A thermal effect test system, a temperature rise characteristic test method and a cooling characteristic test method

Abstract

The present application relates to a kind of neutral electrode thermal effect test system, temperature rise characteristic test method and cooling characteristic test method.The neutral electrode thermal effect test system includes: host computer, generates test configuration instruction;Central control module, connect host computer and interact data;Multiple electronic skin modules, contain skin contact surface, the human body skin impedance network for simulating the skin impedance of different population, temperature measuring feedback device for temperature acquisition and heating device;High-frequency variable-frequency constant-current source module, output high-frequency constant current makes neutral electrode and impedance network heat production;Central control module receives temperature parameter and / or constant-current output parameter and uploads host computer.The present application can effectively realize the thermal effect test of neutral electrode.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical electrical equipment testing, in particular to a thermal effect testing system, a temperature rise characteristic testing method and a cooling characteristic testing method. BACKGROUND

[0002] The neutral electrode is a key accessory of high-frequency surgical equipment, which needs to be attached to the human thigh, buttocks and other areas during clinical use, and can avoid local temperature rise too high to cause patient burns by dispersing high-frequency current energy. According to GB9706.202-2021 "Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high-frequency surgical equipment and high-frequency accessory equipment" (hereinafter referred to as "high-frequency special standard"), the neutral electrode needs to be verified for safety through the test of "applying high-frequency constant current-detecting temperature rise", and the standard allows the use of test substitutes (test equipment) to replace the human body for testing.

[0003] The existing neutral electrode thermal effect testing equipment is mainly composed of upper computer software, high-frequency constant current output module and electronic skin module, which can realize multi-gear high-frequency constant current output, and divide the neutral electrode into equal-area rectangular blocks to evaluate local temperature rise. However, such equipment has the following technical defects:

[0004] Group characteristic parameter change evaluation is missing: no equivalent impedance model of age, gender and fat thickness is established, and the temperature rise risk of different groups of people cannot be accurately evaluated. For example, the skin impedance of men is generally higher than that of women, the skin resistance of the elderly group increases, the capacitance decreases, and the increase of fat thickness changes the current penetration depth and heat distribution, but the existing equipment has no gender compensation mechanism, age correction module and fat thickness-impedance correlation model.

[0005] Test reference temperature sensitivity is missing: impedance difference affects power dissipation through Ohm's law, and different test starting temperatures further amplify temperature rise deviation, and the existing equipment lacks compensation mechanism for such variable coupling, resulting in temperature rise results deviating from the true value.

[0006] Systematic evaluation of cooling characteristics is lacking: the heat dissipation efficiency of the neutral electrode directly affects the risk of residual heat accumulation after surgery (such as continuous surgery scenes), and if the electrode has large heat capacity or insufficient heat dissipation path, the temperature may continue to be higher than the safety threshold after power-off, causing delayed burns, but the existing equipment only tests temperature rise and does not evaluate cooling capacity.

[0007] The above defects result in the inability of the existing equipment to comprehensively evaluate the clinical safety of the neutral electrode, which may cause skin burns, tissue liquefaction necrosis and infection and other adverse events, and there is an urgent need for a testing system that can simulate multiple population characteristics, accurately control the reference temperature and has cooling evaluation capability. SUMMARY

[0008] In view of the above problems of the prior art, the present application provides a thermal effect test system, a temperature rise characteristic test method and a cooling characteristic test method, which effectively realize thermal effect test of a neutral electrode.

[0009] Specifically, the present application provides a thermal effect test system, comprising:

[0010] a host computer configured to generate a test configuration instruction of a neutral electrode to be tested;

[0011] a central control module connected to the host computer;

[0012] a plurality of electronic skin modules, each of which has a skin contact surface abutting against the neutral electrode, and each of which further comprises a human skin impedance network, a temperature feedback device and a heating device in communication with the skin contact surface, the human skin impedance network is configured to simulate skin impedance of different population characteristics according to an instruction issued by the central control module, the temperature feedback device is configured to collect temperature of the skin contact surface, and the heating device is configured to apply a quantitative heat to the neutral electrode according to an instruction issued by the central control module;

[0013] a high-frequency variable-frequency constant-current source module configured to output a high-frequency constant current with a specified frequency and amplitude according to an instruction issued by the central control module, and the high-frequency constant current flows through the neutral electrode and the human skin impedance network to generate heat;

[0014] The central control module receives temperature parameters fed back by the electronic skin modules and / or constant current output parameters fed back by the high-frequency variable-frequency constant-current source module, and uploads the temperature parameters and / or the constant current output parameters to the host computer.

[0015] According to an embodiment of the present application, the human skin impedance network comprises at least a gender module, an age module and a fat thickness module connected in series, each of which comprises a plurality of MOS tubes and resistance-capacitance elements, and the MOS tubes are configured to select different resistance-capacitance element combinations to simulate skin impedance corresponding to different genders, ages and fat thicknesses.

[0016] According to an embodiment of the present application, in the gender module, resistance values of resistance-capacitance elements corresponding to females range from 50Ω to 500Ω, and capacitance values range from 100pF to 390pF; and resistance values of resistance-capacitance elements corresponding to males range from 50Ω to 500Ω, and capacitance values range from 100pF to 390pF.

[0017] In the age module, resistance values of resistance-capacitance elements corresponding to an age of 30 years range from 10Ω to 390Ω, and capacitance values range from 510pF to 1000pF; and resistance values of resistance-capacitance elements corresponding to an age of 60 years range from 10Ω to 390Ω, and capacitance values range from 510pF to 1000pF.

[0018] In the fat thickness module, the resistance value of the resistance-capacitance element corresponding to the fat thickness of 5mm ranges from 100Ω to 2000Ω, and the capacitance value ranges from 470pF to 2200pF; the resistance value of the resistance-capacitance element corresponding to the fat thickness of 20mm ranges from 100Ω to 2000Ω, and the capacitance value ranges from 470pF to 2200pF.

[0019] According to one embodiment of the present application, the resistance in the resistance-capacitance element is a non-inductive resistance, and the series and parallel inductance is less than 10nH.

[0020] According to one embodiment of the present application, the thermal effect test system further comprises a feedback sampling module for monitoring the current and voltage signals output by the high-frequency variable-frequency constant-current source module in real time and feeding back to the high-frequency variable-frequency constant-current source module for PID adjustment.

[0021] According to one embodiment of the present application, the thermal effect test system further comprises a power supply module for supplying power to the upper computer, the central control module, the electronic skin module, the high-frequency variable-frequency constant-current source module and the feedback sampling module.

[0022] According to one embodiment of the present application, the heating device comprises a programmable pulse direct-current heating wire, the heating device generates a heating pulse signal according to the instruction issued by the central control module, and heats the neutral electrode through the programmable pulse direct-current heating wire, the period T of the heating pulse signal is 500ms, the adjustable range of the pulse width pw is 5μs-500ms, and the adjustable range of the corresponding duty cycle is 0.1%-100%.

[0023] The present application also provides a temperature rise characteristic test method suitable for the thermal effect test system, comprising the following steps:

[0024] S1, arranging a plurality of electronic skin modules to form a skin module array, and attaching the neutral electrode to be tested to the skin contact surface of the electronic skin module;

[0025] S2, the central control module receives the test configuration instruction issued by the upper computer and issues it to the electronic skin module and the high-frequency variable-frequency constant-current source module;

[0026] S3, the human skin impedance network simulates the skin impedance of different groups of people according to the instruction issued by the central control module, and the high-frequency variable-frequency constant-current source module outputs the high-frequency constant current flowing through the neutral electrode and the human skin impedance network according to the instruction issued by the central control module, and the temperature feedback device is used to collect the temperature of the skin contact surface;

[0027] S4, the central control module receives the temperature parameters fed back by the electronic skin module and the constant current output parameters fed back by the high-frequency variable-frequency constant-current source module, and uploads them to the upper computer.

[0028] S5, the host computer generates temperature rise characteristic data based on the temperature parameter and the constant current output parameter.

[0029] According to one embodiment of the present application, before the high-frequency constant current source module outputs high-frequency constant current in step S3, a temperature test is performed, including the steps of:

[0030] The current temperature T2 is fed back to the central control module by the temperature measurement feedback device;

[0031] The central control module compares the current temperature T2 and the set reference temperature T1, and if |T2-T1|≤0.1℃, the high-frequency constant current source module outputs high-frequency constant current to the electronic skin module.

[0032] The present application also provides a cooling characteristic test method, which is suitable for the thermal effect test system described above, including the steps of:

[0033] T1, a plurality of electronic skin modules are arranged to form a skin module array, and a neutral electrode to be tested is attached to the skin contact surface of the electronic skin module, and the current temperature of the skin contact surface is fed back by the temperature measurement feedback device as a reference temperature T4;

[0034] T2, the central control module receives a test configuration instruction issued by the host computer and issues it to the electronic skin module, and the test configuration instruction contains a target temperature T3;

[0035] T3, the human skin impedance network simulates the skin impedance of different population characteristics according to the instruction issued by the central control module, the temperature measurement feedback device feeds back the current temperature T5 of the skin contact surface, and the heating device applies a constant amount of heat to the neutral electrode, and when |T5-T4|≤0.1℃, the heating device stops heating;

[0036] T4, the central control module continuously receives the current temperature T5 fed back by the electronic skin module and uploads it to the host computer, and when |T5-T3|≤0.1℃, the neutral electrode cooling is completed;

[0037] T5, the host computer generates a temperature-time cooling curve based on the received current temperature T5.

[0038] The thermal effect test system, temperature rise characteristic test method and cooling characteristic test method provided by the present application realize the thermal effect test of the neutral electrode by integrating the electronic skin module and the high-frequency constant current source module.

[0039] It should be understood that the above general description and the following detailed description of the present application are exemplary and illustrative, and are intended to provide further explanation of the present application as claimed. Attached Figure Description

[0040] The accompanying drawings are included to provide further explanation of the invention; they are incorporated into and constitute a part of this application. The drawings illustrate embodiments of the invention and, together with this specification, serve to explain the principles of the invention. In the drawings:

[0041] Figure 1 A schematic diagram of the thermal effect testing system according to an embodiment of the present invention is shown.

[0042] Figure 2 A schematic diagram of the structure of an electronic skin module according to an embodiment of the present invention is shown.

[0043] Figure 3 A schematic diagram of the heating pulse signal of a heating device according to an embodiment of the present invention is shown.

[0044] Figure 4 A flowchart of a temperature rise characteristic testing method according to an embodiment of the present invention is shown.

[0045] Figure 5 A flowchart of a cooling characteristic testing method according to an embodiment of the present invention is shown.

[0046] Figure 6 A schematic diagram of the cooling characteristic curve of the neutral electrode according to an embodiment of the present invention is shown. Detailed Implementation

[0047] It should be noted that, unless otherwise specified, the embodiments and features described in this application can be combined with each other.

[0048] The technical solutions of the embodiments of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only a part of the embodiments of this application, and not all of them. The following description of at least one exemplary embodiment is merely illustrative and is in no way intended to limit this application or its application or use. All other embodiments obtained by those skilled in the art based on the embodiments of this application without creative effort are within the scope of protection of this application.

[0049] It should be noted that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to limit the exemplary embodiments according to this application. As used herein, the singular form is intended to include the plural form as well, unless the context clearly indicates otherwise. Furthermore, it should be understood that when the terms "comprising" and / or "including" are used in this specification, they indicate the presence of features, steps, operations, devices, components, and / or combinations thereof.

[0050] The application is not limited by the relative positioning of parts and steps, numerical expressions, and numerical values set forth in these examples unless otherwise specifically stated. It is to be understood that the dimensions of the various parts shown in the drawings are not drawn to scale for the sake of convenience in description. Techniques, methods, and apparatus known to those of ordinary skill in the relevant art can not be discussed in detail, but should be considered part of the specification where appropriate. In all examples shown and discussed herein, any specific value is to be interpreted as merely exemplary and not as a limitation. Thus, other examples of the exemplary embodiments can have different values. It is noted that like numbers and letters refer to like elements throughout the several views of the drawings, and thus, once an element is defined in one view, it need not be discussed further in subsequent views.

[0051] In the description of the present application, it should be understood that the orientation words such as "front, back, up, down, left, right", "transverse, vertical, perpendicular, horizontal" and "top, bottom" and the like indicate the orientation or positional relationship shown in the drawings, which are only for the convenience of describing the present application and simplifying the description, and do not indicate and imply that the devices or elements referred to must have a particular orientation or be constructed and operated in a particular orientation, unless otherwise stated, and therefore cannot be understood as a limitation on the scope of protection of the present application; the orientation words "inner, outer" refer to the inner and outer relative to the contour of the parts themselves.

[0052] In addition, it should be noted that the use of the words "first", "second" and the like to define parts is only for the convenience of distinguishing the corresponding parts, and the above words have no special meaning unless otherwise stated, and therefore cannot be understood as a limitation on the scope of protection of the present application. In addition, although the terms used in the present application are selected from commonly known terms, some terms mentioned in the specification of the present application can be selected by the applicant according to his or her judgment, and the detailed meaning of each term is explained in the relevant part of the description. In addition, the present application is not only understood by the actual terms used, but also by the meaning implied by each term.

[0053] Figure 1 The structural schematic diagram of a thermal effect test system according to an embodiment of the present application is shown. Figure 2 The structural schematic diagram of an electronic skin module according to an embodiment of the present application is shown. As shown in the figure, the thermal effect test system 100 provided by the present application is a thermal effect test system suitable for a neutral electrode, which realizes effective testing of the thermal effect of the neutral electrode through the cooperation of multiple modules. The thermal effect test system 100 mainly includes an upper computer 101, a central control module 102, multiple electronic skin modules 103, and a high-frequency variable-frequency constant-current source module 104.

[0054] The host computer 101 generates test configuration instructions for the neutral electrode to be tested according to test requirements, and the instructions contain key parameter settings required for subsequent tests, providing initial control basis for the entire test process.

[0055] The central control module 102 is responsible for data interaction between the host computer 101 and other modules, and it establishes a connection with the host computer 101 to receive the test configuration instructions issued by the host computer 101, and at the same time undertakes the dual tasks of instruction distribution and data summarization. On the one hand, it issues the received test configuration instructions to the electronic skin module 103 and the high-frequency variable-frequency constant-current source module 104, ensuring that each execution module works according to the pre-set test scheme; on the other hand, it receives the temperature parameters fed back by the electronic skin module 103 and the constant-current output parameters fed back by the high-frequency variable-frequency constant-current source module 104 in real time, and uploads these key test data to the host computer 101, realizing the data flow in the test process.

[0056] The multiple electronic skin modules 103 are used to simulate the human skin environment and collect temperature information. Each electronic skin module 103 is provided with a skin contact surface 105 that can be in contact with the neutral electrode, providing a test carrier for the neutral electrode. The electronic skin module 103 internally integrates a human skin impedance network 106, a temperature measurement feedback device 107, and a heating device 108. Specifically, the human skin impedance network 106 can respond to the instructions issued by the central control module 102, and through adaptive adjustment, it can simulate the skin impedance characteristics corresponding to different population characteristics (such as gender, age, and fat thickness), restoring the impedance environment in the real use scenario. The temperature measurement feedback device 107 is responsible for collecting the real-time temperature of the skin contact surface 105, providing data support for temperature monitoring and judgment during the test process; the heating device 108 applies a certain amount of heat to the neutral electrode according to the instructions of the central control module 102, meeting the heat input requirements in scenarios such as temperature drop characteristic testing.

[0057] The high-frequency variable-frequency constant-current source module 104 is used to output high-frequency constant current of specified frequency and amplitude according to the instructions issued by the central control module 102. The high-frequency constant current will flow through the neutral electrode attached to the electronic skin module 103, and form a loop with the human skin impedance network 106, generating heat in the loop through energy conversion, providing necessary heat conditions for neutral electrode temperature rise characteristic testing, and ensuring that the test process can simulate the thermal effect scenario of the neutral electrode under the action of high-frequency current in clinical use.

[0058] It should be noted that the skin contact surface 105 of the electronic skin module 103 can be flexibly adjusted according to the maximum area of the neutral electrode to be measured. Both the area of a single skin contact surface 105 and the total number of skin contact surfaces 105 can be adjusted. Preferably, the area of a single skin contact surface 105 can be set to 1 cm2, a plurality of electronic skin modules 103 are arranged to form a 30x30 skin module array, and the total number of skin contact surfaces 105 is 900. The array size can completely cover the effective contact area of the mainstream neutral electrode on the market, and ensure that the temperature rise or cooling data of different areas of the neutral electrode can be accurately collected.

[0059] Reference Figure 2 In some examples, the human skin impedance network 106 realizes accurate reproduction of the skin impedance of different population characteristics through a modular design. The human skin impedance network 106 at least includes a gender module 109, an age module 110, and a fat thickness module 111 for simulating differences in gender, age, and fat thickness. Each module works in series, and each module is internally integrated with multiple MOS tubes 112 and resistance-capacitance elements 113. Among them, the MOS tube 112, as a core gating component, can respond to the control signals (such as G1 signal corresponding to gender selection, G2 signal corresponding to age selection, and G3 signal corresponding to fat thickness selection) output by the central control module 102, and match the skin impedance characteristics corresponding to different gender, age, and fat thickness populations by switching different combinations of resistance-capacitance elements 113.

[0060] In some examples, in the gender module 109, the resistance value range of the resistance-capacitance element 113 corresponding to a female is preferably 50Ω-500Ω, and the capacitance value range is preferably 100pF-390pF; the resistance value range of the resistance-capacitance element 113 corresponding to a male is preferably 50Ω-500Ω, and the capacitance value range is preferably 100pF-390pF.

[0061] In the age module 110, the resistance value range of the resistance-capacitance element 113 corresponding to an age of 30 years old is preferably 10Ω-390Ω, and the capacitance value range is preferably 510pF-1000pF; the resistance value range of the resistance-capacitance element 113 corresponding to an age of 60 years old is preferably 10Ω-390Ω, and the capacitance value range is preferably 510pF-1000pF.

[0062] In the fat thickness module 111, the resistance value range of the resistance-capacitance element 113 corresponding to a fat thickness of 5mm is preferably 100Ω-2000Ω, and the capacitance value range is preferably 470pF-2200pF; the resistance value range of the resistance-capacitance element 113 corresponding to a fat thickness of 20mm is preferably 100Ω-2000Ω, and the capacitance value range is preferably 470pF-2200pF.

[0063] It is easy to understand that, as an example, but not limited, more groups of MOS tubes 112 and capacitive elements 113 can be added in the age module 110 and the fat thickness module 111 to provide more detailed age and fat thickness selection. For example, a group of capacitive elements 113 with a fat thickness of 15 mm can be added in the fat thickness module 111 to ensure that the impedance simulation under each population characteristic is more in line with the clinical real skin state.

[0064] Preferably, to avoid the interference of the inductance of the resistance itself on the test accuracy in the high-frequency current environment, the resistance in the above capacitive element 113 adopts non-inductive resistance, and the series and parallel inductance is strictly controlled below 10nH, which can effectively reduce signal distortion and phase shift, and ensure the stability of impedance characteristics in high-frequency test scenarios.

[0065] Returning to Figure 1 In some examples, to further improve the system test accuracy, the thermal effect test system 100 further includes a feedback sampling module 114. The feedback sampling module 114 is used to monitor the current and voltage signals output by the high-frequency variable-frequency constant-current source module 104 in real time, and feeds back the monitoring data to the high-frequency variable-frequency constant-current source module 104 in real time. The high-frequency variable-frequency constant-current source module 104 starts the PID adjustment mechanism based on the feedback data, dynamically corrects the output parameters, ensures that the frequency and amplitude of the high-frequency constant current always meet the test configuration requirements, effectively controls the current output accuracy deviation to be less than 1%, and provides guarantee for the stability of heat generation in the temperature rise characteristic test.

[0066] In some examples, the thermal effect test system 100 further includes a power supply module 115 for powering the host computer 101, the control module 102, the electronic skin module 103, the high-frequency variable-frequency constant-current source module 104, and the feedback sampling module 114. The power supply module 115 provides stable and adaptive power for the working requirements of each module, ensures that each component always maintains a stable running state during the test process, and avoids test data deviation or module function abnormalities caused by power fluctuations.

[0067] In some examples, the heating device 108 includes a programmable pulse direct current heating wire. The heating device 108 can generate a heating pulse signal with a specific waveform according to the control instruction (such as the heating parameter transmitted through the H signal) issued by the control module 102. Figure 3A schematic diagram of a heating pulse signal of a heating device in an embodiment of the present application is shown, with the abscissa representing time t and the ordinate representing pulse voltage V, and the pulse signal assuming a periodic rectangular pulse form. As shown in the figure, the period T of the heating pulse signal can be fixed at 500 ms, and the pulse width pw can be flexibly adjusted within the range of 5 us to 500 ms, corresponding to a duty cycle adjustable range of 0.1% to 100%. By adjusting the pulse parameters, the heat applied by the heating wire to the neutral electrode can be accurately controlled, the accurate heating of the neutral electrode to the target temperature is achieved, and a stable initial thermal state is provided for the subsequent monitoring of the cooling process and the generation of the cooling characteristic curve.

[0068] The present application also provides a temperature rise characteristic test method suitable for the aforementioned thermal effect test system. Figure 4 A flow chart of a temperature rise characteristic test method in an embodiment of the present application is shown. As shown in the figure, the temperature rise characteristic test method comprises the following steps:

[0069] S1, arranging a plurality of electronic skin modules to construct a skin module array, which can provide a multi-point acquisition basis for temperature monitoring. Then, the neutral electrode to be tested is attached to the skin contact surface of the electronic skin module, so that the neutral electrode and the electronic skin module form stable contact, creating a prerequisite for subsequent current conduction and temperature acquisition;

[0070] S2, the central control module receives the test configuration instruction issued by the upper computer, which contains the target population characteristics (such as gender, age, fat thickness) and high-frequency constant current parameters (frequency, amplitude). Then, the central control module transmits the instruction to the electronic skin module and the high-frequency variable constant current source module, realizing the collaborative start and parameter configuration of each functional module;

[0071] S3, in the test execution phase, the human skin impedance network responds to the instruction of the central control module, selects the corresponding resistance-capacitance element combination through the internal MOS tube, simulates the skin impedance state of different population characteristics, and restores the electrical environment of the neutral electrode in different clinical use scenarios; at the same time, the high-frequency variable constant current source module outputs a high-frequency constant current that can flow through the neutral electrode and the human skin impedance network according to the instruction of the central control module, providing a stable excitation signal for the temperature rise test; in this process, the feedback sampling module monitors the current and voltage signals output by the high-frequency variable constant current source module in real time, and feeds back the monitoring data to the module for PID adjustment, to ensure that the high-frequency constant current output accuracy deviation is always within a controllable range, avoiding the interference of current fluctuation on the temperature rise result; and the temperature measuring feedback device collects temperature data of the skin contact surface of the electronic skin module at a fixed interval in real time, converts the temperature signal into an electrical signal, and feeds it back to the central control module, providing continuous and reliable basic information for subsequent temperature rise analysis;

[0072] S4, the central control module receives the temperature parameters fed back by the electronic skin module and the constant current output parameters fed back by the high-frequency variable-frequency constant current source module, and uploads them to the upper computer;

[0073] S5, the upper computer analyzes and calculates based on the temperature parameters and the constant current output parameters through the built-in data processing algorithm, which can not only generate temperature rise characteristic data reflecting the overall temperature rise trend of the neutral electrode, but also generate temperature rise distribution curves of different regions of the neutral electrode in combination with the temperature information collected at multiple points.

[0074] In some examples, to avoid the initial temperature deviation interfering with the accuracy of the temperature rise characteristic test results, the temperature rise characteristic test method of the application sets a strict temperature calibration link before starting the high-frequency constant current output in step S3, to ensure the consistency of the test conditions by controlling the initial temperature reference. Specifically, before the high-frequency variable-frequency constant current source module outputs the high-frequency constant current, the temperature measurement feedback device is first started to collect the temperature of the skin contact surface of the electronic skin module in the current environment, i.e. the current temperature T2, and feed back the temperature data in the form of an electrical signal to the central control module. The central control module will call the built-in comparison logic to compare the received current temperature T2 with the system preset reference temperature T1. The reference temperature T1 is usually the initial temperature collected at the first test after the system is started, which is used as the temperature reference for the entire test sequence. When the absolute value of the difference between the two, |T2-T1|, is ≤0.1℃, the central control module determines that the initial temperature has met the test reference requirements, and at this time the high-frequency variable-frequency constant current source module is allowed to output the high-frequency constant current to the electronic skin module, ensuring that the temperature rise test is started under stable initial temperature conditions. If |T2-T1|>0.1℃, the central control module does not allow the high-frequency constant current output, but controls the temperature measurement feedback device to continuously collect T2 at fixed intervals and repeatedly compare, until the temperature deviation meets the threshold requirement, to eliminate the influence of environmental temperature fluctuations or module self-heating drift on the initial conditions, from the source to ensure the reliability of the temperature rise data, so that the test results can truly reflect the temperature rise characteristics of the neutral electrode under specific population characteristics.

[0075] For the specific temperature rise characteristic test process, after the skin module array deployment and the neutral electrode are attached (corresponding to step S1), the operator can configure the relevant parameters according to the test requirements (such as evaluating the temperature rise of the neutral electrode under multiple scenarios such as "male + 30 years old + 5mm fat thickness" and "female + 60 years old + 20mm fat thickness") through the software configured by the upper computer, and the software automatically generates N continuous test sequences; at the same time, the software automatically records the initial temperature before the first test after the system is started as the reference temperature T1.

[0076] Subsequently, the system sequentially performs the i-th (i is from 1 to N) test: before starting each test sequence (corresponding to the temperature calibration link of step S3), the temperature measuring feedback device first collects the current temperature T2 of the skin contact surface and feeds back to the central control module, and the central control module compares T2 with the reference temperature T1, if |T2-T1|≤0.1℃, it is determined that the current initial temperature meets the test requirements, and the high-frequency constant current output of the current sequence is allowed to start; if |T2-T1|>0.1℃, the system suspends the test, waits for the temperature to stabilize naturally, and repeatedly collects T2 and compares at a fixed interval of 1s until the temperature difference meets the threshold.

[0077] After the current test sequence is completed, the system automatically switches to the next test sequence, and the above-mentioned temperature calibration step is repeated before starting each sequence; after all N test sequences are completed, the host computer collects the temperature rise data of all sequences and outputs the complete temperature rise record, and the whole temperature rise characteristic test process ends.

[0078] The application also provides a cooling characteristic test method suitable for the aforementioned thermal effect test system. Figure 5 The flow chart of the cooling characteristic test method of one embodiment of the application is shown. As shown in the figure, the cooling characteristic test method comprises the steps of:

[0079] T1, a skin module array is constructed by arranging a plurality of electronic skin modules, which can provide a multi-point and omnidirectional collection basis for temperature monitoring, then the neutral electrode to be tested is attached to the skin contact surface of the electronic skin module, ensuring that the neutral electrode and the simulated skin surface form a stable and fitted contact state; at the same time, the temperature measuring feedback device collects the current temperature of the skin contact surface in the current state in real time, which is used as the reference temperature T4 of the cooling test, providing a reference for the end state of the subsequent cooling process;

[0080] T2, the central control module receives the test configuration instruction issued by the host computer and issues it to the electronic skin module, and the test configuration instruction contains the target temperature T3 that the neutral electrode needs to be heated to, which is the starting heat state reference that needs to be reached in the cooling process;

[0081] T3, in the test execution phase, the human skin impedance network simulates the skin impedance state of different population characteristics according to the instruction of the central control module, selects the corresponding resistance-capacitance element combination through the internal MOS tube gating, so as to approach the diversified actual application scene; at the same time, the temperature feedback device continuously collects the current temperature T5 of the skin contact surface, and the heating device starts work according to the parameters issued by the central control module, which contains a programmable pulse direct current heating wire outputting a specific waveform of heating pulse signal, and adjusts the pulse duty cycle to accurately control the heat applied to the neutral electrode. In this process, the temperature feedback device can continuously collect the current temperature T5 of the skin contact surface at a fixed interval of 1 second, and feed back the data to the central control module in real time. The central control module continuously compares the difference of |T5-T3| through the built-in comparison logic, when |T5-T3|≤0.1℃, it is determined that the neutral electrode has reached the preset starting heat state, and the heating device stops working immediately; when |T5-T3|>0.1℃, it returns to the pulse duty cycle adjustment link through the PID algorithm, and dynamically adjusts the duty cycle to continuously heat, avoiding the interference of excessive heating or insufficient heating on the cooling process;

[0082] T4, the central control module continuously receives the current temperature T5 feedback by the electronic skin module, and synchronously uploads these real-time temperature data to the upper computer. The central control module continuously compares the difference of |T5-T4| at the same time, when |T5-T4|≤0.1℃, it indicates that the temperature of the neutral electrode has fallen back to the initial reference temperature of the test, and the cooling process is completed;

[0083] T5, the upper computer generates a temperature-time cooling curve based on the received current temperature T5 data in the whole period through the corresponding data processing algorithm, which can intuitively present the dynamic process of the neutral electrode from the target temperature T3 to the reference temperature T4. At the same time, the upper computer can also calculate the cooling half-life period, average cooling rate and other key parameters based on the curve, which provides the basis for the quantitative evaluation of the heat dissipation efficiency of the neutral electrode, and helps to judge the residual heat risk of the neutral electrode in the continuous operation scene.

[0084] Figure 6A schematic diagram of the neutral electrode cooling characteristic curve of one embodiment of the present application is shown, with the abscissa representing time (unit: s) and the ordinate representing temperature (unit: ℃). As shown in the figure, the curve shows a change trend of gradually decreasing from high temperature and tending to be stable. The initial temperature is about 41 ℃, it decreases rapidly in about 7 seconds, then the cooling rate gradually slows down, and finally tends to be stable near about 23 ℃. This curve shape intuitively reflects the process of heat dissipation of the neutral electrode through heat conduction, heat radiation and other ways after the completion of heating. By analyzing the slope of the curve (cooling rate), the final stable temperature and other characteristics, the heat dissipation efficiency of the neutral electrode can be quantitatively evaluated. For example, the rapid cooling period reflects the heat exchange capacity of the electrode and the contact surface of the simulated skin, and the slow cooling period reflects the slow dissipation of residual heat, thereby providing a key basis for judging the residual heat risk of the neutral electrode in the clinical continuous use scenario.

[0085] The present application provides a thermal effect test system, a temperature rise characteristic test method and a cooling characteristic test method, which have the following beneficial effects:

[0086] 1. Population-specific simulation: Through the multi-dimensional resistance-capacitance network of MOS tube gating, the gender, age and fat thickness are simulated cooperatively for the first time, covering the skin impedance characteristics of most of the population, and the temperature rise test result has small error with the real scene in clinic, reducing the safety risk of population specificity.

[0087] 2. Test precision is significantly improved: the reference temperature control precision reaches ±0.1 ℃, combined with the PID adjustment of the feedback sampling module, the test error caused by the initial temperature deviation and current fluctuation is effectively avoided, and the repeatability error of the temperature rise test is small.

[0088] 3. More comprehensive evaluation dimension: the cooling characteristic test is added, the heat dissipation efficiency of the neutral electrode is quantified through programmable pulse heating and real-time temperature monitoring, and the residual heat risk in the continuous operation scenario can be identified.

[0089] 4. High degree of automation: temperature calibration, resistance-capacitance switching and heating control are all automatic without human intervention, reducing the operation burden of the test personnel; the electronic skin module array supports the global temperature rise monitoring of the neutral electrode, avoiding the omission of local overheating.

[0090] 5. Strong compatibility and expansibility: the electronic skin module array can be adjusted according to the area of the neutral electrode, and the resistance-capacitance network can be expanded by adding MOS tube units to cover more population characteristics, adapting to the test needs of different specifications of neutral electrodes.

[0091] It is obvious to those skilled in the art that various modifications and variations can be made to the above exemplary embodiments of the present application without departing from the spirit and scope of the present application. Therefore, it is intended to cover the modifications and variations of the present application falling within the scope of the appended claims and their equivalent technical solutions.

Claims

1. A thermal effect test system suitable for a neutral electrode, comprising: a host computer configured to generate test configuration instructions for a neutral electrode to be tested; a central control module connected to the host computer; a plurality of electronic skin modules, each of which has a skin contact surface abutting the neutral electrode, and each of which further comprises a human skin impedance network, a temperature feedback device, and a heating device in communication with the skin contact surface, the human skin impedance network simulating the skin impedance of different population characteristics according to instructions issued by the central control module, the temperature feedback device configured to collect the temperature of the skin contact surface, and the heating device configured to apply a quantitative amount of heat to the neutral electrode according to instructions issued by the central control module; a high-frequency variable-frequency constant-current source module configured to output a high-frequency constant current of a specified frequency and amplitude according to instructions issued by the central control module, the high-frequency constant current flowing through the neutral electrode and the human skin impedance network to generate heat; wherein the central control module receives temperature parameters fed back by the electronic skin modules and / or constant current output parameters fed back by the high-frequency variable-frequency constant-current source module, and uploads them to the host computer.

2. The thermographic testing system of claim 1, wherein, The human skin impedance network comprises at least a gender module, an age module, and a fat thickness module connected in series, each of which contains a plurality of MOS transistors and resistance-capacitance elements, the MOS transistors being configured to select different combinations of resistance-capacitance elements to simulate the skin impedance corresponding to different genders, ages, and fat thicknesses.

3. The thermographic testing system of claim 2, wherein, In the gender module, the resistance values of the resistance-capacitance elements corresponding to females range from 50Ω to 500Ω, and the capacitance values range from 100pF to 390pF; the resistance values of the resistance-capacitance elements corresponding to males range from 50Ω to 500Ω, and the capacitance values range from 100pF to 390pF. In the age module, the resistance values of the resistance-capacitance elements corresponding to an age of 30 years range from 10Ω to 390Ω, and the capacitance values range from 510pF to 1000pF; the resistance values of the resistance-capacitance elements corresponding to an age of 60 years range from 10Ω to 390Ω, and the capacitance values range from 510pF to 1000pF. In the fat thickness module, the resistance values of the resistance-capacitance elements corresponding to a fat thickness of 5mm range from 100Ω to 2000Ω, and the capacitance values range from 470pF to 2200pF; the resistance values of the resistance-capacitance elements corresponding to a fat thickness of 20mm range from 100Ω to 2000Ω, and the capacitance values range from 470pF to 2200pF.

4. The thermographic testing system of claim 3, wherein, The resistors in the resistance-capacitance elements are non-inductive resistors, and the series and parallel inductance values are less than 10nH.

5. The thermographic testing system of claim 1, wherein, The thermal effect test system further comprises a feedback sampling module configured to monitor the current and voltage signals output by the high-frequency variable-frequency constant-current source module in real time, and feed them back to the high-frequency variable-frequency constant-current source module for PID adjustment.

6. The thermographic testing system of claim 5, wherein, The thermal effect test system further comprises a power supply module configured to supply power to the host computer, the central control module, the electronic skin modules, the high-frequency variable-frequency constant-current source module, and the feedback sampling module.

7. The thermographic testing system of claim 1, wherein, The heating device comprises a programmable pulse direct current heating wire, the heating device generates a heating pulse signal according to an instruction issued by the central control module, and heats the neutral electrode through the programmable pulse direct current heating wire, a period T of the heating pulse signal is 500 ms, an adjustable range of a pulse width pw is 5 microseconds to 500 ms, and an adjustable range of a corresponding duty cycle is 0.1% to 100%.

8. A temperature rise characteristic test method suitable for use in a thermal effect test system as claimed in any one of claims 1 to 7, characterized in that, The method comprises the steps of: S1, arranging a plurality of electronic skin modules to form a skin module array, and attaching the neutral electrode to be tested to a skin contact surface of the electronic skin module; S2, the central control module receives a test configuration instruction issued by the upper computer and issues the test configuration instruction to the electronic skin module and the high-frequency variable-frequency constant-current source module; S3, the human skin impedance network simulates the skin impedance of different groups of people according to an instruction issued by the central control module, the high-frequency variable-frequency constant-current source module outputs high-frequency constant current flowing through the neutral electrode and the human skin impedance network according to an instruction issued by the central control module, and the temperature feedback device is used to collect the temperature of the skin contact surface; S4, the central control module receives temperature parameters fed back by the electronic skin module and constant-current output parameters fed back by the high-frequency variable-frequency constant-current source module, and uploads the temperature parameters and the constant-current output parameters to the upper computer; S5, the upper computer generates temperature rise characteristic data based on the temperature parameters and the constant-current output parameters.

9. The temperature rise characteristic test method according to claim 8, wherein Before the high-frequency variable-frequency constant-current source module outputs high-frequency constant current in step S3, a temperature test is performed, which comprises the steps of: The current temperature T2 is collected by the temperature feedback device and fed back to the central control module; The central control module compares the current temperature T2 with the set reference temperature T1, and if |T2-T1|≤0.1℃, the high-frequency variable-frequency constant-current source module outputs high-frequency constant current to the electronic skin module.

10. A method for testing the cooling characteristics, which is applicable to the thermal effect testing system as claimed in any one of claims 1 to 7, characterized in that, The method comprises the steps of: T1, arranging a plurality of electronic skin modules to form a skin module array, and attaching the neutral electrode to be tested to a skin contact surface of the electronic skin module, and the temperature feedback device feeds back the current temperature of the skin contact surface as a reference temperature T4; T2, the central control module receives a test configuration instruction issued by the upper computer and issues the test configuration instruction to the electronic skin module, and the test configuration instruction contains a target temperature T3; T3, the human skin impedance network simulates the skin impedance of different groups of people according to an instruction issued by the central control module, the temperature feedback device feeds back the current temperature T5 of the skin contact surface, and the heating device applies a constant amount of heat to the neutral electrode, and when |T5-T4|≤0.1℃, the heating device stops heating; T4, the central control module continuously receives the current temperature T5 fed back by the electronic skin module and uploads the current temperature T5 to the upper computer, and when |T5-T3|≤0.1℃, the neutral electrode is cooled down; T5, the upper computer generates a temperature-time cooling curve based on the received current temperature T5.

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