setting the judgment conditions in step S02 of Figure 8. Example of GUI for setting the judgment conditions in steps S06 and S07 of Figure 8. Example of GUI for setting the judgment conditions in step S08 of Figure 8. Example of GUI for the output screen of the judgment results. Example of GUI for the diagnostic results of the status of the automatic analyzer.

[0009] Hereinafter, one embodiment of the present invention will be described in detail with reference to the drawings.

[0010] Figure 1 shows the overall configuration of the diagnostic system. The diagnostic system for diagnosing the status of the automated analyzer consists of an automated analyzer 100 and a diagnostic device 200, as shown in Figure 1, with each device connected via a network such as the Internet. Although Figure 1 shows an example where one automated analyzer 100 is connected to the diagnostic device 200, in reality, multiple automated analyzers 100 are connected to the diagnostic device 200. The diagnostic device 200 may be a server built on a single computer or a cloud-type server built on a group of multiple computers.

[0011] First, I will explain the configuration and operation of the automated analyzer 100.

[0012] The reaction vessel 1 is cleaned by a cleaning mechanism 17 and a pure water pump 15 for cleaning. Then, purified water is dispensed into each of the reaction vessels 1, and a photometer consisting of a light source lamp 3, a spectral diffraction grating 4, and a photodetector 5 measures the absorbance. The absorbance measured at this time is called the water blank absorbance. Once the measurement of the water blank absorbance is complete, the system water is removed from the reaction vessel 1.

[0013] Next, the sample dispensing mechanism 11 and the sample dispensing pump 14 dispense the sample from the sample cup 7 held on the sample disc 8 into the reaction vessel 1 held on the reaction disc 2. Similarly, the reagent dispensing mechanism 12 and the reagent dispensing pump 16 dispense the reagent from the reagent bottle 9 held on the reagent disc 10 into the reaction vessel 1. After that, the stirring mechanism 13 stirs the sample and reagent in the reaction vessel 1. The absorbance change of the reaction solution in the reaction vessel 1 is measured by a photometer at regular time intervals determined by the rotation of the reaction disc 2. The reaction vessel 1 is immersed in the reaction vessel circulating water in the reaction tank 18, and since the temperature of this reaction vessel circulating water is kept constant by the constant temperature water supply device 6, the chemical reaction of the reaction solution in the reaction vessel 1 is stably promoted. Once the absorbance measurement is complete, the reaction vessel 1 is washed again by the washing mechanism 17 and the washing pure water pump 15 and used for the measurement of the next sample.

[0014] The configuration of the photometer will now be explained. Light emitted from the light source lamp 3 passes through the reaction vessel 1 and is spectrally separated into each wavelength component by the spectral diffraction grating 4. At the spectral target, the required number of photodetectors 5 are installed at positions corresponding to the wavelengths required for measurement. The photodetectors 5 convert the incident light into an electric current, generating a current proportional to the amount of light. This current is called the photocurrent. The electrical signal, which is proportional to the concentration of the target component contained in the sample, is converted into a digital value by the AD conversion unit 20, then stored in the memory device 23 via the interface bus 27, and processed for analysis by the control unit 22.

[0015] The control unit 22 controls the reaction disk 2, each dispensing mechanism, and the photometer to execute the analysis sequence for the sample. When the control unit 22 calculates the concentration of the sample, absorbance data corrected by the water blank absorbance is used. Since absorbance fluctuates due to the effects of scratches and dirt on the container and changes in the light intensity of the light source lamp, the water blank absorbance is generally measured immediately before measuring the sample. The communication unit 28 is an interface for exchanging data with the diagnostic device 200 via a network.

[0016] As described above, reaction vessel 1 is used repeatedly in the order of washing, water blank measurement, and sample measurement. Water blank measurement is performed when reaction vessel 1 passes in front of the photometer as reaction disc 2 rotates, with purified water dispensed into reaction vessel 1. Because purified water has low wettability, air bubbles tend to adhere to the inner wall of reaction vessel 1. If air bubbles adhere to the inner wall of reaction vessel 1, it may not be possible to measure the absorbance correctly. Therefore, in water blank measurement, stirring is not performed after discharging water into reaction vessel 1 to prevent the generation of air bubbles. In addition, reaction vessel 1 is surrounded by circulating water from the reaction tank, which is kept at a constant temperature of 37°C. As the temperature of the blank water in reaction vessel 1 rises, dissolved oxygen is more likely to be generated as air bubbles, so water blank measurement needs to be completed in a short time. However, considering the variability of the measured values, multiple water blank absorbances are measured for the same reaction vessel 1.

[0017] Figure 2A shows the circulation flow path including the constant temperature water supply device of the automated analyzer. System water is supplied from the water supply tank 101 by the first water supply pump 102, degassed in the first degasser 103, then branched in the branch pipe 104 and supplied to the dispensing mechanism 106 and the washing mechanism 17 via the first flow path 105. The reaction vessel circulating water 107 is connected via a second flow path 108 independent of the first flow path 105 and supplied to the reaction vessel 18 using the second water supply pump 109. The second flow path 108 is equipped with a water supply solenoid valve 111 and a drain solenoid valve 112 and is an independent flow path from the first flow path 105. The reaction vessel circulating water 107 is circulated in the following order: reaction vessel 18, second degasser 113, cooling device 114, second water supply pump 109, and heating device 115. The reaction vessel 1 is arranged circumferentially within the reaction tank 18, which is filled with reaction tank circulating water 107. To ensure a stable chemical reaction in the reaction liquid within the reaction vessel 1, the temperature of the reaction tank circulating water 107 is kept constant by the action of the cooling device 114 and the heating device 115. The water level of the reaction tank circulating water 107 decreases due to evaporation, overflow from the reaction tank 18, etc. In this case, water is supplied from the water supply tank 101 by the first water supply pump 102.

[0018] The adhesion of bubbles to the inner wall of the reaction vessel 1 and the incorporation of bubbles into the reaction vessel circulating water 107 disturb the absorbance measurement. Therefore, the system water and the reaction vessel circulating water 107 are constantly degassed by the first degasser 103 and the second degasser 113. Furthermore, considering the possibility that generated bubbles may adhere to the reaction vessel 1 or the optical axis window, surfactants are generally added to the reaction vessel circulating water 107.

[0019] Figure 2B shows an example of the configuration of a degassing device. The degassing device 150 contains, for example, hollow fibers, and a container 152 is provided so as to surround the flow path 151. The container 152 is connected to a vacuum pump 153, and the vacuum pump 153 creates negative pressure inside the container 152, thereby degassing the system water or reaction vessel circulating water 107 in the flow path. For example, if the hollow fibers are cut or if a blockage occurs in the flow path connected to the vacuum pump 153, the system water or reaction vessel circulating water 107 may pass through the degassing device 150 without proper degassing. Alternatively, if the airtightness inside the container 152 is compromised due to damage to the container 152, the degassing of the system water or reaction vessel circulating water 107 flowing through the flow path may not be sufficient.

[0020] Next, the influence of air bubbles adhering to the inner wall of the reaction vessel 1 and the incorporation of air bubbles into the reaction vessel circulating water 107 on the water blank absorbance range will be explained using Figures 3 and 4. Figures 3 and 4 show an example of the results of plotting the range (maximum value - minimum value) of water blank absorbance obtained three times during water blank measurement before sample measurement. In this embodiment, the case where the number of water blank absorbance measurements is three is used as an example, but any number of measurements, such as two or four, may be used. If any of the absorbance data measured three times are affected by air bubbles adhering to the inner wall of the reaction vessel 1 or air bubbles mixed into the reaction vessel circulating water 107, the water blank absorbance range will increase.

[0021] Figure 3 is a graph showing an example of the water blank absorbance range obtained when there is no influence from air bubbles adhering to the inner wall of the reaction vessel or from air bubbles being mixed into the circulating water of the reaction vessel. As can be seen from Figure 3, the water blank absorbance range is generally 0.001 or less, and even the largest values ​​are within about 0.002.

[0022] Figure 4 is a graph showing examples of water blank absorbance ranges obtained when there are effects from bubbles adhering to the inner wall of the reaction vessel or bubbles being mixed into the circulating water of the reaction vessel. When bubbles adhere to the inner wall of reaction vessel 1 and are located on the optical axis, the incident light is scattered by the bubbles, and the amount of scattering increases as the bubbles grow, so the water blank absorbance range becomes larger. When bubbles are generated in the circulating water 107 of the reaction vessel and the generated bubbles randomly cross the optical path of the photometer, an increase in the water blank absorbance range is also observed. In both cases, the size and amount of bubbles vary, and the amount of change in absorbance changes depending on the size and amount of bubbles, so the range of distribution of the water blank absorbance range becomes large. According to Figure 4, the maximum value of the water blank absorbance range is approximately 0.01, but some values ​​exceed this.

[0023] Next, the influence of bubble adhesion to the inner wall of reaction vessel 1 and bubble incorporation into the reaction vessel circulating water 107 on the relative magnitudes of water blank absorbances obtained multiple times in water blank measurements will be explained using Figures 5A to 6C.

[0024] Figures 5A to 5C show the relative magnitudes of three water blank absorbances obtained when the amount of bubbles in the reaction vessel circulating water 107 increases. Figure 5A is a graph showing an example of the results obtained by plotting the difference between the water blank absorbance obtained in the first measurement and the water blank absorbance obtained in the second measurement, after performing 400 water blank measurements in which water blank absorbances were obtained in three measurements. Figure 5B is a graph showing an example of the results obtained by plotting the difference between the water blank absorbance obtained in the second measurement and the water blank absorbance obtained in the third measurement, after performing 400 water blank measurements in which water blank absorbances were obtained in three measurements. Figure 5C is a graph showing an example of the results obtained by plotting the difference between the water blank absorbance obtained in the first measurement and the water blank absorbance obtained in the third measurement, after performing 400 water blank measurements in which water blank absorbances were obtained in three measurements.

[0025] When the amount of bubbles in the reaction vessel circulating water 107 increases, the absorbance of the water blank increases when bubbles cross the optical axis between the three water blank measurements. However, since this increase occurs randomly, the increase in the range of water blank absorbance also occurs randomly. Therefore, as shown in Figures 5A to 5C, no regularity is observed in the relative magnitudes of the three water blank absorbance measurements. One possible cause of the increase in the amount of bubbles in the reaction vessel circulating water 107 is the decrease in the degassing performance of the second degasser.

[0026] Figures 6A to 6C show the relative magnitudes of the three water blank absorbances obtained when bubbles adhere to the inner wall of reaction vessel 1. Figure 6A is a graph showing an example of the results obtained by plotting the difference between the water blank absorbance obtained in the first measurement and the water blank absorbance obtained in the second measurement, after performing 400 water blank measurements in which water blank absorbances were obtained in three measurements. Figure 6B is a graph showing an example of the results obtained by plotting the difference between the water blank absorbance obtained in the second measurement and the water blank absorbance obtained in the third measurement, after performing 400 water blank measurements in which water blank absorbances were obtained in three measurements. Figure 6C is a graph showing an example of the results obtained by plotting the water blank absorbance obtained in the second measurement and the water blank absorbance obtained in the third measurement, after performing 400 water blank measurements in which water blank absorbances were obtained in three measurements.

[0027] When bubbles adhere to the inner wall of reaction vessel 1 and are located on the optical axis, the bubbles grow as the system water in reaction vessel 1 is heated by the circulating water 107 in the reaction tank, increasing the amount of incident light scattered, and thus the water blank absorbance increases. Therefore, as shown in Figures 6A to 6C, the water blank absorbance obtained three times in the water blank measurement tends to increase with each measurement. One possible cause of the increase in the amount and frequency of bubbles adhering to the inner wall of reaction vessel 1 is an increase in the amount of bubbles in the system water. It is assumed that the amount of bubbles in the system water will increase if the degassing performance of the first degasser deteriorates or if there is a problem with the flow channel tube or tube connection.

[0028] Figure 7 is a functional block diagram of the diagnostic device. As shown in Figure 7, the diagnostic device 200 includes a communication unit 210, storage 220, processor 230, memory 240, output unit 250, and input unit 260. The communication unit 210 is an interface that communicates with the automatic analyzer 100 and exchanges data with the automatic analyzer 100 via the network. The storage unit includes a water blank measurement data storage unit 221, a judgment condition storage unit 222, and a judgment result storage unit 223.

[0029] In Figure 7, the functions conceptually executed by the processor are shown as a water blank measurement data management unit 241, an absorbance range calculation unit 242, and a determination unit 243, and the programs for realizing each function are stored in memory 240. The programs may be provided pre-installed in ROM or similar media, or they may be provided or distributed as files in an installable or executable format recorded on a computer-readable recording medium. Furthermore, the programs may be stored on a computer connected to a network and provided or distributed by downloading them via the network.

[0030] The water blank measurement data management unit 241 stores the water blank absorbance received from the automatic analyzer 100 via the communication unit 210 in the water blank measurement data storage unit 221. The absorbance range calculation unit 242 calculates the difference between the maximum and minimum values ​​among the multiple water blank absorbances obtained for the same reaction vessel 1, and stores this as the water blank absorbance range in the water blank measurement data storage unit 221. The water blank absorbance range may also be calculated by the control unit 22 of the automatic analyzer 100, in which case the water blank measurement data management unit 241 stores the water blank absorbance range received from the automatic analyzer 100 directly in the water blank measurement data storage unit 221. Here, since data such as water blank absorbance is transmitted to the diagnostic device 200 from multiple automatic analyzers, the water blank measurement data storage unit stores data for each automatic analyzer 100. The determination unit 243 determines the state of bubbles in each automatic analyzer 100 based on the water blank absorbance and the water blank absorbance range. The specific details of this determination will be described later.

[0031] The output unit 250 outputs the judgment result (such as an alarm or countermeasure) from the judgment unit 243, and is, for example, a display. The input unit 260 is for setting conditions such as thresholds used in the judgment by the judgment unit 243, and is, for example, a keyboard or mouse. Note that the output unit 250 and the input unit 260 may be integrated into a single unit, such as a touch panel operation display unit.

[0032] Next, we will explain a specific method for diagnosing the state of bubbles in an automated analyzer, using Figure 8. Figure 8 is a flowchart for determining the factors causing variations in water blank absorbance.

[0033] First, the control unit 22 of the automatic analyzer 100 measures the absorbance of the water blank three times during the water blank measurement (hereinafter, the absorbance of the water blank measured the first time will be referred to as CB1, the absorbance of the water blank measured the second time as CB2, and the absorbance of the water blank measured the third time as CB3), and transmits the measurement results to the diagnostic device 200 via the communication unit 28 (step S01). Since this water blank measurement is included in the analysis sequence of the automatic analyzer 100, no further water blank measurement is required.

[0034] Figure 9 shows an example of a GUI (Graphical User Interface) for setting the measurement conditions for water blank measurement. The measurement condition setting screen 800 is a screen output to the output unit 250 of the diagnostic device 200, and includes a measurement condition setting unit 801 and an exclusion condition setting unit 802. The measurement condition setting unit 801 sets which wavelengths of water blank measurement will be used for the determination. In this example, wavelengths that the photometer can measure are listed and the user can select one. The exclusion condition setting unit 802 sets which water blank measurements will be excluded during the determination. For example, immediately after changing the reaction vessel circulating water 107, degassing by the degasser may be insufficient, and the amount of bubbles in the reaction vessel circulating water 107 may be higher than normal. For this reason, the water blank absorbance measured within a predetermined time after changing the reaction vessel circulating water 107 can be set not to be used for the determination. Alternatively, immediately after the light source lamp is turned on, the amount of light from the light source lamp may be unstable. Therefore, the absorbance of the water blank measured within a predetermined time after the light source lamp is switched on can be set not to be used for the determination.

[0035] Next, the determination unit 243 determines whether all three measured water blank absorbances (CB1, CB2, CB3) are higher than the first threshold (step S02).

[0036] If large bubbles adhere to the inner wall of reaction vessel 1 and are located on the optical axis, the amount of scattering of incident light increases, causing all three measured water blank absorbances to rise. Also, if the dispensing mechanism does not discharge system water properly and the height of the system water from the bottom of reaction vessel 1 reaches a predetermined height, the incident light is diffusely reflected, and the water blank absorbance becomes abnormally high all three times. Possible causes of these phenomena include an abnormal amount of bubbles mixed into the system water or a malfunction in the opening and closing of the solenoid valve. In step S02, if the water blank absorbance is determined to be higher than the first threshold, the determination unit 243 notifies the output unit 250 of a serious malfunction in the device, such as the adhesion of large bubbles to the inner wall of reaction vessel 1 or a malfunction in the discharge of system water (step S03).

[0037] Figure 10 shows an example of a GUI for setting the judgment conditions in step S02 of Figure 8. The judgment condition (1) setting screen 900 is a screen output to the output unit 250 of the diagnostic device 200 and includes a threshold setting unit 901 and a detailed condition setting unit 902. The threshold setting unit 901 sets the first threshold used in the judgment in step S02 of Figure 8. When bubbles adhere to the inner wall of the reaction vessel 1, the range of increase in water blank absorbance differs depending on the size and number of bubbles. Also, the range of increase in water blank absorbance differs when large bubbles are present in the reaction vessel 1 and when there is a system water discharge failure. For this reason, it is possible to set the first threshold according to the target to be detected. The detailed condition setting unit 902 sets the detailed conditions for the water blank absorbance used in the judgment in step S02. The water blank absorbance for reaction vessels where the number of uses after replacement or the number of washes after measuring a specific item is below a predetermined value (second threshold) can be set not to be used in the judgment in step S02. Furthermore, the GUI may be configured to allow setting the water blank absorbance of reaction vessels whose number of uses after performing specific maintenance items is below a predetermined value to not be used in the determination in step 02. The conditions (thresholds) set in the GUI are stored in the determination condition storage unit 222.

[0038] In step S02, if the water blank absorbance is determined to be below the first threshold, the absorbance range calculation unit 242 calculates the water blank absorbance range based on the difference between the maximum and minimum values ​​of the three measured water blank absorbances (step S04). Subsequently, the absorbance range calculation unit 242 stores the calculated water blank absorbance range, along with the three measured water blank absorbances, in the water blank measurement data storage unit 221 (step S05).

[0039] Next, the determination unit 243 determines whether the number of data points for the water blank absorbance and the water blank absorbance range has reached or exceeds the third threshold (step S06). If the number of data points has not reached or exceeded the third threshold, the process returns to step S01, and the control unit 22 performs the water blank measurement on the next reaction vessel, and the same process is repeated thereafter.

[0040] In step S06, if the number of data points reaches or exceeds the third threshold, the determination unit 243 determines whether the frequency of the water blank absorbance range exceeding the fourth threshold during a predetermined period is higher than the fifth threshold (step S07).

[0041] Figure 11 shows an example of a GUI for setting the judgment conditions in steps S06 and S07 of Figure 8. In step 07, one judgment condition may be set as shown in Figure 8 and it may be determined whether that condition is met, or multiple judgment conditions may be set and the determination may be made based on a combination of those conditions (AND condition, OR condition, etc.). For this reason, the judgment condition (2) setting screen 1000 is equipped with an activation unit 1001 and is a GUI that allows multiple judgment conditions to be set.

[0042] In the data count setting unit 1002, the number of data points (third threshold) required for the determination in step S06 is set. Note that in this determination condition (2) setting screen 1000, the acquisition time setting unit 1003 can also be used to set the data acquisition time for water blank measurement, rather than the number of data points themselves. As shown in the determination condition for the first item in Figure 11, if both the data count setting unit 1002 and the acquisition time setting unit 1003 are set, the condition for step S06 is considered to have been met when either of them is satisfied.

[0043] The index setting unit 1004 sets an index used for the determination in step S07, and the threshold setting unit 1005 sets a threshold (fourth threshold) used for the determination in step S07. Here, "frequency of threshold exceeding" is set as an index statistically obtained from data of a water blank absorbance range, and "50" is set as the threshold (fourth threshold). In addition, a condition (fifth threshold) for determining whether an index is appropriate, that is, "threshold exceeding occurs at a frequency of 10 or more times per hour", is set by the threshold exceeding frequency setting unit 1006.

[0044] Note that step S07 in FIG. 8 is an example, and the determination may be performed using other indexes and conditions. For example, the index may be a statistical value such as an average value or standard deviation (SD) of a water blank absorbance range over a certain period, and the threshold (fourth threshold) and the condition (fifth threshold) are not limited to a common eigenvalue for each model, and a normal data distribution may be obtained for each apparatus and used as a reference. The indexes and conditions set via the GUI are stored in the determination condition storage unit 222.

[0045] In step S07, when it is determined that the frequency at which the water blank absorbance range exceeds the fourth threshold is higher than the fifth threshold, the determination unit 243 determines whether the frequency at which the three-time measured water blank absorbance shows an upward trend, that is, satisfies CB1<CB2<CB3, is higher than a sixth threshold (step S08).

[0046] FIG. 12 is an example of a GUI for setting determination conditions in step S08 of FIG. 8. On a determination condition (3) setting screen 1100, "360 out of 400 times of 3-point water blank measurement" is set as a condition (sixth threshold) for determining whether the frequency satisfying CB1<CB2<CB3 is appropriate. Note that the fourth threshold may be set for the number of data acquired within a certain period of time in addition to the total number of data. In addition, the magnitude relationship may be a condition including an equal sign. The conditions (thresholds) set via the GUI are stored in the determination condition storage unit 222.

[0047] In step S08, reference data may be acquired in advance when the apparatus is in a normal state, and the correction value calculated from the reference data may be used to correct the water blank absorbances at three points before the determination. The correction method is specifically described below. First, when the apparatus is in a normal state, the water blank measurement data management unit 241 records CBref1, CBref2, and CBref3 in the water blank measurement data storage unit 221 as reference data of water blank absorbances measured three times in water blank measurement. Next, the water blank measurement data management unit 241 calculates RDCB2=CBref2-CBref1 and RDCB3=CBref3-CBref1 as correction values, and records the correction values in the water blank measurement data storage unit 221. Thereafter, the water blank measurement data management unit 241 performs leveling on the water blank absorbances CB1, CB2, and CB3 measured three times in water blank measurement by using the aforementioned correction values. In the leveling process, corrected CB1=CB1, corrected CB2=CB2-RDCB2, and corrected CB3=CB3-RDCB3, and the magnitude relationship among the obtained corrected CB1, corrected CB2, and corrected CB3 is used for the determination in step S08.

[0048] In step S08, if it is determined that the frequency at which the water blank absorbances measured three times (corrected CB1, corrected CB2, corrected CB3) show an increasing tendency that corrected CB1<corrected CB2<corrected CB3, increasing with each measurement, is higher than a sixth threshold, the determination unit 243 determines that the frequency of air bubbles adhering to the inner wall of the reaction vessel 1 has increased, and notifies the output unit 250 of this fact (step S09).

[0049] On the other hand, in step S08, if it is determined that the frequency of the increasing tendency is equal to or lower than the sixth threshold, and no regularity is found in the magnitude relationship of the three-times measured water blank absorbances, the determination unit 243 determines that air bubbles mixed into the reaction tank circulating water 107 have increased, and notifies the output unit 250 of this fact (step S10).

[0050] In addition, in step S07, if it is not determined that the frequency at which the water blank absorbance range exceeds the fourth threshold is higher than the fifth threshold, the determination unit 243 determines that neither the air bubbles adhering to the inner wall of the reaction vessel 1 nor the air bubbles contained in the reaction tank circulating water 107 have increased.

[0051] The above method makes it possible to isolate the factors causing the increased variation in water blank absorbance measured multiple times. However, if in step S08 it is determined that the frequency of the increasing trend is higher than the sixth threshold, it should be noted that not only the bubbles adhering to the inner wall of the reaction vessel 1 but also the bubbles mixed into the reaction vessel circulating water 107 may be increasing.

[0052] Figure 13 shows an example of the GUI for the judgment result output screen. The judgment result output screen 1200 is a screen output to the output unit 250 of the diagnostic device 200, and consists of a date display unit 1201, a time display unit 1202, a result notification unit 1203, and a countermeasure display unit 1204. The date display unit 1201 and the time display unit 1202 display the date and time when the judgment result was notified. The result notification unit 1203 notifies the user of an increase in bubbles adhering to the inner wall of the reaction vessel, an increase in bubbles mixed into the circulating water of the reaction tank, etc. The countermeasure display unit 1204 displays countermeasures in order of priority. For example, if it is determined that there is an increase in bubbles adhering to the inner wall of the reaction vessel, an increase in the amount of bubbles in the system water or deterioration of the condition of the inner wall of the reaction vessel may be considered, and therefore, checking the device flow path or replacing the reaction vessel will be displayed as countermeasures. The judgment results are stored in the judgment result storage unit 223 of the diagnostic device for each automatic analyzer.

[0053] Figure 14 shows an example of a GUI for the diagnostic results of an automated analyzer. The diagnostic result display screen 1300 is a screen output to the output unit 250 of the diagnostic device 200, and consists of a device selection unit 1301 and a display content selection unit 1302. The device selection unit 1301 allows the user to select which automated analyzer's diagnostic results to display from the serial number. Diagnostic results for multiple serial numbers may be displayed simultaneously for comparison. The display content selection unit 1302 allows the user to select which results to display. The user may select a water blank absorbance range, the difference between the first and second absorbances of three water blank absorbance measurements, the difference between the second and third absorbances, or the difference between the first and third absorbances, or the water blank absorbance itself.

[0054] It should be noted that the present invention is not limited to the embodiments described above, and various modifications are included. For example, in the embodiments described above, a determination unit provided by a diagnostic device 200 connected to the automatic analyzer 100 via a network determined the state of the bubbles. However, the automatic analyzer 100 itself may be equipped with a determination unit, and the automatic analyzer 100 may determine the state of the bubbles itself.

[0055] 1: Reaction vessel, 2: Reaction disk, 3: Light source lamp, 4: Diffraction grating for spectroscopy, 5: Photodetector, 6: Constant temperature water supply device, 7: Sample cup, 8: Sample disk, 9: Reagent bottle, 10: Reagent disk, 11: Sample dispensing mechanism, 12: Reagent dispensing mechanism, 13: Stirring mechanism, 14: Sample dispensing pump, 15: Pure water pump for washing, 16: Reagent dispensing pump, 17: Washing mechanism, 18: Reaction tank, 20: AD conversion unit, 22: Control unit, 23: Memory device, 24: Display, 25: Printer, 26: Keyboard, 27: Interface bus, 101: Water supply tank, 102: First water supply pump, 103: First degassing device, 104: Branch pipe, 105: First 106: Flow path, 107: Dispensing mechanism, 108: Reaction vessel circulating water, 109: Second flow path, 111: Water supply solenoid valve, 112: Drain solenoid valve, 113: Second degassing device, 114: Cooling device, 115: Heating device, 151: Flow path, 152: Container, 153: Vacuum pump, 200: Diagnostic device, 210: Communication unit, 220: Storage, Water blank measurement data storage unit, 222: Judgment condition storage unit, 223: Judgment result record 230: Processor, 240: Memory, 241: Water Blank Measurement Data Management Unit, 242: Absorbance Range Calculation Unit, 243: Judgment Unit, 250: Output Unit, 260: Input Unit, 800: Measurement Condition Setting Screen, 801: Measurement Condition Setting Unit, 802: Exclusion Condition Setting Unit, 900: Judgment Condition (1) Setting Screen, 901: Threshold Setting Unit, 902: Detailed Condition Setting Unit, 1000: Judgment Condition (2) Setting Screen, 1001: Activation Unit, 1002: Data count setting unit, 1003: Acquisition time setting unit, 1004: Indicator setting unit, 1005: Threshold setting unit, 1006: Threshold overflow frequency setting unit, 1100: Judgment condition (3) setting screen, 1200: Judgment result output screen, 1201: Date display unit, 1202: Time display unit, 1203: Result notification unit, 1204: Countermeasure display unit, 1300: Diagnosis result display screen, 1301: Device selection unit, 1302: Display content selection unit

Claims

1. A diagnostic system for diagnosing the state of an automated analyzer comprising: a reaction vessel; a reaction disk that holds a reaction vessel while immersed in circulating water in the reaction vessel; a dispensing mechanism for dispensing liquid into the reaction vessel; a first channel for supplying purified water to the dispensing mechanism; a second channel for supplying the circulating water into the reaction vessel; a photometer for measuring the absorbance of the liquid dispensed into the reaction vessel; and a control unit for controlling the reaction disk, the dispensing mechanism, and the photometer to perform sample analysis, wherein the diagnostic system has a determination unit that distinguishes and determines the factors causing variations in water blank absorbance based on the water blank absorbance, which is the absorbance measured by the photometer when the purified water is dispensed into the reaction vessel by the dispensing mechanism, and the photometer measures multiple water blank absorbances for the same reaction vessel in the water blank measurement before sample measurement. The diagnostic system is characterized in that the determination unit determines that the number of bubbles adhering to the inner wall of the reaction vessel is increasing when the relative magnitudes of the absorbance of the water blank measured multiple times tend to increase as the temperature of the purified water in the reaction vessel rises over time.

2. A diagnostic system according to claim 1, characterized in that the determination unit determines that there is an abnormality in the automatic analyzer if the absorbance of the water blank measured multiple times is all higher than the first threshold.

3. A diagnostic system according to claim 1, wherein each reaction vessel has a storage unit that stores a plurality of water blank absorbances and water blank absorbance ranges, the water blank absorbance range is the difference between the maximum and minimum values ​​among a plurality of water blank absorbances obtained for the same reaction vessel, and when the number of water blank absorbances and water blank absorbance ranges stored in the storage unit reaches a predetermined number of data, the determination unit determines whether an index statistically determined from the water blank absorbance range data satisfies predetermined conditions, and if the index does not satisfy the conditions, the determination unit determines that the bubbles adhering to the inner wall of the reaction vessel and the bubbles contained in the circulating water have not increased.

4. A diagnostic system according to claim 3, wherein the index is the frequency at which the water blank absorbance range exceeds a second threshold, and the condition is that the frequency is higher than a third threshold.

5. A diagnostic system according to claim 3, wherein, when the index satisfies the conditions, the determination unit determines whether the frequency of the magnitude relationship showing an upward trend is higher than a fourth threshold, and if the frequency is higher than the fourth threshold, the determination unit determines that the amount of bubbles adhering to the inner wall of the reaction vessel is increasing, and if the frequency is not higher than the fourth threshold, the determination unit determines that the amount of bubbles and debris contained in the circulating water is increasing.

6. A diagnostic system according to claim 3, comprising a diagnostic device connected to the automatic analyzer by a network, wherein the diagnostic device has a determination unit, a storage unit, and an output unit, and the output unit outputs the determination result made by the determination unit.

7. A diagnostic system according to claim 2, characterized in that the absorbance of the water blank for the reaction vessel whose number of uses is less than or equal to the fifth threshold is not used to determine an abnormality in the automated analyzer.

8. An automatic analyzer comprising: a reaction vessel; a reaction disk that holds a reaction vessel while immersed in circulating water in the reaction vessel; a dispensing mechanism for dispensing liquid into the reaction vessel; a first channel for supplying system water to the dispensing mechanism; a second channel for supplying the circulating water into the reaction vessel; a photometer for measuring the absorbance of the liquid dispensed into the reaction vessel; a control unit for performing sample analysis by controlling the reaction disk, the dispensing mechanism, and the photometer; and a determination unit for distinguishing and determining the factors causing variations in water blank absorbance based on water blank absorbance, which is the absorbance measured by the photometer while the system water has been dispensed into the reaction vessel by the dispensing mechanism, wherein the photometer measures multiple water blank absorbances for the same reaction vessel, and the determination unit determines that the number of bubbles adhering to the inner wall of the reaction vessel is increasing when the relative magnitudes of the multiple water blank absorbances tend to increase as the temperature of the purified water in the reaction vessel rises over time.

9. A diagnostic method for an automated analyzer comprising: a reaction vessel; a reaction disk that holds a reaction vessel while immersed in circulating water in the reaction vessel; a dispensing mechanism for dispensing liquid into the reaction vessel; a first channel for supplying system water to the dispensing mechanism; a second channel for supplying the circulating water into the reaction vessel; a photometer for measuring the absorbance of the liquid dispensed into the reaction vessel; and a control unit that controls the reaction disk, the dispensing mechanism, and the photometer to perform analysis of a sample, wherein the system water is dispensed into the reaction vessel by the dispensing mechanism, and the photometer measures multiple water blank absorbances for the same reaction vessel, the determination unit determines that the number of bubbles adhering to the inner wall of the reaction vessel is increasing when the relative magnitudes of the multiple water blank absorbances tend to increase as the temperature of the purified water in the reaction vessel rises over time.

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