JP4982283B2 - Automatic analyzer - Google Patents

Description

  The present invention relates to an automatic analyzer, and particularly to management of constant temperature water used in a reaction analyzer of the same apparatus.

  The performance of water used in a reaction tank of an automatic analyzer is usually supplied and maintained by a pure water production apparatus including a filter. In this water supply, for example, when the conductivity exceeds a predetermined value, the water is transmitted to the operator by a display display, an alarm sound, or the like by a pure water manufacturing apparatus. There is also a pure water device having a UV sterilization function for preventing the growth of microorganisms. However, there was no control function related to water quality on the side of the automatic analyzer at the supply destination, so a system that forcibly discards and replaces the water in the device after a predetermined period of time has passed. The antibacterial treatment was also performed (for example, refer to Patent Documents 1 and 2).

  The water used in the automatic analyzer is generally kept high because the internal temperature is higher than room temperature. Moreover, since constant temperature water is maintained at 37 degreeC in order to stabilize reaction, it exists in the environment where bacteria are easy to grow. Such deterioration of water in the environment causes fungus membranes (slimming) in tanks and flow paths in the apparatus, causing various trouble states such as discoloration, clogging, and offensive odor. In addition, the adhesion of the photometric part to the glass or the reaction vessel wall, which is important in the analyzer, directly or indirectly affects the measurement data.

It is important in terms of ensuring the reliability of the device to detect and remove the deterioration of water quality in advance and prevent the generation of fungal membranes and the influence on measurement data.
JP 9-318635 A Japanese Patent Laid-Open No. 10-282109

  The problem to be solved is that the automatic analyzer has no water quality monitoring function and no control function based on the monitoring.

  The present invention has been made in view of the conventional problems as described above. In the automatic analyzer, maintenance is performed before the water quality deteriorates with respect to ion-exchanged water used in a large amount and stored. An object of the present invention is to provide an automatic analyzer including a mechanism system to be implemented.

To achieve the above object, an automatic analyzer according to claim 1 of the present invention includes a supply water collecting means for water sampling of internal automatic analyzer, the water sampled by said feed water collecting means, a predetermined Including a culture means installed in a culture environment that accelerates the growth of various bacteria due to high temperature and high humidity, a detection means for detecting the amount of bacteria contained in the water sampled by the collection means, and a bacteria detected by the detection means And a control means for issuing a warning when the amount exceeds a predetermined value or stopping the measuring operation of the apparatus.

Furthermore, in the automatic analyzer according to claim 2 of the present invention, the water sampling by the supply water collecting means is performed by the control CPU of the automatic analyzer that executes a system control program in which the suction position and the discharge position are changed. An injection probe or a test sample dispensing probe is provided which is performed by inhalation or discharge.

  Furthermore, in the automatic analyzer according to claim 3 of the present invention, the sampling timing of the constant temperature water is set by instructing selection of at least one sampling timing pattern obtained by combining a plurality of sampling timings. Provide what you want.

  According to the present invention, periodic culture and water quality diagnosis for water in an automatic analyzer is performed, and water exchange sterilization processing is performed based on the determination, thereby increasing the time required for recovery due to exacerbation of various bacteria. It is possible to keep the water in the apparatus clean without causing it.

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

  FIG. 1 is a block diagram schematically showing constituent elements of an embodiment of an automatic analyzer according to the present invention. FIG. 2 schematically shows the functional configuration for the action and operation of the culture / observation unit 50 for inspecting and determining the state of the in-apparatus water of the pure water tank 31 and the reaction tank 21 of this embodiment, that is, the in-apparatus supply water. FIG. Further, FIG. 3 is a flowchart showing a processing procedure in the bacteria count system that determines whether or not the amount of bacteria by the culture / observation unit 50 of the present embodiment exceeds a predetermined value.

  The outline of the present embodiment is as follows: a constant temperature water that is one of the supply water in the apparatus is placed on a culture dish of a bacteria test or a bottle culture container set in advance in the culture / observation unit 50 according to a predetermined procedure. Part is collected, and the amount of bacteria colonies in the culture vessel, that is, the bacteria, in the culture container after a predetermined culture period is observed, and the state of various bacteria contained in the collected water such as constant temperature water is grasped at an early stage. For this collection, the culture / observation unit 50 is linked to the configuration of the automatic analyzer using the dispensing function such as a reagent dispensing probe or a test sample dispensing probe equipped in the automatic analyzer, and Depending on the result of the determination for various germs, for example, the disposal / re-supplying of the constant temperature water in the reaction tank is updated using its circulation function.

  As shown in the schematic block diagram of FIG. 1, the configuration of the automatic analyzer 10 of the present invention includes a reaction unit mainly composed of a reaction vessel 21, a reagent unit mainly composed of a reagent storage 23, Culture / determining the occurrence of miscellaneous bacteria on a sampler part mainly composed of a disk-shaped or rack-shaped sampler 24 for preparing a test sample and a constant temperature water sample obtained by collecting a part of the constant temperature water in the reaction tank of the reaction part A system control CPU unit 11, a data A / D conversion unit 12, and a mechanism unit control interface (I / F) connected to the observation unit unit 50 and further connected to the data bus 17 to control the entire apparatus 10 and perform data analysis. 2, a result output unit 14, an operation input unit 15, a display unit 16, a control / data I / F unit 18 for the culture / observation unit unit 50, and the supply water unit 30 illustrated in FIG. 2. . The present embodiment is a water quality management system that can be applied to all of the in-apparatus supply water supplied to various processing units in the automatic analyzer 10, but avoids complicated explanation, and hereinafter, to the reaction tank 21. A case relating to constant temperature water which is the main supply water will be described as an example.

  In the present embodiment configured as described above, the operation of the test analysis for the specimen sample that is generally performed is the same as the operation of the general automatic analyzer, and the test sample dispensing probe 26 is the sampler 24 in the sampler unit. The system control CPU 11 controls the operation of dispensing a part of the sample in the inspection sample container placed on the reaction container 22 into one of the reaction containers 22 immersed in the reaction tank 21. In the reagent part, each of the reagent dispensing probes 25a and 25b is a reaction container in which a predetermined amount of one of the predetermined reagents stored in the reagent storage 23 is immersed in the reaction tank 21 and the sample has already been dispensed. The operation of dispensing into one of 22 is performed under the same control by the system control CPU unit 11. Then, the reaction container 22 into which the test sample and the reagent to be automatically analyzed are dispensed is immersed in the constant temperature water of the reaction tank 21 and rotated counterclockwise in the figure while being sampled by the stirring unit 29. Is agitated, spectrally analyzed by the multi-wavelength photometry system unit 28, the sample is discarded and the reaction vessel 22 is washed by the washing unit 27, and the inside of the reaction vessel 21 is rotated to the next round of inspection sample dispensing. The operation to be performed while being performed is also controlled by the system control CPU unit 11. The result data of the spectroscopic analysis by the multi-wavelength photometry system unit 28 on the test sample in the target reaction vessel 22 during this circulation is obtained by computer processing of the system control CPU unit 11 via the data A / D conversion unit 12. The analysis result of the test sample is displayed and output on the result output unit 14 or the display unit 16.

  On the other hand, the culture / observation unit 50 provided in the present embodiment has a configuration overview in FIG. 1 and a functional configuration in the left part of FIG. And a transport part 57a for transporting the sample medium 59n of the collection part 52 or the photographing part 53 to the culture chamber part 58 and a transport part 57b for transporting the culture medium part 58 to the photographing part 53. Further, the culture / observation unit 50 analyzes the image data from the imaging unit 53 and a temperature / humidity control unit 56 that maintains the inside of the culture chamber 51 and the periphery of the imaging unit 53 at a predetermined constant temperature and humidity. For example, a colony counter 54 that discriminates and counts miscellaneous fungal colonies of a predetermined size or more, and a determination unit that determines and predicts the growth of fungi of the constant temperature water in the reaction vessel of the sample target from the counting result and the morphology of the miscellaneous fungal colonies 55.

  Further, as shown in the right part of FIG. 2, a pure water tank 31 for supplying constant temperature water to the reaction tank 21, and pure water is supplied to the pure water tank 31 in the reaction tank portion of the automatic analyzer 10. An ion exchange deionizer 37 to be supplied, a liquid pump 32 for sucking or discharging the reagent dispensing probe 25b, a waste liquid tank 36 for storing the waste liquid flushed with the reagent dispensing probe 25b, and an electromagnetic branch for changing the pipe connection The valves 34 and 35 are provided in the same manner as a general automatic analyzer.

Furthermore, in this embodiment, the reagent dispensing probe that rotates between the reagent container of the reagent storage 23 and the reaction container of the reaction tank 21 during a general automatic analysis test in the reaction tank section of the automatic analyzer 10. At the timing of collecting the sample water for culturing, the liquid injection pump 32 draws water from the pure water tank 31 and then rotates and moves to a position 25b-2 on the collection unit side of the culture / observation unit 50. It is configured.

  As shown in the schematic configuration diagram of FIG. 1, for example, the culture / observation unit 50 is positioned so that the sampling unit 52 of the culture / observation unit 50 is positioned within the rotationally movable dispensing possible region of the reagent dispensing probe 25a. 50 is installed in the place of the arrangement space of each part which comprises the automatic analyzer 10. FIG. In addition, when it is difficult to set the installation position of the collection part 52 as described above, the sampling part 52 may be positioned within the region where the inspection sample dispensing probe 26 can be rotationally moved. In this case, the test sample dispensing probe 26 rotates and moves to the position of the collection part of the culture / observation unit 50 installed near the sampler 24 at the collection timing of the supply water in the apparatus.

  Next, the operation and operation of the present embodiment configured as described above will be described in detail along the process steps shown in the flowchart of FIG.

  The processing procedure of the embodiment of the present invention shown in this flowchart is incorporated and incorporated in the system control CPU unit 11 of the automatic analyzer 10 as a computer program. Alternatively, the culture / observation unit 50 may be retrofitted to an existing automatic analyzer, and a computer program for this processing procedure may be added to the system control CPU.

  The first step S11 of the processing procedure of the present embodiment shown in FIG. 3 activates a first timer function that collects constant temperature water in the automatic analyzer at a predetermined timing. The first timer starts counting up based on the most recent supply water exchange time, and sets the sampling timing of the constant temperature water to be cultivated for miscellaneous fungi.

  This count-up is detected in the next step S12 and sampling of constant temperature water is started. The sampling timing set in the first timer varies depending on the environment of the medical facility where the automatic analyzer 10 is installed. One of the different sampling timing patterns as shown in FIG. The selection of the day count or the time count is also appropriately selected with reference to the installation status of the automatic analyzer, the past ion exchange water replacement cycle, the installation of the circulating sterilizer, and the like.

  For example, as shown in FIG. 4, the pattern of this collection timing is the first collection Sm1 after T1 days immediately after the constant temperature water exchange. Thereafter, every day, T2 = T3 = Tn = 1 day, the second sampling Sm2, the third sampling Sm3,..., The Nth sampling Smn is performed.

(Pattern b) shows the first sampling Sm1 after 1 day immediately after the constant temperature water exchange or after T1 day. Thereafter, the second sampling Sm2, the third sampling Sm3,..., The Nth sampling Smn are performed at equal intervals (T1 = T2 = T3 =...) On the same day as the first sampling. .

(Pattern c) shows that the first sampling Sm1 is T1 days after the constant temperature water exchange, the second sampling Sm2 is T2 days later, the third sampling Sm3 is T3 days later, ... The second sampling Smn is performed after Tn days (where T1> T2> T3>...> Tn = 1 day). Are incorporated in advance in the control program of the system control CPU section. In general, the disinfection filter is installed and the disinfectant is put in, and the timing is in the daily order. However, the timing reference may be in the time order depending on the configuration or installation status of the automatic analyzer.

  By the time-up to each sampling timing of the first timer, first, in step S13, one of the sample medium 59 containers prepared in advance in the culture / observation unit 50 is moved to the position of the collection unit 52 by the transport unit 57a. Move to. A number of various sampling timing patterns as shown in FIG. 4 are prepared and stored in the apparatus, assuming various installation environments and operating conditions, and are suitable for the situation of the medical institution where the apparatus is installed. The pattern may be provided as a default setting.

  When the movement of the medium 59 is completed, Step S14 is executed, and the reagent dispensing probe (or the test sample dispensing probe) samples the sample water for culturing the bacteria. Further, the reagent dispensing probe (or the test sample dispensing probe) is rotated and moved to the position of the collection unit 52 of the culture / observation unit 50, that is, the position of the reagent dispensing probe 25a-2 shown in FIG. The sampled constant temperature water is dropped onto the sample medium 59 placed in the collection unit 52.

  The sample medium 59 into which the sample water has been dispensed is moved again to the sealed culture chamber 58 of the culture / observation unit 50 by the transport unit 57a in step S15. In the culture chamber 58, the identification number in the sampling order is set. At the same time, the cultivation of various bacteria mixed in the sample water is started.

  The culture environment of the sample dropped on the sample medium 59 in the culture chamber 58 is the same standard culture setting as the constant temperature water setting environment of the reaction tank 21 and increases the culture speed. For example, the maintenance temperature in the culture chamber 58 And one of the accelerated culture settings with a slightly higher maintenance humidity. The environment of the culture chamber 58 is maintained throughout the day regardless of whether the automatic analyzer 10 is in operation or not, and the environment preceding the actual proliferation of miscellaneous bacteria in the reaction tank 21, that is, the environment for accelerating culture is maintained. Set to be.

  When the first sample medium 59 in the sampling order is stored in the culture chamber 58, the second timer is started to start counting up the culture period for each sample medium 59 in each order. This second timer is a so-called timer that is activated and set for each sample medium in each order, or in the reference clock, the sampling order is based on the first set time of the sample medium 59 and the nth A clock having a timer function based on the sampling execution time of the second time and the time after the elapse of a predetermined culture time may be used. In step S16, when a predetermined culture period has elapsed for the sample medium 59 in each sampling order by the second timer, the next step S17 is performed on the sample medium 59n. If the culture period has not been reached, the cultivation of the miscellaneous fungi in step S15 is maintained in the culture chamber 58.

In step S17, the sample medium 59n after the predetermined culture period has passed is transferred from the culture storage unit 58 to the imaging unit 53 by the transport unit 57b, and the imaging unit 53 performs colony counting of the sample medium 59x in the culture container. The colony count is generally on the captured image of the sample medium 59 to be performed, by determining based on the relationship between colony diameter and the number of colonies as the reaction vessel pollution state is determined in step S18. These criteria are determined in advance based on empirical rules and supply water contamination history at the time of equipment installation, depending on the conditions of the automatic analyzer model, reaction tank and flow path volume, installation environment, and ion exchange water supply equipment. Has been. The standard characteristics may be determined based on the determination criteria corresponding to the occurrence of slime in the flow path or the reaction tank. In this case, the determination is made for contamination (adherent bacteria) in the flow path or the reaction tank 21. Is done.

  If it is determined in step S18 that it is within the standard range, the result is output and displayed in step S21, and the constant temperature water in the reaction vessel 21 is used as it is. Return to the beginning of step S15.

  If the determination in step S18 is out of the standard range, the process proceeds to step S19, and the state of the constant temperature water is notified of the “maintenance required” warning together with the determination result.

  Furthermore, the maintenance for draining and injecting the ion-exchanged water in the pure water tank 31 shown in step S20 is automatically performed by the system control CPU 11 upon receiving the “maintenance required” notification of the determination result in step S19. A control step may be added. Further, the maintenance of this step S20 is performed at night when the automatic analysis work is suspended, and the system control CPU unit 11 that has received the “maintenance required” notification of the determination result of step S19 operates the automatic analyzer. During this time, a standby state may be set, and for example, a procedure for controlling “start of maintenance” may be executed by operating an operation operation end switch for the automatic analyzer.

  According to the present embodiment, the supply water in the automatic analyzer, in particular, the constant temperature water in the reaction tank is sampled at a predetermined time, and miscellaneous fungi contained in the collected sample water are transferred to the culture medium and proliferated from within the apparatus. Since the contamination state is determined with respect to the culture medium sample cultured in an environment in which the contamination is accelerated, it is possible to detect the contamination state of various germs preceding the contamination in the actual apparatus. Based on this detection, automatic maintenance that maintains the high quality of the supply water in the device without excessive sterilization in the flow path, constant temperature water replacement, or constant temperature water replacement timing by performing maintenance of the supply water in the device. Equipment can be provided. In addition, the maintenance frequency can be reduced by setting the criteria for determining the contamination status strictly and performing maintenance before the contamination with bacteria worsens.

The block diagram which showed typically this-application embodiment. The schematic diagram which shows the function structure of the supply water part and culture | cultivation / observation unit of the automatic analyzer of this embodiment. The flowchart which shows the process of collection, culture | cultivation, and determination of the sample water of the automatic analyzer of this embodiment. The timing pattern which shows the example of the sample water sampling of this embodiment.

Explanation of symbols

10 ... Automatic analyzer,
11 ... System control CPU unit,
12: Data A / D converter,
13: Mechanism part control interface (I / F) part,
14 ... Result output part,
15 ... operation input part,
16 ... display part,
17 ... System bus,
18: Control / data I / F section,
21 ... Reaction tank,
22 ... reaction vessel,
23 ... Reagent storage,
24 ... Sampler,
25, 25a, 25b ... Reagent dispensing probe,
26 ... Inspection sample dispensing probe,
27 ... Cleaning unit,
28 ... Multi-wavelength photometry system part,
29 ... stirring unit,
30 ... Supply water section,
31 ... pure water tank,
32 ... Injection pump,
33 ... pure water injection pipe,
34, 35 ... Solenoid branch valve,
36 ... Waste liquid tank,
37 ... Ion exchange water purifier,
38 ... Reaction tank pouring drainage pipe,
50 ... Culture / observation unit,
51 ... culture means,
52 ... sampling part,
53 ... Shooting part,
54 ... Colony counter,
55... Determination unit,
56 ... temperature and humidity control unit,
57a, 57b ... conveying section,
58 ... culture storage section,
59, 59a, 58b, 59n ... sample medium.

Claims (5)

A feed water collecting means for sampling an automatic analyzer the water inside,
Detecting the amount of bacteria contained in the water sampled by the sampling means, including culture means for setting the water sampled by the supply water sampling means in a culture environment that accelerates the growth of various bacteria at a predetermined high temperature and high humidity Detecting means for
Control means for issuing a warning when the amount of bacteria detected by the detection means exceeds a predetermined value, or for stopping the measurement operation of the apparatus;
The automatic analyzer characterized by comprising. The water sampling by the supply water sampling means is performed by the reagent dispensing probe or the test sample dispensing probe being inhaled or ejected by the control CPU of the automatic analyzer that executes the system control program in which the inhalation position and the ejection position are changed. The automatic analyzer according to claim 1, wherein the automatic analyzer is performed.   2. The automatic analyzer according to claim 1, wherein the sampling timing of the constant temperature water is set by instructing selection of at least one sampling timing pattern obtained by combining a plurality of sampling timings. The automatic analyzer according to any one of claims 1 to 3, further comprising setting means for setting a pattern of a collection timing for collecting water inside the automatic analyzer.   The setting means sets an internal water collection timing pattern based on at least one of the installation status of the automatic analyzer, the past ion exchange water replacement cycle, and the installation of the circulating sterilizer. The automatic analyzer according to claim 4.