JP2013242244A - Automatic analyzer - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide an automatic analyzer equipped with a function of properly determining the replacement time of components.SOLUTION: An automatic analyzer includes: an analyzing unit which performs the measurement of a biological sample by sequentially executing a plurality of treatment procedures; and a control unit having a communication path with the analyzing unit. The control unit records alarms generated in the analyzing unit as histories (S301, S302), and determines whether or not the trend of alarm generation histories satisfies predetermined component replacement conditions (such as generation interval, frequency and the number of alarms) (S303), thereby determining the replacement time of components.

Description

  The present invention relates to an automatic analyzer, and for example, relates to an automatic analyzer that performs qualitative and quantitative analysis of multiple types of biological samples such as blood, urine, and cerebrospinal fluid.

  For example, Patent Document 1 discloses a method for monitoring measurement data that changes with time as the number of uses increases, and predicting the replacement time of parts on the assumption that the measurement data conforms to a predetermined life function.

Japanese Patent Laid-Open No. 5-322870

  For example, in an automatic analyzer that measures a plurality of types of biological samples such as blood (serum and plasma), urine, cerebrospinal fluid, etc., maintenance inspection is usually performed regularly. If a part has failed in the maintenance inspection, the part is ordered and then repaired after it arrives. However, in this case, a situation may occur in which the automatic analyzer becomes difficult to use during the period from when the parts are ordered until the repair is completed, and the operating rate of the apparatus may be reduced. Therefore, it is important to replace parts at an appropriate timing before the parts break down.

  As a method for determining the replacement period of parts, for example, a fixed life operating amount (for example, an upper limit value of cumulative energization time) is determined for each part, and the operation amount of each component (for example, cumulative energization time) has reached the life operating amount. A method of exchanging at the time is conceivable. However, since the usage environment of the automatic analyzer varies depending on the customer, each component may be far from an actual failure even when it reaches its operating life. That is, each part does not necessarily operate even if it is energized, and the frequency of operation may differ for each part depending on the customer's usage environment.

  Therefore, as another method for determining the replacement time of parts, as shown in Patent Document 1, a method of sequentially acquiring measurement data associated with the number of times of use and predicting the replacement time based on the regularity is considered. It is done. However, for parts whose measurement data varies depending on the number of times of use, regularity is not found even when the measurement data is monitored, and it may be difficult to determine the replacement time. In addition, depending on the type of component, it may be difficult to obtain measurement data itself.

  The present invention has been made in view of the above, and one of its purposes is to provide an automatic analyzer capable of appropriately determining the replacement time of parts and realizing improved maintainability. . The above and other objects and novel features of the present invention will be apparent from the description of this specification and the accompanying drawings.

  Of the inventions disclosed in the present application, the outline of a typical embodiment will be briefly described as follows.

  The automatic analyzer according to the present embodiment includes an analysis unit that measures a biological sample by sequentially executing a plurality of processing procedures, and a control unit that has a communication path between the analysis units. The alarm generated in the analysis unit is recorded as a history, and the replacement time of each part constituting the analysis unit is determined based on the tendency of the alarm generation history.

  According to the one embodiment, in the automatic analyzer, it is possible to appropriately determine the part replacement time and improve the maintainability.

1 is a schematic diagram showing an example of the overall configuration of an automatic analyzer according to an embodiment of the present invention. It is the schematic which shows the structural example of the control unit in FIG. It is a flowchart which shows an example of the processing content in the condition determination part of FIG. It is a figure which shows an example of the function of the alarm generation log | history management part in FIG. It is a figure which shows an example of the function of the components replacement condition setting part in FIG. It is a figure which shows an example of the function of the replacement parts management part in FIG.

  In the following embodiment, when it is necessary for the sake of convenience, the description will be divided into a plurality of sections or embodiments. However, unless otherwise specified, they are not irrelevant, and one is the other. Some or all of the modifications, details, supplementary explanations, and the like are related. Further, in the following embodiments, when referring to the number of elements (including the number, numerical value, quantity, range, etc.), especially when clearly indicated and when clearly limited to a specific number in principle, etc. Except, it is not limited to the specific number, and may be more or less than the specific number.

  Further, in the following embodiments, the constituent elements (including element steps and the like) are not necessarily indispensable unless otherwise specified and apparently essential in principle. Needless to say. Similarly, in the following embodiments, when referring to the shapes, positional relationships, etc. of the components, etc., the shapes are substantially the same unless otherwise specified, or otherwise apparent in principle. And the like are included. The same applies to the above numerical values and ranges.

  Hereinafter, embodiments of the present invention will be described in detail with reference to the drawings. Note that components having the same function are denoted by the same reference symbols throughout the drawings for describing the embodiment, and the repetitive description thereof will be omitted.

<< Overall configuration and operation of automatic analyzer >>
FIG. 1 is a schematic diagram showing an example of the overall configuration of an automatic analyzer according to an embodiment of the present invention. The automatic analyzer shown in FIG. 1 includes an analysis unit 100 and a control unit (computer system) 112 having a communication path between the analysis unit 100. The control unit 112 can be connected to the server 116 and the like via the network 115. The control unit 112 requests the analysis unit 100 to analyze the sample, and the analysis unit 100 executes a series of analysis processing procedures as described below in response to this, and the analysis result obtained as a result is sent to the control unit. 112 is notified.

  In the analysis unit 100, a sample (biological sample) such as blood, urine, or cerebrospinal fluid is mounted in the rack 103, and the rack 103 is installed in the sample supply unit 101. The rack 103 installed in the sample supply unit 101 is transferred to the dispensing line 106 in the analysis module 105 through the sample transport line 102 in response to a sample analysis request. On the other hand, the reaction container 113 is moved to the sample dispensing position by the rotation operation of the reaction disk 108. Then, the sample on the rack 103 transferred to the dispensing line 106 enters the reaction container 113 via the sample probe 107 in accordance with the analysis parameters, analysis request items, etc. stored in the memory in the control unit 112. A predetermined amount is dispensed.

  Next, the reaction container 113 into which the sample is dispensed moves to the reagent mixing position by the rotation operation of the reaction disk 108. Although not shown, a reagent bottle filled with a reagent for mixing and reacting with a specimen is mounted on the reagent disk 110. The reagent bottle is moved to the reagent dispensing position by the rotation operation of the reagent disk 110, and the reagent probe 109 transfers the reagent in the reagent bottle to the reaction disk according to the analysis parameters stored in the memory in the control unit 112. A predetermined amount is dispensed into the reaction vessel 113 on 108. The probes (107, 109) are components including a dispensing mechanism that can suck and discharge a target liquid by a pressure generating mechanism such as a syringe.

  The reaction disk 108 is maintained at a predetermined temperature by, for example, a heat retaining tank or the like in order to promote the reaction. Thereafter, the specimen and the reagent in the reaction vessel 113 are stirred and mixed by the stirring mechanism 111. When the reaction vessel 113 in which this mixing is performed crosses the photometry position by the rotation operation of the reaction disk 108, the absorbance is measured by the multiwavelength photometer 114 or the like. The photometric absorbance is converted into concentration data. The analysis result obtained thereby is transmitted to the control unit 112. The rack 103 on the dispensing line 106 is stored in the sample storage unit 104 through the sample transport line 102. In this manner, the user can perform various parameter settings necessary for measurement, sample registration, confirmation of analysis results, and the like using the control unit (computer system) 112.

<Details of control unit>
FIG. 2 is a schematic diagram illustrating a configuration example of the control unit in FIG. A control unit (computer system) 112 shown in FIG. 2 includes an alarm generation history management unit 201a including an alarm generation history storage unit 201b, a component replacement condition setting unit 202a including a component replacement condition storage unit 202b, and a replacement component storage unit 203b. Including a replacement part management unit 203a and a condition determination unit 204. Each storage unit (201b to 203b) is realized mainly by a storage device such as a hard disk. Each of the alarm occurrence history management unit 201a, the component replacement condition setting unit 202a, and the replacement component management unit 203a appropriately converts the data in the corresponding storage unit by program processing using a processor, a memory, and the like, such as a database system. It is realized by managing. The condition determination unit 204 is realized by program processing using a processor, a memory, and the like.

  When an alarm occurs while the analysis unit 100 of FIG. 1 is operating, the alarm occurrence history management unit 201a acquires the date and time of alarm occurrence and the alarm number, and stores them in the alarm occurrence history storage unit 201b. The part replacement condition setting unit 202a sets a replacement condition for determining a part replacement time for each alarm number, and stores it in the part replacement condition storage unit 202b. Here, [1] alarm occurrence interval, [2] alarm occurrence frequency, and [3] accumulated alarm occurrence frequency are set as replacement conditions. The replacement part management unit 203a sets a corresponding replacement part for each alarm number and stores it in the replacement part storage unit 203b.

<< Details of condition judgment part >>
FIG. 3 is a flowchart showing an example of processing contents in the condition determination unit of FIG. In FIG. 3, when an alarm is generated during the operation of the analysis unit 100 in FIG. 1 (S301), the condition determination unit 204 refers to the stored information in the alarm occurrence history storage unit 201b in FIG. 2 updated accordingly. (S302). Here, the alarm is a function for notifying that when an abnormality occurs during operation of the automatic analyzer (analysis unit 100), and is a function that the automatic analyzer generally has. More specifically, for example, an alarm is an identifier (in which an abnormality (failure) has occurred when an abnormality (failure) occurs in a series of analysis processing procedures as described in FIG. There are cases where there are several hundred types or more of the following as an example.

  In FIG. 1, for example, a rack 103 is transported through a sample transport line 102 and stored in a sample storage unit 104 using a rack storage mechanism. At this time, if the rack 103 cannot be properly stored in the sample storage unit 104, an alarm having an alarm number corresponding to the procedure is generated. In this case, the rack storage mechanism is estimated as the cause of the alarm. Further, for example, the reaction disk 108 moves the reaction container 113 to a predetermined position by a rotation operation, and the sample probe 107 sucks the sample (biological sample) from the rack 103 and makes it react at the predetermined position. Inject into container 113. At this time, if the reaction vessel 113 cannot move to a predetermined position, an alarm having an alarm number corresponding to the procedure is generated. In this case, the reaction disk 108 is estimated as the cause of the alarm. Alternatively, when the suction operation or the injection operation is not properly performed, an alarm having an alarm number corresponding to the procedure is generated. In this case, the sample probe 107 is estimated as the cause of the alarm. When an alarm is generated, unless the failure is a serious failure, the processing is usually continued after the failure is resolved by manual operation or the like.

  Subsequently, in FIG. 2, the condition determination unit 204 determines whether or not the storage information in the alarm occurrence history storage unit 201b referred to in S302 satisfies the replacement condition stored in the component replacement condition storage unit 202b (S303). ). Here, for example, if at least one of the three types of replacement conditions described above ([1] alarm occurrence interval, [2] alarm occurrence frequency, [3] cumulative number of alarm occurrences) is satisfied, parts are replaced. Judge that it is time. Although details will be described later, one or a combination of these three types of replacement conditions is selected as an actual replacement condition for each alarm number by using the component replacement condition setting unit 202a. It is also possible.

  [1] With regard to the alarm generation interval, the interval between the last alarm occurrence and the previous alarm occurrence is equal to or less than the determination value stored in the component replacement condition storage unit 202b. In this case, the condition is satisfied. [2] The alarm occurrence frequency is satisfied when a predetermined number of alarms are generated within a predetermined period before the last alarm occurrence. A predetermined period and a predetermined number of times as determination values at this time are stored in the component replacement condition storage unit 202b. [3] Regarding the cumulative number of occurrences of the alarm, the condition is satisfied when the cumulative number of occurrences of the alarm at the time of the last occurrence of the alarm is equal to or greater than the determination value stored in the component replacement condition storage unit 202b.

  Next, the condition determination unit 204 notifies the user of the replacement part corresponding to the alarm number in order to notify the user that it is determined that it is time to replace the part (S304). Specifically, it is displayed on the screen or the like which parts need to be replaced via the replacement part management unit 203a together with the fact that the parts need to be replaced. Then, when the part replacement is performed by the user (S305), the condition determination unit 204 resets the stored information in the alarm occurrence history storage unit 201b corresponding to the alarm number toward the alarm occurrence history management unit 201a. (S306).

  By using the method as described above, it is possible to appropriately determine the replacement time of parts, and it is possible to improve the maintainability of the automatic analyzer. That is, it is possible to cover almost all parts in the automatic analyzer without using measurement data as in Patent Document 1, and use an alarm that tends to occur frequently with signs of a failure. Monitor changes in component status based on the number of times. As a result, it is possible to grasp the signs of failure, and it is possible to replace parts at an appropriate timing before the failure occurs, so that maintainability is improved and an automatic analyzer due to a component failure This can prevent a decrease in operating rate.

《Details of alarm occurrence history management unit》
FIG. 4 is a diagram illustrating an example of a function of the alarm occurrence history management unit in FIG. The stored information in the alarm occurrence history storage unit 201b is used for determining the replacement time of the parts as described in FIG. 3, and the alarm occurrence history display screen as shown in FIG. 4, for example, via the alarm occurrence history management unit 201a. 401 can be displayed. The screen is displayed in accordance with, for example, a user instruction, and can be used during maintenance / inspection (maintenance) of the automatic analyzer. On the alarm occurrence history display screen 401, an alarm occurrence list 402 indicating the date and time when the alarm occurred and the alarm number is displayed. Although illustration is omitted, in the alarm occurrence list 402, for example, by specifying an alarm number, it is possible to perform filtering to display an occurrence date and time specialized for the alarm number.

  An alarm occurrence history graph 403 is further displayed on the alarm occurrence history display screen 401. In the alarm occurrence history graph 403, by selecting an alarm number, the relationship between the date and time of occurrence and the cumulative number of occurrences is displayed as a time-series graph. In the graph, it is possible to check the alarm occurrence time by selecting the ▲ plot. By referring to such an alarm occurrence history graph 403, it is possible to visually confirm the alarm occurrence frequency and the total number of occurrences. Therefore, for example, such a graph can be used when it is desired to further optimize the replacement conditions set by the user using the component replacement condition setting unit 202a.

<Details of parts replacement condition setting section>
FIG. 5 is a diagram illustrating an example of a function of the component replacement condition setting unit in FIG. The information stored in the component replacement condition storage unit 202b is used for determining the replacement time of the component as described in FIG. 3, and also includes a replacement time determination method as shown in FIG. 5 via the component replacement condition setting unit 202a. It can be displayed on the selection screen 501 and can be edited in addition. In the replacement time determination method selection screen 501, it is possible to manually change the replacement conditions for parts. In this case, the user first inputs the alarm number to be changed to the alarm number selection field 502. Then, the replacement condition selection field 504 is used to select which of the three types of replacement conditions described in FIGS. 2 and 3 is used as the replacement condition for the part corresponding to the alarm number, and a determination value corresponding to that is selected. Input to corresponding fields (alarm interval setting field 505, alarm frequency setting field 506, alarm cumulative number setting field 507).

  Here, in the replacement condition selection field 504, various ones such as only one of the three types of replacement conditions, two (3) AND conditions, or two (3) OR conditions, etc. It is possible to define various combinations. The user then presses the enter button 508 after making such an input. As a result, the storage information in the component replacement condition storage unit 202b is updated, and is subsequently reflected in the processing flow as shown in FIG.

  Furthermore, here, it is also possible to automatically change the conditions for the replacement time of the parts on the selection screen 501 for the replacement time determination method. At this time, the user inputs the alarm number to be changed to the alarm number selection field 502 and presses the automatic acquisition button 503. As a result, the contents of the replacement condition selection field 504 and the contents of the determination value setting fields (505 to 507) corresponding thereto are automatically distributed from the server 116 of FIG. The storage information of the unit 202b is updated, and is subsequently reflected in the processing flow as shown in FIG. In this case, the server 116 of FIG. 1 stores in advance exchange conditions determined by, for example, the manufacturer of the automatic analyzer. By using this automatic setting function, the user can easily store, for example, standard conditions in the component replacement condition storage unit 202b.

<Details of Replacement Parts Management Department>
FIG. 6 is a diagram illustrating an example of the function of the replacement part management unit in FIG. The storage information of the replacement part storage unit 203b is used when notifying the parts to be replaced as described in FIG. 3, and is displayed on the replacement part screen 601 as shown in FIG. 6, for example, via the replacement part management unit 203a. In addition, it can be edited. As described with reference to FIG. 3 and the like, when the stored information in the alarm occurrence history storage unit 201b satisfies the condition in the component replacement condition storage unit 202b, the replacement part management unit 203a receives the instruction from the condition determination unit 204. A replacement part screen 601 as shown in FIG. On the replacement part screen 601, the alarm number and the corresponding part are displayed as a replacement part list 602. In this example, the replacement flag is set to the alarm number that satisfies the conditions of the part replacement condition storage unit 202b. 607 is attached.

  When such a replacement part screen 601 is displayed, the user appropriately replaces the parts shown in the replacement part list 602. When exchanging parts, the user selects the corresponding alarm number in the replacement parts list 602 and presses the exchange execution button 603. As a result, the replacement flag 607 disappears and, as described in FIG. 3, the alarm occurrence history management unit 201a is notified that the parts have been replaced, and the stored information in the alarm occurrence history storage unit 201b corresponding to the alarm number is stored. Is reset.

  In addition, the user can display the replacement part screen 601 via the replacement part management unit 203a when necessary, and can correct the relationship between the alarm number and the part on the screen. In this case, the user first presses the change button 604 on the replacement part screen 601. Then, the part to be changed is displayed in the replacement part list 602 while appropriately using the scroll button 608 or the like, and the changed part name is input in the “replacement part” field. Thereafter, when the user presses the change determination button 605, the storage information of the replacement part storage unit 203b is updated, and is subsequently reflected in the processing flow as shown in FIG.

  Even when the replacement part screen 601 is displayed via the processing flow of FIG. 3 (that is, when part replacement is required), part replacement may not be performed immediately. In that case, the user can close the replacement part screen 601 by pressing a “execute replacement later” button 606 on the replacement part screen 601. However, when a part needs to be replaced (that is, when the replacement flag 607 remains), the replacement part management unit 203a (or the condition determination unit 204), for example, starts up the automatic analyzer or at regular intervals. Or the like to display the replacement part screen 601 and request the user to replace the part. Further, the user can display the replacement part screen 601 at any time while the automatic analyzer is running.

  As mentioned above, the invention made by the present inventor has been specifically described based on the embodiments. However, the present invention is not limited to the above-described embodiments, and various modifications can be made without departing from the scope of the invention.

  For example, it is possible to provide an automatic setting function as shown in FIG. 5 on the replacement part screen 601 in FIG.

  DESCRIPTION OF SYMBOLS 100 ... Analysis unit 101 ... Sample supply part 102 ... Sample conveyance line 103 ... Rack, 104 ... Sample storage part, 105 ... Analysis module, 106 ... Dispensing line, 107 ... Sample probe, 108 ... Reaction disk, 109 ... Reagent probe, 110 ... reagent disk, 111 ... stirring mechanism, 112 ... control unit, 113 ... reaction vessel, 114 ... multi-wavelength photometer, 115 ... network, 116 ... server, 201a ... alarm generation history management unit, 201b ... alarm generation History storage unit 202a ... part replacement condition setting unit 202b ... part replacement condition storage unit 203a ... replacement part management unit 203b ... replacement part storage unit 204 ... condition determination unit 401 ... alarm occurrence history display screen 402 ... Alarm occurrence list, 403 ... Alarm occurrence history graph, 501 ... Replacement time decision Method selection screen, 502 ... Alarm number selection field, 503 ... Automatic acquisition button, 504 ... Replacement condition selection field, 505 ... Alarm interval setting field, 506 ... Alarm frequency setting field, 507 ... Alarm cumulative number setting field, 508 ... Decision Button, 601 ... Replacement part screen, 602 ... Replacement part list, 603 ... Replacement execution button, 604 ... Change button, 605 ... Change determination button, 606 ... Later replacement button, 607 ... Replacement flag, 608 ... Scroll button.

Claims (10)

An analysis unit configured by a plurality of parts and measuring a biological sample by sequentially executing a plurality of processing procedures;
A control unit having a communication path with the analysis unit;
The analysis unit generates an alarm including an identifier that identifies the processing procedure in which the abnormality has occurred when an abnormality occurs in the execution process of the plurality of processing procedures.
The control unit is
A history management unit for storing the occurrence history of the alarm in time series;
For each identifier, as a determination condition, a condition setting unit that sets a determination value corresponding to the determination item and at least one determination item of the occurrence interval of the alarm, the occurrence frequency, and the cumulative number of occurrences;
In any one of the identifiers, when the alarm occurrence history in the history management unit satisfies the determination condition in the condition setting unit, the part in the analysis unit corresponding to the identifier is set as a replacement part candidate. An automatic analyzer having a condition determining unit to be defined. The automatic analyzer according to claim 1, wherein
The history management unit resets the alarm occurrence history corresponding to the replacement part candidate when notified that the part replacement based on the replacement part candidate determined by the condition determination unit has been performed. Automatic analyzer with functions. The automatic analyzer according to claim 2,
The condition setting unit has a function of causing the user to select either manual setting or automatic setting when setting the determination condition. When the user selects automatic setting, an external server is connected via the network. An automatic analyzer that obtains the determination item and the determination value from and sets the determination condition. The automatic analyzer according to claim 3,
When the user selects manual setting, the condition setting unit, on the screen, causes the determination item to select any one of the alarm occurrence interval, the occurrence frequency, the cumulative occurrence number, or a combination thereof, An automatic analyzer that inputs the determination value corresponding to the selected determination item. The automatic analyzer according to claim 2,
The history management unit is an automatic analyzer having a function of displaying, for each of the identifiers, the history of occurrence of the alarm as a graph indicating the transition of the cumulative number of occurrences with respect to time in response to a user request. The automatic analyzer according to claim 2,
The control unit further includes a parts management unit that manages a correspondence relationship between the plurality of parts in the analysis unit and the identifier of the alarm. The automatic analyzer according to claim 6,
The condition determination unit determines the replacement part candidate via the component management unit,
The parts management unit is an automatic analyzer having a function of displaying the replacement part candidates on a screen. The automatic analyzer according to claim 7,
The component management unit further confirms on the screen whether or not a component replacement based on the replacement component candidate is performed and notifies the history management unit if it is present. An automatic analyzer for performing the reset. The automatic analysis apparatus according to claim 8, wherein the component management unit further gives an option for performing a later part replacement to the user on the screen, and when the user selects the option, the component management unit displays the screen. An automatic analyzer that temporarily closes and then displays the replacement part candidate on the screen again at a predetermined timing. The automatic analysis apparatus according to claim 6, wherein the component management unit has a function of causing a user to edit a correspondence relationship between the plurality of components in the analysis unit and the identifier of the alarm on a screen. apparatus.

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