Radio frequency field interference evaluation method for flexible wearable ultrasonic electrocardiogram monitoring equipment

Abstract

The invention relates to the technical field of medical instrument inspection, in particular to a radio frequency field interference evaluation method for flexible wearable ultrasonic electrocardiogram monitoring equipment. The invention provides a radio frequency field interference evaluation method for flexible wearable ultrasonic electrocardiogram monitoring equipment, which comprises the following steps of: simulating a typical radio frequency field environment when the flexible wearable ultrasonic electrocardiogram monitoring equipment works, and constructing a standardized test model and system; and the influence of radio frequency electromagnetic interference on the monitoring accuracy and stability of key performance indexes of the equipment is quantitatively evaluated. The invention provides a standardized and repeatable test flow and evaluation index, so that a key basis can be provided for safety and effectiveness evaluation of equipment.

Description

Technical Field

[0001] This invention relates to the field of medical device testing technology, specifically a method for evaluating radio frequency field interference in a flexible wearable ultrasound electrocardiogram monitoring device. Background Technology

[0002] With the continuous advancement of big data and wireless communication, flexible wearable ultrasound electrocardiogram (ECG) monitoring devices are increasingly widely used in the medical field due to their non-invasive, real-time monitoring, and lightweight characteristics. The development of wireless technology also means that these devices are exposed to complex electromagnetic environments during practical use, especially radio frequency (RF) electromagnetic fields from Wi-Fi, Bluetooth, and mobile communication base stations (4G / 5G). Currently, the evaluation of RF transmitter interference in medical devices is mainly at the pre-evaluation stage, lacking quantitative evaluation methods for RF field interference in such flexible, multimodal, wearable biomedical devices. Simultaneously, current medical devices with communication capabilities lack multi-dimensional evaluation methods for safety assessment. Therefore, designing a scientifically sound and reliable near-field interference evaluation method for RF transmitters in flexible wearable ultrasound ECG monitoring is a problem that needs to be solved. Summary of the Invention

[0003] The purpose of this invention is to address the shortcomings of the prior art by providing a standardized and repeatable testing process and evaluation index for evaluating radio frequency field interference in flexible wearable ultrasound electrocardiogram monitoring devices. This method is simple and quick to evaluate, conforms to the actual clinical use of flexible wearable ultrasound electrocardiogram monitoring, and has high reproducibility of evaluation results.

[0004] To achieve these objectives and other advantages of the present invention, a method for evaluating radio frequency field interference in a flexible wearable ultrasound electrocardiogram monitoring device is provided, comprising the following steps:

[0005] S1. Set up a test platform, construct an RF transmission and feedback system as an interference source in an anechoic chamber, and at the same time construct a uniform domain in which the electromagnetic field is uniform.

[0006] S2. Adjust the radio frequency transmission and feedback system so that its radio frequency signal covers the entire uniform domain and the electromagnetic field strength in the uniform domain reaches the strength required for testing, so as to construct a pseudo-radio frequency field.

[0007] S3. Attach the flexible wearable ultrasound ECG monitoring device to the human body phantom to meet its flexible and wearable characteristics, place it in the radio frequency field constructed in S2, and then turn on the flexible wearable ultrasound ECG monitoring device to put it into normal working state.

[0008] S4. The key performance indicators of the flexible wearable ultrasound ECG monitoring device are collected synchronously through the measuring device. The key performance indicators include at least ultrasound image data and ECG signals, with the distance between the measuring device and the interference source at this time as the initial spacing.

[0009] S5. The field strength of the radio frequency field is increased in a stepwise manner. If the key performance indicators of the flexible wearable ultrasound ECG monitoring device decrease during this period, the current field strength is used as the critical field strength. At the same time, the distance between the measuring device and the interference source is increased. Then, the field strength of the radio frequency field is increased until the field strength of the radio frequency field reaches the preset field strength. The real-time distance between the measuring device and the interference source at this time is obtained as the first distance.

[0010] S6. Restore the distance between the measuring device and the interference source to the initial spacing in S4, and adjust the field strength of the radio frequency field to the critical field strength obtained in S5. Increase the distance between the measuring device and the interference source in a stepwise manner. When the communication index of the measuring device is lower than the preset index reduction threshold, obtain the real-time distance between the measuring device and the interference source at this time as the second distance.

[0011] S7. The larger of the first distance obtained in S5 and the second distance obtained in S6 is taken as the safe distance for EMC evaluation.

[0012] Furthermore, in the method for evaluating radio frequency field interference of a flexible wearable ultrasound electrocardiogram monitoring device, the radio frequency transmission and feedback system constructed in S1 includes a spectrum analyzer, a power amplifier, a signal source, an antenna, and a field strength probe. In S2, the field strength of the radio frequency field is adjusted by configuring different antennas and controlling the signal source to output radio frequency signals with specific frequencies and modulation methods. In S4, the distance between the measuring device and the antenna is used as the initial spacing. In S5, the distance between the measuring device and the interference source is increased by moving the antenna.

[0013] Furthermore, in the method for evaluating radio frequency field interference of a flexible wearable ultrasound electrocardiogram monitoring device, in step S3, the field strength probe is fed back to the spectrum analyzer to record the power at various points in the uniform domain, and the electromagnetic field strength in the uniform domain is adjusted and compensated by the power amplifier to achieve the required strength for testing.

[0014] Furthermore, in the method for evaluating radio frequency field interference of a flexible wearable ultrasound electrocardiogram monitoring device, the signal source is any one of RFID 54V / m, Bluetooth 28V / m, GSM 28V / m, and 5G cellular signal 20V / m.

[0015] Furthermore, in the method for evaluating radio frequency field interference of a flexible wearable ultrasound electrocardiogram monitoring device, the window size of the uniform domain in S2 is... .

[0016] Furthermore, in the method for evaluating radio frequency field interference of a flexible wearable ultrasound electrocardiogram monitoring device, the distance between the measuring device and the interference source in S4 is initially 25cm.

[0017] Furthermore, in the method for evaluating radio frequency field interference of a flexible wearable ultrasound electrocardiogram monitoring device, in step S5, the real-time distance between the measuring device and the interference source is obtained through a remote laser ranging system.

[0018] Furthermore, in the method for evaluating radio frequency field interference of a flexible wearable ultrasound ECG monitoring device, in step S5, after each increase in the distance between the measuring device and the interference source, the flexible wearable ultrasound ECG monitoring device is rotated by a three-dimensional turntable to obtain the imaging quality of the flexible wearable ultrasound ECG monitoring device at different angles at the same distance.

[0019] Furthermore, in the method for evaluating radio frequency field interference of a flexible wearable ultrasound electrocardiogram monitoring device, the measuring device is a mobile phone, which communicates with the flexible wearable ultrasound electrocardiogram monitoring device via Wi-Fi or Bluetooth.

[0020] Furthermore, the method for evaluating radio frequency field interference in a flexible wearable ultrasound electrocardiogram monitoring device further includes:

[0021] Repeat steps S5-S7 multiple times, and use the average of the safe distances obtained from the multiple EMC evaluations as the final safe distance for the EMC evaluation.

[0022] The beneficial effects of this invention are:

[0023] 1. The radio frequency field interference evaluation method for flexible wearable ultrasound ECG monitoring devices of the present invention takes into account the standardization of complex signal sources, fully simulates the pulse characteristics and phase modulation of complex signal sources, improves the comprehensiveness and objectivity of the evaluation results, and provides a strong guarantee for the stable application of flexible wearable ultrasound ECG monitoring devices in complex electromagnetic environments.

[0024] 2. The radio frequency field interference evaluation method for flexible wearable ultrasound electrocardiogram monitoring devices of the present invention, through multi-angle and multi-distance testing, not only evaluates the stability of the device, but also explores the minimum distance at which the device is subject to interference; this further enhances the scientificity and practicality of the evaluation method, and provides a more reliable basis for clinical application.

[0025] 3. The radio frequency field interference evaluation method for flexible wearable ultrasound electrocardiogram monitoring devices of the present invention effectively reduces the risks for enterprises in product development and application, and enhances market competitiveness.

[0026] Other advantages, objectives and features of the present invention will become apparent in part from the following description, and in part from those skilled in the art through study and practice of the invention. Attached Figure Description

[0027] Figure 1 This is a flowchart of a method for evaluating radio frequency field interference in a flexible wearable ultrasound electrocardiogram monitoring device according to an embodiment of the present invention;

[0028] Figure 2 This is a flowchart of S5 in one embodiment of the present invention;

[0029] Figure 3 This is a flowchart of S6 in one embodiment of the present invention. Detailed Implementation

[0030] The present invention will now be described in detail and completely with reference to the accompanying drawings. Those skilled in the art will be able to implement the present invention based on these descriptions. Before describing the present invention with reference to the accompanying drawings, it should be particularly noted that the technical solutions and features provided in various parts of the present invention, including the following description, can be combined with each other without conflict.

[0031] Furthermore, the embodiments of the present invention described below are generally only some, not all, of the embodiments of the present invention. Therefore, all other embodiments obtained by those skilled in the art based on the embodiments of the present invention without inventive effort should fall within the scope of protection of the present invention.

[0032] like Figure 1-2 As shown, an embodiment of the present invention provides a method for evaluating radio frequency field interference of a flexible wearable ultrasound electrocardiogram monitoring device, comprising the following steps:

[0033] S1. Build a test platform. Construct an RF transmission and feedback system as an interference source in an anechoic chamber. Simultaneously, construct a uniform domain with a uniform electromagnetic field. The window size of the uniform domain is [size missing]. The radio frequency transmission and feedback system includes a spectrum analyzer, a power amplifier, a signal source, an antenna, and a field strength probe; the signal source is any one of RFID 54V / m, Bluetooth 28V / m, GSM 28V / m, and 5G cellular signal 20V / m.

[0034] S2. By configuring different antennas and controlling the signal source to output radio frequency signals of specific frequencies and modulation methods, the field strength of the radio frequency field is adjusted so that the radio frequency signal of the radio frequency transmission and feedback system covers the entire uniform domain, and the electromagnetic field strength in the uniform domain reaches the strength required for testing, so as to construct a pseudo-radio frequency field.

[0035] S3. Attach the flexible wearable ultrasound ECG monitoring device to the human body phantom to meet its flexible and wearable characteristics, place it in the radio frequency field constructed in S2, and then turn on the flexible wearable ultrasound ECG monitoring device to put it into normal working state.

[0036] S4. Key performance indicators of the flexible wearable ultrasound ECG monitoring device are collected synchronously through a measuring device. The key performance indicators include at least ultrasound image data (such as B-mode images) and ECG signals, with the distance between the measuring device and the antenna at this time as the initial spacing. The measuring device is a mobile phone, which communicates with the flexible wearable ultrasound ECG monitoring device via Wi-Fi or Bluetooth.

[0037] S5, such as Figure 2 As shown, the field strength of the radio frequency field is increased in a stepwise manner. If the key performance indicators of the flexible wearable ultrasound ECG monitoring device decrease during this period, the current field strength is used as the critical field strength. At the same time, the distance between the measuring device and the interference source is increased, and then the field strength of the radio frequency field is increased until the field strength of the radio frequency field reaches the preset field strength. The real-time distance between the measuring device and the interference source at this time is obtained as the first distance.

[0038] S6. Restore the distance between the measuring device and the interference source to the initial spacing in S4, and adjust the field strength of the radio frequency field to the critical field strength obtained in S5. Increase the distance between the measuring device and the interference source in a stepwise manner. When the communication index of the measuring device is lower than the preset index reduction threshold, obtain the real-time distance between the measuring device and the interference source at this time as the second distance.

[0039] S7. The larger of the first distance obtained in S5 and the second distance obtained in S6 is taken as the safe distance for EMC evaluation.

[0040] Key performance indicators for acquiring ultrasound and electrocardiogram signals (such as image artifacts, electrocardiogram signal amplitude, etc.) and key performance indicators for acquisition communication (delay, bit error rate, etc.).

[0041] Each time the distance between the measuring device and the interference source is increased, the flexible wearable ultrasound ECG monitoring device rotates via a three-dimensional turntable, acquiring the imaging quality of the flexible wearable ultrasound ECG monitoring device at different angles at the same distance.

[0042] Repeat steps S5-S7 multiple times, and use the average of the safe distances obtained from the multiple EMC evaluations as the final safe distance for the EMC evaluation.

[0043] In this embodiment, the interference source increases the radio frequency field strength in 1V / m increments, and the interference source's dwell time on the flexible wearable ECG monitoring ultrasound device is 3 seconds each time it applies electromagnetic interference. Since wireless communication interference occurs in various directions, the flexible wearable ECG monitoring ultrasound device is placed on a three-dimensional turntable. The turntable drives the flexible wearable ECG monitoring ultrasound device to rotate in 45° increments. Through these steps, the performance of the flexible wearable ECG monitoring ultrasound device in complex electromagnetic environments is accurately evaluated, ensuring its safety and reliability in clinical use.

[0044] Viewing key performance indicators of the flexible wearable ECG monitoring ultrasound via mobile phone includes: placing the flexible wearable ECG monitoring ultrasound device in a radio frequency field environment; if no decrease in key performance indicators based on basic performance occurs during the interference process, the anti-interference performance of the device is determined to meet the requirements; the field strength can be increased in expected steps, and the distance can be tested at different angles until the key performance indicators decrease; the critical field strength and safe distance at this time are recorded as the critical value of the anti-interference performance of the flexible wearable ECG monitoring ultrasound device, so as to more accurately evaluate its reliability in practical applications.

[0045] The distance between the device and the interference source is accurately measured using a remote laser ranging system to ensure data accuracy. Multiple tests are repeated, and the average value is taken as the final result to improve the stability and reliability of the evaluation. Furthermore, as an extension, this invention also considers the impact of ambient temperature and humidity on the test results. Temperature and humidity sensors are used to monitor and record data in real time to ensure the consistency of test conditions, further improving the scientific rigor and practicality of the evaluation method.

[0046] According to the YY9706.102-2021 standard, the conformity assessment of flexible wearable ultrasound ECG monitoring devices is based on whether the product meets the conformity criteria established based on basic safety and basic performance. A multi-dimensional (performance indicators, communication indicators) evaluation system is constructed based on the critical interference field strength data obtained when the key performance indicators of the product's basic performance degrade, and the safe distance for EMC evaluation is obtained.

[0047] Although embodiments of the present invention have been disclosed above, they are not limited to the applications listed in the specification and embodiments. They can be applied to various fields suitable for the present invention. For those skilled in the art, other modifications can be easily made. Therefore, without departing from the general concept defined by the claims and their equivalents, the present invention is not limited to the specific details and embodiments shown and described herein.

Claims

1. A method for evaluating radio frequency field interference in a flexible wearable ultrasound electrocardiogram monitoring device, characterized in that, Includes the following steps: S1. Set up a test platform, construct an RF transmission and feedback system as an interference source in an anechoic chamber, and at the same time construct a uniform domain in which the electromagnetic field is uniform. S2. Adjust the radio frequency transmission and feedback system so that its radio frequency signal covers the entire uniform domain and the electromagnetic field strength in the uniform domain reaches the strength required for testing, so as to construct a pseudo-radio frequency field. S3. Attach the flexible wearable ultrasound ECG monitoring device to the human body phantom to meet its flexible and wearable characteristics, place it in the radio frequency field constructed in S2, and then turn on the flexible wearable ultrasound ECG monitoring device to put it into normal working state. S4. The key performance indicators of the flexible wearable ultrasound ECG monitoring device are collected synchronously through the measuring device. The key performance indicators include at least ultrasound image data and ECG signals, with the distance between the measuring device and the interference source at this time as the initial spacing. S5. The field strength of the radio frequency field is increased in a stepwise manner. If the key performance indicators of the flexible wearable ultrasound ECG monitoring device decrease during this period, the current field strength is used as the critical field strength. At the same time, the distance between the measuring device and the interference source is increased. Then, the field strength of the radio frequency field is increased until the field strength of the radio frequency field reaches the preset field strength. The real-time distance between the measuring device and the interference source at this time is obtained as the first distance. S6. Restore the distance between the measuring device and the interference source to the initial spacing in S4, and adjust the field strength of the radio frequency field to the critical field strength obtained in S5. Increase the distance between the measuring device and the interference source in a stepwise manner. When the communication index of the measuring device is lower than the preset index reduction threshold, obtain the real-time distance between the measuring device and the interference source at this time as the second distance. S7. The larger of the first distance obtained in S5 and the second distance obtained in S6 is taken as the safe distance for EMC evaluation.

2. The method for evaluating radio frequency field interference of a flexible wearable ultrasound electrocardiogram monitoring device as described in claim 1, characterized in that, The radio frequency transmission and feedback system constructed in S1 includes a spectrum analyzer, a power amplifier, a signal source, an antenna, and a field strength probe. In S2, the field strength of the radio frequency field is adjusted by configuring different antennas and controlling the signal source to output radio frequency signals with specific frequencies and modulation methods. In S4, the distance between the measuring device and the antenna is used as the initial spacing. In S5, the distance between the measuring device and the interference source is increased by moving the antenna.

3. The method for evaluating radio frequency field interference of a flexible wearable ultrasound electrocardiogram monitoring device as described in claim 2, characterized in that, In S3, the field strength probe feeds back to the spectrum analyzer, records the power at various points in the uniform domain, and adjusts the compensation through the power amplifier to make the electromagnetic field strength in the uniform domain reach the required strength for the test.

4. The method for evaluating radio frequency field interference of a flexible wearable ultrasound electrocardiogram monitoring device as described in claim 2, characterized in that, The signal source is any one of RFID 54V / m, Bluetooth 28V / m, GSM 28V / m, and 5G cellular signal 20V / m.

5. The method for evaluating radio frequency field interference of a flexible wearable ultrasound electrocardiogram monitoring device as described in claim 1, characterized in that, The window size of the uniform region in S2 is .

6. The method for evaluating radio frequency field interference of a flexible wearable ultrasound electrocardiogram monitoring device as described in claim 1, characterized in that, The initial distance between the measuring device and the interference source in S4 is 25cm.

7. The method for evaluating radio frequency field interference of a flexible wearable ultrasound electrocardiogram monitoring device as described in claim 1, characterized in that, The real-time distance between the measuring device and the interference source is obtained through a remote laser ranging system.

8. The method for evaluating radio frequency field interference of a flexible wearable ultrasound electrocardiogram monitoring device as described in claim 7, characterized in that, In S5, each time the distance between the measuring device and the interference source is increased, the flexible wearable ultrasound ECG monitoring device rotates via a three-dimensional turntable, acquiring the imaging quality of the flexible wearable ultrasound ECG monitoring device at different angles at the same distance.

9. The method for evaluating radio frequency field interference of a flexible wearable ultrasound electrocardiogram monitoring device as described in claim 1, characterized in that, The measuring device is a mobile phone, which communicates with the flexible wearable ultrasound electrocardiogram monitoring device via Wi-Fi or Bluetooth.

10. A method for evaluating radio frequency field interference in a flexible wearable ultrasound electrocardiogram monitoring device as described in any one of claims 1-9, characterized in that, Also includes: Repeat steps S5-S7 multiple times, and use the average of the safe distances obtained from the multiple EMC evaluations as the final safe distance for the EMC evaluation.

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