JP7617896B2 - Component measuring device, component measuring device set, and information processing method - Google Patents

Description

The present disclosure relates to a component measuring device, a component measuring device set, and an information processing method.

Conventionally, in the fields of biochemistry and medicine, devices that measure components to be measured contained in samples such as blood as specimens are known. For example, Patent Document 1 discloses a blood glucose meter that measures the amount of glucose in blood by applying blood to a measurement tip attached to the blood glucose meter.

JP 2011-064596 A

When measuring the components to be measured using a device such as a blood glucose meter, if it is possible to confirm whether the device is operating normally, it will be possible to measure the components to be measured appropriately.

The present disclosure aims 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.

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 the actual measured value of the intensity of light received 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 intensity of light received at the light receiving unit is within a predetermined specified range.

In one embodiment of the present disclosure, the control unit determines whether or not an abnormality has occurred based on at least one of the absolute output value of the light receiving unit when the light emitting unit is not emitting the emission light, and 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.

In 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 specified range and when the relative output value is not within a predetermined second specified range when the component measuring chip is not inserted into the chip insertion space.

In 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 specified range, and if the relative output value is within a predetermined fourth specified range, the control unit determines that an abnormality has occurred in the attachment state of the measuring chip to the component measuring device.

In one embodiment of the present disclosure, the control unit determines the type of abnormality based on the absolute output value or the relative output value.

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

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

In 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 the circuit connected to the light receiving unit.

In one embodiment of the present disclosure, the control unit determines that a light insufficiency abnormality has occurred if the relative output value is below the lower limit value of the second specified range.

In one embodiment of the present disclosure, the control unit determines that an abnormality in the amount of light emitted has occurred if the relative output value exceeds the upper limit value of the second specified range.

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

In one embodiment of the present disclosure, the control unit determines that an abnormality in ambient light has occurred, in which a predetermined amount or more of ambient light reaches the light receiving unit, 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.

In 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 an abnormality in light receiving sensitivity has occurred due to an abnormality in the light receiving unit itself or an abnormality in the circuit connected to the light receiving unit.

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 the sample using the actual measured value of the intensity of light received by 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 intensity of light received by the light receiving unit is within a predetermined specified range.

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 irradiation 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 intensity of light received by 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 intensity of light received by the light receiving unit is within a predetermined specified range.

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.

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. FIG. 2 is a cross-sectional view taken along line II in FIG. FIG. 2 is a cross-sectional view taken along line II-II in FIG. FIG. 2 is a top view showing the component measuring chip shown in FIG. 1 . FIG. 5 is a cross-sectional view taken along line III-III in FIG. FIG. 2 is a functional block diagram of the component measuring device shown in FIG. 1 . 2 is a diagram showing the positional relationship of a plurality of light sources in the component measuring device shown in FIG. 1 . FIG. 8 is a diagram showing the irradiation position of light emitted from the mixture of the multiple light sources shown in FIG. 7 . 4 is a flowchart showing an example of a component measuring process executed by the component measuring device of FIG. 1 . 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 measuring process. 8 is a diagram showing a schematic diagram of the light receiving intensity of one set of irradiation light emitted from the first light source to the fifth light source in FIG. 7 by a light receiving section. 10 is a diagram illustrating the light receiving intensity of the light emitted from the first light source to the fifth light source by the light receiving unit. FIG. 10 is a flowchart illustrating an example of a first received light intensity determination process. 10 is a flowchart illustrating an example of a second received light intensity determination process. 10 is a diagram illustrating the light receiving intensity of the light emitted from the first light source to the fifth light source by the light receiving unit. FIG. 10 is a diagram illustrating the light receiving intensity of the light emitted from the first light source to the fifth light source by the light receiving unit. FIG. 10 is a flowchart illustrating an example of a third received light intensity determination process. 13 is a flowchart illustrating an example of a fourth received light intensity determination process. 10 is a diagram illustrating the light receiving intensity of the light emitted from the first light source to the fifth light source by the light receiving unit. FIG.

Hereinafter, embodiments 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 Figures 1 to 19. Common components in each figure are denoted by the same reference numerals.

First, one 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 I-I 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.

As shown in Figures 1 to 3, the component measuring device set 100 comprises 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 measured component 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.

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.

The component measuring device 1 includes a housing 10 made of a resin material, a group of buttons provided on the top surface of the housing 10, a display unit 11 configured with liquid crystal or LEDs (Light Emitting Diodes) provided on the top surface of the housing 10, and a removal lever 12 that is operated when removing the component measuring chip 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.

As shown in FIG. 1, the housing 10 includes a main body 10a having a generally rectangular 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 that protrudes outward from the main body 10a and has a removal lever 12 provided 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 causes the chip mounting unit 10b of the component measuring device 1 to engage 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, such as providing a claw portion in the tip mounting unit 10b that can engage with a part of the component measuring chip 2.

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.

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 attachment 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 includes a tip attachment portion to which the component measurement tip 2 can be attached. Therefore, in addition to the shape of the housing 10 of this embodiment, various shapes can be adopted to make it easier for the operator to hold it with one hand, for example.

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 the blood glucose measuring device 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 that instructs the operator to perform a specific operation. The operator can operate the power button 13 and operation button 14 of the button group while checking the content displayed on the display unit 11.

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, when 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 the irradiation light emitted by the light emitting unit 66. The light receiving unit 72 receives the 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 in 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.

The light-emitting unit 66 has five light sources. Specifically, the light-emitting unit 66 has 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. Here, 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 the flow direction A (direction toward the right in FIG. 2) in which the sample flows in the flow path 23 of the component measurement 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 the flow path width direction B (both left and right directions in FIG. 3) perpendicular to the flow direction A. Details of the arrangement of the first light source 67 to the fifth light source 68d will be described later (see FIG. 7).

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 III-III in FIG. 4. As shown in FIGS. 4 and 5, the component measuring chip 2 comprises a base member 21 having a substantially rectangular plate-like outer shape, a measuring 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 formed of a light-blocking 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. Details of the measurement spot will be described later.

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 section 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 section 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.

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 create a state in which the mixture X containing the color component spreads 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.

2, for ease 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. As the measurement reagent 22 dissolves in the sample, a color reaction with the sample progresses, and mixture X is positioned at the holding position and in its vicinity.

In this embodiment, the flow path 23 is formed 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 of the base member 21 in the thickness direction C.

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 irradiation light passes through the base member 21 and the cover member 25 will be a sufficient signal for measurement. Examples of the transparent organic resin materials include polyethylene terephthalate (PET), polymethyl methacrylate (PMMA), polystyrene (PS), cyclic polyolefin (COP), cyclic olefin copolymer (COC), polycarbonate (PC), and the like; and transparent inorganic materials such as glass and quartz.

The measurement reagent 22 contains 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.

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 near 660 nm, but is not limited to a coloring reagent with a peak wavelength near 660 nm, and is appropriately selected depending on the purpose.

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 the holding position where the measurement reagent 22 of the flow path 23 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. 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.

Figure 6 is a functional block diagram of the component measuring device 1 shown in Figures 1 to 3. As shown in Figure 6, the component measuring device 1 includes a control unit 50, a photometry unit 51, a memory 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.

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 part by reading and executing a program stored in the memory unit 52, etc. The memory 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 to execute the component measurement method shown in this embodiment.

When operating in the first mode, the control unit 50 can measure the components to be measured in the sample by operating the photometry unit 51. Furthermore, when executing the measurement process of the components to be measured by the component measuring device 1, the control unit 50 can execute a process to detect whether normal measurement can be performed. Furthermore, the control unit 50 can execute a process to determine whether there is a possibility that the selection of the processing mode is incorrect. Details of the process to measure the components to be measured, the process to detect whether normal measurement can be performed, and the process to determine whether there is a possibility that the selection of the processing mode is incorrect will be described later.

The photometry unit 51 is an optical system capable of acquiring the optical characteristics of a mixture X containing a sample and a color component. Specifically, the photometry unit 51 includes a light emitting unit 66 and a light receiving unit 72.

The light-emitting unit 66 emits irradiation light toward the chip insertion space S. The light-emitting unit 66 is provided with a plurality of light sources. Specifically, the light-emitting unit 66 of this embodiment is provided with five light sources that emit irradiation light having different spectral radiation characteristics (e.g., visible light, infrared light). More specifically, as described above, the light-emitting unit 66 of this embodiment is provided with 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. The positional relationship between the first light source 67 to the fifth light source 68d is the positional relationship shown in Figures 2 and 3. Details of the actual positional relationship between the first light source 67 to the fifth light source 68d will be described later (see Figure 7).

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. can be applied. As the first light source 67 to the fifth light source 68d, the above-mentioned LED elements are easy to use, taking into account versatility, etc. In this embodiment, the first light source 67 to the fifth light source 68d are composed of 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.

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 area where the color component is located. As shown in Figures 2 and 3, the light receiving unit 72 in this embodiment is composed of one light receiving element arranged opposite the light emitting unit 66 with the component measurement 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 measurement chip 2 and transmitted through the component measurement 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.

In the present specification, the area within the component measuring device 1 that is irradiated with light from the light-emitting unit 66 and that is irradiated with light that can be detected by the light-receiving unit 72 is 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.

Each of the first light source 67 to the fifth light source 68d receives a drive power signal from a light emission control circuit provided 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 corresponding to the received light. This analog signal is amplified and AD converted by the light receiving control circuit provided in the photometry unit 51, and converted into a digital signal (hereinafter referred to as the detection signal).

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

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, by a known thermometer. The temperature measured by the temperature measuring unit 53 can be used, for example, in adjusting the amount of light emitted from the light emitting unit 66 described later.

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

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 results of component measurement by the component measuring device 1 to an external device connected in a communicative 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 communicative manner.

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

The operation unit 58 is an input interface that allows the 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 composed of 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 input operations. 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.

The buzzer unit 59 notifies information by outputting a buzzer sound. The buzzer unit 59 outputs a buzzer sound at a predetermined timing that is set in advance. For example, the buzzer unit 59 outputs a 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.

Next, we will explain the measurement process of the measured components in the 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.

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

The memory 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 sample to blood (whole blood) as a percentage.

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 the color component generated by the color reaction between the component to be measured 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 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 above-mentioned 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 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 component to be measured.

Figure 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 Figure 1) of the component measuring device 1. For ease of explanation, in Figure 7, the position of the light receiving unit 72 in the flow path 23 of the component measuring chip 2 is shown by a two-dot chain line, and in this embodiment, mixture X is generated at the above-mentioned holding position in the flow path 23 and in its vicinity.

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 measurement chip 2).

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.

3 and 7, the first light source 67, the second light source 68a, and the third light source 68b are arranged side by side along the flow path width direction B with the first light source 67 at the center. In this embodiment, as shown in FIG. 8, 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 the 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 the third irradiation position SL3 of the irradiated light from the third light source 68b overlap in the flow path width direction B.

That is, the first light source 67 to the third light source 68b are arranged so 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 areas in the flow path width direction A of the first irradiation position SL1 to the third irradiation position SL3 overlap in the flow path width direction B. It is more preferable that the areas in the flow path width direction B of the first light source 67 to the third light source 68b of the first irradiation position SL1 to the third irradiation position SL3 also overlap in the flow direction A.

In this embodiment, the first light source 67 and the second light source 68a are arranged 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 arranged. The first light source 67 and the third light source 68b are arranged 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 arranged. In this way, the first light source 67, the second light source 68a, and the third light source 68b are arranged adjacent to each other in the flow path width direction B without any other light source being interposed therebetween.

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.

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 the first irradiation position SL1 in the mixture X of the light irradiated from the first light source 67 and the 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 on the mixture X is equal to or less than a predetermined value. 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.

As for the first light source 67 and the fifth light source 68d, the first irradiation position SL1 in the mixture X of the light irradiated from the first light source 67 and the fifth irradiation position SL5 in the mixture X of the light irradiated from the fifth light source 68d are arranged side by side along the flow direction A so that the difference in the angles of incidence on the mixture X is a predetermined value or less and the regions can be overlapped. More specifically, there is no gap between the first light source 67 and the fifth light source 68d in the flow direction A in which 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.

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 when viewed from above, and the first light source 67 is held in the center (the intersection of the cross) when viewed from above. The second light source 68a is held at a position on one side of the center where the first light source 67 is held in the flow path width direction B, and the third light source 68b is held at a position on the other side of the flow path width direction B. The fifth light source 68d is held at a position in the flow direction A of the center where the first light source 67 is held, and the fourth light source 68c is held at a position opposite the flow direction A.

Here, in this embodiment, the second light source 68a and the third light source 68b emitting irradiation light of the second predetermined wavelength λ2 and the third predetermined wavelength λ3 are arranged side by side along the flow path width direction B with respect to the first light source 67. Also, the fourth light source 68c and the fifth light source 68d emitting irradiation light of the fourth predetermined wavelength λ4 and the fifth predetermined wavelength λ5 are arranged side by side along the flow direction A with respect to the first light source 67. As will be described in detail later, the second predetermined wavelength λ2 and the third predetermined wavelength λ3 are wavelengths belonging to the infrared region, and the fourth predetermined wavelength λ4 and the fifth predetermined wavelength λ5 are wavelengths belonging to the visible region.

2 and 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 69a located between the mixture X and the light receiving unit 72, which adjusts the amount of light that reaches the light receiving unit 72 out of the transmitted light transmitted through the mixture X. The difference between the angle of incidence of the irradiation light from the first light source 67 on the mixture X and the angle of incidence of the irradiation light from each of the second light source 68a to the fifth light source 68d on the mixture X affects the accuracy of estimating the amount of noise. Therefore, the smaller the difference between the angle of incidence of the irradiation light from the first light source 67 on the mixture X and the angle of incidence of the irradiation light from each of the second light source 68a to the fifth light source 68d on the mixture X, the more preferable it is. In other words, the longer the distance T1 between the first light source 67 to the fifth light source 68d and the first diaphragm 69a in the facing direction (the same direction as the thickness direction C of the component measuring chip 2 in Figures 2 and 3), the more preferable it is for improving the estimation accuracy of the noise amount. On the other hand, by reducing the distance T2 between the first light source 67 to the fifth light source 68d and the light receiving unit 72 in the facing direction, the improvement of the light efficiency and the miniaturization of the component measuring device 1 can be realized.

In addition, if the 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 is large, the measurement points do not match, and the accuracy of the measurement results of the measured components 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 portion 69a in the opposing 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 portion 69a, one surface of the component measuring chip 2 is formed of a light-shielding material 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 material to form an aperture, or the light-shielding material may be cut out to form an aperture.

2 and 3, the component measuring device 1 is provided with a second aperture section 69b located between the first light source 67 to the fifth light source 68d and the mixture X, and adjusting the amount of light reaching the mixture X from the first light source 67 to the fifth light source 68d. In particular, it is preferable that the second aperture section 69b is designed so that light reflected by the inner wall of the second aperture 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 aperture section 69a. It can be considered that the light emitted from the first light source 67 to the fifth light source 68d is optically 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 aperture section 69b does not reach the first aperture section 69b and is reflected by some wall surface, it will not enter the first aperture section 69a due to multiple reflections. In this embodiment, the optical axis of each light source is designed to be mirror-reflected on the inner wall of the second diaphragm portion 69b, but in reality, the light is diffusely reflected on the inner wall of the second diaphragm portion 69b, and the 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 of the stray light and the incident angle of the first light source 67 is equal to or less than a predetermined value.

The component measuring device 1 of this embodiment is capable of mounting a component measuring chip 2 that divides a flow path 23 through which a sample flows and has a measuring reagent 22, which contains 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 containing 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. It is preferable that the component measuring device 1 is configured so that the disposable component measuring chip 2 is detachable.

Next, we will explain how the control unit 50 of the component measuring device 1 of this embodiment calculates the concentration of the measured component in the sample in the first mode.

In this embodiment, the component measuring device 1 performs the measurement using a color reaction between glucose as the measured component in the sample and the color reagent in the measurement reagent 22, without separating the plasma components containing glucose from the sample (e.g., whole blood) and the color reagent. The component measuring device 1 estimates the absorbance at a predetermined measurement wavelength of the color component generated by the color reaction between glucose and the color 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 measured component.

In general, when a sample contains components other than the color component to be measured, optical phenomena can occur that can affect the measurement results of the concentration of the component to be measured, which is based on the absorbance of the color component, as disturbance factors (noise). For example, "light scattering" caused by 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" caused by pigment components other than the color component to be measured (specifically, mainly hemoglobin when the sample is blood), can cause the absorbance to be measured to be greater than the true value.

When using mixture X, which contains a sample having specific absorption characteristics in addition to the color component to be measured, 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.

When the sample is blood, 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 specific 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.

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 the color component generated by the 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.

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 explained. Hemoglobin in red blood cells mainly contains oxyhemoglobin that is bound to oxygen, and reduced hemoglobin in which oxygen dissociates in areas where the partial pressure of oxygen is low. Oxyhemoglobin is found in large amounts in arterial blood, as reduced hemoglobin passes through the lungs and binds to oxygen, and carries oxygen throughout the body through the arteries. For example, when blood is collected as a sample from the pad of a finger, the blood is from capillaries, so the amount of oxyhemoglobin is relatively large. Conversely, reduced hemoglobin is found in large amounts in venous blood.

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 taking into account 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 all hemoglobin. In order to more accurately estimate the absorbance derived from the color component to be measured, it is important to take into account the ratio of reduced hemoglobin to oxygenated hemoglobin.

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

Below, further details of the component measurement method performed by the component measuring device 1 are described.

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

The measurement wavelength for measuring the absorbance of the color component to be measured may be a wavelength at which the light absorption rate 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 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 absorbance due to light absorption by 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 absorbance due to light absorption by 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.

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, taking into consideration the absorption characteristics of hemoglobin, it is desirable to ensure that the wavelength range (600 nm or less) in which the absorbance due to light absorption by hemoglobin is large does not overlap with the measurement wavelength in the absorbance spectrum of the coloring component.

Below, a method for estimating the absorbance of the color component at 660 nm, which is the measurement wavelength of this embodiment, is described. The component measuring device 1 measures the absorbance of the mixture X at four second predetermined wavelengths λ2 to 5th predetermined wavelengths λ5 that are 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 these 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 of this embodiment is the first predetermined wavelength λ1 described above.

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

More specifically, as the four second actual measurement values D2 to fifth actual measurement values D5 mentioned above, two second actual measurement values D2 and third actual measurement values D3 of the absorbance of 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 fourth actual measurement values D4 and fifth actual measurement values D5 of the absorbance of 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.

In other words, the component measuring device 1 utilizes, as the second measured value D2 and the third measured value D3 described above, 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 the long wavelength range W1 on the longer wavelength side than the wavelength range W3.

Furthermore, as the fourth actual value D4 and the fifth actual value D5 described above, the component measuring device 1 utilizes the fourth actual value D4 and the fifth actual 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.

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 from each of 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 memory unit 52 as actual measurement value data. The control unit 50 can acquire the actual measurement value data from the memory unit 52. The means by which the control unit 50 acquires the first actual measurement value D1 to fifth actual measurement value D5 are not limited to the above-mentioned means, and can be acquired by various known means.

The control unit 50 then corrects the first actual measurement value D1 using the second actual measurement value D2 to the fifth actual measurement value D5 to estimate the absorbance of the color component at the first predetermined wavelength λ1 (660 nm in this example), which is the measurement wavelength. In the long wavelength region W1, where light scattering of blood cell components and the like is dominant, the absorbance spectrum of the mixture X becomes approximately linear. Therefore, 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, thereby making it possible to estimate to some extent the absorbance at the first predetermined wavelength λ1, which is the measurement wavelength, that is caused by disturbance factors (noise) other than the absorbance caused by the color component.

Furthermore, the component measuring device 1 can calculate the glucose concentration in the sample by taking into account 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 (the fourth predetermined wavelength and the fifth predetermined wavelength) selected based on the ratio of reduced hemoglobin to oxygenated hemoglobin.

Specifically, the component measuring device 1 uses, as the fourth predetermined wavelength λ4, 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, and uses, as the fifth predetermined wavelength λ5, a wavelength at which the difference in absorption coefficient between reduced hemoglobin and oxygenated hemoglobin is greater than the first predetermined value. More specifically, as the fourth predetermined wavelength λ4, 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 value as a predetermined threshold, and as the fifth predetermined wavelength λ5, a wavelength at which the ratio of the absorption coefficient of oxygenated hemoglobin to the absorption coefficient of reduced hemoglobin is less than the first threshold value. In other words, as the fourth predetermined wavelength λ4 and the fifth predetermined wavelength λ5, two wavelengths are used: 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 value and a wavelength at which the ratio is less than the first threshold value. This allows the control unit 50 to perform a more accurate correction that takes into account the ratio of reduced hemoglobin to oxygenated hemoglobin when correcting the first actual value D1 using the second actual value D2 to the fifth actual value D5.

As the two wavelengths selected based on the ratio of reduced hemoglobin to oxygenated hemoglobin, it is preferable to use two wavelengths that have a large difference in light absorption of hemoglobin due to the ratio of reduced hemoglobin to oxygenated hemoglobin. Therefore, in this embodiment, a wavelength is used as the fourth predetermined wavelength λ4 at which the ratio of the absorption coefficient of oxygenated hemoglobin to the absorption coefficient of reduced hemoglobin is 0.8 or more. Also, it is preferable to use a wavelength as the fifth predetermined wavelength λ5 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.

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, while also 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 measured component (glucose concentration measurement in this embodiment).

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, but 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.

Specifically, the second predetermined wavelength λ2 in the long wavelength range W1 where light scattering of blood cell components is dominant is a wavelength at which the difference in absorption coefficient between reduced hemoglobin and oxygenated hemoglobin is equal to or less than a second predetermined value, and the third predetermined wavelength λ3 in the long wavelength range W1 is a wavelength that is greater than the second predetermined value. More specifically, the second predetermined wavelength λ2 is 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 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 at which 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 ranges in which the ratio of the absorption coefficient of oxygenated hemoglobin to the absorption coefficient of reduced hemoglobin is different as the second predetermined wavelength λ2 and the third predetermined wavelength λ3, whereby when the control unit 50 corrects the first measured value D1 using the second measured value D2 to the fifth measured value D5, it is possible to perform a highly accurate correction that takes the ratio of reduced hemoglobin to oxygenated hemoglobin into even greater consideration.

In particular, in the long wavelength range W1, the influence of light scattering by blood cell components and the like is dominant, but the influence of light absorption by hemoglobin is also included to the same extent as the measurement wavelength of the component to be measured, so 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.

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 oxyhemoglobin 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.

The third predetermined wavelength λ3 is a wavelength in the long wavelength range W1 at which 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 that is the long-wavelength side of the peak wavelength range of the absorbance spectrum of the color component. This eliminates the influence of light absorption by the color component, and makes it possible to more accurately estimate noise in the long wavelength range W1 that is dominated by the influence of light scattering of blood cell components, etc. 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 which the absorbance of the color component is zero, that is, the wavelength that is 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 for a sample and/or a mixture containing the color-forming component. Furthermore, 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.

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

Next, we will explain the method of correction processing in the first mode by the control unit 50 of the component measuring device 1.

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

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 data and correction coefficient data stored in the memory unit 52.

Here, the correction coefficient data is derived by a regression analysis previously performed using the formula shown in the following equation (1).

B(λ) means the absorbance at wavelength λ caused by disturbance factors (noise) other than the absorbance of the color component, and the regression calculation is performed using the above formula (1) using various blood samples to derive the 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 the absorbance spectrum of the adjusted blood samples is measured, and the 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 is 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.

In order to more easily calculate 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 absorbance of mixture X at the measurement wavelength of 660 nm from the actual absorbance of mixture X at the fourth predetermined wavelength λ4 of 520 nm and the second predetermined wavelength λ2 of 850 nm.

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 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 the second 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. The method includes a step S2 of deriving the hematocrit value using at least one of the first measured value D1 to the fifth measured value 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.

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, if 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 correction 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 memory 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. Note that, when 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 actual 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 obtained measurement wavelength, and the derived hematocrit value and the glucose concentration.

When executing the component measurement process, the control unit 50 of the component measuring device 1 emits irradiation light from the first light source 67 to the fifth light source 68d according to a predetermined algorithm, and the light receiving unit 72 measures the intensity of the received light. Details of the light quantity measurement process that the control unit 50 executes when executing the component measurement process are described below.

Figure 10 is a flowchart showing an example of a light quantity measurement process executed by the component measuring device 1 in a component measurement process. The flow in Figure 10 is executed, for example, when an operator inputs a processing mode and inputs the start of processing. Here, the following explanation will be given assuming that the operator has selected the first mode for measuring the component to be measured as the processing mode.

Here, when executing the component measurement process, the control unit 50 causes the first light source 67 to the fifth light source 68d to emit irradiation light in sequence, with each process being one set of emitting 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 unit 72 receiving the irradiation light emitted from the first light source 67 to the fifth light source 68d. In FIG. 11, the horizontal axis shows time, and the vertical axis shows the received light 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 causes the first light source 67 to the fifth light source 68d to emit light so that the light receiving unit 72 receives almost the same intensity of the light irradiated from each of the first light source 67 to the fifth light source 68d. "Almost the same 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.

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 immediately 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.

11, the control unit 50 emits irradiation light to the measurement area 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 molecular Brownian motion and sedimentation, as well as interference as a wave property. Therefore, it is preferable that the second actual value D2 and the third actual value D3 used to correct the influence of light scattering are obtained at a timing closer in time to the first actual value D1 to be corrected. This is because obtaining them at a timing closer in time makes them less susceptible to temporal fluctuations. Therefore, as in this embodiment, the influence of light scattering can be corrected with higher accuracy by emitting the second light source 68a and the third light source 68b, which emit irradiation light of the second predetermined wavelength λ2 and the third predetermined wavelength λ3, at timings adjacent to and before and after the timing at which the first light source 67 is caused to emit pulsed light of the first predetermined wavelength λ1, which is the measurement wavelength.

In addition, 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.

With reference to Figure 10, when the control unit 50 detects an operation or input to start processing, for example by 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 up 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 to achieve a predetermined value of received light intensity (relative output value).

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 executes the emission of irradiation light from the first light source 67 to the fifth light source 68d so that it can detect whether or not the component measuring chip 2 is attached to the component measuring device 1.

Figure 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 Figure 10. In Figure 12, the horizontal axis shows time, and the vertical axis shows the received light intensity. As shown in Figure 12, the control unit 50 repeatedly outputs the set of the emission process described in Figure 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 again stops outputting the irradiation light. 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.

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

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 process executed by the control unit 50 to detect whether or not normal measurement can be performed, as described above. Figure 13 is a flowchart showing an example of the first received light intensity determination process.

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

The absolute output value used here refers to the output value from the AD converter connected to the light receiving unit 72 according to the intensity of light received by the light receiving unit 72 when no light is 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 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 no light is emitted from the light emitting unit 66 (first light source 67 to fifth light source 68d). In other words, 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 obtained 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 calculated 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.

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. In addition, 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.

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 the 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 obtained 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.

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. In other words, 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.

If 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 the acquired absolute output value is below the lower limit of the first specified range (step S33). For example, if the first specified range is 51 to 3,900, the control unit 50 determines in step S33 whether the acquired absolute output value is 50 or less.

If 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, since the light receiving intensity at the light receiving unit 72 output from the AD converter is lower than the first specified range recognized as the 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 an abnormality (circuit abnormality) has occurred in the reference voltage.

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 the light receiving sensitivity caused by an abnormality in the light receiving unit 72 itself or an abnormality in the circuit connected to the light receiving unit 72 has occurred (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, when the absolute output value is not below the lower limit of the first 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 first specified range recognized as the 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 the 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.

If the control unit 50 determines in step S34 that a circuit abnormality such as a reference voltage has occurred, or if it 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 the 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. In addition, if 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, if there is a possibility that an abnormality has occurred, the process will not be executed. The same applies to the case where the occurrence of an error described below has been notified.

If the control unit 50 determines in step S32 that the acquired absolute output value is within the first specified range (Yes in step S32), it determines that no abnormality was found in the determination process based on the absolute output value, that is, that the value 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.

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 the 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.

Next, the control unit 50 determines whether the acquired relative output value is within a predetermined range. Specifically, the control unit 50 determines whether the acquired relative output value is within, 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. This step allows the control unit 50 to detect an abnormality in the light emitting unit 66 or the light path before the component measuring chip 2 is inserted into the component measuring device 1.

If the control unit 50 determines that the acquired relative output value is not included in the second specified range (No in step S37), it determines whether 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 to 3,900, the control unit 50 determines in step S38 whether the acquired relative output value is 600 or less.

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 deficiency 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 deficiency abnormality includes a lack of light emitted from the light emitting unit 66 and the light receiving unit 72 not being able to 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 cover member 25 becoming dirty. 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 to 600. 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.

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, when the relative output value is not below the lower limit of the second specified range, it is a case where 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 amount higher 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.

If the control unit 50 determines in step S39 that a light quantity insufficiency abnormality has occurred, or if it 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 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. The operator can stop the measurement operation at the stage when the error is notified, which can suppress the consumption of excess component measuring chips 2 and blood collection.

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 judgment process based on the relative output value, i.e., that the output is normal.

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

In this way, the control unit 50 according to this embodiment can execute a process to detect whether or not the component measuring device 1 is capable of performing normal measurement. If the control unit 50 determines that an abnormality may have occurred in the component measuring device 1, it can notify the operator of the possibility that an abnormality has occurred by reporting this fact. 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.

In the example described with reference to FIG. 13, the control unit 50 executes a judgment process based on the absolute output value and a judgment process based on the relative output value, but the control unit 50 does not necessarily have to execute both a judgment process based on the absolute output value and a judgment 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 a judgment process based on the absolute output value and a judgment process based on the relative output value.

In the example described with reference to FIG. 13, the control unit 50 performs a determination process based on the absolute output value and then a 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 performed in this order. For example, the control unit 50 may perform a determination process based on the relative output value and then a determination process based on the absolute output value, or the control unit 50 may perform the determination process based on the absolute output value and the determination process based on the relative output value consecutively or simultaneously.

Referring again to FIG. 10, when the control unit 50 determines that the light receiving 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 light receiving intensity at the light receiving unit 72. Specifically, the control unit 50 determines whether or not the component measuring chip 2 has been inserted into the chip insertion space S in step S14. Alternatively, the control unit 50 may determine whether or not the component measuring chip 2 has been inserted into the chip insertion space S in steps S13 and S14.

To explain more specifically, for example, the operator attaches the component measurement chip 2 to 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 attached to the component measurement device 1 and is in the state shown in Figures 2 and 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 the received light at the light receiving unit 72 compared to when the component measuring chip 2 is not attached.

For this reason, the control unit 50 determines whether or not the component measuring chip 2 has been attached to the component measuring device 1 by detecting a change in the intensity of received light at the light receiving unit 72. 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 that indicates 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 portion of the irradiated light is blocked by the members constituting the component measuring chip 2 and does not reach the light receiving unit 72).

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 in which it is presumed 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).

In addition, when the component measuring chip 2 is formed of a light-shielding material except for the measured site, after the light receiving unit 72 detects no light amount (i.e., 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 amount of light of the received light intensity detected by the light receiving unit 72 is detected 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 at 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 light receiving intensity determination process (step S14). Note that step S13 may be omitted, and steps S12 and S14 may be performed.

The second received light intensity determination process is a process for determining whether or not the component measuring chip 2 has been attached (inserted) into 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.

Here, the details of the second received light intensity determination process executed by the control unit 50 in step S14 will be described. Figure 14 is a flowchart showing an example of the second received light intensity determination process.

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

As a judgment 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 S51).

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, when the measurement spot of the component measuring chip 2 is positioned in the optical path and the light emitting unit 66 is not turned on, the range of the light receiving intensity at the light receiving unit 72 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 excessive light entering from the outside. That is, by using the third designated 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 designated range. The third designated 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 designated range can be set to 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.

If the control unit 50 determines that the acquired absolute output value is not within the third specified range (No in step S52), it determines whether the acquired absolute output value is below the lower limit of the third specified range (step S53). For example, if the third specified range is 51 to 200, the control unit 50 determines in step S53 whether the acquired absolute output value is 50 or less.

If 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 light receiving intensity at the light receiving unit 72 output from the AD converter is lower than the first specified range recognized as the 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.

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 the fourth designated range of the absolute output value (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 measurement chip 2 is inserted into the component measurement device 1, and can also determine whether there is an effect from disturbance light. Disturbance light is light that reaches the light receiving unit 72 from the outside of the component measurement 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 measurement 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 amount of 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.

The fourth specified range can be determined appropriately depending on 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 is a value consecutive to the upper limit of the third specified range. For example, as in this embodiment, when the third specified range is 51 to 200, the fourth specified range can be 201 to 3900. However, the fourth specified range is not limited to the example shown here, and may be determined appropriately.

If the control unit 50 determines that the acquired absolute output value is within 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 201 or more and 3900 or less.

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 the light receiving sensitivity due to an abnormality in the light receiving unit or other abnormality in the circuit connected to the light receiving unit 72 has occurred (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 the light receiving sensitivity has occurred.

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 the error notification 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.

If the control unit 50 determines in step S52 that the acquired absolute output value is within the third specified range (Yes in step S52), it determines that no abnormality was found in the determination process based on the absolute output value, that is, that the value 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.

In the judgment process based on the relative output value, the control unit 50 judges whether or not the component measuring chip 2 is properly inserted into the component measuring device 1. In other words, the control unit 50 judges whether or not the component measuring chip 2 is 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 corresponding to the received light intensity from the light receiving unit 72 (step S58).

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. In other words, 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, in step S59, the judgment value V is calculated by V = Vr / 2000.

The control unit 50 judges whether the judgment value V calculated in step S59 is included in the fifth designated range (step S60). The fifth 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. That is, when the judgment value V is within the fifth designated range, the control unit 50 can recognize that the component measuring chip 2 is attached to the component measuring device 1 and the measurement spot is arranged in the light path. The fifth 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 fifth designated range is greater than 0.05 and less than or equal to 0.3. That is, the fifth designated range corresponds to the case where the relative output value (amount of light received) after the component measuring chip 2 is inserted into the component measuring device 1 is greater than 5% and less than or equal to 30% of the relative output value (amount of light received) before the component measuring chip 2 is inserted into the component measuring device 1. The fifth designated range reflects the intensity of light transmitted through the measurement reagent 22 in the component measuring chip 2 before the sample is introduced.

If the control unit 50 determines that the judgment value V is within the fifth specified range, that is, 0.05<V≦0.3 (Yes in step S60), it determines that the component measuring chip 2 is properly inserted into the component measuring device 1. In the following of this specification, this judgment result is also simply referred to as "chip normal recognition." In this case, the control unit 50 determines in step S14 of Figure 10 that the received light intensity is within the normal range (Yes in step S14). Then, it proceeds to step S15 of the flow in Figure 10.

If the control unit 50 determines that the judgment value V is not included in the fifth specified range, that is, if it determines that V≦0.05 or 0.3<V (No in step S60), it determines whether the judgment 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 measuring chip 2 is inserted into the component measuring device 1 in an inappropriate manner. The sixth specified 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 sixth specified range is greater than 0.01 and less than or equal to 0.05. In other words, the sixth specified range corresponds to a case in which the relative output value (amount of light received) after the component measuring chip 2 is inserted into the component measuring device 1 is greater than 1% and less than or equal to 5% of the relative output value (amount of light received) before the component measuring chip 2 is inserted into the component measuring device 1. In addition, the sixth specified range in this specification means the range described as the "fourth specified range" in the claims.

When the control unit 50 determines that the judgment value V is within the sixth specified range, that is, when it determines that 0.01<V≦0.05 (Yes in step S61), it determines that the component measuring chip 2 is inserted into the component measuring device 1 in an inappropriate manner. In this case, when the judgment 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 measuring chip 2, that the measurement spot is not correctly positioned in the optical path, or that a used component measuring chip 2 is incorrectly attached. In this specification, this judgment result is also simply referred to as "chip recognition failure" hereinafter. In this case, the control unit 50 determines that the received light intensity is not within the normal range (No in step S14) in step S14 of FIG. 10. 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 error notification may be the same as the above example. In this way, the control unit 50 can detect whether or not normal measurement can be performed by notifying an error when there is a possibility that the component measuring chip 2 has been inserted in an improper manner.

If the control unit 50 determines that the judgment value V is not within the sixth designated range (No in step S61), it proceeds to step S60. The transition from step S61 to step S60 may cause the control unit 50 to recognize that the component measuring chip 2 is not sufficiently inserted into the chip insertion space S. In this manner, the control unit 50 repeats steps S60 and S61 until it determines that the judgment value V is within the fifth designated range or determines that the judgment value V is within the sixth designated range.

In this embodiment, when the judgment value V is not within the fifth or sixth specified range, that is, when V≦0.01 or 0.3<V, the control unit 50 does not need to make a judgment as to whether the chip is recognized normally or not. In this case, the component measuring chip 2 may not be inserted into the component measuring device 1, which is not an appropriate state for making a judgment as to whether the chip is recognized normally or not. For example, when the component measuring chip 2 is formed of a light-shielding material other than the measured site, the component measuring chip 2 blocks the irradiated light from the light emitting unit 66 while the component measuring chip 2 is being inserted into the component measuring device 1. In this case, the irradiated light is blocked and is not received by the light receiving unit 72. Therefore, the relative output value becomes close to 0, and the judgment value V may be 0.01 or less. However, in this case, the component measuring chip 2 is in the middle of being inserted, which is not an appropriate state for making a judgment as to whether the chip is recognized normally or not. Therefore, in this case, no judgment is made, and the judgment is made when the judgment value V is within the fifth or sixth specified range.

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 an abnormality may occur, it can inform the operator of the possibility of an abnormality 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. In addition, 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, component measuring device set, and 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.

In the example described with reference to FIG. 14, the control unit 50 executes a judgment process based on the absolute output value and a judgment process based on the relative output value, but the control unit 50 does not necessarily have to execute both a judgment process based on the absolute output value and a judgment process based on the relative output value. For example, the control unit 50 executes a judgment process based on the relative output value to determine whether the component measuring chip 2 is attached (inserted) into the component measuring device 1 and to detect at least some abnormalities.

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, a more accurate determination can be made depending on the properties of the irradiated light.

In addition, in the second light receiving intensity determination process, the control unit 50 may determine that the condition is satisfied (i.e., Yes in each branch of the flow in FIG. 14) when the output value from the AD converter is within a predetermined range (the third specified range to the sixth specified range) over a predetermined period of time. 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 the first light source 67 to the fifth light source 68d emit light. 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 second light receiving 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 temporarily falls within the predetermined range due to some factor other than the insertion of the component measuring chip 2.

In addition, when the control unit 50 determines the predetermined period based on the number of times the first light source 67 to the fifth light source 68d emit light, the control unit 50 may change the interval at which the set of output of 16 emission processes and the stop of output of the irradiation light are executed 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. In particular, the control unit 50 may shorten the interval at which the set of output of 16 emission processes 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 16 emission processes 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 16 emission processes 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.

Figure 15 is a diagram that shows the light intensity 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 is a diagram that shows the light intensity received by the light receiving unit 72 mainly in steps S13 to S16 or steps S14 to S16 of Figure 10. In Figure 15, the horizontal axis shows time and the vertical axis shows the light intensity received. Figure 15 shows the light intensity received by the light receiving unit 72 after, for example, a Yes judgement is made in step S12 of Figure 10.

For example, when an 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, as shown from time _t1 to _t2 in FIG. 15, the light receiving unit 72 is in a state where it is not receiving the irradiation light.

When the component measuring chip 2 is attached to the component measuring device 1 at time _t2 , the light receiving unit 72 receives the light that is transmitted through the measurement reagent 22 out of the irradiation light emitted from the first light source 67 to the fifth light source 68d (time _t3 in FIG. 15). As shown in FIG. 15, the received light intensity at the light receiving unit 72 is smaller than that before the component measuring chip 2 is attached. In addition, 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.

When the control unit 50 receives the light transmitted through the measurement reagent 22 at time _t3 , it shortens the interval for executing the pair of output of the set of 16 ejection processes and stop of output of the irradiation light 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. 10.

Referring again to FIG. 10, 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 measurement chip 2 is 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 is 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, and is preferably an intensity that can ensure the measurement resolution required for the measurement of the component to be measured.

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 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 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 light from the first light source 67 to the fifth light source 68d at the light receiving unit 72 is an intensity suitable for performing the component measurement process described with reference to FIG. 9.

The control unit 50 can adjust the current supplied to each of the first light source 67 to the fifth light source 68d. The control unit 50 can adjust the current 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" here includes not only a predetermined light receiving intensity, but also a case where the light receiving intensity falls within a predetermined range from the predetermined light receiving intensity. For example, 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 light receiving unit 72 of the light receiving intensity is approximately constant. In this case, for example, the output value from the AD converter (12 bits) of the light receiving intensity can be treated as being uniform in the range of 3300±50. By adjusting the current in this way, 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 varies with changes in the environmental temperature. In this embodiment, a 12-bit AD converter is used, but the output value can be set to be the same depending on the resolution.

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.

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 at 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 at the light receiving unit 72 reaches the predetermined value, the control unit 50 determines that an abnormality has occurred in the component measuring device 1 and may alert this fact with a buzzer sound.

15, as shown in schematic form after time _t4 , 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 measurement tip 2 is correctly attached, the amount of light from the light sources is increased, thereby reducing power consumption.

Referring again to FIG. 10, after adjusting the current supplied to the first light source 67 to the fifth light source 68d in step S15, the control unit 50 acquires a reference received light intensity (step S16). The reference received light intensity is the 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 the determination process of the fourth received light intensity in step S20 described below.

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, described below, that the sample and the measurement reagent 22 have come into contact.

Figure 16 is a diagram showing the light intensity 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 is a diagram showing the light intensity received by the light receiving unit 72 mainly after step S17 of Figure 10 is executed. As shown in Figure 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 judgment performed in checking the fourth received light intensity in step S20 described later.

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.

The control unit 50 then determines whether or not the component measuring chip 2 is inserted into the chip insertion space S based on the 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 determining the third received light intensity in step S19. In other words, 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.

The principle of determining whether 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 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 presumed that the component measuring chip 2 is inserted into the chip insertion space S.

Here, the details of the third received light intensity determination process executed by the control unit 50 in step S19 will be described. Figure 17 is a flowchart showing an example of the third received light intensity determination process.

The control unit 50 performs two types of judgment processing in the third received light intensity judgment processing. One is a judgment processing based on the absolute output value output from the light receiving unit 72, and the other is a judgment processing based on the relative output value output from the light receiving unit 72. The judgment processing based on the absolute output value is performed in steps S81 to S87 of the flow in FIG. 17, and the judgment processing based on the relative output value is performed in steps S88 to S90 of the flow in FIG. 17.

As a judgment 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).

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 being within 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 as appropriate.

If the control unit 50 determines that the acquired absolute output value is not within the third specified range (No in step S82), it determines whether the acquired absolute output value is below the lower limit of the third specified range (step S83). For example, if the third specified range is 51 to 200, the control unit 50 determines in step S83 whether the acquired absolute output value is 50 or less.

If 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 light receiving intensity at the light receiving unit 72 output from the AD converter is lower than the first specified range recognized as the 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.

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 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, etc. Here, the fourth specified range is the same as the fourth specified range in step S55 of the flow in Figure 14 described above. That is, in this embodiment, the fourth specified range is 201 or more and 3900 or less. However, the fourth specified range is not limited to the example shown here and may be determined as appropriate.

If the control unit 50 determines that the acquired absolute output value is within 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 201 or more and 3900 or less.

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 the light receiving sensitivity due to an abnormality in the light receiving unit or other abnormality in the circuit connected to the light receiving unit 72 has occurred (step S87). In step S85, if 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, if 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 the light receiving sensitivity has occurred.

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 in which the error is notified 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.

If the control unit 50 determines in step S82 that the acquired absolute output value is within the third specified range (Yes in step S82), it determines that no abnormality was found in the determination process based on the absolute output value, i.e., that the value 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.

In the judgment process based on the relative output value, the control unit 50 judges whether or not the component measuring chip 2 is properly inserted into the component measuring device 1. In other words, the control unit 50 judges whether or not the component measuring chip 2 is 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 corresponding to the received light intensity from the light receiving unit 72 (step S88).

The control unit 50 determines whether the relative output value acquired in step S88 is within the seventh designated range (step S89). The seventh designated range is a range within 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 depending on the specifications of the component measuring device 1 and the appropriate component measuring chip 2, etc. In this embodiment, the seventh designated range is 51 or more and 3900 or less.

If the control unit 50 determines that the acquired relative output value is within 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. 10.

On the other hand, if the control unit 50 determines that the acquired relative output value is not within 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, if the relative output value is not within the seventh specified range, the relative output value is 50 or less or 3901 or more.

For example, if the component measuring chip 2 is formed of a light-shielding material other than the measured 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 material 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. In other words, 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.

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 can be 3901 or more. In other words, 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.

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

In this way, the control unit 50 in this embodiment determines whether the component measuring chip 2 is properly attached (inserted) into the component measuring device 1.

In the example described with reference to FIG. 17, the control unit 50 executes a judgment process based on the absolute output value and a judgment process based on the relative output value, but the control unit 50 does not necessarily have to execute both a judgment process based on the absolute output value and a judgment process based on the relative output value. For example, the control unit 50 can determine whether or not the component measuring chip 2 is properly attached (inserted) to the component measuring device 1 by executing a judgment process based on the relative output value.

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, a more accurate determination can be made depending on the properties of the irradiated light.

In addition, in the third received light intensity determination process, the control unit 50 may determine that the condition is satisfied (i.e., Yes in each branch of the flow in FIG. 17) when the output value from the AD converter is included within a predetermined range (third specified range, fourth specified range, or seventh specified range) over a predetermined period of time. 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 the first light source 67 to the fifth light source 68d emit light. 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 received light intensity determination process, 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 temporarily falls within the predetermined range due to some factor that is not related to the insertion state of the component measuring chip 2.

After step S20, the control unit 50 may execute the process of determining the third received light intensity similar to step S19 at appropriate regular or irregular timing to determine whether 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. 10.

Referring again to FIG. 10, 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 the selection of the processing mode may be incorrect, and the second item is to determine whether or not to start component measurement.

Specifically, in this embodiment, the control unit 50 determines whether the sample has reached the measurement reagent 22 using the reference light receiving intensity acquired in step S16, 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 determines 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 the 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 is lower than the reference received light intensity by a second determination threshold or more. The second determination threshold can be appropriately determined. For example, the second determination threshold can be set to 98.5% of the reference received light intensity.

Here, the reason why irradiation light of two different wavelengths, the third predetermined wavelength λ3 and the fourth predetermined wavelength λ4, is used in the determination process of the fourth received light intensity in this embodiment will be explained. 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 whole blood or plasma is used as the sample.

For example, when the sample is whole blood, the sample contains red blood cells. When whole blood containing red blood cells is irradiated with irradiation light of the third predetermined wavelength λ3 (940 nm), the refractive index of whole blood is larger than that of air, so the refractive index difference with the component of the component measurement chip 2 containing the measurement reagent 22 is reduced, 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.

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, as in the case of irradiation with irradiation light of the third predetermined wavelength λ3. However, when 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 irradiation light of the fourth predetermined wavelength λ4 (520 nm) is irradiated to whole blood, when the sample reaches the measurement reagent 22, the light receiving intensity received by 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 test reagent 22 can be detected by the fourth predetermined wavelength λ4.

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 that does not contain red blood cells or hemoglobin, the refractive index of the plasma is larger than that of air, so the refractive index difference with the component of the component measuring chip 2 containing the measurement reagent 22 is reduced, and the transmitted light passing through the measurement reagent 22 increases, increasing the light receiving intensity at the light receiving unit 72, while the glucose contained in the plasma reacts with the measurement reagent 22 to develop color, absorbing light in the fourth predetermined wavelength λ4 band, and 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 color development offset the increase and decrease in the light receiving intensity. 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).

In contrast, when plasma is irradiated with irradiation light of the third predetermined wavelength λ3 (940 nm), an increase in the light receiving intensity occurs due to the refractive index, similar to when irradiation light of the fourth predetermined wavelength λ4 is irradiated. On the other hand, even if the glucose contained in the plasma reacts with the measurement reagent 22 to produce 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 light receiving intensity due to the refractive index has a large influence, and the light receiving intensity received by the light receiving unit 72 increases. Therefore, when the sample is plasma, the third predetermined wavelength λ3 can be used to detect that the sample has reached the measurement reagent 22.

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 that 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 that the sample has reached the measurement reagent 22 even if it is unknown whether the sample is whole blood or plasma.

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

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, taking into consideration 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 plasma described in the above-mentioned principle. In other words, 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.

Utilizing these properties, the control unit 50 can distinguish between whole blood and control fluid (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). In other words, the component measuring device 1, component measuring device set 100, and information processing device of the present invention can distinguish between samples by using the shortest wavelength light and the longest wavelength light among multiple wavelengths used to detect the component to be measured.

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 flowchart 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 measured component as the processing mode. Alternatively, it is assumed that the first mode is set as the initial setting of the control unit 50.

In steps S71 and S72, the control unit 50 determines whether or not the processing mode selected by the operator may be incorrect. 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).

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).

If 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 judgment 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 the predetermined value (No in step S20). In this case, the control unit 50 proceeds to step S18 and calculates the moving average again.

If 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 judgment 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.

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 processing operations by the operator regarding the processing mode by distinguishing between whole blood, which is measured most frequently, and samples other than whole blood. Also, if it is determined that the set processing mode is incorrect, the measurement processing may be performed in the other correct processing mode.

After checking the output in step S73 (e.g., 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).

When the control unit 50 receives an input to process in the first mode (first mode in step S74), it decides to execute the first mode process. 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 to react). 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 the process of steps S21 to S24 as the first mode process.

For example, when plasma is used as a sample instead of whole blood, the moving average of the received light intensity for the irradiation 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 processing in the first mode by inputting the selection of the first mode.

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 a process of performing a measurement process corresponding 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.

When the control unit 50 determines in step S72 that the moving average of the received light intensity for the irradiation 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 processing from step S21 to step S24 as processing in the first mode. When the control unit 50 determines in step S72 that the moving average of the received light intensity for the irradiation 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 processing in the first mode is not erroneous. Therefore, in this case, processing in the first mode can be executed without confirming with the operator whether the selection of the processing mode is correct or not.

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 a mistaken determination that the sample and the measurement reagent 22 have come into contact when the received light intensity temporarily increases or decreases due to some factor other than contact between the sample and the measurement reagent 22.

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, as in the case where the component measuring chip 2 is inserted, 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. Therefore, the control unit 50 may determine that the component measuring chip 2 has been removed from the component measuring device 1 when, for example, 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. In addition, 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 onto 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.

When the control unit 50 determines that the difference between the light receiving intensity received by the light receiving unit 72 and the reference light receiving intensity exceeds a predetermined value (Yes in step S20), the control unit 50 determines the initial value of the light receiving intensity received by the light receiving unit 72 as the processing of the first mode (step S21). The initial value (reference value) is the actual measured 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, the output value of the light receiving intensity at the light receiving unit 72 from the AD converter. In step S20, the control unit 50 can determine the output value of the light receiving intensity a predetermined time before the time when it is determined that the difference between the light receiving intensity received by the light receiving unit 72 and the reference light receiving intensity 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 closer to the 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 irradiation light may change. However, by shortening the predetermined time, the actual measurement value obtained in the next step S22 and the acquisition condition of the output value can be made closer. In this way, by determining the initial value after determining 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.

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 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.

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

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).

On the other hand, if 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), it proceeds to step S24. In this way, even after the acquisition of the actual measurement value has started, it can be determined whether the component measuring chip 2 is properly attached to the component measuring device 1.

The control unit 50 ends the acquisition of the actual measurement values a predetermined time after starting the 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 determined appropriately 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 performed in the component measurement process.

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 was described, but the glucose concentration can also be measured in a similar manner when the sample is plasma.

Figure 19 is a diagram showing the light intensity 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 is a diagram showing the light intensity received by the light receiving unit 72 mainly in steps S18 to S22 of Figure 10. In Figure 19, the horizontal axis shows time, and the vertical axis shows the light intensity received.

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). The control unit 50 executes a fourth received light intensity determination process in step S20. The control unit 50 repeats steps S18 and S20 until it is determined in the fourth received light intensity determination process 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 _t6 in FIG. 19).

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 at time _t6 exceeds a predetermined value (Yes in step S20), it determines the initial value of the intensity of light received by the light receiving unit 72 (step S21). For example, the control unit 50 determines the output value of the intensity of light received from the AD converter at time _t5 , which is 0.5 seconds before time _t6 , as the initial value. The control unit 50 also starts acquiring the actual measurement value from time _t6 (step S22). The control unit 50 ends acquiring the actual measurement value after a predetermined time has elapsed (step S24). Note that, if there is a possibility that the second mode is selected (Yes in step S71) and the processing mode has not been input in step S73, the acquired initial value and actual measurement value may be stored in memory, and the measurement value may be calculated and displayed according to the processing mode after the input of the processing mode is confirmed.

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 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 it may be a measurement of another physical quantity. 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 it is also possible to use cholesterol, sugars, ketone bodies, uric acid, hormones, nucleic acids, antibodies, antigens, etc. in blood 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.

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 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 to be correct. 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 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 can be 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.

In the above embodiment, it has been explained that the control unit 50 outputs to confirm whether the selection of the processing mode is correct, and when it receives 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 that other processing mode.

Alternatively, regardless of whether the operator has selected the first mode or the second mode in advance, the control unit 50 may determine whether 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 the selection of the processing mode is correct or not. 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 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).

The present invention relates to a component measuring device, a component measuring device set, and an information processing device.

1: Component measuring device 2: Component measuring chip 10: Housing 10a: Main body 10b: Chip mounting section 11: Display section 12: Removal lever 13: Power button 14: Operation button 21: Base member 22: Measurement reagent 23: Flow path 23a: Gap 24: Supply section 25: Cover member 26: Eject pin 50: Control section 51: Photometric section 52: Memory section 53: Temperature measuring section 54: Power supply section 55: Battery 56: Communication section 57: Clock section 58: Operation section 59: Buzzer section 66: Light emitting section 67: First light source 68a: Second light source 68b: Third light source 68c: Fourth light source 68d: Fifth light source 69a: First aperture section 69b: Second aperture section 72: Light receiving section 80: Holder member 100: Component measuring device set

Claims (6)

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 . 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. 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. 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. 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 . 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