Analysis device and method for determining presence or absence of abnormality

Abstract

In order to detect, on the basis of a potential difference generated between an ion-selective electrode and a reference electrode, abnormalities with respect to component replacement defects and deterioration, and to determine the presence or absence of abnormalities, the present disclosure proposes an analysis device for measuring the electrolyte concentration in a sample, the waveform acquisition unit associates the acquired waveforms for each drive timing, detects a peak value of the waveform appearing in the vicinity of the time of the drive timing, and calculates a feature quantity. Here, with reference to FIG. 4, the characteristic quantity includes the electromotive force at the peak value and / or the time between the time of the driving timing and the time at which the peak value is generated. Then, the waveform analysis unit determines the presence or absence of an abnormality on the basis of the feature amount.

Description

Technical Field

[0001] The present disclosure relates to an analysis device and a method for determining the presence or absence of an abnormality in the analysis device. Background Art

[0002] Currently, in order to measure the concentration of ions (electrolytes) such as potassium, sodium, and chloride in a biological sample, an analysis device is equipped with a plurality of ion selective electrodes (ISEs) corresponding to the ions to be detected.

[0003] Automatic analyzers use an electrolyte analysis unit having an ion-selective electrode alone or as a component of a biochemical automatic analyzer or the like in order to automatically, rapidly, and continuously perform clinical examinations.

[0004] The ion selective electrode is used in combination with a reference electrode, and the activity (concentration) of the target ion is determined by measuring the potential difference generated between the ion selective electrode and the reference electrode.

[0005] In the field of clinical testing, the concentrations of electrolytes contained in biological samples such as blood, particularly serum, plasma, and urine are often quantified.

[0006] In automatic analyzers, the mainstream method for quantifying the above-mentioned sample is a dilution method in which a predetermined amount of diluent is added to and mixed with a predetermined amount of the sample to dilute the sample, and then measurement is performed using an ion selective electrode.

[0007] The dilution method has the advantages of requiring a small amount of specimen, low concentrations of coexisting substances such as proteins and lipids in the measurement solution, minimal contamination effects from coexisting substances, and high stability of the ion-selective electrode.

[0008] A container called a dilution tank is used for dilution of the sample, and the diluted sample (measurement solution) prepared in the dilution tank is transported through piping to a flow cell type ion selective electrode for measurement.

[0009] The internal standard solution and the specimen are dispensed alternately into the dilution tank and measured alternately with the specimen.

[0010] Electrolyte concentrations in living organisms are maintained within a narrow range, and even small changes in concentrations can have significant clinical and therapeutic implications.

[0011] Therefore, extremely high measurement accuracy is required for ion-selective electrodes, and various technologies have been developed to minimize measurement errors.

[0012] For example, Patent Document 1 describes a method in which the potential is measured in a state where an internal standard solution is filled in an ion selective electrode, and the presence or absence of an abnormality in an electrolyte analysis unit is determined based on the measurement data.

[0013] Prior art literature

[0014] Patent Literature

[0015] Patent Document 1: Japanese Patent Application Laid-Open No. 2016-188872 Summary of the Invention

[0016] Problems to be solved by the invention

[0017] In an electrolyte analysis cell, measurement errors occur due to defects in the installation of replacement parts that need to be replaced periodically and due to their deterioration over time after installation.

[0018] Such replacement parts are replaced as often as every few months, so the frequency of failure is high, and the possibility of causing measurement errors is potentially high.

[0019] However, conventional techniques do not consider abnormality determination regarding failure and degradation of replacement parts.

[0020] An object of the present disclosure is to provide an analysis device and a method for determining the presence or absence of an abnormality, which can detect an abnormality such as a failure or degradation of a replacement component based on a potential difference generated between an ion selective electrode and a reference electrode.

[0021] Means for solving problems

[0022] As an example of the analysis device disclosed herein, the analysis device for measuring the electrolyte concentration in a sample comprises: a plurality of ion-selective electrodes that obtain a potential based on the electrolyte concentration; a reference electrode that obtains a potential based on a reference solution; a flow path that supplies the sample or reference solution to the ion-selective electrodes and the reference electrode; a plurality of driving units that control the flow path, aspirate the sample, discharge the sample, aspirate the reference solution, and discharge the reference solution; a potential measuring unit that measures an electromotive force between the potential obtained by the ion-selective electrodes and the potential obtained by the reference electrode; and a waveform acquiring unit that acquires waveforms representing the electromotive force. a waveform that changes; a waveform analyzing unit that uses the change in the electromotive force for analysis; and a drive control unit that outputs a control signal to one or more of the drive units in association with each of a plurality of drive timings associated with the component to be replaced, the waveform acquiring unit associating the acquired waveform with each of the drive timings, detecting a peak of the waveform that appears near the time of the drive timing to calculate a feature quantity, the feature quantity including the electromotive force at the peak and at least one of the time between the moment of the drive timing and the moment of generation of the peak, and the waveform analyzing unit determining whether there is an abnormality based on the feature quantity.

[0023] As an example of the method disclosed herein, in a method for determining the presence or absence of an abnormality in an analysis device for measuring an electrolyte concentration in a sample, the analysis device comprises: a plurality of ion-selective electrodes that obtain a potential based on the electrolyte concentration; a reference electrode that obtains a potential based on a reference solution; a flow path that supplies the sample or reference solution to the ion-selective electrodes and the reference electrode; a plurality of driving units that control the flow path, aspirate the sample, discharge the sample, aspirate the reference solution, and discharge the reference solution; a potential measuring unit that measures an electromotive force between the potential obtained by the ion-selective electrodes and the potential obtained by the reference electrode; and a waveform acquiring unit that acquires waveforms representing changes in the electromotive force. A waveform; a waveform analysis unit that uses the change in the electromotive force for analysis; and a drive control unit that outputs a control signal to one or more of the drive units in association with each of a plurality of drive timings associated with a component to be replaced, the method comprising the following steps: the waveform acquisition unit associates the acquired waveform with each of the drive timings, detects a peak of the waveform that appears near the time of the drive timing to calculate a feature quantity, the feature quantity including the electromotive force at the peak and at least one of the time between the moment of the drive timing and the moment of generation of the peak, the method comprising the step of the waveform analysis unit determining whether there is an abnormality based on the feature quantity.

[0024] Effects of the Invention

[0025] According to one aspect of the present disclosure, it is possible to reduce the man-hours required for manually checking for defects and degradation of replacement parts of an electrolyte analysis unit.

[0026] According to another aspect of the present disclosure, replacement parts can be appropriately replaced, and measurement errors in electrolyte analysis can be prevented before they occur. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] Figure 1 This is a structural diagram of the analysis device according to the first embodiment.

[0028] Figure 2 This is a flowchart showing the processing procedures of the waveform acquisition unit and the waveform analysis unit in the first embodiment.

[0029] Figure 3 This is a flowchart showing the process of obtaining the time history waveform of the electromotive force and calculating the characteristic amount in the first embodiment.

[0030] Figure 4 This is a graph showing a method for calculating characteristic quantities of the time history waveform of the electromotive force according to the first embodiment.

[0031] Figure 5 This is a flowchart showing the management procedure of the acquisition timing of the electromotive force waveform according to the first embodiment.

[0032] Figure 6 This is a flowchart showing the abnormality determination processing procedure of the first embodiment.

[0033] Figure 7 This is a graph showing the abnormality determination method using the temporal change of the characteristic amount of the electromotive force waveform according to the first embodiment.

[0034] Figure 8 An example of a display screen outputted on the display unit according to the first embodiment is shown. DETAILED DESCRIPTION

[0035] Next, a mode for carrying out the present disclosure (referred to as “embodiment”) will be described in detail with reference to the drawings as appropriate.

[0036] [First embodiment]

[0037] Figure 1 It is a configuration diagram of the analyzing device 100 according to the first embodiment.

[0038] The analyzing device 100 includes an electrolyte analyzing unit 1, an electromotive force waveform processing unit 2, and a device control unit 3. The analyzing device 100 measures the electrolyte concentration in a sample, and executes a method for determining the presence or absence of an abnormality.

[0039] The electrolyte analysis unit 1 includes:

[0040] A plurality of ion-selective electrodes 101 that generate a potential corresponding to the ion concentration in the sample (for example, three types: a chloride ion electrode 101a, a potassium ion electrode 101b, and a sodium ion electrode 101c);

[0041] The reference electrode 104 generates a constant reference potential in order to measure the potential of the ion selective electrode 101 as a potential difference (electromotive force);

[0042] The delivery tube 102 , which forms a flow path between the ion selective electrode 101 and the reference electrode 104 , is an example of a replaceable component that is periodically replaced;

[0043] a pinch valve 105 for opening and closing the flow path of the delivery tube 102;

[0044] a dilution tank 110 for storing an internal standard solution and a measurement solution (hereinafter sometimes referred to as a "test sample" or sometimes also a sample) obtained by mixing a test substance and a diluent;

[0045] a vacuum suction nozzle 106 for sucking the discharge liquid of the measured sample from the dilution tank 110;

[0046] a delivery nozzle 107 for introducing the liquid filled in the dilution tank 110 into the flow path of the ion selective electrode 101;

[0047] a diluent supply nozzle 108 for supplying diluent to the dilution tank 110;

[0048] an internal standard solution supply nozzle 109 that supplies an internal standard solution (IS) to a dilution tank 110;

[0049] a waste liquid tank 111 for discarding the sample and internal standard solution remaining in the dilution tank 110;

[0050] a vacuum pump 112 for sucking the sample and internal standard solution remaining in the dilution tank 110 and discarding them into the waste liquid tank 111;

[0051] Solenoid valves 121 to 127 for opening and closing each flow path;

[0052] An internal standard solution syringe pump 131 that fills the flow path with internal standard solution (IS);

[0053] a syringe pump 132 for diluent, which fills the flow path with diluent;

[0054] a delivery syringe pump 133 , which introduces the reference electrode solution into the flow path of the reference electrode 104 ;

[0055] an internal standard solution bottle 141 containing an internal standard solution (IS);

[0056] a diluent bottle 151 containing a diluent; and

[0057] The reference electrode solution bottle 161 contains a reference electrode solution (reference solution).

[0058] The three ion-selective electrodes 101 each acquire a potential based on the concentration of the corresponding electrolyte. The reference electrode 104 acquires a potential based on a reference solution. The analyzer 100 also includes various flow paths that supply samples or reference solutions to the ion-selective electrodes 101 and reference electrode 104.

[0059] The electromotive force waveform processing unit 2 includes:

[0060] a potential measuring section 20 for measuring a potential difference (electromotive force) between the ion selective electrode 101 and the reference electrode 104;

[0061] a waveform acquisition unit 21 that constantly acquires the potential change of the electromotive force measured by the potential measurement unit 20 as a waveform of a time history and calculates a feature value from the acquired waveform;

[0062] a waveform storage unit 22 that stores the waveform and feature values ​​acquired by the waveform acquisition unit 21; and

[0063] The waveform analysis unit 23 performs abnormality determination using the waveform and feature values ​​stored in the waveform storage unit 22 , and stores parameters used for abnormality determination in the waveform storage unit 22 .

[0064] The potential measuring unit 20 measures the electromotive force between the potential obtained by any one of the ion-selective electrodes 101 and the potential obtained by the reference electrode 104. The waveform acquiring unit 21 acquires a waveform representing changes in the electromotive force. The waveform analyzing unit 23 analyzes the changes in the electromotive force and determines the presence of an abnormality based on the waveform's characteristic values. The waveform storage unit 22 stores the waveform and characteristic values.

[0065] The device control unit 3 includes:

[0066] a control unit 30 for comprehensively controlling the entire analyzing device 100;

[0067] A drive control unit 31 connected to the control unit 30 controls the input and output of signals for operating various drive units installed in the analysis device 100;

[0068] An input unit 32 , which is connected to the control unit 30 and is a device such as a mouse, keyboard, or touch panel for the user to input action instructions and various parameters to the analysis device 100 ; and

[0069] The display unit 33 is connected to the control unit 30 and displays the status of the analysis device 100 including the processing results of the waveform analysis unit 23 using a GUI or the like.

[0070] The control unit 30 has, for example, a hardware structure similar to a known computer, and includes, for example, a computing unit and a storage unit. The computing unit includes, for example, a processor, and the storage unit includes, for example, a storage medium such as a semiconductor memory device or a magnetic disk drive. Some or all of the storage medium may be non-transitory storage medium.

[0071] The storage unit may store a program. When the processor executes the program, the computer functions as the control unit 30.

[0072] The pinch valve 105, vacuum suction nozzle 106, delivery nozzle 107, vacuum pump 112, solenoid valves 121-127, internal standard solution syringe pump 131, diluent syringe pump 132, and delivery syringe pump 133 in the electrolyte analysis unit 1 each function as a drive unit. These multiple drive units control the flow path, aspirate and discharge the sample, aspirate and discharge the reference solution, and perform other functions. A drive control unit 31 controls the input and output of signals for operating these drive units.

[0073] In particular, the drive control unit 31 outputs a control signal to one or more drive units in association with each of a plurality of drive timings associated with the component to be replaced. For example, all drive units may be components to be replaced, or only a portion of the drive units may be components to be replaced, or the components to be replaced may include structures other than the drive units.

[0074] Figure 2 This is a flowchart showing the processing procedures of the waveform acquisition unit 21 and the waveform analysis unit 23 .

[0075] First, when the analysis device 100 performs electrolyte analysis, the waveform acquisition unit 21 always acquires the potential change of the electromotive force measured by the potential measurement unit 20 as a waveform of the time history (hereinafter referred to as the electromotive force waveform), and calculates the feature value obtained from the acquired waveform (S201).

[0076] Here, use Figure 3 The processing steps of process S201 will be described in detail.

[0077] Figure 3 This is a flowchart showing the process of acquiring an electromotive force waveform and calculating a characteristic value by the waveform acquiring unit 21 according to the first embodiment.

[0078] First, when the analyzing device 100 executes electrolyte analysis, the waveform acquiring unit 21 starts a process of converting the electromotive force measured by the potential measuring unit 20 into a digital value and constantly acquiring the value as a waveform of a time history ( S301 ).

[0079] Next, the waveform acquisition unit 21 detects the action timing of various driving units carried by the electrolyte analysis unit 1 after executing the processing S301 (i.e., in the process of waveform acquisition) (S302→Yes), and calculates the peak value and the time when the peak value is reached (hereinafter referred to as the peak time) as the characteristic value based on the electromotive force waveform before and after the action timing (S303).

[0080] The operation timing can be detected based on the transmission of a timing signal (e.g., a trigger signal via communication) from the control unit 30 and the drive timing information of various drive units preset in the waveform acquisition unit 21 based on the timing information.

[0081] Here, use Figure 4 The method of calculating the feature amount in the process S303 will be described in detail.

[0082] Figure 4 Graph showing a method for calculating characteristic quantities of an electromotive force waveform by the waveform acquisition unit 21 of the first embodiment. Figure 4 The example is used when determining an abnormality in the delivery pipe 102.

[0083] Figure 4 (a) shows the driving timing detected by the waveform acquisition unit 21, Figure 4 (b) shows an example of the peak value and the peak time calculated in synchronization with the driving timing.

[0084] exist Figure 4 In (a), among the operation series of the driving unit mounted on the flow path of the transport tube 102 as a periodically replaced replacement component, comparative liquid suction, pinch valve drive, and transport nozzle drive are described as examples of drive timing.

[0085] Figure 4 The driving timing of (a) is a part of the operation sequence when the reference electrode solution is supplied to the flow path of the reference electrode 104 .

[0086] The driving timing “comparative liquid suction” is constituted by the opening of the electromagnetic valves 121 and 122 , the closing of the pinch valve 105 , and the driving of the delivery syringe pump 133 .

[0087] The drive timing “pinch valve drive” includes opening of the pinch valve 105 performed as part of the operation when the sample in the dilution tank 110 is introduced into the flow path of the ion selective electrode 101 .

[0088] The driving timing “transport nozzle driving” is also a part of the operation for introducing the sample in the dilution tank 110 into the flow path of the ion selective electrode 101 , and includes the lowering of the transport nozzle 107 .

[0089] Based on the waveforms associated with these drive timings, an abnormality in the delivery tube 102 is determined. The association between the drive timings and the replacement components (for example, when determining an abnormality in the delivery tube 102 as a replacement component, reference is made to the drive timings for comparison liquid aspiration, pinch valve actuation, and delivery nozzle actuation) is stored, for example, in the waveform analysis unit 23.

[0090] In the present embodiment, the peak value and the peak time are calculated in synchronization with the drive timing (time t1 ) of the pinch valve drive and the drive timing (time t2 ) of the delivery nozzle drive.

[0091] Figure 4 (b) shows an example of calculating the peak value (E1) and peak time (T1) of the electromotive force waveform synchronized with time t1, and the peak value (E2) and peak time (T2) of the electromotive force waveform synchronized with time t2. Here, for example, "peak time (T1) synchronized with time t1" refers to the value of time T1 expressed with time t1 as a reference. As a specific example, the elapsed time from time t1 to time T1 (or the elapsed time from time T1 to time t1 is negative) is equal to T1.

[0092] The waveform acquisition unit 21 searches for and calculates the peak of the electromotive force waveform during a peak detection time ( Tw1 ) which is a preset time width based on time t1 (for example, a time period including predetermined times before and after time t1 ).

[0093] exist Figure 4 In the example (b), the negative peak at time tp1 is calculated. T1 = tp1 - t1. In the calculation of the peak, it can be determined in advance whether to search for a positive peak or a negative peak.

[0094] Similarly, the waveform acquisition unit 21 searches for and calculates the peak of the electromotive force waveform during a peak detection time (Tw2) which is a preset time width based on time t2 (for example, a time period including predetermined times before and after time t2).

[0095] exist Figure 4 In the example of (b), the peak of the negative value at time tp2 is calculated: T2 = tp2 - t2.

[0096] Finally, the waveform acquisition unit 21 outputs the characteristic quantities (E1, E2, T1, T2) calculated so far as a peak data set.

[0097] In this manner, the waveform acquisition unit 21 associates the acquired waveforms for each driving timing, detects a peak of the waveform that appears near the driving timing, and calculates a feature value.

[0098] In this embodiment, the characteristic quantities include the electromotive force at the peak (peak value (E1) and peak value (E2) of the electromotive force waveform) and the time (T1, T2) between the driving timing (t1, t2) and the peak generation time (tp1, tp2). In a modified example, the characteristic quantity may include only one of these.

[0099] Here, return Figure 3 The processing S303 is continued to be described.

[0100] After processing S303 , the waveform acquisition unit 21 stores the peak data set in the waveform storage unit 22 ( S304 ), and proceeds to processing S305 .

[0101] Furthermore, when the operation timing of the various driving units mounted on the electrolyte analysis unit 1 is not detected in the process S302 ( S302 →No), the process proceeds to the process S305 in the same manner.

[0102] Next, the waveform acquisition unit 21 determines whether the analysis operation of the analysis device 100 is completed. If completed ( S305 → Yes), the process proceeds to step S306 . If not completed ( S305 → No), the process returns to step S302 to continue the processing operation.

[0103] Finally, the waveform acquisition unit 21 performs statistical processing (for example, calculating the mean value, variance, standard deviation, etc. for E1 and T1, respectively) on the peak data sets with the same type of drive timing (for example, E1 and T1 corresponding to "pinch valve drive") among the multiple peak data sets acquired, and stores the results in the waveform storage unit 22 (S306).

[0104] Furthermore, the waveform acquisition unit 21 may sequentially store the acquired electromotive force waveform and driving timing in the waveform storage unit 22 .

[0105] Furthermore, the waveform acquisition unit 21 may store the electromotive force waveform and the drive timing obtained by performing statistical processing using the acquired electromotive force waveform and a plurality of drive timings.

[0106] The peak data set described above together with the electromotive force waveform and / or driving timing is referred to as electromotive force monitoring data.

[0107] In this embodiment, an example is described in which the results of processes S304 and S306 are stored in the waveform storage unit 22. However, the waveform storage unit 22 may not be used, and the results of processes S304 and S306 may be handed over to the waveform analysis unit 23, and abnormality determination may be performed in the processing of the waveform analysis unit 23 described later.

[0108] Here, return Figure 2 The processing S201 is continued to be described.

[0109] After processing S201 , the waveform acquisition unit 21 manages the long-term time (in units of year, month, day, and time), ie, the time stamp, of the electromotive force waveform and peak data set stored in the waveform storage unit 22 .

[0110] Here, use Figure 5 The details of the process S202 will be described.

[0111] Figure 5 This is a flowchart showing the management procedure of the acquisition timing of the electromotive force waveform according to the first embodiment.

[0112] First, the waveform acquisition unit 21 determines whether a replacement component (e.g., the transport tube 102) input via the input unit 32 has been replaced (S501). For example, data indicating when a user has replaced a replacement component is separately recorded, and the waveform acquisition unit 21 refers to this data to determine whether the replacement has been performed. If the replacement component has been replaced (S501 → Yes), the replacement date and time of the replacement component is updated and stored in the waveform storage unit 22 (S502). If the replacement component has not been replaced (S501 → No), the process proceeds to S503.

[0113] Next, the waveform acquisition unit 21 stores the following timestamps in correspondence with the electromotive force monitoring data stored in the waveform storage unit 22 (S503), wherein the timestamps are a set of information on the processing moment and the elapsed time from the replacement date of each replacement component.

[0114] Here, return Figure 2 The processing S202 is continued to be described.

[0115] After the waveform acquisition unit 21 completes processing S202 , the waveform analysis unit 23 uses the electromotive force monitoring data and time stamps stored in the waveform storage unit 22 to determine abnormality in the electrolyte analysis unit 1 such as failure of a replacement component ( S203 ).

[0116] Here, use Figure 6 The details of the process S203 will be described.

[0117] Figure 6This is a flowchart showing the abnormality determination processing procedure of the first embodiment.

[0118] First, parameters such as a threshold value set in advance in the waveform analysis unit 23 via the input unit 32 are compared with the peak data set stored in the waveform storage unit 22 ( S601 ).

[0119] For example, as with Figure 7 As will be described later, the comparison is performed based on the relative magnitude of the two peaks (E1(t) - E2(t)). If the relative magnitude is within a predetermined normal range, the comparison result is determined to be within the normal range. If the relative magnitude is outside the normal range, the comparison result is determined to be outside the normal range. For example, a person skilled in the art can appropriately determine the normal range for each type of drive timing.

[0120] In process S602 , if the comparison result of process S601 is within the normal range ( S602 → Yes), the process proceeds to process S603 ; if it is not within the normal range ( S602 → No), the process proceeds to process S608 .

[0121] In the process S603, it is determined whether the Figure 6 Whether the replacement parts have been replaced after the treatment. For example, Figure 5 The replacement date and time in S502 is Figure 5 The determination is made by comparing the timestamp in S503. If it has been replaced (S603 → Yes), the latest electromotive force monitoring data is compared with the previous value of the electromotive force monitoring data (i.e., the value before the replacement) (S604). If it has not been replaced (S603 → No), the process proceeds to S606.

[0122] In the process S604, the normal range is determined as a predetermined range based on the previous value of the electromotive force monitoring data, for example, whether the change amount relative to the previous value is below a predetermined allowable value or below an allowable ratio. Figure 7 As will be described later in this connection, determination is made based on the amount of change in the relative amounts (E1(t)-E2(t)) of the two peaks.

[0123] In processing S605, if the latest electromotive force monitoring data in processing S604 is within the normal range (for example, the change from the last time is less than the predetermined allowable value or less than the allowable ratio) (S605→Yes), enter processing S606; if it is not within the normal range (for example, the change from the last time exceeds the predetermined allowable value or allowable ratio) (S605→No), enter processing S608.

[0124] In step S606 , the amount of change and the change trend of the characteristic amount and the like over time are calculated based on the history and time stamp of the electromotive force monitoring data, and an abnormality is determined based on the calculated amount of change and change trend.

[0125] Here, use Figure 7 The details of the process S606 will be described.

[0126] Figure 7 This is a graph showing the abnormality determination method using the temporal change of the electromotive force waveform calculated by the waveform analysis unit 23 according to the first embodiment.

[0127] Figure 7 (a) shows an example of temporal changes and abnormality determination using electromotive force monitoring data, and is a graph showing the temporal changes of two peaks (E1(t), E2(t)) and the temporal changes of the relative amounts of the two peaks (E1(t)-E2(t)).

[0128] Here, changes can be confirmed in the relative amount of the peak value (E1(t)-E2(t)) at the time Ta and the time Tb.

[0129] The determination threshold value of the change amount is set in advance in the waveform analysis unit 23 , and may be set via the input unit 32 .

[0130] After the time Ta and the time Tb change, the change tendencies Wa and Wb can be confirmed in the relative amounts of the peak values ​​(E1(t)-E2(t)), respectively.

[0131] In this case, the change at time Ta in the change trend Wa is temporary. Thus, if the relative quantity (E1(t) - E2(t)) temporarily changes and then returns to its pre-change value (or within a predetermined range based on the pre-change value) within a predetermined time, it is determined to be measurement interference and not a component replacement abnormality.

[0132] On the other hand, in the change trend Wb, the change at time Tb continues for a predetermined time or longer. Thus, if the value of the relative quantity (E1(t) - E2(t)) does not return to its pre-change value (or to within a predetermined range based on the pre-change value) even after a predetermined time has passed, it is determined that the replacement component has deteriorated, i.e., that the replacement component is abnormal.

[0133] In addition, the criteria for determining these change tendencies may be set in advance in the waveform analysis unit 23 , or may be set via the input unit 32 .

[0134] Figure 7(b) also shows an example of temporal changes and abnormality judgment using electromotive force monitoring data, and is a graph showing the temporal changes of two peak values ​​(E1(t), E2(t)) and the temporal changes of the relative amounts of the two peak values ​​(E1(t)-E2(t)).

[0135] Here, a change can be observed in the peak value E1 ( t ) after time Tc and time Td, and a change can be observed in the relative amount of the peak value ( E1 ( t ) − E2 ( t )) after time Td.

[0136] The determination threshold value of the change amount is set in advance in the waveform analysis unit 23 , and may be set via the input unit 32 .

[0137] After the change at time Tc, change tendencies Wc1 and Wc2 can be respectively confirmed in two peaks (E1(t), E2(t)).

[0138] On the other hand, the relative amount (E1(t)-E2(t)) of the peak value shows no change trend after time Tc. In other words, the relative amount (E1(t)-E2(t)) is constant after time Tc.

[0139] In this example, no trend in the relative amount of the peak (E1(t) - E2(t)) can be confirmed. Therefore, if the relative amount (E1(t) - E2(t)) does not change, it is considered to be a change caused by the environment, such as temperature or flow path conditions, and is not considered a component replacement abnormality.

[0140] On the other hand, after the time Td changes, a change tendency Wd (a decreasing tendency of the electromotive force) can be confirmed in the relative amount of the peak value (E1(t)-E2(t)).

[0141] In this example, the change trend Wd lasts for a certain period of time. Thus, if the relative amount (E1(t)-E2(t)) continues to change for a predetermined period of time, it is determined that the replacement component is deteriorating, that is, it is determined to be abnormal.

[0142] Furthermore, the reference duration for determining whether the change tendency Wd continues may be changed according to the elapsed time from the component replacement included in the time stamp.

[0143] In addition, the criteria for determining these change tendencies may be set in advance in the waveform analysis unit 23 , or may be set via the input unit 32 .

[0144] The above-described criteria for abnormality determination are merely examples and are not limiting.

[0145] Here, return Figure 6 The processing S606 is continued to be described.

[0146] After processing S606 , if the result of the determination in processing S606 is that there is no abnormality ( S607 →Yes), it is determined that there is no abnormality in the electrolyte analysis unit 1 and the processing ends.

[0147] After processing S606, if the result of the determination in processing S606 is abnormal (S607→No), the process proceeds to processing S608.

[0148] Process S608 is executed when at least one of the series of processes described above by the waveform analysis unit 23 is determined to be abnormal, and determines and notifies the abnormal part and degree of the abnormality.

[0149] The content of the abnormal portion determination varies depending on the processing steps of the waveform analysis unit 23 for determining the abnormality.

[0150] If it is determined to be abnormal in process S602 (S602→No), since the determination is made based only on the feature amount at a specific time point, the abnormality level is the first abnormality level greater than other abnormalities, and it can be determined that immediate action is required.

[0151] When it is determined to be abnormal in processing S605 (S605→No), since the judgment is made before and after the replacement of the component, the second abnormality degree is smaller than the first abnormality degree, and the replacement component (corresponding drive timing component) as the abnormal part is determined and output.

[0152] When it is determined to be abnormal in processing S607 (S607→No), similarly, since the determination is made based on the change over time since the component replacement, the second abnormality degree is smaller than the first abnormality degree, and the replacement component as the abnormal part is determined and output.

[0153] Finally, in step S608 , these determination results are notified using the display unit 33 .

[0154] Furthermore, in the process S608 , comparison may be made with the electromotive force monitoring data of each of the ion selective electrodes 101 (chloride ion electrode 101 a , potassium ion electrode 101 b , and sodium ion electrode 101 c ).

[0155] For example, when it is determined that the chloride ion electrode 101a is abnormal but it is determined that the potassium ion electrode 101b and the sodium ion electrode 101c are not abnormal, the chloride ion electrode 101a can be included in the candidates as the abnormal site determination result.

[0156] Furthermore, in the process S608, the results may be compared with the presence or absence of abnormality during the sample measurement.

[0157] For example, when an abnormal value is observed in the measurement result during sample measurement, the abnormality degree is large (for example, the first abnormality degree), and it can be determined that immediate action is required.

[0158] Furthermore, the notification method level can be changed according to the degree of abnormality in the sample measurement results. For example, at a certain abnormality level, the device continues operating while outputting a warning message, while at a higher abnormality level, the device stops operating. As another example, at a certain abnormality level, restarting the device after stopping is unconditionally permitted, but at a higher abnormality level, restarting the device is prohibited until the replacement part determined to be abnormal is replaced.

[0159] All the above processing is completed and returned Figure 2 The processing of the waveform analysis unit 23 ends at S203.

[0160] In this manner, the analyzing device 100 of Embodiment 1 determines the presence or absence of an abnormality. In particular, abnormality determination is performed in association with each of a plurality of drive timings associated with a component to be replaced, thereby appropriately detecting a defect in a replacement component.

[0161] Those skilled in the art will be able to appropriately define the association between drive timing and components to be replaced, depending on the configuration of the analysis device, etc. In particular, by associating components other than the drive unit with the drive timing of any of the components to be replaced, abnormalities can be detected even in components other than the drive unit.

[0162] For example, the transport nozzle 107 is not a driving unit, but the transport nozzle 107 is connected to the driving timing (for example, Figure 4 By establishing correlation with the drive timing "comparison liquid suction", the drive timing "pinch valve drive" and / or the drive timing "transport nozzle drive" of (a), an abnormality of the transport nozzle 107 can be detected.

[0163] In addition, if Figure 7 As shown, the waveform analysis unit 23 determines an abnormality based on the temporal change of the feature quantity stored in the waveform storage unit 22. With such a configuration, an abnormality that cannot be detected in a single measurement can be appropriately detected.

[0164] In addition, if Figure 6 As shown, the waveform analysis unit 23 determines whether there is any abnormality after replacing the component to be replaced. Figure 6 The determination process can be performed before measuring the electrolyte concentration in the sample. In this case, the presence or absence of abnormality is determined before measuring the electrolyte concentration in the sample. This can avoid affecting the sample measurement.

[0165] In addition, the waveform analysis unit 23 generates a waveform based on a plurality of feature quantities (in Figure 7 In the example, the presence or absence of an abnormality is determined using a characteristic quantity E1 related to the drive timing of the pinch valve drive and a characteristic quantity E2 related to the drive timing of the delivery nozzle drive. This configuration can also appropriately detect abnormalities that cannot be detected from a single type of drive.

[0166] As a variation of the above-mentioned first embodiment, it can be configured so that when it is determined that an abnormality exists, the waveform analysis unit 23 determines the cause of the abnormality based on the characteristic quantities related to the waveform obtained in the measurement operation of the electrolyte concentration in the sample and the characteristic quantities related to the waveform obtained in the measurement operation of the electrolyte concentration not in the sample.

[0167] For example, Figure 7 In the example, the characteristic quantity E1 can be set as the characteristic quantity related to the waveform obtained during the measurement operation of the sample, and the characteristic quantity E2 can be set as the characteristic quantity related to the waveform obtained when the measurement operation is not in progress. Figure 6 In the process S608, the cause of the abnormality is identified and outputted. According to such a configuration, even if an abnormality appears only during the measurement of the sample, the abnormality can be appropriately detected.

[0168] Figure 8 An example of a display screen 800 outputted on the display unit 33 according to the first embodiment is shown.

[0169] The display screen 800 includes a setting input screen 801 and a result display screen 802 .

[0170] The setting input screen 801 displays the setting contents of the calculation processing and abnormality determination processing of the waveform acquisition unit 21 and the waveform analysis unit 23 set using the input unit 32 .

[0171] The result display screen 802 displays the electromotive force waveform stored in the waveform storage unit 22 and a graph showing temporal changes in characteristic quantities of the electromotive force waveform.

[0172] Furthermore, the result display screen 802 displays the determination result including the abnormal part and the degree of abnormality determined by the waveform analysis unit 23 .

[0173] With the above-described configuration, in this embodiment, it is possible to reduce the man-hours required for manually checking for defects and degradation of replacement components, including the transport tube 102 of the electrolyte analysis unit 1 .

[0174] Furthermore, replacement parts can be appropriately replaced, and measurement errors in electrolyte analysis can be prevented before they occur.

[0175] Description of Reference Signs

[0176] 1…Electrolyte analysis unit

[0177] 2…Electromotive force waveform processing unit

[0178] 3…Device control unit

[0179] 20…Potential measurement unit

[0180] 21…Waveform acquisition unit

[0181] 22…Waveform storage unit

[0182] 23…Waveform analysis unit

[0183] 30…Control Department

[0184] 31…Drive control unit

[0185] 32…Input

[0186] 33…Display unit

[0187] 100…Analysis device

[0188] 101…Ion Selective Electrode

[0189] 101a…chloride ion electrode

[0190] 101b…Potassium ion electrode

[0191] 101c…Sodium ion electrode

[0192] 102…Transport pipe

[0193] 104…reference electrode

[0194] 105…Pinch valve (drive unit)

[0195] 106…Vacuum suction nozzle ((driving unit)

[0196] 107…Conveying nozzle (driving unit)

[0197] 108…Dilution liquid supply nozzle

[0198] 109…Internal standard liquid supply nozzle

[0199] 110…Dilution tank

[0200] 111…waste liquid tank

[0201] 112…Vacuum pump (drive unit)

[0202] 121-127...Solenoid valve (drive unit)

[0203] 131…Syringe pump for internal standard solution (drive unit)

[0204] 132…Dilution syringe pump (drive unit)

[0205] 133…Transport syringe pump (drive unit)

[0206] 141…Internal standard solution bottle

[0207] 151…Dilution bottle

[0208] 161…Reference electrode solution bottle

[0209] 800…Display screen

[0210] 801…Setting input screen

[0211] 802…Result display screen

[0212] E1…Peak value (characteristic quantity)

[0213] E2…Peak value (characteristic quantity)

[0214] T1...time (feature quantity)

[0215] T2...time (feature quantity).

Claims

1. An analysis device for measuring the electrolyte concentration in a sample, characterized in that: The analysis device comprises: a plurality of ion-selective electrodes that acquire a potential based on electrolyte concentration; a reference electrode, which acquires a potential based on a reference solution; a flow path for supplying a sample or a reference solution to the ion selective electrode and the reference electrode; a plurality of driving units for controlling the flow path, aspirating the sample, discharging the sample, aspirating the reference solution, and discharging the reference solution; a potential measuring section for measuring an electromotive force between the potential obtained by the ion selective electrode and the potential obtained by the reference electrode; a waveform acquisition unit that acquires a waveform representing a change in the electromotive force; a waveform analysis unit that performs analysis using changes in the electromotive force; and a drive control unit that outputs a control signal to the one or more drive units in association with each of a plurality of drive timings associated with the component to be replaced, The waveform acquisition unit associates the acquired waveform with each of the drive timings, detects a peak of the waveform that appears near the drive timing, and calculates a feature value. The feature quantity includes at least one of the electromotive force at the peak and the time between the driving timing and the peak generation time. The waveform analysis unit determines the presence or absence of an abnormality based on the feature amount.

2. The analysis device according to claim 1, characterized in that The analyzing device includes a waveform storage unit that stores the waveform and the feature value. The waveform analysis unit determines abnormality based on the temporal change of the feature value stored in the waveform storage unit.

3. The analysis device according to claim 1, wherein The waveform analysis unit determines the presence or absence of the abnormality after the component to be replaced is replaced and before the electrolyte concentration in the sample is measured.

4. The analysis device according to claim 1, wherein The waveform analysis unit determines the presence or absence of an abnormality based on a plurality of feature quantities associated with different types of drive timings.

5. The analysis device according to claim 1, wherein When it is determined that an abnormality exists, the waveform analysis unit identifies the cause of the abnormality based on feature quantities related to the waveform obtained during the operation of measuring the electrolyte concentration in the sample and feature quantities related to the waveform obtained when the operation is not measuring the electrolyte concentration in the sample.

6. A method for determining the presence or absence of an abnormality in an analysis device for measuring an electrolyte concentration in a sample, characterized in that: The analysis device comprises: a plurality of ion-selective electrodes that acquire a potential based on electrolyte concentration; a reference electrode, which acquires a potential based on a reference solution; a flow path for supplying a sample or a reference solution to the ion selective electrode and the reference electrode; a plurality of driving units for controlling the flow path, aspirating the sample, discharging the sample, aspirating the reference solution, and discharging the reference solution; a potential measuring section for measuring an electromotive force between the potential obtained by the ion selective electrode and the potential obtained by the reference electrode; a waveform acquisition unit that acquires a waveform representing a change in the electromotive force; a waveform analysis unit that performs analysis using changes in the electromotive force; and a drive control unit that outputs a control signal to the one or more drive units in association with each of a plurality of drive timings associated with the component to be replaced, The method comprises the following steps: The waveform acquisition unit associates the acquired waveform with each of the drive timings, detects a peak of the waveform that appears near the drive timing, and calculates a feature value. The feature quantity includes at least one of the electromotive force at the peak and the time between the driving timing and the peak generation time. The method includes the step of the waveform analysis unit determining the presence or absence of an abnormality based on the feature amount.

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