RU174590U1 - The monitor is multifunctional computerized - Google Patents

Abstract

The utility model relates to medical equipment, namely to biomedical measurements for diagnostic purposes in cardiorespiratory studies of the heart. The technical result consists in simplifying, cheapening, reducing energy consumption, mass and level of spurious emissions in a multifunctional computerized medical monitor using modern software and hardware processing, display and computerized analysis of medical information. This result is achieved due to the fact that in the well-known multifunctional computerized monitor, powered from the network and from the battery, which contains a motherboard with ports for removable memory cards and plugging into the local computer network, a SOM processor module, a multi-channel ECGP module of human biosignal meters, a keyboard , speaker and LCD display, the power input of which is connected to the corresponding power output of the motherboard display, the motherboard is made with an additional interface USB HUB with the ability to connect modules for additional human biosignal meters and with the possibility of using a single Li-Ion battery instead of lead batteries, the SOM processor module is based on an ARM processor with a low-voltage differential signaling (LVDS) interface and is installed on the motherboard, a multi-channel module The ECGP of human biosignal meters is made with USB2.0 interfaces, while the keyboard is connected directly to the SOM processor module, and the LCD display is configured to th channel information receiving LVDS and connected to the output of the processor module SOM cable based on copper twisted pair. 2 ill.

Description

This useful model relates to medical equipment, namely to biomedical measurements for diagnostic purposes in cardiorespiratory studies of the heart and respiratory systems of a person (taking an electrocardiogram - hereinafter ECG, measuring heart rate - hereinafter heart rate, blood and tissue oxygen saturation - SpO2 saturation, etc. ) and can be used to diagnose arrhythmias, blockades, cardiac ischemia and other diseases of the cardiovascular system.

A non-invasive method for diagnosing acute ischemic disease and a multi-channel electrocardiograph for its implementation are known (US patent No. 5419337, АВВ 5/0452, А61В 5/0404), containing an ECG removal unit, including an array of electrodes (up to 100 electrodes) and the corresponding number of amplification channels, multiplexer , programmable amplifier, analog-to-digital converter (ADC), microcontroller, removable memory card, analyzers and displays of heart rate and ST-segment, the operation of which is provided by the corresponding microco software package the controller, wherein the sample values ST-segment across all channels is continuously displayed on the display screen in three-dimensional image. The disadvantage of this device is the structural complexity and the inability to use as a simple wearable means of monitoring human cardiac activity and the diagnosis of exacerbation of heart disease.

A wearable ECG monitoring device is known, which partially eliminates this drawback while maintaining the basic functionality of the above analogue (patent RU No. 2266041, АВВ 5/0452, АВВ 5/0404). This technical result is achieved due to the fact that the aforementioned multi-channel electrocardiograph containing a microprocessor unit with a common bus, a multi-channel ECG removal unit and a multiplexer in series, the control input of which is connected to a common bus, an ADC whose output is connected to a common bus, and a removable memory card , a keyboard and an indication and signaling unit are introduced, connected via the first and second registers entered respectively to the common bus, to which it is also connected via the third input the histr is a removable memory card, the ADC input is connected to the multiplexer output, and the display and signaling unit is capable of simultaneously displaying both the current and previous averaged values of the ECG parameters delayed for a given time, and the microprocessor unit software is capable of calculating and storing such parameter values and with the possibility of selective recording them on a removable memory card in accordance with the program specified from the keyboard.

The disadvantages of the above analogues are the insufficiently informative measurements due to the fact that only ECG parameters are measured in them, and there is no possibility of automated analysis of information and its presentation on the monitor screen in a form convenient for the operator for the purpose of more accurate diagnosis of exacerbation of heart diseases.

At the same time, it is known, for example, from the textbook Shershnev V.G. et al. "Clinical rheography, Kiev," Health ", 1977, pp. 3-7, that a significant increase in the information content of monitoring of the cardiovascular system and increase the reliability of diagnosis of heart disease can be achieved by simultaneously recording and analyzing the ECG and the results of a non-invasive blood supply study organs, which is based on the measurement of changes in the electrical resistance of tissues, in connection with changing blood supply.For an even more reliable assessment of the situation, it is also advisable to use The patient’s breathing and arterial pressure (BP) application is also of great importance, as is the use of computer processing programs for human biosignals and high-quality display of digital output and trends. The result of insufficient informational content is the high probability of false alarms, which leads to irrational workload of medical personnel, and in some cases, the choice of an insufficiently effective treatment method.

Therefore, in modern models of devices for monitoring the state of the cardiovascular system of patients, more complex computer processing of data obtained simultaneously from several non-invasive sensors recording ECG, heart rate, blood pressure, SpO2, body temperature and other medical and biological parameters of a person is used.

The applicant conducted a patent search for secure technical solutions in the classes of the current IPC - 2016 related to this topic:

А61В 5/02 - measurement of pulse, heart rate, pressure or blood flow; simultaneous heart rate and blood pressure; assessment of the state of the cardiovascular system;

А61В 5/0205 - ... simultaneous assessment of the conditions of the cardiovascular system and other body systems, such as the heart and respiratory organs

A61B 5/0402 - ... electrocardiography, i.e. ECG;

A61B 5/0404 - ... portable devices.

Given the selected subgroups, the search for analogues was carried out by the following keywords: "Electrocardiography OR ECG AND display OR monitor" in the Russian segment of the esp @ cenet Internet service (en.espacenet.com), as well as on the site www.findpatent.ru (by Russian-language counterparts).

As a result of this search, the following main analogues were identified: “Mobile communication device with the possibility of cardiac monitoring”, RU 2463952, АВВ 5/04, А61В 5/0432, А61В 5/0404, А61В 5/053; "Method for remote monitoring of human condition", WO 2016123212, A61B 5/04; A61B 5/0402; A61B 5/0404; A61B 5/0408; "Blood Pressure Monitor", WO 2008120950, АВВ 5/0404; "Method and ECG device for displaying an ECG", WO 2006110549, A61B 5/04; "Portable cardiological monitor including radio communication", WO 2006110549, АВВ 5/04; “Ambulatory electrocardiographic monitor and method of its use”, EP 2438853, А61В 5/024, А61В 5/0404, А61В 5/0428, А61В 5/0432; "Multifunctional medical monitor", US 2015150471, А61В 5/00, А61В 5/0408, А61В 5/0432, А61В 5/044; "A device for collecting patient health data", US 2015134364, G06F 19/00; "Active monitor", US 2014012143, A61B 5/0205, etc.

As shown by a patent search, the original new technical solutions cited in some of the above inventions-analogues are quite far from reliable, time-tested technical solutions used, in particular, in the line of multifunctional computer monitors of the MMK-ALTON family, commercially available the applicant company (www.altonika.ru).

Since the beginning of the 2000s, the company has already released several models of these monitors (www.altonika.ru) and continues to further improve them using the latest advances in the development of the component base and software (software). The artistic design solution used in this line is protected by an industrial design patent RU No. 53229, MKPO: 24-01.

In terms of technical nature, the closest analogue of the proposed technical solution is the multifunction computerized monitor MMK-Alton (GKUN.944188.002TU, www.altonika.ru), the core of the computing system of which is the motherboard from an industrial computer with an LCD display connected to a parallel interface, flash memory card, printer module, blood pressure meter module, galvanic isolated power supply, lead-acid rechargeable battery, Ethernet interface, sound alert unit, measurement module A , RISK-SOM processor module and a unit combining the data of various biomedical measurements (ECGP module), which are connected to the inputs of taps ECG, SPO2 sensor and temperature sensors.

Monitors of the MMK-Alton family are mass-produced and widely used as bedside monitors in the intensive care units of hospitals, and in the portable version, in the ambulance service. Periodically, at the applicant enterprise, these devices are reengineered taking into account the latest advances in the development of medical science and technology.

As for the shortcomings of the closest analogue, they are mainly related to the difficulties encountered when trying to apply the latest achievements in the field of digital processing and displaying biomedical information, requiring a high speed of information transfer within the local computer network, which, in essence, are modern multifunctional computerized medical monitors. First of all, this concerns the use of high-resolution and ultra-high-resolution LCD displays in them and the improvement of software in the direction of expanding the functionality of the device and improving its ergonomic characteristics. Modern microcircuits and devices built on their basis are developing more and more power and speed of processing information flows. With an increase in speed and bit depth, the problem of data exchange both between microcircuits and between the modules in the device becomes more and more acute. As noted in an article by Yu. Goncharov in the journal World of Microelectronics (www.compitech.ru), earlier in local area networks (LANs) either multi-bit parallel buses with sufficiently “capricious" signal systems were used for this, or, in the case of intermodular and inter-system exchange - all kinds of tricks, up to expensive optical systems for transmitting and converting information and specialized microcontrollers.

In this case, inevitably there was a rise in price, complication and decrease in the reliability of devices, as well as an increase in energy consumption and the occurrence of problems of electromagnetic compatibility (EMC) with other electronic medical devices.

An alternative direction is the use of technical solutions that implement the well-known method of low-voltage differential signaling (low-voltage differential signaling or LVDS), which allows you to transmit information at high frequencies using cheap connections based on copper twisted pair. Its application allows to achieve a transmission speed of up to 400-600 Mbit / s for one pair, commensurate with the capabilities of optical communication channels, and almost without the use of all kinds of exotic elements (optocouplers, etc.).

In order to achieve such speeds, the proposed device uses the appropriate architecture, components and circuit-technical solutions that implement the specified LVDS method.

The expected technical result is to simplify, reduce the cost, reduce mass, energy consumption and the level of spurious emissions when converting the closest analogue to modern software and hardware for processing, displaying and computerized analysis of medical information.

This technical effect is planned to be achieved due to the fact that in a well-known multifunctional computerized monitor that contains a motherboard with USB and Ethernet interfaces for communication with removable memory cards and with a local Ethernet network, a processor board (module) SOM, a multi-channel ECGP module for measuring human biosignals including an electrocardiograph, SpO2 and body temperature sensors, a blood pressure meter module with a cuff and a printer module associated with the corresponding inputs / outputs of the motherboard s, an AC power supply and an audible warning unit, respectively connected to the power input and to the analog output of the motherboard, a keyboard with an integrated encoder, and an LCD display whose power input is connected to the corresponding power output of the motherboard display, and also the battery associated with the additional input / output power of the motherboard, the motherboard is made with an additional USB HUB interface for communication with the multi-channel ECGP module of human biosignal meters and with a SOM processor module, as well as with the ability to connect additional human biosignal meters and power from a Li-Ion battery to the motherboard, the SOM processor board is based on an ARM processor with a low-voltage differential signaling (LVDS) interface and is integrated into the motherboard , the multichannel ECGP module of human biosignal meters is made with USB2.0 interfaces, while the keyboard with the built-in encoder is connected directly to the SOM processor board, and the LCD display is n to receive information on the channel LVDS and connected to a corresponding output processor board SOM cable based on copper twisted pair.

The essence of the proposed technical solution is illustrated in FIG. 1 - FIG. 2.

In FIG. 1 shows a structural diagram of the proposed monitor.

In FIG. Figure 2 shows a photograph of the motherboard with the SOM processor board installed on it.

In FIG. 1 the following block names are used: 1 - ECG taps; 2 - multi-channel ECGP module of human biosignal meters; 3 - SpO2 sensor; 4 - temperature sensors; 5 - motherboard; 6 - module of blood pressure meter; 7 - cuff; 8 - keyboard with encoder; 9 - LCD display; 10 - processor module SOM; 11 - speaker; 12 - printer module; 13 - power supply from an alternating current network; 14 - rechargeable Li-Ion battery.

The proposed monitor contains a motherboard 5 with USB and Ethernet interfaces for communication, respectively, with removable memory cards and a LAN, a processor board 10 SOM, a multi-channel module 2 ECGP meters of human biosignals, including 1 ECG taps, 3 SpO2 sensors and 4 sensors temperature, module 6 of the AD meter with a cuff 7 and module 12 of the printer associated with the corresponding inputs / outputs of the motherboard 5, the power supply unit 13 from the AC mains and the speaker 11 connected, respectively, to the power input and to the analog output of the motherboard you are 5, a keyboard 8 with a built-in encoder and an LCD 9, whose power input is connected to the corresponding power output on the motherboard 5, as well as a rechargeable Li-Ion battery connected to the additional power input / output of the motherboard 5, while the motherboard 5 is made with a USB HUB interface for communication with a multichannel module 2 of ECGP of human biosignal meters and with processor module 10 SOM, as well as with the ability to connect additional human biosignal meters to the motherboard and with It is powered by a Li-Ion battery 14, the processor board 10 SOM is based on the ARM processor (instead of the RISK processor) with the LVDS interface and is installed on the motherboard 5, and the multi-channel module 2 of the ECGP of the human biosignal meters is made with USB2.0 interfaces for communication with the motherboard 5, while the keyboard 8 with the built-in encoder is connected directly to the processor board 10 SOM, and the LCD display 9 is configured to receive information on the LVDS channel and connected to the corresponding output of the processor board 10 SOM cable Newer copper twisted pair.

The applicant company produced and passed the necessary tests of prototypes of the inventive multifunctional computerized monitor. In accordance with the technical design for this monitor (Technical design, “MK-4 Monitor”, Explanatory Note, DLBA.941118.001 PZ), it provides

- eat and display electrocardiosignals with the possibility of flexible implementation of any set of 7 leads (I, II, III, aVR, aVL, aVF, V) when using a five-wire ECG cable;

- measurement of biomedical parameters by ECG;

- measuring the level of displacement of the ST segment relative to the contour in all removable ECG leads;

- registration of the breathing signal by the impedance method;

- measurement of systolic, diastolic and mean blood pressure by indirect oscillometric method;

- SpO2 measurement by photoplethysmography (PPG) with calculation of the pulse rate (PE);

- measurement of the concentration of carbon dioxide in the inhaled (FiCO2) and exhaled air (EtCO2) and respiratory rate (RR) (optional);

- measurement of body temperature by two temperature sensors and the difference of these measurements;

- setting the alarm limits and giving alarms for all measured parameters that caused the alarm state;

- remembering the trend of change (trends) of the measured parameters, the ability to view them in the form of graphs or tables.

The LCD display 9 has the following information display areas: graphic information area; Patient Information Area the area of numerical values of the measured parameters and the area of system information.

The last three areas are constantly present on the screen.

The patient information area contains the patient’s age category, bed number, and medical history number.

The range of numerical values of the measured parameters contains the measured numerical values of heart rate, BH, systolic and diastolic blood pressure;

- the temperature of the two sensors and the temperature difference of these sensors.

The screen constantly displays the measured numerical values of the displacement level of the ST segments on two ECG leads.

Next to each measured numerical value of the parameter, there are numerical values of the alarm thresholds for this parameter and a symbol for enabling or disabling the alarm when the parameter value exceeds the thresholds.

The system information area contains the numerical values of the current time in the format hh: mm: ss and the date in the format DD.MM.YYYY according to GOST R ISO 8601.

The graphic information area has three display modes: "Monitoring screen", "Graphic trends screen", "Tabular trends screen".

In the "Monitoring Screen" mode, the following are displayed on the monitor screen:

- up to seven ECG signals for any selected from seven leads (I, II, III, aVR, aVL, aVF, V);

- breathing signal;

- photoplethysmogram signal.

In the "Graphic Trends Screen" mode, the monitor screen displays the trends of all measured parameters, combined into the following sets:

- set No. 1 - heart rate, blood pressure, SpO2, emergency through the PPG channel;

- set No. 2 - up to seven ST segment shift graphs for any of the leads (ST I, ST II, ST III, ST aVR, ST aVL, ST aVF, ST V);

- set No. 3 - up to three temperature graphs (T1, T2 and ΔT) (in the presence of a temperature module);

- set No. 4 - BH, measured by the impedance method or capnometer module (if any);

In the "Table Trends Screen" mode, the screen displays:

числовые значения ЧСС, SpO2, ЧП, АД, T1, Т2, ΔT, ЧД, ST I, ST II, ST III,

numerical values of heart rate, SpO2, state of emergency, blood pressure, T1, T2, ΔT, BH, ST I, ST II, ST III,

ST aVR, ST aVL, ST aVF, ST V.

ST aVR, ST aVL, ST aVF, ST V.

In each display mode, configuration options (selection of measured parameters and displayed signals), the inclusion of an alarm mode and the ability to set upper and lower limits for the allowable heart rate, ST segment displacement levels for all leads, SpO2, PE, systolic and diastolic blood pressure, temperature are provided , BH and concentration of carbon dioxide (in the presence of a capnometer module).

The monitor has a stop (“freeze”) mode for detailed viewing of ECG elements.

In the "Table Trends Screen" mode, the screen displays the numerical values of heart rate, SpO2, PE, BP, T1, T2, ΔT, BH, ST I, ST II, ST III, ST aVR, ST aVL, ST aVF, ST V. Interval display is selected from a number - 1, 2, 5, 15, 30 or 60 min.

The input impedance at all inputs is at least 10 MΩ in accordance with the requirements of 201.12.1.101.3 GOST R IEC 60601-2-27.

Common mode interference suppression coefficient - not less than 100000 in accordance with the requirements of 201.12.1.101.10 GOST R IEC 60601-2-27.

Non-uniformity of the amplitude-frequency characteristic - in accordance with the requirements of 201.12.1.101.8 GOST R IEC 60601-2-27.

Limits of permissible absolute error in determining Sp02 - in accordance with the requirements of 50.101.1 GOST ISO 9919).

The measuring range of the pulse rate (PE) is from 25 to 240 in accordance with the requirements of 50.104 GOST ISO 9919.

Limits of permissible error of measurement of emergency - in accordance with the requirements of 50.104 GOST ISO 9919.

The monitor provides a measurement of blood pressure in the cuff 7 - in the range from 20 to 280 mm Hg. (for adult patients).

The proposed device is ready for mass production in accordance with the technical specifications TU 26.60.12.129-001-65186122-2016, which was confirmed by the decision of the customer commission.

Considered multifunctional computerized monitor operates as follows.

The signals from the 1 ECG taps located on the human body are fed to the corresponding parallel inputs of the multi-channel ECGP module 2 of the human bio-signal meters. The other parallel inputs of this module are supplied with analog signals from the SpO2 sensor 3 and from the temperature sensors 4. After filtering, amplifying, digitizing and sampling these signals in the indicated multichannel ECGP module 2 of human biosignal meters, the corresponding digital messages are sent via USB2.0 interface of this module to the USB HUB interface of motherboard 5. Through this interface, they can exchange digital messages with motherboard 5 modules of additional measuring instruments of human biosignals. Module 6 of the BP meter with cuff 7 provides measurement of the blood pressure of a person and, similarly to the ECGP module, converts the received analog signal to digital messages and transmits them to the motherboard 5. In the opposite direction, control signals from the motherboard 5 can be received in the indicated modules of the meters. the analogue is the MMK-Alton monitor, the multichannel ECGP module 2 of human biosignal meters and other meter modules were connected to the motherboard 5 using the UART interface, and the collection, distribution and processing carried out a special microcontroller-collector, which, using the keyboard 8 and the encoder built into it, controlled the display of information on the LCD 9 and the sound notification using a buzzer, in the proposed device, the motherboard 5 does not contain microcontrollers, and all the computing and control functions are performed by the processor SOM module 10 installed directly on the motherboard 5 (Fig. 2). From this module via the I2S protocol, in particular, an audio message is received, which on the motherboard 5 is converted into a high-quality analog signal. This allows you to use a full-fledged speaker 11 (instead of a booser) as a block of sound notification and play through it any sound signals, including voice phrases. As a result, the quality of sound alerts has improved, and the rejection of an expensive microcontroller-collector made it possible to significantly reduce the cost of the device. The role of the collector in this case is assigned to the USB HUB interface installed on the motherboard. Keyboard 8 with an encoder is connected directly to the SOM processor board 10, with which high-quality display of the output graphic and text information on the LCD 9 is displayed. Information from the 10 SOM processor board is transmitted to the LCD 9 through the LVDS interface using the simplest cable based on copper twisted pair.

The LVDS interface uses differential signaling with low signal levels. A current package with a current of 3.5 mA is issued to the line. The line load is served by a parallel-connected differential LVDS receiver and a 100 ohm resistor. The receiver itself has a high input impedance and the main signal formation occurs on the load resistor. At a line current of 3.5 mA, a voltage drop of 350 mV is formed on it, which is detected by the receiver. When switching the direction of the current in the line, the polarity of the voltage across the load resistor changes, forming a state of logical zero and a logical unit. The transmission scheme used has a number of advantages. LVDS-interface has a high data transfer rate. The maximum speed defined by the standard is up to 622 Mb / s, which is comparable to the speed of the optical interface. At the same time, the real speed of the LVDS channel is limited by two factors: the speed of data feed and retrieval and the transmission medium parameters. Unlike the closest analogue, the modules of the biosignal meters in this device are connected via USB2.0, which provides data transfer rates up to 480 Mbps (instead of 1 Mbps in the UART interface), which in combination with the use of LVDS provides an increased data exchange rate between all elements of the LAN of the proposed device with a minimum level of radiation.

In addition, the differential signal transmission method used in LVDS allows minimizing the influence of external interference. A small voltage change, symmetrical transmission lines and a low voltage rise (1V / ns) cause a low level of pickups from the interface itself. In turn, the low level of crosstalk and low sensitivity to external crosstalk make it possible to use high connection density both on the printed circuit board and in the cable. The LVDS transmission method is independent of the supply voltage and operates at a transmitter and receiver voltage of 5V, 3V or 2.5V. At the same time, pairing devices with different supply voltages is not a problem. The transmission method used also allows to significantly reduce the power consumption of the interface. At a 100 Ohm load, LVDS with a voltage drop of 400 mV is 1.2 mW. For comparison, the RS-422 interface has a power dissipation at a load of about 90 mW, which is 75 times more than that of LVDS.

During the execution by the processor module 10 of the SOM system, standard and control programs and settings specified via the keyboard 8 with a built-in encoder, a significant ECG area (for example, ST-segment) is allocated for each heartbeat cycle for each channel, its characteristic value is calculated (for example , the maximum value of the level), by searching through all channels the most dangerous characteristic value is determined (which increases reliability, for example, when the electrodes are accidentally shifted or if their contour is broken the one with the human body). For one or several time periods (for example, for the last minute, last hour, etc.), the average of the most dangerous characteristic values is calculated and displayed on the LCD screen 9. When the most dangerous characteristic values go beyond the set limits, an alarm signal is generated and / or the corresponding high-quality voice announcement played by the speaker 11. Current and delayed characteristic values in accordance with the program settings are selectively recorded on a removable card wrinkles, which increases the recording time. In this case, both a flash card and a removable SD card can be used. Like the closest analogue, the proposed device allows you to document the necessary information. For this, the flows of the corresponding output information coming from the processor module 10 SOM through the motherboard 5 are sent to the printer module 12. As in the closest analogue, the power of the motherboard 5 can be carried out both from the power supply 13 from the AC network (220V, 50 Hz), and from the battery. Compared to the previous version of the motherboard 5, which supported charging only from lead batteries , the new version provides charging from a rechargeable Li-Ion battery 14, which reduces the charging time by 4 times (from 10 to 2.5 hours) and makes the monitor easier.

Thus, the proposed utility model allows to obtain the expected technical result, which consists in simplifying, reducing the cost, reducing energy consumption, mass and level of spurious emissions in a multifunctional medical monitor when switching to modern software and hardware for processing, displaying and computerized analysis of medical information

Claims (1)

A multifunctional computerized monitor that contains a motherboard with USB and Ethernet interfaces for communication, respectively, with removable memory cards and a local area network, a SOM processor module, a multi-channel ECGP module for measuring human biosignals, including an electrocardiograph, saturation sensors (SpO2), and temperature, a blood pressure monitor module with a cuff and a printer module associated with the corresponding inputs / outputs of the motherboard, an AC power supply and a speaker, under assigned, respectively, to the power input and to the analog output of the motherboard, a keyboard with a built-in encoder and LCD display, the power input of which is connected to the corresponding power connector on the motherboard, as well as a battery connected to the additional input / output of the motherboard power, characterized in that the motherboard is made with an additional USB HUB interface for communication with a multi-channel ECGP module of human biosignal meters and with a SOM processor module, as well as with connectivity options As regards to the motherboard of modules for additional measuring instruments of human biosignals and with the possibility of powering the motherboard from a Li-Ion battery, the SOM processor module is based on an ARM processor with a low-voltage differential signaling (LVDS) interface and is installed on the motherboard, a multi-channel ECGP meter module human biosignals are made with USB2.0 interfaces, while a keyboard with an integrated encoder is connected directly to the SOM processor module, and the LCD display is configured to receiving information on the LVDS channel and is connected to the corresponding output of the SOM processor module with a cable based on copper twisted pair cable.

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