Component measuring device, component measuring device set, and information processing method

Abstract

This component measuring device has a chip insertion space for inserting a component measuring chip, and comprises: a light receiving unit; a light emitting unit which emits irradiation light to the light receiving unit; and a control unit which measures a component to be measured in a sample, by using an actually measured value of the light receiving intensity of the light receiving unit. The control unit determines whether or not an abnormality has occurred in the component measuring device on the basis of whether or not the light receiving intensity of the light receiving unit is within a predetermined designated range.

Description

[Technical field]

[0001] The present disclosure relates to a component measuring device, a component measuring device set, and an information processing method. [Background technology]

[0002] Conventionally, in the fields of biochemistry and medicine, there are known devices that measure components to be measured contained in a sample such as blood as a specimen. For example, Patent Document 1 discloses a blood glucose meter that measures the amount of glucose in blood by attaching blood to a measurement chip attached to the blood glucose meter. [Prior art documents] [Patent documents]

[0003] [Patent Document 1] JP 2011-064596 A Summary of the Invention [Problem to be solved by the invention]

[0004] When measuring a component to be measured using a device such as a blood glucose meter, if it is possible to confirm whether the device is operating normally, the component to be measured can be measured appropriately.

[0005] An object of the present disclosure is to provide a component measuring device, a component measuring device set, and an information processing method that are capable of detecting whether normal measurement can be performed when measuring a component to be measured. [Means for solving the problem]

[0006] A component measuring device as a first aspect of the present disclosure is a component measuring device having a chip insertion space for inserting a component measuring chip, and comprising a light receiving unit, a light emitting unit which emits irradiation light to the light receiving unit, and a control unit which measures the component to be measured in a sample using an actual measured value of the received light intensity at the light receiving unit, wherein the control unit determines whether or not an abnormality has occurred in the component measuring device based on whether or not the received light intensity at the light receiving unit is within a predetermined specified range.

[0007] As one embodiment of the present disclosure, the control unit determines whether or not an abnormality has occurred based on at least one of an absolute output value of the light receiving unit when the light emitting unit is not emitting the emission light, and a relative output value which is the difference between the output value of the light receiving unit when the light emitting unit is emitting the irradiation light and the output value of the light receiving unit when the light emitting unit is not emitting the irradiation light.

[0008] As one embodiment of the present disclosure, the control unit determines that an abnormality has occurred in the component measuring device when the absolute output value is not within a predetermined first designated range and when the relative output value is not within a predetermined second designated range when the component measuring chip is not inserted into the chip insertion space.

[0009] As one embodiment of the present disclosure, when the component measuring chip is inserted into the chip insertion space, if the absolute output value is not within a predetermined third designated range and if the relative output value is within a predetermined fourth designated range, the control unit determines that an abnormality has occurred in the attachment state of the measuring chip to the component measuring device.

[0010] As one embodiment of the present disclosure, the control unit determines a type of abnormality based on the absolute output value or the relative output value.

[0011] As one embodiment of the present disclosure, when the control unit determines that an abnormality has occurred in the component measuring device, it notifies that an error has occurred.

[0012] As one embodiment of the present disclosure, the control unit determines that an abnormality has occurred in a circuit connected to the light receiving unit when the absolute output value is below a lower limit value of the first specified range.

[0013] As one embodiment of the present disclosure, when the absolute output value exceeds the upper limit value of the first specified range, the control unit determines that an abnormality in light receiving sensitivity has occurred due to an abnormality in the light receiving unit itself or an abnormality in a circuit connected to the light receiving unit.

[0014] As one embodiment of the present disclosure, the control unit determines that a light amount insufficiency abnormality has occurred when the relative output value is below a lower limit value of the second specified range.

[0015] As one embodiment of the present disclosure, the control unit determines that an abnormality in the amount of light emitted has occurred when the relative output value is above an upper limit value of the second specified range.

[0016] As one embodiment of the present disclosure, the control unit determines that an abnormality has occurred in a circuit connected to the light receiving unit when the absolute output value is below a lower limit value of the third specified range.

[0017] In one embodiment of the present disclosure, when the absolute output value exceeds the upper limit value of the third specified range and is included in a predetermined fourth specified range that is continuous from the upper limit value of the third specified range, the control unit determines that an ambient light abnormality has occurred in which a predetermined amount or more of ambient light reaches the light receiving unit.

[0018] As one embodiment of the present disclosure, when the absolute output value exceeds the upper limit value of the fourth specified range, the control unit determines that a light receiving sensitivity abnormality has occurred due to an abnormality in the light receiving unit itself or an abnormality in a circuit connected to the light receiving unit.

[0019] A component measuring device set as a second aspect of the present disclosure comprises a component measuring chip and a component measuring device having a chip insertion space for inserting the component measuring chip, the component measuring device comprising a light receiving unit, a light emitting unit which emits irradiated light, and a control unit which measures the component to be measured in a sample using an actual measured value of the received light intensity at the light receiving unit, and the control unit determines whether or not an abnormality has occurred in the component measuring device based on whether or not the received light intensity at the light receiving unit is within a predetermined specified range.

[0020] An information processing method as a third aspect of the present disclosure is an information processing method executed by a component measuring device having a chip insertion space for inserting a component measuring chip, and comprising: a light emitting unit that emits irradiated light; a light receiving unit; and a control unit that measures the component to be measured in a sample using an actual measured value of the light receiving intensity at the light receiving unit, and includes a step of determining whether or not an abnormality has occurred in the component measuring device based on whether or not the light receiving intensity at the light receiving unit is within a predetermined specified range. Effect of the Invention

[0021] According to the present disclosure, it is possible to provide a component measuring device, a component measuring device set, and an information processing method that are capable of detecting whether normal measurement can be performed when measuring a component to be measured. [Brief description of the drawings]

[0022] [Figure 1] 1 is a top view of a component measuring device set in which a component measuring chip is attached to a component measuring device as one embodiment. FIG. [Diagram 2] FIG. 2 is a cross-sectional view taken along line II in FIG. [Diagram 3] FIG. 2 is a cross-sectional view taken along line II-II in FIG. [Figure 4] FIG. 2 is a top view showing the component measuring chip shown in FIG. [Diagram 5] FIG. 5 is a cross-sectional view taken along line III-III in FIG. [Figure 6] FIG. 2 is a functional block diagram of the component measuring device shown in FIG. [Figure 7] 2 is a diagram showing the positional relationship of a plurality of light sources in the component measuring device shown in FIG. 1. [Figure 8] 8 is a diagram showing the irradiation position of light emitted from the mixture of the multiple light sources shown in FIG. 7. FIG. [Figure 9] 2 is a flowchart showing an example of a component measuring process executed by the component measuring device of FIG. 1. [Figure 10] 4 is a flowchart showing an example of a light quantity measurement process executed by the component measuring device of FIG. 1 in the component measurement process. [Figure 11] 8 is a diagram showing a schematic diagram of the light receiving intensity by a light receiving section of one set of irradiation light emitted from the first light source to the fifth light source in FIG. 7. FIG. [Figure 12] 4 is a diagram illustrating the light receiving intensities of the light emitted from the first light source to the fifth light source by the light receiving section. FIG. [Figure 13] 10 is a flowchart showing an example of a first received light intensity determination process. [Figure 14] 10 is a flowchart showing an example of a second received light intensity determination process. [Figure 15] 4 is a diagram illustrating the light receiving intensities of the light emitted from the first light source to the fifth light source by the light receiving section. FIG. [Figure 16] 4 is a diagram illustrating the light receiving intensities of the light emitted from the first light source to the fifth light source by the light receiving section. FIG. [Figure 17] 13 is a flowchart showing an example of a third received light intensity determination process. [Figure 18] 13 is a flowchart showing an example of a fourth received light intensity determination process. [Figure 19] 4 is a diagram illustrating the light receiving intensities of the light emitted from the first light source to the fifth light source by the light receiving section. FIG. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0023] Hereinafter, an embodiment of a component measuring device, a component measuring device set, and an information processing method according to the present disclosure will be described with reference to Fig. 1 to Fig. 19. Common members in each drawing are denoted by the same reference numerals.

[0024] First, an embodiment of the component measuring device according to the present disclosure will be described. Fig. 1 is a top view showing a component measuring device set 100 in which a component measuring chip 2 is attached to a component measuring device 1 in this embodiment. Fig. 2 is a cross-sectional view showing a cross section along II in Fig. 1, and Fig. 3 is a cross-sectional view showing a cross section along II-II in Fig. 1. Figs. 2 and 3 show an enlarged view of the vicinity of the location where the component measuring chip 2 is attached.

[0025] As shown in Figs. 1 to 3, the component measuring device set 100 includes a component measuring device 1 and a component measuring chip 2. The component measuring device 1 of this embodiment is a blood glucose level measuring device capable of measuring the concentration of glucose in a plasma component as a component to be measured in a sample. The component measuring chip 2 of this embodiment is a blood glucose level measuring chip that can be attached to one end of the blood glucose level measuring device as the component measuring device 1. The "sample" referred to here may be whole blood (blood) or separated plasma. The sample may also be an aqueous solution containing glucose.

[0026] The component measuring device 1 may be capable of executing processing in a plurality of modes. In this embodiment, the component measuring device 1 is capable of executing processing in one of two processing modes: a first mode for measuring the component to be measured, and a second mode for checking the performance of the component measuring device 1. The processing mode is selected, for example, by an operator of the component measuring device 1 performing a predetermined input operation on the component measuring device 1. In this embodiment, the selected processing mode corresponds to the processing mode to be executed. However, when the processing mode is automatically determined, for example, by the component measuring device 1, the determined processing mode becomes the processing mode to be executed.

[0027] The component measuring device 1 includes a housing 10 made of a resin material, a group of buttons provided on the upper surface of the housing 10, a display unit 11 configured with liquid crystal or LED (Light Emitting Diode) or the like provided on the upper surface of the housing 10, and a removal lever 12 that is operated when removing the component measuring tip 2 attached to the component measuring device 1. The group of buttons in this embodiment is configured with a power button 13 and an operation button 14.

[0028] As shown in FIG. 1, the housing 10 includes a main body 10a having a generally rectangular outer shape as viewed from above, with the above-mentioned button group and display unit 11 provided on the upper surface, and a tip mounting unit 10b protruding outward from the main body 10a and provided with a removal lever 12 on the upper surface. As shown in FIG. 2, a tip insertion space S is defined inside the tip mounting unit 10b, with a tip opening 10s formed on the tip surface of the tip mounting unit 10b at one end. When mounting the component measuring chip 2 to the component measuring device 1, the component measuring chip 2 is inserted from the outside into the tip insertion space S through the tip opening 10s, and the component measuring chip 2 is pushed to a predetermined position. This brings the component measuring chip 2 into a state where the tip mounting unit 10b of the component measuring device 1 engages with the component measuring chip 2, and the component measuring chip 2 can be mounted on the component measuring device 1. The component measuring chip 2 can be engaged by various configurations, for example, by providing a claw portion that can engage with a part of the component measuring chip 2 in the tip mounting unit 10b.

[0029] When removing the component measuring chip 2 attached to the component measuring device 1 from the component measuring device 1, the component measuring chip 2 is released from the locked state by the chip attachment part 10b of the component measuring device 1 by operating the above-mentioned removal lever 12 from outside the housing 10. At the same time, the eject pin 26 (see FIG. 2) in the housing 10 is displaced in conjunction with the above, and the component measuring chip 2 can be removed from the component measuring device 1.

[0030] The housing 10 of this embodiment is configured to include a main body portion 10a that is substantially rectangular when viewed from above (see FIG. 1) and a tip mounting portion 10b that protrudes outward from the main body portion 10a, but the housing is not limited to the shape of the housing 10 of this embodiment as long as it is configured to include a tip mounting portion to which the component measuring tip 2 can be attached. Therefore, in addition to the shape of the housing 10 of this embodiment, various shapes can be adopted that make it easier for an operator to hold it with one hand, for example.

[0031] The display unit 11 can display information on the components to be measured measured by the component measuring device 1. In this embodiment, the glucose concentration measured by a blood glucose measuring device serving as the component measuring device 1 can be displayed on the display unit 11. The display unit 11 may be configured to display not only information on the components to be measured, but also various other information such as the measurement conditions of the component measuring device 1 and instruction information for instructing the operator to perform a specific operation. The operator can operate the power button 13 and operation buttons 14 of the button group while checking the content displayed on the display unit 11.

[0032] 2 and 3, the component measuring device 1 includes a light emitting unit 66 and a light receiving unit 72. As shown in FIG. 2 and FIG. 3, in a state where the component measuring chip 2 is attached to the chip insertion space S of the component measuring device 1, the component measuring chip 2 is irradiated with irradiation light emitted by the light emitting unit 66. The light receiving unit 72 receives transmitted light that has passed through the component measuring chip 2 out of the irradiation light irradiated from the light emitting unit 66 to the component measuring chip 2. In this embodiment, the light emitting unit 66 and the light receiving unit 72 are arranged opposite each other across the chip insertion space S. The arrangement of the light emitting unit 66 and the light receiving unit 72 is not limited to this. The light receiving unit 72 may be located at a position where it can detect light that passes through the sample in the component measuring chip 2. For example, the light emitting unit 66 and the light receiving unit 72 may be arranged on the same side of the component measuring chip 2, and a reflective member may be provided on the side facing the light emitting unit and the light receiving unit across the chip insertion space S and the sample.

[0033] The light emitting unit 66 includes five light sources. Specifically, the light emitting unit 66 includes a first light source 67, a second light source 68a, a third light source 68b, a fourth light source 68c, and a fifth light source 68d. As shown in FIG. 2, the first light source 67, the fourth light source 68c, and the fifth light source 68d are arranged at different positions in a flow direction A (direction toward the right in FIG. 2) in which a sample flows in the flow path 23 of the component measuring chip 2 described later. Also, as shown in FIG. 3, the first light source 67, the second light source 68a, and the third light source 68b are arranged at different positions in a flow path width direction B (both left and right directions in FIG. 3) perpendicular to the flow direction A. The arrangement of the first light source 67 to the fifth light source 68d will be described in detail later (see FIG. 7).

[0034] Next, the component measuring chip 2 will be described. FIG. 4 is a top view showing the component measuring chip 2. FIG. 5 is a cross-sectional view taken along line III-III in FIG. 4. As shown in FIGS. 4 and 5, the component measuring chip 2 includes a base member 21 having a substantially rectangular plate-like outer shape, a measurement reagent 22 held on the base member 21, and a cover member 25 that covers the base member 21. The cover member 25 may be made of a light-shielding material in areas other than the area where the measurement spot is formed when the component measuring chip 2 is inserted into the component measuring device 1. The measurement spot will be described in detail later.

[0035] A groove is formed on one side of the thickness direction of the base member 21 (in this embodiment, the thickness direction is the same as the thickness direction C of the component measuring chip 2 shown in Figures 2 and 3, so it will be referred to as the thickness direction C hereinafter). The groove of the base member 21 is covered with the cover member 25 to become a hollow portion extending in a direction perpendicular to the thickness direction C, and this hollow portion constitutes the flow path 23 of the component measuring chip 2. At one end of the flow path 23, a supply part 24 capable of supplying a sample from the outside is formed. In addition, a measurement reagent 22 is held at the bottom of the groove of the base member 21 among the inner walls of the flow path 23, and the sample supplied to the supply part 24 from the outside moves in the flow direction A along the flow path 23 by using, for example, capillary action, reaches the holding position where the measurement reagent 22 is held, and comes into contact with the measurement reagent 22. The measurement reagent 22 contains a coloring reagent that dissolves in the sample and reacts with the measured component in the sample to develop a color. Therefore, when the measurement reagent 22 comes into contact with the component to be measured in the sample, a color reaction occurs in which the color-developing reagent contained in the measurement reagent 22 develops color, and a colored component (reaction product) is produced.

[0036] A gap 23a is formed between the cover member 25 and the measurement reagent 22. The sample moving in the flow direction A through the flow path 23 from the supply unit 24 provided at one end dissolves the measurement reagent 22 and reaches the other end of the flow path 23 while reacting. Therefore, by allowing the sample to reach the entire area of ​​the measurement reagent 22 in the flow direction A, it is possible to make the mixture X containing the color component spread in an area that can become a measurement spot. Here, the mixture X contains at least the sample, the unreacted or reacted measurement reagent 22, and the color component.

[0037] 2, for convenience of explanation, the sample is omitted and "mixture X" is shown to be present at the holding position of the measurement reagent 22, but mixture X diffuses not only to the holding position of the measurement reagent 22 but also to the vicinity of the holding position of the measurement reagent 22, such as gap 23a. More specifically, the sample entering the flow path 23 from the supply unit 24 contacts the measurement reagent 22 at the holding position and reaches the downstream end of the flow path 23 through gap 23a, so that the inside of the flow path 23 is filled with the sample. The measurement reagent 22 dissolves in the sample, and a color reaction with the sample progresses, resulting in a state in which mixture X is located at the holding position and its vicinity.

[0038] In the present embodiment, the flow path 23 is configured by a hollow portion defined by the base member 21 and the cover member 25, but the flow path is not limited to this configuration. The flow path may be formed only by a groove formed on the outer surface of one side in the thickness direction C of the base member 21.

[0039] It is preferable to use a transparent material for the base member 21 and the cover member 25 so that the amount of transmitted light after the irradiated light passes through the material becomes a sufficient signal for measurement. Examples of the transparent material include transparent organic resin materials such as polyethylene terephthalate (PET), polymethyl methacrylate (PMMA), polystyrene (PS), cyclic polyolefin (COP), cyclic olefin copolymer (COC), polycarbonate (PC), etc.; and transparent inorganic materials such as glass and quartz.

[0040] The measurement reagent 22 includes a coloring reagent that reacts with the component to be measured in the sample and causes a coloring reaction that changes color depending on the blood concentration of the component to be measured. The measurement reagent 22 of this embodiment is applied to the bottom of the groove as the flow path 23. The measurement reagent 22 of this embodiment reacts with glucose as the component to be measured in the sample. Examples of the measurement reagent 22 of this embodiment include a mixed reagent of (i) glucose oxidase (GOD), (ii) peroxidase (POD), (iii) 1-(4-sulfophenyl)-2,3-dimethyl-4-amino-5-pyrazolone, and (iv) N-ethyl-N-(2-hydroxy-3-sulfopropyl)-3,5-dimethylaniline, sodium salt, monohydrate (MAOS), or a mixed reagent of glucose dehydrogenase (GDH) and a tetrazolium salt. Furthermore, a buffer such as a phosphate buffer or a mediator may be included. The types and components of the measurement reagent 22 are not limited to these.

[0041] However, in the measurement reagent 22 of this embodiment, a coloring reagent is selected in which the peak wavelength in the absorbance spectrum of the coloring component generated by the color reaction with glucose in the sample is different from the peak wavelength caused by the light absorption characteristics of hemoglobin in blood cells. The coloring reagent contained in the measurement reagent 22 of this embodiment has an absorbance spectrum of the coloring component with a peak wavelength around 660 nm, but is not limited to a coloring reagent with a peak wavelength around 660 nm, and is appropriately selected depending on the purpose.

[0042] As shown in FIG. 2, when the component to be measured is measured by the component measuring device 1, the component measuring chip 2 is mounted in the chip mounting portion 10b. When a sample is supplied to the supply portion 24 provided at one end of the component measuring chip 2, the sample moves in the flow path 23 by capillary action, for example, and reaches a holding position in the flow path 23 where the measurement reagent 22 is held, and the glucose in the sample (plasma) reacts with the measurement reagent 22 at this holding position. Then, at the holding position of the flow path 23, a mixture X containing a color-producing component is generated. The so-called colorimetric component measuring device 1 irradiates the mixture X containing the color-producing component with irradiation light, detects the amount of transmitted light (or the amount of reflected light), and obtains a detection signal that correlates with the intensity of color development according to the blood concentration. Then, the component measuring device 1 can measure the component to be measured by referring to a calibration curve created in advance. As described above, the component measuring device 1 of this embodiment can measure the glucose concentration in the plasma component in the sample.

[0043] Fig. 6 is a functional block diagram of the component measuring device 1 shown in Fig. 1 to Fig. 3. As shown in Fig. 6, the component measuring device 1 includes a control unit 50, a photometry unit 51, a storage unit 52, a temperature measurement unit 53, a power supply unit 54, a battery 55, a communication unit 56, a clock unit 57, an operation unit 58, a buzzer unit 59, and a display unit 11.

[0044] The control unit 50 is composed of an MPU (Micro-Processing Unit) or a CPU (Central Processing Unit), and can realize the control operation of each unit by reading and executing a program stored in the storage unit 52 etc. The storage unit 52 is composed of a non-transient storage medium that is volatile or non-volatile, and can read or write various data (including programs) necessary for executing the component measurement method shown in this embodiment.

[0045] When operating in the first mode, the control unit 50 can measure the component to be measured in the sample by operating the photometry unit 51. Furthermore, when executing the measurement process of the component to be measured by the component measuring device 1, the control unit 50 can execute a process of detecting whether or not normal measurement can be performed. Furthermore, the control unit 50 can execute a process of determining whether or not there is a possibility that the selection of the processing mode is incorrect. Details of the process of measuring the component to be measured, the process of detecting whether or not normal measurement can be performed, and the process of determining whether or not there is a possibility that the selection of the processing mode is incorrect will be described later.

[0046] The photometry unit 51 is an optical system capable of acquiring optical characteristics of a mixture X containing a sample and a color component.

[0047] The light-emitting unit 66 emits irradiation light toward the chip insertion space S. The light-emitting unit 66 includes a plurality of light sources. Specifically, the light-emitting unit 66 of this embodiment includes five light sources that emit irradiation light having different spectral radiation characteristics (for example, visible light and infrared light). More specifically, as described above, the light-emitting unit 66 of this embodiment includes the first light source 67, the second light source 68a, the third light source 68b, the fourth light source 68c, and the fifth light source 68d. The positional relationship between the first light source 67 to the fifth light source 68d is the positional relationship shown in FIG. 2 and FIG. 3. Details of the actual positional relationship between the first light source 67 to the fifth light source 68d will be described later (see FIG. 7).

[0048] The peak wavelengths of the light emitted from the first light source 67 to the fifth light source 68d are λ1 to λ5, respectively. As the first light source 67 to the fifth light source 68d, various light emitting elements such as LED elements, EL (Electro-Luminescence: organic electroluminescence) elements, inorganic EL elements, LD (Laser Diode: laser diode) elements, etc. are applicable. As the first light source 67 to the fifth light source 68d, the above-mentioned LED elements are easy to use in consideration of versatility, etc. In this embodiment, the first light source 67 to the fifth light source 68d are configured by LED elements. Hereinafter, the above-mentioned "peak wavelength" will be described as the wavelength of light emitted from each light source, and for convenience of explanation, the peak wavelength λ1 of the first light source 67 will be described as the "first predetermined wavelength λ1", the peak wavelength λ2 of the second light source 68a will be described as the "second predetermined wavelength λ2", the peak wavelength λ3 of the third light source 68b will be described as the "third predetermined wavelength λ3", the peak wavelength λ4 of the fourth light source 68c will be described as the "fourth predetermined wavelength λ4", and the peak wavelength λ5 of the fifth light source 68d will be described as the "fifth predetermined wavelength λ5". For convenience, the "peak wavelength" in this embodiment is shown as a single numerical value, but may also include a wavelength range of ±20 nm of each numerical value.

[0049] The light receiving unit 72 receives the transmitted light or reflected light of the irradiation light emitted from the light emitting unit 66 in the region where the color component is located. As shown in Figs. 2 and 3, the light receiving unit 72 of this embodiment is composed of one light receiving element arranged facing the light emitting unit 66 with the component measuring chip 2 in between. In this embodiment, the light receiving unit 72 receives the transmitted light that is irradiated from the first light source 67 to the fifth light source 68d of the light emitting unit 66 to the mixture X generated at the holding position of the measurement reagent 22 on the component measuring chip 2 and transmitted through the component measuring chip 2. As the light receiving unit 72, various photoelectric conversion elements including a PD (Photo diode) element, a photoconductor, and a PT (Photo Transistor) can be used.

[0050] In the present specification, the area irradiated with light detectable by the light receiving unit 72 among the areas irradiated with light from the light emitting unit 66 in the component measuring device 1 will be referred to as the measurement area. When measurement is performed, the color component (or mixture X) to be detected is present in the measurement area.

[0051] Each of the first light source 67 to the fifth light source 68d receives a drive power signal from a light emission control circuit included in the photometry unit 51, and turns on and off based on the drive power signal. The light receiving unit 72 outputs an analog signal according to the received light. This analog signal is amplified and AD converted by the light receiving control circuit included in the photometry unit 51, and converted into a digital signal (hereinafter referred to as a detection signal).

[0052] 6 again, the storage unit 52 can be composed of a semiconductor memory, a magnetic memory, or the like. The storage unit 52 stores, for example, various information and programs for operating the component measuring device 1. The storage unit 52 may also function as a work memory.

[0053] The temperature measuring unit 53 measures the temperature in the vicinity of the component measuring chip 2. The temperature measuring unit 53 measures, for example, the temperature of the chip insertion space S. The temperature measuring unit 53 may be configured, for example, with a known thermometer. The temperature measured by the temperature measuring unit 53 can be used, for example, in adjusting the amount of irradiation light emitted from the light emitting unit 66 described later.

[0054] The power supply unit 54 supplies the power stored in the battery 55 to each functional unit of the component measuring device 1 .

[0055] The communication unit 56 transmits and receives various information by performing wired or wireless communication with an external device. For example, the communication unit 56 transmits the result of the component measurement by the component measuring device 1 to the external device connected in a communicable manner. The communication unit 56 may receive a signal for causing the component measuring device 1 to execute an operation from the external device connected in a communicable manner.

[0056] The clock unit 57 measures and keeps time and may be configured with, for example, an RTC (Real Time Clock).

[0057] The operation unit 58 is an input interface for an operator of the component measuring device 1 to perform input operations on the component measuring device 1. In this embodiment, the operation unit 58 is configured with a power button 13 and an operation button 14. However, the configuration of the operation unit 58 is not limited to the power button 13 and the operation button 14, and may be realized in any form that allows the operator to perform an input operation. For example, by operating the operation unit 58, the operator can select (decide) whether to cause the component measuring device 1 to execute the first mode or the second mode.

[0058] The buzzer unit 59 notifies information by outputting a buzzer sound. The buzzer unit 59 outputs the buzzer sound at a predetermined timing that is set in advance. For example, the buzzer unit 59 outputs the buzzer sound when the component measurement process by the component measuring device 1 is completed, when a malfunction occurs in the component measuring device 1, etc.

[0059] Next, a measurement process of a component to be measured in a sample in the first mode by the control unit 50 of the component measuring device 1 and the arrangement of the first light source 67 to the fifth light source 68d will be described.

[0060] The control unit 50 instructs the photometry unit 51 to perform a measurement operation, and measures the concentration of the component to be measured using the detection signal and various data acquired by the photometry unit 51.

[0061] The storage unit 52 stores the actual measurement value data of the first actual measurement value D1 to the fifth actual measurement value D5, which are the absorbance of the mixture X at the first predetermined wavelength λ1 to the fifth predetermined wavelength λ5, respectively, measured by the photometry unit 51, correction coefficient data including a group of correction coefficients correlating with the absorbance of the mixture X at the second predetermined wavelength λ2 to the fifth predetermined wavelength λ5, and calibration curve data such as a calibration curve showing the relationship between the absorbance of the color component in the mixture X obtained by correcting the absorbance of the mixture X actually measured at the first predetermined wavelength λ1 using the correction coefficient data and various physical quantities (e.g., glucose concentration) and a calibration curve showing the relationship between the absorbance of hemoglobin in the mixture X and the hematocrit value. The "hematocrit value" is a value that indicates the volume ratio of blood cell components in the blood as a sample to blood (whole blood) as a percentage.

[0062] The component measuring device 1 can measure the analyte in the sample based on the optical characteristics of the mixture X containing the color component generated by the color reaction between the analyte in the sample and the reagent. Specifically, the component measuring device 1 can estimate the amount of noise other than the color component contained in the first measured value D1 of the absorbance of the mixture X measured by irradiating the mixture X with the irradiation light of the first predetermined wavelength λ1 as the measurement wavelength, using the irradiation light of the second predetermined wavelength λ2 to the fifth predetermined wavelength λ5. More specifically, the component measuring device 1 can estimate the amount of noise using the second measured value D2 to the fifth measured value D5 of the absorbance of the mixture X measured by irradiating the mixture X with the irradiation light of the second predetermined wavelength λ2 to the fifth predetermined wavelength λ5, and can measure the absorbance of the color component and further the analyte.

[0063] Fig. 7 is a diagram showing the positional relationship of the first light source 67 to the fifth light source 68d when viewed from the top surface (see Fig. 1) side of the component measuring device 1. For convenience of explanation, in Fig. 7, the position of the light receiving part 72 in the flow channel 23 of the component measuring chip 2 is shown by a two-dot chain line, and in this embodiment, the mixture X is generated at the holding position in the flow channel 23 and in its vicinity.

[0064] 2, 3 and 7, the first light source 67 to the fifth light source 68d are arranged facing the mixture X located in the sample flow path 23. More specifically, the first light source 67 to the fifth light source 68d in this embodiment are arranged facing the holding position of the measurement reagent 22 in the sample flow path 23 in a direction perpendicular to both the flow direction A and the flow path width direction B (in this embodiment, the same direction as the thickness direction C of the component measuring chip 2).

[0065] 3 and 7, the first light source 67 and the second light source 68a are arranged side by side along a flow path width direction B perpendicular to the sample flow direction A at the position of the mixture X in the sample flow path 23. In this embodiment, the first light source 67 and the second light source 68a are arranged such that a first irradiation position SL1 on the mixture X of the irradiation light from the first light source 67 and a second irradiation position SL2 on the mixture X of the irradiation light from the second light source 68a overlap in the flow path width direction B.

[0066] 3 and 7, the first light source 67, the second light source 68a, and the third light source 68b are arranged side by side in the flow path width direction B with the first light source 67 at the center. In this embodiment, the first light source 67 and the third light source 68b are arranged such that an area in the flow direction A of the mixture X at a first irradiation position SL1 of the irradiated light from the first light source 67 and an area in the flow direction A of the mixture X at a third irradiation position SL3 of the irradiated light from the third light source 68b overlap in the flow path width direction B, as shown in FIG.

[0067] That is, the first light source 67 to the third light source 68b are arranged such that their respective irradiation positions overlap in the flow path width direction B. It is preferable that the first light source 67 to the third light source 68b are arranged side by side along the flow path width direction B, and that the regions of the first irradiation position SL1 to the third irradiation position SL3 in the flow path width direction A overlap in the flow path width direction B. It is more preferable that the regions of the first light source 67 to the third light source 68b in the flow path width direction B of the first irradiation position SL1 to the third irradiation position SL3 also overlap in the flow direction A.

[0068] In this embodiment, the first light source 67 and the second light source 68a are disposed adjacent to each other in the flow path width direction B, and there is no gap between the first light source 67 and the second light source 68a in which another light source can be disposed. The first light source 67 and the third light source 68b are disposed adjacent to each other in the flow path width direction B, and there is no gap between the first light source 67 and the third light source 68b in which another light source can be disposed. In this way, the first light source 67, the second light source 68a, and the third light source 68b are disposed adjacent to each other in the flow path width direction B, with no other light source interposed therebetween.

[0069] 2 and 7, the first light source 67 and the fourth light source 68c are arranged side by side along the flow direction A. Also, as shown in Fig. 2 and 7, the first light source 67 and the fifth light source 68d of this embodiment are arranged side by side along the flow direction A. That is, the first light source 67, the fourth light source 68c, and the fifth light source 68d are arranged side by side along the flow direction A with the first light source 67 at the center.

[0070] In this embodiment, the first light source 67 and the fourth light source 68c are arranged side by side along the flow direction A such that a first irradiation position SL1 in the mixture X of the light irradiated from the first light source 67 and a fourth irradiation position SL4 in the mixture X of the light irradiated from the fourth light source 68c overlap in area while the difference in the angle of incidence to the mixture X is a predetermined value or less. More specifically, there is no gap between the first light source 67 and the fourth light source 68c in the flow direction A in which another light source can be disposed, and the first light source 67 and the fourth light source 68c are adjacent to each other in the flow direction A.

[0071] The first light source 67 and the fifth light source 68d are also arranged side by side along the flow direction A so that a first irradiation position SL1 in the mixture X of the light irradiated from the first light source 67 and a fifth irradiation position SL5 in the mixture X of the light irradiated from the fifth light source 68d can overlap in area while the difference in the angle of incidence to the mixture X is a predetermined value or less. More specifically, there is no gap between the first light source 67 and the fifth light source 68d in the flow direction A where another light source can be disposed, and the first light source 67 and the fifth light source 68d are adjacent to each other in the flow direction A.

[0072] As shown in FIG. 7, the first light source 67 to the fifth light source 68d of this embodiment are held by a thin plate-shaped holder member 80. The holder member 80 of this embodiment has a cross-shaped outer shape in a top view, and the first light source 67 is held at the center (intersection of the cross) in a top view. The second light source 68a is held at a position on one side in the flow path width direction B with respect to the center where the first light source 67 is held, and the third light source 68b is held at a position on the other side in the flow path width direction B. The fifth light source 68d is held at a position in the flow direction A with respect to the center where the first light source 67 is held, and the fourth light source 68c is held at a position opposite to the flow direction A.

[0073] In this embodiment, a second light source 68a and a third light source 68b that emit irradiation light of a second predetermined wavelength λ2 and a third predetermined wavelength λ3 are arranged side by side with respect to the first light source 67 along the flow path width direction B. Further, a fourth light source 68c and a fifth light source 68d that emit irradiation light of a fourth predetermined wavelength λ4 and a fifth predetermined wavelength λ5 are arranged side by side with respect to the first light source 67 along the flow direction A. Although details will be described later, the above-mentioned second predetermined wavelength λ2 and the third predetermined wavelength λ3 are wavelengths that belong to the infrared region, and the above-mentioned fourth predetermined wavelength λ4 and fifth predetermined wavelength λ5 are wavelengths that belong to the visible region.

[0074] In this embodiment, as shown in FIG. 2 and FIG. 3, the light receiving unit 72 faces the first light source 67 to the fifth light source 68d in the thickness direction C across the mixture X located in the flow path 23 of the attached component measuring chip 2, and receives the transmitted light of the irradiation light from the first light source 67 to the fifth light source 68d transmitted through the mixture X. As shown in FIG. 2 and FIG. 3, the component measuring device 1 is provided with a first diaphragm unit 69a located between the mixture X and the light receiving unit 72, and adjusting the amount of light reaching the light receiving unit 72 out of the transmitted light transmitted through the mixture X. The difference between the incidence angle of the irradiation light from the first light source 67 on the mixture X and the incidence angle of the irradiation light from each of the second light source 68a to the fifth light source 68d on the mixture X affects the estimation accuracy of the noise amount. Therefore, it is preferable that the difference between the incidence angle of the irradiation light from the first light source 67 on the mixture X and the incidence angle of the irradiation light from each of the second light source 68a to the fifth light source 68d on the mixture X is as small as possible. In other words, it is preferable to increase the distance T1 between the first light source 67 to the fifth light source 68d and the first diaphragm portion 69a in the facing direction (the same direction as the thickness direction C of the component measuring chip 2 in Figs. 2 and 3) in order to improve the estimation accuracy of the noise amount. On the other hand, by decreasing the distance T2 between the first light source 67 to the fifth light source 68d and the light receiving portion 72 in the facing direction, it is possible to improve the light efficiency and reduce the size of the component measuring device 1.

[0075] Furthermore, if there is a large deviation (hereinafter referred to as "measurement field difference") between the area of ​​the first irradiation position SL1 of the first light source 67 and the areas of the second irradiation position SL2 to the fifth irradiation position SL5 of the second light source 68a to the fifth light source 68d, the measurement points do not match, and the accuracy of the measurement results of the components to be measured may decrease. Therefore, it is preferable to make this measurement field difference small. Therefore, it is preferable to shorten the distance T3 between the mixture X and the first aperture section 69a in the facing direction (the same direction as the thickness direction C of the component measuring chip 2 in Figures 2 and 3). More preferably, in addition to the first aperture section 69a, one surface of the component measuring chip 2 is formed of a light-shielding member and an opening through which the measurement light can pass is provided to form an aperture. In this case, only the measurement spot may be formed of a transparent member to form an aperture, or the light-shielding member may be cut out to form an aperture.

[0076] Furthermore, as shown in FIG. 2 and FIG. 3, the component measuring device 1 is provided with a second diaphragm section 69b that is located between the first light source 67 to the fifth light source 68d and the mixture X and adjusts the amount of light that reaches the mixture X from the first light source 67 to the fifth light source 68d. In particular, the second diaphragm section 69b is preferably designed so that light reflected by the inner wall of the second diaphragm section 69b (hereinafter referred to as "stray light") among the light emitted from the first light source 67 to the fifth light source 68d does not enter the first diaphragm section 69a. It can be considered that the light emitted from the first light source 67 to the fifth light source 68d is attenuated to 5% by one wall reflection and disappears after three or more multiple reflections. Therefore, in this embodiment, if the stray light reflected by the inner wall of the second diaphragm section 69b does not reach the first diaphragm section 69b and is reflected by some wall, it will not enter the first diaphragm section 69a due to multiple reflections. In this embodiment, the optical axis of each light source is designed to be specularly reflected by the inner wall of the second diaphragm portion 69b, but in reality, the light is diffusely reflected by the inner wall of the second diaphragm portion 69b, and stray light also has a predetermined distribution. Therefore, in this embodiment, even if a part of the stray light enters the first diaphragm portion 69a, it is preferable to set the above-mentioned distance T4 etc. so that the difference between the incident angle and the incident angle of the first light source 67 is a predetermined value or less.

[0077] The component measuring device 1 of this embodiment is capable of mounting a component measuring chip 2 that defines a flow path 23 through which a sample flows and that has a measurement reagent 22, which includes a color-developing reagent that undergoes a color reaction with a component to be measured in the sample, disposed in the flow path 23. The component measuring device 1 of this embodiment is capable of measuring a component to be measured in a sample based on the optical properties of a mixture that includes a color-developing component generated by reaction with the component to be measured in the flow path 23, by mounting the component measuring chip 2. The component measuring device 1 is preferably configured so that the disposable component measuring chip 2 is detachable.

[0078] Next, a method for calculating the concentration of a component to be measured in a sample in the first mode by the control unit 50 of the component measuring device 1 according to this embodiment will be described.

[0079] In this embodiment, the component measuring device 1 performs the measurement using a sample (e.g., whole blood) and a color-developing reagent without separating the plasma component containing glucose from the sample, by using a color reaction between glucose as the component to be measured in the sample and a color-developing reagent in the measurement reagent 22. The component measuring device 1 estimates the absorbance at a predetermined measurement wavelength of the colored component generated by the color reaction between glucose and the color-developing reagent based on the absorbance at each wavelength of the entire mixture X obtained by this color reaction, and can calculate the concentration of the component to be measured.

[0080] In general, when a sample contains components other than the color component to be measured, the measurement result of the concentration of the component to be measured based on the absorbance of the color component may be affected as a disturbance factor (noise) due to the occurrence of optical phenomena. For example, the occurrence of "light scattering" due to blood cell components in the sample, the surface of the component measurement chip, or fine particles such as dust attached to the component measurement chip, or "light absorption" due to pigment components other than the color component to be measured (specifically, mainly hemoglobin when the sample is blood), tends to result in the measured absorbance being greater than the true value.

[0081] When using a mixture X containing a sample having specific absorption characteristics in addition to the color component to be measured, in order to accurately measure the absorbance due to the color component, it is necessary to remove disturbance factors (noise) due to the absorption characteristics of the sample from the actual measured value of absorbance at a specified measurement wavelength.

[0082] When the sample is blood, examples of disturbance factors include light scattering by blood cell components and light absorption by hemoglobin. More specifically, it is necessary to estimate the amount of disturbance factors (noise) such as light scattering by blood cell components and light absorption by hemoglobin at a predetermined measurement wavelength (e.g., 660 nm) where the light absorption rate of the color component to be measured is high, and correct the actual measured value of absorbance at the same measurement wavelength. The component measuring device 1 according to this embodiment performs this correction to calculate the concentration of the component to be measured.

[0083] In this embodiment, the component measuring device 1 can measure the component to be measured in the sample based on the optical characteristics of the mixture X containing a color component generated by a color reaction between the sample and the measurement reagent 22. Specifically, in this embodiment, the concentration of glucose contained in the plasma component in the sample is measured.

[0084] Here, the principle of measuring glucose concentration and the wavelengths λ1 to λ5 of the light emitted by the first light source 67 to the fifth light source 68d, respectively, will be described. Hemoglobin in red blood cells mainly contains oxyhemoglobin bound to oxygen and reduced hemoglobin in which oxygen is dissociated in a place where the oxygen partial pressure is low. Oxyhemoglobin plays a role in transporting oxygen throughout the body through arteries after passing through the lungs and binding to oxygen, and can be found in large amounts in arterial blood. For example, when blood is collected as a sample from the pad of a finger, the blood is from capillaries, so the amount of this oxyhemoglobin is relatively large. Conversely, reduced hemoglobin can be found in large amounts in venous blood.

[0085] In the existing technology, it is common to correct the absorbance obtained at the measurement wavelength corresponding to the color component to be measured, for example, by using the hematocrit value, without considering the ratio of reduced hemoglobin to oxygenated hemoglobin. However, the absorption coefficient of reduced hemoglobin and the absorption coefficient of oxygenated hemoglobin do not match, and the absorption amount by reduced hemoglobin and the absorption amount by oxygenated hemoglobin differ depending on the wavelength. For example, when the measurement wavelength for measuring the absorbance of the color component to be measured is 660 nm, the absorption coefficient of reduced hemoglobin is about 0.9, and the absorption coefficient of oxygenated hemoglobin is about 0.09. In other words, if the ratio of oxygenated hemoglobin to reduced hemoglobin is 1:1, the absorption coefficient of oxygenated hemoglobin corresponds to about 10% of the absorption coefficient of the total hemoglobin. In order to more accurately estimate the absorbance derived from the color component to be measured, it is important to consider the ratio of reduced hemoglobin to oxygenated hemoglobin.

[0086] Therefore, in the component measuring device 1, the measurement wavelength (first predetermined wavelength λ1) for measuring the absorbance of the color component contained in the mixture X is set to 660 nm, and correction is performed to remove the influence of light scattering by blood cell components, etc. and the influence of light absorption by hemoglobin taking into account the ratio of reduced hemoglobin to oxygenated hemoglobin as disturbance factors (noise) from the actual absorbance value of the mixture X measured at this measurement wavelength. As a result, the absorbance of the color component contained in the mixture X is estimated, and the glucose concentration is calculated using a calibration curve showing the relationship between this estimated absorbance and the glucose concentration.

[0087] The component measuring method executed by the component measuring device 1 will be described in further detail below.

[0088] First, the color reagent in the measurement reagent 22 used in this embodiment produces a color component by color reaction with glucose in the sample, and the absorbance of the color component has a peak at around 600 nm. In this embodiment, the measurement wavelength for measuring the absorbance of the color component is 660 nm.

[0089] The measurement wavelength for measuring the absorbance of the color component to be measured may be a wavelength at which the light absorptance of the color component is relatively large and at which the influence of light absorption by hemoglobin is relatively small. Specifically, the wavelength may be a wavelength that corresponds to the full width at half maximum of the peak wavelength range in the absorbance spectrum of the color component to be measured and belongs to a wavelength range W3 in which the ratio of absorbance due to light absorption by hemoglobin to the total absorbance is relatively small. The wavelength range "corresponding to the full width at half maximum of the peak wavelength range" means a range from a wavelength showing half-maximum on the short wavelength side to a wavelength showing half-maximum on the long wavelength side when the full width at half maximum of the peak wavelength range in the absorbance spectrum is specified. The absorbance spectrum of the color component to be measured in this embodiment has a peak wavelength near 600 nm, and a wavelength range corresponding to the full width at half maximum is about 500 nm to about 700 nm. In addition, the influence of light absorption by hemoglobin on the total absorbance is relatively small in a wavelength range of 600 nm or more. Therefore, in this embodiment, the wavelength range W3, which corresponds to the full width at half maximum of the peak wavelength range in the absorbance spectrum of the color component to be measured and in which the ratio of the absorbance due to the light absorption of hemoglobin to the total absorbance is relatively small, is 600 nm or more and 700 nm or less. Therefore, the measurement wavelength is not limited to 660 nm in this embodiment, and another wavelength in the range of 600 nm to 700 nm may be used as the measurement wavelength. Since the signal representing the absorbance of the color component is strong and the ratio of the absorbance due to the light absorption of hemoglobin to the total absorbance is reduced as much as possible in the wavelength range, the absorbance derived from the color component can be measured more accurately, it is preferable to use the measurement wavelength around 660 nm, which is a slightly longer wavelength than the peak wavelength around 600 nm in the absorbance spectrum of the color component. More specifically, the measurement wavelength is preferably a wavelength in the range of 630 nm to 680 nm, more preferably a wavelength in the range of 640 nm to 670 nm, and particularly preferably 660 nm as in this embodiment. A preferred example of such a color-developing reagent is a tetrazolium salt.

[0090] Furthermore, in this embodiment, a coloring reagent is used in which the full width at half maximum of the peak wavelength range in the absorbance spectrum of the coloring component is about 500 nm to about 700 nm, but a coloring reagent in which the full width at half maximum of the peak wavelength range is different from this range may be used. However, as described above, in consideration of the absorption characteristics of hemoglobin, it is desirable to prevent the wavelength range (600 nm or less) in which the absorbance due to light absorption by hemoglobin is large from overlapping with the measurement wavelength in the absorbance spectrum of the coloring component.

[0091] Hereinafter, a method for estimating the absorbance of the color component at the measurement wavelength of 660 nm in this embodiment will be described. The component measuring device 1 actually measures the absorbance of the mixture X at four second predetermined wavelengths λ2 to 5th predetermined wavelengths λ5 different from the measurement wavelength (660 nm), and corrects the first measured value D1 of the absorbance of the mixture X at the measurement wavelength using the four second measured values ​​D2 to 5th measured values ​​D5 and predetermined correction coefficient data, thereby estimating the absorbance of the color component at the measurement wavelength. The measurement wavelength in this embodiment is the above-mentioned first predetermined wavelength λ1.

[0092] The component measuring device 1 utilizes, as the above-mentioned four second measured values ​​D2 to fifth measured values ​​D5, two second measured values ​​D2 and third measured values ​​D3 of the absorbance of the mixture X at two second predetermined wavelengths λ2 and third predetermined wavelengths λ3, respectively, which are longer than the measurement wavelength, the first predetermined wavelength λ1, and two fourth measured values ​​D4 and fifth measured values ​​D5 of the absorbance of the mixture X at two fourth predetermined wavelengths λ4 and fifth predetermined wavelengths λ5, respectively, which are shorter than the measurement wavelength, the first predetermined wavelength λ1.

[0093] More specifically, as the four second measured values ​​D2 to fifth measured values ​​D5 mentioned above, two measured values ​​D2 and D3 of the absorbance of the mixture X at two second predetermined wavelengths λ2 and third predetermined wavelengths λ3, respectively, which are on the longer wavelength side than the first predetermined wavelength λ1, which is the measurement wavelength, and which belong to a wavelength range in which the influence of light scattering by blood cell components and the like is dominant in the total absorbance, and two measured values ​​D4 and D5 of the absorbance of the mixture X at two fourth predetermined wavelengths λ4 and fifth predetermined wavelengths λ5, respectively, which are on the shorter wavelength side than the first predetermined wavelength λ1, which is the measurement wavelength, and which belong to a wavelength range in which the influence of light absorption by hemoglobin is large in the total absorbance, are used.

[0094] In other words, the component measuring device 1 utilizes, as the above-mentioned second measured value D2 and third measured value D3, the absorbance of the mixture X at the second specified wavelength λ2 and the third specified wavelength λ3, respectively, which belong to a longer wavelength range than the measurement wavelength belonging to the wavelength range corresponding to the full width at half maximum of the peak wavelength range in the absorbance spectrum of the color component to be measured, for example, belong to a long wavelength range W1 on the longer wavelength side than the wavelength range W3.

[0095] In addition, the component measuring device 1 uses, as the above-mentioned fourth measured value D4 and fifth measured value D5, the fourth measured value D4 and the fifth measured value D5, which are the absorbance of the mixture X at a fourth predetermined wavelength λ4 and a fifth predetermined wavelength λ5, respectively, which belong to a shorter wavelength range than the measurement wavelength belonging to a wavelength range corresponding to the full width at half maximum of the peak wavelength range in the absorbance spectrum of the color component to be measured, for example, which belong to a short wavelength range W2 on the shorter wavelength side than the wavelength range W3.

[0096] In the component measuring device 1, the control unit 50 acquires the above-mentioned first actual measurement value D1 to fifth actual measurement value D5 from the photometry unit 51. Specifically, the mixture X is irradiated with irradiation light including the emission wavelengths of the first predetermined wavelength λ1 to fifth predetermined wavelength λ5 from the first light source 67 to fifth light source 68d of the light emitting unit 66. The light receiving unit 72 receives the transmitted light that passes through the mixture X among the irradiation light. Then, the control unit 50 calculates the absorbance of the mixture X at each wavelength from the relationship between the irradiation light and the transmitted light, and stores the first actual measurement value D1 to fifth actual measurement value D5, which are the absorbance of the mixture X at each wavelength, in the storage unit 52 as actual measurement value data. The control unit 50 can acquire the actual measurement value data from the storage unit 52. The means by which the control unit 50 acquires the first actual measurement value D1 to fifth actual measurement value D5 is not limited to the above-mentioned means, and various known means can be used to acquire them.

[0097] Then, the control unit 50 corrects the first actual measurement value D1 using the second actual measurement value D2 to the fifth actual measurement value D5, and estimates the absorbance of the color component at the first predetermined wavelength λ1 (660 nm in this example), which is the measurement wavelength. Since the absorbance spectrum of the mixture X becomes approximately linear in the long wavelength region W1 where light scattering of blood cell components and the like is dominant, the component measuring device 1 obtains the second actual measurement value D2, which is the absorbance at the second predetermined wavelength λ2, and the third actual measurement value D3, which is the absorbance at the third predetermined wavelength λ3, and obtains the slope between the second actual measurement value D2 and the third actual measurement value D3, it is possible to estimate to some extent the absorbance at the first predetermined wavelength λ1, which is the measurement wavelength, caused by disturbance factors (noise) other than the absorbance caused by the color component.

[0098] Furthermore, the component measuring device 1 can calculate the glucose concentration in the sample by considering the ratio of reduced hemoglobin to oxygenated hemoglobin in red blood cells in addition to the optical characteristics of blood cell components in the sample. Therefore, the component measuring device 1 can perform more accurate correction by using two wavelengths (fourth predetermined wavelength and fifth predetermined wavelength) selected according to the ratio of reduced hemoglobin to oxygenated hemoglobin.

[0099] Specifically, the component measuring device 1 uses a wavelength at which the difference in absorption coefficient between reduced hemoglobin and oxygenated hemoglobin is equal to or less than a first predetermined value as the fourth predetermined wavelength λ4, and uses a wavelength at which the difference in absorption coefficient between reduced hemoglobin and oxygenated hemoglobin is greater than the above-mentioned first predetermined value as the fifth predetermined wavelength λ5. More specifically, the component measuring device 1 uses a wavelength at which the ratio of the absorption coefficient of oxygenated hemoglobin to the absorption coefficient of reduced hemoglobin is equal to or greater than a first threshold as a predetermined threshold as the fourth predetermined wavelength λ4, and uses a wavelength at which the ratio of the absorption coefficient of oxygenated hemoglobin to the absorption coefficient of reduced hemoglobin is less than the above-mentioned first threshold as the fifth predetermined wavelength λ5. In other words, two wavelengths, a wavelength at which the ratio of the absorption coefficient of oxygenated hemoglobin to the absorption coefficient of reduced hemoglobin is equal to or greater than a first threshold and a wavelength at which the ratio is less than the first threshold, are used as the fourth predetermined wavelength λ4 and the fifth predetermined wavelength λ5. As a result, when the control unit 50 corrects the first measured value D1 using the second measured value D2 to the fifth measured value D5, it can perform a more accurate correction that takes into account the ratio of reduced hemoglobin to oxygenated hemoglobin.

[0100] The two wavelengths selected based on the ratio of reduced hemoglobin to oxygenated hemoglobin are preferably two wavelengths with a large difference in light absorption of hemoglobin depending on the ratio of reduced hemoglobin to oxygenated hemoglobin. Therefore, in this embodiment, the fourth predetermined wavelength λ4 is a wavelength at which the ratio of the absorption coefficient of oxygenated hemoglobin to the absorption coefficient of reduced hemoglobin is 0.8 or more. In addition, the fifth predetermined wavelength λ5 is preferably a wavelength at which the ratio of the absorption coefficient of oxygenated hemoglobin to the absorption coefficient of reduced hemoglobin is less than 0.8. In this embodiment, as an example, the fourth predetermined wavelength λ4 is 520 nm and the fifth predetermined wavelength λ5 is 589 nm.

[0101] In this way, in the short wavelength range W2 where the optical absorption of the entire hemoglobin varies greatly depending on the ratio of reduced hemoglobin to oxygenated hemoglobin, the fourth predetermined wavelength λ4 and the fifth predetermined wavelength λ5 where the difference in the optical absorption of the entire hemoglobin becomes large can be used to accurately estimate the noise absorbance at the first predetermined wavelength λ1 (660 nm in this embodiment) which is the measurement wavelength, taking into account the ratio of reduced hemoglobin to oxygenated hemoglobin. Therefore, the component measuring device 1 can accurately measure the absorbance of the color component at the first predetermined wavelength λ1 which is the measurement wavelength, and further the measurement component (glucose concentration measurement in this embodiment).

[0102] In this embodiment, only the fourth predetermined wavelength λ4 and the fifth predetermined wavelength λ5 are wavelengths that take into consideration the influence of the ratio of reduced hemoglobin to oxygenated hemoglobin. However, it is more preferable to use similar wavelengths for the second predetermined wavelength λ2 and the third predetermined wavelength λ3 in addition to the fourth predetermined wavelength λ4 and the fifth predetermined wavelength λ5.

[0103] Specifically, the second predetermined wavelength λ2 in the long wavelength range W1 where light scattering of blood cell components and the like is dominant is a wavelength where the difference in absorption coefficient between reduced hemoglobin and oxygenated hemoglobin is equal to or less than the second predetermined value, and the third predetermined wavelength λ3 in the long wavelength range W1 is a wavelength where the difference in absorption coefficient between reduced hemoglobin and oxygenated hemoglobin is equal to or less than the second predetermined value. More specifically, the second predetermined wavelength λ2 is a wavelength where the ratio of the absorption coefficient of oxygenated hemoglobin to the absorption coefficient of reduced hemoglobin is equal to or more than the first threshold value and equal to or less than the second threshold value, and the third predetermined wavelength λ3 in the long wavelength range W1 is a wavelength where the ratio of the absorption coefficient of oxygenated hemoglobin to the absorption coefficient of reduced hemoglobin is less than the first threshold value or is greater than the second threshold value. The second threshold value is another predetermined threshold value that is greater than the first threshold value. In other words, it is preferable to use two wavelengths in which the ratio of the absorption coefficient of oxygenated hemoglobin to the absorption coefficient of reduced hemoglobin is different ranges as the second predetermined wavelength λ2 and the third predetermined wavelength λ3. This allows the control unit 50 to perform a more accurate correction that takes into further consideration the ratio of reduced hemoglobin to oxygenated hemoglobin when correcting the first measured value D1 using the second measured value D2 to the fifth measured value D5.

[0104] In particular, in the long wavelength range W1, although the influence of light scattering due to blood cell components and the like is dominant, the influence of light absorption by hemoglobin is also included to the same extent as the measurement wavelength of the measured component. Therefore, it is preferable to use, as the second specified wavelength λ2 and the third specified wavelength λ3, two wavelengths at which the light absorption by hemoglobin changes relatively greatly depending on the ratio of reduced hemoglobin to oxygenated hemoglobin.

[0105] Therefore, in this embodiment, it is preferable to use, as the second predetermined wavelength λ2, a wavelength in the range in which the ratio of the absorption coefficient of oxygenated hemoglobin to the absorption coefficient of reduced hemoglobin is 0.8 or more and 1.5 or less. In this embodiment, as an example, the second predetermined wavelength λ2 is 850 nm. Note that the second predetermined wavelength λ2 is selected from the range of 790 nm to 850 nm.

[0106] The third predetermined wavelength λ3 is a wavelength in the long wavelength range W1, where the absorbance of the color component included in the total absorbance at the third predetermined wavelength λ3 is 10% or less, preferably 6% or less, more preferably 3% or less, and even more preferably substantially 0% of the absorbance of the color component included in the total absorbance at the measurement wavelength. In other words, it is particularly preferable to use a wavelength that is equal to or greater than the wavelength at the long wavelength side of the peak wavelength range of the absorbance spectrum of the color component. This makes it possible to eliminate the influence of light absorption of the color component and more accurately estimate noise in the long wavelength range W1 that is dominated by the influence of light scattering of blood cell components and the like. In this embodiment, the third predetermined wavelength λ3 is a wavelength selected from 920 to 950 nm, and is, for example, 940 nm. It is particularly preferable to use the third predetermined wavelength λ3 at a wavelength at which the absorbance of the color component is zero, that is, a wavelength at the long wavelength side of the peak wavelength range of the absorbance spectrum of the color component. The "total absorbance" in the above-mentioned "absorbance of the color-forming component included in the total absorbance" refers to the absorbance measured in a sample and / or a mixture containing the color-forming component. Also, the "absorbance of the color-forming component" in the above-mentioned "absorbance of the color-forming component included in the total absorbance" refers to the absorbance of the reaction product generated by the color reaction between the analyte in the sample and the color-forming reagent in the reagent, i.e., the absorbance derived from the color-forming component.

[0107] As described above, the component measuring device 1 can correct the first measured value D1, which is the measured value of the absorbance of the mixture X at the measurement wavelength, using the second measured value D2 to the fifth measured value D5, which are the measured values ​​of the absorbance of the mixture X at the second predetermined wavelength λ2 to the fifth predetermined wavelength λ5, respectively, and estimate the absorbance of the color component at the measurement wavelength.

[0108] Next, a method of correction processing in the first mode by the control unit 50 of the component measuring device 1 will be described.

[0109] As described above, the memory unit 52 of the component measuring device 1 stores the actual measurement value data of the first actual measurement value D1 to the fifth actual measurement value D5, which are the absorbance of the mixture X at the first predetermined wavelength λ1 to the fifth predetermined wavelength λ5, respectively, measured by the photometry unit 51, a group of correction coefficient data correlating with the absorbance of the mixture X at the second predetermined wavelength λ2 to the fifth predetermined wavelength λ5, respectively, and calibration curve data showing the relationship between the absorbance of the color component in the mixture X and various physical quantities, which is obtained by correcting the absorbance of the mixture X actually measured at the first predetermined wavelength λ1 using the correction coefficient data.

[0110] The control unit 50 derives the absorbance of the color component at the first wavelength λ1, which is the measurement wavelength, based on the actual measurement value data and the correction coefficient data stored in the storage unit 52.

[0111] Here, the correction coefficient data is derived by a regression analysis carried out in advance using the following formula (1).

[0112]

number

[0113] B(λ) means absorbance at wavelength λ caused by disturbance factors (noise) other than absorbance of color components, and regression calculation is performed by using various blood samples according to the above formula (1) to derive coefficients b0, b1, b2, b3, and b4. As described above, in this embodiment, 850 nm is used as the second predetermined wavelength λ2, 940 nm as the third predetermined wavelength λ3, 520 nm as the fourth predetermined wavelength λ4, and 589 nm as the fifth predetermined wavelength λ5. In addition, the various blood samples are based on six blood samples with different component compositions, and blood samples with hematocrit values ​​adjusted to a range of 10% to 70% are prepared, and absorbance spectra of the adjusted blood samples are measured, and coefficients b0, b1, b2, b3, and b4 are derived using regression analysis. Based on the derived coefficients b0 to b4, a group of correction coefficients correlating with the absorbance of mixture X at each of the second predetermined wavelength λ2 to the fifth predetermined wavelength λ5 are derived. By using the correction coefficient data including these correction coefficients, the actual measured value of the absorbance of mixture X at the measurement wavelength of 660 nm can be corrected from the actual measured values ​​of the absorbance of mixture X at 520 nm, 589 nm, 850 nm, and 940 nm, and the absorbance of the color component at 660 nm can be estimated.

[0114] In order to more simply determine the blood glucose level, the above formula can be simplified and the absorbance of the color component at 660 nm can be estimated by correcting the actual measured value of the absorbance of the mixture X at the measurement wavelength of 660 nm from the actual measured value of the absorbance of the mixture X at the fourth predetermined wavelength λ4 of 520 nm and the second predetermined wavelength λ2 of 850 nm.

[0115] Fig. 9 is a flowchart showing an example of a component measurement process executed by the component measuring device 1. As shown in Fig. 9, the component measurement process includes a step S1 of acquiring a first actual measurement value D1 which is the absorbance of the mixture X at a first predetermined wavelength λ1 as a measurement wavelength, a second actual measurement value D2 which is the absorbance of the mixture X at a second predetermined wavelength λ2, a third actual measurement value D3 which is the absorbance of the mixture X at a third predetermined wavelength λ3, a fourth actual measurement value D4 which is the absorbance of the mixture X at a fourth predetermined wavelength λ4, and a fifth actual measurement value D5 which is the absorbance of the mixture X at a fifth predetermined wavelength λ5; The method includes a step S2 of deriving the hematocrit value using at least one of the first to fifth measured values ​​D5, a step S3 of correcting the first measured value D1 using the second measured value D2 to the fifth measured value D5 and a correction coefficient obtained by regression calculation to obtain the absorbance of the color component at a first predetermined wavelength λ1 as the measurement wavelength, and a step S4 of calculating the measured component in the sample from the absorbance of the color component at the first predetermined wavelength λ1 as the measurement wavelength and the derived hematocrit value.

[0116] In step S1, as described above, the first actual measurement value D1 to the fifth actual measurement value D5 are obtained using the light-emitting unit 66 and the light-receiving unit 72 of the photometry unit 51. In this embodiment, in step S2, the hematocrit value is derived based on the fourth actual measurement value D4 or based on the fourth actual measurement value D4 and the second actual measurement value D2. Specifically, in step S2, the absorbance of hemoglobin is estimated from the fourth actual measurement value D4 or from the fourth actual measurement value D4 and the second actual measurement value D2, and the hematocrit value is derived. Furthermore, when the fourth actual measurement value D4 or the fourth actual measurement value D4 and the second actual measurement value D2 include absorption of the color component, a correction calculation is performed to subtract the absorption of the color component from the fourth actual measurement value D4 or the fourth actual measurement value D4 and the second actual measurement value D2, respectively, and the hematocrit value is derived from the obtained corrected value. In this embodiment, the hematocrit value is derived from a calibration curve showing the relationship between the absorbance of hemoglobin in the mixture X and the hematocrit value stored in the storage unit 52. In step S3, the first measured value D1 is actually corrected using the second measured value D2 to the fifth measured value D5 and a correction coefficient obtained by regression calculation, and the absorbance of the color component at the first measurement wavelength is estimated and obtained. If the second measured value D2 to the fifth measured value D5 include the absorption of the color component, a correction calculation is performed to subtract the absorption of the color component from each measured value, and recalculation is performed from the obtained correction value to estimate and obtain the absorbance of the color component at the first predetermined wavelength λ1. Finally, in step S4, the glucose concentration is calculated using a calibration curve showing the relationship between the absorbance of the color component at the first predetermined wavelength λ1, which is the acquired measurement wavelength, and the derived hematocrit value and the glucose concentration.

[0117] When executing the component measurement process, the control unit 50 of the component measurement device 1 causes the first light source 67 to the fifth light source 68d to emit irradiation light in accordance with a predetermined algorithm, and the light receiving unit 72 measures the received light intensity. Hereinafter, the light quantity measurement process executed by the control unit 50 when executing the component measurement process will be described in detail.

[0118] Fig. 10 is a flow chart showing an example of a light quantity measurement process executed by the component measurement device 1 in the component measurement process. The flow of Fig. 10 is executed, for example, when an operator inputs a processing mode and inputs the start of processing. Here, the following description will be given on the assumption that the operator selects the first mode for measuring the component to be measured as the processing mode.

[0119] Here, when performing the component measurement process, the control unit 50 causes the first light source 67 to the fifth light source 68d to emit the irradiation light in sequence, with each process being one set of emitting the irradiation light as pulsed light from the first light source 67 to the fifth light source 68d. FIG. 11 is a diagram showing a schematic diagram of one set of irradiation light emitted from the first light source 67 to the fifth light source 68d, and is a graph showing the light receiving intensity of the irradiation light emitted from the first light source 67 to the fifth light source 68d by the light receiving unit 72. In FIG. 11, the horizontal axis shows time, and the vertical axis shows the light receiving intensity. As shown in FIG. 11, the control unit 50 causes the first light source 67 to the fifth light source 68d to emit light in sequence at a predetermined time interval. In the example shown in FIG. 11, the control unit 50 causes the first light source 67 to the fifth light source 68d to emit light at a predetermined time interval of 1 msec. 11, the control unit 50 controls the first light source 67 to the fifth light source 68d to emit light so that the light emitted from each of the first light source 67 to the fifth light source 68d has a substantially uniform light intensity at the light receiving unit 72. The term "substantially uniform light intensity" means that when the component measurement process is performed with the light receiving intensity at the light receiving unit 72, the difference in the light receiving intensity obtained from the emission of each light source is within a range that does not affect the result of the component measurement process.

[0120] Here, the control unit 50 causes the first light source 67 to the fifth light source 68d to emit light in a predetermined order in one set of emission processing. In particular, the control unit 50 causes the second light source 68a and the third light source 68b to emit irradiation light of the second predetermined wavelength λ2 and the third predetermined wavelength λ3, which are predominantly affected by light scattering by blood cell components, to emit light at timings adjacent to and before and after the timing at which the first light source 67 emits pulsed light of the first predetermined wavelength λ1, which is the measurement wavelength.

[0121] For example, in the example shown in FIG. 11, the control unit 50 emits irradiation light to the measurement region in the order of the fifth light source 68d, the third light source 68b, the first light source 67, the second light source 68a, and the fourth light source 68c in one set of emission processing. Therefore, the light receiving unit 72 receives irradiation light in the order of the fifth predetermined wavelength λ5, the third predetermined wavelength λ3, the measurement wavelength (first predetermined wavelength λ1), the second predetermined wavelength λ2, and the fourth predetermined wavelength λ4 at a predetermined time interval (1 msec). Light scattering by blood cell components varies over time due to the influence of Brownian motion and sedimentation of molecules, and further interference as a property of waves. Therefore, it is preferable that the second actual measurement value D2 and the third actual measurement value D3 used to correct the influence of light scattering are obtained at a timing closer in time to the first actual measurement value D1 to be corrected. This is because obtaining the values ​​closer in time makes them less susceptible to the influence of temporal fluctuations. Therefore, as in this embodiment, by emitting irradiation light of the second predetermined wavelength λ2 and the third predetermined wavelength λ3, which are dominated by the influence of light scattering by blood cell components, etc., at timings adjacent to and before and after the timing at which the first light source 67 is made to emit pulsed light of the first predetermined wavelength λ1, which is the measurement wavelength, as in the present embodiment, the influence of light scattering can be corrected with higher accuracy.

[0122] The control unit 50 does not necessarily have to emit the irradiation light in the order of the fifth light source 68d, the third light source 68b, the first light source 67, the second light source 68a, and the fourth light source 68c in one set of emission processing. The control unit 50 may cause the second light source 68a and the third light source 68b to emit light at timings adjacent to and before and after the timing at which the first light source 67 emits light.

[0123] 10, when the control unit 50 detects an operation or input for starting processing by, for example, an operator of the component measuring device 1, it adjusts the current supplied to the first light source 67 to the fifth light source 68d (step S10). Step S10 may be performed when the component measuring device 1 is started for the first time. In step S10, the amount of current supplied to the first light source 67 to the fifth light source 68d may be set in advance so that the received light intensity (relative output value) becomes a predetermined value.

[0124] Then, the control unit 50 starts emitting irradiation light from the first light source 67 to the fifth light source 68d (step S11). At this time, the control unit 50 causes the first light source 67 to the fifth light source 68d to emit irradiation light so that it can detect whether or not the component measuring chip 2 is attached to the component measuring device 1.

[0125] FIG. 12 is a diagram showing the light receiving intensity of the irradiation light emitted from the first light source 67 to the fifth light source 68d by the light receiving unit 72 in step S11 of FIG. 10. In FIG. 12, the horizontal axis shows time, and the vertical axis shows the light receiving intensity. As shown in FIG. 12, the control unit 50 repeatedly outputs the set of the emission process described in FIG. 11. For example, the control unit 50 repeatedly executes the set of the emission process 1 to 200 times per second. In this embodiment, the set of the emission process is repeatedly executed 16 times per second. After repeating the set of the emission process 16 times, the control unit 50 stops outputting the irradiation light. Then, after a predetermined time (here, 1 second) has elapsed from the start of the set of the 16 emission processes, the control unit 50 again repeatedly outputs the set of the emission process 16 times without interruption. After repeating the set of the emission process 16 times, the control unit 50 stops outputting the irradiation light again. The control unit 50 repeats this combination of outputting a set of 16 emission processes and stopping the output of the irradiation light every second until step S14, which will be described later.

[0126] Next, the control unit 50 executes a first received light intensity determination (step S12). Specifically, the control unit 50 determines whether the received light intensity at the light receiving unit 72 is within a normal range in the first received light intensity determination process (step S12).

[0127] Here, the details of the first received light intensity determination process executed by the control unit 50 in step S12 will be described. The first received light intensity determination process is the above-mentioned process executed by the control unit 50 to detect whether or not normal measurement can be performed. Fig. 13 is a flowchart showing an example of the first received light intensity determination process.

[0128] The control unit 50 performs two types of determination processes in the first received light intensity determination process, that is, the process of detecting whether or not normal measurement can be performed. One is a determination process based on the absolute output value output from the light receiving unit 72, and the other is a determination process based on the relative output value output from the light receiving unit 72. The determination process based on the absolute output value is performed in steps S31 to S35 of the flow in FIG. 13, and the determination process based on the relative output value is performed in steps S36 to S40 of the flow in FIG. 13.

[0129] The absolute output value used here refers to an output value from an AD converter connected to the light receiving unit 72 according to the light receiving intensity at the light receiving unit 72 when the light is not emitted from the light emitting unit 66 (first light source 67 to fifth light source 68d). The relative output value refers to the difference between the output value from the AD converter connected to the light receiving unit 72 when the light is emitted from the light emitting unit 66 (first light source 67 to fifth light source 68d) and the output value from the AD converter connected to the light receiving unit 72 when the light is not emitted from the light emitting unit 66 (first light source 67 to fifth light source 68d). That is, the relative output value is obtained by subtracting the output value A observed when the light emitting unit 66 is not emitting light from the output value R' observed when the light emitting unit 66 is emitting light. The absolute output value A and the relative output value R are acquired and calculated while the light emitting unit 66 is repeatedly turned on and off. For example, as shown by the arrows in Fig. 11, at a predetermined timing while the irradiation light of the fifth predetermined wavelength λ5 is being emitted, a relative output value R5 of the fifth predetermined wavelength λ5 is obtained, and at a timing a predetermined time before the predetermined timing when the irradiation light is not being emitted, an absolute output value A5 of the fifth predetermined wavelength λ5 is obtained. The same applies to the first predetermined wavelength λ1 to the fourth predetermined wavelength λ4. The absolute output value and the relative output value used here can be obtained by using a moving average of a plurality of absolute output values ​​and a plurality of relative output values ​​obtained within a predetermined section for a light source of the same wavelength.

[0130] In this embodiment, an AD converter with a resolution of 12 bits is used as the converter. However, the resolution of the AD converter does not necessarily have to be 12 bits, and an AD converter with an appropriate resolution can be used. Also, the value of the AD converter with a resolution of 12 bits can be converted into the output value of an AD converter with another resolution.

[0131] As a determination process based on the absolute output value, the control unit 50 first obtains an absolute output value corresponding to the received light intensity from the light receiving unit 72 (step S31). Specifically, the light receiving unit 72 outputs an output value corresponding to the received light intensity from an AD converter, and the control unit 50 obtains the output value output from the AD converter. In step S31, the control unit 50 obtains the absolute output value. The absolute output value can be found by using a moving average from each received light intensity value obtained at multiple timings when the light emitting unit 66 is not emitting light. The number of averaging processes may be set appropriately.

[0132] Next, the control unit 50 judges whether the acquired absolute output value is included in a predetermined range. Specifically, the control unit 50 judges whether the acquired absolute output value is included in, for example, a first designated range of the absolute output value, which is set in advance (step S32). By executing step 32 in this manner, the presence or absence of an abnormality is judged for the light receiving unit 72 and / or the circuit connected to the light receiving unit 72 before the start of the measurement process of the substance to be measured. Therefore, the first designated range is set as a range in which the absolute output value of the light receiving intensity at the light receiving unit 72 output from the AD converter is recognized as a normal range. That is, the first designated range reflects the presence or absence of an abnormality in the light receiving unit 72 and the circuit connected to the light receiving unit 72. The first designated range can be appropriately determined according to the specifications of the component measuring device 1, and for example, when a 12-bit AD converter is used as in this embodiment, the first designated range can be set to 51 or more and 3900 or less. However, the first designated range is not limited to the example shown here and may be appropriately determined.

[0133] When the control unit 50 determines that the acquired absolute output value is not included in the first specified range (No in step S32), it determines whether or not the acquired absolute output value is below the lower limit of the first specified range (step S33). For example, when the first specified range is 51 or more and 3900 or less, the control unit 50 determines in step S33 whether or not the acquired absolute output value is 50 or less.

[0134] When the control unit 50 determines that the acquired absolute output value is below the lower limit of the first specified range (Yes in step S33), it determines that an abnormality (circuit abnormality) has occurred in the circuit connected to the light receiving unit 72 (step S34). In this example, the absolute output value is below the lower limit of the first specified range when the absolute output value is between 0 and 50. In this case, the received light intensity at the light receiving unit 72 output from the AD converter is lower than the first specified range recognized as a normal range, so it is highly likely that a leakage current or the like that affects the measurement has occurred. Therefore, the control unit 50 determines that an abnormality (circuit abnormality) in the reference voltage or the like has occurred.

[0135] On the other hand, when the control unit 50 determines that the acquired absolute output value is not below the lower limit of the first specified range (No in step S33), it determines that an abnormality in light receiving sensitivity has occurred due to an abnormality in the light receiving unit 72 itself or an abnormality in the circuit connected to the light receiving unit 72 (step S35). When the absolute output value is not below the lower limit of the first specified range, since it is determined in step S32 that the absolute output value is not within the first specified range, the acquired absolute output value exceeds the upper limit of the first specified range. That is, in this example, the absolute output value does not fall below the lower limit of the first specified range when the absolute output value is 3901 or more and 4095 or less. In this case, since the light receiving intensity at the light receiving unit 72 output from the AD converter is higher than the first specified range that is recognized as a normal range, it is highly likely that structural damage or current interruption of the light receiving unit 72 that affects the measurement has occurred. Therefore, the control unit 50 determines that an abnormality in light receiving sensitivity has occurred. In step S35, in addition to the above-mentioned abnormality in light receiving sensitivity, damage to the tip opening 10s of the component measuring device 1 before the component measuring tip 2 is attached can also be detected.

[0136] When the control unit 50 determines in step S34 that a circuit abnormality such as a reference voltage has occurred, or when the control unit 50 determines in step S35 that an abnormality in the light receiving sensitivity has occurred, it determines in step S12 of FIG. 10 that the light receiving intensity is not within a normal range (No in step S12). In this case, the control unit 50 notifies that an error has occurred, for example, by outputting a buzzer sound from the buzzer unit 59 (step S25). The control unit 50 may output an error according to the type of abnormality determined. For example, the control unit 50 may output a different buzzer sound according to the type of abnormality determined, or notify the type of abnormality determined by voice. The control unit 50 may notify the type of abnormality determined by displaying it on the display unit 11. Note that when an error has occurred, the control unit 50 may stop the process. For example, after notifying the error, the control unit 50 stops the measurement process of the measured component. As a result, when there is a possibility that an abnormality has occurred, the process is not executed. The same applies to the case where the occurrence of an error described below has been notified.

[0137] If the control unit 50 determines in step S32 that the acquired absolute output value is included in the first specified range (Yes in step S32), it determines that no abnormality has been found in the determination process based on the absolute output value, that is, that the system is normal, and starts the determination process based on the relative output value. Specifically, the control unit 50 proceeds to the process of step S36.

[0138] As a determination process based on the relative output value, the control unit 50 acquires a relative output value corresponding to the received light intensity from the light receiving unit 72 (step S36). Specifically, the light receiving unit 72 outputs an output value corresponding to the received light intensity from an AD converter, and the control unit 50 acquires the output value output from the AD converter. In step S36, the control unit 50 acquires the relative output value by calculating it based on the output value output from the AD converter.

[0139] Next, the control unit 50 judges whether the acquired relative output value is included in a predetermined range. Specifically, the control unit 50 judges whether the acquired relative output value is included in, for example, a second designated range of the relative output value, which is set in advance (step S37). The second designated range is a range in which the relative output value of the light receiving intensity at the light receiving unit 72 output from the AD converter is recognized as a normal range. The second designated range can be appropriately determined according to the specifications of the component measuring device 1. For example, when a 12-bit AD converter is used as in this embodiment, the second designated range can be 601 or more and 3900 or less. However, the second designated range is not limited to the example shown here and may be appropriately determined. By this step, the control unit 50 can detect an abnormality in the light emitting unit 66 or in the light path before the component measuring chip 2 is inserted into the component measuring device 1.

[0140] If the control unit 50 determines that the acquired relative output value is not within the second specified range (No in step S37), it determines whether or not the acquired relative output value is below the lower limit of the second specified range (step S38). For example, if the second specified range is 601 or more and 3900 or less, the control unit 50 determines in step S38 whether or not the acquired relative output value is 600 or less.

[0141] When the control unit 50 determines that the acquired relative output value is below the lower limit of the second specified range (Yes in step S38), it determines that a light amount insufficiency abnormality has occurred due to dirt on the photometering unit 51 or a decrease in the output of the light-emitting unit 66 (step S39). The light amount insufficiency abnormality includes a case where the amount of light emitted from the light-emitting unit 66 is insufficient and a case where the light-receiving unit 72 cannot detect a sufficient amount of light required to measure the object to be measured. The dirt on the photometering unit 51 indicates that there may be dirt (adhesion of foreign matter) that blocks light somewhere in the optical path from the light-emitting unit 66 to the light-receiving unit 72. For example, the light from the light-emitting unit 66 is blocked by the dirt on the cover member 25. In addition, a decrease in the output of the light-emitting unit 66 indicates that there may be an abnormality in the light source itself or an abnormality in the circuit connected to the light-emitting unit 66. In this example, the relative output value is below the lower limit of the second specified range when the relative output value is 0 or more and 600 or less. In this case, since the difference between the output from the AD converter when light is being emitted from the light-emitting unit 66 (first light source 67 to fifth light source 68d) and the output from the AD converter when light is not being emitted from the light-emitting unit 66 (first light source 67 to fifth light source 68d) is less than a predetermined value, it is highly likely that the photometry unit 51 is dirty or the output of the light-emitting unit 66 has decreased. Therefore, the control unit 50 determines that an insufficient light amount abnormality has occurred.

[0142] On the other hand, when the control unit 50 determines that the acquired relative output value is not below the lower limit of the second specified range (No in step S38), it determines that an abnormality in the amount of light emitted due to an excessive amount of light emitted has occurred (step S40). When the relative output value is not below the lower limit of the second specified range, since it is determined in step S37 that the relative output value is not within the second specified range, the acquired relative output value exceeds the upper limit of the second specified range. That is, in this example, the relative output value is not below the lower limit of the second specified range when the relative output value is 3901 or more and 4095 or less. In this case, when the light receiving intensity at the light receiving unit 72 output from the AD converter is higher than the second specified range recognized as the normal range, it is considered that it is highly likely that the LED emits a light with a higher amount of light than the amount of light that the light receiving unit 72 can receive. That is, it is considered that it is highly likely that an overcurrent is generated in the LED due to an abnormality in the circuit connected to the light emitting unit 66. Therefore, the control unit 50 determines that an abnormality in the amount of light emitted has occurred.

[0143] When the control unit 50 determines in step S39 that a light quantity insufficiency abnormality has occurred, or when the control unit 50 determines in step S40 that a light emission quantity abnormality has occurred, it determines in step S12 of FIG. 10 that the received light intensity is not within the normal range (No in step S12). In this case, the control unit 50 notifies the occurrence of an error, for example, by outputting a buzzer sound from the buzzer unit 59 (step S25). The manner of the error notification may be the same as the above example. This makes it possible to inform the operator whether or not the component measuring device 1 is in a normal measurement operation state before actually inserting the component measuring chip 2 into the component measuring device 1. Since the operator can stop the measurement operation at the stage when the error is notified, it is possible to suppress consumption of extra component measuring chips 2 and blood collection.

[0144] If the control unit 50 determines in step S37 that the acquired relative output value is within the second specified range (Yes in step S37), it determines that no abnormality was found in the determination process based on the relative output value, that is, that the value is normal.

[0145] If the control unit 50 determines in step S32 that the acquired absolute output value is within the first designated range (Yes in step S32) and determines in step S37 that the acquired relative output value is within the second designated range (Yes in step S37), it determines in step S12 of Fig. 10 that the received light intensity is within the normal range (Yes in step S12). Then, it proceeds to step S13 in the flow of Fig. 10. In the case of an embodiment in which step S13 in the flow of Fig. 10 is not executed, it proceeds to step S14.

[0146] In this way, the control unit 50 according to the present embodiment can execute a process for detecting whether or not the component measuring device 1 can perform normal measurement. When the control unit 50 determines that there is a possibility that an abnormality has occurred in the component measuring device 1, it can notify the operator of the possibility that an abnormality has occurred by notifying the operator of the possibility. In addition, the control unit 50 can also notify the operator of the type of error by outputting an error according to the type of abnormality that has been determined.

[0147] 13, the control unit 50 executes the determination process based on the absolute output value and the determination process based on the relative output value, but the control unit 50 does not necessarily have to execute both the determination process based on the absolute output value and the determination process based on the relative output value. For example, the control unit 50 can detect at least some abnormalities by executing at least one of the determination process based on the absolute output value and the determination process based on the relative output value.

[0148] In the example described with reference to Fig. 13, the control unit 50 executes the determination process based on the absolute output value and then executes the determination process based on the relative output value. However, the determination process based on the absolute output value and the determination process based on the relative output value do not necessarily have to be executed in this order. For example, the control unit 50 may execute the determination process based on the relative output value and then execute the determination process based on the absolute output value, or may execute the determination process based on the absolute output value and the determination process based on the relative output value consecutively or simultaneously.

[0149] 10 again, when the control unit 50 determines that the received light intensity at the light receiving unit 72 is within the normal range (Yes in step S12), it determines whether or not the component measuring chip 2 has been inserted into the chip insertion space S based on a change in the received light intensity at the light receiving unit 72. Specifically, the control unit 50 determines in step S14 whether or not the component measuring chip 2 has been inserted into the chip insertion space S. Alternatively, the control unit 50 may determine in steps S13 and S14 whether or not the component measuring chip 2 has been inserted into the chip insertion space S.

[0150] More specifically, for example, the operator mounts the component measurement chip 2 on the component measurement device 1. That is, the operator inserts the component measurement chip 2 into the chip insertion space S of the component measurement device 1. While the component measurement chip 2 is inserted into the chip insertion space S, at least a part of the irradiation light emitted from the first light source 67 to the fifth light source 68d is absorbed by the members constituting the component measurement chip 2 and does not reach the light receiving unit 72. Then, when the component measurement chip 2 is mounted on the component measurement device 1 and is in the state shown in FIG. 2 and FIG. 3, an optical path is formed between the first light source 67 to the fifth light source 68d and the light receiving unit 72 through a part of the component measurement chip 2. The part where the optical path is formed in the component measurement chip 2 is the measurement spot. In this embodiment, the measurement reagent 22 is located in the middle of the optical path. That is, the measurement spot is located on the measurement reagent 22. Therefore, of the irradiation light emitted from the first light source 67 to the fifth light source 68d toward the measurement region, only a portion of the light that has passed through the measurement reagent 22 is received by the light receiving unit 72. In other words, when the component measuring chip 2 is attached to the component measuring device 1, a difference occurs in the intensity of received light at the light receiving unit 72 compared to when the component measuring chip 2 is not attached.

[0151] For this reason, the control unit 50 detects a change in the intensity of received light at the light receiving unit 72, thereby determining whether or not the component measuring chip 2 has been attached to the component measuring device 1. The control unit 50 determines that the component measuring chip 2 has been inserted into the chip insertion space S when it detects that the intensity of received light at the light receiving unit 72 has fallen within a predetermined range in which it is presumed that the component measuring chip 2 has been inserted into the chip insertion space S after the amount of received light at the light receiving unit 72 is less than a predetermined amount (i.e., a state in which at least a part of the irradiated light is blocked by a member constituting the component measuring chip 2 and does not reach the light receiving unit 72).

[0152] In this embodiment, the control unit 50 determines that the component measuring chip 2 has been inserted into the chip insertion space S when it detects that the light receiving intensity at the light receiving unit 72 falls within a predetermined range indicating that the component measuring chip 2 has been inserted into the chip insertion space S, based on the light receiving intensity at the light receiving unit before the component measuring chip 2 was inserted into the chip insertion space S (step S14).

[0153] In addition, when the component measuring chip 2 is formed of a light-shielding material except for the measurement site, after the light receiving unit 72 detects no light amount (that is, the irradiated light is blocked by the material constituting the component measuring chip 2 and does not reach the light receiving unit 72), the control unit 50 may detect that the received light intensity is within a predetermined range to determine whether the component measuring chip 2 is inserted. In this case, the control unit 50 first determines whether the light receiving unit 72 receives no irradiated light (step S13). In this specification, the state in which the irradiated light is not received includes a case in which the light receiving unit 72 detects a light amount of a received light intensity that is detectable when the irradiated light emitted from the first light source 67 to the fifth light source 68d is blocked by the component measuring chip 2. Whether the irradiated light is not received can be determined by, for example, setting a threshold value in advance and checking whether the output value of the AD converter of the received light intensity in the light receiving unit 72 is below the threshold value. When the control unit 50 determines that the light receiving unit 72 is not in a state where the irradiated light is not received (No in step S13), the control unit 50 repeats step S13 until it determines that the light receiving unit 72 is in a state where the irradiated light is not received. When the control unit 50 determines that the light receiving unit 72 is in a state where the irradiated light is not received (Yes in step S13), the control unit 50 executes a second received light intensity determination process (step S14). Note that step S13 may be omitted, and steps S12 and S14 may be performed.

[0154] The second received light intensity determination process is a process for determining whether or not the component measuring chip 2 is attached (inserted) to the component measuring device 1. Furthermore, the second received light intensity determination process enables the control unit 50 to detect whether or not normal measurement can be performed. In other words, the second received light intensity determination process also serves as a process for detecting whether or not normal measurement can be performed.

[0155] Here, the second received light intensity determination process executed by the control unit 50 in step S14 will be described in detail. Fig. 14 is a flow chart showing an example of the second received light intensity determination process.

[0156] The control unit 50 performs two types of determination processing in the determination processing of the second received light intensity. One is a determination processing based on the absolute output value output from the light receiving unit 72, and the other is a determination processing based on the relative output value output from the light receiving unit 72. The determination processing based on the absolute output value is executed from step S51 to step S57 in the flow of FIG. 14, and the determination processing based on the relative output value is executed from step S58 to step S61 in the flow of FIG. 14.

[0157] As the determination process based on the absolute output value, the control unit 50 first obtains an absolute output value corresponding to the intensity of received light from the light receiving unit 72 (step S51).

[0158] Next, the control unit 50 judges whether the acquired absolute output value is included in a predetermined range. Specifically, the control unit 50 judges whether the acquired absolute output value is included in, for example, a third designated range of the absolute output value, which is set in advance (step S52). The third designated range is a range in which the absolute output value of the light receiving intensity at the light receiving unit 72 output from the AD converter when the component measuring chip 2 is attached to the chip insertion space S is recognized as a normal range. That is, the range of the light receiving intensity at the light receiving unit 72 when the measurement spot of the component measuring chip 2 is located in the optical path and the light emitting unit 66 is not turned on corresponds to the third designated range. Therefore, the upper limit value of the third designated range is lower than the upper limit value of the first designated range. In step S52, the control unit 50 can check whether there is an abnormality in the light receiving unit 72 and the circuit connected to the light receiving unit 72 after the component measuring chip 2 is inserted into the component measuring device 1, as well as whether there is an intrusion of excessive light from the outside. That is, by using the third specified range as a reference, the control unit 50 can detect abnormalities in the amount of light caused from outside the component measuring device 1, in addition to abnormalities detected based on the first specified range. The third specified range can be determined appropriately according to the specifications of the component measuring device 1 and the component measuring chip 2, and for example, when a 12-bit AD converter is used as in this embodiment, the third specified range can be set to 51 or more and 200 or less. However, the third specified range is not limited to the example shown here, and may be determined appropriately.

[0159] When the control unit 50 determines that the acquired absolute output value is not included in the third specified range (No in step S52), it determines whether or not the acquired absolute output value is below the lower limit of the third specified range (step S53). For example, when the third specified range is 51 or more and 200 or less, the control unit 50 determines in step S53 whether or not the acquired absolute output value is 50 or less.

[0160] When the control unit 50 determines that the acquired absolute output value is below the lower limit of the third specified range (Yes in step S53), it determines that a circuit abnormality such as a reference voltage caused by an abnormality in the circuit connected to the light receiving unit 72 has occurred (step S54). In this example, the absolute output value is below the lower limit of the third specified range when the absolute output value is between 0 and 50. In this case, since the received light intensity at the light receiving unit 72 output from the AD converter is lower than the first specified range recognized as a normal range, it is highly likely that a leakage current or the like that affects the measurement has occurred. Therefore, the control unit 50 determines that a circuit abnormality has occurred.

[0161] When the control unit 50 determines that the acquired absolute output value is not below the lower limit of the third designated range (No in step S53), it determines whether the acquired absolute output value is included in a fourth designated range of absolute output values ​​(step S55). The fourth designated range is a range in which it is recognized that the light received by the light receiving unit 72 includes abnormal light from the outside. In step S55, the control unit 50 can check whether there is abnormal light from the light emitting unit 66 after the component measuring chip 2 is inserted into the component measuring device 1, and can also determine whether there is an effect of disturbance light. Disturbance light is light that reaches the light receiving unit 72 from the outside of the component measuring device set 100 when measuring the substance to be measured. For example, due to damage to the tip opening 10s of the chip mounting unit 10b or damage to the component measuring chip 2, external light generated by lighting in the measurement environment enters the chip insertion space S in excess of a predetermined amount, making it impossible for the light receiving unit 72 to accurately detect the light corresponding to the amount of the substance to be measured. In step S55, it is possible to detect whether or not there is an effect of disturbance light that may affect the measurement of the substance to be measured.

[0162] The fourth specified range can be appropriately determined according to the specifications of the component measuring device 1 and the component measuring chip 2. The lower limit of the fourth specified range is set to a value greater than the upper limit of the third specified range and consecutive to the upper limit of the third specified range. For example, in the present embodiment, when the third specified range is 51 or more and 200 or less, the fourth specified range can be 201 or more and 3900 or less. However, the fourth specified range is not limited to the example shown here and may be appropriately determined.

[0163] When the control unit 50 determines that the acquired absolute output value is included in the fourth specified range of absolute output values ​​(Yes in step S55), it determines that a predetermined amount or more of disturbance light has reached the light receiving unit 72, and determines that a disturbance light abnormality has occurred (step S56). In this example, the control unit 50 determines that a disturbance light abnormality has occurred when the acquired absolute output value is equal to or greater than 201 and equal to or less than 3900.

[0164] On the other hand, when the control unit 50 determines that the acquired absolute output value is not included in the fourth specified range of the absolute output value (No in step S55), it determines that an abnormality in light receiving sensitivity has occurred due to an abnormality in the light receiving unit or other abnormality in the circuit connected to the light receiving unit 72 (step S57). In step S54, when the absolute output value is not included in the fourth specified range, the absolute output value exceeds the upper limit value of the fourth specified range. That is, in this example, when the absolute output value is not included in the fourth specified range, it is a case where the absolute output value is 3901 or more and 4095 or less. In this case, since the light receiving intensity at the light receiving unit 72 output from the AD converter is higher than the fourth specified range recognized as the normal range, it is highly likely that structural damage to the light receiving unit or current interruption (state in which no current flows) that affects the measurement has occurred. Therefore, the control unit 50 determines that an abnormality in light receiving sensitivity has occurred.

[0165] If the control unit 50 determines in step S54 that a circuit abnormality has occurred, if it determines in step S56 that an abnormality in ambient light has occurred, or if it determines in step S57 that an abnormality in light receiving sensitivity has occurred, it determines in step S14 of FIG. 10 that the light receiving intensity is not within the normal range (No in step S14). In this case, the control unit 50 notifies that an error has occurred, for example, by outputting a buzzer sound from the buzzer unit 59 (step S25). The manner of notifying the error may be the same as the above example. By notifying an error in this way when there is a possibility that an abnormality has occurred, the control unit 50 can detect whether normal measurement can be performed or not.

[0166] If the control unit 50 determines in step S52 that the acquired absolute output value is included in the third specified range (Yes in step S52), it determines that no abnormality has been found in the determination process based on the absolute output value, that is, that the system is normal, and starts the determination process based on the relative output value. Specifically, the control unit 50 proceeds to the process of step S58.

[0167] In the determination process based on the relative output value, the control unit 50 determines whether or not the component measuring chip 2 is properly inserted into the component measuring device 1. That is, the control unit 50 determines whether or not the component measuring chip 2 is properly inserted into the component measuring device 1 so that the measurement can be started normally. First, the control unit 50 acquires a relative output value according to the received light intensity from the light receiving unit 72 (step S58).

[0168] Next, the control unit 50 calculates a judgment value (step S59). The judgment value is a numerical value used in the judgment in steps S60 and S61, and is a value obtained by dividing the relative output value after the insertion of the component measuring chip 2 by the relative output value before the insertion of the component measuring chip 2. That is, the judgment value is a value obtained by dividing the relative output value acquired in step S58 by the relative output value (blank value) acquired in step S36. The relative output value before the insertion of the component measuring chip 2 may be automatically adjusted, for example, in the manufacturing process of the component measuring device 1. In a normal case where there is no dirt (foreign matter attached) in the optical path, the value is close to the relative output value after the adjustment. For example, if the target value in the adjustment of the relative output value is set to 2000 and the relative output value acquired in step S36 is also 2000, then if the relative output value acquired in step S58 is Vr, the judgment value V is calculated in step S59 by V=Vr / 2000.

[0169] The control unit 50 determines whether the determination value V calculated in step S59 is included within the fifth specified range (step S60). The fifth specified range is a range in which it is recognized that the component measurement chip 2 is properly inserted into the component measurement device 1. That is, when the determination value V is within the fifth specified range, the control unit 50 can recognize that the component measurement chip 2 is attached to the component measurement device 1 and the measurement spot is arranged in the optical path. The fifth specified range can be appropriately determined according to the specifications of the component measurement device 1 and the appropriate component measurement chip 2, etc. In the present embodiment, it is assumed that the fifth specified range is greater than 0.05 and equal to or less than 0.3. That is, the fifth specified range corresponds to the case where the relative output value (light reception amount) after inserting the component measurement chip 2 into the component measurement device 1 exceeds 5% and is equal to or less than 30% with respect to the relative output value (light reception amount) before inserting the component measurement chip 2 into the component measurement device 1. The fifth specified range reflects the intensity of the light transmitted through the measurement reagent 22 in the component measurement chip 2 before the sample is introduced.

[0170] When the control unit 50 determines that the determination value V is included within the fifth specified range, that is, when it determines that 0.05 < V ≤ 0.3 (Yes in step S60), it determines that the component measurement chip 2 is properly inserted into the component measurement device 1. This determination result is hereinafter simply referred to as "chip normal recognition" in this specification. In this case, the control unit 50 determines in step S14 of FIG. 10 that the light reception intensity is within the normal range (Yes in step S14). Then, it proceeds to step S15 of the flow in FIG. 10.

[0171] When the control unit 50 determines that the determination value V is not included in the fifth specified range, that is, when it determines that V ≤ 0.05 or 0.3 < V (No in step S60), it determines whether the determination value V is included in the sixth specified range (step S61). The sixth specified range is a range in which it is recognized that the component measurement chip 2 is inserted into the component measurement device 1 in an inappropriate manner. The sixth specified range can be appropriately determined according to the specifications of the component measurement device 1 and the appropriate component measurement chip 2, etc. In the present embodiment, it is assumed that the sixth specified range is greater than 0.01 and less than or equal to 0.05. That is, the sixth specified range corresponds to the case where the relative output value (light reception amount) after inserting the component measurement chip 2 into the component measurement device 1 exceeds 1% and is less than or equal to 5% with respect to the relative output value (light reception amount) before inserting the component measurement chip 2 into the component measurement device 1. Note that the sixth specified range in this specification means the range described as the "fourth specified range" in the claims.

[0172] When the control unit 50 determines that the determination value V is included in the sixth specified range, that is, when it determines that 0.01 < V ≤ 0.05 (Yes in step S61), it determines that the component measurement chip 2 is inserted into the component measurement device 1 in an inappropriate manner. In this case, when the determination value V is within the sixth specified range, the control unit 50 can recognize that at least a part of the optical path is blocked by the component measurement chip 2, that the measurement spot is not correctly positioned in the optical path, or that a used component measurement chip 2 is erroneously mounted. This determination result is also simply referred to as "chip recognition failure" hereinafter in this specification. In this case, the control unit 50 determines in step S14 of FIG. 10 that the light reception intensity is not within the normal range (No in step S14). In this case, the control unit 50 notifies that an error has occurred, for example, by outputting a buzzer sound from the buzzer unit 59 (step S25). The mode of error notification may be the same as the above example. By notifying an error when there is a possibility that the component measurement chip 2 is inserted in an inappropriate manner in this way, the control unit 50 can detect whether normal measurement can be performed.

[0173] When the control unit 50 determines that the determination value V is not included within the sixth specified range (No in step S61), it proceeds to step S60. By the transition from step S61 to step S60, the control unit 50 may be made to recognize that the insertion of the component measurement chip 2 into the chip insertion space S is insufficient. In this way, the control unit 50 repeats steps S60 and S61 until it determines that the determination value V is included within the fifth specified range or determines that the determination value V is included within the sixth specified range.

[0174] Note that in the present embodiment, when the determination value V is not within the fifth specified range nor within the sixth specified range, that is, when V ≤ 0.01 or 0.3 < V, the control unit 50 does not necessarily need to make a determination as to whether the chip is normally recognized or the chip recognition is poor. In this case, it is possible that the component measurement chip 2 is not inserted into the component measurement device 1, and this is not an appropriate state for making a determination as to whether the chip is normally recognized or the chip recognition is poor. For example, when a portion other than the measurement site of the component measurement chip 2 is formed of a light-shielding member, while the component measurement chip 2 is being inserted into the component measurement device 1, the irradiation light from the light-emitting unit 66 is blocked by the component measurement chip 2. In this case, the irradiation light is blocked and is not received by the light-receiving unit 72. Therefore, the relative output value becomes a value close to 0, and the determination value V may become 0.01 or less. However, in this case, it is in the middle of the insertion of the component measurement chip 2, and this is not an appropriate state for making a determination as to whether the chip is normally recognized or the chip recognition is poor. Therefore, in this case, no determination is made, and a determination is made when the determination value V is within the fifth specified range or the sixth specified range.

[0175] In this way, the control unit 50 according to this embodiment judges whether the component measuring chip 2 is attached (inserted) to the component measuring device 1. The control unit 50 can further detect whether normal measurement can be performed. When the control unit 50 judges that there is a possibility of an abnormality occurring, it can inform the operator of the possibility of an abnormality occurring by notifying the operator of the occurrence. In addition, the control unit 50 can also inform the operator of the type of error by outputting an error according to the type of abnormality judged. Note that, when the control unit 50 judges that the chip recognition is poor, it may prompt the operator to correctly attach the component measuring chip 2 by notifying the operator. In this way, the component measuring device, the component measuring device set, and the information processing method according to this embodiment can judge an abnormality of the component measuring device or the component measuring device set by the light emitting unit 66 and the light receiving unit 72 used for quantifying the measured component, without adding a mechanical configuration for detecting an abnormality to the component measuring device 1 or the component measuring chip 2.

[0176] 14, the control unit 50 executes the determination process based on the absolute output value and the determination process based on the relative output value, but the control unit 50 does not necessarily have to execute both the determination process based on the absolute output value and the determination process based on the relative output value. For example, the control unit 50 executes the determination process based on the relative output value to determine whether the component measuring tip 2 is attached (inserted) to the component measuring device 1 and to detect at least some abnormalities.

[0177] In the process of determining the second received light intensity, the third to sixth designated ranges may be determined for each of the first to fifth light sources 67 to 68d, or may be the same for all of the first to fifth light sources 67 to 68d. For example, the absorption and reflection properties of the measurement reagent 22 may differ depending on the wavelengths λ1 to λ5 of the irradiated light emitted from the first to fifth light sources 67 to 68d. Therefore, for example, by applying different third to sixth designated ranges depending on the absorptance of the measurement reagent 22, more accurate determination can be made depending on the properties of the irradiated light.

[0178] In addition, in the second received light intensity determination process, the control unit 50 may determine that the condition is satisfied (i.e., in the case of Yes in each branch of the flow in FIG. 14) when the output value from the AD converter is included within a predetermined range (the third specified range to the sixth specified range) over a predetermined period. The predetermined period may be determined, for example, by a predetermined time. In this case, the predetermined period is determined, for example, as 3 seconds. The predetermined period may be determined, for example, by the number of times of light emission from the first light source 67 to the fifth light source 68d. In this case, the predetermined period is determined, for example, as three sets of output of a set of 16 emission processes and stoppage of output of the irradiation light (i.e., three consecutive sets). In this way, by providing a predetermined period for determination in the second received light intensity determination process, it becomes easier to prevent erroneous determination that the component measuring chip 2 is attached to the component measuring device 1 when the output value from the AD converter is temporarily included within the predetermined range due to some factor other than the insertion of the component measuring chip 2.

[0179] In addition, when the control unit 50 determines the predetermined period based on the number of times of light emission of the first light source 67 to the fifth light source 68d, when the light receiving unit 72 detects reception of light for the first time after the state in which the irradiation light is not received in step S13, the control unit 50 may change the interval at which the set of output of the 16 times of emission processing and the stop of output of the irradiation light are executed. In particular, the control unit 50 may shorten the interval at which the set of output of the 16 times of emission processing and the stop of output of the irradiation light are executed. For example, as described above, in step S11, when the set of output of the 16 times of emission processing and the stop of output of the irradiation light are executed every second, the control unit 50 may shorten the interval at which this set is executed to 0.5 seconds. This makes it possible to shorten the interval at which the set of output of the 16 times of emission processing and the stop of output of the irradiation light are executed, making it easier to determine the result of the second received light intensity determination process earlier.

[0180] Fig. 15 is a diagram showing the light receiving intensity of the light emitted from the first light source 67 to the fifth light source 68d by the light receiving unit 72, mainly in steps S13 to S16 or steps S14 to S16 in Fig. 10. In Fig. 15, the horizontal axis shows time, and the vertical axis shows the light receiving intensity. Fig. 15 shows the light receiving intensity by the light receiving unit 72 after, for example, the determination in step S12 in Fig. 10 is Yes.

[0181] For example, when the operator starts to insert the component measuring chip 2 into the chip insertion space S of the component measuring device 1, the irradiation light emitted from the first light source 67 to the fifth light source 68d is blocked by the members constituting the component measuring chip 2. In this case, at time t 1 From 2 4, the light receiving section 72 is in a state where it is not receiving irradiated light.

[0182] time t 2 When the component measuring chip 2 is attached to the component measuring device 1, the light receiving section 72 receives the light that has passed through the measurement reagent 22 out of the irradiation light emitted from the first light source 67 to the fifth light source 68d (at time t 3 15, the received light intensity at the light receiving section 72 is smaller than that before the component measuring chip 2 is attached. Moreover, the degree of change in the received light intensity before and after the component measuring chip 2 is attached differs for each of the first light source 67 to the fifth light source 68d.

[0183] The control unit 50 3 When the control unit 50 receives the light transmitted through the measurement reagent 22, the interval between executing the pair of output of the set of 16 ejection processes and stopping of the output of the irradiation light is shortened from 1 second to 0.5 seconds. Then, when the control unit 50 executes the process of determining the second received light intensity and determines that the component measuring chip 2 is attached (inserted) into the component measuring device 1 and normal measurement can be performed, it proceeds to step S15 in FIG.

[0184] 10 again, when the control unit 50 determines that the light receiving intensity at the light receiving unit 72 is within a predetermined range (Yes in step S14), it adjusts the amount of irradiation light emitted from the light emitting unit 66. After the component measuring chip 2 is completely attached, the control unit 50 adjusts the current supplied to the first light source 67 to the fifth light source 68d to adjust the amount of irradiation light emitted from the light emitting unit 66 (step S15). The control unit 50 adjusts the amount of irradiation light so that the amount of irradiation light becomes a predetermined intensity used in the measurement of the component to be measured. The predetermined intensity used in the measurement of the component to be measured may be appropriately determined according to the specifications of the light receiving unit 72, etc., and is preferably an intensity that can ensure the measurement resolution required for the measurement of the component to be measured.

[0185] Specifically, the control unit 50 adjusts the current supplied to the first light source 67 to the fifth light source 68d so as to increase it. By increasing the current supplied to the first light source 67 to the fifth light source 68d, the amount of irradiation light emitted from the first light source 67 to the fifth light source 68d increases. More specifically, the control unit 50 adjusts the current supplied to the first light source 67 to the fifth light source 68d so as to increase the light receiving intensity of the irradiation light from the first light source 67 to the fifth light source 68d at the light receiving unit 72. In particular, it is preferable that the control unit 50 adjusts the current supplied to the first light source 67 to the fifth light source 68d so that the light receiving intensity of the irradiation light from the first light source 67 to the fifth light source 68d at the light receiving unit 72 becomes an intensity suitable for performing the component measurement process described with reference to FIG. 9.

[0186] The control unit 50 can adjust the currents supplied to the first light source 67 to the fifth light source 68d, respectively. The control unit 50 can adjust the currents supplied to the first light source 67 to the fifth light source 68d so that the light receiving unit 72 receives light from each of the first light source 67 to the fifth light source 68d in a uniform light intensity. The term "uniform" used here includes not only a predetermined light receiving intensity, but also a case where the light receiving unit 72 receives light within a predetermined range from the predetermined light receiving intensity. For example, the control unit 50 adjusts the currents supplied to the first light source 67 to the fifth light source 68d so that the output value of the light receiving unit 72 from the AD converter of the light receiving intensity is substantially constant. In this case, for example, the output value of the light receiving intensity from the AD converter (12 bits) can be treated as being uniform in a range of 3300±50. By adjusting the current in this manner, the measurement resolution of the light receiving unit 72 is improved, making it easier to perform more accurate component measurement. Such current adjustment can suppress the influence of fluctuations in the amount of light emitted from the first light source 67 to the fifth light source 68d, even if the amount of light fluctuates due to changes in the environmental temperature. In this embodiment, a 12-bit AD converter is used, but it can be set to have an equivalent output value according to the resolution.

[0187] In step S15, the control unit 50 may determine the amount of current to be supplied to the first light source 67 to the fifth light source 68d based on the temperature measured by the temperature measurement unit 53. This makes it easier to suppress fluctuations in the amount of irradiated light due to temperature.

[0188] In addition, in step S15, when the control unit 50 adjusts the current supplied to the first light source 67 to the fifth light source 68d so that the output value from the AD converter of the received light intensity in the light receiving unit 72 becomes a predetermined value (e.g., 3300), if the current supplied exceeds a predetermined current threshold (e.g., 15 mA) before the output value from the AD converter of the received light intensity in the light receiving unit 72 reaches the predetermined value, the control unit 50 may determine that an abnormality has occurred in the component measuring device 1 and alert the user to this effect with a buzzer sound.

[0189] Referring to FIG. 15, at time t 4As shown diagrammatically below, in step S15, the current supplied to the first light source 67 to the fifth light source 68d is amplified, and the intensity of the light received by the light receiving unit 72 increases. That is, after the measuring tip 2 is correctly attached, the amount of light of the light sources is increased, thereby reducing power consumption.

[0190] 10 again, the control unit 50 acquires a reference received light intensity (step S16) after adjusting the current supplied to the first light source 67 to the fifth light source 68d in step S15. The reference received light intensity is an output value of the received light intensity in the light receiving unit 72 from the AD converter at a specific time point after executing step S15. It is preferable that the reference received light intensity is acquired immediately after executing step S15. The reference received light intensity is used in a fourth received light intensity determination process in step S20, which will be described later.

[0191] The control unit 50 also causes the first light source 67 to the fifth light source 68d to emit light continuously (step S17). Specifically, the control unit 50 continuously executes a set of emission processes shown in Fig. 11. In this manner, pulsed light is emitted from the first light source 67 to the fifth light source 68d, for example, every 1 msec. The control unit 50 continues to output such pulsed light until it is determined in step S20, which will be described later, that the sample and the measurement reagent 22 have come into contact with each other.

[0192] Fig. 16 is a diagram showing the intensity of light received by the light receiving unit 72 of the irradiation light emitted from the first light source 67 to the fifth light source 68d, and mainly shows the intensity of light received by the light receiving unit 72 after step S17 in Fig. 10 is executed. As shown in Fig. 16, pulsed light is continuously emitted from the first light source 67 to the fifth light source 68d, and the light receiving unit 72 receives this pulsed light. By continuously emitting light from the first light source 67 to the fifth light source 68d in this way, it is possible to improve the time resolution of the determination performed in checking the fourth received light intensity in step S20 described later.

[0193] The control unit 50 calculates a moving average of the light receiving intensity received by the light receiving unit 72 while the first light source 67 to the fifth light source 68d are continuously emitting light in step S17 (step S18). The control unit 50 can calculate the moving average of the light receiving intensity of an appropriate number of pulsed lights, for example, the moving average of the light receiving intensity of the pulsed lights of five light sources. It is preferable that the control unit 50 calculates the moving average of the light receiving intensity of the pulsed light for each light source. In this embodiment, at least the moving average of the light receiving intensity of the pulsed light of the fourth predetermined wavelength λ4 (520 nm) used in step S20 is calculated. The control unit 50 may calculate the moving average of the light receiving intensity of the pulsed light of the third predetermined wavelength λ3 (940 nm) in addition to the fourth predetermined wavelength λ4. In this case, blood with a wide range of hematocrit values ​​can be measured.

[0194] Then, the control unit 50 determines whether or not the component measuring chip 2 is inserted into the chip insertion space S based on a change in the received light intensity at the light receiving unit 72. Specifically, the control unit 50 determines whether or not the component measuring chip 2 is inserted into the chip insertion space S by performing a third received light intensity determination in step S19. That is, the determination process of the third received light intensity is a process for determining whether or not the component measuring chip 2 is attached (inserted) into the component measuring device 1.

[0195] The principle of determining whether or not the component measuring chip 2 is inserted into the chip insertion space S in step S19 is the same as in step S14. That is, the control unit 50 can determine whether or not the component measuring chip 2 remains attached to the component measuring device 1 based on the light receiving intensity at the light receiving unit 72. Specifically, the control unit 50 determines that the component measuring chip 2 is inserted into the chip insertion space S when the light receiving intensity at the light receiving unit 72 is within a predetermined range within which it is assumed that the component measuring chip 2 is inserted into the chip insertion space S.

[0196] Here, a detailed description will be given of the third received-light intensity determination process executed by the control unit 50 in step S19. Fig. 17 is a flowchart showing an example of the third received-light intensity determination process.

[0197] The control unit 50 performs two types of determination processing in the third received light intensity determination processing. One is a determination processing based on an absolute output value output from the light receiving unit 72, and the other is a determination processing based on a relative output value output from the light receiving unit 72. The determination processing based on the absolute output value is executed from step S81 to step S87 in the flow of FIG. 17, and the determination processing based on the relative output value is executed from step S88 to step S90 in the flow of FIG. 17.

[0198] As the determination process based on the absolute output value, the control unit 50 first obtains an absolute output value corresponding to the received light intensity from the light receiving unit 72 (step S81).

[0199] Next, the control unit 50 judges whether the acquired absolute output value is included in a predetermined range. Specifically, the control unit 50 judges whether the acquired absolute output value is included in, for example, a third designated range of the absolute output value, which is set in advance (step S82). The third designated range is a range in which the absolute output value of the light receiving intensity at the light receiving unit 72 output from the AD converter when the component measuring chip 2 is attached to the insertion space S is recognized as a normal range. Here, the third designated range is the same as the third designated range in step S52 of the flow of FIG. 14 described above. That is, when a 12-bit AD converter is used, the third designated range can be 51 or more and 200 or less. However, the third designated range is not limited to the example shown here and may be determined appropriately.

[0200] When the control unit 50 determines that the acquired absolute output value is not included in the third specified range (No in step S82), it determines whether or not the acquired absolute output value is below the lower limit of the third specified range (step S83). For example, when the third specified range is 51 or more and 200 or less, the control unit 50 determines in step S83 whether or not the acquired absolute output value is 50 or less.

[0201] When the control unit 50 determines that the acquired absolute output value is below the lower limit of the third specified range (Yes in step S83), it determines that a circuit abnormality such as a reference voltage caused by an abnormality in the circuit connected to the light receiving unit 72 has occurred (step S84). In this example, the absolute output value is below the lower limit of the third specified range when the absolute output value is between 0 and 50. In this case, since the received light intensity at the light receiving unit 72 output from the AD converter is lower than the first specified range recognized as a normal range, it is highly likely that a leakage current or the like that affects the measurement has occurred. Therefore, the control unit 50 determines that a circuit abnormality has occurred.

[0202] When the control unit 50 determines that the acquired absolute output value is not below the lower limit of the third specified range (No in step S83), it determines whether or not the acquired absolute output value is included in a fourth specified range of absolute output values ​​(step S85). The fourth specified range is a range in which the light received by the light receiving unit 72 is deemed to include abnormal light from the outside or the like. Here, the fourth specified range is the same as the fourth specified range in step S55 of the flow in FIG. 14 described above. That is, in this embodiment, the fourth specified range is equal to or greater than 201 and equal to or less than 3900. However, the fourth specified range is not limited to the example shown here, and may be determined as appropriate.

[0203] When the control unit 50 determines that the acquired absolute output value is included in the fourth specified range of absolute output values ​​(Yes in step S85), it determines that a predetermined amount or more of disturbance light has reached the light receiving unit 72, and determines that a disturbance light abnormality has occurred (step S86). In this example, the control unit 50 determines that a disturbance light abnormality has occurred when the acquired absolute output value is equal to or greater than 201 and equal to or less than 3900.

[0204] On the other hand, when the control unit 50 determines that the acquired absolute output value is not included in the fourth specified range of the absolute output value (No in step S85), it determines that an abnormality in light receiving sensitivity has occurred due to an abnormality in the light receiving unit or other abnormality in the circuit connected to the light receiving unit 72 (step S87). In step S85, when the absolute output value is not included in the fourth specified range, the absolute output value exceeds the upper limit value of the fourth specified range. That is, in this example, when the absolute output value is not included in the fourth specified range, it is a case where the absolute output value is 3901 or more and 4095 or less. In this case, since the light receiving intensity at the light receiving unit 72 output from the AD converter is higher than the fourth specified range recognized as the normal range, it is highly likely that structural damage to the light receiving unit or current interruption (state in which no current flows) that affects the measurement has occurred. Therefore, the control unit 50 determines that an abnormality in light receiving sensitivity has occurred.

[0205] If the control unit 50 determines in step S84 that a circuit abnormality has occurred, if it determines in step S86 that an abnormality in ambient light has occurred, or if it determines in step S87 that an abnormality in light receiving sensitivity has occurred, it determines in step S19 of FIG. 10 that the light receiving intensity is not within the normal range (No in step S19). In this case, the control unit 50 notifies that an error has occurred, for example, by outputting a buzzer sound from the buzzer unit 59 (step S25). The manner of notifying the error may be the same as the above example. By notifying an error in this way when there is a possibility that an abnormality has occurred, the control unit 50 can detect whether normal measurement can be continued or not.

[0206] If the control unit 50 determines in step S82 that the acquired absolute output value is included in the third specified range (Yes in step S82), it determines that no abnormality has been found in the determination process based on the absolute output value, that is, that the system is normal, and starts the determination process based on the relative output value. Specifically, the control unit 50 proceeds to the process of step S88.

[0207] In the determination process based on the relative output value, the control unit 50 determines whether or not the component measuring chip 2 is properly inserted into the component measuring device 1. That is, the control unit 50 determines whether or not the component measuring chip 2 is properly inserted into the component measuring device 1 so that the measurement can be started normally. First, the control unit 50 acquires a relative output value according to the received light intensity from the light receiving unit 72 (step S88).

[0208] The control unit 50 judges whether the relative output value acquired in step S88 is included in a seventh designated range (step S89). The seventh designated range is a range in which it is recognized that the component measuring chip 2 is properly inserted into the component measuring device 1. In other words, when the relative output value is within the seventh designated range, the control unit 50 can recognize that the component measuring chip 2 is attached to the component measuring device 1 and a measurement spot is positioned in the optical path. The seventh designated range can be appropriately determined according to the specifications of the component measuring device 1 and the appropriate component measuring chip 2. In this embodiment, the seventh designated range is 51 or more and 3900 or less.

[0209] When the control unit 50 determines that the acquired relative output value is included in the seventh specified range (Yes in step S89), it determines that the component measuring chip 2 is properly inserted into the component measuring device 1. In this case, the control unit 50 proceeds to step S20 in the flow of FIG.

[0210] On the other hand, when the control unit 50 determines that the acquired relative output value is not included in the seventh specified range of relative output values ​​(No in step S89), it determines that the component measuring chip 2 is not properly inserted into the component measuring device 1 (step S90). In step S89, when the relative output value is not included in the seventh specified range, the relative output value is 50 or less or 3901 or more.

[0211] For example, when the component measuring chip 2 is formed of a light-shielding member other than the measurement site, when the component measuring chip 2 is not properly inserted into the component measuring device 1, the light emitted from the light-emitting unit 66 is blocked by the light-shielding member of the component measuring chip 2. In this case, the emitted light is blocked and not received by the light-receiving unit 72. In this case, the relative output value may be 50 or less. That is, when the relative output value is 50 or less, it can be determined that the component measuring chip 2 is not properly inserted into the component measuring device 1.

[0212] On the other hand, for example, when the component measuring chip 2 is completely removed from the component measuring device 1, the light emitted from the light emitting unit 66 is directly received by the light receiving unit 72. In this case, the relative output value may be 3901 or more. That is, when the relative output value is 3901 or more, it can be determined that the component measuring chip 2 is completely removed from the component measuring device 1.

[0213] The "ingredient measuring chip removed" in step S90 includes a case where the ingredient measuring chip 2 is not properly inserted into the ingredient measuring device 1 as described above, and a case where the ingredient measuring chip 2 is completely removed from the ingredient measuring device 1. When the control unit 50 determines in step S90 that the ingredient measuring chip 2 is not properly inserted into the ingredient measuring device 1, it notifies that an error has occurred, for example by outputting a buzzer sound from the buzzer unit 59 (step S25). The manner of notifying the error may be the same as the above example. In this way, the control unit 50 can notify of an error when there is a possibility that the ingredient measuring chip 2 is not properly inserted into the ingredient measuring device 1.

[0214] In this manner, the control unit 50 according to this embodiment determines whether the component measuring chip 2 is properly attached (inserted) to the component measuring device 1 or not.

[0215] 17, the control unit 50 executes the determination process based on the absolute output value and the determination process based on the relative output value, but the control unit 50 does not necessarily have to execute both the determination process based on the absolute output value and the determination process based on the relative output value. For example, the control unit 50 can determine whether or not the component measuring tip 2 is properly attached (inserted) to the component measuring device 1 by executing the determination process based on the relative output value.

[0216] In the third received light intensity determination process, the third specified range, the fourth specified range, or the seventh specified range may be determined for each of the first light source 67 to the fifth light source 68d, or may be the same for all of the first light source 67 to the fifth light source 68d. For example, the absorption and reflection properties of the measurement reagent 22 may differ depending on the wavelengths λ1 to λ5 of the irradiated light emitted from the first light source 67 to the fifth light source 68d. Therefore, for example, by applying the third specified range, the fourth specified range, or the seventh specified range that differs depending on the absorptance of the measurement reagent 22, it is possible to make a more accurate determination depending on the properties of the irradiated light.

[0217] In addition, in the third determination process of the received light intensity, the control unit 50 may determine that the condition is satisfied (i.e., in the case of Yes in each branch of the flow in FIG. 17) when the output value from the AD converter is included within a predetermined range (the third designated range, the fourth designated range, or the seventh designated range) over a predetermined period. The predetermined period may be determined, for example, by a predetermined time. In this case, the predetermined period is determined, for example, as 3 seconds. The predetermined period may be determined, for example, by the number of times of light emission from the first light source 67 to the fifth light source 68d. In this case, the predetermined period is determined, for example, as three sets of output of a set of 16 emission processes and stop of output of the irradiation light (i.e., three consecutive sets). In this way, by providing a predetermined period for determination in the third determination process of the received light intensity, it becomes easier to prevent erroneous determination that the component measuring chip 2 is properly attached to the component measuring device 1 when the output value from the AD converter is temporarily included within the predetermined range due to some factor not related to the insertion state of the component measuring chip 2.

[0218] After step S20, the control unit 50 may execute the process of determining the third received light intensity similar to step S19 at an appropriate timing, either periodically or irregularly, to determine whether or not the component measuring chip 2 is properly attached to the component measuring device 1. For example, in this embodiment, the control unit 50 executes the process of determining the third received light intensity similar to step S19 at the timing shown in step S23 of FIG.

[0219] 10 again, when the control unit 50 determines that the received light intensity at the light receiving unit 72 is within a predetermined range (Yes in step S19), it executes a fourth received light intensity determination process (step S20). The fourth received light intensity determination process is a process for determining two items. The first item is to determine whether or not there is a possibility that the selection of the processing mode is incorrect, and the second item is to determine whether or not to start component measurement.

[0220] Specifically, in this embodiment, the control unit 50 judges whether or not the sample has reached the measurement reagent 22 using the reference light receiving intensity acquired in step S16, and the moving average of the light receiving intensity of the pulsed light of the third predetermined wavelength λ3 and the moving average of the light receiving intensity of the pulsed light of the fourth predetermined wavelength λ4 calculated in step S18. In this embodiment, the control unit 50 judges in step S20 that the sample has reached the measurement reagent 22 when the moving average of the light receiving intensity of the pulsed light of the third predetermined wavelength λ3 received by the light receiving unit 72 is higher than the reference light receiving intensity by a first judgment threshold or more. The first judgment threshold can be appropriately determined. For example, the first judgment threshold can be set to 101.3% of the reference light receiving intensity. In this embodiment, in step S20, the control unit 50 determines that the sample has reached the measurement reagent 22 when the moving average of the received light intensity of the pulsed light of the fourth predetermined wavelength λ4 received by the light receiving unit 72 becomes lower than the reference received light intensity by a second determination threshold or more. The second determination threshold can be determined appropriately. For example, the second determination threshold can be set to 98.5% of the reference received light intensity.

[0221] Here, in this embodiment, the reason for using irradiation light of two different wavelengths, the third predetermined wavelength λ3 and the fourth predetermined wavelength λ4, in the determination process of the fourth received light intensity will be described. The sample used for the component measuring device 1 according to this embodiment may be whole blood or plasma. However, the properties such as absorbance for irradiation light of each wavelength are different when the sample is whole blood and when it is plasma. However, by using irradiation light of two different wavelengths, the third predetermined wavelength λ3 and the fourth predetermined wavelength λ4, as in the component measuring device 1 according to this embodiment, it is possible to detect that the sample has reached the measurement reagent 22 regardless of whether the sample is whole blood or plasma.

[0222] For example, when the sample is whole blood, the sample contains red blood cells. When the whole blood containing red blood cells is irradiated with the irradiation light of the third predetermined wavelength λ3 (940 nm), the refractive index of the whole blood is larger than that of the air, so the difference in refractive index between the component of the component measuring chip 2 containing the measurement reagent 22 is small, and the transmitted light passing through the measurement reagent 22 increases, increasing the light receiving intensity at the light receiving unit 72, while the irradiation light is scattered by the red blood cells, decreasing the light receiving intensity at the light receiving unit 72. Therefore, the increase in the light receiving intensity due to the refractive index and the decrease in the light receiving intensity due to scattering by the red blood cells offset the increase and decrease in the light receiving intensity. Therefore, when the sample is whole blood, there are cases where the irradiation light of the third predetermined wavelength λ3 (940 nm) cannot detect that the sample has reached the measurement reagent 22.

[0223] In contrast, when whole blood is irradiated with irradiation light of the fourth predetermined wavelength λ4 (520 nm), an increase in the light receiving intensity due to the refractive index and a decrease in the light receiving intensity due to scattering by red blood cells occur, similar to when the irradiation light of the third predetermined wavelength λ3 is irradiated. However, when the irradiation light of the fourth predetermined wavelength λ4 is irradiated, hemoglobin has a property of easily absorbing light of the fourth predetermined wavelength λ4, so that the irradiation light is largely absorbed by hemoglobin, and the light receiving intensity at the light receiving unit 72 decreases. In addition, the glucose contained in the whole blood reacts with the measurement reagent 22 to develop a color, so that more light in the band of the fourth predetermined wavelength λ4 is absorbed, and the light receiving intensity at the light receiving unit 72 decreases. Therefore, when the whole blood is irradiated with irradiation light of the fourth predetermined wavelength λ4 (520 nm), when the sample reaches the measurement reagent 22, the light receiving intensity at the light receiving unit 72 decreases due to the effect of absorption of the irradiation light of the fourth predetermined wavelength λ4. Therefore, when the sample is whole blood, the arrival of the sample at the measurement reagent 22 can be detected by the fourth predetermined wavelength λ4.

[0224] On the other hand, when the sample is plasma, the sample does not contain red blood cells or hemoglobin. When the irradiation light of the fourth predetermined wavelength λ4 (520 nm) is irradiated to plasma not containing red blood cells or hemoglobin, the refractive index of the plasma is larger than that of the air, so the refractive index difference with the member of the component measuring chip 2 containing the measurement reagent 22 is small, and the transmitted light passing through the measurement reagent 22 increases, and the received light intensity at the light receiving unit 72 increases, while the glucose contained in the plasma reacts with the measurement reagent 22 to develop color, and the light in the band of the fourth predetermined wavelength λ4 is absorbed, and the received light intensity at the light receiving unit 72 decreases. Therefore, the increase in the received light intensity due to the refractive index and the decrease in the received light intensity due to the color development offset each other. Therefore, when the sample is plasma, there are cases where the contact of the sample with the measurement reagent 22 cannot be detected by the irradiation light of the fourth predetermined wavelength λ4 (520 nm).

[0225] In contrast, when plasma is irradiated with irradiation light of the third predetermined wavelength λ3 (940 nm), an increase in the received light intensity occurs due to the refractive index, as in the case of irradiation with irradiation light of the fourth predetermined wavelength λ4. On the other hand, even if glucose contained in plasma reacts with the measurement reagent 22 to develop a color, light in the band of the third predetermined wavelength λ3 is not easily absorbed. Therefore, when plasma is irradiated with irradiation light of the third predetermined wavelength λ3 (940 nm), the effect of the increase in the received light intensity due to the refractive index has a large influence, and the received light intensity received by the light receiving unit 72 increases. Therefore, when the sample is plasma, it is possible to detect that the sample has reached the measurement reagent 22 by the third predetermined wavelength λ3.

[0226] Based on the above principle, the control unit 50 can determine whether the sample has reached the measurement reagent 22 when the sample is plasma based on whether the third predetermined wavelength λ3 has increased compared to the reference light receiving intensity, and can determine whether the sample has reached the measurement reagent 22 when the sample is whole blood based on whether the fourth predetermined wavelength λ4 has decreased compared to the reference light receiving intensity. Thus, according to this embodiment, it is possible to detect whether the sample has reached the measurement reagent 22 whether the sample is whole blood or plasma. Furthermore, according to this embodiment, it is possible to detect whether the sample has reached the measurement reagent 22 even if it is unknown whether the sample is whole blood or plasma.

[0227] Furthermore, the component measuring device 1 according to this embodiment can execute processing in one of two processing modes: a first mode for measuring the component to be measured, and a second mode for checking the performance of the component measuring device 1. When executing processing in the first mode, the operator uses whole blood or plasma as a sample. When executing processing in the second mode, the operator uses a solution (control solution) dedicated to the second mode as a sample.

[0228] The control liquid is an aqueous solution of the substance to be measured, and is an aqueous glucose solution. The glucose concentration of the control liquid is appropriately selected from, for example, 30 to 300 mg / dL. A viscosity adjusting agent, a buffer, a surfactant, and a pigment component that mimics the color of blood may be added to the control liquid. The control liquid in this embodiment is prepared to be colorless and transparent in consideration of the change over time of the pigment component. In this way, since the control liquid is colorless and transparent, when the control liquid is used as a sample, it exhibits the same properties as the blood plasma described in the above-mentioned principle. That is, when the control liquid is used, the contact of the solution with the measurement reagent 22 cannot be detected by the irradiation light of the fourth predetermined wavelength λ4. On the other hand, the arrival of the solution at the measurement reagent 22 can be detected by the irradiation light of the third predetermined wavelength λ3.

[0229] By utilizing such a property, the control unit 50 can distinguish between whole blood and a control liquid (or plasma) as a sample, and can therefore determine the first item (whether the selection of the processing mode is correct) and the second item (whether to start component measurement). That is, the component measuring device 1, component measuring device set 100, and information processing device according to the present invention can distinguish between samples by using light with the shortest wavelength and light with the longest wavelength among a plurality of wavelengths used to detect the component to be measured.

[0230] Here, the details of the fourth received light intensity determination process executed by the control unit 50 in step S20 will be described. Fig. 18 is a flow chart showing an example of the fourth received light intensity determination process. As described above, in this embodiment, when starting the flow of Fig. 10, it is assumed that the operator selects the first mode for measuring the component to be measured as the processing mode. Alternatively, it is assumed that the first mode is set as the initial setting of the control unit 50.

[0231] The control unit 50 determines whether or not there is a possibility that the processing mode selected by the operator is incorrect in steps S71 and S72. Specifically, the control unit 50 first determines whether or not the moving average calculated in step S18 of Fig. 10 has reached a first determination threshold (step S71).

[0232] If the control unit 50 determines that the moving average of the received light intensity for the irradiation light of the third predetermined wavelength λ3 has not reached the first judgment threshold (No in step S71), it determines whether the moving average calculated in step S18 of FIG. 10 has reached the second judgment threshold (step S72).

[0233] When the control unit 50 determines that the moving average of the received light intensity for the irradiation light of the fourth predetermined wavelength λ4 has not reached the second determination threshold (No in step S72), it determines in step S20 of Fig. 10 that the difference between the received light intensity received by the light receiving unit 72 and the reference received light intensity has not exceeded a predetermined value (No in step S20). In this case, the control unit 50 proceeds to step S18 and calculates the moving average again.

[0234] When the control unit 50 determines in step S71 that the moving average of the received light intensity for the irradiation light of the third predetermined wavelength λ3 has reached the first determination threshold (Yes in step S71), it outputs to the operator of the component measuring device 1 to confirm whether or not the selection of the processing mode is correct (step S73). The output to confirm whether or not the selection of the processing mode is correct can be executed in various ways. For example, the output to confirm whether or not the selection of the processing mode is correct can be executed by displaying on the display unit 11.

[0235] Here, in this embodiment, as described above, the operator selects the first mode for measuring the component to be measured as the processing mode. Alternatively, the first mode is selected as the initial setting. That is, it is possible that whole blood is used as the sample. However, the fact that the moving average of the received light intensity for the irradiation light of the third predetermined wavelength λ3 has reached the first judgment threshold means that the sample is not whole blood but a control liquid or plasma. Therefore, in step S73, by outputting whether or not the selection of the processing mode is correct, the operator can be prompted to confirm whether or not the processing in the first mode should be continued. This makes it possible to reduce the number of input processes by the operator regarding the processing mode by distinguishing between whole blood, which is most frequently measured, and samples other than whole blood. Also, when it is determined that the set processing mode is incorrect, the measurement process may be performed in the other correct processing mode.

[0236] After checking the output in step S73 (for example, the display on the display unit 11), the operator again inputs whether the processing is to be executed in the first mode or the second mode. The control unit 50 accepts the operator's input regarding the processing mode (step S74).

[0237] When the control unit 50 receives an input to perform processing in the first mode (first mode in step S74), it decides to execute processing in the first mode. In this case, since it is determined in step S71 that the moving average of the received light intensity for the irradiation light of the third predetermined wavelength λ3 has reached the first judgment threshold, it can be said from the above-mentioned principle that the sample has reached the measurement reagent 22 (started reaction). Therefore, in this case, in step S20 of FIG. 10, the control unit 50 determines that the difference between the received light intensity received by the light receiving unit 72 and the reference received light intensity has exceeded a predetermined value (Yes in step S20), and proceeds to step S21 to start processing in steps S21 to S24 as processing in the first mode.

[0238] For example, when plasma is used as a sample instead of whole blood, the moving average of the received light intensity for the irradiated light of the third predetermined wavelength λ3 reaches the first judgment threshold, so that even if the selection of the first mode input by the operator is correct, a confirmation of whether or not the selection of the processing mode is correct is output in step S73. In this case, the operator can execute the processing of the first mode by inputting the selection of the first mode.

[0239] On the other hand, when the control unit 50 receives an input to process in the second mode (second mode in step S74), it executes the second mode process (step S75). The second mode process is a process for confirming the performance of the component measuring device 1. The second mode process, for example, includes performing a measurement process according to the measurement of the control liquid, calculating the measurement result, and displaying on the display unit 11 that the measurement of the control liquid has been performed.

[0240] When the control unit 50 determines in step S72 that the moving average of the received light intensity for the irradiated light of the fourth predetermined wavelength λ4 has reached the second judgment threshold (Yes in step S72), it determines in step S20 of FIG. 10 that the difference between the received light intensity received by the light receiving unit 72 and the reference received light intensity has exceeded a predetermined value (Yes in step S20), and proceeds to step S21 to start the processing of steps S21 to S24 as the processing of the first mode. When the control unit 50 determines in step S72 that the moving average of the received light intensity for the irradiated light of the fourth predetermined wavelength λ4 has reached the second judgment threshold (Yes in step S72), it can be said that it has been confirmed that whole blood is used as the sample, and therefore it can be said that the input to execute the processing of the first mode is not erroneous. Therefore, in this case, the processing of the first mode can be executed without confirming with the operator whether the selection of the processing mode is correct or not.

[0241] In this embodiment, in determining the fourth received light intensity, the reference received light intensity is compared with the moving average of the third predetermined wavelength λ3 and the moving average of the fourth predetermined wavelength λ4. By using the moving average in this manner, it becomes easier to prevent erroneous determination that the sample and the measurement reagent 22 have come into contact with each other when the received light intensity temporarily increases or decreases due to some factor other than contact between the sample and the measurement reagent 22.

[0242] In step S20, the control unit 50 may further provide a threshold value for determining whether the component measuring chip 2 has been removed from the component measuring device 1. For example, when the component measuring chip 2 is removed from the chip insertion space S, at least a part of the irradiation light emitted from the first light source 67 to the fifth light source 68d does not reach the light receiving unit 72 due to the members constituting the component measuring chip 2, as in the case where the component measuring chip 2 is inserted. Therefore, the control unit 50 may determine that the component measuring chip 2 has been removed from the component measuring device 1, for example, when the relative output value from the AD converter of the received light intensity becomes smaller than a predetermined threshold value. At this time, for example, a buzzer sound may be output from the buzzer unit 59 to notify that an error has occurred. Furthermore, when the component measuring chip 2 is completely removed from the component measuring device 1, the irradiation light emitted from the first light source 67 to the fifth light source 68d is directly irradiated to the light receiving unit 72, and the received light intensity at the light receiving unit 72 increases. Therefore, for example, when the relative output value of the received light intensity from the AD converter becomes larger than a predetermined threshold value, the control unit 50 may determine that the component measuring chip 2 has been removed from the component measuring device 1. At this time, for example, the buzzer unit 59 may output a buzzer sound to notify that an error has occurred.

[0243] When the control unit 50 determines that the difference between the intensity of light received by the light receiving unit 72 and the reference intensity of light received exceeds a predetermined value (Yes in step S20), the control unit 50 determines an initial value of the intensity of light received by the light receiving unit 72 as the processing of the first mode (step S21). The initial value (reference value) is an actual measurement value of the absorbance of the irradiated light in the mixture X at a specific time before the sample reaches the measurement reagent 22, that is, an output value of the intensity of light received by the light receiving unit 72 from the AD converter. In step S20, the control unit 50 can determine the output value of the intensity of light received a predetermined time before the time when it is determined that the difference between the intensity of light received by the light receiving unit 72 and the reference intensity of light received exceeds the predetermined value as the initial value. The predetermined time can be set appropriately, for example, to 0.5 seconds. The shorter the predetermined time, the more the output value under conditions (e.g., the surrounding environment) after the sample reaches the measurement reagent 22 can be set as the initial value. For example, when the first light source 67 to the fifth light source 68d are continuously illuminated, the temperature of the first light source 67 to the fifth light source 68d may rise, and the amount of emitted light may change. However, by shortening the predetermined time, the actual measurement value acquired in the next step S22 can be made closer to the acquisition condition of the output value. In this way, by determining the initial value after it is determined that the sample has reached the measurement reagent 22, the output value immediately before the sample reaches the measurement reagent 22 is set as the initial value (reference value), and the actual measurement value can be derived.

[0244] Furthermore, when the control unit 50 determines that the sample has reached the measurement reagent 22, it starts acquiring actual measured values ​​of the absorbance of the irradiated light in the mixture X in order to measure the component to be measured (step S22). The actual measured values ​​correspond to the first to fifth actual measured values ​​in the flow of FIG. 9. In this way, the control unit 50 can automatically start acquiring the actual measured values ​​when it determines that the sample containing the component to be measured has started a color reaction with the measurement reagent 22. Therefore, the component measuring device 1 has improved usefulness.

[0245] In this embodiment, the control unit 50 starts acquiring the actual measured value in step S22, and then executes a process of determining the third received light intensity (step S23). The process of determining the third received light intensity executed in step S23 is similar to that in step S19. That is, in step S23, the process described with reference to the flow in FIG. 17 is executed.

[0246] If the control unit 50 determines that the received light intensity at the light receiving unit 72 is not within a predetermined range (No in step S23), it notifies the user that an error has occurred, for example by outputting a buzzer sound from the buzzer unit 59 (step S25).

[0247] On the other hand, when the control unit 50 determines that the light receiving intensity at the light receiving unit 72 is within the predetermined range (Yes in step S23), the control unit 50 proceeds to step S24. In this way, even after the acquisition of the actual measurement value is started, it can be determined whether the component measuring tip 2 is properly attached to the component measuring device 1 or not.

[0248] The control unit 50 ends the acquisition of the actual measurement values ​​after a predetermined time has elapsed since the start of acquisition of the actual measurement values ​​in step S22 (step S24). At this time, the control unit 50 may stop light emission from the first light source 67 to the fifth light source 68d. The predetermined time can be appropriately determined depending on the properties of the measurement reagent 22, etc., and can be, for example, 9 seconds. In this way, the control unit 50 ends the irradiation light emission process executed in the component measurement process.

[0249] The control unit 50 can measure the glucose concentration in the sample by executing the component measurement method described in this embodiment using the acquired actual measurement value. Note that, in the above embodiment, the method for measuring the glucose concentration when the sample is whole blood has been described, but the glucose concentration can also be measured by a similar method when the sample is plasma.

[0250] Fig. 19 is a diagram showing the light receiving intensity of the irradiation light emitted from the first light source 67 to the fifth light source 68d by the light receiving unit 72, mainly in steps S18 to S22 of Fig. 10. In Fig. 19, the horizontal axis shows time, and the vertical axis shows the light receiving intensity.

[0251] While the first light source 67 to the fifth light source 68d are continuously emitting light in step S17, the control unit 50 calculates a moving average of the intensity of received light received by the light receiving unit 72 (step S18). In step S20, the control unit 50 executes a fourth received light intensity determination process. In the fourth received light intensity determination process, the control unit 50 continues to perform the calculations until it is determined that the difference between the received light intensity received by the light receiving unit 72 and the reference received light intensity exceeds a predetermined value (until time t 6 Steps S18 and S20 are repeated until

[0252] The control unit 50 6 If it is determined that the difference between the intensity of the light received by the light receiving unit 72 and the reference intensity of the light received by the light receiving unit 72 exceeds a predetermined value (Yes in step S20), the control unit 50 determines an initial value of the intensity of the light received by the light receiving unit 72 (step S21). 6 Time t 0.5 seconds before 5 The control unit 50 determines the output value of the AD converter of the received light intensity at time t 6 Then, acquisition of the actual measurement values ​​is started (step S22). After a predetermined time has elapsed, the control unit 50 ends acquisition of the actual measurement values ​​(step S24). If there is a possibility that the second mode will be selected (Yes in step S71) and the processing mode has not been input in step S73, the acquired initial values ​​and actual measurement values ​​may be stored in memory, and after the input of the processing mode is confirmed, the measurement values ​​may be calculated and displayed according to the processing mode.

[0253] The component measuring device, the component measuring device set, and the information processing device according to the present invention are not limited to the specific description of the above-mentioned embodiment, and various modifications are possible within the scope of the gist of the invention described in the claims. In the above-mentioned embodiment, the glucose concentration is measured as the measurement of glucose as the measured component, but it is not limited to the concentration, and another physical quantity may be measured. In the above-mentioned embodiment, glucose in the plasma component is exemplified as the measured component in blood, but it is not limited to this, and for example, cholesterol, sugars, ketone bodies, uric acid, hormones, nucleic acids, antibodies, antigens, etc. in blood can be used as the measured component. Therefore, the component measuring device is not limited to a blood glucose measuring device. Furthermore, in the above-mentioned embodiment, the light receiving unit 72 receives the transmitted light that passes through the component measuring chip 2, but it may be a light receiving unit that receives the reflected light reflected from the component measuring chip 2.

[0254] In the above embodiment, the process of determining whether the selection of the processing mode may be incorrect is described as follows: if the operator has previously selected the first mode as the processing mode, but the control unit 50 has determined that the processing in the second mode may be appropriate, that is, if the moving average of the received light intensity for the irradiation light of the third predetermined wavelength λ3 has reached the first judgment threshold, the selection of the processing mode is confirmed. However, the process of determining whether the selection of the processing mode may be incorrect is not limited to this. For example, if the operator has previously selected the second mode as the processing mode, but the control unit 50 has determined that the processing in the first mode may be appropriate, that is, if the moving average of the received light intensity for the irradiator of the fourth predetermined wavelength λ4 has reached the second judgment threshold, the control unit 50 may confirm whether the selection of the processing mode is correct. In this way, the control unit 50 may determine whether the sample is to be used in the processing mode selected based on the input operation based on whether the difference between the reference received light intensity and the received light intensity is higher than the first judgment threshold or lower than the second judgment threshold. If the sample is not one that is used in the processing mode selected based on the input operation, the control unit 50 determines that the selection of the processing mode may be incorrect.

[0255] In the above embodiment, the control unit 50 outputs to confirm whether the selection of the processing mode is correct, and when it receives an input from the operator regarding the processing mode, it executes the processing in the input processing mode. However, the control unit 50 does not necessarily have to execute the processing after receiving the input. For example, the control unit 50 may automatically select a processing mode and execute the processing after executing the processes of steps S71 and S72. In other words, when the control unit 50 determines that the selection of the processing mode may be incorrect, it may automatically select another processing mode that has not been selected and execute the processing in the other processing mode.

[0256] Alternatively, regardless of whether the operator has selected the first mode or the second mode in advance, the control unit 50 may determine whether or not the selection of the processing mode may be incorrect when the moving average of the received light intensity reaches the first judgment threshold or the second judgment threshold. In this case, regardless of whether the operator has selected the first mode or the second mode in advance, when the moving average of the received light intensity reaches the first judgment threshold or the second judgment threshold, an output may be output to confirm whether or not the selection of the processing mode is correct. Alternatively, in this case, if the operator determines that the selection of the processing mode may be incorrect based on the judgment result of whether or not the selection of the processing mode may be incorrect, the operator may be notified. Alternatively, if the operator has selected the second mode in advance, the control unit 50 may automatically switch to the first mode when the moving average of the received light intensity exceeds the second judgment threshold, and perform processing in the first mode (measurement processing of the sample). [Industrial Applicability]

[0257] The present invention relates to a component measuring device, a component measuring device set, and an information processing device. [Explanation of symbols]

[0258] 1: Component measuring device 2: Component measurement chip 10: Housing 10a: Main body 10b: Tip mounting part 11: Display section 12:Removal lever 13: Power button 14: Operation buttons 21: Base material 22: Measurement reagents 23: Flow path 23a: void 24: Supply section 25: Cover material 26: Eject pin 50: Control unit 51: Photometry section 52: Storage part 53:Temperature measurement part 54: Power supply section 55:Battery 56: Communications Department 57: Clock section 58:Operation section 59: Buzzer section 66: Light emitting part 67: 1st light source 68a:Second light source 68b: Third light source 68c: 4th light source 68d: 5th light source 69a: First throttle section 69b: Second squeeze section 72: Light receiving part 80: Holder member 100: Component measuring device set

Claims

1. A chip insertion space for inserting a component measuring chip is provided. A light receiving unit; A light emitting unit that emits irradiation light to the light receiving unit; a control unit that measures a component to be measured in a sample using an actual measurement value of the intensity of light received by the light receiving unit; A component measuring device comprising: The control unit determines that an abnormality has occurred in the component measuring device when the component measuring chip is not inserted into the chip insertion space and when the absolute output value of the light receiving unit when the light emitting unit is not emitting the irradiation light is not included in a predetermined first designated range, and when the relative output value, which is the difference between the output value of the light receiving unit when the light emitting unit is emitting the irradiation light and the output value of the light receiving unit when the light emitting unit is not emitting the irradiation light, is not included in a predetermined second designated range.

2. The component measuring device of claim 1, wherein the control unit determines that an abnormality has occurred in the attachment state of the component measuring chip to the component measuring device when the absolute output value is not within a predetermined third designated range and when the relative output value is within a predetermined fourth designated range when the component measuring chip is inserted into the chip insertion space.

3. The component measuring device according to claim 1 , wherein the control unit determines a type of abnormality based on the absolute output value or the relative output value.

4. The component measuring device according to claim 1 , wherein the control unit notifies the occurrence of an error when it is determined that an abnormality has occurred in the component measuring device.

5. A component measuring chip; A component measuring device having a chip insertion space for inserting the component measuring chip; Equipped with The component measuring device is A light receiving unit; A light emitting unit that emits irradiation light; a control unit that measures a component to be measured in a sample using an actual measurement value of the intensity of light received by the light receiving unit; Equipped with The control unit determines that an abnormality has occurred in the component measuring device when the component measuring chip is not inserted into the chip insertion space and the absolute output value of the light receiving unit when the light emitting unit is not emitting the irradiation light is not included in a predetermined first designated range, and when the relative output value, which is the difference between the output value of the light receiving unit when the light emitting unit is emitting the irradiation light and the output value of the light receiving unit when the light emitting unit is not emitting the irradiation light, is not included in a predetermined second designated range.

6. An information processing method executed by a component measuring device having a chip insertion space for inserting a component measuring chip, the component measuring device including: a light emitting unit that emits irradiation light; a light receiving unit; and a control unit that measures a component to be measured in a sample using an actual measurement value of the light receiving unit, the information processing method comprising: a step of determining that an abnormality has occurred in the component measuring device when the absolute output value of the light receiving unit when the light emitting unit is not emitting the irradiation light is not included in a predetermined first designated range and when a relative output value which is the difference between the output value of the light receiving unit when the light emitting unit is emitting the irradiation light and the output value of the light receiving unit when the light emitting unit is not emitting the irradiation light is not included in a predetermined second designated range in a state where the component measuring chip is not inserted into the chip insertion space; An information processing method comprising:

Images