Household monitoring and alarming system for self-testing fetal movement and fetal heart

By designing a home-based fetal movement and heart rate monitoring alarm system, the problem of low efficiency in traditional fetal heart rate monitoring systems has been solved. This system enables convenient and efficient fetal health monitoring and timely reminders, improving the user experience for pregnant women and enhancing medical efficiency.

CN122004816APending Publication Date: 2026-05-12SHANGHAI BAOSHAN DISTRICT LUODIAN HOSPITAL
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Patent Information

Application Number
CN202410037435.7
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2024-01-10
Publication Date
2026-05-12

AI Technical Summary

Technical Problem

Traditional fetal heart rate monitoring systems require pregnant women to come to the hospital in person, which is time-consuming, cumbersome, and inefficient, making it difficult to easily and efficiently assess the fetal condition during the perinatal period.

Method used

A home-based monitoring and alarm system for fetal movement and heart rate is designed, including a power supply module, an information acquisition module, a wireless communication module, a data analysis module, a historical data tracking module, a user support module, a fetal heart rate extraction algorithm module, a fetal heart rate data preprocessing and fetal heart rate calculation module. It uses Bluetooth or Wi-Fi technology to transmit data, has a built-in intelligent algorithm to analyze fetal movement and heart rate data, and provides user support.

Benefits of technology

It enables real-time monitoring of fetal movement and fetal heart rate at home. The system is easy to operate, can promptly alert to abnormalities, and stores historical data for doctors to analyze, reducing pregnant women's anxiety and promoting healthy births.

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Abstract

The invention discloses a household monitoring and alarming system for self-testing fetal movement and fetal heart. According to the system, fetal movement and fetal heart rate can be monitored in real time, and it is ensured that a mother can know the condition of a fetus at any time. The system adopts a Bluetooth or Wi-Fi technology to wirelessly transmit data to a smart phone or other equipment, so that a mother can conveniently check and store the data. An intelligent algorithm is built in the system to analyze fetal movement and fetal heart data, and if abnormity is detected, the system needs to remind a pregnant woman in time and suggest to see a doctor. The system can store historical monitoring data, a doctor can conveniently carry out long-term trend analysis, a user support module in the system provides online or telephone customer support and use tutorial and health education information, pregnant women are helped to better understand and use the device, and therefore the convenience and rapidness of the whole system during use are improved, and the system is suitable for popularization and application. Therefore, anxiety of the pregnant woman can be reduced, the pregnant woman can see a doctor in time when problems are found, and prenatal and postnatal care can be promoted.
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Description

Technical Field

[0001] This invention belongs to the field of fetal movement and fetal heart rate monitoring technology, specifically a home-based monitoring and alarm system for monitoring fetal movement and fetal heart rate. Background Technology

[0002] In recent years, with changes in people's lifestyles and the relaxation of policies, the number of pregnant women has gradually increased, and the proportion of high-risk pregnancies cannot be ignored. Fetal safety is an important component of perinatal care, and fetal heart rate monitoring is currently the main monitoring method for assessing fetal well-being. Fetal heart rate monitoring is commonly used, simple, easy to perform, and non-invasive in obstetric clinical work. It can detect fetal heart rate abnormalities early, allowing for effective delivery methods and emergency measures before irreversible damage to the fetus, resulting in the timely delivery of the best possible newborn. Prenatal fetal heart rate monitoring for pregnant women can more accurately assess the intrauterine condition of the fetus and plays an important role in preventing neonatal asphyxia and fetal distress.

[0003] However, traditional fetal heart rate monitoring systems require pregnant women to come to the hospital in person, which is time-consuming, cumbersome, and inefficient, making it difficult to conduct simple and efficient perinatal fetal status assessment. Summary of the Invention

[0004] The purpose of this invention is to provide a home-based monitoring and alarm system for fetal movement and heart rate to address the aforementioned problems.

[0005] The technical solution adopted in this invention is as follows: A home-based monitoring and alarm system for fetal movement and heart rate, comprising a power supply module, an information acquisition module, a wireless communication module, a data analysis module, a historical data tracking module, a user support module, a fetal heart rate extraction algorithm module, and a fetal heart rate preprocessing and calculation module. The output terminal of the power supply module is connected to the input terminal of the information acquisition module, the output terminal of the information acquisition module is connected to the input terminal of the wireless communication module, the output terminal of the wireless communication module is connected to the input terminal of the data analysis module, the output terminal of the data analysis module is connected to the input terminal of the historical data tracking module, and the output terminal of the historical data tracking module is connected to the input terminal of the user support module.

[0006] In a preferred embodiment, the data analysis module internally includes a fetal electrocardiogram (ECG) extraction algorithm module, a fetal ECG data preprocessing module, and a fetal heart rate calculation module. The overall output terminals of the fetal ECG extraction algorithm module, fetal ECG data preprocessing module, and fetal heart rate calculation module are connected to the input terminal of the data analysis module.

[0007] In a preferred embodiment, the information acquisition module includes: a preamplifier circuit composed of an instrumentation amplifier, used to increase the voltage level of the original signal; a first-order active high-pass filter, consisting of an MCP6271 operational amplifier and an RC filter configured with Sallen-Key, which can eliminate DC offset generated between electrodes; a fifth-order active Bessel low-pass filter, consisting of a first-order low-pass filter and two second-order Sallen-Key filters, used to remove the influence of high-frequency noise; and a dual-T active notch filter, consisting of two "T"-shaped RC filters combined with an MCP6271 operational amplifier, used to reduce interference from the 50Hz power frequency and its harmonics. A right leg drive circuit is added at the front end of the acquisition circuit to eliminate common-mode signal interference generated by the mother. Furthermore, a bio-ECG integrated chip circuit is added to obtain higher quality fetal heart rate signals.

[0008] In a preferred embodiment, the wireless communication module uses a BLE4.0 Bluetooth module for communication with devices such as desktop computers and smartphones, promptly transmitting collected fetal data to a host computer for fetal health analysis. It also allows modification of matching parameters such as role and serial port baud rate, device name, and password, making it easy to use. The BLE4.0 module is a unique transparent low-power Bluetooth module for embedded systems. Based on TI's CC2540, the module implements AT command control or a transparent serial TTL interface, enabling the device to communicate with any BLE-enabled device with minimal power consumption. Furthermore, it can also function as a USB-to-TTL converter, allowing the system to have a USB port without additional chips.

[0009] In a preferred embodiment, the data analysis module internally includes a processor module, which uses an MSP430F5529 as the main control unit. The MSP430F5529 microcontroller unit is designed for practical applications, integrating multiple analog circuits, digital circuits, and a microprocessor onto a single chip to provide a monolithic solution. The design of the control circuit for the fetal heart rate and movement monitoring system in a home environment mainly includes: configuring the system clock, subsystem clock, and auxiliary clock for the main control unit, maintaining a balance in processing speed at different high and low frequencies; controlling the ECG sampling rate and system clock cycle using a timer; signal sampling and quantization are performed by an internal 12-bit ADC, followed by digital filtering, waveform display, and data transmission.

[0010] In a preferred embodiment, the fetal ECG extraction algorithm module uses a Kalman filter for fetal ECG extraction. The Kalman filter belongs to the category of adaptive filters and is a very effective method for eliminating maternal ECG. It only requires a maternal ECG as a reference, and then it can filter out maternal ECG and increase the amplitude of FECG. From a mathematical perspective, the acquired mixed ECG signal actually consists of three parts: maternal ECG, noise, and FECG: ECG = FECG + MECG + NOISE. The NOISE component can be filtered out using software filtering, mainly including 50Hz power frequency, electromyography signals, baseline fluctuations, and maternal movement. After removing the NOISE component, the maternal ECG is further eliminated using a filter.

[0011] In a preferred embodiment, the fetal electrocardiogram (FECG) data preprocessing first uses a smoothing filter in digital filtering to construct a 50Hz notch filter to smooth the extracted signal, removing power frequency interference and baseline drift from the abdominal electrocardiogram. The high-quality electrocardiogram obtained after the previous preprocessing is then extracted using adaptive filtering technology. The heart rate of the extracted FECG can then be evaluated by calculating the main peak and dividing the counted heartbeats by the signal duration.

[0012] In a preferred embodiment, after determining an initial threshold, the fetal heart rate calculation module then detects the R wave. During subsequent sampling intervals, sampling points are detected. If X(n) is greater than THD, the R wave peak is determined by the maximum value X(max) within X(n). Earlier R wave peaks are detected first, and then new thresholds are continuously derived by combining the existing data. The formula for determining the new threshold is THDnew = 0.8 × THD + 1.5 × X(max) × 0.2. The fetal heart rate calculation module uses a first-order differential thresholding method for detecting fetal movement signals. To identify correct fetal movement data, the signal must first undergo differential calculation within a set time window. Based on this, the peak values ​​in the signal can be located, and then the extreme values ​​are determined from the peak values ​​and compared with the set threshold. To improve the accuracy of the detection, the fetal movement threshold and the length of the time window should be set according to the relative strength of the mother's perception of fetal movement and any interference.

[0013] In a preferred embodiment, the historical data tracking module can store historical monitoring data, facilitating long-term trend analysis by doctors.

[0014] In a preferred embodiment, the user support module provides online or telephone customer support, as well as user tutorials and health education information to help pregnant women better understand and use the device.

[0015] In summary, due to the adoption of the above technical solution, the beneficial effects of the present invention are:

[0016] In this invention, the system can monitor fetal movement and fetal heart rate in real time, ensuring that the mother can understand the fetus's condition at any time. The system uses Bluetooth or Wi-Fi technology to wirelessly transmit data to smartphones or other devices, allowing the mother to easily view and store the data. The system has a built-in intelligent algorithm to analyze fetal movement and heart rate data; if an abnormality is detected, the system should promptly alert the pregnant woman and recommend medical attention. The system can store historical monitoring data, facilitating long-term trend analysis by doctors. The system is easy for pregnant women to assemble and operate themselves, ensuring usability even without professional knowledge. The system features a simple and intuitive user interface, making it easy for pregnant women to understand and operate, including multilingual support to accommodate users in different regions. The system's internal user support module provides online or telephone customer support, as well as user tutorials and health education information, helping pregnant women better understand and use the device. This improves the overall convenience and speed of system use, making it a helpful tool for pregnant women. It can not only reduce their anxiety but also enable them to seek medical attention promptly when problems are detected, promoting healthy births. Attached Figure Description

[0017] Figure 1 This is an overall system block diagram of the present invention;

[0018] Figure 2 This is a system block diagram of the data analysis module in this invention.

[0019] The diagram is labeled as follows: 1-Power supply module, 2-Information acquisition module, 3-Wireless communication module, 4-Data analysis module, 5-Historical data tracking module, 6-User support module, 7-Fetal heart rate extraction algorithm module, 8-Fetal heart rate data preprocessing, 9-Fetal heart rate calculation module. Detailed Implementation

[0020] To make the objectives, technical solutions, and advantages of this invention clearer, the invention will be further described in detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely illustrative and not intended to limit the invention.

[0021] Reference Figure 1-2 ,

[0022] A home-based monitoring and alarm system for fetal movement and heart rate monitoring includes a power supply module 1, an information acquisition module 2, a wireless communication module 3, a data analysis module 4, a historical data tracking module 5, a user support module 6, a fetal heart rate extraction algorithm module 7, a fetal heart rate data preprocessing module 8, and a fetal heart rate calculation module 9. The output of the power supply module 1 is connected to the input of the information acquisition module 2, the output of the information acquisition module 2 is connected to the input of the wireless communication module 3, the output of the wireless communication module 3 is connected to the input of the data analysis module 4, the output of the data analysis module 4 is connected to the input of the historical data tracking module 5, and the output of the historical data tracking module 5 is connected to the input of the user support module 6.

[0023] The data analysis module 4 is internally equipped with a fetal heart rate extraction algorithm module 7, a fetal heart rate data preprocessing module 8, and a fetal heart rate calculation module 9. The overall output of the fetal heart rate extraction algorithm module 7, the fetal heart rate data preprocessing module 8, and the fetal heart rate calculation module 9 is connected to the input of the data analysis module 4.

[0024] Information acquisition module 2 includes: a preamplifier circuit consisting of an Instrumentation Amplifier (IA) to increase the voltage level of the original signal; a first-order active high-pass filter (HPF) composed of an MCP6271 operational amplifier and a Sallen-Key configured RC filter, which eliminates DC offset between electrodes; a fifth-order active Bessel low-pass filter (LPF) composed of a first-order low-pass filter and two second-order Sallen-Key filters, designed to remove high-frequency noise; and a dual-T active notch filter (ANF) composed of two T-shaped RC filters and an MCP6271 operational amplifier, designed to reduce interference from the 50Hz power frequency and its harmonics. A right leg drive (RLD) circuit is added to the front end of the acquisition circuit to eliminate common-mode signal interference generated by the mother. Furthermore, a bio-ECG integrated chip circuit is added to obtain higher quality fetal heart rate signals.

[0025] Wireless communication module 3 uses a BLE 4.0 Bluetooth module for communication with devices such as desktop computers and smartphones, promptly transmitting collected fetal data to the host computer for fetal health analysis. It also allows modification of master / slave modes, serial port baud rate, device name, password, and other matching parameters, making it easy to use. The BLE 4.0 module is a unique transparent low-power Bluetooth module for embedded systems. Based on TI's CC2540, the module implements AT command control or a transparent serial TTL interface, enabling devices to communicate with any BLE-enabled device with minimal power consumption. Furthermore, it can also function as a USB-to-TTL converter, allowing the system to have a USB port without the need for an additional chip.

[0026] The data analysis module 4 internally houses a processor module, which uses the MSP430F5529 as the main control unit. The MSP430F5529 microcontroller unit (MCU) is designed for practical applications, integrating multiple analog circuits, digital circuits, and a microprocessor onto a single chip to provide a monolithic solution. The design of the control circuit for the fetal heart rate and movement monitoring system in a home environment mainly includes: configuring the system clock MCLK, subsystem clock SCLK, and the main control unit's auxiliary clock ACLK, maintaining a balance in processing speed at different high and low frequencies; controlling the ECG sampling rate and system clock cycle using a timer; signal sampling and quantization are performed by an internal 12-bit ADC, followed by digital filtering, waveform display, and data transmission.

[0027] The fetal ECG extraction algorithm module 7 uses a Kalman filter for fetal ECG extraction. The Kalman filter belongs to the category of adaptive filters and is a very effective method for eliminating maternal ECG signals. It only requires a maternal ECG signal as a reference, and then it can filter out maternal ECG signals and increase the amplitude of the FECG. From a mathematical perspective, the acquired mixed ECG signal actually consists of three parts: maternal ECG (MECG), noise (NOISE), and FECG: ECG = FECG + MECG + NOISE. The NOISE component can be filtered out using software filtering, mainly consisting of 50Hz power frequency, electromyography (EMG) signals, baseline fluctuations, and maternal movement. After removing the NOISE component, the maternal ECG signal is further eliminated using a filter.

[0028] Fetal ECG data preprocessing 8 First, a 50Hz notch filter is constructed using a smoothing filter in digital filtering to smooth the extracted signal, removing power frequency interference and baseline drift from the abdominal ECG. The high-quality ECG obtained after the previous preprocessing is then extracted using adaptive filtering technology. The heart rate of the extracted FECG can then be evaluated by calculating the main peak and dividing the counted heartbeats by the signal duration.

[0029] After determining the initial threshold, the fetal heart rate calculation module 9 then detects the R wave. It detects sampling points within the subsequent sampling interval. If X(n) is greater than THD, the R wave peak is determined by the maximum value X(max) within X(n). It first detects the earlier appearing R wave peaks and then continuously provides new thresholds based on the existing data. The formula for determining the new threshold is THDnew = 0.8 × THD + 1.5 × X(max) × 0.2. The fetal heart rate calculation module 9 uses a first-order differential thresholding method for detecting fetal movement signals. To identify correct fetal movement data, the signal must first undergo differential calculation within a set time window. This allows the location of various peaks in the signal, and then the extreme values ​​are determined from the peaks and compared with the set thresholds. To improve the accuracy of the detection, the fetal movement threshold and the length of the time window are set according to the relative strength of the mother's perception of fetal movement and the interference.

[0030] Historical data tracking module 5 can store historical monitoring data, facilitating long-term trend analysis by doctors.

[0031] User support module 6 provides online or telephone customer support, as well as user tutorials and health education information to help pregnant women better understand and use the device.

[0032] In this invention, the system should be able to monitor fetal movement and fetal heart rate in real time, ensuring that the mother can understand the fetus's condition at any time. The system uses Bluetooth or Wi-Fi technology to wirelessly transmit data to smartphones or other devices, allowing the mother to easily view and store the data. The system has a built-in intelligent algorithm to analyze fetal movement and heart rate data; if an abnormality is detected, the system should promptly alert the pregnant woman and recommend medical attention. The system can store historical monitoring data, facilitating long-term trend analysis by doctors. The system is easy for pregnant women to assemble and operate themselves, ensuring usability even without professional knowledge. The system features a simple and intuitive user interface, making it easy for pregnant women to understand and operate, including multilingual support to accommodate users in different regions. The system's internal user support module 6 provides online or telephone customer support, as well as user tutorials and health education information, helping pregnant women better understand and use the device, thereby improving the overall convenience and speed of system use. It will be a helpful assistant for pregnant women, not only reducing their anxiety but also enabling them to seek medical attention promptly when problems are detected, promoting healthy births.

[0033] It should be noted that, in this document, relational terms such as "first" and "second" are used only to distinguish one entity or operation from another, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Furthermore, the terms "comprising," "including," or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such a process, method, article, or apparatus. Without further limitations, an element defined by the phrase "comprising one..." does not exclude the presence of other identical elements in the process, method, article, or apparatus that includes said element.

[0034] The above embodiments are only used to illustrate the technical solutions of the present invention, and are not intended to limit it. Although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some of the technical features. Such modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the spirit and scope of the technical solutions of the embodiments of the present invention.

Claims

1. A home-based monitoring and alarm system for fetal movement and heart rate, comprising a power supply module (1), an information acquisition module (2), a wireless communication module (3), a data analysis module (4), a historical data tracking module (5), a user support module (6), a fetal heart rate extraction algorithm module (7), a fetal heart rate data preprocessing module (8), and a fetal heart rate calculation module (9), characterized in that: The output terminal of the power supply module (1) is connected to the input terminal of the information acquisition module (2), the output terminal of the information acquisition module (2) is connected to the input terminal of the wireless communication module (3), the output terminal of the wireless communication module (3) is connected to the input terminal of the data analysis module (4), the output terminal of the data analysis module (4) is connected to the input terminal of the historical data tracking module (5), and the output terminal of the historical data tracking module (5) is connected to the input terminal of the user support module (6).

2. The home-based monitoring and alarm system for fetal movement and heart rate as described in claim 1, characterized in that: The data analysis module (4) is internally equipped with a fetal heart rate extraction algorithm module (7), a fetal heart rate data preprocessing module (8), and a fetal heart rate calculation module (9). The overall output terminals of the fetal heart rate extraction algorithm module (7), fetal heart rate data preprocessing module (8), and fetal heart rate calculation module (9) are connected to the input terminals of the data analysis module (4).

3. The home-based monitoring and alarm system for fetal movement and heart rate as described in claim 1, characterized in that: The information acquisition module (2) includes: a preamplifier circuit composed of an instrumentation amplifier, which is used to increase the voltage level of the original signal; a first-order active high-pass filter (HPF), which consists of an MCP6271 operational amplifier and an RC filter with a Sallen-Key configuration, which can eliminate the DC offset generated between the electrodes; a fifth-order active Bessel low-pass filter (LPF), which consists of a first-order low-pass filter and two second-order Sallen-Key filters, which is used to remove the influence of high-frequency noise; a dual-T active notch filter, which is composed of two "T"-shaped RC filters and an MCP6271 operational amplifier, which is used to reduce the interference of 50Hz power frequency and its harmonics; a right leg drive circuit is added at the front end of the acquisition circuit to eliminate common-mode signal interference generated by the mother; in addition, a bio-electrocardiogram integrated chip circuit is added to obtain a higher quality fetal heart rate signal.

4. The home-based monitoring and alarm system for fetal movement and heart rate as described in claim 1, characterized in that: The wireless communication module (3) uses a BLE4.0 Bluetooth module to communicate with devices such as desktop computers and smartphones, and transmits the collected fetal data to the host computer in a timely manner to facilitate the analysis of the fetal health status. It can also modify the role (master and slave mode) and matching parameters such as serial port baud rate, device name, and password, making it easy to use. The BLE4.0 module is a unique transparent low-power Bluetooth module for embedded systems. The module based on TI's CC2540 implements AT command control or a transparent serial TTL interface, enabling the device to communicate with any BLE-supporting device with minimal power consumption. In addition, it can also serve as a USB to TTL conversion module, allowing the system to have a USB port without additional chips.

5. The home-based monitoring and alarm system for fetal movement and heart rate as described in claim 1, characterized in that: The data analysis module (4) is equipped with a processor module, which uses MSP430F5529 as the main control unit. The MSP430F5529 microcontroller unit is mainly designed for practical application needs. It integrates multiple analog circuits, digital circuits and microprocessors on one chip to provide a single-chip solution. The design of the control circuit for the fetal heart rate and fetal movement monitoring system in a home environment mainly includes: configuring the system clock (MCLK), subsystem clock (SCLK) and auxiliary clock (ACLK) of the main control unit, and maintaining a balance of processing speed at different high and low frequencies; controlling the sampling rate of ECG and the system clock cycle by a timer; the sampling and quantization of the signal are completed by the internal 12-bit ADC, and then digital filtering, waveform display and data transmission can be performed.

6. The home-based monitoring and alarm system for fetal movement and heart rate as described in claim 1, characterized in that: The fetal ECG extraction algorithm module (7) uses a Kalman filter to extract fetal ECG. The Kalman filter belongs to the category of adaptive filters and is also a very effective way to eliminate maternal ECG. It only needs to provide a maternal ECG as a reference, and then it can filter out the maternal ECG and increase the amplitude of FECG. From a mathematical point of view, the acquired mixed ECG signal is actually composed of three parts: maternal ECG (MECG), noise (NOISE) and FECG: ECG = FECG + MECG + NOISE. The NOISE part can be filtered out by software filtering. It mainly includes 50Hz power frequency, electromyography signal, baseline fluctuation and maternal movement. After the NOISE part is removed, the maternal ECG is eliminated by filter.

7. The home-based monitoring and alarm system for fetal movement and heart rate as described in claim 1, characterized in that: The preprocessing of fetal electrocardiogram data (8) first uses a smoothing filter in digital filtering to construct a 50Hz notch filter to smooth the extracted signal, remove power frequency interference and baseline drift of the abdominal electrocardiogram, and then uses adaptive filtering technology to extract the high-quality electrocardiogram obtained by the previous preprocessing. Then the heart rate of the extracted FECG can be evaluated by calculating the main peak and dividing the counted heartbeats by the signal duration.

8. The home-based monitoring and alarm system for fetal movement and heart rate as described in claim 1, characterized in that: After the fetal heart rate calculation module (9) determines the initial threshold, it then performs R wave detection; in the subsequent sampling interval, it detects the sampling points. If X(n) is greater than THD, the R wave peak is determined by the maximum value X(max) within X(n); it first detects the earlier R wave peak, and then continuously gives a new threshold based on the data that has appeared; the formula for determining the new threshold is THDnew=0.8×THD+1.5×X(max)×0.

2. The fetal heart rate calculation module (9) adopts the first-order differential threshold method for detecting fetal movement signals; to identify the correct fetal movement data, the signal must first complete the differential operation within the set time window, based on which the peak values ​​in the signal can be located, and then the extreme values ​​are determined by the peak values ​​and compared with the set threshold; in order to improve the accuracy of the test, the fetal movement threshold and the length of the time window should be set according to the relationship between the mother's feeling of fetal movement and the interference.

9. A home-based monitoring and alarm system for fetal movement and heart rate as described in claim 1, characterized in that: The historical data tracking module (5) can store historical monitoring data, which is convenient for doctors to conduct long-term trend analysis.

10. A home-based monitoring and alarm system for fetal movement and heart rate as described in claim 1, characterized in that: The user support module (6) provides online or telephone customer support, as well as user tutorials and health education information to help pregnant women better understand and use the device.