Management device, management system and management procedures

Abstract

Management device (8) for performing a functional test and calibration of an electronic sphygmomanometer (1) for detecting an internal pressure change of an air bellows with a sensor and calculating a blood pressure value based on an output value of the sensor; wherein the management device comprises: a connection unit (10) for connecting the electronic sphygmomanometer; a test unit (801, 802, 803, 804) for testing a device performance of the electronic sphygmomanometer while connected to the connection unit; a calibration unit (805) for calibrating the device functionality of the electronic sphygmomanometer according to the test result from the test unit; and a first output unit (815, 818, 821) for outputting the test result from the test unit or the presence or absence of a calibration in the calibration unit;wherein the test unit comprises a second test unit (803, 804) for performing an operation to test the accuracy of the sensor's output value while connected to the electronic sphygmomanometer via the connection unit; and wherein the calibration unit (805) calibrates the sensor's output value in the electronic sphygmomanometer according to the test result of the second test unit; wherein the connection unit comprises a communication unit (815) for communication with the electronic sphygmomanometer and a hose connection unit for connecting an air hose (10) to configure an enclosed space with the interior of the electronic sphygmomanometer;wherein the second test unit comprises: a measurement control unit (803) for applying a predetermined pressure with reference to the enclosed space while connected to the interior of the electronic sphygmomanometer via the hose connection unit, and for outputting a control signal for measuring the internal pressure of the enclosed space with the sensor with reference to the electronic sphygmomanometer, a recording unit (815) for obtaining the internal pressure measured by the sensor from the electronic sphygmomanometer according to a stored relationship between the sensor signal from the sensor and the sensor output value, and a pressure determination unit (804) for determining whether a difference between the predetermined pressure and the internal pressure is within a tolerable range;and wherein the calibration unit comprises a calibration control unit (805) for outputting a control signal to change the stored relationship between the sensor signal from the sensor and the sensor output value with reference to the electronic sphygmomanometer when the pressure determination unit (804) determines that the difference is outside the tolerable range.

Description

TECHNICAL FIELDThe present application relates to management devices, management systems, and management methods, and more particularly, to a management device, a management system, and a management method for performing a function test and calibration of an electronic phygmomanometer.PRIOR ARTA blood pressure is an index for analyzing circulatory diseases where performing risk analysis based on the blood pressure is effective for preventing cardiovascular diseases such as stroke, heart failure, and myocardial infarction.Usually, diagnosis is performed from the blood pressure (ocular blood pressure) measured in medical facilities, for example, at the time of hospital visit, health check, or the like. However, it has been found from studies in recent years that the blood pressure (blood pressure measurement at home) measured at home is more useful in the diagnosis of circulatory diseases than the occasional blood pressure. Accompanied with this, a phygmomanometer used at home is widely used.When using the phygmomanometer at home, the fact that whether the measurement accuracy of the phygmomanometer is high is not known. The sensor for detecting pressure most influences the measurement accuracy of the phygmomanometer. The sensor has different characteristics for each, and thus calibration that satisfies the characteristics of the single sensor is required at the time of factory shipment or the like. A technique for easily achieving the calibration of the sensor is shown in Japanese Unexamined Patent Publication No. 7-51233 (Japanese Patent No. 3178175) (Patent Document 1), which is a patented invention by the applicant of the present application. In this patented invention, a plurality of patterns of a relationship of the difference between an application pressure value and a detection pressure value are stored in advance, and a pattern close to the relationship of the present difference is selected and set in the nonvolatile memory of the phygmomanometer to easily perform the calibration of the sensor.PRIOR ART DOCUMENTSPatent Document 1: Japanese Unexamined Patent Publication No. 7-51233WO 2009 / 093 515 A1, published after the priority date of the present application, discloses a management device for performing a function test and a calibration of an electronic phygmomanometer for detecting an internal pressure change of an air bellows with a sensor and calculating a blood pressure value based on an output value of the sensor; the management device including a connection unit for connecting the electronic phygmomanometer; a test unit for testing an instrument performance of the electronic phygmomanometer while being connected to the electronic phygmomanometer with the connection unit; a calibration unit for calibrating the instrument performance of the electronic phygmomanometer according to the test result from the test unit; and a first output unit for outputting the test result from the test unit or a presence or absence of calibration in the calibration unit.JP H 0751233 A discloses an electronic phygmomanometer in which a structure is provided equipped with a writable, non-volatile storage means, pressure regulation data being previously set and stored on this means.DE 10 2006 011 956 A1 discloses a calibration method for electronic blood pressure monitors. At this time, a calibration device sends a pressure point signal to itself and the electronic blood pressure meter after they are connected to each other. The electronic blood pressure meter measures the pressure point signal and returns the measured pressure point signal to the calibration device. The calibration device receives the measured pressure point signal from the electronic blood pressure meter and compares it with the pressure point signal it measures. Then, it judges whether or not the pressure value of the electronic blood pressure meter is in an allowable range. If it is not within the permissible range, the calibration device sends at least two training pressure point signals to the electronic blood pressure meter for measurement and storage.DE 36 37 884 A1 discloses an electric blood pressure measuring device having a cuff which can usually be applied to the upper arm and which can be pumped up at least to the systolic pressure by means of an air pump arranged in the housing of the device and has a microphone for receiving the pulse, which is connected in the device housing to a transducer for generating electrical signals indicating the systolic pressure and pulse on a display, and having an electrically actuatable, automatic pressure relief valve and having a pressure relief valve and a calibration connection, wherein a shut-off valve is provided which is arranged together with the pressure relief valve within the housing of the blood pressure measuring device and is connected to the latter in a connection transmitting the pressure of the pump and can be switched over from the measurement process to the calibration process and vice versa with the aid of a switch on the housing surface.DISCLOSURE OF THE INVENTIONDUE TO THE PROBLEMS SOLVED BY THE INVENTIONHowever, blood pressure continuously varies due to various environmental factors such as stress, time, eating and exercise. Thus, the measurement result may deviate between the occasional blood pressure and the home blood pressure, or the blood pressure value may deviate for each measurement even in the home blood pressure if measured a plurality of times. At home, a determination cannot be made as to whether the difference in blood pressure value arises due to an environmental factor or due to measurement accuracy of the phygmomanometer.When used at home, the user is unable to know whether the measurement accuracy of the electronic phygmomanometer is high, and thus can feel an uncertainty in the measurement accuracy of the electronic phygmomanometer if the blood pressure value is different. Some users thus perform an order to send the electronic phygmomanometer to the manufacturer company to check whether the electronic phygmomanometer is defective. Blood pressure cannot be measured while the electronic phygmomanometer is sent to the producer company. Some users may feel an uncertainty in the measurement accuracy of the electronic phygmomanometer and cannot perform the measurement. If the blood pressure is not obtained at home, the information useful for the diagnosis of circulatory diseases is decreased.In the light of the foregoing problems, an object of the present invention is to provide a management device, a management system, and a management method that enable an easy-to-perform function test of the electronic phygmomanometer and calibration that can be performed without particular knowledge.MEANS FOR SOLVING THE PROBLEMTo achieve the above object, according to one aspect of the present invention, there is provided a management device of a management device according to claim 1.According to a further embodiment of the present invention, a management system according to claim 9 is provided.According to another aspect of the present invention, there is provided a management method as claimed in claim 11.EFFECTS OF THE INVENTIONAccording to the present invention, the functional test of the electronic phygmomanometer can be easily performed without expert knowledge on the device structure of the electronic phygmomanometer, and calibration can be performed. Consequently, the measurement result of the phygmomanometer becomes reliable, the blood pressure measurement can be performed regularly as a result even at home, and the blood pressure at home, which is useful information in the diagnosis of the circulatory disease, can be obtained.BRIEF DESCRIPTION OF THE DRAWINGSFIG. 1 is a view illustrating a specific example of a configuration of a calibration system according to the present embodiment and a configuration of each device included in the calibration system. FIG. 2 is a view describing calibration of a pressure sensor disposed in a phygmomanometer. FIG. 3 is a view describing calibration of a pressure sensor disposed in a phygmomanometer. FIG. 4 is a flow chart illustrating a specific example of a flow of functions performed in the calibration system. FIG. 5 is a flowchart illustrating the flow of an operation in the air leakage test during the operation of FIG. 4. FIG. 6 is a flowchart illustrating the flow of an operation in the device deviation test during the operation of FIG. 4. FIG. 7 is a view illustrating a specific example of a screen of the test result. FIG. 8 is a view illustrating a specific example of a screen of the test result. FIG. 9 is a view illustrating a specific example of a screen of the test result. FIG. 10 is a view illustrating a specific example of a screen of the test result. FIG. 11 is a view illustrating a specific example of a screen displaying the record of calibration. FIG. 12 is a view illustrating a specific example of a screen requesting the next test and calibration. FIG. 13 is a view illustrating another specific example of the configuration of the calibration system according to the present embodiment and the configuration of each device disposed in the calibration system.BEST MODE FOR CARRYING OUT THE INVENTIONEmbodiments of the present invention will be described in detail with reference to the drawings. In the following description, the same reference numerals are given to the same components and configuring elements. The names and functions thereof are also the same.FIG. 1 is a view illustrating a specific example of a configuration of a calibration system according to the present embodiment and a configuration of each device included in the calibration system. Referring to FIG. 1, the calibration system includes an electronic phygmomanometer (hereinafter referred to as phygmomanometer 1), and a calibration device 8 or a management device for testing the phygmomanometer 1 and calibrating as necessary, as described later. The phygmomanometer and the calibration device 8 are electrically connected to a communication cable 11 to perform two-way communication. The communication between the phygmomanometer 1 and the calibration device 8 includes communication that satisfies the standard such as RS-232 (Recommended Standard 232), but may be another communication. The communication is not limited to wired communication, and may be wireless communication such as infrared communication.The phygmomanometer 1 includes a main body part 2 and is connected to an air tube 10 at the time of blood pressure measurement by an air bladder 13 included in a cuff 5. In addition to the connection of the calibration device 8 to the communication cable 11 at the time of the test described later, connection of the calibration device 8 to the air hose 10 is made instead of the air bladder 13. The cuff 5 is wound around the upper arm, i.e., the measurement site. An operation unit 3 including a switch for arranging the start of measurement and a display unit 4 for displaying measurement results and the like is disposed on the front side of the main body part.The main body part 2 includes a pressure sensor 23 for measuring a change in the internal pressure of the air bladder 13, a pump 21, and a valve 22 connected to the air bladder 13 with the air hose 10 therebetween. The pressure sensor 23, the pump 21, and the valve 22 are respectively connected to an oscillation circuit 28, a driving circuit 26, and a driving circuit 27, and the oscillation circuit 28, the driving circuit 26, and the driving circuit 27 are in turn respectively connected to a CPU (Central Processing Unit) 40 for controlling the entire phygmomanometer 1.The CPU 40 is also connected to the display unit 4, the operation unit 3, a memory 6, and a communication interface (hereinafter abbreviated to I / F) 7. The memory 6 stores control programs executed by the CPU 40, measurement results, test results described later, and the like. The memory 6 is also a work area when the CPU 40 executes the program. The communication I / F is an interface that connects the calibration device 8 to the communication cable 11 for communication.The control program stores a measurement program for executing a normal blood pressure measurement process and a calibration program, which will be described later, for performing a mode (hereinafter referred to as a calibration mode) subjected to a test and a calibration based on the instruction of the calibration device 8. When the CPU 40 reads out and executes the measurement program, the phygmomanometer 1 shifts to a mode (hereinafter, referred to as a normal mode) for performing the measurement operation, and the blood pressure measurement operation is performed according to the operation signal or the like from the operation unit 3. When the CPU 40 reads out and executes the calibration program, the phygmomanometer 1 shifts to a calibration mode, and the test and calibration operation is performed by operating each unit according to the instruction received from the calibration device 8 at the communication I / F 7.The CPU 40 executes a predetermined program stored in the memory 6 based on the operation signal input from the operation unit, and outputs a control signal to the drive circuit 26 and the drive circuit 27. The driving circuit 26 and the driving circuit 27 drive the pump 21 and the valve 22 according to the control signal. The pump 21 has the drive controlled by the drive circuit 26 according to the control signal from the CPU 40 to blow air into the air bladder 13. The valve 22 has the opening and closing thereof controlled by the driving circuit 27 according to the control signal from the CPU 40 to discharge air in the air bladder 13.The pressure sensor 23 is a capacitive sensor where a capacitance value changes by a change in the internal pressure of the air bladder. The oscillation circuit 28 inputs a signal having a frequency corresponding to the capacitance value of the pressure sensor 23 to the CPU 40.The CPU 40 stores a coefficient in advance, and determines the internal pressure of the air bladder 13, that is, the sensor output value from the signal from the pressure sensor 23 and the relevant coefficient. The CPU 40 performs a predetermined operation based on the change in the internal pressure of the air bladder 13 obtained by the pressure sensor 23, and outputs the control signal to the driving circuit 26 and the driving circuit 27 according to the result thereof. The CPU 40 performs an operation of calculating the blood pressure value based on the change in the internal pressure of the air bladder 13 obtained from the pressure sensor 23 and displaying the measurement result on the display unit 4, and outputs the data and the control signal to the display unit 4 for display.The air hose 10 is attachable to the calibration device 8, where the calibration device 8 with the phygmomanometer 1 is connected to the air hose 10 by connecting the air hose 10 to the calibration device 8. The calibration device 8 includes a pump 811, a valve 812, a pressure gauge 813, and a reservoir 814. The container 814 may be a substitute for a cuff when a test or calibration of the phygmomanometer 1 is performed. If the air hose 10 is connected to the calibration device 8, the pump 811, the valve 812, the pressure gauge 813, and the container 814 of the calibration device 8 are connected with the pressure sensor 23, the pump 21, and the valve 22 of the phygmomanometer 1 with the air hose 10 interposed therebetween, thereby configuring a closed space.The pump 811 and the valve 812 are connected to a drive circuit 816 and a drive circuit 817, respectively, and the drive circuit 816 and the drive circuit 817 are in turn connected to a CPU 800 for controlling the entire calibration apparatus 8. The pressure gauge 813 is also connected to the CPU 800.The CPU 800 is connected to a display unit 818, an operation unit 820, a memory 819, and a communication I / F 815, 821. The memory 819 stores a control program or the like to be executed by the CPU 800. Moreover, the memory 819 is also a work area when the CPU 800 executes the program. The communication I / F 815 is an interface that connects the phygmomanometer 1 to the communication cable 11 for communication. The communication I / F 821 is an interface for communication with other devices using the communication function if the calibration device 8 has the communication function such as a communication function through the Internet.The operation unit 820 includes a power switch for turning ON / OFF the power supply, a start switch for starting the test operation, and a stop switch for stopping the test operation, which will be described later.The CPU 800 executes a predetermined program stored in the memory 819 based on an operation signal when the switch disposed in the operation unit 820 is pressed, and outputs a control signal to the drive circuit 816 and the drive circuit 817. The driving circuit 816 and the driving circuit 817 control the pump 811 and the valve 812 according to the control signal. The pump 811 has the drive controlled by the drive circuit 816 according to the control signal from the CPU 800 to blow air into the closed space if the air hose 10 is connected to the calibration device 8. The valve 812 has the opening and closing thereof controlled by the driving circuit 817 according to the control signal from the CPU 40 to outflow air in the closed space. The pressure gauge 813 includes a pressure gauge similar to the phygmomanometer 1, and measures the internal pressure of the closed space if the air hose 10 is connected to the calibration device 8, and outputs the measurement results to the CPU 800.The CPU 800 includes an air loss test unit 801, an air loss determination unit 802, a device deviation test unit 803, a device deviation determination unit 804, and a calibration unit 805. It is shown in FIG. 1 that these are functions mainly formed in the CPU 800 when the CPU 800 reads out and executes the control program stored in the memory 819 according to the operation signal from the operation unit 820, but at least some of such functions may be formed to include any of the hardware arrangements shown in FIG. 1.The air loss test unit 801 controls the operation for an air loss test, which will be described later. The air loss determination unit 802 determines the presence or absence of air loss based on the air loss amount obtained as a result of the air loss test. The device deviation test unit 803 controls the operation for the device discrimination test according to the determination result of the air loss determination unit 802. The device deviation is determined as an error from a measurement device in the measurement regulations or the like, and specifically corresponds to a value obtained by subtracting the true value from the measurement value. The device abnormality determination unit 804 determines success / failure of the device discrimination test based on the device abnormality obtained as a result of the device discrimination test. The calibration unit 805 performs calibration to correct the output value of the pressure sensor 23 of the phygmomanometer 1 according to the result of the device discrimination test. As described below, the calibration refers to a process of correcting the function of the sensor output with respect to the application pressure of the pressure sensor 23, and specifically refers to a process of changing the coefficient to be used to acquire the sensor output value by a signal from the pressure sensor 23 in the CPU 40 of the phygmomanometer 1. The calibration unit 805 generates and outputs the control signal for changing the coefficient with respect to the phygmomanometer 1.The calibration device 8 is connected to the phygmomanometer 1, the air hose 10, and the communication cable 11, and tests the device performance of the phygmomanometer 1. The calibration device 8 calibrates the pressure sensor 23 according to the result of the instrument discrimination test. Other test of the device performance includes inputting a pseudo pulse wave signal to the phygmomanometer 1 and testing whether the blood pressure measurement process is performed correctly.In general, the characteristics of the pressure sensor are not constant, and the sensor output (frequency) may not necessarily linearly change as shown by dots in FIG. 2, even if the application pressure is linearly changed.The sensor characteristics of the pressure sensor change as the pressure sensor changes over years. In other words, a line L1 in FIG. 3 represents the sensor characteristics at the time of delivery, whereas the lines L2, L3 represent the sensor characteristics after the change of the pressure sensor over the years. The change in the pressure sensor characteristics shown by the line L 2 is an offset that has changed with respect to the original sensor characteristics that have been set at the time of delivery, and the sensor output is a constant change regardless of the application pressure. The change in the sensor characteristics shown by the line L 2 can be corrected by misalignment of the sensor output at the time of opening under atmospheric pressure to take a set output value corresponding to the original sensor characteristics, which is stored in advance in the initialization process performed at the time of connecting to the power supply (power on). In the change of the sensor characteristics shown by the line L 3, the change ratio according to the application pressure differs in addition to the offset change. In other words, the change in the sensor characteristics shown by the line L 3 includes a change in the tilt corresponding to the change in the sensor output with respect to the change in the application pressure in addition to the offset change. The calibration device 8 determines coefficients α and β from an approximate line obtained from the current sensor outputs, in which the relationship of the sensor output with respect to the application pressure is represented with a line L in FIG. 2 with respect to the change of the sensor output with respect to the application pressure of the pressure sensor 23 of the phygmomanometer 1 shown in FIG. 2. The coefficients ε and η from an approximation line are determined in the same manner as above with respect to the sensor characteristics after the change of the pressure sensor over the years, shown by an approximation line L3 of FIG. 3.The flowchart on the left side of FIG. 4 illustrates the operation of the calibration device 8, and the flowchart on the right side illustrates the operation of the phygmomanometer 1. Such operations are realized when the CPU of each device reads out and executes the program stored in the memory, and controls each unit shown in FIG. 1. The operation shown in the flowchart on the left side of FIG. 4 starts when the power switch in the operation unit 820 of the calibration device 8 is pressed and the power supply is turned on.Referring to FIG. 4, when the power supply of the calibration device 8 is turned on, the working range of the memory 819 is initialized, and the initialization process for performing 0 mmHg setting or the like of the pressure gauge 813 is performed in step S 101, and thereafter, it is monitored whether the phygmomanometer 1 is connected to the air hose 10 (step S 103). This can be done with a mechanism for placing a switch (not shown) on the fitting with the air hose 10 of the calibration device 8, such that the switch is pressed when the air hose 10 is attached. A storage device such as an IC chip and a reading device may be disposed on the terminal part of the air hose 10 and the main body part of the calibration device 8, and the CPU 800 may determine that the connection is established when the communication therebetween is detected.The phygmomanometer 1 is connected when the air hose 10 is connected to the calibration device 8 (YES in step S 103), where if the operation signal indicating the pressing of the start switch instructing the start of the test operation is input from the operation unit 820 in such a state (YES in step S 105), the CPU 800 transmits a command to transition the phygmomanometer 1 to the calibration mode from the communication I / F in step S 107 to the phygmomanometer 1.In the phygmomanometer 1, when receiving the command transmitted in step S 107 from the calibration device 8 having the communication I / F 7 (YES in step S 201), the CPU 40 turns on the power supply, reads out and executes the calibration program from the memory according to the command, and shifts from the operation mode to the calibration mode in step S 203. In step S 203, the CPU 40 may automatically turn on the power supply, or a screen prompting for operation by, for example, "Please turn on power" stored in advance may be displayed on the display unit 818 of the calibration device 8 so that the power switch of the operation unit 3 of the phygmomanometer 1 is operated. The transition to the calibration mode may be performed when the CPU 40 automatically reads out the calibration program according to the control signal, or may be performed when the CPU 40 detects one of application of a predetermined pressure pattern to the air hose 10 from the calibration device 8 instead of the control signal, application of a supply voltage to the phygmomanometer 1 in a predetermined voltage pattern, reception of operation of the switch if the phygmomanometer 1 includes such a specific switch, or operation of the switch of the operation unit 3 in a predetermined pattern with the control signal.In step S 109, the air loss test unit 801 performs the control in the calibration device 8 to perform the operation for the air loss test. The air loss test is executed when a predetermined operation is performed in step S 205 of the phygmomanometer 1 with the operation of the calibration device 8.In step S 111, the air loss determination unit 802 determines whether the result of the air loss test in steps S 109 and S 205 is appropriate, that is, whether there is air loss in the phygmomanometer 1. If the air loss test is OK, that is, if it is determined that there is no air loss in the phygmomanometer 1 (YES in step S 111), the device deviation test unit 803 performs the control to perform the operation for the device deviation test in the calibration device 8 in step S 113. The device deviation test is executed when a predetermined operation is performed in step S 207 of the phygmomanometer 1 with the operation of the calibration device 8. The result of the operation in the phygmomanometer 1 in step S 207 is transmitted to the calibration device 8.In step S 115, the device deviation determination unit 804 determines whether the result of the device deviation test in step S 113, S 207 is appropriate, that is, whether the device deviation of the phygmomanometer 1 is within a tolerable range. If the device deviation test is not okay, that is, if the output value obtained in the test exceeds a tolerable range from the "true value" with the application output value as the "true value" (NO in step S 115), and the number of executions of the operation for calibrating the pressure sensor, which will be described later, does not satisfy the set predetermined number (NO in step S 117), the calibration unit 805 transmits a control signal to the phygmomanometer 1 to cause the phygmomanometer 1 to execute the calibration operation for calibrating the pressure sensor 23. In step S 118, the calibration unit 805 may transmit the control signal set in advance to update the coefficient that the CPU 40 uses to obtain the sensor output value from the signal from the pressure sensor 23 by a predetermined amount stored in advance, or may calculate the update amount of the coefficient from the device deviation obtained in the device deviation test of step S 113 and transmit a control signal to perform update by such an amount.In the phygmomanometer 1, when receiving the control signal transmitted from the calibration device 8 having the communication I / F 7 in step S 118, the CPU 40 performs the calibration operation in step S 209. In other words, the CPU 40 updates the coefficient to be used to acquire the sensor output value from the signal from the pressure sensor 23 according to a control signal to correct and calibrate the sensor output value of the pressure sensor 23.After the calibration operation of steps S118, S209 is performed, the device deviation test of steps S113, S207 is performed again to check the function of the pressure sensor after calibration, and the calibration operation is further performed according to the test result. The number of calibration operations of steps S 118, S 209 is set in advance where the CPU 800 determines the pressure sensor 23 of the phygmomanometer 1 to be faulty if the device deviation test is not in order even after the calibration of step S 118 is performed a predetermined number of times (NO in step S 115 and YES in S 117).After the operation for a series of tests is completed, the CPU 800 performs a process of displaying a screen displaying the above test results on the display unit 8818 to provide a display on the display unit 818 in step S 119. The control signal for storing the test results and recording the calibration in the memory 6 of the phygmomanometer 1 is also generated and transmitted to the phygmomanometer 1 with the information to be stored. In the phygmomanometer 1, the CPU 40 performs a process of storing the transmitted test results and recording the calibration in a predetermined area of the memory 6 in accordance with the control signal transmitted from the calibration device 8 in step S119 in step S211. In this case, the test results and the record of calibration may be displayed in the display unit 4.The test results and the record of the calibration can also be stored on the calibration device 8 side. In other words, the CPU 800 may store the test results and the record of calibration in a predetermined area of the memory 819 together with the information (e.g., serial number, user name registered in advance, etc.) for indicating the phygmomanometer 1. The information for indicating the phygmomanometer 1 may be acquired when the CPU 800 automatically makes a request to the phygmomanometer 1 once the connection of the communication cable 11 of the phygmomanometer 1 is detected in step S 103, may be automatically read from a predetermined area of the memory 6, or a screen requesting input may be displayed on the display unit 818 at the corresponding time and acquired when an input from a button (not shown) and the like is received from the operation unit 820.Moreover, when it is determined that there is an air loss in the test or when it is determined that the device deviation is out of the tolerable range and the calibration of the pressure sensor 23 is performed, the CPU 40 preferably adds at least information indicating that it is likely that the accuracy of the measurement value stored in the memory 6 from the previous test or the date and time of calibration to the operation at that time may not be satisfactory. Thus, when such a measurement value is read out and used in the diagnosis, such a value cannot be used, thus improving the reliability of the measurement value in the phygmomanometer 1.Thereafter, in step S 121, the CPU 800 transmits a command from the communication I / F 815 to the phygmomanometer 1 for the phygmomanometer 1 to be in the normal mode, and ends the series of operations. In the phygmomanometer 1, when the command transmitted from the calibration device 8 having the communication I / F 7 in step S 121 is received, the CPU 40 executes the measurement program from the memory 6 according to the command in step S 213 to switch from the operation mode to the normal mode, and ends the operation in the series of the calibration mode.FIG. 5 is a flowchart showing the flow of operations in the air loss test in steps S 109, S 205, and similarly, the flowchart on the left side shows the operation in the calibration device 8 and the flowchart on the right side shows the operation in the phygmomanometer 1.Referring to FIG. 5, when the operation for the air leakage test starts, the air leakage test unit 801 of the CPU 800 outputs a control signal to the driving circuit 817 to close the valve 812 in step S 302. In step S 303, the air loss test unit 801 generates a control signal for blocking the valve, and outputs the same to the phygmomanometer 1 from the communication I / F 815.In the phygmomanometer 1 switched to the calibration mode in step S 203, when the control signal transmitted from the calibration device 8 with the communication I / F 7 in step S 303 is received (YES in step S 401), the CPU 40 outputs a control signal to the drive circuit 27 according to the control signal to close the valve 22 in step S 403.In step S 305, the air loss test unit 801 outputs a control signal to the driving circuit 816 to apply a predetermined pressure to the pressure sensor 23 of the phygmomanometer 1, and drives the pump 811 to blow air at an amount corresponding to the predetermined pressure of the container 814 and the air hose 10. When the air loss test unit 801 detects elapse of a predetermined time T 1 (step S 307) after application of a predetermined pressure by blowing a predetermined amount of air into the air hose, the pressure P 1 in the container 814 and the air hose 10 is measured with the pressure gauge 813 in step S 309. Further, when the air loss test unit 801 detects elapse of a predetermined time T 2 thereafter (step S 311), the pressure P 2 in the air hose 10 including the container 814 and the pressure gauge 813 is measured in step S 313.According to step S 302 and step S 403, in the phygmomanometer 1 and the calibration device 8 connected to the air hose 10, a space connected to the air hose 10, the pump 21, the valve 22, and the pressure sensor 23 of the phygmomanometer 1, and the pump 811, the valve 812, the pressure gauge 813, and the container 814 of the calibration device 8 is thereby configured. Accordingly, the pressure P 1 measured in step S 309 and the pressure P 2 measured in step S 313 are also regarded as the pressure inside the phygmomanometer 1.In step S 315, the air loss test unit 801 calculates the air loss amount by subtracting the pressure P 1 obtained in step S 309 from the pressure P 2 obtained in step S 313. Subsequently, in step S 315, the difference of the internal pressure (P 1) after elapse of the time T 1 and the internal pressure (P 2) after elapse of the time T 2 are calculated as the air loss amount, on the assumption that the change of the pressure has occurred after elapse of the time T 1 until elapse of the time T 2 due to air loss.In step S 317, the air loss determination unit 802 compares the pressure difference calculated as the air loss amount in step S 315 with the threshold value satisfying the above standard stored in advance, and determines that there is no air loss in the main body part of the phygmomanometer 1 (step S 319) if the difference is less than the threshold value (YES in step S 317). If not (NO in step S 317), a determination is made that there is air leakage in the main body part of the phygmomanometer 1 (step S 321).After the series of operations is completed, the air loss test unit 801 generates a control signal for opening the valve and outputs the same to the phygmomanometer 1 from the communication I / F in step S 323. When receiving the control signal received from the calibration device 8 having the communication I / F 7 in step S 323 (YES in step S 405), the CPU 40 outputs a control signal to the drive circuit 27 according to such a control signal to open the valve in step S 407.In step S 325, the air leakage test unit 801 outputs a control signal to the driving circuit 817 to open the valve 812, and ends the operation for the series of air leakage tests.FIG. 6 is a flowchart showing the flow of an operation in the device deviation test in steps S 113, S 207, and similarly, the flowchart on the left side shows the operation in the calibration apparatus 8 and the flowchart on the right side shows the operation in the phygmomanometer 1.Referring to FIG. 6, when the operation for the device deviation test starts, the device deviation test unit 803 of the CPU 800 outputs a control signal to the driving circuit 817 to close the valve 812 in step S 501. In step S 303, the device deviation test unit 803 generates a control signal for closing the valve, and outputs the same to the phygmomanometer 1 from the communication I / F 815.In the phygmomanometer 1 switched to the calibration mode in step S 203, when the control signal transmitted from the calibration device 8 with the communication I / F 7 in step S 503 is received (YES in step S 601), the CPU 40 outputs a control signal to the drive circuit 27 according to the control signal to close the valve 22 in step S 603.In step S 505, the device deviation test unit 803 outputs a control signal to the driving circuit 816 to apply a predetermined pressure P 1 to the pressure sensor 23 of the phygmomanometer 1, and drives the pump 811 to blow air of an amount corresponding to the pressure P 1 into the container 814 and the air hose 10. When the predetermined pressure P 1 is applied by blowing a predetermined amount of air into the container 814 and the air tube 10, the device deviation test unit 803 generates a control signal for measuring the internal pressure of the container 814 and the air tube 10 in the phygmomanometer 1, and outputs the same to the phygmomanometer 1 from the communication I / F 815.In the phygmomanometer 1, when the control signal is received from the calibration device 8 with the communication I / F 7, the CPU 40 acquires the sensor output value using the signal from the pressure sensor 23 and the coefficient, and outputs the internal pressure P measured in the phygmomanometer 1 represented with the sensor output value to the calibration device 8 from the communication I / F in step S 605. In step S 507, the calibration device 8 acquires the internal pressure, that is, the measurement value transmitted from the phygmomanometer 1 in step S 605.In step S 509, the device deviation test unit 803 stores the internal pressure P, that is, the measurement value in the phygmomanometer 1 received and acquired from the phygmomanometer 1 in step S 507, in a predetermined area of the memory 819 in association with the pressure value P 1 applied in step S 505.If the test method for the device deviation test set forth in JIS T1115-2005 is performed, the above operations are repeated during pressurization at a predetermined pressure interval. Specific examples of the pressure P 1 to be applied include 0, 50, 100, 150, 200, 250, 295 mmHg. In other words, if the pressurization has not reached the upper limit of the test at the time of pressurization stored in advance after step S 511 or step S 513 (NO in step S 515), the pressurized pressure P 1 is further applied at the predetermined pressure interval, and the operations after step S 505 are repeated.If the pressurization has reached the upper limit and the test is completed at the time of pressurization (YES in step S 515), a similar operation during a depressurization is repeated at a predetermined pressure interval if the test method for the device deviation test set in JIS T 1115-2005 is performed. In other words, the device deviation test unit 803 outputs a control signal for measuring the internal pressure P with respect to the phygmomanometer 1 after reducing the internal pressure of the air tube 10 to a predetermined pressure P2 in step S 517, so that the measured internal pressure P is obtained from the phygmomanometer 1 in step S 195, and the internal pressure P or the measurement value in the phygmomanometer 1 is stored in a predetermined range of the memory 819 in association with the pressure P2 applied in step S 517 in step S 523. The operation at the time of the depressurization is also repeated until the lower limit pressure (YES in step S 527) is reached at a predetermined pressure interval similar to the pressurization time.By the above operations, the pressure P measured in the phygmomanometer 1 for each pressure P 1 at the time of pressurization and the pressure P measured in the phygmomanometer 1 for each pressure P 2 at the time of pressure reduction are stored in the predetermined area of the memory 819 of the calibration device 8. If the test method for the device deviation test set forth in JIS T1115-2005 is performed, the operations of steps S 505 to S 515 and S 517 to S 512 are preferably performed twice each.Using the values stored by the above operations, the device deviation testing unit 803 calculates the device deviation in step S 529, and the device deviation determining unit 804 determines whether such a device deviation is within a tolerable range. In other words, in step S 529, the device deviation testing unit 803 calculates the difference from the "true value" of the pressure P measured in the phygmomanometer 1 as the device deviation with the applied pressures P 1, P 2 as the "true value" for the time of pressurization and the time of depressurization, respectively. The device deviation determination unit 804 compares the calculated device deviation with the allowable value stored in advance, and determines whether the device deviation is less than or equal to the allowable value. If the test method for the device deviation test set forth in JIS T1115-2005 is performed, such determination is preferably performed using the average value of twice the device deviation for the pressurization time and the depressurization time. The device deviation determination unit 804 determines that the device deviation test is successful (step S 531) if it is determined that the device deviation is less than or equal to the allowable value compared to the allowable value of the device deviations obtained in the series of operations, that is, all the device deviations are within the tolerable range (no NG in step S 529). When even only a device deviation is larger than the allowable value, that is, even when only a device deviation is out of the tolerable range (NG in step S 529), the device deviation determination unit 804 determines that the device deviation test has failed (step S 533).After the series of operations is completed, the device deviation test unit 803 generates a control signal for opening the valve and outputs the same to the phygmomanometer 1 from the communication I / F 815 in step S535. When the control signal transmitted from the calibration device 8 having the communication I / F 7 in step S 535 is received (YES in step S 609), the CPU 40 outputs a control signal to the drive circuit according to the control signal to open the valve 22 in step S 611.In step S 537, the device deviation test unit 803 outputs the control signal to the drive circuit 817 to open the valve 812 and ends the operation for the series of device deviation tests.When the above operations are performed in the calibration system including the phygmomanometer 1 and the calibration device 8, the user of the phygmomanometer 1 can easily perform the function test of the phygmomanometer 1 by simply connecting the air hose 10 and the communication cable 11 to the calibration device 8 and operating the start switch even if the user does not have expert knowledge.If it is determined that there is no air leakage in the main body part of the phygmomanometer 1 in the air leakage test of steps S 109, S 205 in step S 111, and if it is determined that the device deviation of the phygmomanometer 1 is within the tolerable range in the device deviation test of steps S 113, S 207 in step S 115, the test result that there is no abnormality in the air loss of the phygmomanometer 1 and that there is also no abnormality in the detection accuracy of the pressure sensor 23 is displayed on the display unit 8818 as shown in FIG. 7 in step S 119. The reliability with respect to the measurement result in the phygmomanometer 1 can then be improved, and measurement of the measured blood pressure at home can be promoted.If it is determined that there is air leakage in the main body part of the phygmomanometer 1 in the air leakage test of steps S 109, S 205 in step S 111, the test result that there is abnormality in air leakage of the phygmomanometer 1 is displayed on the display unit 818 as shown in FIG. 8 in step S 119. Thus, the measurement is not performed using the phygmomanometer 1 in which the air escapes from the inside. The user of the phygmomanometer 1 can quickly take measures such as instructing repair of the phygmomanometer 1 at the manufacturer's company or the like.If it is determined that there is no air leakage in the main body part of the phygmomanometer 1 in the air leakage test of steps S 109, S 205 in step S 111, and if the calibration operation of steps S 118, S 209 is performed according to the result of the device deviation test of steps S 113, S 207 in step S 115, the test result indicating, although there is an abnormality in the detection accuracy of the pressure sensor 23, that the pressure sensor 23 is being calibrated is displayed on the display unit 818 as shown in FIG. 9 in step S 119. The reliability with respect to the measurement result in the phygmomanometer 1 can then be improved, and measurement of the measured blood pressure at home can be promoted. If the pressure sensor 23 is determined to be defective when the device deviation is not within a predetermined range even after the calibration of steps S 118, S 209 is performed a predetermined number of times, the test result that there is an abnormality in the measurement accuracy of the pressure of the phygmomanometer 1 is displayed on the display unit 818 as shown in FIG. 10 in step S 119. The measurement is then not performed using the phygmomanometer 1 with the low measurement accuracy in which the sensor output of the pressure sensor 23 is improper. The user of the phygmomanometer 1 can react quickly, such as ordering the repair of the phygmomanometer 1 at the manufacturer's company.The test of the phygmomanometer 1 is carried out when the user connects the air hose 10 and the communication cable 11 to the calibration device 8 and operates the start switch, where the pressure sensor 23 is calibrated according to the result of the device deviation test. The calibration device 8 is a device that is in possession of the user together with the phygmomanometer 1, so that a performance of the test at home can be considered. It can also be considered to install the device in stores such as pharmacy so that the user can put the phygmomanometer 1 in the place where the calibration device 8 is installed and conduct the test.The test and calibration of the pressure sensor 23 are preferably performed in an interval with a constant time period or an interval of a number of measurements to ensure the measurement accuracy of the phygmomanometer 1. The CPU 40 of the phygmomanometer 1 displays the information indicating the date and time at which the latest calibration has been performed on the display unit 4 based on the record of the calibration stored in a predetermined area of the memory 6 in step S211. As shown in FIG. 11, such display may be performed when the measurement operation (not shown) is performed and the measurement result is displayed on the display unit 4. The display may also be made after the initialization operation performed at the start of the measurement operation. Accordingly, the user of the phygmomanometer 1 can connect the calibration device 8 and perform the test when it is determined that a constant time has elapsed since the date and time at which the latest calibration has been performed or that the measurement is performed a constant number of times.The CPU 40 of the phygmomanometer 1 may determine, as a timing controller, to perform the test and the calibration of the pressure sensor 23 when it is detected that a predetermined time has elapsed since the most recent calibration or test based on the record of the calibration or the test result stored in a predetermined area of the memory in step S 211, and display a screen requesting the next test or calibration as shown in FIG. 12.In the above example, the CPU 800 of the calibration device 8 generates a control signal for storing the test result and recording the calibration in the memory 6 of the phygmomanometer 1, and transmits the same from the communication I / F 815 to the phygmomanometer 1 together with the information to be stored in step S 119; however, when the calibration system includes another device such as a server (not shown), the control signal may be generated for storage in another device and transmitted from the communication I / F 821 to another device together with the information to be stored. Another apparatus relates to a server for customer management and the like, which is set up by the manufacturer company of the phygmomanometer 1. In this case, the CPU 800 of the calibration device 8 transmits the information (e.g., serial number, user registered in advance, or the like) for indicating the phygmomanometer 1 for another device, together with the above-described information. In another apparatus, the transmitted information is stored for each phygmomanometer. Moreover, another device may monitor the elapsed time period and the date on which the latest test and calibration have been performed for each phygmomanometer, and determine, as a timing controller, to perform the test and calibration of the pressure sensor when it is detected that a predetermined time period has elapsed, and output the same as a service recommendation to the user of the phygmomanometer 1.Moreover, the calibration device 8 may include only the drive mechanism, and the control of the calibration device 8 may be performed in another device such as a personal computer (PC) for executing the calibration program. FIG. 13 is a view illustrating a specific example of the configuration of the calibration system in this case where a PC 9 is provided as another device for performing control of the calibration device 8. Exemplarily, the configuration in which the CPU 800 is disposed in the PC 9 of each configuration of the calibration device 8 shown in FIG. 1 is illustrated. Each unit of the calibration device 8 is controlled by the CPU 800 of the PC 9 connected to the calibration device 8, and the above-described test operation is performed. The PC 9 further includes a communication I / F 901 for communicating with another device by connecting to the Internet or the like.For example, the manner of use may be considered, such as rental of the calibration device 8 to members subscribed to a service for managing the health index on the web, download (installation) of the calibration program in the user-owned PC 9, and connect the calibration device 8 to the PC 9, and then connect the phygmomanometer 1 to the calibration device 8 to perform the test and calibration of the phygmomanometer 1 at the user home. Use of the calibration device 8 can be allowed only to the members by providing a usable expiration date for the calibration program. In this case, the test result and the record that the calibration has been performed acquired in the PC 9 are transmitted from the communication I / F to the server or the like set by the operator of the service, and stored in the server. In the server, the timing for performing the test and calibration of the pressure sensor 23 is determined in a similar manner to the server for customer management described above, and information indicating the same can be transmitted to the PC 9 as E-mail.The calibration program may be recorded in a computer readable recording medium such as a flexible disk, a compact disk read only memory (CD-ROM), a random access memory (ROM 8) ROM 8, a memory card, or the like as an addition to the computer, and provided as a computer program. Alternatively, the program may be provided by being recorded in a recording medium such as a hard disk included in the computer. The program may also be provided by downloading through the network.The program according to the present invention may be executed for calling the required module at a predetermined timing in a predetermined array and executing the process of the program modules provided as a part of the operating system (OS) of the computer. In this case, the relevant module is not included in the program itself and operates cooperatively with the OS to execute the process. The program according to the present embodiment also includes the program that does not include such a module.The program according to the present embodiment can be provided by being included in a part of another program such as the measurement program. In this case, the module comprised by another program is also not comprised by the program itself and is cooperatively operated with another program to execute the process. The program according to the present embodiment also includes the program included by another program.The computer program to be provided is installed and executed in a program storage unit such as a hard disk. The computer program includes the program itself and the storage medium in which the program is recorded.The embodiments disclosed herein are to be considered illustrative in all aspects and should not be construed as limiting. The scope of the present invention is defined by the claims rather than by the description set forth above, and all changes which are similar in meaning to the claims and are within the scope of the claims are intended to be included herein.DESCRIPTION OF THE REFERENCE NUMERALS1 Phygmomanometer 2 Main body part 3, 820 Operation unit 4, 818 Display unit 5 Cuff 6, 819 Memory 7, 815, 821, 901 Communication I / F 8 Calibration device 10 Air hose 11 Communication cable 13 Air bladder 21, 811 Pump 22, 812 Valve 23 Pressure sensor 26, 27, 816, 817 Driving circuit 28 Oscillation circuit 40, 800 CPU 801 Air loss test unit 802 Air loss determination unit 803 Device deviation test unit 804 Device deviation determination unit 805 Calibration unit 813 Pressure gauge 814 Container

Claims

A management device (8) for performing a function test and calibration of an electronic phygmomanometer (1) for detecting an internal pressure change of an air bladder with a sensor and calculating a blood pressure value based on an output value of the sensor; the management device comprising: a connection unit (10) for connecting the electronic phygmomanometer; a test unit (801, 802, 803, 804) for testing an instrument performance of the electronic phygmomanometer while being connected to the electronic phygmomanometer with the connection unit; and a calibration unit (805) for calibrating the instrument performance of the electronic phygmomanometer according to the test result from the test unit; A first output unit (815, 818, 821) for outputting the test result from the test unit or a presence or absence of calibration in the calibration unit; wherein the test unit comprises a second test unit (803, 804) for performing an operation for testing the accuracy of the output value of the sensor while being connected to the electronic phygmomanometer with the connection unit; and wherein the calibration unit (805) calibrates the output value of the sensor in the electronic phygmomanometer according to the test result of the second test unit; wherein the connection unit comprises a communication unit (815) for communication with the electronic phygmomanometer and a hose connection unit for connecting an air hose (10) to configure a closed space with the interior space of the electronic phygmomanometer; wherein the second test unit comprises: a measurement control unit (803) for applying a predetermined pressure with respect to the closed space while being connected to the inside of the electronic phygmomanometer with the hose connection unit, and outputting a control signal for measuring the inside pressure of the closed space with the sensor with respect to the electronic phygmomanometer; a receiving unit (815) for obtaining the inside pressure measured with the sensor from the electronic phygmomanometer according to a stored relationship between the sensor signal from the sensor and the output value of the sensor; and a pressure determination unit (804) for determining whether a difference between the predetermined pressure and the inside pressure is within a tolerable range; and wherein the calibration unit includes a calibration control unit (805) for outputting a control signal for changing the stored relationship between the sensor signal from the sensor and the output value of the sensor with respect to the electronic phygmomanometer when it is determined by the pressure determination unit (804) that the difference is out of the tolerable range.The management device according to claim 1, wherein the test unit comprises a first test unit (801, 802) for performing an operation for testing an air pressure loss within the electronic phygmomanometer.The management device according to claim 2, wherein the connection unit comprises a communication unit (815) for communication with the electronic phygmomanometer and a hose connection unit for connecting an air hose (10) to configure a closed space with the interior of the electronic phygmomanometer; the first test unit comprises an air loss determination unit (802) for applying a predetermined pressure with respect to the closed space while being connected to the interior of the electronic phygmomanometer with the hose connection unit, and for determining a presence or absence of an air loss within the electronic phygmomanometer based on a temporal change of the predetermined pressure; The first output unit notifies on a screen when it is determined by the air loss determination unit that there is an air loss within the electronic phygmomanometer.The management device according to claim 1, wherein when it is determined that the difference is out of range even after the calibration is performed a predetermined number of times by the calibration unit, the first output unit displays on a screen that the sensor has a defect.The management device according to claim 1, wherein the electronic phygmomanometer comprises a mode for performing measurement and a mode for performing test for operation modes; and a second output unit (815) for outputting a control signal for changing the operation mode to the mode for performing the test with respect to the electronic phygmomanometer is further arranged when it is detected to be connected to the electronic phygmomanometer with the connection unit.The management device according to claim 1, further comprising a first storage unit (819) for storing information regarding when the calibration is performed by the calibration unit.The management device according to claim 1, further comprising a communication unit (821) for communication with other devices; wherein the first output unit transmits the test result of the test unit or a presence or absence of the calibration in the calibration unit to another device having the communication unit together with information for indicating the electronic phygmomanometer.The management device according to claim 1, further comprising a second storage unit (819) for storing the test result of the test unit together with information indicating the electronic phygmomanometer.A management system, comprising: an electronic phygmomanometer (1) for detecting an internal pressure change of an air bladder and calculating a blood pressure value based on an output value of the sensor; and a management device (8) connected to the electronic phygmomanometer for performing a function test and a calibration of the electronic phygmomanometer; wherein the management device comprises a test unit (801, 802, 803, 804) for performing an operation for testing a device performance of the electronic phygmomanometer while being connected to the electronic phygmomanometer, a calibration unit (804) for calibrating the device performance of the electronic phygmomanometer according to the test result from the test unit, and an output unit (815, 818, 821) for outputting the test result of the test unit or a presence or absence of calibration in the calibration unit; and the electronic phygmomanometer includes a control unit (21, 22, 26, 27, 40) for operating the electronic phygmomanometer according to a control signal output in the test unit, a measurement unit (7) for transmitting a signal corresponding to the output value of the sensor to the management device according to a stored relationship between the sensor signal from the sensor and the output value of the sensor with the operation, and a switching unit (40) for switching the stored relationship between the sensor signal from the sensor and the output value of the sensor according to a control signal output in the calibration unit.The management system according to claim 9, wherein the electronic phygmomanometer further comprises a first storage unit (6) for storing the blood pressure value together with information indicating the specific time point of measurement, a second storage unit (6) for storing information indicating that calibration has been performed together with information indicating the specific time point of calibration according to a control signal output in the output unit, and a processing unit (40) for performing a process of adding information indicating a measurement result before calibration is performed with respect to the blood pressure value, whereupon calibration is performed immediately before calibration until the time point of calibration of the information stored in the first storage unit according to the control signal output in the output unit.A management method of an electronic phygmomanometer in a management system, comprising: an electronic phygmomanometer (1) for detecting an internal pressure change from an air bladder having a sensor and calculating a blood pressure value based on an output value of the sensor; and a management device (8) connected to the electronic phygmomanometer for performing a function test and a calibration of the electronic phygmomanometer; the method comprising the steps of: the management device detecting a connection to the electronic phygmomanometer, and performing an operation for testing an instrument function capability of the electronic phygmomanometer while being connected to the electronic phygmomanometer (S107, S109, S113); said electronic phygmomanometer being operated according to a control signal output from said management device in a step of performing said operation for testing said device operability; said electronic phygmomanometer transmitting a signal corresponding to an output value of said sensor to said management device with said operation according to a stored relationship between said sensor signal from said sensor and said output value of said sensor (S605, S607); said management device determining said device operability of said electronic phygmomanometer based on said signal transmitted from said electronic phygmomanometer and / or said signal detected in said connected state (S111, S115); the management device calibrates (S118) the device performance of the electronic phygmomanometer according to the determination, wherein the electronic phygmomanometer changes (S209) the stored relationship between the sensor signal from the sensor and the output value of the sensor according to a control signal output from the management device in the step of calibrating the device performance; and the management device outputs (S119) the test result or a presence or absence of calibration of the output value of the sensor.

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