Heat effect test system, temperature rise characteristic test method and cooling characteristic test method

Abstract

The invention relates to a neutral electrode heat effect test system, a temperature rise characteristic test method and a cooling characteristic test method. The neutral electrode heat effect test system comprises an upper computer for generating a test configuration instruction; the central control module is connected with the upper computer and interacts data; each electronic skin module comprises a skin contact surface, a human body skin impedance network capable of simulating skin impedance of different crowds, a temperature measurement feedback device for collecting temperature and a heating device; the high-frequency variable-frequency constant-current source module outputs high-frequency constant current to enable the neutral electrode and the impedance network to generate heat; the central control module receives the temperature parameters and / or the constant current output parameters and uploads the temperature parameters and / or the constant current output parameters to the upper computer. According to the invention, the heat effect test of the neutral electrode can be effectively realized.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical electrical equipment testing, in particular to a thermal effect test system, a temperature rise characteristic test method and a cooling characteristic test 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 accessories" (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. The existing neutral electrode thermal effect test 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: 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 and 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. 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 a compensation mechanism for such variable coupling, resulting in temperature rise results deviating from the true value. 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 scenarios), 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. The above defects result in that the existing equipment cannot 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 test system that can simulate multiple population characteristics, accurately control the reference temperature and has cooling evaluation capability. SUMMARY

[0003] 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 the thermal effect test of the neutral electrode.

[0004] Specifically, the application provides a thermal effect test system, which comprises: a host computer configured to generate a test configuration instruction of 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 against the neutral electrode, and each of which further comprises a human skin impedance network, a temperature feedback device and a heating device, the human skin impedance network is configured to simulate the skin impedance of different population characteristics according to the instruction issued by the central control module, the temperature feedback device is configured to collect the temperature of the skin contact surface, and the heating device is configured to apply a quantitative heat to the neutral electrode according to the instruction issued by the central control module; 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 the 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; wherein the central control module receives the temperature parameters fed back by the electronic skin modules and / or the constant current output parameters fed back by the high-frequency variable-frequency constant-current source module, and uploads the parameters to the host computer.

[0005] According to one embodiment of the 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 the skin impedance corresponding to different genders, ages and fat thicknesses.

[0006] According to one embodiment of the application, in the gender module, the resistance value of the resistance-capacitance elements corresponding to a female ranges from 50Ω to 500Ω, and the capacitance value ranges from 100pF to 390pF; and the resistance value of the resistance-capacitance elements corresponding to a male ranges from 50Ω to 500Ω, and the capacitance value ranges from 100pF to 390pF. In the age module, the resistance value of the resistance-capacitance elements corresponding to an age of 30 years ranges from 10Ω to 390Ω, and the capacitance value ranges from 510pF to 1000pF; and the resistance value of the resistance-capacitance elements corresponding to an age of 60 years ranges from 10Ω to 390Ω, and the capacitance value ranges from 510pF to 1000pF. In the fat thickness module, the resistance value of the resistance-capacitance elements corresponding to a fat thickness of 5mm ranges from 100Ω to 2000Ω, and the capacitance value ranges from 470pF to 2200pF; and the resistance value of the resistance-capacitance elements corresponding to a fat thickness of 20mm ranges from 100Ω to 2000Ω, and the capacitance value ranges from 470pF to 2200pF.

[0007] 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 10 nH.

[0008] 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.

[0009] According to one embodiment of the present application, the thermal effect test system further comprises a power supply module for supplying power to the host computer, the central control module, the electronic skin module, the high-frequency variable-frequency constant-current source module, and the feedback sampling module.

[0010] According to one embodiment of the present application, the heating device comprises a programmable pulse direct current heating wire, and 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 500 ms, the adjustable range of the pulse width pw is 5 μs-500 ms, and the adjustable range of the corresponding duty cycle is 0.1%-100%.

[0011] The present application also provides a temperature rise characteristic test method suitable for the thermal effect test system described above, comprising the following steps: 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; S2, the central control module receives the test configuration instruction issued by the host computer and issues it 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 the instruction issued by the central control module, and 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 the 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 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 host computer; S5, the host computer generates temperature rise characteristic data based on the temperature parameters and constant current output parameters.

[0012] According to one embodiment of the present application, before the high-frequency variable-frequency constant-current source module outputs high-frequency constant current in step S3, a temperature test is performed, comprising the following steps: 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 and 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.

[0013] The application further provides a cooling characteristic test method, which is suitable for the thermal effect test system and comprises the following steps: T1, a plurality of electronic skin modules are arranged to form a skin module array, a neutral electrode to be tested is attached to a skin contact surface of the electronic skin module, and a temperature feedback device feeds back a current temperature of the skin contact surface as a reference temperature T4; T2, the central control module receives a test configuration instruction sent by the upper computer and sends 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 skin impedance of different groups of people according to the instruction sent by the central control module, the temperature feedback device feeds back a current temperature T5 of the skin contact surface, and the heating device applies a constant 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 completes cooling; T5, the upper computer generates a temperature-time cooling curve based on the received current temperature T5.

[0014] The thermal effect test system, the temperature rise characteristic test method and the cooling characteristic test method provided by the application realize thermal effect test of the neutral electrode by integrating the electronic skin module and the high-frequency variable-frequency constant-current source module.

[0015] It should be understood that the above general description and the following detailed description of the application are exemplary and illustrative, and are intended to provide further explanation of the application as claimed. BRIEF DESCRIPTION OF DRAWINGS

[0016] The accompanying drawings are included to provide further explanation of the application, which are incorporated into and constitute a part of the application, and show embodiments of the application, and together with the specification, serve to explain the principles of the application. In the drawings: Figure 1 Fig. 1 shows a structure schematic diagram of a thermal effect test system of an embodiment of the application.

[0017] Figure 2 Fig. 2 shows a structure schematic diagram of an electronic skin module of an embodiment of the application.

[0018] Figure 3A schematic diagram of a heating pulse signal of a heating device of one embodiment of the present application is shown.

[0019] Figure 4 A flow chart of a temperature rise characteristic test method of one embodiment of the present application is shown.

[0020] Figure 5 A flow chart of a temperature fall characteristic test method of one embodiment of the present application is shown.

[0021] Figure 6 A schematic diagram of a temperature fall characteristic curve of a neutral electrode of one embodiment of the present application is shown. DETAILED DESCRIPTION

[0022] It should be noted that the embodiments in the present application and the features in the embodiments can be combined with each other without conflict.

[0023] The technical solutions in the embodiments of the present application will be described clearly and completely below with reference to the drawings in the embodiments of the present application. Obviously, the described embodiments are only some of the embodiments of the present application, but not all the embodiments. The following description of at least one exemplary embodiment is merely illustrative in nature and is in no way limiting of the application or its applications or uses. Based on the embodiments in the present application, all other embodiments obtained by those of ordinary skill in the art without creative effort are within the scope of the present application.

[0024] It should be noted that the terms used herein are only intended to describe specific embodiments and are not intended to limit the exemplary embodiments according to the present application. As used herein, the singular forms are intended to include the plural forms unless the context clearly indicates otherwise, and it should be further understood that the terms "comprise" and / or "include" when used herein specify the presence of stated features, steps, operations, devices, components and / or combinations thereof.

[0025] Unless specifically stated otherwise, the relative arrangements of the components and steps, numerical expressions, and values shown in the embodiments presented herein are not meant to limit the scope of the present application. It is to be understood that the dimensions of the various parts shown in the drawings are not necessarily to scale, and that for the convenience of description, the size relationships between the parts of the drawings are not necessarily to scale. Techniques, methods, and devices known to those of ordinary skill in the relevant art can not be discussed in detail, but should be considered as part of the description of the present application. In all examples shown and discussed herein, any specific value should be interpreted as merely illustrative and not as a limitation. Thus, other examples of the exemplary embodiments can have different values. It should be noted that like reference numerals and letters refer to like items in the following drawings, and thus, once an item is defined in one drawing, it need not be discussed further in subsequent drawings.

[0026] 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, 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 each component.

[0027] In addition, it should be noted that the use of "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, 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 and used terms, some terms mentioned in the specification of the present application may be selected by the applicant according to his or her judgment, and the detailed meanings thereof are explained in the relevant part of the description. In addition, the present application is required to be understood not only by the actual terms used, but also by the meaning implied by each term.

[0028] Figure 1 The structural schematic diagram of the thermal effect test system of one embodiment of the present application is shown. Figure 2 The structural schematic diagram of the electronic skin module of one 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 neutral electrodes, which realizes effective test of thermal effect of neutral electrodes through cooperative work of multiple modules. The thermal effect test system 100 mainly includes a host computer 101, a central control module 102, multiple electronic skin modules 103 and a high-frequency variable-frequency constant-current source module 104.

[0029] Among them, the host computer 101 generates test configuration instructions for the neutral electrode to be tested according to the test requirements, which contains the key parameter settings required for subsequent tests, and provides the initial control basis for the whole test process; The central control module 102 is responsible for the data interaction between the host computer 101 and other modules. It establishes a connection with the host computer 101 to receive the test configuration instructions issued by the host computer 101, and 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. The plurality of 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 to adaptively adjust 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 constant 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. 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 flows through the neutral electrode attached to the electronic skin module 103 and forms a loop with the human skin impedance network 106, generating heat in the loop through energy conversion to provide the necessary heat conditions for neutral electrode temperature rise characteristic testing, 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.

[0030] 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 tested. 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, and multiple electronic skin modules 103 are arranged to form a 30x30 skin module array with a total of 900 skin contact surfaces 105. The array size can completely cover the effective attachment area of the mainstream neutral electrode on the market, ensuring that the temperature rise or drop data of different areas of the neutral electrode can be accurately collected.

[0031] Reference Figure 2In some examples, the human skin impedance network 106 realizes accurate reproduction of 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 groups of MOS tubes 112 and resistance-capacitance elements 113. Among them, the MOS tube 112 as the core gating component can respond to the control signal (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 the combination mode of different resistance-capacitance elements 113.

[0032] In some examples, in the gender module 109, the resistance value range of the resistance-capacitance element 113 corresponding to the 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 the male is preferably 50Ω-500Ω, and the capacitance value range is preferably 100pF-390pF; In the age module 110, the resistance value range of the resistance-capacitance element 113 corresponding to the 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 the age of 60 years old is preferably 10Ω-390Ω, and the capacitance value range is preferably 510pF-1000pF; In the fat thickness module 111, the resistance value range of the resistance-capacitance element 113 corresponding to the 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 the fat thickness of 20mm is preferably 100Ω-2000Ω, and the capacitance value range is preferably 470pF-2200pF.

[0033] It is easy to understand that, as an example but not limitation, more groups of MOS tubes 112 and resistance-capacitance 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, in the fat thickness module 111, a group of resistance-capacitance elements 113 corresponding to the fat thickness of 15mm can be added to ensure that the impedance simulation under each population characteristic is more in line with the real skin state in the clinic.

[0034] Preferably, in order 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 resistance-capacitance 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 the impedance characteristics in the high-frequency test scene.

[0035] Returning toFigure 1 In some examples, to further improve the system test accuracy, the thermal effect test system 100 further comprises 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 feed 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 protection for the stability of heat generation in the temperature rise characteristic test.

[0036] In some examples, the thermal effect test system 100 further comprises a power supply module 115 for supplying power to 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 abnormality caused by power supply fluctuation.

[0037] In some examples, the heating device 108 comprises 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 3 A schematic diagram of the heating pulse signal of the heating device of one embodiment of the present application is shown, with the horizontal coordinate being time t and the vertical coordinate being pulse voltage V. The pulse signal presents 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 μs to 500 ms, and the corresponding duty cycle adjustable range is 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 realized, and a stable initial thermal state is provided for the monitoring of the subsequent cooling process and the generation of the cooling characteristic curve.

[0038] The present application also provides a temperature rise characteristic test method suitable for the thermal effect test system described above. Figure 4 A flow chart of the temperature rise characteristic test method of one embodiment of the present application is shown. As shown in the figure, the temperature rise characteristic test method comprises the following steps: 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, which creates a prerequisite for subsequent current conduction and temperature acquisition. 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 will forward the instruction to the electronic skin module and the high-frequency variable constant current source module, realizing the cooperative start and parameter configuration of each functional module. S3, in the test execution phase, the human skin impedance network responds to the instructions of the central control module, selects the corresponding resistance-capacitance element combination through the internal MOS tube gating, 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 the high-frequency constant current that can flow through the neutral electrode and the human skin impedance network according to the instructions 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 precision deviation is always within a controllable range, avoiding the interference of current fluctuation on the temperature rise result; while the temperature feedback device collects the temperature data of the skin contact surface of the electronic skin module at fixed intervals in real time, and feeds back the temperature signal converted into an electric signal to the central control module, providing continuous and reliable basic information for subsequent temperature rise analysis; 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 constant current source module, and uploads them to the upper computer. S5, the upper computer analyzes and operates based on the temperature parameters and 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 combined with multi-point collected temperature information.

[0039] 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 present application sets a strict temperature calibration link before starting the high-frequency constant current output in step S3, and ensures 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 feeds 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 during the first test after the system is started, and 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°C, 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°C, 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, thereby eliminating the influence of environmental temperature fluctuations or module self-thermal drift on the initial conditions, and ensuring the reliability of the temperature rise data from the source, so that the test results can truly reflect the temperature rise characteristics of the neutral electrode under specific population characteristics.

[0040] For a specific temperature rise characteristic test process, after the skin module array deployment and the neutral electrode is 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 the conditions of "male + 30 years old + 5 mm fat thickness", "female + 60 years old + 20 mm fat thickness", etc.) 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.

[0041] Subsequently, the system performs the ith (i from 1 to N) test in sequence: before starting each test sequence (corresponding to the temperature calibration link of step S3), the temperature measurement feedback device first collects the temperature T2 of the current skin contact surface and feeds it back to the central control module, which compares T2 with the reference temperature T1. If |T2-T1|≤0.1°C, 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°C, the system suspends the test, waits for the temperature to stabilize naturally, and repeatedly collects T2 at a fixed interval of 1s and compares, until the temperature difference meets the threshold.

[0042] After the current test sequence is completed, the system automatically switches to the next test sequence, and the above temperature calibration step is repeated before the start of each sequence; after all N test sequences are executed, the host computer collects the temperature rise data of all sequences and outputs the complete temperature rise record, and the entire temperature rise characteristic test process ends.

[0043] The application also provides a cooling characteristic test method suitable for the aforementioned thermal effect test system. Figure 5 A 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 following steps: 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, and then the neutral electrode to be tested is attached to the skin contact surface of the electronic skin module to ensure that the neutral electrode forms a stable and fitted contact state with the simulated skin surface; at the same time, the temperature measurement feedback device collects the current temperature of the skin contact surface in the current state in real time, which is taken as the reference temperature T4 of the cooling test to provide a reference for the end state of the subsequent cooling process; T2, the central control module receives the test configuration instruction issued by the host computer and sends it to the electronic skin module, and the test configuration instruction contains the target temperature T3 to which the neutral electrode needs to be heated, which is the starting heat state reference to be reached in the cooling process; T3, in the test execution phase, the human skin impedance network simulates the skin impedance state of different population characteristics according to the instructions of the central control module, and selects the corresponding resistance-capacitance element combination through the internal MOS tube gating to approach the diversified actual application scenarios; at the same time, the temperature measurement feedback device continuously collects the current temperature T5 of the skin contact surface, and the heating device starts working according to the parameters sent by the central control module, which contains a programmable pulse DC heating wire outputting a heating pulse signal with a specific waveform, and the heat applied to the neutral electrode is accurately controlled by adjusting the pulse duty cycle. In this process, the temperature measurement 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 |T5-T3| through the built-in comparison logic, and when |T5-T3|≤0.1℃, it is determined that the neutral electrode has reached the preset starting heat state, and the heating device is immediately controlled to stop working; when |T5-T3|>0.1℃, it returns to the pulse duty cycle adjustment link through the PID algorithm to dynamically adjust the duty cycle for continuous heating, so as to avoid the interference of excessive heating or insufficient heating on the cooling process; T4, the central control module continuously receives the current temperature T5 fed back by the electronic skin module and synchronously uploads these real-time temperature data to the host computer. The central control module continuously compares the difference |T5-T4| at the same time, and 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 determined to be completed; T5, the host computer generates a temperature-time cooling curve based on the received full-time current temperature T5 data through a corresponding data processing algorithm, which can intuitively present the dynamic process of the neutral electrode falling from the target temperature T3 to the reference temperature T4; at the same time, the host computer can also calculate the cooling half-life, the average cooling rate and other key parameters based on the curve, which provides a basis for the quantitative evaluation of the heat dissipation efficiency of the neutral electrode, and helps to judge the postoperative residual heat risk of the neutral electrode in the continuous operation scene.

[0044] Figure 6 A schematic diagram of the neutral electrode cooling characteristic curve of an embodiment of the application is shown, the abscissa represents time (unit: s), and the ordinate represents 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℃, which decreases rapidly in about 7 seconds, and 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 after completing heating through heat conduction, heat radiation and other ways. By analyzing the slope (cooling rate) of the curve, the final stable temperature and other characteristics, the heat dissipation efficiency of the neutral electrode can be quantitatively evaluated. For example, the rapid cooling stage in the early stage reflects the heat exchange capacity of the electrode and the contact surface of the simulated skin, and the slow release of the residual heat in the later stage, thereby providing a key basis for judging the postoperative residual heat risk of the neutral electrode in the continuous use scene in the clinic.

[0045] The heat effect test system, the temperature rise characteristic test method and the cooling characteristic test method provided by the application have the following beneficial effects: 1. Population-specific simulation: through the multi-dimensional resistance-capacitance network of the MOS tube gating, the gender, age and fat thickness are simulated cooperatively for the first time, the skin impedance characteristics of most of the population are covered, the temperature rise test result has small error with the real scene in the clinic, and the safety risk of population specificity is reduced. 2. Test precision is significantly improved: the reference temperature control precision is ±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. 3. More comprehensive evaluation dimension: the cooling characteristic test is increased, 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 scene can be identified. 4. High degree of automation: temperature calibration, resistance-capacitance switching and heating control are not required in the whole process, the operation burden of the test personnel is reduced; the array of the electronic skin module supports the global temperature rise monitoring of the neutral electrode, and local overheating is avoided. 5. Strong compatibility and scalability: 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 adapt to the test requirements of different specifications of neutral electrodes.

[0046] It is obvious to those skilled in the art that various modifications and variations can be made to the above-mentioned exemplary embodiments of the present application without departing from the spirit and scope of the present application. Therefore, it is intended that the present application cover modifications and variations of the present application which come within the scope of the appended claims and their equivalents.

Claims

1. A thermal effect testing system for a neutral electrode, comprising: The host computer is used to generate test configuration instructions for the neutral electrode to be tested; A central control module connected to the host computer; Multiple electronic skin modules, each having a skin contact surface in contact with the neutral electrode, the electronic skin modules further comprising a human skin impedance network, a temperature measurement feedback device, and a heating device in communication with the skin contact surface, the human skin impedance network simulating skin impedances of different population characteristics according to instructions issued by the central control module, the temperature measurement feedback device being used to collect the temperature of the skin contact surface, and the heating device applying a fixed 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, wherein the high-frequency constant current flows through the neutral electrode and the human skin impedance network to generate heat; The central control module receives the temperature parameter fed back by the electronic skin module and / or the constant current output parameter fed back by the high-frequency variable frequency constant current source module, and uploads the received data to the host computer.

2. The thermal effect testing system according to claim 1, wherein: The human skin impedance network includes at least a gender module, an age module, and a fat thickness module connected in series for simulating the characteristics of different populations. Each module contains multiple groups of MOS tubes and resistor-capacitor elements. The MOS tubes are used to select different combinations of resistor-capacitor elements to simulate the skin impedance corresponding to different genders, ages, and fat thicknesses.

3. The thermal effect testing system according to claim 2, wherein: In the gender module, the resistance value range of the RC components for females is 50Ω to 500Ω, and the capacitance value range is 100pF to 390pF; the resistance value range for males is 50Ω to 500Ω, and the capacitance value range is 100pF to 390pF. In the age module, the resistance value range of the RC components corresponding to the age of 30 is 10Ω to 390Ω, and the capacitance value range is 510pF to 1000pF. The resistance value range of the RC components corresponding to the age of 60 is 10Ω to 390Ω, and the capacitance value range is 510pF to 1000pF. In the fat thickness module, the resistance value range of the RC components corresponding to the fat thickness of 5mm is 100Ω~2000Ω, and the capacitance value range is 470pF~2200pF. The resistance value range of the RC components corresponding to the fat thickness of 20mm is 100Ω~2000Ω, and the capacitance value range is 470pF~2200pF.

4. The thermal effect testing system according to claim 3, wherein: The resistors in the RC elements are non-inductive resistors, and their series and parallel inductances are less than 10nH.

5. The thermal effect testing system according to claim 1, wherein: The thermal effect testing system also includes a feedback sampling module for real-time monitoring of the current and voltage signals output by the high-frequency variable frequency constant current source module, and feeding back the current and voltage signals to the high-frequency variable frequency constant current source module for PID adjustment.

6. The thermal effect testing system according to claim 5, wherein: The thermal effect testing system also includes a power supply module for supplying power to the host computer, central control module, electronic skin module, high-frequency variable frequency constant current source module and feedback sampling module.

7. The thermal effect testing system according to claim 1, wherein: The heating device includes a programmable pulse DC heating wire, which generates a heating pulse signal according to the instructions issued by the central control module, and heats the neutral electrode through the programmable pulse DC heating wire. The period T of the heating pulse signal is 500ms, the adjustable range of the pulse width pw is 5μs to 500ms, and the corresponding adjustable range of the duty cycle is 0.1% to 100%.

8. A temperature rise characteristic testing method, applicable to the thermal effect testing system according to any one of claims 1 to 7, characterized in that: Including steps: S1, arranging a plurality of the electronic skin modules to form a skin module array, and placing the neutral electrode to be tested against the skin contact surface of the electronic skin module; S2, the central control module receives the test configuration instruction issued by the host computer and sends it 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 population characteristics according to the instructions issued by the central control module, the high-frequency variable frequency constant current source module outputs a high-frequency constant current flowing through the neutral electrode and the human skin impedance network according to the instructions issued by the central control module, and the temperature measurement feedback device is used to collect the temperature of the skin contact surface; S4, the central control module receives the temperature parameter fed back by the electronic skin module and the constant current output parameter fed back by the high-frequency variable frequency constant current source module, and uploads them to the host computer; S5, the host computer generates temperature rise characteristic data based on the temperature parameter and the constant current output parameter.

9. The temperature rise characteristic testing method according to claim 8, wherein: Before the high-frequency variable frequency constant current source module outputs the high-frequency constant current in step S3, a temperature test is performed, including the following steps: The current temperature T2 is collected by the temperature measurement 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. If |T2-T1|≤0.1°C, the high-frequency variable frequency constant current source module outputs a high-frequency constant current to the electronic skin module.

10. A cooling characteristic testing method, applicable to the thermal effect testing system according to any one of claims 1 to 7, characterized in that: Including steps: T1, arranging a plurality of the electronic skin modules to form a skin module array, placing the neutral electrode to be measured against the skin contact surface of the electronic skin module, and the temperature measurement feedback device feedbacks the current temperature of the skin contact surface as a reference temperature T4; T2, the central control module receives the test configuration instruction issued by the host computer and sends it to the electronic skin module, the test configuration instruction includes the target temperature T3; At T3, the human skin impedance network simulates the skin impedance of different people according to the instructions issued by the central control module. The temperature measurement feedback device feeds back the current temperature of the skin contact surface at T5. The heating device applies a fixed amount of heat to the neutral electrode. When |T5-T4|≤0.1°C, the heating device stops heating. At 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. When |T5-T3|≤0.1°C, the neutral electrode cooling is completed; T5, the host computer generates a temperature-time cooling curve based on the received current temperature T5.

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