Electrical Stimulation Device and Patient Management System

Abstract

An electrical stimulation device that has a stimulation electrode that can supply an electrical stimulation signal. The electrical stimulation device includes: a storage unit that stores a scheduled hospital visit date for a patient that is a user of the electrical stimulation device; and a hospital visit alert provision means that provides the patient with a hospital visit alert that encourages a hospital visit when the patient has not made a hospital visit despite the passage of the scheduled hospital visit date. A patient management system that includes: a communication means for communicating with the electrical stimulation device; and a hospital visit date setting means that sets the scheduled hospital visit date for the patient at the electrical stimulation device via the communication means.

Description

[Technical field]

[0001] The present invention relates to electrical stimulation devices and patient management systems. [Background technology]

[0002] 2. Description of the Related Art Various electrical stimulation treatment devices and electrical stimulation training devices have been proposed which are provided with electrode pads for applying electrical stimulation to the human body.

[0003] For example, Patent Document 1 discloses a pelvic visceral dysfunction / pain treatment device comprising a CPU (central processing unit), an emergency stimulation switch connected to the CPU, a manual maximum stimulation setting dial connected to the CPU, a stimulation frequency changeover switch, an output section having a D / A converter, electrical stimulation, and electrodes to which the electrical stimulation is applied, including an indifferent electrode and an interested electrode (stimulating electrode). In this device, electrical stimulation is applied to the pelvic splanchnic nerves and pudendal nerves, which are the second to fourth sacral nerves of the human body, from the skin directly above the second to fourth posterior sacral foramina, thereby exciting these nerves and treating urinary disorders. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] JP 2007-075304 A Summary of the Invention [Problem to be solved by the invention]

[0005] The electrodes of the electrical stimulation device are usually attached to the human body via a conductive sheet such as an adhesive gel pad.

[0006] To obtain the appropriate stimulation effect with each electrical stimulation device, it is necessary to use gel pads that are suitable for each electrical stimulation device. For example, it is preferable to use genuine products that have been tested by each manufacturer (e.g., in clinical trials) and whose effectiveness and safety have been confirmed.

[0007] On the other hand, even if a genuine product is used, for example, the adhesion of dirt or dust to the adhesive surface may increase the electrical resistance of the gel pad, making it difficult to output sufficient electrical stimulation to the human body. Therefore, it is preferable to be able to manage the period during which the effect of the gel pad lasts.

[0008] In this way, it is preferable for the user of the electrical stimulation device to ensure that the gel pads are genuine, that the expiration date of the gel pads has not passed, and that the gel pads comply with predetermined usage conditions.

[0009] Therefore, one embodiment of the present invention provides an electrical stimulation device that can encourage patients to visit a hospital and have them visit the hospital.

[0010] Another embodiment of the present invention provides an electrical stimulation device that, when a genuine conductive sheet is provided, can appropriately manage the expiration date of the conductive sheet.

[0011] Yet another embodiment of the present invention provides an electrical stimulation device that can ensure patient attendance, support delivery of proper treatment and outcomes, and improve patient adherence. [Means for solving the problem]

[0012] An electrical stimulation device according to one embodiment of the present invention is an electrical stimulation device having stimulation electrodes capable of supplying an electrical stimulation signal, and includes a memory unit that stores a scheduled visit date of a patient who is a user of the electrical stimulation device, and a visit alert notification means that, if the patient does not visit the hospital after the scheduled visit date has passed, issues a visit alert to the patient encouraging them to visit the hospital. [Brief description of the drawings]

[0013] [Figure 1] FIG. 1 is a perspective view showing an electrical stimulation device in use. [Diagram 2] FIG. 2 is a schematic perspective view (front side) of the lead of FIG. [Diagram 3] FIG. 3 is a schematic perspective view (rear side) of the conductor in FIG. [Figure 4] FIG. 4 is a front view of the device body of FIG. [Diagram 5] FIG. 5 is a rear view of the device body of FIG. [Figure 6] FIG. 6 is a plan view of the device body of FIG. [Figure 7] FIG. 7 is a block diagram showing the electrical configuration of the electrical stimulation device. [Figure 8] FIG. 8 is a diagram showing an example of a program stored in the storage unit of FIG. [Figure 9] FIG. 9 is a flowchart showing an example (first pattern) of a display flow of the setting screen for the visit date. [Figure 10] FIG. 10 is a flowchart showing an example (second pattern) of a display flow of the setting screen for the visit date. [Figure 11] FIG. 11 is a flowchart showing a first pattern of the flow of a hospital visit alert, a suspension notice, and a suspension alert. [Figure 12] FIG. 12 is a flowchart showing a second pattern of the flow of a hospital visit alert, a suspension notice, and a suspension alert. [Figure 13] FIG. 13 is a flowchart showing a third pattern of the flow of a hospital visit alert, a suspension notice, and a suspension alert. [Figure 14] FIG. 14 is a diagram showing changes over time in the current value of the electrical stimulation device. [Figure 15] FIG. 15 is a flowchart showing a fourth pattern of the flow of a hospital visit alert, a suspension notice, and a suspension alert. [Figure 16] FIG. 16 is a schematic front view of the conductive sheet. [Figure 17] FIG. 17 is a treatment image diagram for explaining the flow of FIG. [Figure 18] FIG. 18 is a diagram for explaining a first modified example of the conductive sheet of FIG. [Figure 19]FIG. 19 is a diagram for explaining a second modified example of the conductive sheet of FIG. [Figure 20] FIG. 20 is a flowchart showing a fifth pattern of the flow of a hospital visit alert, a suspension notice, and a suspension alert. [Figure 21] FIG. 21 is a flow chart showing an example of a flow for canceling a visit / suspension alert / suspension notice. [Figure 22] FIG. 22 is a schematic diagram of a network including a patient management system according to one embodiment of the present invention. [Figure 23] FIG. 23 is a block diagram showing the configuration of the patient information server of FIG. [Figure 24] FIG. 24 is a block diagram showing the configuration of the doctor's terminal of FIG. [Diagram 25] FIG. 25 is a diagram for explaining a display example of patient management information. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0014] <Embodiments of the present invention> First, the embodiments of the present invention will be listed and described.

[0015] An electrical stimulation device according to one embodiment of the present invention is an electrical stimulation device having stimulation electrodes capable of supplying an electrical stimulation signal, and includes a memory unit that stores a scheduled visit date of a patient who is a user of the electrical stimulation device, and a visit alert notification means that, if the patient does not visit the hospital after the scheduled visit date has passed, issues a visit alert to the patient encouraging them to visit the hospital.

[0016] According to this configuration, the patient is notified of the hospital visit alert, so that the patient can be encouraged to visit the hospital. This allows the patient to visit the hospital, and allows the medical staff to correctly check the progress of the patient's treatment. As a result, even when the electrical stimulation treatment is performed at home, for example, the patient can receive appropriate support from the medical staff to achieve appropriate treatment and therapeutic effects.

[0017] An electrical stimulation device according to one embodiment of the present invention further includes a stop alert execution means for stopping the operation function of the electrical stimulation device, and the stop alert execution means may stop the operation function of the electrical stimulation device if the visit alert is not lifted within a certain period of time after the visit alert is notified by the visit alert notification means.

[0018] This configuration can increase the pressure to encourage patients to visit the hospital.

[0019] An electrical stimulation device according to one embodiment of the present invention further includes a stop notification execution means for notifying in advance that the operation function of the electrical stimulation device will be stopped by the stop alert execution means, and the stop notification execution means may notify of the stop of the operation function of the electrical stimulation device if the visit alert is not lifted within a certain period of time after the visit alert is notified by the visit alert notification means.

[0020] The electrical stimulation device according to one embodiment of the present invention further includes an authority identification means for identifying an authority having the authority to set the scheduled visit date, and when the authority identification means determines that the person operating the electrical stimulation device is the authority, the authority identification means may allow access to a setting screen for the scheduled visit date.

[0021] This configuration makes it possible to prevent the planned hospital visit date from being freely set, thereby enabling medical staff to properly manage the patient's treatment schedule.

[0022] An electrical stimulation device according to one embodiment of the present invention further includes a stop alert execution means for stopping an operation function of the electrical stimulation device, and the stop alert execution means may stop the operation function of the electrical stimulation device if, after the authority identification means has determined that the person is an authorized person, the authority identification means does not again determine that the person is an authorized person even after a certain period of time has elapsed.

[0023] An electrical stimulation device according to one embodiment of the present invention further includes a stop notification execution means for notifying in advance that the operation function of the electrical stimulation device will be stopped by the stop alert execution means, and the stop notification execution means may give a notification of the stop of the operation function of the electrical stimulation device if, after the authority identification means has determined that the person is an authorized person, the authority identification means has not again determined that the person is an authorized person even after a certain period of time has elapsed.

[0024] An electrical stimulation device according to one embodiment of the present invention further includes a stop alert execution means for stopping the operation function of the electrical stimulation device, and a current value detection means for detecting the value of a current flowing to a patient each time the electrical stimulation device is used, and the stop alert execution means may observe a change in the current value as the number of times the electrical stimulation device is used increases, and may stop the operation function of the electrical stimulation device if an output below a predetermined allowable current value continues for a certain period of time.

[0025] This configuration can increase the pressure to encourage patients to visit the hospital.

[0026] An electrical stimulation device according to one embodiment of the present invention further includes a stop warning execution means for warning in advance that the operation function of the electrical stimulation device will be stopped by the stop alert execution means, and the stop warning execution means may observe changes in the current value as the number of times the electrical stimulation device is used increases, and warn of the stop of the operation function of the electrical stimulation device if an output below a predetermined allowable current value continues for a certain period of time.

[0027] In the electrical stimulation device according to one embodiment of the present invention, the permissible current value may be in the range of 1 mA to 100 mA.

[0028] An electrical stimulation device according to one embodiment of the present invention further includes a stop alert execution means for stopping the operation function of the electrical stimulation device, an identification information detection means for detecting sheet identification information individually applied to a conductive sheet that can be attached to the stimulation electrode in order to adhere the stimulation electrode to a patient's skin, and a counting means for counting at least one of the number of times the electrical stimulation device has been used and the number of days elapsed since the date of detection of the sheet identification information after detecting the sheet identification information, and the stop alert execution means may stop the operation function of the electrical stimulation device when at least one of the number of times the device has been used and the number of days elapsed exceed a predetermined reference value.

[0029] This configuration can increase the compelling force to encourage patients to visit the hospital. It can also prevent patients from continuing electrical stimulation treatment using a conductive sheet with reduced functionality. For example, the electrical resistance of the conductive sheet may increase due to the adhesion of dirt or dust to the adhesive surface, making it difficult to output sufficient electrical stimulation to the human body. Therefore, after the sheet identification information is detected, it is preferable to manage at least one of the number of uses and the number of days that the functionality of the conductive sheet will continue.

[0030] An electrical stimulation device according to one embodiment of the present invention further includes a stop notification execution means for notifying in advance that the operation function of the electrical stimulation device will be stopped by the stop alert execution means, and the stop notification execution means may give a notification of the stop of the operation function of the electrical stimulation device when at least one of the number of uses and the number of elapsed days approaches a predetermined reference value.

[0031] The electrical stimulation device of one embodiment of the present invention further includes a stop alert execution means for stopping the operation function of the electrical stimulation device, and a location information acquisition means for acquiring location information of the electrical stimulation device, and the stop alert execution means may stop the operation function of the electrical stimulation device when location information of a specified medical institution is not acquired by the location information acquisition means for a certain period of time.

[0032] This configuration can increase the pressure to encourage patients to visit the hospital.

[0033] An electrical stimulation device according to one embodiment of the present invention further includes a stop warning execution means for warning in advance that the operation function of the electrical stimulation device will be stopped by the stop alert execution means, and the stop warning execution means may warn of the stop of the operation function of the electrical stimulation device when location information of a specified medical institution is not acquired by the location information acquisition means for a certain period of time.

[0034] An electrical stimulation device according to one embodiment of the present invention further includes a hospital visit alert cancellation means for canceling the hospital visit alert, and the authorized person identification means may allow access to a hospital visit alert cancellation screen when it determines that the person operating the electrical stimulation device is an authorized person who has the authority to cancel the hospital visit alert.

[0035] This configuration makes it possible to prevent the hospital visit alert from being cancelled at will, thereby enabling medical staff to properly manage the patient's treatment schedule.

[0036] An electrical stimulation device according to one embodiment of the present invention further includes a stop alert cancellation means for canceling the stop alert, and the authorized person identification means may allow access to a stop alert cancellation screen when it determines that the person operating the electrical stimulation device is an authorized person who has the authority to cancel the stop alert.

[0037] According to this configuration, it is possible to prevent the stop alert from being released at will, thereby enabling medical personnel to properly manage the treatment schedule of the patient.

[0038] An electrical stimulation device according to one embodiment of the present invention further includes a stop warning cancellation means for cancelling the stop warning made by the stop warning execution means, and the authority identification means may allow access to a stop warning cancellation screen when it determines that the person operating the electrical stimulation device is an authority person who has the authority to cancel the stop warning.

[0039] According to this configuration, it is possible to prevent the suspension notice from being cancelled at will, thereby enabling medical staff to properly manage the treatment schedule of patients.

[0040] A patient management system according to one embodiment of the present invention includes a communication means for communicating with the electrical stimulation device, and a visit date setting means for setting the patient's planned visit date in the electrical stimulation device via the communication means.

[0041] According to this configuration, the authority to set the planned visit date can be given to the medical staff, which allows the medical staff to properly manage the patient's treatment schedule.

[0042] The patient management system according to one embodiment of the present invention may further include a hospital visit alert cancellation means for cancelling a hospital visit alert generated in the electrical stimulation device via the communication means.

[0043] According to this configuration, medical staff can be given the authority to cancel the hospital visit alert. This can increase the compelling force to encourage patients to visit the hospital. In addition, medical staff can properly manage the patient's treatment schedule.

[0044] The patient management system according to one embodiment of the present invention may further include a stop alert canceling means for canceling a stop alert generated in the electrical stimulation device via the communication means.

[0045] According to this configuration, medical staff can be given the authority to cancel the stop alert. This can increase the compelling force to encourage patients to visit the hospital. In addition, medical staff can properly manage the treatment schedule of patients.

[0046] The patient management system according to one embodiment of the present invention may further include a stop notice cancellation means for cancelling a stop notice generated in the electrical stimulation device via the communication means.

[0047] According to this configuration, medical staff can be given the authority to cancel the suspension notice. This can increase the compelling force to encourage patients to visit the hospital. In addition, medical staff can properly manage the treatment schedule of patients. Detailed Description of the Preferred Embodiments of the Present Invention Next, an embodiment of the present invention will be described in detail with reference to the accompanying drawings. [Overall configuration of electrical stimulation device] FIG. 1 is a perspective view showing an electrical stimulation device 1 in use.

[0048] The electrical stimulation device 1 is a device (electrical stimulation treatment device) that improves urination disorders such as urine storage disorders (overactive bladder) by applying an electrical stimulation signal from the back side of the sacrum of a human body 10 (subject). In this embodiment, the electrical stimulation device 1 is mainly described as a urination disorder treatment device, but the electrical stimulation device 1 contributes to improving not only urination disorders but also fecal incontinence such as urge fecal incontinence and leakage fecal incontinence by applying electrical stimulation from the back side of the sacrum.

[0049] The electrical stimulation device 1 includes a lead 2 for electrical stimulation treatment, a device main body 3, and a wiring cord 4.

[0050] The conductor 2 includes a sheet body 5, an indifferent electrode 6, and a pair of stimulating electrodes 7A, 7B. The conductor 2 is a sheet to which a plurality of pad-shaped electrodes are attached, and therefore may be referred to as, for example, an electrode pad.

[0051] Conductive sheets 8, 9A, and 9B are attached onto the indifferent electrode 6 and the pair of stimulating electrodes 7A and 7B, respectively.

[0052] The conductive sheets 8, 9A, 9B are formed of, for example, a conductive adhesive gel in order to pass the current output from the pair of stimulation electrodes 7A, 7B to the human body 10. In this embodiment, the conductive sheets 8, 9A, 9B are formed of pads having a thickness of about 0.8 mm. The conductive sheets 8, 9A, 9B are translucent, and both surfaces are adhesive. The conductive sheets 8, 9A, 9B are translucent gel-like with adhesiveness, and may be called, for example, a conductive adhesive pad, a conductive gel pad, or the like.

[0053] The conductor 2 is fixed to the skin of the human body 10 by adhering one side of the conductive sheets 8, 9A, 9B to the skin of the human body 10. In this embodiment, the conductive sheet 8 is attached to the indifferent electrode 6, the conductive sheet 9A is attached to one stimulating electrode 7A, and the conductive sheet 9B is attached to the other stimulating electrode 7B.

[0054] The device body 3 is electrically connected to the conductor 2 by a wiring cord 4. The device body 3 has built-in control circuits including, for example, a CPU, memories such as ROM and RAM, and a timer. The person to be treated can output an electrical signal (voltage) for outputting a current of a predetermined frequency to the conductor 2 by operating various operation buttons 26 and a monitor 24 provided on the device body 3. As a result, an electrical stimulus is applied to the human body 10 from the pair of stimulation electrodes 7A, 7B of the conductor 2. [Electrode configuration] Fig. 2 is a schematic perspective view (front side) of the conductor 2 in Fig. 1. Fig. 3 is a schematic perspective view (rear side) of the conductor 2 in Fig. 1. Next, an example of the conductor 2 that can be used in the electrical stimulation device 1 described above will be shown.

[0055] The conductor 2 includes a sheet body 5, an indifferent electrode 6, and a pair of stimulating electrodes 7A, 7B.

[0056] The sheet body 5 is made of a flexible material that can bend in accordance with the bending (movement) of the human body 10. In this embodiment, the sheet body 5 is made of an insulating flat sheet member having a first surface 11 that faces the skin of the human body 10 and a second surface 12 opposite to the first surface 11.

[0057] Examples of materials for the sheet body 5 include insulating materials such as resin films, nonwoven fabrics, and paper. These may be used alone or in combination of two or more. In this embodiment, the sheet body 5 is formed of a single injection-molded sheet made of silicone resin.

[0058] A recess 13 and recesses 14A, 14B in which the indifferent electrode 6 and the pair of stimulating electrodes 7A, 7B are respectively disposed are formed on the first surface 11 of the sheet main body 5. The indifferent electrode 6 and the pair of stimulating electrodes 7A, 7B are respectively disposed in the recess 13 and the recesses 14A, 14B.

[0059] A first terminal 19 is integrally provided on the second surface 12 of the sheet body 5. The first terminal 19 is electrically connected to the indifferent electrode 6 on the first surface 11 of the sheet body 5, for example, by a lead wire (not shown). Second terminals 20A and 20B are integrally provided on the second surface 12 of the sheet body 5. The second terminals 20A and 20B are electrically connected to a pair of stimulation electrodes 7A and 7B on the first surface 11 of the sheet body 5, for example, by a lead wire (not shown).

[0060] To manufacture the conductor 2 as described above, for example, first, the indifferent electrode 6 and the pair of stimulating electrodes 7A, 7B are molded by compression molding. Next, the obtained indifferent electrode 6 and the pair of stimulating electrodes 7A, 7B are inserted into a mold as insert members, and the material of the sheet body 5 (silicone resin in this embodiment) is filled into the mold. This allows the conductor 2 to be obtained as an insert molded product.

[0061] However, the method of manufacturing the conductor 2 is not limited to the above-mentioned insert molding, and may be, for example, a method in which the indifferent electrode 6 and the pair of stimulating electrodes 7A, 7B, and the sheet body 5 are manufactured as separate molded products, and then the indifferent electrode 6 and the pair of stimulating electrodes 7A, 7B are fitted into the recess 13 and the recesses 14A, 14B of the sheet body 5, respectively. [Device configuration] Fig. 4 is a front view of the device body 3 of Fig. 1. Fig. 5 is a rear view of the device body 3 of Fig. 1. Fig. 6 is a plan view of the device body 3 of Fig. 1.

[0062] The device main body 3 includes a housing 23, a monitor 24 provided on the front surface of the housing 23, and a start / stop button 25 and a plurality of operation buttons 26 provided below the monitor 24.

[0063] In this embodiment, the housing 23 is formed in a substantially elliptical shape and may be made of, for example, a plastic case. A first socket 27 and a second socket 28 are provided on the upper surface of the housing 23.

[0064] The first socket 27 is, for example, an output port to which the wiring cord 4 is connected. On the other hand, the second socket 28 is, for example, a charging port to which a cord of an AC adapter (not shown) is connected. In other words, the device main body 3 can be turned on by power supplied from a charged battery or an outlet via an AC adapter.

[0065] The monitor 24 may be formed in a long rectangular shape along the longitudinal direction of the housing 23, and may be disposed toward one end of the housing 23 in the longitudinal direction. The monitor 24 may be, for example, a monochrome or color liquid crystal monitor. The monitor 24 may display, for example, the pulse waveform and frequency of the electrical stimulation signal from the pair of stimulation electrodes 7A and 7B, the electrocardiogram waveform and heart rate of the patient, error messages, a visit alert and a stop alert, which will be described later, and the like. This allows the patient to easily know the operating state of the electrical stimulation device 1. The monitor 24 may be, for example, a touch panel on which a predetermined operation screen is displayed and which allows the user to operate the screen.

[0066] The start / stop button 25 and the multiple operation buttons 26 may be disposed on the other end side of the housing 23 in the longitudinal direction relative to the monitor 24.

[0067] Furthermore, operation button 26 may have various functions depending on the model of electrical stimulation device 1. For example, as a memory function of electrical stimulation device 1, a treatment menu including the width (pulse width) of the pulse wave of the stimulation signal, the frequency, etc. suitable for each of a plurality of treatment subjects is stored in device body 3, and operation button 26 may be a button operated to read the menu.

[0068] The device body 3 also has a built-in reader 29 as an example of an identification information detection means. The reader 29 may be built in, for example, on the other end side of the longitudinal direction of the housing 23 with respect to the monitor 24 as shown in Fig. 4, or may be built in on the rear side of the monitor 24 as shown in Fig. 5. The reader 29 may include, for example, a reader that reads an RF tag used in an RFID (Radio Frequency IDentifier). [Electrical configuration of the electrical stimulation device] Fig. 7 is a block diagram showing the electrical configuration of the electrical stimulation device 1. Fig. 8 is a diagram showing an example of a program stored in the storage unit 37 of Fig. 7.

[0069] Referring to Figure 7, the electrical stimulation device 1 includes, as electrical configurations, a controller 30 as an example of a control unit, an input unit 31, an output unit 32, a communication I / F 33, a position information receiving unit 34 as an example of a position information acquisition means, and a reading unit 35.

[0070] The controller 30 may be configured with a semiconductor chip such as a microcomputer (microcomputer), etc. The controller 30 may include, for example, a processor 36, a storage unit 37, and a timer 38 as an example of a counting means.

[0071] The processor 36 may be configured, for example, as a CPU including a control device, an arithmetic unit, a register, an interface with the storage unit 37, and an interface with the input unit 31, the output unit 32, and the communication I / F 33. The processor 36 executes a program 39 (PGM: Program) stored in the storage unit 37. The processor 36 may output the calculation result to the output unit 32, or output the result to an external device via the communication I / F 33.

[0072] The storage unit 37 includes, for example, a ROM and a RAM, and stores programs 39. The programs 39 may include, for example, a voltage application program 39A, a visit date setting program 39B, a visit alert notification program 39C, a visit alert cancellation program 39D, an authority identification program 39E, a current value observation program 39F, a stop alert execution program 39G, a stop alert cancellation program 39H, a stop notice execution program 39I, a stop notice cancellation program 39J, and the like.

[0073] The voltage application program 39A may be a program for applying a voltage to the indifferent electrode 6 and the stimulating electrodes 7A and 7B.

[0074] The visit date setting program 39B may be a program that stores the next visit date information input from the input unit 31, the next visit date information received from the outside via the communication I / F 33, etc. in the storage unit 37. The processor 36 may function as a visit date setting means by executing the visit date setting program 39B.

[0075] The hospital visit alert notification program 39C may be a program that generates a signal of hospital visit alert information when an execution condition of the hospital visit alert is satisfied. The hospital visit alert notification program 39C may be a program that outputs the generated signal of the hospital visit alert information to the output unit 32. The hospital visit alert notification program 39C may be a program that outputs the generated signal of the hospital visit alert information to an external output device (for example, a patient's personal terminal (smartphone, tablet computer, etc.)) via the communication I / F 33. The processor 36 may function as a hospital visit alert notification means by executing the hospital visit alert notification program 39C.

[0076] The hospital visit alert cancellation program 39D may be a program that cancels the hospital visit alert based on a hospital visit alert cancellation signal input from the input unit 31 or a hospital visit alert cancellation signal received from the outside via the communication I / F 33. The processor 36 may function as a hospital visit alert cancellation means by executing the hospital visit alert cancellation program 39D.

[0077] Authorized person identification program 39E may be a program for identifying whether or not a person operating electrical stimulation device 1 is an authorized person who has been granted a predetermined authority. Processor 36 may function as authorized person identification means by executing authorized person identification program 39E.

[0078] The current value observation program 39F may be a program for observing a current value flowing from the indifferent electrode 6 and the stimulating electrodes 7A, 7B to the patient by applying a voltage to the indifferent electrode 6 and the stimulating electrodes 7A, 7B. The processor 36 may function as a current value detection means by executing the current value observation program 39F.

[0079] The stop alert execution program 39G may be a program that generates a signal of stop alert information when an execution condition of the stop alert is satisfied. The stop alert execution program 39G may be a program that stops the operation function of the electrical stimulation device 1 based on the generated signal of the stop alert information. The processor 36 may function as a stop alert execution means by executing the stop alert execution program 39G.

[0080] The stop alert cancellation program 39H may be a program that cancels the stop alert based on a stop alert cancellation signal input from the input unit 31 or a stop alert cancellation signal received from the outside via the communication I / F 33. The processor 36 may function as a stop alert cancellation means by executing the stop alert cancellation program 39H.

[0081] The stop notice execution program 39I may be a program that generates a signal of stop notice information when a stop notice execution condition is satisfied. The stop notice execution program 39I may be a program that outputs the generated stop notice information (for example, the date of execution of the stop alert) to the output unit 32. The processor 36 may function as a stop notice execution means by executing the stop notice execution program 39I.

[0082] The stop notice cancellation program 39J may be a program that cancels the stop notice based on a stop notice cancellation signal input from the input unit 31 or a stop notice cancellation signal received from the outside via the communication I / F 33. The processor 36 may function as a stop notice cancellation means by executing the stop notice cancellation program 39J.

[0083] The storage unit 37 may store as data the results of processing executed by the processor 36. The data of the results of processing may include, for example, the start date and time of the electrical stimulation treatment, the end date and time, the treatment time, the reference voltage (for example, the initial voltage set by the doctor), the treatment voltage (for example, the voltage adjusted according to the physical condition of the treated person for each treatment session), and the presence or absence of various alerts such as a hospital visit alert.

[0084] The timer 38 has, for example, a counter function for counting clocks. The timer 38 may count the number of pulses of the stimulation voltage when the voltage application program 39A is executed. The processor 36 may change the polarity of the voltage applied between one of the stimulation electrodes 7A and the indifferent electrode 6, and the polarity of the voltage applied between the stimulation electrode 7B and the indifferent electrode 6, based on the count number of the timer 38.

[0085] The input unit 31 is electrically connected to the controller 30. The input unit 31 may include an operation unit 40 for causing the processor 36 to execute a desired process. The operation unit 40 may include, for example, the above-mentioned start / stop button 25, the operation button 26, a touch panel of the monitor 24, etc.

[0086] The output unit 32 is electrically connected to the controller 30. The output unit 32 may include a display unit 41 that visually outputs the processing result executed by the processor 36, and an audio output unit 42 that audibly outputs the processing result. In this embodiment, hospital visit alert information, stop alert information, and stop advance notice information processed by the processor 36 may be output. The display unit 41 may include, for example, the monitor 24 described above. The audio output unit 42 may include, for example, a speaker (not shown) attached to the housing 23 described above.

[0087] The communication I / F 33 mediates data exchange between the electrical stimulation device 1 and an external electronic device (e.g., medical electronic devices such as doctor terminals 103, 111 (described later), personal terminals such as smartphones and tablet computers, etc.). Such data exchange may be performed by either wired communication or wireless communication. For example, by connecting the electrical stimulation device 1 to the external electronic device via the communication I / F 33, the results of processing executed by the processor 36 can be output to the external electronic device. As the processing results, visit alert information, stop alert information, and stop advance notice information processed by the processor 36 may be output from at least one of a display and a speaker of the personal terminal such as a smartphone or tablet computer.

[0088] Position information receiving unit 34 is a unit that identifies the current location of electrical stimulation device 1 and may include, for example, a GPS (Global Positioning System) receiver. The location history of electrical stimulation device 1 recorded via position information receiving unit 34 may be stored in storage unit 37.

[0089] The reading unit 35 may include, for example, the above-mentioned reader 29. That is, the reading unit 35 may include a reader that reads an RF tag used in an RFID (Radio Frequency Identifier). [Explanation of the need for visit alerts and stop alerts] A patient can receive electrical stimulation treatment at home using the electrical stimulation device 1. This is because the electrical stimulation device 1 is a portable device and can be carried from a medical institution. However, in order to obtain a sufficient therapeutic effect in home care, the patient himself needs to operate the electrical stimulation device 1 appropriately and visit the hospital regularly to receive support from a medical professional (doctor, etc.). For example, if the patient ignores the visit date set by the medical professional and does not visit the hospital, uses non-genuine conductive sheets 8, 9A, 9B, or uses conductive sheets 8, 9A, 9B whose expiration date has passed, it is difficult to obtain a sufficient therapeutic effect. Therefore, in this embodiment, if the patient does not follow the treatment schedule set by the medical professional, a predetermined visit alert is activated to encourage the patient to visit the hospital. In addition, if a visit alert is generated and the patient's visit cannot be confirmed even after a certain period of time has passed, a predetermined stop alert is activated as a more compulsory measure than the visit alert. The stop alert is a process for stopping the operation function of the electrical stimulation device 1, and once the stop alert is activated, the patient cannot receive electrical stimulation treatment using his own electrical stimulation device 1 until the alert is released. By activating the visit alert and the stop alert, the patient can be sure to visit the hospital, and the medical staff can correctly check the progress of the patient's treatment. As a result, even when the electrical stimulation treatment is performed at home, the patient can receive appropriate support from the medical staff to achieve appropriate treatment and therapeutic effect. Note that a stop notice may be issued prior to the activation of the stop alert, which gives a notice that the stop alert will be activated.

[0090] Prior to issuance of a hospital visit alert, a stop notice, and a stop alert, a hospital visit date is set in electrical stimulation device 1. The hospital visit date is the next hospital visit date (e.g., the next consultation date) determined by a medical professional when the patient visits a medical institution for a checkup. The next hospital visit date is an item necessary for medical professionals to provide appropriate support, and therefore cannot be set by the patient himself / herself, but is set by a predetermined authorized person such as the patient's doctor.

[0091] A specific flow to the next visit date setting screen will be described below. In this embodiment, two typical patterns will be described. [Explanation of the display flow of the visit date setting screen (first pattern)] FIG. 9 is a flowchart showing an example (first pattern) of a display flow of the setting screen for the visit date.

[0092] To access the visit date setting screen, the electrical stimulation device 1 (device) is powered on to start the electrical stimulation device 1 (step S1) with reference to Fig. 9. When the electrical stimulation device 1 starts up, a main screen is displayed first (step S2). The main screen may be, for example, a screen displaying a treatment menu for performing electrical stimulation treatment.

[0093] Next, a request for access to the setting screen for the visit date is executed (step S3). The access request is made by a predetermined request operation, such as inputting a password via the operation buttons 26 or the touch panel of the monitor 24, or pressing multiple operation buttons 26 simultaneously. Usually, such a predetermined request operation is not known to the patient and is a confidential matter within a group of medical professionals.

[0094] Next, based on the access request, it is determined whether the person operating the electrical stimulation device 1 is an authorized person (step S4). If it is determined that the person is not an authorized person (NO in step S4), access to the visit date setting screen is denied, and the screen returns to the main screen. For example, this may occur if an incorrect password is entered, or if a specified button operation is not performed. On the other hand, if the specified request operation is performed correctly and it is determined that the person is an authorized person (step S5), the user is guided to the visit date setting screen (step S6). For example, the screen switches from the main screen to the visit date setting screen. [Explanation of the display flow of the visit date setting screen (second pattern)] FIG. 10 is a flowchart showing an example (second pattern) of a display flow of the setting screen for the visit date.

[0095] Access to the visit date setting screen may be performed according to the flow of FIG.

[0096] To access the setting screen for the visit date, referring to FIG. 10, the electrical stimulation device 1 (device) is powered on to start the electrical stimulation device 1 (step S1). After the start-up, it is determined whether the person operating the electrical stimulation device 1 is an authorized person (step S2). If it is determined that the person is an authorized person (YES in step S2), a main screen for authorized people is displayed (step S3). If it is not determined that the person is an authorized person (NO in step S2), a normal main screen is displayed (step S4). The determination of whether the person is an authorized person is made by a predetermined request operation, such as inputting a password via the operation button 26 or the touch panel of the monitor 24, or pressing multiple operation buttons 26 simultaneously. Usually, such a predetermined request operation is not known to the patient and is a confidential matter within a group of medical professionals.

[0097] The main screen for the authorized person has a function of making a request for access to a setting screen for a visit date. The request for access to the setting screen for a visit date may be made, for example, by pressing a menu that transitions to the setting screen for a visit date. In addition, the main screen for the authorized person and the normal main screen may be, for example, a screen that displays a treatment menu for performing electrical stimulation treatment.

[0098] Then, by executing an access request to a setting screen for a visit date (step S5), the setting screen for a visit date is displayed (step S6). [Explanation of visit date setting] The setting screen may include an input form that displays, for example, the date, time, department, doctor in charge, etc. The input form may be of various input formats, such as direct input, selection (e.g., pull-down), etc.

[0099] A medical professional can set the next visit date by inputting the date into this setting screen. The set visit date is stored in storage unit 37 of electrical stimulation device 1. The next time electrical stimulation device 1 is started, the next visit date may be displayed on the main screen.

[0100] The specific flow of the visit alert, the stop notice, and the stop alert that notify the patient when the set visit date has passed will be described below. The visit alert, the stop notice, and the stop alert include multiple patterns, but in this embodiment, five representative patterns will be described. [Explanation of visit alert, suspension notice and suspension alert (first pattern)] FIG. 11 is a flowchart showing a first pattern of the flow of a hospital visit alert, a suspension notice, and a suspension alert.

[0101] After a new visit date is set following the flow of Fig. 9 or 10, when the power of the electrical stimulation device 1 (device) is turned on and the electrical stimulation device 1 starts up (step S1), it is determined whether this point (start-up point) is past the visit date (step S2). If it is determined that the visit date has not passed (the visit date has not arrived) (NO in step S2), the main screen is displayed (step S3). From this point on, the patient can receive the desired electrical stimulation treatment.

[0102] On the other hand, if it is determined that the visit date has passed (the visit date has arrived) (YES in step S2), a visit alert is executed (step S4). The visit alert can be executed using various means. For example, the visit alert may be executed visually by displaying a message encouraging the visit on the monitor 24 (display unit 41). The message may be, for example, "Please visit the hospital." Furthermore, an exclamation mark may be written alongside the message to express a visual warning. Alternatively, the visit alert may be executed auditorily by issuing a voice message encouraging the visit from the voice output unit 42. The visual and auditory visit alerts may be executed either one or both.

[0103] Next, it is determined whether a certain period of time has passed since the notification of the hospital visit alert (step S5). This determination condition is the execution condition for the stop advance notice. The period of time that has passed since the notification of the hospital visit alert may be measured, for example, by timer 38. This period of time may be, for example, about 1 to 7 days from the date of the notification of the hospital visit alert. If it is determined that the certain period of time has not passed since the notification of the hospital visit alert (NO in step S5), the main screen is displayed (step S3). Thereafter, the patient can receive the desired electrical stimulation treatment.

[0104] On the other hand, if it is determined that a certain period of time has passed since the visit alert was issued (YES in step S5), a stop notice is issued (step S6). The stop notice can be issued by using various means. For example, the stop notice may be issued visually by displaying a message on the monitor 24 (display unit 41) notifying the user of the stop. The message may be, for example, "If the user is not confirmed to visit the hospital by the deadline, the use of the device will be stopped." Furthermore, an exclamation mark may be written alongside the message to express a visual warning. Alternatively, the stop notice may be issued audibly by issuing a voice message notifying the user of the stop from the voice output unit 42. The visual and audio stop notices may be issued either alone or both.

[0105] Next, it is determined whether a certain period of time has passed since the notification of the stop notice (step S7). This determination condition is the execution condition for the stop alert. The period of time that has passed since the notification of the stop notice may be measured, for example, by timer 38. This period of time may be, for example, about 1 to 7 days from the date of the notification of the stop notice. If it is determined that the certain period of time has not passed since the notification of the stop notice (NO in step S7), the main screen is displayed (step S3). Thereafter, the patient can receive the desired electrical stimulation therapy.

[0106] In other words, even if the visit date has passed, the effect on the treatment effect is relatively small if only a few days have passed, so the patient can continue to receive care at home. However, until the visit alert and stop notice are released (see FIG. 21), the process of step S1, YES in step S2, step S4, YES in step S5, and step S6 in FIG. 11 is executed every time the electrical stimulation device 1 is started, so the visit alert and stop notice are repeatedly executed. This repeated visit alert and stop notice can increase the compelling force to encourage the patient to visit the hospital.

[0107] On the other hand, if it is determined that a certain period of time has passed since the stop notice was issued (YES in step S7), a stop alert is executed (step S8). The stop alert stops the operation function of the electrical stimulation device 1 (step S9). For example, it becomes impossible to perform operations related to the electrical stimulation treatment of the electrical stimulation device 1. For example, the start / stop button 25 and the multiple operation buttons 26 become disabled, and it is not possible to perform the electrical stimulation treatment after the stop alert is issued. This increases the compelling force to encourage patients to visit the hospital.

[0108] In the stop alert, in addition to stopping the operation function of the electrical stimulation device 1, the fact that the stop alert has been activated may be transmitted. For example, the fact that the stop alert has been activated may be visually transmitted by displaying a message on the monitor 24 (display unit 41) that the electrical stimulation device 1 has been stopped. The message may be, for example, "Use of the device will be stopped." Furthermore, an exclamation mark may be written alongside the message to express a visual warning. Alternatively, the fact that the stop alert has been activated may be audibly transmitted by emitting a voice message from the audio output unit 42 that the stop alert has been activated. The visual and audio transmissions may be performed either alone or both. [Explanation of visit alert, suspension notice and suspension alert (second pattern)] FIG. 12 is a flowchart showing a second pattern of the flow of a hospital visit alert, a suspension notice, and a suspension alert.

[0109] In the flow of the second pattern, after the electrostimulator 1 is started (step S1), it is determined whether or not this point (start-up time) is past the visit date (step S2). If it is determined that the visit date has not passed (the visit date has not arrived) (NO in step S2), the main screen is displayed (step S3). From this point on, the patient can receive the desired electrostimulation treatment. On the other hand, if the start-up time of the electrostimulator 1 is past the visit date (YES in steps S1 and S2), a visit alert is issued in the same manner as in the flow of the first pattern of FIG. 11 (step S4).

[0110] Next, after it has been confirmed that the operator is an authorized person by the flow of FIG. 9 or FIG. 10, it is determined whether a certain period of time has passed (step S5). This determination condition is the execution condition for the stop notice. If it is determined that the certain period of time has not passed since it was confirmed that the operator is an authorized person (NO in step S5), the main screen is displayed (step S3). After this, the patient can receive the desired electrical stimulation treatment. On the other hand, if it is determined that the certain period of time has passed since it was confirmed that the operator is an authorized person (YES in step S5), the stop notice is executed in the same manner as the first pattern flow of FIG. 11 (step S6).

[0111] Next, after it is confirmed that the operator is an authorized person by the flow of FIG. 9 or FIG. 10, it is determined whether or not a certain period of time has passed since the stop notice period (step S7). If it is determined that the certain period of time has not passed since the stop notice period (NO in step S7), the main screen is displayed (step S3). From this point on, the patient can perform the desired electrical stimulation treatment. On the other hand, if it is determined that the operator is an authorized person and then a certain period of time has passed since the stop notice period (YES in step S7), a stop alert is executed as in the flow of the first pattern of FIG. 11 (step S8). The stop alert stops the operation function of the electrical stimulation device 1 (step S9). [Explanation of visit alert, suspension notice and suspension alert (third pattern)] Fig. 13 is a flow chart showing a third pattern of the flow of the hospital visit alert, the stop advance notice, and the stop alert. Fig. 14 is a diagram showing the change over time in the current value of the electrical stimulation device 1.

[0112] In the flow of the third pattern, after the electrostimulator 1 is started (step S1), it is determined whether or not this point (start-up time) is past the visit date (step S2). If it is determined that the visit date has not passed (the visit date has not arrived) (NO in step S2), the main screen is displayed (step S3). After this, the patient can receive the desired electrostimulation treatment. On the other hand, if the start-up time of the electrostimulator 1 is past the visit date (YES in steps S1 and S2), a visit alert is issued as in the flow of the first pattern of FIG. 11 (step S4).

[0113] Next, based on the change in the stimulation current value flowing to the patient, it is determined whether the current value continues to be less than a predetermined allowable current value 43 for a certain period 44 (step S5). The current value observation period is, for example, the period from the date on which the most recent visit to the hospital is set to the time when the electrical stimulation device 1 is started. Here, the change over time in the current value flowing to the patient will be described in detail with reference to FIG.

[0114] For example, repeated use of the conductive sheets 8, 9A, 9B causes dirt and dust to adhere to the adhesive surfaces of the conductive sheets 8, 9A, 9B. When dirt and dust adhere to the adhesive surfaces, the adhesive strength of the conductive sheets 8, 9A, 9B decreases and the sheet resistance increases. In other words, the current flowing through the stimulation electrodes 7A, 7B decreases. Therefore, as shown in FIG. 14, the deterioration of the function of the conductive sheets 8, 9A, 9B can be determined by observing the change in the current value flowing through the conductive sheets 8, 9A, 9B (gel pads).

[0115] In observing the change in the current value, for example, at the start of treatment, a very weak voltage is applied from the indifferent electrode 6 and the stimulation electrodes 7A, 7B, and the current value flowing through the stimulation site is measured. This current value may be an index for determining the expiration date of the conductive sheets 8, 9A, 9B, and is recorded in the memory unit 37 as an expiration date confirmation current value 45, for example, and the number of records is also counted. The number of records may be counted only when a predetermined treatment time (for example, 15 minutes) is completed. Then, when the current value continues to decrease stepwise from the rise and fall of the recorded expiration date confirmation current value 45 as shown in FIG. 14, the number of records is continued to be counted. On the other hand, when an upward trend in the current value is detected, such as after replacing the conductive sheets 8, 9A, 9B (gel pads), the number of records is reset to 0. When the expiration confirmation current value 45 continues to decrease and the current value less than the allowable current value 43 (for example, in the range of 1 mA to 100 mA) continues for a certain period 44 (YES in step S5), a stop notice is executed (step S6) in the same manner as in the flow of the first pattern in FIG. 11. When the current value less than the allowable current value 43 (for example, in the range of 1 mA to 100 mA) continues for a certain period 44 after the stop notice is executed (YES in step S7), a stop alert is executed (step S8) in the same manner as in the flow of the first pattern in FIG. 11. The continuation of the current value less than the allowable current value 43 means a decrease in the function of the conductive sheets 8, 9A, and 9B, and it is determined that it is difficult to obtain a sufficient therapeutic effect. The stop alert stops the operation function of the electrical stimulation device 1 (step S9).

[0116] 14, if the current value 45 continues to decrease but is equal to or greater than the allowable current value 43, or if the current value is less than the allowable current value 43 but has not continued for a certain period 44 (NO in step S5, NO in step S7), the main screen is displayed (step S3). After this, the patient can receive the desired electrical stimulation treatment. [Explanation of visit alert, suspension notice and suspension alert (Pattern 4)] Fig. 15 is a flow chart showing a fourth pattern of the flow of the visit alert, the stop notice, and the stop alert. Fig. 16 is a schematic front view of the conductive sheets 8, 9A, and 9B. Fig. 17 is a treatment image diagram for explaining the flow of Fig. 15. Fig. 18 is a diagram for explaining a first modified example of the conductive sheets 8, 9A, and 9B in Fig. 16. Fig. 19 is a diagram for explaining a second modified example of the conductive sheets 8, 9A, and 9B in Fig. 16.

[0117] In the flow of the fourth pattern, after the electrostimulator 1 is started (step S1), it is determined whether or not this point (start-up time) is past the visit date (step S2). If it is determined that the visit date has not passed (the visit date has not arrived) (NO in step S2), the main screen is displayed (step S3). From this point on, the patient can receive the desired electrostimulation treatment. On the other hand, if the start-up time of the electrostimulator 1 is past the visit date (YES in steps S1 and S2), a visit alert is issued in the same manner as in the flow of the first pattern of FIG. 11 (step S4).

[0118] Next, it is determined whether the expiration date of the conductive sheets 8, 9A, 9B has passed (step S5). Here, the expiration date of the conductive sheets 8, 9A, 9B will be described in detail with reference to Figs.

[0119] First, referring to FIG. 16, the conductive sheets 8, 9A, and 9B each include a sheet body 46 formed, for example, in a quadrangular shape, more specifically, in a rectangular shape. The RF tag 47 may be provided on the periphery of the sheet body 46. The RF tag 47 may be fixed to the sheet body 46 by being partially embedded in the gel-like sheet body 46, or may be fixed to the sheet body 46 by crimping or crimping. In this way, if the RF tag 47 is provided on the periphery of the sheet body 46, it can be made less susceptible to the moisture in the gel forming the conductive sheets 8, 9A, and 9B and the metal part forming the conductor 2. As a result, detection by the RF tag 47 can be performed with high accuracy.

[0120] As the RF tag 47, various RF tags can be used, but it is preferable to use, for example, an anti-collision type passive tag. If the RF tag 47 is an anti-collision type, it can simultaneously detect multiple conductive sheets 8, 9A, and 9B. Also, if the RF tag 47 is a passive tag, it is easier to make it smaller and thinner than an active tag. Therefore, it is less likely to interfere with the electrical stimulation, and the effect on the electrical stimulation can be suppressed. Also, since passive tags are relatively inexpensive, it is possible to suppress cost increases.

[0121] The frequency band used by the RF tag 47 is not particularly limited, but it is preferable to use, for example, a UHF frequency (especially, about 860 MHz to 960 MHz). If the frequency is in this range, the communication speed is fast, and a stable communication state can be ensured even if there is some interference. The RF tag 47 stores information such as an assigned unique identification number.

[0122] To manage the status of the conductive sheets 8, 9A, 9B, such as their expiration date, using the RF tag 47, for example, as shown in FIG. 17, when a user (human body 10) attaches the conductor 2 near the sacrum and starts treatment using electrical stimulation, the information stored in the RF tag 47 is read by a reader 29 (see FIGS. 4 and 5) which is an example of the reading unit 35 in FIG. 7.

[0123] In relation to the determination of the number of uses, the identification information of the RF tag 47 is also stored in the storage unit 37 of the controller 30. For example, details of the identification information, the date of detection (reading) of the identification information, etc. are stored. Based on this identification information, the number of uses and the number of days elapsed since the new conductive sheets 8, 9A, 9B began to be used can be counted. Note that the number of uses may be counted only when a predetermined treatment time (e.g., 15 minutes) is completed, for example. Also, when the identification information of the same conductive sheets 8, 9A, 9B is read consecutively, the record number count may be continued, and when the identification information is changed, the record number count may be reset to 0.

[0124] Then, if the expiration date (e.g., 28 consecutive uses) of any one of the conductive sheets 8, 9A, and 9B is approaching (YES in step S5), a stop notice is issued in the same manner as in the first pattern flow of FIG. 11 (step S6).

[0125] Then, if any one of the conductive sheets 8, 9A, 9B has reached its expiration date (e.g., 28 consecutive uses) (YES in step S7), a stop alert is issued in the same manner as in the flow of the first pattern in Fig. 11 (step S8). The expiration date of the conductive sheets 8, 9A, 9B means that the functions of the conductive sheets 8, 9A, 9B have deteriorated, and it is determined that it is difficult to obtain a sufficient therapeutic effect. Then, the operation function of the electrical stimulation device 1 is stopped by the stop alert (step S9).

[0126] On the other hand, if the expiration date of any one of the conductive sheets 8, 9A, 9B has not passed (NO in step S5), the main screen is displayed (step S3). After this, the patient can receive the desired electrical stimulation treatment.

[0127] It should be noted that the RF tag 47 does not need to be directly attached to the conductive sheets 8, 9A, and 9B as shown in Fig. 16, and may be indirectly attached to the conductive sheets 8, 9A, and 9B. For example, the RF tag 47 may be attached to a protective film 48 for protecting a sheet main body 46 as shown in Fig. 18, or to a packaging body 49 that contains the conductive sheets 8, 9A, and 9B as shown in Fig. 19.

[0128] 18 and 19, the RF tag 47 is not directly attached to the conductive sheets 8, 9A, 9B. Therefore, the identification information of the RF tag 47 is read, for example, before the protective film 48 is peeled off or in the state of the packaged product 50 packaged in the wrapping body 49. Since the identification information of the RF tag 47 can be read before the conductive sheets 8, 9A, 9B are attached to the conductor 2, during reading, for example, it is possible to hold the device main body 3 in one's hand over the RF tag 47 and check the process information (for example, "Gel ID being read") displayed on the monitor 24.

[0129] Although not shown, the expiration dates of the conductive sheets 8, 9A, and 9B may be managed by a serial code or the like as an example of identification information individually given to the conductive sheets 8, 9A, and 9B. [Explanation of visit alert, suspension notice and suspension alert (5th pattern)] FIG. 20 is a flowchart showing a fifth pattern of the flow of a hospital visit alert, a suspension notice, and a suspension alert.

[0130] In the flow of the fifth pattern, after the electrostimulator 1 is started (step S1), it is determined whether or not this point (start-up time) is past the visit date (step S2). If it is determined that the visit date has not passed (the visit date has not arrived) (NO in step S2), the main screen is displayed (step S3). After this, the patient can receive the desired electrostimulation treatment. On the other hand, if the start-up time of the electrostimulator 1 is past the visit date (YES in steps S1 and S2), a visit alert is issued in the same manner as in the flow of the first pattern of FIG. 11 (step S4).

[0131] Next, it is determined whether or not there is a history of acquiring location information from the medical institution (step S5). The medical institution is a medical institution where the target patient regularly visits. For example, it is determined whether or not location information of the medical institution has been acquired by the location information receiving unit 34 from the date when the latest visit date was set until the start of the electrical stimulation device 1. If it is determined that there is a history of acquiring location information from the medical institution (NO in step S5), the main screen is displayed (step S3). After this, the patient can perform the desired electrical stimulation treatment. On the other hand, if it is determined that there is no history of acquiring location information from the medical institution from the time of the notification of the visit alert until this time (YES in step S5), a stop notice is executed similarly to the flow of the first pattern in FIG. 11 (step S6).

[0132] Next, the presence or absence of a location information acquisition history from the medical institution is determined from the stop notice notification (step S7). If it is determined that there is a location information acquisition history from the medical institution (NO in step S7), the main screen is displayed (step S3). From this point on, the patient can receive the desired electrical stimulation treatment. On the other hand, if it is determined that there is no location information acquisition history from the medical institution from the time of the stop notice notification to this point (YES in step S7), a stop alert is executed as in the first pattern flow of FIG. 11 (step S8). The stop alert stops the operation function of the electrical stimulation device 1 (step S9). [Explanation of the procedure for canceling visits, suspension alerts, and suspension notices] FIG. 21 is a flow chart showing an example of a flow for canceling a visit / suspension alert / suspension notice.

[0133] As mentioned above, once a visit alert and stop alert (sometimes collectively referred to as a visit-stop alert) or stop notice is activated, it will continue until it is cancelled. Therefore, to reset a visit-stop alert and stop notice, it is necessary to cancel the visit-stop alert and stop notice. If patients were able to cancel a visit-stop alert and stop notice freely, the visit-stop alert and stop notice would become a mere formality, so they can only be cancelled by predetermined authorities, such as the patient's doctor.

[0134] To cancel the visit / stop alert / stop notice, the electrical stimulator 1 (device) is turned on to start the electrical stimulator 1 (step S1) with reference to Fig. 21. When the electrical stimulator 1 starts up, the main screen is first displayed (step S2).

[0135] Next, a request for access to the setting screen for the visit date is executed (step S3). The access request is made by a predetermined request operation, such as inputting a password via the operation buttons 26 or the touch panel of the monitor 24, or pressing multiple operation buttons 26 simultaneously. Usually, such a predetermined request operation is not known to the patient and is a confidential matter within a group of medical professionals.

[0136] Next, based on the access request, it is determined whether the person operating the electrical stimulation device 1 is an authorized person (step S4). If it is determined that the person is not an authorized person (NO in step S4), access to the setting screen for the visit date is denied, and the screen returns to the main screen. For example, this may occur if the input password is incorrect or if a specified button operation is not performed. On the other hand, if the specified request operation is performed correctly and it is determined that the person is an authorized person (step S5), the user is guided to a screen for canceling visit, stop alert, and stop notice (step S6). For example, the screen switches from the main screen to a screen for canceling visit, stop alert, and stop notice.

[0137] Healthcare professionals can reset visit, stop alerts, and stop notices by canceling the visit, stop alerts, and stop notices on this cancellation screen. [Patient management system using electrical stimulation device] Fig. 22 is a schematic diagram of a network including a patient management system 101 according to an embodiment of the present invention. Fig. 23 is a block diagram showing the configuration of the patient information server 102 in Fig. 22. Fig. 24 is a block diagram showing the configuration of the doctor's terminal 103 in Fig. 22.

[0138] Patient management system 101 includes at least a patient information server 102 and a doctor terminal 103. Patient management system 101 is a system for managing treatment information of patients who are given electrical stimulation treatment.

[0139] The patient information server 102 functions as a database server in which treatment information (treatment history, treatment method, examination history, medication information, etc.) of each patient is stored based on identification information given to each patient. The patient information server 102 may be set in a hospital 104 where a family doctor 131 of each patient 132 works. The patient information server 102 may be installed in a location separate from the hospital 104. The patient information server 102 may be connected to a local area network (LAN) 105 in the hospital 104, and connected to a doctor's terminal 103 via the LAN 105. Data exchange via the LAN 105 may be performed by either wired communication or wireless communication.

[0140] The patient information server 102 may be connected to a local area network (LAN) 108 of a hospital 107 other than the hospital 104 or to a local area network (LAN) 110 of a home 109 via a wide area network (WAN) 106 such as the Internet. A doctor's terminal 111 connected to the LAN 108 of the hospital 107 may be able to access the patient information server 102 via the WAN 106. An electrical stimulation device 1 connected to the LAN 110 of the home 109 may be able to access the patient information server 102 via the WAN 106.

[0141] Referring to FIG. 23, the patient information server 102 includes a processor 112, a communication I / F 113, and a storage device 114.

[0142] The processor 112 may be configured, for example, as a CPU including a control device, an arithmetic unit, a register, an interface with the storage device 114, and an interface with the communication I / F 113. The processor 112 provides data information stored in the storage device 114 in response to an external request.

[0143] The communication I / F 113 mediates data exchange between the patient information server 102 and external electronic devices (e.g., medical electronic devices such as doctor terminals 103, 111, electrical stimulation device 1 owned by patient 132, personal terminals such as smartphones and tablet computers, etc.). Such data exchange may be performed by either wired communication or wireless communication.

[0144] The storage device 114 includes, for example, a ROM and a RAM, and stores information about the patient 132. The information stored in the storage device 114 may include, for example, patient identification information 115 and electrical stimulation treatment record information 116.

[0145] The patient identification information 115 may include the patient 132's ID, name, date of birth, address, contact information, emergency contact information, medical history, information on the electrical stimulation device 1 used by the patient 132 (such as a terminal identification number), etc. The electrical stimulation treatment record information 116 may include record information on the electrical stimulation performed by the patient 132 using the electrical stimulation device 1 (for example, the start date and time for each treatment, the end date and time, the treatment time, the reference voltage (for example, the initial voltage set by the doctor 131), the treatment voltage (for example, the voltage adjusted according to the physical condition of the treated person for each treatment), whether or not the treatment has been completed, whether or not there has been an alert for visiting the hospital, information related to the urine collection of the patient 132 (for example, the maximum urine collection volume, the number and time of urination, and the amount of urine, etc.), etc.). Note that one "treatment session" may include electrical stimulation treatment record information 116 for one session performed by the patient 132 using the electrical stimulation device 1.

[0146] The doctor terminal 103 functions as a terminal for a doctor 131 to confirm and update treatment information of a patient 132. With reference to Fig. 24, the doctor terminal 103 includes a processor 121, an input device 122, a display device 123, a communication I / F 124 as an example of a communication means, and a storage device 125.

[0147] The processor 121 may be configured with a CPU including, for example, a control device, an arithmetic unit, a register, an interface with the storage device 125, and an interface with the communication I / F 124. The processor 121 executes a program 126 (PGM: Program) stored in the storage device 125. The input device 122 may include, for example, a keyboard, a mouse, etc. The display device 123 may include, for example, a display, etc.

[0148] Communication I / F 124 mediates data exchange between doctor terminal 103 and external electronic devices (e.g., medical electronic devices such as patient information server 102, electrostimulator 1 owned by patient 132, personal terminals such as smartphones and tablet computers, etc.). Such data exchange may be performed by either wired communication or wireless communication. As shown in FIG. 22, doctor terminal 103 can communicate with electrostimulator 1 of patient 132 visiting hospital 104 via LAN 105. Doctor terminal 103 can also communicate with electrostimulator 1 of patient 132 at home 109 via LAN 110, WAN 106, and LAN 105.

[0149] The storage device 125 includes, for example, a ROM and a RAM, and stores a program 126. The program 126 may include, for example, a patient information reading program 126A, a patient information updating program 126B, a visit date setting program 126C, a visit alert cancellation program 126D, a stop alert cancellation program 126E, a stop advance cancellation program 126F, and the like.

[0150] The patient information reading program 126A may be a program for reading the information 115-116 and the like stored in the patient information server 102 into the doctor terminal 103 via the communication I / F 124. For example, the information 115-116 is read into the doctor terminal 103 by requesting the patient information server 102 to read the information 115-116 using the input device 122.

[0151] Patient information update program 126B may be, for example, a program that updates electrical stimulation treatment record information 116 stored in patient information server 102. Electrical stimulation treatment record information 116 may be updated, for example, by reading treatment information stored in electrical stimulation device 1 into doctor terminal 103 when patient 132 visits a hospital.

[0152] Visit date setting program 126C may be a program for setting the next visit date in electrical stimulation device 1 of patient 132. For example, by inputting information about the visit date (e.g., date, time, department, doctor in charge, etc.) on a visit date setting screen displayed on display device 123, the visit date information is transmitted to electrical stimulation device 1 of patient 132 via communication I / F 124.

[0153] Hospital visit alert cancellation program 126D may be a program that cancels a hospital visit alert (see FIGS. 11 to 20) issued to electrical stimulation device 1 of patient 132. For example, when doctor 131 cancels the hospital visit alert in hospital 104, a signal of the cancellation information is transmitted to electrical stimulation device 1 of patient 132 via LAN 105, and the hospital visit alert is canceled. At this time, unlike FIG. 21, the terminal that cancels the hospital visit alert is terminal 103 owned by doctor 131, so that the process of identifying the authorized person (step S4 in FIG. 21) is not required. Note that doctor 131 can also remotely cancel the hospital visit alert of electrical stimulation device 1 of patient 132 at home 109 via LAN 105, WAN 106, and LAN 110, if necessary.

[0154] Stop alert cancellation program 126E may be a program that cancels a stop alert (see FIGS. 11 to 20) issued to electrical stimulation device 1 of patient 132. For example, when doctor 131 cancels the stop alert in hospital 104, a signal of the cancellation information is transmitted to electrical stimulation device 1 of patient 132 via LAN 105, and the stop alert is canceled. At this time, unlike FIG. 21, the terminal that cancels the stop alert is terminal 103 owned by doctor 131, so that the process of identifying an authorized person (step S4 in FIG. 21) is not required. Note that doctor 131 can also remotely cancel the stop alert of electrical stimulation device 1 of patient 132 at home 109 via LAN 105, WAN 106, and LAN 110 as necessary.

[0155] Stop notice cancellation program 126F may be a program that cancels a stop notice (see Figs. 11 to 20) issued to electrical stimulation device 1 of patient 132. For example, when doctor 131 cancels the stop notice in hospital 104, a signal of the cancellation information is transmitted to electrical stimulation device 1 of patient 132 via LAN 105, and the stop notice is canceled. At this time, unlike Fig. 21, the terminal that cancels the stop notice is terminal 103 owned by doctor 131, so that the process of identifying the authorized person (step S4 in Fig. 21) is not required. Note that doctor 131 can also remotely cancel the stop alert of electrical stimulation device 1 of patient 132 at home 109 via LAN 105, WAN 106, and LAN 110 as necessary.

[0156] Fig. 25 is a diagram for explaining a display example of patient management information. With reference to Fig. 25, in the patient management system 101, information on electrical stimulation treatment for each patient is organized by treatment session (No.), and a doctor can check the treatment information in a list. In addition, the presence or absence of a visit alert is recorded in the same column for the same treatment session, and is associated with each other. Therefore, when the patient visits the hospital, appropriate advice can be provided to the patient, such as the importance of regular visits to the hospital, the treatment effect that can be achieved by regular visits, etc., based on the confirmation of the daily treatment time and the average output voltage during treatment from the treatment record information, and the number of visit alerts, etc.

[0157] Although one embodiment of the present invention has been described above, the present invention can be embodied in other forms. For example, various design modifications can be made within the scope of the claims.

[0158] In addition, the following additional notes are given regarding preferred aspects extracted from the above-described embodiment. [Appendix 1-1] An electrical stimulation device having a stimulation electrode capable of supplying an electrical stimulation signal, a controller configured to be electrically connected to the stimulation electrodes; The controller: a memory for storing a planned visit date of a patient who is a user of the electrical stimulation device; The electrical stimulation device executes a visit alert notification program that notifies the patient of a visit alert encouraging the patient to visit the hospital if the patient does not visit the hospital even after the scheduled visit date has passed. [Appendix 1-2] The electrical stimulation device described in Appendix 1-1, wherein the controller executes a stop alert execution program to stop the operation function of the electrical stimulation device if the visit alert is not canceled even after a certain period of time has elapsed after the visit alert is notified. [Appendix 1-3] The electrical stimulation device described in Appendix 1-2, wherein the controller executes a stop notification execution program that provides advance notice of a stop of the operating function of the electrical stimulation device if the visit alert is not canceled within a certain period of time after the visit alert is notified. [Appendix 1-4] The electrical stimulation device described in Appendix 1-1, wherein the controller executes an authority identification program that identifies an authority having the authority to set the scheduled visit date, and when it is determined that the person operating the electrical stimulation device is the authority, allows access to a setting screen for the scheduled visit date. [Appendix 1-5] The electrical stimulation device described in Appendix 1-4, wherein the controller executes a stop alert execution program that executes a stop alert to stop the operating function of the electrical stimulation device if the person operating the electrical stimulation device is determined to be the authorized person after a certain period of time has elapsed and the person is not again determined to be the authorized person. [Appendix 1-6] The electrical stimulation device described in Appendix 1-5, wherein the controller executes a stop notification execution program that provides advance notice of a stop of the operating function of the electrical stimulation device if, after determining that the person operating the electrical stimulation device is the authorized person, the authorized person identification means does not again determine that the person is the authorized person even after a certain period of time has elapsed. [Appendix 1-7] The controller: Each time the electrical stimulation device is used, a current value detection program is executed to detect a current value flowing to a patient; The electrical stimulation device described in Appendix 1-1 executes a stop alert execution program that observes changes in the current value associated with an increase in the number of times the electrical stimulation device is used, and stops the operation function of the electrical stimulation device if an output below a predetermined allowable current value continues for a certain period of time. [Appendix 1-8] The electrical stimulation device described in Appendix 1-7, wherein the controller observes changes in the current value as the number of times the electrical stimulation device is used increases, and executes a stop warning execution program that warns in advance that the operating function of the electrical stimulation device will be stopped if an output below a predetermined allowable current value continues for a certain period of time. [Appendix 1-9] The electrical stimulation device according to claim 1-7 or 1-8, wherein the allowable current value is in a range of 1 mA to 100 mA. [Appendix 1-10] A detection device is provided in the electrical stimulation device, and detects sheet identification information individually provided on a conductive sheet that can be attached to the stimulation electrode in order to attach the stimulation electrode to the skin of a patient; The electrical stimulation device described in Appendix 1-1, wherein after detecting the sheet identification information, the controller counts at least one of the number of times the electrical stimulation device has been used and the number of days elapsed since the date of detection of the sheet identification information, and when at least one of the number of times the electrical stimulation device has been used and the number of days elapsed exceeds a predetermined reference value, executes a stop alert execution program to stop the operating function of the electrical stimulation device. [Appendix 1-11] The electrical stimulation device described in Appendix 1-10, wherein the controller executes a stop notification execution program that provides advance notice of a stop of the operating function of the electrical stimulation device when at least one of the number of uses and the number of days elapsed approaches a predetermined reference value. [Appendix 1-12] a position information receiver provided to the electrical stimulation device and configured to acquire position information of the electrical stimulation device; The electrical stimulation device described in Appendix 1-1, wherein the controller executes a stop alert execution program that stops the operation function of the electrical stimulation device when location information of a specified medical institution is not acquired by the location information acquisition means for a certain period of time. [Appendix 1-13] The electrical stimulation device described in Appendix 1-12, wherein the controller executes a stop notification execution program that provides advance notice of a stop of the operating function of the electrical stimulation device when location information of a specified medical institution is not acquired by the location information acquisition means for a certain period of time. [Appendix 1-14] The electrical stimulation device described in Appendix 1-4, wherein the controller executes a visit alert cancellation program that allows access to a visit alert cancellation screen when it determines that the person operating the electrical stimulation device is an authorized person with the authority to cancel the visit alert. [Appendix 1-15] The electrical stimulation device described in Appendix 1-5 or Appendix 1-6, wherein the controller executes a stop alert cancellation program that allows access to a cancellation screen for the stop alert when it is determined that the person operating the electrical stimulation device is an authorized person who has the authority to cancel the stop alert. [Appendix 1-16] The electrical stimulation device described in Appendix 1-6 or Appendix 1-15 which cites Appendix 1-6, wherein the controller executes a stop notice cancellation program which allows access to a stop notice cancellation screen when it determines that the person operating the electrical stimulation device is an authorized person with the authority to cancel the stop notice. [Appendix 1-17] A system for managing treatment information of a patient receiving electrical stimulation treatment, An electrical stimulation device according to any one of Supplementary Note 1-1 to Supplementary Note 1-16; A first terminal capable of communicating with the electrical stimulation device according to any one of Supplementary Note 1-1 to Supplementary Note 1-16 and having a processor; The processor executes a visit date setting program that sets the patient's planned visit date in the electrical stimulation device via a communication line. [Appendix 1-18] The patient management system described in Appendix 1-17, wherein the processor executes a visit alert cancellation program to cancel a visit alert generated in the electrical stimulation device via a communication line. [Appendix 1-19] The electrical stimulation device is an electrical stimulation device according to any one of Supplementary Note 1-2, Supplementary Note 1-3, Supplementary Note 1-5 to Supplementary Note 1-13, Supplementary Note 1-15, and Supplementary Note 1-16; The patient management system of claim 1-17 or 1-18, wherein the processor executes a stop alert cancellation program to cancel a stop alert generated in the electrical stimulation device via a communication means. [Appendix 1-20] The electrical stimulation device is an electrical stimulation device according to any one of Supplementary Note 1-3, Supplementary Note 1-6, Supplementary Note 1-8, Supplementary Note 1-11, Supplementary Note 1-13, and Supplementary Note 1-16; The patient management system according to claim 1-17 or 1-18, wherein the processor executes a stop notice cancellation program that cancels a stop notice generated in the electrical stimulation device via a communication line.

[0159] This application corresponds to Patent Application No. 2020-211445 filed with the Japan Patent Office on December 21, 2020, the entire disclosure of which is incorporated herein by reference. [Explanation of symbols]

[0160] 1: Electrical stimulation device 2: Guide 3: Device body 4: Wiring cord 5: Seat body 6 :Indifferent electrode 7A: Stimulating electrode 7B: Stimulating electrode 8: Conductive sheet 9A: Conductive sheet 9B: Conductive sheet 10:Human body 11: 1st page 12:Second side 13: Recess 14A: Recess 14B: Recess 19: 1st terminal 20A: 2nd terminal 20B: 2nd terminal 23: Housing 24: Monitor 25: Stop button 26: Operation buttons 27: First socket 28: Second socket 29: Reader 30: Controller 31: Input section 32: Output section 33: Communication I / F 34: Location information receiving unit 35: Reading section 36: Processor 37: Storage section 38: Timer 39: Program 39A: Voltage application program 39B: Visit Date Setting Program 39C: Hospital visit alert notification program 39D: Visit Alert Cancellation Program 39E: Authorized Person Identification Program 39F: Current value observation program 39G: Stop alert execution program 39H: Stop alert release program 39I: Stop notice execution program 39J: Suspension Notice Release Program 40:Operation unit 41: Display section 42: Audio output section 43: Allowable current value 44: For a certain period of time 45: Current value for checking expiration date 46: Seat body 47: RF tag 48: Protective film 49: Packaging 50: Packaged products 101: Patient Management System 102: Patient information server 103: Doctor's terminal 104: Hospital 105: LAN 106 :WAN 107: Hospital 108: LAN 109: Home 110: LAN 111: Doctor's terminal 112: Processor 113: Communication I / F 114:Storage device 115: Patient Identification Information 116: Electrical stimulation treatment record information 121: Processor 122: Input device 123:Display equipment 124: Communication I / F 125: Storage device 126: Program 126A: Patient information reading program 126B: Patient Information Update Program 126C: Visit Date Setting Program 126D: Visit Alert Cancellation Program 126E: Stop alert release program 126F: Suspension notice release program 131: Doctor 132 :patient

Claims

1. An electrical stimulation device having a stimulation electrode capable of supplying an electrical stimulation signal, A storage unit that stores a planned visit date of a patient who is a user of the electrical stimulation device; and a visit alert notifying means for notifying the patient of a visit alert encouraging the patient to visit the hospital if the patient does not visit the hospital even after the scheduled visit date has passed.

2. The electrical stimulation device further includes a stop alert execution means for generating a stop alert that stops the operation function of the electrical stimulation device; The electrical stimulation device according to claim 1 , wherein the stop alert execution means stops an operating function of the electrical stimulation device if the visit alert is not canceled even after a certain period of time has elapsed after the visit alert is notified by the visit alert notification means.

3. The method further includes a stop notification execution means for notifying in advance that the stop alert execution means will stop the operation function of the electrical stimulation device, The electrical stimulation device of claim 2, wherein the stop notification execution means notifies the user of a stop of an operating function of the electrical stimulation device if the visit alert is not canceled within a certain period of time after the visit alert notification means notifies the user of the visit alert.

4. The electrical stimulation device further includes an authority identification means for identifying an authority having authority to set the scheduled hospital visit date, The electrical stimulation device according to claim 1 , wherein the authorized person identification means allows access to the planned visit date setting screen when it is determined that the person operating the electrical stimulation device is the authorized person.

5. The electrical stimulation device further includes a stop alert execution means for generating a stop alert that stops the operation function of the electrical stimulation device; The electrical stimulation device according to claim 4, wherein the stop alert execution means stops an operation function of the electrical stimulation device when the authorized person identification means determines that the person is the authorized person but the authorized person identification means does not determine that the person is the authorized person again even after a certain period of time has elapsed.

6. The method further includes a stop notification execution means for notifying in advance that the stop alert execution means will stop the operation function of the electrical stimulation device, The electrical stimulation device of claim 5, wherein the stop notification execution means notifies the user of a stop of the operating function of the electrical stimulation device when the authorized person identification means determines that the user is an authorized person after a certain period of time has elapsed since the authorized person identification means determined that the user is an authorized person, but the authorized person identification means does not determine that the user is an authorized person again.

7. A stop alert execution means for generating a stop alert that stops the operation function of the electrical stimulation device; and a current value detection means for detecting a current value flowing to the patient each time the electrical stimulation device is used. The electrical stimulation device of claim 1, wherein the stop alert execution means observes a change in the current value as the number of times the electrical stimulation device is used increases, and stops the operating function of the electrical stimulation device if an output below a predetermined allowable current value continues for a certain period of time.

8. The method further includes a stop notification execution means for notifying in advance that the stop alert execution means will stop the operation function of the electrical stimulation device, The electrical stimulation device of claim 7, wherein the stop notification execution means observes changes in the current value as the number of times the electrical stimulation device is used increases, and issues a notification that the operating function of the electrical stimulation device will be stopped if an output below a predetermined allowable current value continues for a certain period of time.

9. 9. The electrical stimulation device according to claim 7, wherein the permissible current value is in the range of 1 mA to 100 mA.

10. A stop alert execution means for generating a stop alert that stops the operation function of the electrical stimulation device; an identification information detection means for detecting sheet identification information individually provided on a conductive sheet that can be attached to the stimulation electrode in order to attach the stimulation electrode to the skin of a patient; 2. The electrical stimulation device of claim 1, further comprising a counting means for counting at least one of the number of times the electrical stimulation device has been used and the number of days elapsed since the date of detection of the sheet identification information after the sheet identification information is detected, and the stop alert execution means stops an operating function of the electrical stimulation device when at least one of the number of times the electrical stimulation device has been used and the number of days elapsed exceeds a predetermined reference value.

11. The method further includes a stop notification execution means for notifying in advance that the stop alert execution means will stop the operation function of the electrical stimulation device, The electrical stimulation device according to claim 10 , wherein the stop notice execution means issues a notice of a stop of an operating function of the electrical stimulation device when at least one of the number of uses and the number of elapsed days approaches a predetermined reference value.

12. A stop alert execution means for generating a stop alert that stops the operation function of the electrical stimulation device; and a position information acquiring means for acquiring position information of the electrical stimulation device, The electrical stimulation device according to claim 1 , wherein the stop alert execution means stops an operation function of the electrical stimulation device when location information of a predetermined medical institution is not acquired by the location information acquisition means for a certain period of time.

13. The method further includes a stop notification execution means for notifying in advance that the stop alert execution means will stop the operation function of the electrical stimulation device, The electrical stimulation device according to claim 12 , wherein the stop notification execution means notifies the user of a stop of an operating function of the electrical stimulation device when location information of a predetermined medical institution is not acquired by the location information acquisition means for a certain period of time.

14. Further comprising a visit alert canceling means for canceling the visit alert, The electrical stimulation device according to claim 4, wherein the authorized person identification means allows access to a screen for canceling the visit alert when it is determined that the person operating the electrical stimulation device is an authorized person who has the authority to cancel the visit alert.

15. Further comprising a stop alert canceling means for canceling the stop alert, The electrical stimulation device according to claim 5 or 6, wherein the authority identification means allows access to a screen for canceling the stop alert when it is determined that the person operating the electrical stimulation device is an authority having the authority to cancel the stop alert.

16. The vehicle further includes a stop notice canceling means for canceling the stop notice by the stop notice execution means, The electrical stimulation device described in claim 6 or claim 15 that cites claim 6, wherein the authority identification means allows access to a screen for canceling the stop notice when it determines that the person operating the electrical stimulation device is an authority having the authority to cancel the stop notice.

17. A communication means for communicating with the electrical stimulation device according to any one of claims 1 to 16; and a visit date setting means for setting a planned visit date of the patient in the electrical stimulation device via the communication means.

18. The patient management system according to claim 17, further comprising a visit alert canceling means for canceling a visit alert generated in the electrical stimulation device via the communication means.

19. The electrical stimulation device is an electrical stimulation device according to any one of claims 2, 3, 5 to 13, 15 and 16, The patient management system according to claim 17 or 18, further comprising a stop alert canceling means for canceling the stop alert generated in the electrical stimulation device via the communication means.

20. The electrical stimulation device is an electrical stimulation device according to any one of claims 3, 6, 8, 11, 13 and 16, 19. The patient management system according to claim 17, further comprising a stop notice canceling means for canceling a stop notice issued to the electrical stimulation device via the communication means.

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