JP2018132411A - Component measuring device and method for executing examination of component measuring device - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a component measuring device which can display information on the previous examinations as well when displaying an examination when an impact is applied.SOLUTION: A blood sugar measuring instrument 10 (component measuring device) includes: an examination controller 60; a shock sensor 52 detecting an impact force; and an impact determination processing unit 50 for determining the necessity of an impact-time examination on the basis of the impact force. The examination controller 60 generates an impact-time display screen 94 associated with the execution of the impact-time examination and displays the screen in a monitor 26. The impact-time display screen 94 includes a current examination value TI and a previous examination value BI. This makes it easier for a user to determine whether the blood sugar measuring instrument 10 has been affected by the impact force.SELECTED DRAWING: Figure 4

Description

  The present invention relates to a component measuring device that measures the amount of a component in a liquid, and a method for inspecting the component measuring device.

  As a component measuring apparatus, for example, a blood glucose meter that measures the component amount (blood glucose level) of a glucose component in blood is known. This type of blood glucose meter is configured to be portable so that various users can easily measure blood glucose levels. The portable blood glucose meter is also used as a medical device for ward examination (POCT: Point Of Care Testing) in which blood collection, examination and measurement value confirmation are performed in the vicinity of the patient.

  Such a blood glucose meter (particularly a POCT device) is required to periodically perform a QC (Quality Control) check in order to stabilize measurement accuracy. Thereby, the measurement accuracy of the period from the time determined as QC inspection pass to the next QC inspection pass determination is ensured. In addition, the blood glucose meter is subject to a large impact force such as a drop during its handling, which may cause a reduction in measurement accuracy, and it is desirable to perform a QC inspection even when a large impact force is received. For example, the blood glucose meter (biosensor) disclosed in Patent Document 1 is configured to detect an impact applied to the blood glucose meter and to exclude the abnormal value when an abnormal waveform is detected as a measured value.

International Publication No. 2008/013224

  By the way, the blood glucose meter may have an inspection value near the boundary of the acceptable range even if the inspection value is within the acceptable range in the QC inspection after the impact. The value may have changed significantly. That is, even if the inspection value is within the acceptable range, if the blood glucose meter is affected by an impact, the measurement accuracy may be reduced during use of the blood glucose meter.

  However, conventionally, regarding the result of the QC check, the check value and the pass / fail judgment result are displayed in the same manner on the monitor of the blood glucose meter even in the QC check at the normal time or at the time of impact. Therefore, there is a problem that it is difficult for the user to determine whether or not the blood glucose meter is affected by an impact.

  The present invention has been made in view of the above circumstances, and a component measuring apparatus capable of further enhancing the handling by notifying the display of the inspection at the time of impact including the information of the past inspection. And it aims at providing the inspection implementation method of a component measuring apparatus.

  In order to achieve the above object, the present invention provides a component measuring device for measuring the amount of a component in a liquid, an inspection control unit for controlling the measurement accuracy of the component measuring device, and the component measurement An impact force detection unit that detects an impact force applied to the apparatus, and an impact determination processing unit that determines the necessity of inspection upon impact based on the impact force, and the inspection control unit performs the inspection upon impact In this case, the current inspection result information, which is information related to the result of the inspection at the time of the impact, and the past inspection result information, which is information related to the result of the past inspection, are notified via the notification unit. To do.

  According to the above, the component measuring device notifies the current inspection result information and the past inspection result information through the notification unit in accordance with the inspection at the time of impact. Thereby, the user who received the notification can compare the current inspection result information with the past inspection result information. For example, even if the inspection at the time of impact is acceptable, if the current inspection result information fluctuates with respect to the past inspection result information, it can be recognized that it is affected by the impact and the necessary measures can be taken. . Therefore, the handling property of the component measuring apparatus is further enhanced.

  In addition, the notification unit includes a monitor, and the inspection control unit does not include past inspection result information when the normal inspection is performed in a normal state where it is determined that the inspection at the time of impact is not necessary. An hour display screen may be displayed on the monitor, and when the impact inspection is performed, an impact display screen including the current inspection result information and the past inspection result information may be displayed on the monitor.

  When a normal inspection is performed, a normal display screen that does not include past inspection result information is displayed, so that the user can be well informed of the results of the current inspection. On the other hand, when the inspection at impact is performed, it is possible to easily notify the user that the inspection status is different by displaying the display screen at impact.

  In addition to the above configuration, the inspection control unit preferably displays the current inspection result information and the past inspection result information simultaneously on one screen of the monitor.

  Since the current inspection result information and the past inspection result information are displayed simultaneously on one screen of the monitor, the user can more easily compare the current inspection result information and the past inspection result information.

  Moreover, it is preferable that the current inspection value as the current inspection result information and the past inspection value as the past inspection result information are written together in one graph on the display screen at the time of impact.

  The component measuring apparatus can recognize the change in the inspection value more easily by writing the inspection value and the past inspection value together in one graph.

  In addition to the above configuration, the graph may include information related to an acceptable pass range according to the concentration of the inspection liquid used in the inspection.

  The component measuring device can cause the user to graphically recognize whether or not the inspection value is included in the acceptable pass range by including information on the acceptable pass range in the graph.

  Furthermore, it is preferable that the display screen at the time of impact and the display screen at the normal time display the current inspection value, which is the current inspection result information, as a numerical value, and also display information related to pass / fail of the current inspection value.

  The component measuring device can notify the pass / fail of the inspection more reliably by displaying the numerical value of the inspection during the impact and the inspection during the normal time and the information related to the pass / fail in the display screen during the impact and the display screen during the normal time.

  Moreover, it is preferable that the display screen at the time of impact displays the statistical information of the past inspection as the past inspection result information.

  By displaying the statistical information of a plurality of inspections performed in the past, the user can compare the current inspection at the time of impact with the statistical information. Therefore, the component measuring apparatus can recognize better whether or not it is affected by an impact.

  In addition to the above configuration, the statistical information may include at least one of an average value, a median value, and a standard deviation for a plurality of the past inspections.

  By including at least one of the average value, median value, and standard deviation in the statistical information, the user can compare the inspection at the time of this impact with the included average value, median value, and standard deviation index, The state of the component measuring device can be determined.

  And the said inspection control part is good to encourage implementation for the said inspection at the time of the impact accompanying the determination of the said impact determination process part for every predetermined period.

  The component measuring device can prompt the user to perform inspection at impact every predetermined period, thereby allowing the user to recognize a state in which the measurement accuracy deteriorates due to damage to the terminals and wiring of the electronic circuit due to the impact.

  Further, the inspection control unit may be configured to cancel the state in which the inspection at the time of impact is performed based on an instruction of a management device connected to the component measurement device so as to be able to communicate information.

  As a result, the component measuring device can release the inspection state at the time of impact by the management device at the stage where it is surely found that there is no problem in the component measurement after receiving a large impact force.

  Still further, the component measuring device may be a blood glucose meter that measures the component amount of glucose in blood.

  Thereby, the blood glucose meter can maintain the measurement accuracy of the blood glucose level satisfactorily even when it receives a large impact force.

  In order to achieve the above object, the present invention is a method for inspecting a component measuring apparatus for measuring the amount of a component in a liquid, the inspection step for checking the measurement accuracy of the component measuring apparatus, and the component A detection step of detecting an impact force applied to the measuring device, and an impact determination step of determining the necessity of inspection upon impact based on the impact force, wherein the inspection upon impact was performed in the inspection step In this case, the present inspection result information, which is information related to the result of the inspection at the time of the impact, and the past inspection result information, which is information related to the result of the past inspection, are notified via a notification unit.

  According to the present invention, the component measuring device and the method for carrying out the inspection of the component measuring device can further improve the handling property by displaying the inspection information including the past inspection information in the inspection display at the time of impact.

It is a perspective view showing the whole blood glucose meter composition concerning one embodiment of the present invention. It is a functional block diagram of the control circuit in the blood glucose meter of FIG. It is explanatory drawing which shows notionally the relationship between the density | concentration of a test liquid at the time of the QC check of the blood glucose meter of FIG. FIG. 4A is an explanatory diagram showing a normal display screen, and FIG. 4B is an explanatory diagram showing an impact display screen. It is a flowchart which shows the inspection implementation method in the blood glucose meter of FIG. FIG. 6A is an explanatory view showing a display screen at impact according to the first modification, and FIG. 6B is an explanatory view showing a display screen at impact according to the second modification.

  DESCRIPTION OF EXEMPLARY EMBODIMENTS Hereinafter, preferred embodiments of a component measuring apparatus and a method for inspecting a component measuring apparatus according to the present invention will be described in detail with reference to the accompanying drawings.

  As shown in FIG. 1, a component measuring apparatus 10 according to an embodiment of the present invention is configured as a blood sugar level measuring apparatus that measures the component amount (blood sugar level) of a glucose component in blood (hereinafter referred to as a blood glucose meter). 10). The blood glucose meter 10 is configured as a POCT device used by medical personnel (hereinafter referred to as users) such as doctors and nurses in a medical facility. The blood glucose meter 10 may be used as a SMBG (Self-Monitoring of Blood Glucose) device in which the patient himself / herself measures his / her blood glucose level.

  The blood glucose meter 10 includes a chip 12 that directly takes in the blood of a patient, and an apparatus main body 14 that optically measures the blood sugar level of the blood taken in the chip 12. The chip 12 is configured as a disposable type that is discarded for each measurement, while the apparatus main body 14 is configured as a device capable of repeatedly measuring blood glucose levels.

  The chip 12 is easy to be spotted even with a small amount of blood, has a thin nozzle 16 so that the apparatus main body 14 does not directly touch the blood, and is detachably attached to the distal end portion of the apparatus main body 14. For example, the tip 12 takes in blood from the tip (tip opening) of the nozzle 16 and guides it into the attachment portion 18 on the base end side by capillary action. A test paper (not shown) is accommodated in the attachment portion 18, and this test paper allows the introduced blood to be rapidly developed in the depth direction and the planar direction. For example, the test paper is configured by impregnating a reagent (coloring reagent) into a carrier such as a porous membrane capable of absorbing blood. By reacting with the reagent, blood is colored with a color density corresponding to the amount of glucose contained in the blood.

  On the other hand, the apparatus main body 14 includes a housing 20 having a size that can be carried by the user. The casing 20 is slightly elongated so that the user can easily hold it with one hand, and its distal end portion is slightly bent downward while being narrowed toward the distal end direction. A cylindrical attached portion 22 to which the chip 12 can be detachably attached is provided at the distal end portion of the housing 20. Further, an ejector 24 for removing the chip 12 from the mounted portion 22, a monitor 26, and an operation button group 28 are provided on the upper surface of the housing 20, and a barcode reader 30 is provided on the base end surface of the housing 20.

  The monitor 26 provided in the apparatus main body 14 is composed of a liquid crystal, an organic EL, or the like, and displays various information to be provided to the user in blood glucose level measurement, such as blood glucose level, date and time, or other information (for example, error and measurement procedure). It becomes the alerting | reporting part 25 to do. In addition to the monitor 26, the notification unit 25 of the apparatus main body 14 includes an LED notification unit 27 that lights or blinks in various colors, a speaker (not shown) provided in the apparatus main body 14, and the like.

  The operation button group 28 includes, for example, a power button 28a, an up button 28b, a down button 28c, a left button 28d, a right button 28e, a selection button 28f, a data reading button 28g, and the like. Each of the movement buttons 28b to 28e has a function of moving a selection frame (not shown) with respect to an item displayed on the monitor 26 or scrolling the screen in accordance with an operation. The selection button 28f has a function of selecting the function of the item on which the selection frame is positioned on the monitor 26 or canceling the selection and returning to the screen before selection in accordance with the user's pressing operation. The data reading button 28g is provided between the monitor 26 and the mounted portion 22 and operates reading of the barcode reader 30.

  The barcode reader 30 reads a barcode (not shown) by laser scanning. The barcode to be read is attached or pasted in advance to a patient, a healthcare worker, a package of the chip 12, a container for inspection liquid described later, and the like. The blood glucose meter 10 acquires patient identification data, measurer identification data, chip identification data, inspection liquid identification data, and the like by reading each bar code, and stores them in a predetermined database (memory of the control circuit 34). .

  In addition, a detection unit 32 and a control circuit 34 are provided inside the apparatus main body 14. The detection unit 32 includes a light emitting element and a light receiving element (not shown), and is configured as an optical system measuring instrument that irradiates the blood spread in the test paper with the irradiation light from the light emitting element and detects the reflected light by the light receiving element. Has been. The detection value of the reflected light detected by the detection unit 32 is subjected to processing such as A / D conversion and amplification, and is transmitted to the control circuit 34.

  In this embodiment, a colorimetric blood glucose meter 10 that optically detects a blood glucose level in blood will be described as an example. However, the present invention can also be applied to blood glucose meters of other measurement methods. Of course. For example, as another blood glucose meter, there is an electrode type device that detects an electrical change accompanying blood introduction by applying a reagent around the electrode, that is, a current generated between the detection electrode and the counter electrode.

  The control circuit 34 is configured as a computer (control unit) having a processor, a memory, and an input / output interface (not shown), and has a function of controlling blood glucose level measurement by the blood glucose meter 10. The processor executes a control program (not shown) stored in the memory, thereby constructing a functional block unit that measures a blood glucose level as shown in FIG. Specifically, in the control circuit 34, a blood glucose level measurement control unit 40, an impact determination processing unit 50, and an inspection control unit 60 are provided.

  The blood glucose level measurement control unit 40 is a functional unit that controls the operation of the apparatus main body 14 when measuring a blood glucose level, and includes a measurement guide unit 42, a detection unit control unit 44, and a measurement value processing unit 46 therein. Is formed. Further, the blood glucose level measurement control unit 40 is provided with a blood glucose level measurement storage unit 48 (memory storage area) for storing information necessary for measuring the blood glucose level, the measured blood glucose level, and other measurement information.

  The measurement guide unit 42 uses the notification unit 25 to guide the blood sugar level measurement procedure when measuring the blood sugar level. For example, the measurement guide unit 42 instructs the apparatus main body 14 to mount the chip 12, and when the mounting of the chip 12 is detected, requests the patient's blood to be spotted on the tip opening of the nozzle 16. Further, after the blood sugar level is measured, it is urged to remove the chip 12 by operating the ejector 24.

  The detection unit control unit 44 controls the operation of the detection unit 32 in accordance with the chip 12 mounting guide and blood spotting guide by the measurement guide unit 42. Thereby, the detection unit 32 performs optical measurement on the blood of the test paper and outputs the detected detection signal (information on the blood glucose level) to the control circuit 34.

  The measurement value processing unit 46 calculates a blood glucose level based on the detection value (color density) detected by the detection unit 32. At this time, the measurement value processing unit 46 performs correction in consideration of blood concentration (hematocrit value), measurement temperature, test paper lot, patient's medication, etc. so as to obtain a calculated value close to the glucose concentration value. The measured value processing unit 46 stores the calculated blood glucose level in the blood glucose level measurement storage unit 48 in association with the measurement date and time, patient identification data, and the like, and further displays the blood glucose level on the monitor 26.

  In addition, the blood glucose level measurement control unit 40 constantly monitors the blood glucose level measurement permission flag 49 of the blood glucose level measurement storage unit 48 in the activated state of the apparatus main body 14. For example, the state (0 or 1) in the register of the blood sugar level measurement permission flag 49 is changed based on an instruction from the inspection control unit 60 or the external management device 82. The blood sugar level measurement control unit 40 permits blood sugar level measurement when the blood sugar level measurement permission flag 49 is 1, while prohibiting blood sugar level measurement when the blood sugar level measurement permission flag 49 is zero. Note that the notification unit 25 may notify the measurement prohibition status, cause, and the like at the time of prohibition.

  For example, when a user or the like receives a large impact force by accidentally dropping the apparatus main body 14 onto the floor, the measurement accuracy of the blood glucose meter 10 may be reduced. Therefore, it is preferable that the blood glucose meter 10 (control circuit 34) prohibits the measurement of the blood glucose level until the inspection based on the impact (QC inspection for confirming the measurement accuracy) is performed. Thereby, the measurement of the blood glucose level in a state where the measurement accuracy cannot be ensured can be suppressed. Therefore, the impact determination processing unit 50 has a function of receiving a signal from a shock sensor 52 (impact force detection unit) provided in the blood glucose meter 10 and determining the impact force applied to the blood glucose meter 10.

  The shock sensor 52 is a detection device that detects an impact force received by the apparatus main body 14. For example, an acceleration sensor using a MEMS (microelectromechanical system) technology can be applied. More specifically, the shock sensor 52 generates a charge proportional to the acceleration applied to the piezoelectric ceramic beam, converts the charge into a voltage, amplifies it, and converts it into a digital value to obtain a detection value of the impact force. Output to. The shock sensor 52 is not limited to the structure described above, and an appropriate sensor may be employed.

  The impact determination processing unit 50 determines the necessity of QC inspection based on the signal from the shock sensor 52. Specifically, it has an impact determination storage unit 54 (memory storage area) that stores the impact force threshold Ths, and compares the impact force detected by the shock sensor 52 with the impact force threshold Ths. For example, the range of impact force when the apparatus main body 14 is dropped from a drop height of 1 m is about 151 to 90 [G], and the impact force threshold Ths may be set to a minimum value of 90 [G]. Since the impact force applied to the apparatus main body 14 at the time of dropping varies depending on the weight of the apparatus main body 14, the impact force threshold Ths may be an appropriate value according to the design of the apparatus main body 14.

  The impact determination processing unit 50 determines that QC inspection is necessary when the detected impact force value is greater than the impact force threshold Ths, and sets the impact force flag 55 (the flag register is set to 0 to 1). On the contrary, when the detection value of the impact force is equal to or less than the impact force threshold Ths, the impact force flag 55 is kept turned down, and it is determined that QC inspection is unnecessary. The shock sensor 52 and the shock determination processing unit 50 are in a standby state in which a small amount of power is supplied even when the blood glucose meter 10 is turned off, and are configured to detect the shock.

  On the other hand, the inspection control unit 60 of the control circuit 34 performs and manages the QC inspection for confirming the measurement accuracy of the blood glucose level. As described above, the blood glucose meter 10 performs a QC inspection (hereinafter also referred to as an inspection upon impact) when it receives a large impact force, and also performs a QC inspection (hereinafter referred to as a QC inspection) even in a normal state where it does not receive a large impact force. (It is also called normal inspection). As a result, blood glucose level measurement accuracy is maintained even during normal times.

  For this reason, the inspection control unit 60 includes an inspection execution control unit 62, an interval setting unit 64, and an inspection notification unit 66. Further, in the inspection control unit 60, a QC inspection storage unit 68 (memory area) for storing various parameters used in the QC inspection, inspection values measured by the QC inspection, and other information related to the inspection. Is provided.

  The inspection execution time control unit 62 is a functional unit that is responsible for the control when the QC inspection is actually performed, and an inspection guide unit 72, a detection unit control unit 74, and an inspection value processing unit 76 are provided therein. . The contents of the QC check of the blood glucose meter 10 include a method of performing a measurement similar to the blood glucose level measurement using a control liquid (check liquid) (not shown) provided for checking. The inspection at the normal time and the inspection at the time of impact are different in conditions such as the timing for prompting the execution of the QC inspection and the prohibition of blood glucose measurement, and basically the same processing is performed in the QC inspection actually performed by the control unit 62 at the time of inspection. In addition, a plurality of types of inspection liquids having different sugar concentrations (for example, for low concentration, for standard, and for high concentration) are prepared, and an appropriate one is selected by the user.

  The inspection guide unit 72 guides the procedure of the QC inspection through the monitor 26 or a speaker (not shown), triggered by the selection of the execution of the QC inspection in the operation of the operation button group 28 by the user. For example, the inspection guide unit 72 instructs the apparatus main body 14 to mount the chip 12 and, when detecting the mounting of the chip 12, requests the inspection liquid to be applied to the tip opening of the nozzle 16. In response to this guidance, the user drops the inspection liquid, and the inspection liquid taken into the tip opening of the nozzle 16 moves in the tip 12 and spreads on the test paper. The inspection guide unit 72 prompts the user to remove the chip 12 by operating the ejector 24 after the QC inspection.

  The detection unit control unit 74 drives the detection unit 32 in accordance with the spotting guidance of the inspection guide unit 72. That is, the irradiation light is irradiated by the light emitting element, the reflected light reflected from the test paper is received, and the detection value (sugar content information in the inspection liquid) is output to the control circuit 34.

  Then, the inspection value processing unit 76 performs a predetermined operation on the detected value to calculate the inspection value, and stores the inspection value in the QC inspection storage unit 68 and displays it on the monitor 26. Further, inside the inspection value processing unit 76, a QC inspection determination unit 78 for determining whether or not the inspection value is acceptable (that is, whether or not the QC inspection is acceptable), and a result generation unit 80 for displaying the inspection value and the acceptance or failure of the QC inspection. Is provided.

  When the inspection value is determined, the QC inspection determination unit 78 reads the acceptable inspection liquid acceptable range 78a stored in the QC inspection storage unit 68 in advance, and whether or not the calculated inspection value is within the acceptable allowable range 78a. Determine.

  Here, since the inspection value is calculated as a numerical value representing the sugar concentration in the inspection liquid detected by the apparatus main body 14, as shown in FIG. 3, the acceptable pass range 78a is also a numerical range corresponding to the concentration of the inspection liquid. Is stored as information. For example, the acceptable pass range 78a has a median value for each concentration of the inspection liquid, and a predetermined ratio (%) plus or minus is set as an upper limit value and a lower limit value based on the median value. That is, when the inspection value is between the upper limit value and the lower limit value, it can be considered that the measurement accuracy of the apparatus main body 14 is maintained, and when the inspection value exceeds the upper limit value or falls below the lower limit value. It can be considered that the measurement accuracy of the apparatus main body 14 is lowered. In addition, the acceptable pass range 78a may be set in a plurality of stages, and it can be determined that higher accuracy measurement is performed at a stage close to the median value within the acceptable range, and at a stage away from the median value, the test is passed. However, it can be determined that the stage requires attention. By judging in multiple stages in this way, even if there is no problem with the measured value at present, the measurer and the administrator are informed that the device should be preferentially subjected to QC inspection. You can also

  In addition, when the QC inspection determination unit 78 determines that the QC inspection is unsuccessful, the inspection execution control unit 62 may urge the user to take necessary measures through the notification unit 25. Necessary measures in this case include re-implementing the QC inspection, prompting maintenance of the apparatus main body 14, and prompting an inquiry to the manufacturer. If the QC check fails, the blood sugar level measurement may be prohibited by depressing the blood sugar level measurement permission flag 49 (set to 0).

  Further, the inspection value processing unit 76 may perform different processes for the normal inspection and the impact inspection. For example, it is possible to set different acceptable pass ranges 78a for the normal inspection and the shock inspection, and if the narrower allowable pass range 78a is set, the inspection accuracy can be tightened.

  Returning to FIG. 2, the result generation unit 80 generates display information 90 (see FIGS. 4A and 4B) for displaying the result of the QC inspection on the monitor 26. As a result, the user can immediately recognize the result of the QC inspection. The result generation unit 80 according to the present embodiment is configured to change the display information 90 to be generated between the normal inspection and the impact inspection. That is, the result generation unit 80 generates different display information 90 with reference to the state (0 or 1) of the impact force flag 55.

  Specifically, when displaying the normal inspection, for example, a normal display screen 92 as shown in FIG. 4A is generated as the display information 90. On the normal display screen 92, an inspection value display portion 92a for displaying a large inspection value of the normal inspection at the center position of the monitor 26 in the vertical direction (longitudinal direction of the housing 20) is arranged. In addition, the normal display screen 92 is provided with a pass / fail display portion 92b for displaying the pass / fail status of the QC inspection near the upper right corner of the monitor 26. That is, the normal display screen 92 has a simple display form that displays only the inspection value display unit 92a and the pass / fail display unit 92b, so that the user can easily understand the result of the normal inspection.

  On the other hand, when displaying the inspection at impact, for example, a display screen 94 at impact as shown in FIG. 4B is generated as the display information 90. On the display screen 94 at the time of impact, a statistical display portion 94 a is arranged at the center position in the vertical direction of the monitor 26. The statistical display unit 94a includes current inspection result information (current inspection value TI) that is information related to the result of inspection at the time of impact, and past inspection result information (past inspection value BI) that is information related to the result of past inspection. And statistical information SD of the past QC inspection are also displayed. That is, the current inspection result information and the past inspection result information are simultaneously displayed on one screen.

  Further, on the impact display screen 94, an inspection value display unit 94b is arranged above the statistics display unit 94a, and a pass / fail display unit 94c is arranged on the right side of the inspection value display unit 94b (near the upper right corner of the monitor 26). doing. The inspection value display section 94b is smaller in size than the inspection value display section 92a of the normal display screen 92, while the pass / fail display section 94c has the same size as the pass / fail display section 92b.

  As shown in FIG. 4B, the statistical display unit 94a may be formed as a graph representing the inspection value (concentration) of the inspection liquid. For example, the graph is displayed in a display form in which the vertical axis is the concentration of the inspection liquid (inspection value), the horizontal axis is the time axis, and a part thereof is surrounded by a frame 95. In this case, the horizontal lines 95a at the upper and lower positions of the frame 95 indicate the upper limit value and the lower limit value of the inspection value pass allowable range 78a. That is, the inspection value that has passed the QC inspection is displayed between the upper and lower horizontal lines 95a. If the QC inspection fails, the inspection value is not displayed on the statistical display unit 94a, but the user may recognize the result of the current QC inspection by displaying the inspection value display unit 94b or the pass / fail display unit 94c. it can.

  In addition, vertical lines 95b at the left and right positions of the frame 95 indicate a predetermined time range. The predetermined time range is a time interval that can represent one or more results of past QC inspections (including normal inspections) in addition to the results of the current QC inspections. In the illustrated example, the present inspection value TI and the past two past inspection values BI are set as a time range to be displayed together. The time point when the impact force is detected may be displayed by a vertical line or the like.

  And the statistics display part 94a is good to display the average value index line 96 (refer the thick line in FIG. 4B) which shows the average value which averaged the inspection value of the past QC inspection inside the frame 95. FIG. By displaying the average value index line 96 and the inspection value at the time of impact inspection together, the user can easily visually recognize how much the inspection value at the time of impact inspection is deviated (ie, deviation). The average value is preferably calculated using only the inspection values of the past QC inspection that are included in the acceptable pass range 78a.

  Further, the statistical display unit 94a may display a standard deviation index line 97 (see a dotted line in FIG. 4B) indicating the standard deviation calculated from the inspection value of the past QC inspection inside the frame 95. Thereby, for example, when an inspection value is included between the upper and lower standard deviation index lines 97, the user can determine that there is no change in measurement accuracy due to an impact.

  As described above, when the impact inspection is performed, the statistical display unit 94a displays the statistical information SD, so that the user compares the current inspection value with the past inspection value or the past inspection value statistical information SD. The relative positional relationship can be recognized well.

  Returning to FIG. 2, the interval setting unit 64 is a functional unit that sets a period (interval) from the current QC inspection to the next QC inspection. The intervals may be set to different periods for the normal inspection and the impact inspection. That is, the interval setting unit 64 sets the normal time interval UI when the impact force flag 55 is 0, and sets the impact time interval SI when the impact force flag 55 is 1.

  The inspection notification unit 66 has a timer (not shown) inside, and measures the interval set by the interval setting unit 64 (normal interval UI or impact interval SI) to notify the user that the QC inspection is performed. To do. Thereby, the user can implement QC inspection at an appropriate timing. Also, a plurality of shock intervals SI may be set according to the magnitude of the received impact force, and shorter when the magnitude of the impact force received by the shock sensor 52 is greater than 120 [G]. When the impact time interval SI is set and the impact force threshold value is 100 [G] or less, the impact time interval SI can be set to be relatively long.

  The blood glucose meter 10 according to the present embodiment is basically configured as described above, and the processing flow (inspection method for the blood glucose meter 10) and effects thereof will be described below.

  The blood glucose meter 10 is charged while being stored in an appropriate storage location in the medical facility. And it is taken out according to a user's need and used for a patient's blood glucose level measurement. In the blood glucose level measurement, the blood glucose level measurement control unit 40 controls the operation of the detection unit 32 to measure the blood glucose level of the patient.

  In addition, the inspection control unit 60 notifies the user of the execution timing of the QC inspection (normal inspection) based on the setting of the normal time interval UI by the interval setting unit 64 and the time measurement by the inspection notification unit 66. Based on this notification, the user performs a normal inspection at an appropriate timing.

  Furthermore, the blood glucose meter 10 continuously detects the impact force applied to the apparatus main body 14 by the shock sensor 52 (detection step). Then, the impact determination processing unit 50 determines whether or not the signal (detection value) transmitted from the shock sensor 52 exceeds the impact force threshold Ths (impact determination step). When the impact force exceeds the impact force threshold Ths, the impact force flag 55 is raised and the execution of the QC inspection (inspection at impact) is notified. The user performs an inspection upon impact based on this notification. Note that the blood glucose meter 10 may prohibit the measurement of the blood glucose level in accordance with the detection in order to cause the user to perform an inspection upon impact immediately after detecting a large impact force.

  In the QC inspection (normal inspection and impact inspection), the inspection execution control unit 62 executes a processing flow (inspection process) as shown in FIG. Specifically, the inspection execution time control unit 62 continuously determines the QC inspection execution operation by the user (step S10).

  When the user performs a QC inspection operation, the inspection guide unit 72 guides the QC inspection, and controls the detection unit control unit 74 to perform the QC inspection (step S11). Further, when the QC inspection is performed, the inspection value processing unit 76 appropriately processes the detection value of the inspection liquid to calculate the inspection value, and the QC inspection determination unit 78 determines whether the inspection value is acceptable or not. Thereafter, the inspection value processing unit 76 stores the calculated inspection value and pass / fail judgment result in the QC inspection storage unit 68 together with the implementation date and patient identification information and the like (step S12).

  In addition, during the operation of the inspection value processing unit 76, the result generation unit 80 (the inspection execution control unit 62) determines whether the impact force flag 55 is 0 or 1 (step S13). If the impact force flag 55 is 0, the current QC inspection is identified as a normal inspection, and the process proceeds to step S14. If the impact force flag 55 is 1, the current QC inspection is an impact. The time check is identified and the process proceeds to step S15.

  In step S <b> 14, the result generation unit 80 generates a normal display screen 92 (see FIG. 4A) according to the normal inspection, and notifies the inspection result via the monitor 26. Thereby, the user can recognize the result of the normal inspection well.

  In step S15, the result generation unit 80 reads out the inspection value of the past QC inspection stored in the QC inspection storage unit 68 and displays the statistical information SD (average of past QC inspections) for display on the statistical display unit 94a. Value and standard deviation). The result generation unit 80 may be configured to calculate the statistical information SD along with the QC inspection, store the statistical information SD in the QC inspection storage unit 68, and read the stored statistical information SD.

  After step S15, the result generation unit 80 generates an on-impact display screen 94 (see FIG. 4B) according to the on-impact inspection, and notifies the inspection result via the monitor 26 (step S16). Thereby, the user can recognize the result of the inspection at the time of impact favorably.

  In addition, when the impact force flag 55 is 1, the blood glucose meter 10 is connected to the management device 82 and reset processing is performed from the management device 82, thereby defeating the impact force flag 55 (from 0 to 1). Thereby, the display information 90 can shift from the state of displaying the display screen 94 at the time of impact to the state of displaying the display screen 92 at the normal time.

  As described above, the blood glucose meter 10 and the inspection execution method of the blood glucose meter 10 according to the present embodiment include at least the current inspection value TI and the past inspection value BI on the impact display screen 94 generated by the impact inspection. Therefore, the handleability can be further enhanced. For example, by checking the impact display screen 94, the user can be affected by the impact if the current inspection value TI fluctuates with respect to the past inspection value BI, even if the inspection at impact has passed. Can be recognized. Further, since the normal display screen 92 and the shock display screen 94 are different, it is possible to easily notify the user that the inspection situation is different.

  The blood glucose meter 10 allows the user to easily recognize the change in the inspection value by writing the current inspection value TI and the plurality of past inspection values BI together in one graph (statistical display unit 94a). . In addition to this, the blood glucose meter 10 can allow the user to graphically recognize whether or not the inspection value is included in the acceptable pass range 78a by including the acceptable pass range 78a in the statistical display unit 94a. The blood glucose meter 10 can inform the user of the pass / fail of the inspection even more easily by displaying information related to the pass / fail of the inspection during the impact and the normal inspection on the display screen 92 and the display screen 94 during the impact. .

  Further, by displaying the statistical information SD of the past inspection value on the statistical display unit 94a, the user can compare the current inspection value TI and the statistical information SD. Therefore, the blood glucose meter 10 can recognize better whether or not it is affected by the impact. In this case, since the statistical information SD includes at least one of the average value index line 96 and the standard deviation index line 97 (or the median index line), the user compares the current check value TI with the index, A total of 10 states can be determined.

  The blood glucose meter 10 prompts the user to perform the inspection at the time of the impact at every interval SI, thereby allowing the user to recognize the state in which the measurement accuracy decreases due to the damage of the terminals and wiring of the electronic circuit due to the impact. it can. And the blood glucose meter 10 can cancel | release the implementation state of the inspection at the time of impact by the management apparatus 82 in the stage where it turned out that there was no problem in the measurement of a component after receiving a big impact force.

  In addition, this invention is not limited to said embodiment, A various application example or a modification can be taken. For example, the blood glucose meter 10 may output a sound from a speaker (not shown) about the results of the normal inspection and the impact inspection. In the notification by voice, the current inspection value TI and a predetermined number of past inspection values BI or statistical information SD may be output in order.

  Further, for example, the blood glucose meter 10 is configured to reset (set to 0) the state in which the impact force flag 55 is 1 (the state in which the display screen 94 at the time of impact is displayed) based on a command from the management device 82. The state of the flag 55 may be changed by other methods. As an example, the blood glucose meter 10 may automatically reset the impact force flag 55 when the inspection at impact is performed a predetermined number of times (for example, 3 times) and passed. As another example, the blood glucose meter 10 automatically resets the impact force flag 55 when the impact inspection performed after a lapse of a predetermined period (for example, 2 months) from the start date and time of the impact inspection. May be.

  Further, the statistical display unit 94a is not limited to the above display (frame 95, average value index line 96, standard deviation index line 97), and various display forms may be employed. For example, the statistics display unit 94a may display a line indicating a median value according to the concentration of the inspection liquid. The impact display screen 94 may alternately display the current inspection value TI and the past inspection value BI or the statistical information SD on the monitor 26.

  Furthermore, as shown in FIG. 6A, the display screen 100 at the time of impact according to the first modification is a statistical display section 100a as a table that summarizes the inspection values of the current inspection at impact and the inspection values of the past QC inspection. have. For example, the statistic display unit 100a displays the date of QC inspection and the inspection value (concentration) of the QC inspection. The statistics display section 100a also includes information (indicated by an arrow) indicating that the current inspection value has greatly changed from the previous inspection value by a predetermined amount (for example, 5 or more), a deviation amount from the average value of the past QC inspection, and the like. It should be described. Such a display is not limited to the graph display, and a mark corresponding to the amount of change between the previous inspection value BI and the current inspection value TI or the average value may be displayed. In the mark display, the direction of increase / decrease may be expressed similarly to the arrow shown in FIG. 6A, or the attention expression may be changed depending on the number and color of the marks. Further, the mark is not limited to the case of calling attention, but may be displayed in the sense of giving a sense of security when there is reproducibility. Such mark display may be displayed as an icon on the sub-screen at the time of normal measurement in addition to the inspection result display. The graph display has an advantage that it can be compared with the past inspection result information, but there is also a disadvantage that when it is shared by a plurality of users, an appropriate judgment is not made and confusion is caused. By setting the display according to the situation, it is possible to make the user reconfirm about the fluctuation within the acceptable range.

  Furthermore, as shown in FIG. 6B, the impact display screen 110 according to the second modified example generates a graph of the time axis and the concentration as the statistical display unit 110a, and interpolates (broken lines) from the inspection values of the past QC inspection. , Spline curves, etc.) are calculated to display continuous line information. Thereby, the change of the inspection value becomes easier to understand. Then, the result generation unit 80 may calculate and display the prediction line 111 of the future inspection value based on the past interpolation line and the current inspection value. Moreover, as shown in FIG. 6B, the inspection value of the QC inspection may display a range that exceeds the upper limit value of the acceptable pass range 78a or a range that falls below the lower limit value (failed range). In this case, the graph may be scrolled by operating the up button 28b or the down button 28c.

  When such a graph is generated, the accuracy of the judgment can be improved by making the conditions such as the lot information such as the inspection liquid lot and the tip lot to be used, the temperature range during measurement, and the like the same. When calculating the average value of past inspection values, the notation may be limited to the same lot for which the average value within the same lot was calculated, and multiple lots can be distinguished by changing the dot shape and color on the graph. However, it may be indicated simultaneously. When a plurality of lots are described simultaneously, each of the plurality of lots may be displayed in parallel with a median value, or a switching delimiter of each lot may be displayed.

  In the description of the above embodiment, the POCT device, particularly the blood glucose meter 10 that measures the glucose concentration in the blood, has been described. However, the present invention is not limited to the above embodiment, and the scope of the present invention is not deviated. It goes without saying that various modifications are possible. Sample liquids that can be obtained from the living body, such as blood, urine, interstitial liquid, saliva, etc. are applied as sample liquids that are targeted at medical sites. It may be a product. Measurement targets include saccharides, lactic acid, various cholesterols, nucleic acids, antibodies, antigens, proteins, hormones, bacteria, enzymes, drugs, constituents, medical products, tissue markers, metabolites, chemical substances, etc. Applicable to quantitative determination. The component measuring device is not limited to one type of POCT device, but a POCT device capable of performing simultaneous measurement of other items and a large inspection device, or a component measuring device for measuring components such as wastewater and industrial samples It can also be applied to. Further, as a simple measuring apparatus, not only the blood glucose meter 10 (SMBG device for self blood glucose measurement) that measures the amount of the glucose component in the blood, but also various devices that measure the amount of the component of the predetermined component in the liquid. Can be applied to. In addition, the component measuring apparatus is not limited to detection by optical means when detecting the component amount, and for example, the detected value of the component amount may be obtained by electrical means, magnetic means, or antibody reaction means. One example is a blood glucose level measuring device to which an enzyme electrode method is applied, and a component measuring device that measures urine components (such as ketone bodies). In addition, regarding the correction for the calculation error factor, the correction calculation process for the hematocrit value was mentioned, but other factors may be used, and in the case of a multi-item simultaneous measuring device, other items obtained by simultaneous measurement may be used. Good.

DESCRIPTION OF SYMBOLS 10 ... Blood glucose meter 14 ... Apparatus main body 25 ... Information part 26 ... Monitor 28 ... Operation button group 34 ... Control circuit 40 ... Blood glucose level measurement control part 50 ... Shock determination processing part 52 ... Shock sensor 55 ... Impact force flag 60 ... Inspection control Unit 62 ... Inspection execution control unit 64 ... Interval setting unit 66 ... Inspection notification unit 80 ... Result generation unit 82 ... Management device 90 ... Display information 92 ... Normal display screens 92a, 94b ... Inspection value display units 92b, 94c ... Pass / fail Display unit 94, 100, 110 ... Display screen upon impact 94a ... Statistical display unit 95a ... Horizontal line 95b ... Vertical line 96 ... Average value index line 97 ... Standard deviation index line BI ... Past inspection value TI ... Current inspection value

Claims (12)

A component measuring device for measuring the amount of a component in a liquid,
An inspection control unit that controls the inspection of the measurement accuracy of the component measuring device;
An impact force detector for detecting an impact force applied to the component measuring device;
An impact determination processing unit for determining the necessity of inspection upon impact based on the impact force, and
The inspection control unit
When the inspection at the time of impact is carried out, the current inspection result information that is information related to the result of the inspection at the time of impact and past inspection result information that is information related to the result of the past inspection are notified via the notification unit. A component measuring device for informing. In the component measuring device according to claim 1,
The notification unit includes a monitor,
The inspection control unit displays a normal display screen not including past inspection result information on the monitor when the normal inspection is performed in a normal state where it is not determined that the inspection at the time of impact is necessary, The component measuring apparatus, wherein when an inspection at impact is performed, an on-impact display screen including the current inspection result information and the past inspection result information is displayed on the monitor. In the component measuring device according to claim 2,
The inspection control unit simultaneously displays the current inspection result information and the past inspection result information on one screen of the monitor. In the component measuring device according to claim 2 or 3,
The component measurement apparatus, wherein the impact display screen includes the current inspection value as the current inspection result information and the past inspection value as the past inspection result information in one graph. In the component measuring device according to claim 4,
The said graph contains the information which concerns on the acceptance | permission acceptable range according to the density | concentration of the inspection liquid used in the said inspection. The component measuring device characterized by the above-mentioned. In the component measuring device according to any one of claims 2 to 5,
The display screen at the time of impact and the display screen at the normal time display a current inspection value as the current inspection result information as a numerical value, and also display information related to the pass / fail of the current inspection value. . In the component measuring device according to any one of claims 2 to 6,
The said impact display screen displays the statistical information of the said past inspection as said past inspection result information. The component measuring device characterized by the above-mentioned. In the component measuring device according to claim 7,
The statistical information includes at least one of an average value, a median value, and a standard deviation for a plurality of the past inspections. In the component measuring device according to any one of claims 1 to 8,
The component control apparatus urges the inspection control unit to perform the inspection at the time of the impact accompanying the determination of the impact determination processing unit every predetermined period. In the component measuring device according to claim 9,
The said inspection control part cancels | releases the state in which the inspection at the time of an impact is implemented based on the instruction | indication of the management apparatus connected to the said component measuring apparatus so that information communication is possible. The component measuring apparatus characterized by the above-mentioned. In the component measuring device according to any one of claims 1 to 10,
The component measuring device is a blood glucose meter that measures the amount of glucose components in blood. A method for inspecting a component measuring device for measuring the amount of a component in a liquid,
An inspection process for checking the measurement accuracy of the component measuring device;
A detection step of detecting an impact force applied to the component measuring device;
An impact determination step for determining the necessity of inspection upon impact based on the impact force, and
In the inspection process,
When the inspection at the time of impact is carried out, the current inspection result information that is information related to the result of the inspection at the time of impact and past inspection result information that is information related to the result of the past inspection are notified via the notification unit. A method for inspecting a component measuring apparatus, characterized by notifying.

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