JP6654881B2 - Automatic analyzer and method for determining abnormality of automatic analyzer - Google Patents

Description

  The present invention relates to an automatic analyzer for performing qualitative / quantitative analysis of a biological sample such as blood or urine, and a method for determining an abnormality of the automatic analyzer.

  Automated analyzers add and react reagents that specifically react with specific components contained in biological specimens (hereinafter referred to as specimens) such as blood and urine, and measure the absorbance and luminescence of the reaction solution. Qualitative and quantitative analysis.

  In such an automatic analyzer, a step of dispensing a sample to be analyzed contained in a sample container and a reagent to be added to and reacted with the sample to a reaction container is required in order to cause the sample to react with the reagent. The effect of the dispensing process on the quality of analysis performance is great, and early detection of a change in the state of the dispensing mechanism involved in the dispensing process is very important to prevent analysis troubles.

  Causes of analysis troubles include, for example, generation of air bubbles in the syringe tube, deterioration in dispensing reproducibility due to liquid leakage from the syringe tube, and insufficient cleaning of the probe due to a failure of a pump used for cleaning the inside of the probe. Can be

  In an automatic analyzer, for example, as disclosed in Patent Document 1, a sample for quality control is measured, and data obtained at this time are continuously checked, so that there is no problem in the state of the device including the dispensing mechanism. Make sure that.

JP-A-6-281656

  However, the above prior art has the following problems.

  In the above-described automatic analyzer of the related art, even if an abnormality in the quality control data is detected, it may take a long time to identify the cause, or when the sample to be tested is being measured or has been measured. However, there is a problem that the measurement of these samples must be performed again, and the cost and time of the reagents and the like used for the measurement are wasted.

  Further, it is difficult to detect an abnormality such as insufficient cleaning of the probe from the quality control data, and it is not sufficient to detect a change in the state of the dispensing mechanism at an early stage and to prevent a trouble before it occurs.

  The present invention has been made in view of the above, and an object of the present invention is to provide an automatic analyzer and an automatic analyzer capable of detecting a change in the state of a dispensing mechanism at an early stage and preventing waste of cost and time of reagents and the like. Is to be realized.

  The present invention is configured as follows to achieve the above object.

In the automatic analyzer, a dispensing mechanism having a dispensing nozzle for aspirating and discharging a liquid contained in a container, an analyzer for analyzing a sample sucked by the dispensing nozzle and discharged to a reaction container, A pressure sensor that detects a pressure inside the dispensing nozzle of the dispensing mechanism, a pressure signal processing unit that calculates a characteristic amount from the pressure inside the dispensing nozzle detected by the pressure sensor, and a predetermined management reference value And a storage unit for storing the feature amount calculated by the pressure signal processing unit; comparing the feature amount stored in the storage unit with an initial management reference value stored in advance in the storage unit; An abnormality determination unit that determines whether there is an abnormality in the mechanism, and controls the operations of the dispensing mechanism, the pressure sensor, the pressure signal processing unit, the storage unit, and the abnormality determination unit, and the dispensing nozzle controls the liquid. Abnormality determination for suction and discharge An operation control unit that causes the abnormality determination unit to determine whether the dispensing mechanism is abnormal based on the internal pressure detected by the pressure sensor during the operation sequence; On the condition that the number is stored in the storage unit at intervals of time or more and is a certain number or more, a management reference value is generated based on these feature amounts, and is generated instead of the initial management reference value. And a management criterion generation unit for storing the management criterion value in the storage unit .

The abnormality determination unit determines whether there is an abnormality in the dispensing mechanism using the management reference value instead of the initial management reference value .

An abnormality determination method for an automatic analyzer, wherein a liquid dispensing mechanism having a dispensing nozzle for sucking and discharging a liquid, and an analyzer for analyzing a sample sucked by the dispensing nozzle and discharged to a reaction container, A pressure sensor for detecting the pressure inside the dispensing nozzle, a pressure signal processing unit for calculating a characteristic amount from the pressure inside the dispensing nozzle detected by the pressure sensor, a predetermined control reference value and the pressure signal A storage unit that stores the feature amount calculated by the processing unit, and stores the internal pressure detected by the pressure sensor during the abnormality determination operation sequence in which the dispensing nozzle sucks and discharges the liquid. Comparing the feature amount stored in the unit with the initial management reference value, determining whether there is an abnormality in the dispensing mechanism, and storing the feature amount in the storage unit at intervals of a predetermined time or more, And more than a certain On condition that the number, and generates a management reference value based on these characteristic amounts, and determines the presence or absence of abnormality of the dispensing mechanism in the management reference value instead of the initial control reference value.

  ADVANTAGE OF THE INVENTION According to this invention, the automatic analyzer and the abnormality determination method of an automatic analyzer which can detect the state change of a dispensing mechanism at an early stage and can prevent waste of cost and time of a reagent etc. can be implement | achieved.

1 is a schematic diagram of the entire configuration of an automatic analyzer to which the present invention is applied. It is a figure which shows typically the internal structure of the sample dispensing mechanism among a some dispensing mechanism. FIG. 3 is a functional block diagram illustrating details of a control device. It is a figure showing an example of generation of a management standard. It is a flowchart which shows abnormality determination processing. It is a figure which shows the image of setting of a management standard, and abnormality detection. It is a figure which shows the image of detection of an abnormal trend. FIG. 7 is a diagram illustrating a display example of a screen when an abnormality is detected on a display device of the control device. It is a figure showing the example of a display of a screen when a predetermined time or more has passed since the last check execution. It is a figure showing the example of a display of the screen at the time of performing maintenance of the part concerned with a dispensing mechanism. FIG. 3 is a diagram illustrating data transmission and reception between functional blocks in the control device.

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

(1) Overall Configuration of Automatic Analyzer FIG. 1 is a diagram schematically showing the overall configuration of an automatic analyzer to which one embodiment of the present invention is applied.

  In FIG. 1, the automatic analyzer includes a sample disk (sample disk) 10, a first reagent disk 20, a second reagent disk 30, a reaction disk 40, a sample dispensing mechanism 50, a first reagent dispensing mechanism 60, and a second reagent. A dispensing mechanism 70, a photometric mechanism 80, and a control device 90 are provided.

  The sample disk 10 mounts a plurality of sample containers 11 each containing a biological sample (hereinafter, referred to as a sample) such as blood or urine to be analyzed in a circumferential direction. The sample disk 10 is rotationally driven by a rotation driving device (not shown), and transports the sample container 11 in the circumferential direction of the sample disk 10.

  The first reagent disk 20 mounts a plurality of reagent containers 21 each containing a reagent (first reagent) used for analyzing a sample in the circumferential direction. The first reagent disk 20 is driven to rotate in the circumferential direction by a rotation driving device (not shown), and transports the reagent container 21 in the circumferential direction of the first reagent disk 20.

  The second reagent disk 30 has a plurality of reagent containers 31 containing reagents (second reagents) used for analysis of a sample arranged in the circumferential direction. The second reagent disk 30 is rotationally driven in a circumferential direction by a rotation driving device (not shown), and transports the reagent container 31 in a circumferential direction of the second reagent disk 30.

  The reaction disk 40 has a plurality of reaction vessels 41 containing a mixture of a sample and a reagent (reaction liquid) arranged in the circumferential direction. The reaction disk 40 is rotationally driven in a circumferential direction by a rotation driving device (not shown), and conveys the reaction container 41 in a circumferential direction of the reaction disk 40. A stirring mechanism (having a washing bottle and a washing tank) 42 for stirring the mixed liquid accommodated in the reaction container 41 is provided on the transfer path of the reaction container 41 of the reaction disk 40, and the reaction container having been analyzed. A cleaning mechanism 43 for cleaning the surface 41 is provided.

  The sample dispensing mechanism 50 immerses and aspirates a dispensing nozzle 51 (described later with reference to FIG. 2) into a sample to be dispensed contained in the sample container 11 and discharges the sample into the reaction container 41. Is dispensed. The sample dispensing mechanism 50 is driven in the horizontal and vertical directions by a driving device (not shown). The sample dispensing mechanism 50 includes a dispensing channel 53, a pressure sensor 54, and a metering pump 57.

  The first reagent dispensing mechanism 60 immerses a suction nozzle (not shown) in the first reagent to be dispensed contained in the reagent container 21, aspirates the dispensing nozzle, and discharges the dispensed nozzle to the reaction container 41, thereby discharging the first reagent. Is dispensed. The first reagent dispensing mechanism 60 is driven in the horizontal and vertical directions by a driving device (not shown).

  The second reagent dispensing mechanism 70 immerses a dispensing nozzle (not shown) in the second reagent to be dispensed contained in the reagent container 31, aspirates the dispensed nozzle, and discharges the dispensed nozzle into the reaction container 41, thereby discharging the second reagent. Is dispensed. The second reagent dispensing mechanism 70 is driven in the horizontal and vertical directions by a driving device (not shown).

  The photometric mechanism 80 is disposed on the transport path of the reaction vessel 41 in the reaction disk 40, and emits light to the reaction vessel 41 containing the reaction solution to be measured, and is contained in the reaction vessel 41. A spectral detector 82 for detecting transmitted light transmitted through the reaction solution. The detection result of the spectral detector 82 is converted into a digital signal and sent to the control device 90.

  The control device 90 controls the operation of the entire automatic analyzer including the driving devices, and performs analysis processing for analyzing a sample such as blood or urine to be analyzed, and each dispensing mechanism associated with the analysis processing. An input device 91 for inputting various setting values, commands, and the like, and a display for displaying various setting screens, analysis result screens, and the like. And a device 92.

(1-1) Description of Dispensing Mechanisms 50, 60, 70 Next, the dispensing mechanisms 50, 60, 70 shown in FIG. 1 will be described.

  FIG. 2 is a diagram schematically showing the internal configuration of the sample dispensing mechanism 50 as a representative of the plurality of dispensing mechanisms 50, 60, and 70.

  As shown in FIG. 2, the sample dispensing mechanism 50 includes a dispensing nozzle 51 having a dispensing channel 53 for passing a sample 51 a and a system liquid 51 b therein, and a sample 51 a and a system for the dispensing nozzle 51. A metering pump 57 for sucking / discharging the liquid 51b and the separated air 51c, a pressure sensor 54 for detecting the pressure inside the dispensing nozzle 51 (in other words, for the inside of the dispensing channel 53), and a dispensing channel. A pump 59 connected to the pump 53 and a valve 58 provided in a flow path between the dispensing flow path 53 and the pump 59 are provided.

  At one end of the dispensing nozzle 51 on the side immersed in the reagent, a throttle section 52 having a small cross-sectional area of the dispensing channel 53 is provided.

  The metering pump 57 is connected to the other end of the dispensing nozzle 51, and the driving mechanism 56 allows the plunger 55 to enter the dispensing channel 53 or to retract the plunger 55 from the dispensing channel 53. Is performed to adjust the volume in the dispensing channel 53, so that the sample or the like is sucked and discharged from the throttle unit 52.

  The pump 59 supplies the system liquid 51b to the dispensing path 53, and is controlled by the control device 90 together with the open / close state of the valve 58.

  The detection result of the pressure sensor 54 is sent to the control device 90 via the A / D converter 54a.

  The first and second reagent dispensing mechanisms 60 and 70 have the same configuration as the sample dispensing mechanism 50, and a detailed description thereof will be omitted.

(1-2) Control device 90
Next, the control device 90 shown in FIG. 1 will be described.

  FIG. 3 is a schematic functional block diagram of the control device 90.

  In FIG. 3, the control device 90 calculates a feature amount of a digital signal of a pressure signal from the A / D converter 54 a of each of the dispensing mechanisms 50, 60, and 70 in addition to the input device 91 and the display device 92. A pressure signal processing unit 96, a storage unit 93 for storing various information used for the operation of the automatic analyzer such as an analysis process and an abnormality determination process, and a management for automatically generating a management standard based on a feature amount acquired over time. Using the reference generation unit 95 and the management criterion generated by the management criterion generation unit 95 or the management criterion stored in advance in the storage unit 93, it is determined whether the feature amount to be determined is within the management criterion. An abnormality determining unit 94 for performing an abnormality determining process as to whether or not an abnormal trend has occurred; an operation control unit 97 for controlling the operation of the automatic analyzer including the dispensing mechanisms 50 to 60; Analyzing unit 9 to calculate 8 and the like.

  Note that transmission and reception of signals and data of the pressure signal processing unit 96, the storage unit 93, the management reference generation unit 95, the abnormality determination unit 94, and the operation control unit 97 will be described later.

(2) Analysis Process Next, the basic operation of the analysis process of the automatic analyzer according to one embodiment of the present invention will be described.

  In the analysis process, qualitative / quantitative analysis is performed by adding and reacting a reagent that specifically reacts with a specific component contained in a sample such as blood or urine, and measuring the absorbance of the reaction solution.

  First, a sample (sample) to be analyzed is stored in the sample container 11 of FIG. Information (analysis items, reagent types, and the like) necessary for the analysis processing of each sample is input in advance by the input device 91 of the control device 90 and stored in the storage unit 93.

  Next, a predetermined amount of the sample is aspirated from the sample container 11 by the dispensing nozzle 51 of the sample dispensing mechanism 50 and is discharged to the reaction container 41 mounted on the reaction disk 40 for dispensing.

  Subsequently, the first and second reagent dispensing mechanisms 60 and 70 aspirate a fixed amount of the reagent from the reagent containers 21 and 31 and discharge the reagent to the reaction container 41 of the reaction disk 40 to dispense the reagent. I do. The type, amount, timing, and the like of the reagent to be dispensed by the first and second reagent dispensing mechanisms 60 and 70 are determined in advance by the type of the sample, the analysis item, and the like.

  Subsequently, the reaction disk 40 is periodically rotated / stopped, and photometry is performed at a timing when the reaction vessel 41 passes between the photometric mechanisms 80 (between the light source 81 and the spectroscopic detector 82). Photometry is repeated by the spectroscopic detector 82 during a predetermined reaction time, and then the reaction vessel 41 whose analysis has been completed is washed by the washing mechanism 43.

  The photometry by the photometry mechanism 80 is also performed on the plurality of sample containers 41 in parallel. The detection result by the photometric mechanism 80 is sent to the analysis unit 98 of the control device 90, where the concentration of the component according to the type of analysis is calculated and displayed on the display device 91.

  A basic operation of the dispensing process by the dispensing mechanism in the analysis process will be described.

  Here, the sample dispensing mechanism 50 will be described as a representative of the dispensing mechanisms 50, 60, 70.

  In the dispensing process by the sample dispensing mechanism 50 (that is, the sample dispensing process), the dispensing probe 51 is immersed in the sample to be dispensed, aspirated and discharged to a predetermined reaction container 41 by dispensing. Make a note.

  Before aspirating the sample, the control device 90 opens the valve 58 of the dispensing mechanism 50 and fills the inside of the dispensing channel 53 of the dispensing nozzle 51 with the system liquid 51 b supplied from the pump 59. Close. Next, with the tip of the dispensing nozzle 51 in the air, the plunger 55 is moved down by the driving mechanism 56 to suck the separated air 51 c into the dispensing nozzle 51.

  Next, the dispensing probe 51 is lowered into the sample container 11, and the plunger 55 is further lowered while the tip is immersed in the sample so that the sample is narrowed and the dispensing channel 53 of the dispensing probe 51 is dispensed. Suction into. Thereafter, with the dispensing probe 51 moved above the reaction container 41, the plunger 55 is moved up by the drive mechanism 56, and the sample is discharged until it reaches the separation air 51c.

(3) Abnormality determination processing Next, abnormality determination processing of the dispensing mechanism will be described. The pressure signal processing unit 96 of the control device 90 obtains a pressure signal (that is, a detection result of the pressure sensor 54) during an operation sequence performed when a predetermined condition is satisfied, and obtains a feature amount from the obtained pressure signal. Is calculated and stored in the storage unit 93. The management criterion generating unit 95 generates a management criterion based on a feature amount stored over time in the storage unit 93 that satisfies a predetermined condition. The abnormality determination unit 94 determines whether there is an abnormality in the dispensing mechanism based on the management criteria and the characteristic amount.

(3-1) Pressure signal processing The pressure signal processing in the abnormality determination processing will be described. When the predetermined condition is satisfied, each dispensing mechanism 50, 60, 70 is controlled to execute a predetermined operation sequence. Here, the predetermined condition means that the operator selects the execution of the pressure signal acquisition process when the automatic analyzer is started or when a predetermined time or more (for example, 24 hours) has elapsed since the previous operation sequence was performed. It is. If the elapse of a certain time or more is set to elapse of 24 hours or more, it is possible to avoid a situation where the operation sequence is not executed for one day or more.

  The pressure signal processing section 96 of the control device 90 calculates a feature amount from the pressure signal during the present operation sequence.

  This operation sequence is, for example, to suck a predetermined amount of liquid from a detergent bottle for cleaning the probe installed on the reagent disks 20, 30 and the like, move to the cleaning tank of the cleaning mechanism 43, and discharge the sucked liquid. And then cleaning the inside and outside of the probe in the cleaning tank. Alternatively, only the cleaning operation inside and outside the probe in the cleaning tank may be performed.

  If the operation sequence is a dispensing nozzle cleaning sequence in which the dispensing nozzle 51 sucks the detergent from the detergent bottle of the cleaning mechanism 43 and discharges the detergent into the cleaning tank, it is necessary to newly provide a liquid storage tank and the like for the operation sequence. There is no. In addition, if the dispensing nozzle cleaning sequence is set to be executed before suction and discharge of a sample or the like, it can be used as the operation sequence, and it is necessary to provide a separate sequence for the operation sequence. There is no.

  The calculated feature amounts include a pressure average value and a pressure standard deviation value at fixed time intervals, and timings at which minimum and maximum points of pressure fluctuation appear when the operation of the plunger 55 starts and stops. However, it is only necessary to be able to express the characteristics of the pressure fluctuation, and the present invention is not limited to this.

(3-2) Management Reference Generation Next, the management reference generation processing in the abnormality determination processing will be described. The conditions required for the feature data used when the management standard is automatically generated are as follows: the interval of the acquisition time of each feature data is longer than a predetermined time, and the variation in the number of feature data is normal. It is assumed that a predetermined number sufficient to represent is prepared. Here, the predetermined time or more of the time interval of each feature amount data is at least 12 hours or more, and the predetermined number of feature amount data is at least 10 or more.

  The reason why the time interval of each feature amount data is equal to or longer than the predetermined time is to improve the reliability of the management standard by reflecting the variation in the normal state as well as requiring the number of feature amount data equal to or more than the predetermined number. is there.

  FIG. 4 is a diagram illustrating an example of generation of a management standard in the management standard generation unit 95. In FIG. 4, in this example, the generation condition of the management criterion is that the time interval of each feature amount data is 12 hours or more and the number of data is 10. The management criterion generation unit 95 calculates an average value and a standard deviation (SD) of each feature amount when the generation condition of the management criterion is satisfied, and sets, for example, an average ± 3 SD as a management criterion.

  With this setting, the management reference width can be set appropriately.

  The abnormality determination unit 94 determines whether the characteristic amount to be determined is within the management range or not, and whether an abnormal drift has occurred, and determines whether there is an abnormality. Here, the abnormal drift refers to a case where the movement in one direction continuously fluctuates a predetermined number of times and the fluctuation is equal to or more than a predetermined value. This is a case where the standard deviation is twice (SD) or more.

  The management criteria individually set for each of the dispensing mechanisms 50, 60, and 70 can be reset after maintenance of parts related to the dispensing mechanism by an operator or a serviceman.

(3-3) Operation of Abnormality Determination Process Next, the operation of the abnormality determination process will be described. FIG. 5 is a flowchart showing the abnormality determination processing, and FIG. 11 is a functional block diagram for explaining transmission and reception of signals and data of each unit in the abnormality determination processing of the control device 90.

  The same abnormality determination processing is performed by each of the sample dispensing mechanisms 50, the first reagent dispensing mechanism 60, and the second reagent dispensing mechanism 70.

  5 and 11, the operation control unit 97 of the control device 90 determines whether the dispensing mechanisms 50, 60, 70 perform suction / discharge or cleaning at the time of starting the device or when a predetermined condition is satisfied (STEP 1). Then, a predetermined operation sequence including the above as a component is executed (STEP 2).

  The predetermined operation sequence refers to the above-described operation sequence, and is an operation sequence in which a dispensing probe of the dispensing mechanism 50 or the like performs an operation of suctioning and discharging cleaning water from the cleaning tank.

  The pressure signal acquisition unit 96A of the pressure signal processing unit 96 acquires the digital signal of the pressure of the dispensing mechanism 50, 60, 70 sent from the A / D converter 54a, and acquires the digital signal during the operation sequence. The characteristic amount calculation unit 96B calculates the characteristic amount from the pressure data obtained (STEP 3).

  The feature amount calculation unit 96B stores the calculated feature amount in the storage unit 93, and notifies the management reference generation unit 95 that the feature amount has been stored in the storage unit 93.

  The management criterion generation unit 95 confirms whether the generation of the management criterion is completed (STEP 4), and when the generation of the management criterion is completed, determines that the abnormality is determined to be abnormal based on the newly set management criterion. This is transmitted to the determination unit 94 (setting of the management standard will be described later). The abnormality determination unit 94 determines whether there is an abnormality by comparing the feature amount calculated in STEP 3 with the management standard (STEP 5).

  In STEP 5, the abnormality determination unit 94 reads out the feature amount stored in the storage unit 93, and sets a management width set from the average value and the standard deviation value of the feature amount group satisfying a predetermined condition, the feature amount to be determined, and The presence or absence of an abnormality is determined by comparing the characteristic amounts and checking whether an abnormal trend has occurred in the feature amount to be determined. It is also possible to narrow down the area where the abnormality has occurred, based on the feature amount determined to be abnormal.

  When it is determined in STEP 5 that there is no abnormality, the abnormality determination unit 94 notifies the operation control unit 97 that there is no abnormality. In that case, the operation control unit 97 causes the dispensing mechanisms 50, 60, 70, etc. to transition to the standby state (the processing is END).

  If it is determined in STEP 5 that there is an abnormality, the abnormality determination unit 94 notifies the operation control unit 97 that there is an abnormality. In this case, the operation control 97 generates an alarm on the display device 92 to urge the operator or the like to check and adjust the device (STEP 8).

  If the generation of the management criterion is not completed in STEP 4, the abnormality determination unit 94 determines whether there is an abnormality by comparing the management criterion set in advance with the feature amount calculated in STEP 3. (STEP 6). The details of the abnormality determination are the same as in STEP5. When it is determined in STEP 6 that there is no abnormality, the operation control unit 97 shifts the dispensing mechanisms 50, 60, 70, and the like to the standby state (the processing becomes END).

  If it is determined in STEP 6 that there is an abnormality, the abnormality determination unit 94 notifies the operation control unit 97 that there is an abnormality. In this case, the operation control 97 generates an alarm on the display device 92 to urge the operator or the like to check and adjust the device (STEP 7).

  Next, setting of a management reference and detection of an abnormality will be described. FIG. 6 is a diagram showing an image of setting of a management standard and abnormality detection. In FIG. 6, until the generation of the management standard is completed, the management standard set in the apparatus in advance is used for the feature amount calculated from the pressure value. This is a management criterion having a management width that can be determined in advance in the initial state of the apparatus to be normal at the time of manufacture. In each automatic analyzer, a preset management standard can be reset by the input device 91, and in each automatic analyzer, the management standard generator 95 collects and manages pressure data and the like of the automatic analyzer. Generate criteria. By setting individual management criteria for each dispensing mechanism, it is possible to detect a change from a normal state earlier.

  The reset of the initial management reference value can be performed by the user. However, instead of storing the management reference value generated by the management reference generation unit 95 in the storage unit 93 instead of the initial management reference value, the dispensing mechanism When the maintenance of 50, 60, and 70 is performed, the operation control unit 97 may be configured to control the operation so that the initial management reference value is automatically reset and stored in the storage unit 93. it can.

  FIG. 7 is a diagram illustrating an image of detection of an abnormal trend of a feature amount calculated from a pressure value. Although the feature amount to be determined as an abnormality is within the management range having the individual upper limit and lower limit, for example, it moves in one direction five times in succession, and its variation is calculated by the management reference generator 95. This is an example in which an abnormality is determined when the difference is equal to or more than twice the standard deviation (SD). In this determination, in STEP5 and STEP6 shown in FIG. 5, the feature amount is a management criterion set in advance, and whether the variation of the feature amount is within the management range or not is determined as abnormal or normal.

  If the abnormality determination as shown in FIG. 7 is performed, the abnormality determination can be performed before the feature amount exceeds the management width, so that the abnormality determination can be performed even earlier.

(3-4) Display Processing Next, screen display processing for displaying on the display screen of the display device 92 will be described in relation to the abnormality determination operation.

  FIG. 8 is a diagram illustrating a display example of the screen 921 when an abnormality is detected on the display device 92 of the control device 90. The example shown in FIG. 8 is a screen showing a dispensing mechanism that has detected an abnormality (R1 dispensing mechanism in FIG. 8) and displaying a message urging the operator to confirm and adjust.

  By performing the display as shown in FIG. 8, it is possible to perform early adjustment when an abnormality is detected.

  FIG. 9 is a diagram illustrating a display example of a screen when a predetermined time or more has elapsed since the last abnormality check was performed. A message prompting the operator to select whether or not to perform the check is displayed.

  By performing the display as shown in FIG. 9, it is possible to avoid a situation in which the abnormality check is not performed for a long time.

  FIG. 10 is a diagram illustrating a display example of a screen when maintenance is performed on a part related to the dispensing mechanisms 50, 60, and 70. Display a message prompting the operator to select whether to reset the management criteria.

  By performing the display as shown in FIG. 10, it is possible to individually set the management criteria for the abnormality determination with respect to the reset timing for each dispensing mechanism.

  As described above, in one embodiment of the present invention, an automatic analyzer that can detect a change in the state of the dispensing mechanism at an early stage and prevent waste of cost and time of reagents and the like and abnormality determination of the automatic analyzer The method can be realized.

  In other words, the characteristic amount in the suction / discharge operation of washing water or the like is calculated in the dispensing abnormality confirmation operation sequence before the sample analysis operation, not in the sample / reagent suction operation in the sample (sample) analysis operation, and the abnormality is determined to be abnormal or normal. Therefore, if an abnormality has occurred in the dispensing mechanism 50, 60, or 70, the abnormality can be detected before the sample is analyzed, and the waste of the sample and the reagent and the waste of the analysis operation can be reduced. Can be avoided.

  In addition, when the dispensing mechanism sucks and discharges a sample, since the physical properties (viscosity, etc.) characteristics and the amount of suction and discharge differ for each sample, the sample suction and discharge data of the dispensing mechanism during the sample analysis operation is used. Then, it is very difficult to judge whether the dispensing mechanism is abnormal or abnormal, and the reliability is low. However, as in the present invention, the abnormality of the dispensing mechanism is determined by using a liquid having constant physical properties such as washing water. If it is configured to determine normality, it is possible to accurately and reliably determine abnormalities and normalities.

  Further, as shown in FIG. 7, even if the feature amount is within the management range, if the variation range of the feature amount is abnormal, it is determined that the dispensing mechanism is abnormal. Can be detected earlier.

  Further, in the embodiment, in the operation sequence, the detergent is suctioned and discharged to the dispensing nozzle 51. However, instead of the detergent, another liquid such as mere water is suctioned and discharged, and the operation sequence is executed. It may be configured as follows.

  Note that a change in the feature amount of the dispensing mechanism can have the same meaning as a change in the state of the dispensing mechanism.

  10 sample disk (sample disk), 11 sample container, 12 sample container rack, 20 first reagent disk, 21 reagent container, 30 second reagent disk , 31 ... reaction vessel, 40 ... reaction disk, 41 ... reaction vessel, 42 ... stirring mechanism, 43 ... washing mechanism, 50 ... sample dispensing mechanism, 51 ... minute Injection nozzle, 52, throttle section, 53, dispensing channel, 54, pressure sensor, 55, plunger, 56, drive mechanism, 57, metering pump, 58, Valve, 59: pump, 60: first reagent dispensing mechanism, 70: second reagent dispensing mechanism, 80: photometric mechanism, 90: control device, 91: input device , 92: display device, 93: storage unit, 94: abnormality determination unit, 95: management unit Generator, 96 ... pressure signal processing unit, 96A ... the pressure signal acquisition unit, 96B ... feature amount calculation unit, 97 ... operation control unit, 98 ... analyzer

Claims (14)

A dispensing mechanism having a dispensing nozzle for suctioning and discharging the liquid contained in the container,
An analysis unit for analyzing a sample sucked by the dispensing nozzle and discharged to the reaction container,
A pressure sensor for detecting a pressure inside the dispensing nozzle of the dispensing mechanism,
A pressure signal processing unit that calculates a characteristic amount from the pressure inside the dispensing nozzle detected by the pressure sensor,
A storage unit that stores a predetermined management reference value and the feature amount calculated by the pressure signal processing unit,
An abnormality determination unit that compares the feature amount stored in the storage unit with an initial management reference value stored in advance in the storage unit and determines whether there is an abnormality in the dispensing mechanism;
The dispensing mechanism, the pressure sensor, the pressure signal processing unit, the storage unit, and controls the operation of the abnormality determination unit, during the abnormality determination operation sequence in which the dispensing nozzle sucks and discharges the liquid, An operation control unit that causes the abnormality determination unit to determine whether the dispensing mechanism is abnormal based on the internal pressure detected by a sensor;
On the condition that the feature value is stored in the storage unit at intervals of a predetermined time or more and is a number equal to or more than a certain value, a management reference value is generated based on the feature value, and the initial management is performed. A management reference generation unit that stores the management reference value generated in place of the reference value in the storage unit;
Equipped with a,
The automatic analyzer according to claim 1, wherein the abnormality determining unit determines whether there is an abnormality in the dispensing mechanism using the management reference value instead of the initial management reference value . The automatic analyzer according to claim 1,
An input device for inputting an operation by an operator is provided, and the abnormality determination operation sequence is performed when a predetermined time or more has elapsed since the start of the automatic analyzer or the execution of the previous abnormality determination operation sequence, and the operator operates the input device through the input device. An automatic analyzer that is executed when the operation controller is instructed to execute the abnormality determination operation sequence. The automatic analyzer according to claim 2,
The said fixed time is 24 hours, The automatic analyzer characterized by the above-mentioned. The automatic analyzer according to claim 1,
A washing mechanism having a detergent bottle containing a detergent for washing a dispensing nozzle of the dispensing mechanism and a washing tank is provided, and the abnormality determination operation sequence is such that the dispensing nozzle sucks detergent from the detergent bottle, An automatic analyzer characterized by a dispensing nozzle cleaning sequence for discharging into a cleaning tank. The automatic analyzer according to claim 1 ,
The automatic analyzer according to claim 1, wherein the interval of the predetermined time or more is 12 hours or more. The automatic analyzer according to claim 1 ,
The automatic analyzer according to claim 1, wherein the number of the feature amounts equal to or more than a certain number is 10 or more. The automatic analyzer according to any one of claims 1, 5 , and 6 ,
The automatic analysis device according to claim 1, wherein the management criterion generating unit calculates an average value and a standard deviation value of a feature amount group satisfying the above condition and generates a management criterion value for abnormality determination. The automatic analyzer according to claim 1 ,
The management reference value is a management width having an upper limit value and a lower limit value, and the abnormality determination unit determines whether there is an abnormality in the dispensing mechanism based on whether the feature amount is within the management width. An automatic analyzer characterized by: The automatic analyzer according to claim 8 ,
The management criterion generation unit calculates an average value and a standard deviation value of a feature amount group that satisfies the above conditions, and the abnormality determination unit determines that the feature amount is within the management width, but the predetermined number of times. Automatic analysis characterized by determining that the dispensing mechanism is abnormal when the actuator moves in one direction of the upper limit value direction or the lower limit value direction and the movement width is a predetermined multiple of the standard deviation value. apparatus. The automatic analyzer according to claim 1 ,
After the management reference generation unit stores the management reference value generated in place of the initial management reference value in the storage unit, when maintenance of the dispensing mechanism is performed, the operation control unit includes a management reference value. Reset to the initial control reference value. The automatic analyzer according to claim 1,
An automatic analyzer further comprising a display device, wherein, when the abnormality determination section determines that the dispensing mechanism has an abnormality, the operation control section causes the display device to display an alarm. A dispensing mechanism having a dispensing nozzle for sucking and discharging a liquid, an analyzer for analyzing a sample sucked by the dispensing nozzle and discharged to the reaction vessel, and detecting a pressure inside the dispensing nozzle A pressure sensor, a pressure signal processing unit that calculates a characteristic amount from the pressure inside the dispensing nozzle detected by the pressure sensor, and a predetermined management reference value and the characteristic amount calculated by the pressure signal processing unit are stored. In the method for determining an abnormality of an automatic analyzer including a storage unit,
During the abnormality determination operation sequence the dispensing nozzle to suction and discharge the liquid, comparing the pressure in the interior, which is detected by the pressure sensor, and the features and initial management reference value stored in the storage unit And determine whether there is an abnormality in the dispensing mechanism ,
On the condition that the feature amount is stored in the storage unit at intervals of a predetermined time or more, and is a certain number or more, a management reference value is generated based on these feature amounts, and the initial management is performed. An abnormality determination method for an automatic analyzer, wherein the presence or absence of an abnormality in the dispensing mechanism is determined based on the management reference value instead of the reference value . An abnormality determination method for an automatic analyzer according to claim 12 ,
The abnormality determination operation sequence, automatic the elapse of a predetermined time or more from the execution of a startup or previous abnormality determination operation sequence of the automatic analyzer, and the operator and to execute at run time instruction above Symbol abnormality determination operation sequence An abnormality determination method for the analyzer. The abnormality determination method for an automatic analyzer according to claim 12 ,
The automatic analyzer includes a washing mechanism having a detergent bottle containing a detergent for washing a dispensing nozzle of the dispensing mechanism and a washing tank. A method for determining an abnormality in an automatic analyzer, wherein the method is a dispensing nozzle cleaning sequence in which a suction is performed and discharged to the cleaning tank.

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