Novel electroencephalogram acquisition system performance detection method and device

Abstract

The invention discloses a novel electroencephalogram acquisition system performance detection method and device, and the method comprises the steps: firstly determining an electrode coordinate at the top of a head die body, carrying out the centering drilling of a determined coordinate point, and then installing a detected perforated electrode on the head die body through a perforated electrode clamp at the centering drilling position, the method comprises the following steps of: performing copper paint spraying treatment on the inner surface of a hollow head mold body at a non-electrode output position to form a shielding coating, and establishing integration of an electroencephalogram weak signal simulation module and a signal distribution system. Through the scheme that head mold manufacturing based on industrial standards and an original method is combined with electrode and electroencephalogram signal source contact, the detection requirements of current various new-form electroencephalogram acquisition devices are met, and the problem that a current medical instrument detection mechanism cannot detect new-form electrode forms is thoroughly solved. And meanwhile, relevant requirements of relevant national standards and industrial standards on detection of electrodes, lead wires and the like are met.

Description

Technical Field

[0001] The present invention relates to the technical field of registration inspection and periodic calibration of performance indicators of active medical devices, and in particular to a novel method and device for detecting performance of an electroencephalogram (EEG) acquisition system. Background Art

[0002] EEG diagnostic products derived from EEG machines, as well as products derived from EEG machines, will at least be classified as Class II active devices by the National Medical Products Administration (some products for diagnosing mental illnesses and intracranial testing will be classified as Class III), which are relatively strictly regulated types. In order to ensure the effectiveness of EEG machines as disease diagnostic equipment, mandatory performance index tests for EEG machines were added for the first time in the new version of the national mandatory standard GB9706.226-2021 (before this, EEG machines generally used the JJG954 metrology industry standard for performance parameter testing, and some local departments did not enforce it compulsorily). EEG machines that were lower than the specified indicators were judged to have failed the registration inspection and could not obtain the national medical device registration certificate. However, EEG machines collect weak signals at the microvolt level, and the performance index requirements are relatively strict, resulting in a lack of good testing conditions for various testing units. Since the new standard was implemented not long ago, the fairness and rigor of this performance index test has become a shortcoming that the inspection and testing industry needs to strive to improve.

[0003] It is generally believed that using instruments to replace manual work as much as possible and automating inspections is the only way to improve inspection capabilities.

[0004] Through visiting and investigating several EEG registration and inspection implementation agencies with relatively high standards, it is found that the industry is still in the stage of transition from JJG954 to the new standard. The instruments and equipment used are discrete "EEG test signal simulators", and most of them are general equipment that also take into account ECG instrument detection. The number of leads is less than that of EEG (EEG single-unit equipment often has 32 to 64 channels, while ECG single-unit equipment generally only provides 7 channels). In addition, the simulator itself is a universal connector output, which will cause the inspection unit to require the equipment manufacturer to abandon its own supporting electrode system and adapt the simulator's connector to provide customized patient cables, which does not conform to the new standard's idea of ​​​​overall inspection of the entire acquisition system. In addition, the existing standards do not make detailed provisions for the winding method, shielding treatment, and electrode form of the patient cable, which leads to a very confusing inspection agency at this step, and the performance indicators detected are very poorly repeatable.

[0005] The current progress in the EEG industry has in many cases improved the electrode system and enhanced electrode performance and wearing comfort. However, the current detection operation mode is unable to adapt to the new electrode system, so this important component of the EEG acquisition system is excluded from the detection. This also goes against the original intention of the new national standard to evaluate the performance indicators of the "overall acquisition system."

[0006] In order to solve the following two problems, a new method and device for detecting the performance of EEG acquisition system is proposed. The two problems are as follows:

[0007] 1. In view of the problem that medical device testing institutions are unable to adapt to new electrode forms when testing and calibrating EEG machines according to relevant national / industry standards, based on the 10 / 20 standard, we consider designing and manufacturing a head model that meets the needs of multi-channel testing, so as to adapt to the emerging new EEG machine supporting motor forms (integrated caps, helmets, scalp clips, elastic nets, etc.). As part of the "patient cable", the EEG electrode system can truly be in the actual form of acquisition application. During the testing process, within the scope of the standard, it can more truthfully reflect the performance indicators of the entire EEG acquisition system.

[0008] 2. Currently, inspectors lack detailed implementation guidelines for various performance tests of different EEG acquisition systems and rely on their own understanding to perform operations. As a result, inspectors will use different calibration equipment within the scope of the standard, which will bring about differences in equipment characteristics. Coupled with the randomness of patient cable layout, the repeatability of the standard performance test results of the EEG machine will ultimately be poor. Summary of the invention

[0009] In response to the above technical problems, the present invention provides a novel method and device for detecting the performance of an EEG acquisition system, which integrates a signal generating device with an electrode array simulating EEG signals, and meets the detection needs of various new forms of EEG acquisition equipment by combining a head mold based on industry standards and original methods and a contact scheme between electrodes and EEG signal sources.

[0010] To achieve the above object, the technical solution of the present invention is as follows:

[0011] A novel device for detecting the performance of an electroencephalogram (EEG) acquisition system, characterized in that it comprises a head mold body, an electrode fixture with a hole, an electrode body, a weak signal generating module, a test distribution module and a signal distribution control unit. The detection hole arranged at the top of the head mold body is connected to the electrode body through the electrode fixture with a hole, and the other end of the electrode body is connected to an electrode collection board, and the electrode collection board is installed on a head mold conforming bracket inside the head mold body. A weak signal generating module, a test distribution module and a signal distribution control unit are installed on the head mold conforming bracket inside the head mold body. The electrode collection board is connected to the test distribution module, and the test distribution module is connected to the weak signal generating module. The signal distribution control unit is respectively connected to the electrode collection board, the test distribution module and the weak signal generating module. A control limit interface and an isolation power supply interface are provided at the lower end of the head mold body.

[0012] The open-hole electrode clamp consists of a clamp body, a clamp guide rod, a spring, an electrode top cap and a clamping nut. One end of the clamp guide rod is threaded into a threaded groove provided on the clamp body, and the other end of the clamp guide rod is connected to the spring, the electrode top cap and the clamping nut in sequence.

[0013] The head mold body is a hollow structure, and a shielding coating is provided on the inner wall of the head mold body. The inner surface of the hollow head mold body at the non-electrode output position is sprayed with copper paint to form a shielding coating, thereby ensuring that a shielding system is constructed inside the head mold without short-circuiting with the electrode, thereby preventing interference signals from the internal control circuit from leaking out of the head mold.

[0014] The test distribution module comprises a common mode rejection test distribution board and a general performance test distribution board, and the electrode collection board is connected to the common mode rejection test distribution board and the general performance test distribution board respectively.

[0015] The signal distribution centralized control unit is internally provided with a power supply and a signal isolation system. The signal distribution centralized control unit is connected to the display and control terminal via a control line, and the signal distribution centralized control unit is connected to an isolated power supply via a power line.

[0016] A new method for testing the performance of an EEG acquisition system, the specific steps are as follows:

[0017] Step 1. First determine the electrode coordinates on the top of the head mold body, and perform centering drilling at the determined coordinate points, and then install the hole electrode fixture and the hole electrode to be tested on the head mold body at the centering drilling position;

[0018] Step 2. Spraying copper paint on the inner surface of the hollow head mold body at the non-electrode output position to form a shielding coating;

[0019] Step 3. Establish the integration of EEG weak signal simulation module and signal distribution system.

[0020] Specifically, the method for determining the electrode coordinates on the head mold body in step 1 is as follows:

[0021] On the basis of the 10 / 20 standard commonly used in the EEG acquisition industry, based on the average head model and the reference points on the medical scalp anatomy: nose (Nz), the indentation at the root of the bridge of the nose, the external occipital protuberance (Iz), the left preauricular point (LPA), the anterior root of the center of the tragus peak area and the right preauricular point (RPA), the coordinates are set to determine the number of electrodes based on the detection needs. According to the expanded 10 / 20 system diagram modified by the guidelines of the American Society for Clinical Neurophysiology (ACNS) and the head circumference size and the 20% and 10% standardized measurements based on the medical skull anatomical landmarks, the coordinates corresponding to the required electrode channels are determined on the hollow standard plastic head model body.

[0022] Specifically, the specific contents of establishing the integration of the EEG weak signal simulation module and the signal distribution system in step 3 are as follows:

[0023] 1) The internal connection wires of the electrodes fixed in step 1 are aggregated to the electrode collection board for the test signal;

[0024] 2) Allocate the limit numbers on the electrode assembly board to the common mode rejection test distribution board and the general performance test distribution board;

[0025] 3) Connect the control signal interfaces of the common-mode rejection test distribution board and the general performance test distribution board to the signal distribution control unit. The signal distribution control unit contains a power supply and signal isolation system. The output end of the signal distribution control unit directly leads the control line and the power line from the control signal interface and the isolated power interface set on the head mold body, and uses an aviation connector with a complete shielding effect to lead the line out of the head mold body, and then connect the display and control terminal for programming control, as well as the dedicated isolated power supply for detection.

[0026] Beneficial effects of the present invention:

[0027] The present invention integrates a signal generating device with an electrode array simulating EEG signals, and meets the detection requirements of various new forms of EEG acquisition equipment by combining a head mold based on industry standards and original methods with a contact scheme between electrodes and EEG signal sources. This completely solves the problem that current medical device testing agencies cannot detect new types of electrodes. At the same time, it also complies with relevant national and industry standards for the detection of electrodes, lead wires, etc. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] Figure 1 The schematic diagram of the system connection structure for the integrated EEG calibration based on the head model;

[0029] Figure 2 It is a schematic structural diagram of the hole-opening electrode fixture in the present invention;

[0030] Figure 3 It is a schematic diagram of the exploded structure of the hole-opening electrode fixture in the present invention;

[0031] Figure 4This is an expanded 10 / 20 system diagram modified according to the guidelines of the American Society of Clinical Neurophysiology (ACNS); as shown in the figure: 1. Open-hole electrode fixture, 11. Fixture body, 12. Fixture guide rod, 13. Spring, 14. Electrode top cap, 15. Compression nut, 2. Electrode body, 3. Head mold body, 4. Shielding coating, 5. Electrode collection board, 6. Weak signal generation module, 7. Common mode suppression test distribution board, 8. General performance test distribution board, 9. Signal distribution control unit, 10. Control signal interface, 11. Isolated power supply interface, 12. Isolated power supply, 13. Display and control terminal. DETAILED DESCRIPTION

[0032] The technical solution of the present invention will be described clearly and completely below in conjunction with the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0033] In the description of the present invention, it should be noted that the terms "center", "up", "down", "left", "right", "vertical", "horizontal", "inside", "outside", etc. indicate directions or positional relationships based on the directions or positional relationships shown in the accompanying drawings. They are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific direction, be constructed and operated in a specific direction. Therefore, they cannot be understood as limitations on the present invention.

[0034] In the description of the present invention, it should be noted that, unless otherwise clearly specified and limited, the terms "installed", "connected" and "connected" should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection, or it can be indirectly connected through an intermediate medium, or it can be the internal connection of two components. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances. In addition, the technical features involved in the different embodiments of the present invention described below can be combined with each other as long as they do not conflict with each other.

[0035] Example 1

[0036] like Figure 1A novel device for detecting the performance of an electroencephalogram (EEG) acquisition system is provided. A detection hole arranged at the top of a head mold body 3 is connected to an electrode body 2 through an open-hole electrode fixture 1. The head mold body 3 is a hollow structure, and a shielding coating 4 is arranged on the inner wall of the head mold body 3. The inner surface of the hollow head mold body at a non-electrode output position is subjected to copper paint spraying treatment to form a shielding coating, so as to ensure that a shielding system is constructed inside the head mold without short-circuiting with the electrode, so as to prevent interference signals of the internal control circuit from leaking out of the head mold.

[0037] like Figure 2 and 3 The hole electrode fixture 1 is composed of a fixture body 11, a fixture guide rod 12, a spring 13, an electrode top cap 14 and a clamping nut 15. The fixture body 11 is embedded in the head mold body 3, one end of the fixture guide rod 12 is screwed into a thread groove provided on the fixture body 11, and the other end of the fixture guide rod 12 is connected to the spring 13, the electrode top cap 14 and the clamping nut 15 in sequence.

[0038] The other end of the electrode body 2 is connected to the electrode collection board 5, which is installed on the head mold shape-keeping bracket set inside the head mold body 3. The electrode collection board 5 is connected to the common mode suppression test distribution board 7 and the general performance test distribution board 8.

[0039] The common mode suppression test distribution board 7 and the general performance test distribution board 8 are connected to the weak signal generating module 6 installed inside the head mold body 3, and the signal distribution control unit 9 installed inside the head mold body 3 is respectively connected to the electrode collection board 5, the common mode suppression test distribution board 7, the general performance test distribution board 8 and the weak signal generating module 6, wherein the lower end of the head mold body 3 is provided with a control limit interface 10 and an isolated power supply interface 11, and the signal distribution control unit 9 is provided with a power supply and signal isolation system, so that the signal distribution control unit 9 is connected to the display control terminal 13 through a control line, and the signal distribution control unit 9 is connected to the isolated power supply 12 through a power line.

[0040] Specifically, the display and control terminal 13 can be a general-purpose computer or an embedded device.

[0041] A new method for testing the performance of an EEG acquisition system, the specific steps are as follows:

[0042] Step 1. First determine the electrode coordinates on the top of the head mold body 3, and perform centering drilling at the determined coordinate points, and then install the electrode body 2 to be tested on the head mold body 3 through the hole-drilling electrode fixture 1 at the centering drilling position;

[0043] Step 2. Spraying copper paint on the inner surface of the hollow head mold body at the non-electrode output position to form a shielding coating 4;

[0044] Step 3. Establish the integration of EEG weak signal simulation module and signal distribution system.

[0045] Specifically, the method for determining the electrode coordinates on the head mold body in step 1 is as follows:

[0046] On the basis of the 10 / 20 standard commonly used in the EEG acquisition industry, based on the average head model and the reference points on the medical scalp anatomy: nose (Nz), the indentation on the root of the bridge of the nose, the external occipital protuberance (Iz), the left preauricular point (LPA), the front root of the center of the tragus peak area and the right preauricular point (RPA), the coordinates are set to determine the number of electrodes based on the detection needs. According to the extended 10 / 20 system diagram modified by the American Clinical Neurophysiology Society (ACNS) guidelines and the standardized measurement values ​​of 20% and 10% based on the head circumference size and the medical skull anatomical landmarks, the coordinates corresponding to the required electrode channels are determined on the hollow standard plastic head model body. The determined coordinate diagram is as follows: Figure 4 As shown,

[0047] Specifically, the specific contents of establishing the integration of the EEG weak signal simulation module and the signal distribution system in step 3 are as follows:

[0048] 1) The internal connection wires of the electrode body 2 fixed in step 1 are aggregated to the electrode collection board 5 for the test signal;

[0049] 2) Allocate the limit numbers on the electrode collection board 5 to the common mode rejection test distribution board 7 and the general performance test distribution board 8;

[0050] 3) Connect the control signal interfaces of the common-mode suppression test distribution board 7 and the general performance test distribution board 8 to the signal distribution control unit 9. The signal distribution control unit 9 contains a power supply and signal isolation system. The output end of the signal distribution control unit directly leads the control line and the power line from the control signal interface and the isolated power interface set on the head mold body, and uses an aviation connector with a complete shielding effect to lead the line out of the head mold body, and then connect the display and control terminal 13 for programming control, and the isolated power supply 12 dedicated to detection.

[0051] Specifically, the electrode body 2 in step 1 can be made of copper with a thickness of not less than 3 mm to form an oblate cylinder, with a radius not greater than half the distance to the center of the adjacent lead space, and a copper wire is led out at the inner end to connect to the test distribution module.

[0052] Example 2

[0053] When inspecting the electrode body with an opening, one end of the clamp guide rod 12 is screwed into the thread groove provided on the clamp body 11 to complete the fixing connection of the clamp guide rod 12 to the clamp body 11, and then the spring 13 and the electrode top cap 14 are connected to the clamp guide rod 12 in sequence. After completing this step, the electrode body 2 with the opening to be inspected is sleeved on the clamp guide rod 12 (the aperture of the center hole on the electrode body 2 is larger than the diameter of the clamp guide rod 12), and then the clamping nut 15 is threadedly connected to the clamp guide rod 12. As the clamping nut 15 is rotated, it moves toward the direction of the electrode body 2, and then the clamping nut 1 abuts against the electrode body 2, so that the electrode top cap 14 achieves good contact with the electrode body 2 to be inspected.

[0054] Through the above operation, all the electrode bodies 2 to be tested are installed as described above, that is, the fixation of the electrode system and the good contact with the head mold signal generation and distribution device are completed.

[0055] The fixture body 11 is embedded in the position of the head mold body 3 according to the coordinates by pasting and fixing. The size of the hole-opening electrode fixture is suitable for most electrode bodies on the market. If a special electrode body appears, the size of the corresponding fixture guide rod can be changed according to the size of the electrode body, and the fixture guide rod 12 can be bent and disassembled to adapt to individual non-porous electrodes, such as sponge electrodes, claw-type dry electrodes,

[0056] The compression nut 15 can be adapted to a customized butterfly nut to facilitate manual operation, or Figure 2 As shown in FIG. 1 , a torque wrench is needed to tighten the clamping nut 15 to control the clamping force.

[0057] The above shows and describes the basic principles and main features of the present invention and the advantages of the present invention. The various components mentioned in the present invention are common technologies in the existing field. Those skilled in the art should understand that the present invention is not limited to the above embodiments. The above embodiments and descriptions are only to illustrate the principles of the present invention. Without departing from the spirit and scope of the present invention, the present invention may have various changes and improvements, which fall within the scope of the present invention to be protected. The scope of protection claimed by the present invention is defined by the attached claims and their equivalents.

Claims

1. A new device for detecting the performance of an EEG acquisition system, characterized in that It includes a head mold body, an open hole electrode fixture, an electrode body, a weak signal generating module, a test distribution module and a signal distribution control unit. The detection hole arranged on the top of the head mold body is connected to the electrode body through the open hole electrode fixture. The other end of the electrode body is connected to the electrode collection board. The electrode collection board is installed on the head mold shape-keeping bracket inside the head mold body. The weak signal generating module, the test distribution module and the signal distribution control unit are installed on the head mold shape-keeping bracket inside the head mold body. The electrode collection board is connected to the test distribution module, and the test distribution module is connected to the weak signal generating module. The signal distribution control unit is respectively connected to the electrode collection board, the test distribution module and the weak signal generating module. The lower end of the head mold body is provided with a control limit interface and an isolation power supply interface.

2. A novel device for detecting performance of an electroencephalogram acquisition system according to claim 1, characterized in that The open-hole electrode clamp consists of a clamp body, a clamp guide rod, a spring, an electrode top cap and a clamping nut. One end of the clamp guide rod is threaded into a threaded groove provided on the clamp body, and the other end of the clamp guide rod is connected to the spring, the electrode top cap and the clamping nut in sequence.

3. A novel device for detecting performance of an electroencephalogram acquisition system according to claim 1, characterized in that The head mold body is a hollow structure, and a shielding coating is arranged on the inner wall of the head mold body.

4. A novel device for detecting performance of an electroencephalogram acquisition system according to claim 1, characterized in that The test distribution module comprises a common mode rejection test distribution board and a general performance test distribution board, and the electrode collection board is connected to the common mode rejection test distribution board and the general performance test distribution board respectively.

5. The device for detecting the performance of a novel electroencephalogram acquisition system according to claim 1 is characterized in that The signal distribution centralized control unit is internally provided with a power supply and a signal isolation system. The signal distribution centralized control unit is connected to the display and control terminal via a control line, and the signal distribution centralized control unit is connected to an isolated power supply via a power line.

6. A method for detecting the performance of a novel electroencephalogram acquisition system according to any one of claims 1 to 5, wherein the specific steps are as follows: Step 1. First determine the electrode coordinates on the top of the head mold body, and perform centering drilling at the determined coordinate points, and then install the hole electrode fixture and the hole electrode to be tested on the head mold body at the centering drilling position; Step 2. Spraying copper paint on the inner surface of the hollow head mold body at the non-electrode output position to form a shielding coating; Step 3. Establish the integration of EEG weak signal simulation module and signal distribution system.

7. A novel device for detecting performance of an electroencephalogram acquisition system according to claim 6, characterized in that: The method for determining the electrode coordinates on the head mold body in step 1 is as follows: On the basis of the 10 / 20 standard commonly used in the EEG acquisition industry, based on the average head model and the reference points on the medical scalp anatomy: nose (Nz), the indentation at the root of the bridge of the nose, the external occipital protuberance (Iz), the left preauricular point (LPA), the anterior root of the center of the tragus peak area and the right preauricular point (RPA), the coordinates are set to determine the number of electrodes based on the detection needs. According to the expanded 10 / 20 system diagram modified by the guidelines of the American Society for Clinical Neurophysiology (ACNS) and the head circumference size and the 20% and 10% standardized measurements based on the medical skull anatomical landmarks, the coordinates corresponding to the required electrode channels are determined on the hollow standard plastic head model body.

8. The device for detecting the performance of a novel electroencephalogram acquisition system according to claim 6 is characterized in that: The specific contents of establishing the integration of the EEG weak signal simulation module and the signal distribution system in step 3 are as follows: 1) The internal connection wires of the electrodes fixed in step 1 are aggregated to the electrode collection board for the test signal; 2) Allocate the limit numbers on the electrode assembly board to the common mode rejection test distribution board and the general performance test distribution board; 3) Connect the control signal interfaces of the common-mode rejection test distribution board and the general performance test distribution board to the signal distribution control unit. The signal distribution control unit contains a power supply and signal isolation system. The output end of the signal distribution control unit directly leads the control line and the power line from the control signal interface and the isolated power interface set on the head mold body, and uses an aviation connector with a complete shielding effect to lead the line out of the head mold body, and then connect the display and control terminal for programming control, as well as the dedicated isolated power supply for detection.

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