Analysis device and method for determining presence or absence of abnormality

Abstract

In order to provide an analysis device that allows for detection of a defect of a replaceable component and an abnormality with respect to deterioration on the basis of a potential difference produced between an ion-selective electrode and a comparison electrode, and to determine the presence or absence of an abnormality, the present disclosure proposes an analysis device for measuring the electrolyte concentration in a sample. In the analysis device, a waveform acquisition unit associates an acquired waveform with each of drive timings, and detects a peak of the waveform appearing in the vicinity of the drive timing in terms of time to calculate a feature. The feature herein includes at least one of an electromotive force at the peak, and a period between the time of the drive timing and the time of occurrence of the peak. A waveform analysis unit then determines the presence or absence of an abnormality on the basis of the feature (see Fig. 4).

Description

Analyzing device and method for determining whether or not an abnormality exists

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

[0002] Currently, analytical devices are equipped with multiple ion selective electrodes (ISEs) corresponding to the ions to be detected in order to measure the concentrations of ions (electrolytes) such as potassium, sodium, and chloride in biological samples.

[0003] An electrolyte analyzing unit having an ion-selective electrode is used alone or as a component of an automatic biochemical analyzer for automatic, rapid, and continuous clinical testing.

[0004] The ion-selective electrode is used in combination with a reference electrode, and the activity (concentration) of the target ion can be 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 an automatic analyzer, the main method for quantifying the sample is a dilution method in which a predetermined amount of diluent is added to a predetermined amount of sample, the sample is mixed and diluted, and then the sample is measured using an ion-selective electrode.

[0007] The dilution method requires a small amount of sample, and the concentrations of coexisting substances such as proteins and lipids in the measurement solution are low, so the influence of contamination by coexisting substances is small, and the stability of the ion-selective electrode is high.

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

[0009] The internal standard solution and the sample are dispensed into the dilution tank alternately, and the measurement is carried out alternately with the sample.

[0010] Electrolyte concentrations in the body are maintained within a narrow range, and even small changes in concentration 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 reduce measurement errors as much as possible.

[0012] For example, Patent Document 1 describes a method of measuring the potential of an ion selective electrode filled with an internal standard solution and determining whether or not there is an abnormality in the electrolyte analysis section based on the measurement data.

[0013] JP 2016-188872 A

[0014] In the electrolyte analysis unit, measurement errors occur due to improper installation of replacement parts that need to be replaced periodically, and due to deterioration over time after installation.

[0015] Such replacement parts are replaced as frequently as once every few months, which increases the frequency of defects and potentially increases the possibility of causing measurement errors.

[0016] However, in the prior art, no consideration is given to determining whether a replacement part is defective or deteriorated.

[0017] The present disclosure aims to provide an analytical device and a method for determining whether or not an abnormality exists that can detect defects and abnormalities due to deterioration of replacement parts based on the potential difference generated between an ion-selective electrode and a reference electrode.

[0018] an analysis device according to the present disclosure; an analysis device for measuring the concentration of an electrolyte in a sample, the analysis device comprising: a plurality of ion selective electrodes for acquiring a potential based on the concentration of an electrolyte; a comparison electrode for acquiring a potential based on a reference liquid; a flow path for supplying the sample or the reference liquid to the ion selective electrodes and the comparison electrode; a plurality of drive units for controlling the flow path, drawing in the sample, discharging the sample, drawing in the reference liquid, and discharging the reference liquid; a potential measurement unit for measuring an electromotive force between a potential acquired by the ion selective electrodes and a potential acquired by the comparison electrode; a waveform acquisition unit for acquiring a waveform representing a change in the electromotive force; a waveform analysis unit for performing analysis using the change in the electromotive force; and a drive control unit for outputting a control signal to one or more of the drive units in association with each of a plurality of drive timings related to a part to be replaced, the waveform acquisition unit associating the acquired waveforms with each of the drive timings, detecting peaks of the waveforms that appear in the temporal vicinity of the drive timings, and calculating a feature amount, the feature amount including at least one of: the electromotive force at the peak, and the time between the time of the drive timing and the time the peak occurs, The waveform analysis unit determines whether or not there is an abnormality based on the feature amount.

[0019] an example of a method according to the present disclosure is a method for determining the presence or absence of an abnormality in an analytical device for measuring an electrolyte concentration in a sample, the analytical device comprising: a plurality of ion selective electrodes for acquiring a potential based on an electrolyte concentration; a comparison electrode for acquiring a potential based on a reference liquid; a flow path for supplying a sample or a reference liquid to the ion selective electrodes and the comparison electrode; a plurality of drive units for controlling the flow path, drawing in the sample, discharging the sample, drawing in the reference liquid, and discharging the reference liquid; a potential measurement unit for measuring an electromotive force between a potential acquired by the ion selective electrodes and a potential acquired by the comparison electrode; a waveform acquisition unit for acquiring a waveform representing a change in the electromotive force; a waveform analysis unit for performing analysis using the change in the electromotive force; and a drive control unit for outputting a control signal to one or more of the drive units in association with each of a plurality of drive timings related to a part to be replaced, the method comprising the steps of: the waveform acquisition unit associating the acquired waveforms with each of the drive timings, detecting peaks of the waveforms that appear in the temporal vicinity of the drive timings, and calculating a feature amount, the feature amount being the electromotive force at the peak, and - the time between the drive timing and the peak occurrence time, and the method is characterized in that it includes a step in which the waveform analysis unit determines whether or not there is an abnormality based on the feature amount.

[0020] According to one aspect of the present disclosure, the number of steps required to manually check for defects and deterioration of replacement parts of an electrolyte analyzing unit can be reduced.

[0021] According to another aspect of the present disclosure, replacement parts can be appropriately replaced, thereby preventing measurement errors in electrolyte analysis.

[0022] FIG. 1 is a configuration diagram of an analysis device according to the first embodiment. FIG. 2 is a flowchart showing the processing procedures of a waveform acquisition unit and a waveform analysis unit according to the first embodiment. FIG. 3 is a flowchart showing the procedures for acquiring a time history waveform of electromotive force and calculating feature quantities according to the first embodiment. FIG. 4 is a graph showing a method for calculating feature quantities of a time history waveform of electromotive force according to the first embodiment. FIG. 5 is a flowchart showing the procedures for managing the acquisition time of an electromotive force waveform according to the first embodiment. FIG. 6 is a flowchart showing the processing procedures for abnormality determination according to the first embodiment. FIG. 7 is a graph showing an abnormality determination method using changes over time in feature quantities of an electromotive force waveform according to the first embodiment. FIG. 8 is a diagram showing an example of a display screen output to a display unit according to the first embodiment.

[0023] Next, modes for carrying out the present disclosure (referred to as "embodiments") will be described in detail with reference to the drawings as appropriate.

[0024] First Embodiment FIG. 1 is a diagram showing the configuration of an analysis device 100 according to a first embodiment.

[0025] The analytical device 100 includes an electrolyte analysis unit 1, an electromotive force waveform processing section 2, and a device control section 3. The analytical device 100 is a device that measures the electrolyte concentration in a sample, and executes a method for determining the presence or absence of an abnormality in the analytical device 100.

[0026] The electrolyte analysis unit 1 comprises: a plurality of ion selective electrodes 101 (for example, three types: a chloride ion electrode 101a, a potassium ion electrode 101b, and a sodium ion electrode 101c) that generate a potential corresponding to the ion concentration in the sample; a reference electrode 104 that generates a constant reference potential so that the potential of the ion selective electrode 101 can be measured as a potential difference (electromotive force); a sipper tube 102 that forms a flow path between the ion selective electrode 101 and the reference electrode 104 and is an example of a replaceable part that is replaced periodically; a pinch valve 105 that opens and closes the flow path of the sipper tube 102; a dilution tank 110 that stores an internal standard solution and a measurement solution (hereinafter referred to as "specimen"; it may also be called a sample) in which an analyte and a dilution solution are mixed; a vacuum suction nozzle 106 that sucks the waste liquid of the sample from the dilution tank 110 after measurement; and a sipper nozzle 107 that introduces the liquid filled in the dilution tank 110 into the flow path of the ion selective electrode 101. - a diluent supply nozzle 108 for supplying diluent to the dilution tank 110; - an internal standard supply nozzle 109 for supplying an internal standard (IS) to the dilution tank 110; - a waste tank 111 for disposing of the sample and internal standard remaining in the dilution tank 110; - a vacuum pump 112 for sucking the sample and internal standard remaining in the dilution tank 110 and disposing of them in the waste tank 111; - solenoid valves 121 to 127 for opening and closing each flow path; - an internal standard syringe pump 131 for filling the flow path with the internal standard (IS); - a diluent syringe pump 132 for filling the flow path with the diluent; - a sipper syringe pump 133 for introducing the reference electrode solution into the flow path of the reference electrode 104; - an internal standard bottle 141 in which the internal standard (IS) is stored; - a diluent bottle 151 in which the diluent is stored. a reference electrode solution bottle 161 containing a reference electrode solution (reference solution);

[0027] The three types of ion selective electrodes 101 each acquire a potential based on the concentration of the corresponding electrolyte. The comparison electrode 104 acquires a potential based on the reference solution. The analytical device 100 also includes various flow paths, which supply the sample or reference solution to the ion selective electrodes 101 and the comparison electrode 104.

[0028] The electromotive force waveform processing unit 2 comprises: a potential measuring unit 20 that measures the potential difference (electromotive force) between the ion selective electrode 101 and the reference electrode 104; a waveform acquiring unit 21 that constantly acquires the potential change of the electromotive force measured by the potential measuring unit 20 as a time history waveform and calculates feature quantities obtained from the acquired waveform; a waveform storage unit 22 that stores the waveform and feature quantities acquired by the waveform acquiring unit 21; and a waveform analyzing unit 23 that performs an abnormality judgment using the waveform and feature quantities saved in the waveform storage unit 22 and stores parameters used for the abnormality judgment in the waveform storage unit 22.

[0029] The potential measurement unit 20 measures the electromotive force between the potential acquired by one of the ion selective electrodes 101 and the potential acquired by the reference electrode 104. The waveform acquisition unit 21 acquires a waveform representing a change in the electromotive force. The waveform analysis unit 23 performs analysis using the change in the electromotive force and determines the presence or absence of an abnormality based on the feature amount of the waveform. The waveform storage unit 22 stores the waveform and the feature amount.

[0030] The device control unit 3 comprises: a control unit 30 that oversees the overall control of the analysis device 100; a drive control unit 31 that is connected to the control unit 30 and controls signal input and output to operate various drive units mounted on the analysis device 100; an input unit 32 that is connected to the control unit 30 and is a device such as a mouse, keyboard, or touch panel that allows a user of the analysis device 100 to input operation instructions and various parameters; and a display unit 33 that is connected to the control unit 30 and uses a GUI or the like to display the status of the analysis device 100, including the processing results of the waveform analysis unit 23.

[0031] The control unit 30 has a hardware configuration as, for example, a known computer, and includes, for example, a calculation means and a storage means. The calculation means includes, for example, a processor, and the storage means includes, for example, a storage medium such as a semiconductor memory device or a magnetic disk device. Some or all of the storage medium may be non-transitory storage media.

[0032] The storage means may store a program, and the processor executes the program, causing the computer to function as the control unit 30.

[0033] In the electrolyte analysis unit 1, the following components function as drive units, and these drive units control the flow paths, draw in and discharge the sample, draw in and discharge the reference solution, and discharge the reference solution, etc. The drive control unit 31 controls the input and output of signals to operate these drive units.

[0034] 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 part to be replaced. For example, all of the drive units may be parts to be replaced, only some of the drive units may be parts to be replaced, or structures other than the drive units may be included in the parts to be replaced.

[0035] FIG. 2 is a flowchart showing the processing steps of the waveform acquisition unit 21 and the waveform analysis unit 23.

[0036] First, when the analysis device 100 performs electrolyte analysis, the waveform acquisition unit 21 continuously acquires the potential change of the electromotive force measured by the potential measurement unit 20 as a time history waveform (hereinafter referred to as electromotive force waveform), and calculates the feature values ​​obtained from the acquired waveform (S201).

[0037] Here, the details of the processing procedure of step S201 will be described with reference to FIG.

[0038] FIG. 3 is a flowchart showing the procedure for acquiring an electromotive force waveform and calculating a feature amount by the waveform acquiring unit 21 according to the first embodiment.

[0039] First, when the analysis device 100 executes an electrolyte analysis, the waveform acquisition unit 21 starts a process of converting the electromotive force measured by the potential measurement unit 20 into a digital value and continuously acquiring it as a time history waveform (S301).

[0040] Next, after executing process S301 (i.e., while acquiring the waveform), if the waveform acquisition unit 21 detects the operation timing of various drive units mounted on the electrolyte analysis unit 1 (S302 → Yes), it calculates the peak value and the time at which the peak value was reached (hereinafter referred to as the peak time) as characteristic quantities from the electromotive force waveform before and after the time of the operation timing (S303).

[0041] In addition, the detection of the operation timing may be performed 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 that is pre-set in the waveform acquisition unit 21 based on the timing information.

[0042] Here, the method for calculating the feature amount in step S303 will be described in detail with reference to FIG.

[0043] 4 is a graph showing a method for calculating the feature amount of the electromotive force waveform of the waveform acquisition unit 21 according to the first embodiment. The example of FIG. 4 is used when determining whether or not there is an abnormality in the sipper tube 102.

[0044] FIG. 4A shows the drive timing detected by the waveform acquisition unit 21, and FIG. 4B shows an example of peak values ​​and peak times calculated in synchronization with the drive timings.

[0045] In Figure 4(a), examples of drive timings of the drive unit mounted on the flow path of the sipper tube 102, which is a replacement part that is replaced periodically, are explained, including the suction of the reference liquid, pinch valve drive, and sipper nozzle drive.

[0046] The drive timing shown in FIG. 4A is part of the operation sequence when supplying the reference electrode solution to the flow path of the reference electrode 104 .

[0047] The drive timing "suck in comparison liquid" includes the operations of opening the solenoid valves 121 and 122, closing the pinch valve 105, and driving the sipper syringe pump 133.

[0048] The drive timing "pinch valve drive" includes opening of the pinch valve 105, which is 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.

[0049] Similarly, the drive timing “sipper nozzle drive” is part of the operation when introducing the sample in the dilution tank 110 into the flow path of the ion selective electrode 101 , and includes the lowering of the sipper nozzle 107 .

[0050] Based on the waveforms relating to these drive timings, an abnormality in the sipper tube 102 is determined. The association between the drive timings and the replacement parts (for example, when determining an abnormality in the sipper tube 102, which is a replacement part, the comparison liquid suction, pinch valve drive, and sipper nozzle drive are referenced as the drive timing) is stored, for example, in the waveform analysis unit 23.

[0051] In this embodiment, the peak value and the peak time are calculated in synchronization with the driving timing (time t1) of the pinch valve and the driving timing (time t2) of the shipper nozzle.

[0052] 4B shows examples of calculations of 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" means that the value of time T1 is expressed with time t1 as the reference, and as a specific example, the value of the elapsed time from time t1 to time T1 (or the negative value of the elapsed time from time T1 to time t1) is equal to T1.

[0053] The waveform acquisition unit 21 searches for and calculates the peak of the electromotive force waveform within a peak detection time (Tw1), which is a time width based on a predetermined time t1 (for example, a time period including a predetermined time before and after time t1).

[0054] In the example of Figure 4(b), the negative peak at time tp1 is calculated. T1 = tp1 - t1. In calculating the peak, it can be determined in advance whether to search for a positive peak or a negative peak.

[0055] Similarly, the waveform acquisition unit 21 searches for and calculates the peak of the electromotive force waveform within a peak detection time (Tw2), which is a time width based on a predetermined time t2 (for example, a time period including each predetermined time before and after time t2).

[0056] In the example of Fig. 4(b), the negative peak at time tp2 is calculated as T2 = tp2 - t2.

[0057] The waveform acquisition unit 21 finally outputs the feature amounts (E1, E2, T1, T2) calculated up to that point as a peak value data set.

[0058] In this way, the waveform acquisition section 21 associates the acquired waveform with each drive timing, detects the peak of the waveform that appears in the temporal vicinity of the drive timing, and calculates the feature amount.

[0059] In this embodiment, the feature amount includes: - electromotive force at the peak (peak value (E1), peak value (E2) of the electromotive force waveform); and - time (T1, T2) between the drive timing time (t1, t2) and the peak occurrence time (tp1, tp2). In a modified example, the feature amount may include only one of these.

[0060] Here, the explanation will be continued by returning to step S303 in FIG.

[0061] After step S303, the waveform acquisition unit 21 stores the peak value data set in the waveform storage unit 22 (S304), and proceeds to step S305.

[0062] If the operation timing of the various drive units mounted on the electrolyte analyzing unit 1 is not detected in step S302 (S302→No), the process similarly proceeds to step S305.

[0063] Next, the waveform acquisition unit 21 determines whether the analysis operation of the analysis device 100 has been completed, and if it has been completed (S305 → Yes), proceeds to process S306, and if it has not been completed (S305 → No), returns to process S302 and continues the processing operation.

[0064] Finally, the waveform acquisition unit 21 performs statistical processing (e.g., calculation of the mean value, variance, standard deviation, etc. for each of E1 and T1) on peak value data sets that have the same type of drive timing (e.g., E1 and T1 corresponding to "pinch valve drive") among the multiple acquired peak value data sets, and stores the results in the waveform memory unit 22 (S306).

[0065] The waveform acquisition unit 21 may successively store the acquired electromotive force waveform and drive timing in the waveform storage unit 22 .

[0066] Furthermore, the waveform acquisition section 21 may store the electromotive force waveforms and drive timings after performing statistical processing using a plurality of the acquired electromotive force waveforms and drive timings.

[0067] The above-mentioned peak value data set and the electromotive force waveform and / or drive timing are collectively referred to as electromotive force monitoring data.

[0068] In this embodiment, an example has been described in which processing S304 and processing S306 are stored in the waveform memory unit 22, but it is also possible to pass the results of processing S304 and processing S306 to the waveform analysis unit 23 without using the waveform memory unit 22, and determine an abnormality by processing by the waveform analysis unit 23 described below.

[0069] Here, the explanation will be continued by returning to step S201 in FIG.

[0070] After step S201, the waveform acquisition unit 21 manages timestamps, which are long-term timestamps (units of year, month, day, and hour) of the electromotive force waveform and peak value data set stored in the waveform storage unit 22.

[0071] The details of the process S202 will now be described with reference to FIG.

[0072] FIG. 5 is a flowchart showing a procedure for managing the acquisition time of an electromotive force waveform according to the first embodiment.

[0073] First, the waveform acquisition unit 21 determines whether a replacement part (e.g., the sipper tube 102) input via the input unit 32 has been replaced (S501). For example, data on when a user replaces a replacement part is separately recorded, and the waveform acquisition unit 21 determines whether a replacement has been performed by referring to this data. If a replacement has been performed (S501 → Yes), the replacement date and time of the target replacement part is updated and stored in the waveform storage unit 22 (S502). If a replacement has not been performed (S501 → No), the process proceeds to step S503.

[0074] Next, the waveform acquisition unit 21 stores a timestamp, which is a set of information including the time of processing and the elapsed time since the replacement date and time of each replacement part, in association with the electromotive force monitoring data stored in the waveform memory unit 22 (S503).

[0075] Here, the explanation will be continued by returning to step S202 in FIG.

[0076] After the processing S202 of the waveform acquisition unit 21, the waveform analysis unit 23 uses the electromotive force monitoring data stored in the waveform memory unit 22 and the timestamp to determine whether there is an abnormality in the electrolyte analysis unit 1, such as a defective replacement part (S203).

[0077] Here, the details of the process S203 will be described with reference to FIG.

[0078] FIG. 6 is a flowchart showing the procedure for determining abnormality according to the first embodiment.

[0079] First, parameters such as thresholds preset in the waveform analysis unit 23 via the input unit 32 are compared with the peak value data set stored in the waveform storage unit 22 (S601).

[0080] This comparison is performed based on the relative amount (E1(t)-E2(t)) of the two peak values, as will be described later in connection with FIG. 7, for example. If this relative amount is within a predetermined normal range, the comparison result is determined to be within the normal range, and if the relative amount is outside the normal range, the comparison result is determined to be outside the normal range. The normal range can be determined appropriately by those skilled in the art for each type of drive timing, for example.

[0081] In process S602, if the comparison result of process S601 is within the normal range (S602→Yes), the process proceeds to process S603, and if it is not within the normal range (S602→No), the process proceeds to process S608.

[0082] In process S603, it is determined whether a replacement part has been replaced since the process of Fig. 6 was last executed. For example, this determination is made by comparing the replacement date and time in S502 of Fig. 5 with the timestamp in S503 of Fig. 5. If a replacement part has been made (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 replacement) (S604). If a replacement part has not been made (S603 → No), the process proceeds to process S606.

[0083] In step S604, a normal range is determined as a predetermined range based on the previous value of the electromotive force monitoring data, and it is determined whether the amount of change from the previous value is equal to or less than a predetermined allowable value or allowable ratio. As a specific example, as will be described later with reference to FIG. 7, the determination is made based on the amount of change in the relative amount (E1(t)-E2(t)) of the two peak values.

[0084] In process S605, if the latest electromotive force monitoring data in process S604 is within the normal range (for example, if the amount of change from the previous time is less than a predetermined allowable value or less than an allowable ratio) (S605 → Yes), the process proceeds to process S606, and if the latest electromotive force monitoring data is not within the normal range (for example, if the amount of change from the previous time exceeds a predetermined allowable value or allowable ratio) (S605 → No), the process proceeds to process S608.

[0085] In step S606, the amount of change and the trend of change over time of the characteristic amount etc. are calculated from the history of the electromotive force monitoring data and the time stamp, and an abnormality is determined from the calculated amount of change and the trend of change.

[0086] Here, details of the process S606 will be described with reference to FIG.

[0087] FIG. 7 is a graph showing an abnormality determination method using the change over time in the electromotive force waveform calculated by the waveform analysis unit 23 according to the first embodiment.

[0088] FIG. 7(a) shows an example of time-dependent changes and abnormality determination using electromotive force monitoring data, and is a graph showing the time-dependent changes in two peak values ​​(E1(t), E2(t)) and the time-dependent changes in the relative amount of the two peak values ​​(E1(t)-E2(t)).

[0089] Here, a change can be confirmed in the relative amount of the peak value (E1(t)-E2(t)) at time Ta and time Tb.

[0090] The threshold value for determining the amount of change is set in advance in the waveform analysis unit 23 and may be set via the input unit 32 .

[0091] After the changes at time Ta and time Tb, the change trends Wa and Wb can be confirmed in the relative amounts of the peak values ​​(E1(t)-E2(t)), respectively.

[0092] In this case, the change at time Ta in the change trend Wa is temporary. In this way, if the value of the relative quantity (E1(t)-E2(t)) temporarily changes and then returns to the value before the change (or within a predetermined range based on the value before the change) within a predetermined time, it is determined to be a measurement disturbance and is not determined to be an abnormality in the replaced part.

[0093] On the other hand, in the change trend Wb, the change at time Tb continues for a certain period of time or more. In this way, if the value of the relative quantity (E1(t)-E2(t)) changes and does not return to the value before the change (or within a predetermined range based on the value before the change) even after a predetermined time has passed, it is determined that the replacement part has deteriorated, that is, that the replacement part is abnormal.

[0094] The criteria for determining the change trends are set in advance in the waveform analysis unit 23 and may be set via the input unit 32 .

[0095] Similarly, FIG. 7(b) shows an example of time-dependent changes and abnormality determination using electromotive force monitoring data, and is a graph showing the time-dependent changes in two peak values ​​(E1(t), E2(t)) and the time-dependent changes in the relative amount of the two peak values ​​(E1(t)-E2(t)).

[0096] Here, a change can be confirmed in the peak value E1(t) after time Tc and time Td, and in the relative amount of the peak value (E1(t)-E2(t)) after time Td.

[0097] The threshold value for determining the amount of change is set in advance in the waveform analysis unit 23 and may be set via the input unit 32 .

[0098] After the change at time Tc, the change trends Wc1 and Wc2 can be confirmed at two peak values ​​(E1(t), E2(t)).

[0099] On the other hand, the relative amount of the peak values ​​(E1(t) - E2(t)) shows no tendency to change after time Tc, i.e., the relative amount (E1(t) - E2(t)) remains constant even after time Tc.

[0100] In this example, no change trend can be confirmed in the relative amount of the peak values ​​(E1(t) - E2(t)). In this way, when the relative amount (E1(t) - E2(t)) does not change, it is assumed that the change is due to environmental factors such as temperature or flow path conditions, and it is not determined that there is an abnormality in the replaced part.

[0101] On the other hand, after the change at time Td, a change trend Wd (a decreasing trend of the electromotive force) can be confirmed in the relative amount of the peak value (E1(t)-E2(t)).

[0102] In this example, the change trend Wd continues for a certain period of time or more. In this way, if the relative amount (E1(t) - E2(t)) continues to fluctuate for a certain period of time or more, it is determined that the replacement part has deteriorated, that is, the replacement part is determined to be abnormal.

[0103] Furthermore, the reference duration for determining whether the change trend Wd continues may be changed depending on the time elapsed since the part replacement included in the time stamp.

[0104] The criteria for determining the change trends are set in advance in the waveform analysis unit 23 and may be set via the input unit 32 .

[0105] Furthermore, the criteria for determining abnormality described above are merely examples and are not limited to these.

[0106] Here, the explanation will be continued by returning to step S606 in FIG.

[0107] After step S606, if the determination result of step S606 is not abnormal (S607→Yes), the electrolyte analyzing unit 1 determines that there is no abnormality, and the process ends.

[0108] After step S606, if the determination result of step S606 indicates an abnormality (S607→No), the process proceeds to step S608.

[0109] The process S608 is executed when an abnormality is determined in at least one of the above-described series of processes by the waveform analysis unit 23, and determines and notifies the abnormal location and degree of abnormality.

[0110] The determination of the abnormal portion differs depending on the processing step determined as abnormal by the waveform analysis unit 23 .

[0111] If an abnormality is determined in process S602 (S602 → No), the determination is made based only on the characteristic values ​​at a specific time point, so it can be determined that the degree of abnormality is the first abnormality level, which is greater than other abnormalities, and that immediate action is required.

[0112] If an abnormality is determined in process S605 (S605 → No), since the determination was made before and after the part was replaced, the degree of abnormality is the second abnormality degree, which is smaller than the first abnormality degree, and the replaced part (the part related to the relevant drive timing), which is the abnormal part, is identified and output.

[0113] Similarly, if an abnormality is determined in process S607 (S607→No), the determination is based on changes over time since the part was replaced, so the degree of abnormality is the second abnormality degree, which is smaller than the first abnormality degree, and the replaced part, which is the abnormal part, is identified and output.

[0114] Finally, in step S608, the display unit 33 is used to notify the user of these determination results.

[0115] In step S608, a comparison may also be made with the electromotive force monitoring data of each of the ion selective electrodes 101 (chloride ion electrode 101a, potassium ion electrode 101b, and sodium ion electrode 101c).

[0116] For example, if it is determined that there is an abnormality in the chloride ion electrode 101a, but it is determined that there is no abnormality in the potassium ion electrode 101b and the sodium ion electrode 101c, the chloride ion electrode 101a may be included as a candidate for the abnormality location.

[0117] In step S608, a comparison may be made to see whether there is an abnormality during sample measurement.

[0118] For example, if an abnormal value is found in the measurement result when measuring a sample, it can be determined that the degree of abnormality is large (for example, the first degree of abnormality) and that immediate action is required.

[0119] The level of notification can also be changed according to the degree of abnormality in the sample measurement results. For example, at a certain degree of abnormality, a warning message is output and the device continues to operate, but at a higher degree of abnormality, the device stops operating. As another example, at a certain degree of abnormality, the device is allowed to restart unconditionally after it has stopped, but at a higher degree of abnormality, the device is prohibited from restarting until the replacement part determined to be abnormal is replaced.

[0120] All the processes are now completed, and the process returns to step S203 in FIG. 2, where the process of the waveform analysis unit 23 ends.

[0121] In this way, the analyzer 100 according to the first embodiment determines whether or not there is an abnormality. In particular, since the abnormality determination is performed in relation to each of a plurality of drive timings related to the part to be replaced, it is possible to appropriately detect defects in the replacement part.

[0122] The association between the drive timing and the part to be replaced can be defined as appropriate by a person skilled in the art depending on the configuration of the analyzer, etc. In particular, by associating a structure other than the drive unit as a part to be replaced with any of the drive timings, it is possible to detect abnormalities in parts other than the drive unit.

[0123] For example, although the shipper nozzle 107 is not a driving unit, by associating the shipper nozzle 107 with driving timings that may be affected by an abnormality in the shipper nozzle 107 (for example, the driving timing "suction of comparison liquid," the driving timing "pinch valve driving," and / or the driving timing "shipper nozzle driving" in Figure 4(a)), it is possible to detect an abnormality in the shipper nozzle 107.

[0124] 7, the waveform analysis unit 23 determines abnormalities based on changes over time in the feature values ​​stored in the waveform storage unit 22. With this configuration, abnormalities that cannot be detected by a single measurement can be properly detected.

[0125] 6, the waveform analyzer 23 determines whether or not an abnormality exists after the replacement part has been replaced. The determination process of FIG. 6 can be performed before measuring the electrolyte concentration in the sample. In this case, the presence or absence of an abnormality is determined before measuring the electrolyte concentration in the sample. This prevents the sample measurement from being affected.

[0126] Furthermore, the waveform analyzer 23 determines whether or not there is an abnormality based on a plurality of feature quantities respectively associated with different types of drive timing (in the example of FIG. 7, feature quantity E1 associated with the drive timing "pinch valve drive" and feature quantity E2 associated with the drive timing "sipper nozzle drive"). With this configuration, it is possible to appropriately detect abnormalities that cannot be detected from a single type of drive.

[0127] As a modification of the first embodiment, when it is determined that an abnormality exists, the waveform analysis unit 23 may be configured to identify the cause of the abnormality based on: - feature quantities relating to a waveform acquired during the operation of measuring the electrolyte concentration in the sample; and - feature quantities relating to a waveform acquired when the operation of measuring the electrolyte concentration in the sample is not in progress.

[0128] 7, for example, feature E1 can be a feature related to a waveform acquired during sample measurement, and feature E2 can be a feature related to a waveform acquired when sample measurement is not being performed. The cause of the abnormality is identified and output in process S608 in FIG. 6. With this configuration, even an abnormality that becomes apparent only during sample measurement can be properly detected.

[0129] FIG. 8 is a diagram showing an example of a display screen 800 output to the display unit 33 according to the first embodiment.

[0130] The display screen 800 includes a setting input screen 801 and a result display screen 802 .

[0131] The setting input screen 801 displays the setting contents of the calculation processing of the waveform acquisition unit 21 and the waveform analysis unit 23 and the abnormality determination processing that are set using the input unit 32 .

[0132] The result display screen 802 displays the electromotive force waveform stored in the waveform storage unit 22 and a graph showing the change over time in the characteristic amount of the electromotive force waveform.

[0133] Furthermore, the result display screen 802 displays the determination results including the abnormal location and the degree of abnormality determined by the waveform analysis unit 23 .

[0134] With the above configuration, in this embodiment, the number of steps required to manually check for defects and deterioration of replacement parts, including the sipper tube 102 of the electrolyte analyzing unit 1, can be reduced.

[0135] Furthermore, it becomes possible to appropriately replace replacement parts, and measurement errors in electrolyte analysis can be prevented in advance.

[0136] 1...Electrolyte analysis unit 2...Electromotive force waveform processing unit 3...Device control unit 20...Potential measurement unit 21...Waveform acquisition unit 22...Waveform storage unit 23...Waveform analysis unit 30...Control unit 31...Drive control unit 32...Input unit 33...Display unit 100...Analytical device 101...Ion selective electrode 101a...Chloride ion electrode 101b...Potassium ion electrode 101c...Sodium ion electrode 102...Sipper tube 104...Reference electrode 105...Pinch valve (drive unit) 106...Vacuum suction nozzle (drive unit) 107...Sipper nozzle (drive unit) 108...Dilution solution supply nozzle 109...Internal standard solution supply nozzle 110...Dilution tank 111...Waste tank 112...Vacuum pump (drive unit) 121 to 127...Solenoid valves (drive unit) 131...Internal standard solution syringe pump (drive unit) 132...Dilution solution syringe pump (drive unit) 133...Sipper syringe pump (drive unit) 141...Internal standard solution bottle 151...Dilution solution bottle 161...Reference electrode solution bottle 800...Display screen 801...Setting input screen 802...Result display screen E1...Peak value (feature amount) E2...Peak value (feature amount) T1...Time (feature amount) T2...Time (feature amount)

Claims

1. An analytical device for measuring an electrolyte concentration in a sample, comprising: a plurality of ion selective electrodes for acquiring a potential based on an electrolyte concentration; a comparison electrode for acquiring a potential based on a reference liquid; a flow path for supplying a sample or a reference liquid to the ion selective electrodes and the comparison electrode; a plurality of drive units for controlling the flow path, drawing in the sample, discharging the sample, drawing in the reference liquid, and discharging the reference liquid; a potential measurement unit for measuring an electromotive force between a potential acquired by the ion selective electrodes and a potential acquired by the comparison electrode; a waveform acquisition unit for acquiring a waveform representing a change in the electromotive force; a waveform analysis unit for performing analysis using the change in the electromotive force; and a drive control unit for outputting a control signal to one or more of the drive units in association with each of a plurality of drive timings related to a part to be replaced, wherein the waveform acquisition unit associates the acquired waveform with each of the drive timings, detects peaks of the waveform appearing in the temporal vicinity of the drive timings, and calculates a feature amount, the feature amount including at least one of: - the electromotive force at the peak, and - the time between the time of the drive timing and the occurrence time of the peak, The waveform analysis unit determines the presence or absence of an abnormality based on the feature amount.

2. An analytical device according to claim 1, further comprising a waveform memory unit that stores the waveform and the characteristic quantities, and the waveform analysis unit determines whether an abnormality exists based on changes over time in the characteristic quantities stored in the waveform memory unit.

3. An analytical device according to claim 1, wherein the waveform analysis unit determines the presence or absence of the abnormality after the part to be replaced has been replaced and before measuring the electrolyte concentration in the sample.

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

5. An analytical apparatus as claimed in claim 1, characterized in that when it is determined that an abnormality exists, the waveform analysis unit identifies the cause of the abnormality based on: - feature quantities relating to a waveform acquired during the operation of measuring the electrolyte concentration in a sample; and - feature quantities relating to a waveform acquired when the operation of measuring the electrolyte concentration in a sample is not in progress.

6. A method for determining the presence or absence of an abnormality in an analytical device that measures an electrolyte concentration in a sample, the analytical device comprising: a plurality of ion selective electrodes that acquire a potential based on an electrolyte concentration; a comparison electrode that acquires a potential based on a reference liquid; a flow path that supplies a sample or a reference liquid to the ion selective electrodes and the comparison electrode; a plurality of drive units that control the flow path, draw in the sample, discharge the sample, draw in the reference liquid, and discharge the reference liquid; a potential measurement unit that measures an electromotive force between a potential acquired by the ion selective electrodes and a potential acquired by the comparison electrode; a waveform acquisition unit that acquires a waveform representing a change in the electromotive force; a waveform analysis unit that performs analysis using the change in the electromotive force; 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 related to a part to be replaced, the method comprising a step in which the waveform acquisition unit associates the acquired waveforms with each of the drive timings, detects peaks of the waveforms that appear in the temporal vicinity of the drive timings, and calculates a feature amount, the feature amount being selected from the group consisting of: the electromotive force at the peak, and the time between the time of the drive timing and the time of occurrence of the peak. and the method includes a step of the waveform analysis unit determining the presence or absence of an abnormality based on the feature amount.

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