RU9577U1 - ACTIVE DIAGNOSTIC DEVICE AND PERIPHERAL PULSE SENSOR COMPLEX UNIT - Google Patents

Abstract

1. A device for active diagnostics, containing interconnected by a connector block and enclosed in independent housings. A complex unit of a peripheral pulse sensor, including an optocoupler unit with a matching cascade, and an Integrated software and hardware unit, including a pulse wave recording unit, a high-pass bandpass filter, determination units R - R intervals in real time, accumulation of rows of R - R intervals, analysis of the quality of the pulse wave, control of operating modes, memory of classification signs of class ss of a pulse wave, memory of normative data, determination of private and generalized indicators and output of visual information, as well as a control panel for entering anthropometric data of the patient and commands, while the control unit for operating modes is looped with a unit for determining R - R intervals through a filter and a pulse recording unit wave, has direct and feedback with the pulse wave quality analysis unit, which, in turn, has an input from the classification unit of the classification features of the pulse wave classes, and in addition, the control unit Niya has a direct and feedback connection with a unit for determining particular and generalized indicators, an output to a visual information output unit and an input from a control panel, characterized in that the device contains a complex block of a blood pressure sensor and a complex block of actuators associated with a complex hardware-software block through the block of the connector, as well as a multi / demultiplexer, block of switches of operating modes, block of classification analysis and formation of Conclusions, memory block of regulatory recommendations, block

Description

Device for active diagnostics and a complex unit of a peripheral pulse sensor. The utility model relates to medical equipment and can be used both in sports medicine and in conditions of mass prophylactic examinations of the population in the detection and preliminary diagnosis of diseases of the cardiovascular system (CVS), in monitoring systems, as well as for monitoring the state of health in health centers. The current level of medical technology allows both the registration of heart rhythm and the analysis of its various indicators to assess the state of the cardiovascular system. Based on this, it is possible, in turn, to determine indicators of a person’s health and physical condition. Various devices are known that contain bioinformation removal sensors, both stationary and portable, as well as processing units for this bioinformation and its analysis, the operation of which is based on a comparison of recorded bioinformation indicators (initial and after testing exposure) with regulatory data for the subsequent formation of a medical report. M. Cl. 6 A 61 V 5/02

autonomous regulation according to the data on the dynamic response of the heart rhythm, the allocation of R-R intervals is carried out during registration of the ECG. The survey results are presented on the information output unit in the form of textual (list of symptoms and syndromes), digital and graphic materials, the subsequent analysis of which allows the specialist physician to formulate a Conclusion with relevant recommendations.

The need to use complex ECG equipment to isolate RR intervals and the inability to obtain a generalized (full) conclusion in automatic mode should be considered as disadvantages of this device.

A device is known (see the description of US patent No. 4022192 class A61, 5/04, 05/10/07,), which determines the integral parameters of the cardiovascular system through a certain number of cardio intervals. The device contains blocks: pulse sensor, pulses, control, digital information output and determine the parameters of the cardiovascular system. However, this device does not allow to automatically determine the variance (standard deviation) of the R-R intervals, which is one of the determining parameters in the assessment of generalized indicators of the state of the cardiovascular system. In addition, it is not possible to significantly increase the reliability of assessing the state of CVS using this device without using data on blood pressure.

A device for automatic registration of the pulse curve (see description to A. S. No. 72884 of the USSR, A61 B 5/0245), containing a finger sensor, low-frequency amplifier, analog-to-digital converter, as well as blocks: recording, comparison, control, output of digital information. This device allows you to register a pulse wave (sphygmogram) automatically in a clinic or medical center of the enterprise, which provides the possibility of its use in organizing mass preventive examinations. This is possible due to the simplicity of the device and the provision of sufficient accuracy of comparing every two pulse curves following each other, as well as the transmission of encoded curves (encoded) to the digital recorder.

for the subsequent determination of heart rhythm indicators, comparing them with regulatory data and automatically generating the final Conclusion.

A known device for diagnostics (see AC No. 572261, USSR, 5A 61 V 5/00, 1977) contains bioinformation sensors, a low-frequency amplifier, a signal switch, actuators and blocks for determining the parameters of test actions, bioinformation memory, control, visual information, display and printer. The device implements an active diagnosis, which is not an end in itself, in the process of choosing the optimal therapeutic effect for individualized treatment in acute or chronic pathology.

However, as shown by the analysis of the structural diagram, the device, presented in the most general primitive form of connections between blocks, has no design features of execution and does not provide an automatic conclusion.

A device for training and treating CVS is known (see the description of the patent of the Russian Federation No. 2049425, 6A61 B5 / 02.1995), which also implements active diagnostics during training and treatment of patients.

The device, unlike the one described above (AS No. 572261), has a constructive solution based on the modern development of technology, namely, using a computer (microcomputer) with a display and a magnetic disk drive, interfaces, modern sensors and bio-information converters using methods of their algorithmic processing, program control of the process of removal and processing of bioinformation.

However, this device is not advisable to use only as a diagnostic, because its functions are wider, and the design is complex and voluminous. The need for purely diagnostic devices is still great, as noted above, in the context of mass preventive examinations of the population, as well as in health and sports centers.

A device for diagnosing the condition of CVS, containing complex blocks: a peripheral pulse sensor, blood pressure, a hardware block, the output of visual information and a connector that combines all of the above blocks into a single complex (see the book BC Moshkevich Photoplethysmography, 1986, p.25-0; fig. 5-7).

consistent with the input parameters of the means of subsequent processing. The latter include low-frequency amplifiers, an electromechanical pulse wave graphic display unit, and a control unit containing switches for gain ranges, broaching speeds of the paper information carrier, and an input signal switch.

This device provides time-synchronized measurements of the pulse wave and blood pressure, recorded in a graphical image on graph paper. For a specialist physician, the combination of graphic and digitized data corresponding to them serves as one of the important components both for conducting a complete clinical examination, and as independent data, allowing preliminary diagnostics of the condition of CVS.

However, the disadvantages of this device are the low accuracy of registration ("0.1 division of the chart paper scale), the high inertness of the electromechanical unit, which cannot be excluded even using the compression method of measuring the pulse wave.

In addition, it is obvious that the degree of reliability of the diagnostic Conclusion is affected not only by the hardware errors of recording and registration (including the inevitable digitization error), but also by the specialist’s skill level, his individual experience with this device, etc. Therefore, the lack of automation of the process of data acquisition and processing reduces the level of reliability of this diagnostic conclusion.

In addition, since the device is bulky, it can only be used in a hospital (clinic).

A device is known for automatic registration and processing of a pulse wave (see Patent Application No. 961588 A61P / KSM of 03/10/96, Finland, Oy Vitaparkk Ltd SA A61 B, for which a positive decision was issued of July 1, 1997), in a block diagram which can be distinguished two generalized blocks that are joined by a connector block, which in their content can be considered as complex blocks, ..

The first of these is the Integrated Peripheral Pulse Unit, which measures the time-varying amplitude of the pulse wave, converts the energy flux density of the infrared radiation received by the photodetector into a primary electrical signal, which is then converted into a signal whose parameters are consistent with the input parameters of the means for further processing and analysis, located in the second Complex block, which is a software and hardware.

This Complex block contains: a pulse wave recording unit, a high-pass bandpass filter, blocks for determining RR intervals in real time, accumulating rows of RR intervals, analyzing the quality of a pulse wave, controlling operation modes, memory of classification signs of pulse wave classes, standard data memory, determining private and generalized indicators and visual information output, as well as a control panel for entering anthropometric patient data and control commands.

At the same time, the control unit is looped with a block for determining RR intervals through a high-pass filter and a pulse wave recording unit, and also has direct and feedback communication with a pulse wave quality analysis unit, which, in turn, has an input from the memory unit of the classification features of the pulse wave classes . In addition, the control unit has a direct and feedback connection with the unit for determining particular and generalized indicators, as well as an output to the visual information output unit and an input from the control panel for inputting anthropometric patient data and control commands.

The described device allows active diagnostics of the state of the cardiovascular system based on the analysis of the following: rhythmograms of the resting state, rhythmograms taken during various stress tests, classification signs of the pulse wave, blood pressure values and anthropometric data (gender, age, height, weight) of the subject the patient.

The survey results (indicators that directly reflect a particular characteristic of the CVS state, as well as automatically generated private and generalized indicators of the state of the circulatory system) are reflected in the visual information output unit (display and printer).

However, this device is not without drawbacks. These include: О insufficiently high level of degree of automation, which is manifested in the management and control of the pulse wave and blood pressure acquisition (all operations of monitoring the pulse wave acquisition, as well as reading blood pressure values and entering them into the second Complex unit, are performed by the operator, t. e., essentially, the operator acts as a device for recording (fixing) the measured parameters, entering them into the software and hardware unit (when registering blood pressure), and

performs the role of a controller in the feedback circuit between the control unit and the bioinformation pickup devices;

 when choosing parameters of test (test) loads that are adequate to the state of the body, since this choice is made by the operator using the appropriate tables of age and gender standards; О Insufficiently high amplitude-time resolution of the recorded signal (pulse wave).

In addition, this system does not form a final Conclusion and, as a consequence of this, does not form individual Recommendations that are adequate to the survey results. Therefore, the analysis of private and generalized indicators should still be carried out by a specialist doctor.

The consequence of these shortcomings is the insufficiently high degree of reliability of the examination result, since the latter (isolation, analysis and classification of cardiac arrhythmias: extrasystole, conduction disturbance, etc.) is performed by a specialist doctor. Therefore, the level of competence of this specialist, subjectivity and its possible errors will inevitably affect the level of reliability.

In addition, the device for automatic registration and processing of the pulse wave does not have a sufficiently high ergonomics and compactness of the design itself.

Using as a prototype the device described above for automatic registration and processing of the pulse curve (patent application N 961588 for Finland), the authors in the proposed technical solution increase the level of automation of the device, and therefore the degree of reliability of the survey results, which is generated automatically, due to that two more Complex blocks are additionally introduced into the well-known block layout of the device: Complex block of blood pressure sensor and Complex block performer s mechanisms.

In the Complex block of the blood pressure sensor there is a pressure measuring unit, a control and signal conversion unit (with an ADC for converting an analog signal to digital) and an indicator. The pressure measuring unit is connected to a control unit, which, in turn, is connected to the operating mode control unit of the Integrated software and hardware unit through a connector block, a multi / demultiplexer, and an operating mode switch block. In addition, the control unit has an output to the indicator.

In the Comprehensive block of actuators, each of the control units (belonging to a particular actuator and constituting a whole set of control units) has direct and feedback communication with the control unit of the operating modes of the Integrated software and hardware unit through a connector block, a multi / demultiplexer, and an operating mode switch block. The complex unit also contains a set of devices that implement controlled procedures of dosed test loads (psychophysical, physical, etc.), the design features of which are not considered in this application, since they are an object of independent protection.

The Integrated software and hardware block additionally includes: multi / demultiplexer and blocks: operating mode switches, classification analysis and formation of the Conclusion, determination of the parameters of test effects, isolation and analysis of the types of heart rhythm disturbances, regulatory data memory and recommendations for the formation of individual recommendations, arterial data memory pressure (SBP and DBP), memory of anthropometric patient data, formation and output of audio information.

At the same time, a well-known block of accumulating rows of R-R intervals, a memory block of blood pressure data (SBP and DBP) and a memory block of anthropometric data of the patient, the combination of which forms a combined bioinformation memory block consisting of the corresponding subunits, are connected to the known pulse wave recording unit. The block for isolating and analyzing types of cardiac arrhythmias has inputs from the bioinformation memory block and from the real-time determination of RR intervals, as well as an output to the operating mode control unit, which, in turn, has direct and feedback connection with the multi / demultiplexer via a block of operating mode switches and two-way communication with a block for determining the parameters of test actions. The block of classification analysis and the formation of the Conclusion has inputs from the unit for determining private and generalized indicators and the block of normative data, as well as direct two-way communication with the control unit for operating modes and additional communication through the unit for generating individual recommendations. In addition, the unit for generating individual recommendations has an input from the regulatory recommendations memory block, and the multi / demultiplexer, through the connector block, has two-way communication with the Complex blocks: peripheral pulse sensor, blood pressure sensor, and actuators.

The implementation of the device for active diagnostics in the form of independent Complex blocks allows you to use each of them (or several in their combination) in the form of independent devices included as components in other complex systems designed to solve the modified tasks of processing and analysis of bioinformation (pulse wave and blood pressure) and having the ability to pair with these Complex blocks.

Therefore, each of them may have the right to self-defense.

In this application, as an independent technical solution, the Integrated peripheral pulse sensor unit is presented, which contributes to the achievement of the ultimate MJAVW, for which the proposed device for active diagnostics has been developed.

The well-known Integrated peripheral pulse sensor unit used in the diagnostic device (see the link to the B.C. Moshkevich book mentioned above) ensures the reliability of the correct fixed position of the hand when taking bio-information by pressing the finger to the working elements of the optocoupler and attaching the hand to the supporting surface. This provides a complete exclusion of the possibility of registration artifacts associated with the involuntary movement of the hand or finger from which sphygmograms are taken.

However, the technical means by which this is implemented are performed at an elementary primitive level and, in addition, involuntarily cause the patient a feeling of discomfort, since the wrist with the forearm is pulled to the supporting surface by two straps. In addition, the process of fitting and tightening belts in time is comparable with the time of the measurements. Given this and taking into account the existing requirements for modern structural and technical solutions, it should be recognized that the means for fixing the finger and hand described above are currently not very acceptable.

In the known device for automatic registration and processing of a pulse wave (see the reference to application N 961588, Finland above), a Complex block of a peripheral pulse is presented in the form of: a general structural block diagram of a device, a structural diagram of the contact area of a patient’s finger with optocoupler elements that have exits to the surface housing, and taking into account the declared geometric parameters of the placement and orientation of the optical axes of the emitter and photodetector.

This complex unit contains an optocoupler unit with a matching stage, connected to the galvanic isolation unit through a low-pass filter, a low-frequency amplifier, an analog-to-digital analog block (ADC), parallel parallel code and

aftertotal, a complete code block generation unit and an output signal power amplifier. The clock generator is directly connected to the ADC block, and to the parallel to serial code converter through a frequency divider (see the circuit section relating to the Complex block of the peripheral heart rate sensor in Appendix No. 1 to the materials of this application).

In the process of taking the pulse wave, the working finger is placed on a concave portion of the surface (bed) of the body on which the lenses of the optocoupler elements are located. At the end of the bed there is a latch in the form of a vertical stop to prevent the translational movement of the finger (see the structural diagram in Appendix N 2 to the application materials).

However, the well-known complex unit does not provide in full

solutions to pyta & goof goofs to increase the reliability of the diagnostic Conclusion. The basis for this conclusion is the following:

1. the possibility of registration artifacts related to the involuntary movement of the patient’s hand or finger is not ruled out, because: there is absolutely no forced pressing of the working finger to the body in the area of the optocoupler lenses and the fixing of the hand. In addition, there is no control over the process of signal pickup.

2. a sufficiently high degree of quality of the input optical signal is not ensured, due to the use of parallel orientation of the optical axes of the emitter and the photodetector, as a result of which at each current point in the photodetector a mixture of infrared radiation fluxes immediately from all areas of the pulse wave propagation in which it has different phases of passage.

providing amplitude-time resolution of the signal;

- ensuring the contact of the working finger with the measuring element reflected in the structural diagram of the complex block of the peripheral pulse block mentioned above and in the ratios linking the geometric parameters of the placement of the measuring elements of the optocoupler, taking into account its design scheme, is adopted as a prototype.

Taking into account the above-mentioned disadvantages, the main direction of development of the proposed version of the Integrated peripheral pulse sensor unit was to improve the quality of output information while increasing the degree of compactness and improving ergonomics

this sensor.

The problem is solved in that a multi / demultiplexer, an information control and monitoring unit and a calibration signal generator (GKO) block are additionally added to the block diagram of the Peripheral Pulse Sensor Complex Unit, while the multi / demultiplexer is built-in between the units for generating the complete code package and the power amplifier output signal and has additional feedback from the galvanic isolation unit, as well as direct and feedback from the control unit for the removal control.

The upper surface of the housing of the Integrated sensor unit is made with the possibility of support with the fixation of the hand and has the form of a convex hemispherical surface area for supporting the palm, turning mainly into three different-height inclined tracks for the fingers of the hand, above one of which in the exit zone of the optocouplers on the bed the clamp is fixed in the form of a concave spring-loaded clip for the working finger.

In addition, in the optocoupler block, the relative positions of the measuring elements and their optical axes are made with the following relationships :. e, (L) - / (1)

16 ° Ј Ј 45 °, (ф 2arctg (0.5d / h)) (2)

where: rCV

L is the distance between the centers of the flat and convex lenses of the emitter and the photodetector,

t is the average distance (according to data relating to different parts of the skin) from the surface layer of the skin of the finger to the plane that passes through the region of the location of the maximum density distribution of micro vessels,

d is the diameter of the convex lens of the photodetector,

h is the distance between the lower plane of the convex lens and the upper plane of the recording crystal of the photodetector.

In FIG. 1 shows a block diagram of a device for active diagnostics, FIG. 2 shows a block diagram of a complex unit of a peripheral heart rate sensor; FIG. 3 shows the Integrated unit of the peripheral pulse sensor, top view, in FIG. 4 is a section along AA, and in FIG. 5 is a structural layout of the elements of the optocoupler. In FIG. 6 is a copy of a photograph of the appearance of the Complex unit of the peripheral pulse sensor with a connector block and a power supply, in FIG. 7 is a copy of a photograph of the inside of the Peripheral Heart Rate Sensor Complex Unit (top view of the lower electronic board). In FIG. Figure 8 shows graphs of the experimentally measured dependence of the signal amplitude A (t) (pulse wave) on angle a.

The device for active diagnostics contains the Complex block I of the peripheral pulse sensor (KB1), the Complex software and hardware block II (KBN), the Complex block III of the blood pressure sensor (KBS) and the Complex block IV of the actuators (KBIV). All four Complex blocks are interconnected, with the possibility of direct and feedback, by a common BR connector block.

The connector (switching) block is made with the provision of: a) working connections of the Integrated units of the peripheral pulse sensor, pressure sensor and actuators with the Integrated software and hardware unit, b) directional switching of supply and power off to each of these units.

The structural diagram and constructive solution of the Complex block I of the peripheral pulse sensor are essentially discussed below, since they are the subject of self-protection in this application.

The block diagram of the KBN block is characterized by the following interconnections of elements: a multi / demultiplexer 1 is connected to the operating mode control unit (OCR) through an interconnected block of 3 operating mode switches (KRC), a combined bioinformation memory unit 4, and a high-pass bandpass filter 5 , block 6 determine the RR intervals in real time. At the same time, block 4 of the OPB is made of four subunits having the following functions: subunit 4a carries the functions of a known pulse wave recording unit, namely, recording incoming data in the mode without decimation and in the decimation mode (-330 records per second), subunit 4b - a known block for accumulating rows of RR intervals, a sub-block 4c of the inserted blood pressure data memory block (SBP and DBP), and a sub-block 4d - a patient anthropometric data memory block and, in addition, a function for temporarily recording and storing all intermediate data related to I, for example, to assess private and generalized indicators.

In addition, the multi / demultiplexer 1 is additionally connected to the OCR unit 2 by direct and feedback through the KRC unit 3 and by direct communication with the pulse wave quality analysis unit 7, which additionally has an input from the classification unit 8 of the classification features of the pulse wave classes. Block 4 OPB is additionally connected by direct and feedback to block 2 of the OAI. Block 9 of the classification analysis and formation of Conclusions (KAFZ) has inputs from the block 10 of normative data memory and the block 11 for determining private and generalized indicators, as well as the output to block 2 of the OAI directly and additionally connected to it through block 12 of the formation of individual recommendations. At the same time, the block 11 for determining particular and generalized indicators is connected to the block 2 of the OAI direct and feedback.

Block 2 of the URR has an input from the remote control 13 for entering commands, questionnaire (anthropometric) data, as well as the examination time (UVK); the input from the block 4 OPB through block 14 allocation and analysis of rhythm disturbances; output to the printer 15 and to the display 16 through the block 17 of the formation of visual information, as well as the output to the sound speakers 18 through the block 19 of the formation of audio information.

All elements of the structural diagram of the KBN block are united by a common building 20.

The block diagram of the Comprehensive block of blood pressure CBN1 contains a block 21 for measuring blood pressure, a control unit 22 and a signal conversion (ADC) associated with the indicator 23, light bulbs-eyes (LG) 24, 25 and 26 of which are located on the surface of the housing 27, in a convenient place for visual inspection.

The pressure measurement unit 21 is connected to the control and signal conversion (ADC) unit 22, which, in turn, is connected to the OCR unit 2 of the KBN block through the BR connector block, multi / demultiplexer 1, and the КРР block 3.

In the structural diagram of the KBIV block of actuators (in these materials the circuit is not considered in full, since it is a subject of independent protection) there is a set of control units 33, each of which has two-way communication with the URR block 2 of the KB11 block through the BR connector block, multi / demultiplexer 1 and block 3 CRC.

Considering the device for active diagnostics together with the operator and the patient as a certain whole (man-machine complex), two stages can be conditionally distinguished in their interaction: a set of preparatory operations (A) and the device’s actual operation in automatic mode (B).

A. Preparatory operations include:

preparation of the patient (mainly with the participation and / or control of the operator) for the removal of the pulse wave and blood pressure,

Procedures performed by the operator: initial launch of Complex Units I, III, IV, monitoring of the results of the automatic process of checking operability, and entering through the remote control 13 UVK into the 4d sub-block of memory data about the examined patient. In addition, in those cases when, for one reason or another, poor-quality input of measurement data takes place, the operator, after eliminating the reasons, enters the command for re-measurement through the remote control 13 UVK.

procedures carried out in automatic mode to verify the operability of Complex blocks I, II, III and IV.

The preparation of the patient for the pulse wave (including operations associated with placing the palm and fingers on the surface of the KB unit) is described below in the section relating to the operation of the KB1 unit, allocated as an independent object of protection.

Preparing the patient for a blood pressure test includes well-known standard procedures, such as attaching a blood pressure sensor and taking the correct posture (placement of the patient's arms, legs, and body), as well as the procedure for conducting regulated rest.

The initial start-up of the device for active diagnostics is carried out by the operator 29 by turning on the power source 30 (the first toggle switch for the KBN block), followed by a check of the operability of this Complex block in automatic mode.

Since the verification procedures are among the well-known and standard procedures used in microprocessor technology for testing the state of electronic equipment at its initial start-up, the description of these procedures for the RPC unit can be omitted without compromising the understanding of the further discussion.

After the successful completion of the health check of the KBN block, confirmed by the transmission of information about the readiness of the KBN block to the information output blocks 16 and 18, the operator carries out the initial launch of the Complex blocks I, 111 and IV by entering the command from the remote control unit 13 into the URR unit 2; Complex blocks. Then it sequentially supplies voltage to these blocks, including the corresponding toggle switches on power supplies 31 and 30, as a result of which the operating voltage Upa6 from the outputs of the stabilizer and stabilizer block 32, which is built into the power supply block 30, is supplied through the BR connector block to the corresponding Complex blocks.

After that, the operator monitors the results of the automatic process of checking the health of Complex blocks I, III. The main purpose and purpose of such a check is to obtain a guarantee that the condition of the electronic units and communication lines is regulated and that during their operation there will be no interference or deviation, leading to unacceptable distortions in the measured signal. The basis of this check is the calibration procedure, which includes: generating a test calibration signal that simulates a real signal with regulated (standard) parameters,

 it instead of the real signal coming from the optocoupler unit, at the interface point of the optocoupler unit with subsequent processing and conversion units,

a comparison, conducted in block 2 of the OAI, of the test calibration signal with the available standard calibration signal, which corresponds to the normal operating state of the blocks and communication circuits.

Taking into account the fact that the procedures for verifying the operability of Complex blocks I and III are generally identical, it is sufficient to describe the verification

operability procedures of one of them. Since the KB block is allocated as an independent pm & nm t, and is described below, this section gives

Description of the procedure for automatic health check of the KB1N block, which is as follows.

After the operator submits the voltage and receipt of the command to the OCR unit 2, the Start of operation, check of the operability of the Complex units, the OCR unit 2 generates (for the RRC unit 3) a control signal for establishing (opening) a two-way communication channel with the control unit 22 of the KB1N block and through the 3 RRC , multi / demultiplexer 1 and the BR connector block passes the code to it

nelelm

health check commands. Upon receipt of this code, the control unit 22 verifies the magnitude of the operating voltage (Upa6) and determines whether its value is within the specified tolerance.

If the Upae value is within the set tolerance, then the control unit 22 transmits a signal code via the feedback circuit. There is an operating voltage, after which, the URP unit 2 first sends the Calibration command code to the control unit 22, and then generates (for the 3 RRC unit) a control signal for establishing (opening) the data channel of the data block KBN1, after which block 3 KRC opens it.

Upon receipt of the Calibration command code for the control unit 22, this unit generates a command for the indicator unit 23 to display the event There is a voltage, as a result of which LG 24 lights up, then the control unit 22 starts the calibration signal generator for 15 seconds, simulating a regulated level signal from the arterial sensor pressure. This calibration signal is transmitted to the control unit 22.

If the parameters of the calibration signal satisfy the criteria, then the URR block 2 generates the ready signal of the KB1I block and transmits it via the feedback circuit (between the URR blocks 2 and the block 22) to block 22, after which the Ready signal comes from the last to the indicator block 23. This event is displayed by ignition of LG 25, which indicates the readiness of the KB1I block for registering blood pressure. At the same time, a message about the readiness of the KB1P block is also transmitted from block 2 of the URR to the information output blocks 16 and 18.

If the parameters of the calibration signal do not satisfy the criteria, then the OCR unit 2 generates a signal Unavailability of the KB1N block and, similarly to the one described above, a display of this event is formed, as a result of which LG 26 lights up and a corresponding message is displayed on the display and sound speakers. After that, the operator, who monitors the results of the automatic health check, must identify the corresponding cause of the malfunction, eliminate it, and then repeat the check procedure again.

In the event that the Upae value lies outside the established tolerance, the signal code Lack of operating voltage is received from the control unit 22 to the OAU block 2. In accordance with this, block 2 of the OAI does not generate and does not transmit the command code Calibration a, since block 22 does not receive this code, then

in the block 23 of the indicator also does not receive a signal Ready. The display of this event (i.e., voltage event) is the absence of indication (burning) of LG 24. After the signal code is received in block 2 of the OAI, there is no operating voltage (or if it is absent for 10 seconds), the OAI block 2 through blocks 17 and 19 formation transmits a message about the absence of operating voltage on the KB111 block and recommendations for eliminating possible causes. For the operator, this is a signal to de-energize the KB1I unit, identify and eliminate the corresponding cause, and then repeat the voltage supply procedure again.

The sequence of preparatory operations ends with the procedure for entering data about the examined patient, carried out by the operator from the remote control 13 UVK. These data, which enter block 2 of the URR and then to sub-block 4d of the bioinformation memory, include: standard personal information (last name, first name, year of birth, height, weight), information of a dichotomous (alternative) nature about playing sports. In addition, the date and time of the survey are recorded in sub-block 4d.

The health check of the Complex block IV is carried out during the operation of the entire device.

At this, the preparatory operations end and then the device operates in automatic mode.

5. The operation of the device in automatic mode is predetermined by the logical structure of the survey methodology. Within the framework of this logical structure, block 2 of the OAI is endowed with the following functions:

determine the sequence and conduct operations to connect and disconnect blocks, in accordance with the sequence of work,

control of information flows of data transmitted from block to block,

formation of messages to the operator, displayed in visual and / or audio forms, about the transition to the next stage of work (we’ll eat bio information at rest, under test loads, etc.)

formation of messages to the operator and a list of recommendations on his necessary actions related to non-standard (contingency) events in work. The initial information for the formation procedure is the logical meaning of those code messages that come from the control units of the Complex blocks I, III, IV and block 7 of the analysis of the quality of the pulse wave.

The procedures for removing bioinformation (pulse wave and blood pressure) and its subsequent processing, ending with the automatic generation of the Conclusion, begins with the formation of control signals in block 2 of the OCR to establish (open) information channels of communication with the control units of KB1 and KB1N. Upon receipt of these control signals in block 3 of the RRC, the corresponding communication lines are switched. After this, the KBN block is ready to receive bioinformation.

The first cycle of taking a pulse wave and blood pressure refers to measurements taken while the patient is at rest. The signals (measurement data) coming from the Complex blocks I and II have a code of their belonging to one of the types of data (pulse wave or blood pressure) used by block 3 of the CRC to control the switching of data streams. In the KBN block, the reception and processing of this data coming in two parallel streams is carried out in successive portions. At the same time, the amount of data in portions (data arrays) is different: for a pulse wave - the length of the array is 64 points, for blood pressure - 8.

The signals from the KB1N block through the multi / demultiplexer 1 and the KCR block 3 are sent to the SDB block 4 (where they are recorded in subblock 4c), as well as to the URR block 2. In the latter, they are checked for compliance with the criteria for the quality of the input data. In the case of fulfilling the criterion conditions, the unit 2 of the URR generates a signal code, the pressure data is received, input and processing of the next portion of data related to the pulse wave is allowed. This control signal is transmitted to block 3 of the RRC, which for the period of reception of the pulse wave signal closes the communication channel with the block KBN1, while opening the communication channel with the block KB1.

If the criteria for quality of the input data do not meet, the unit 2 of the OAI generates a signal code. Poor data input about

pressure and transfers it through the feedback circuit to the control unit 22 and the signal conversion. Then, from the block 22 to the indicator 23, a signal of Poor input is received - to LG 26. At the same time, the block 2 of the URR through the blocks 17 and 19 of the formation and blocks 16 and 18 output information also transmits a message about poor quality data input pressure. For the operator, this means the occurrence of an abnormal event in the operation of the KB1P unit, the need to eliminate the cause of poor-quality input and repeat the procedure for measuring bioinformation.

The signals from block KB1, which is a temporal sequence of pulse amplitudes An (t) of the pulse wave (dots), are sent to pulse wave quality analysis block 7, to block 4 of the SDB, where they are recorded in subblock 4a and block 2 of the OAI. At each current point in time tj, the last (in the order of arrival) n dependency points An (t) come from the OCR unit 2 to the visual information generation unit 17 and then are displayed on the display screen in the form of an amplitude-time graphical dependence. The number n is set sufficient to be able to display the last several periods of the pulse wave.

Similar to that described, data on systolic CAfl (t) and diastolic pressure DBP (1) are also displayed on the display screen as a graphical dependence. As a result of this, additional visual control of the bioinformation input process is carried out.

In block 7, according to the signal (command) from block 2 of the OAI, the characteristic diagnostic-significant signs of the amplitude-time dependence An (t) are extracted and then the combination of these signs is checked for the classification signs of any of the classes (types) of pulse waves contained in block 8 of the classification features of the pulse wave classes. The result of the compliance check - the identification code (codes) of the pulse wave class is transferred from block 7 to block 2 of the OAI and then to subunit 4d, where, after the pulse wave is taken out, the identification code goes through block 2 of the OAI to block 9 of the KAFZ.

In the event that the analyzed sequence An (t) does not contain the necessary minimum of characteristic features that coincide with the signs of at least one of the classes of the pulse wave, the pulse wave quality analysis unit 7 generates a poor-quality input signal and transmits it to the OCR unit 2, which reflects this an abnormal event, gives a signal of poor-quality input to the KB1 block. In addition, block 2 of the URR issues through blocks 17 and 19 of generating information to blocks 16 and 18 of its output a message about the presence of a poor-quality input signal, a list of necessary actions to eliminate this, including recommendations for adjusting the position of the finger on the sensor and the offer to repeat removal or disconnection of the device for offline verification.

The thinned pulse wave is recorded in subunit 4a at each ATRR time interval of 1 1 / 300c by a signal (command) from block 2 of the OAI. The choice of the value of the ATRR time interval is due to the required accuracy in determining the R-R interval.

According to the signal (command) of the OCR unit 2, from the memory subblock 4a to the real-time filter 5, the initial (unimpaired) portion of the pulse wave recording An (t) related to the time interval (tk), which contains N last (by time of arrival) of the points Ap, according to the same command, through the filter 5, to the block 6 for determining the RR intervals, a thinned-out section of the pulse wave recording related to the same time interval tk is transmitted. The length of this interval should be not less than the length of the minimum possible cardiocycle.

In the filter 5, the obtained recording section (a time series of pulse wave amplitudes) is subjected to high-pass filtering using a numerical filter of finite length. As a result of this, the time series will no longer contain those high-frequency components that could be erroneously identified (in block 14 of the analysis) as a true R-R peak. The filtered signal from the filter 5 is fed to the input of the R-R interval determination unit 6.

Then, in block 6, using mini-max algorithms, an R-R peak is searched for in the filtered signal and, when it is detected, the corresponding instant tRR is recorded. Since the R-R peaks in the initial and filtered signals are separated in time (by a small value of the A1F time equal to the filter operation time), the identification of the R-R peaks in the initial (unfiltered) signal is carried out on the time interval (1kK-D1f) -4-tRR. After identifying the R-R peak in the original signal, the time tRR corresponding to this peak is determined. Further, in the vicinity of tRR, using a spline of at least second order, the moment of the true position of the maximum of the pulse wave t, is refined. The sequence of operations described in this paragraph is repeated in order to search for the subsequent R-R peak and determine the instant of its occurrence t, + 1. The time difference t / + r t gives the time value of the size of the next R-R interval.

The obtained value of the R-R interval is transmitted through the URR block 2 to the sub-block 4b of the bioinformation memory for accumulating the rows of R-R intervals, for the purpose of their subsequent processing, and to the block 14 for isolating and analyzing rhythm disturbances.

In the last (block 14), the absence or presence of cardiac arrhythmias (as well as the identification of certain types of abnormalities) is established by using a quantitative analysis of the membership (correspondence) of the current values of the indicators (both the values of RR intervals and the values derived from them) known (for example , from publications containing Holter monitoring algorithms) to the corridors for these indicators. Moreover, various combinations of these corridors correspond to the characteristic manifestations of the norm and rhythm disturbances - extrasystoles, conduction disturbances, etc. The blood pressure data received by the command of block 2 of the URR from sub-block 4c to block 14 is used (in affiliation analysis algorithms) to increase the reliability of the analysis. The results of this analysis in the form of code features are transferred to block 2 of the OAI and through it to subunit 4d, and upon completion of the bio-information acquisition through the block 2 of the OAI to block 9 of the KAFZ.

To carry out the function of monitoring the processing process from the operator 29, the OCR unit 2 implements the visualization of this process by displaying a graphical dependence fRR RR (t) through the block 17 on the display screen (16).

Upon completion of the bioinformation removal related to the measurements taken while the patient is at rest, the URR block 2 generates a signal for determining particular and generalized indicators (in block 11) using the data set of the SDB block 4: memory of time series RR (t), GARDEN (1) and DBP (1), the time of the examination, code signs of the presence / absence of rhythm disturbances, and data entered previously through the remote control 13 UVK (gender, age, height, weight). The value of the particular and generalized indicators defined in block 11 are transmitted through block 2 of the OAI to sub-block 4d of block 4 of the operational safety base.

The following cycles of taking a pulse wave and blood pressure are carried out upon exposure (during exposure and / or after) to a patient of various in nature load tests (loads), which is carried out using actuators 33 of Complex block IV.

The following can be used as test loads: psychophysical load, functional test. In-depth breathing, physical exercise, after which blood pressure is additionally recorded.

Each of these cycles begins with the (automatic) establishment in block 2 of the OCR code-sign J of the next test effect, which is transmitted to block 28 for determining the parameters of the test actions. The last by the value of the code-sign J carries out the determination of the relevant parameters and passes them to block 2 of the OAI. The parameters of the optimal test effects are determined taking into account the totality of particular and generalized indicators of the state of the circulatory system of a particular patient. For example, for a psychophysical load test, this is the duration of the test, the frequency of blinking of annoying visual images, the pitch and volume level of the sound signal - an alarm image; for a functional test In-depth breathing test duration, time intervals of the phases of respiration, the ratio between them; for the test physical activity - the duration of the test, the patient's energy consumption for the physical work performed by him, etc.

Upon receipt from block 28 of the values of the parameters of the optimal test actions by block 2 of the RRM, the latter generates, in accordance with the next value of the code-sign J, a command to block 3 of the RRC operating modes to establish (switch) the information communication line (via multi / demultiplexer 1 and the connector block BR) with a control unit 33 (with a control unit paired with a load test) of the K5IV block.

On the formed communication chain, the block 2 of the URR sends a signal code to check the state of readiness of the actuator and, upon receipt of a confirmation of readiness, sends the codes of the parameters of the test effect and the signal to start the test to the paired control unit 33 of the KBIV block. Then, the block 2 of the URR, similarly to the above, establishes an information connection (with confirmation of readiness) with the control units of the blocks KEM and KB1I. Further work of these Complex blocks is carried out similarly as described above.

Upon receipt by the control unit 33 of the values of the parameters of the test actions, this unit generates a sequence of control signals that drive the actuator (device) into action. Depending on the type of test, actuators perform the following:

-fast change (blinking) on the display screen of annoying pictures-images, accompanied by loud and sharp sound signals (psychophysical load),

- visualization of visual multimedia graphic and audio means of the deep breathing program (individual with respect to the patient), which is a dynamically deployed, cyclically closed sequence of phases of breathing,

- visualization by visual multimedia graphic and audio means of a physical activity program (from among those used in a clinic or sports medicine), which is a dynamically developed, cyclically closed sequence of phases of physical activity that a patient must perform, for example, on a bicycle simulator.

is not yet exhausted, the new value of the code-sign J is transferred to block 28 for determining the parameters of the test actions and according to the algorithm described above, the procedure for the next test is repeated and so on until the exhaustion of the entire list of tests.

Upon completion of the registration procedures for blood pressure and pulse wave (accumulation of the corresponding time series of blood pressure CAfl (t), flAfl (t) and series of RR intervals), block 2 of the URR generates a signal for determining particular and generalized indicators in block 11, the values of which are transmitted through the block 2 OAI in sub-block 4d.

In block 11 for determining particular and generalized indicators for the rest state and for load tests, the primary and secondary statistical parameters, as well as problem-oriented specific parameters are evaluated, which characterize, for example, the fulfillment of balance conditions, rate of change, and recovery time of parameters to the initial level. The initial data necessary for carrying out these assessments (series of RR intervals, blood pressure CAfl (t), DBP (1), time of day of measurement, and anthropometric data of the examined patient (gender, age, height, weight) are transferred from block 4 to the block 11 according to the team of unit 2 of the OAI.After the definition of the above parameters is completed, particular and generalized indicators are determined that, by the command of the unit 2 of the OAI, are received in block 9 of the KAFZ.

In block 9 of KAFZ, a generalized classification analysis is performed using a combination of particular and generalized indicators, the results of their convolution and regulatory data from block 10 of the regulatory data and recommendations memory. Based on the results of this analysis, the text of the final Conclusion is automatically generated, which is transferred to the block 12 for the formation of individual recommendations by command from the OAI block 2.

In this block, the selection of a specific variant of individual recommendations corresponding to a specific Conclusion is carried out using: - the correspondence table; the i-th version of the Conclusion - the first version of the recommendations; -text array of normative recommendations from block 10.

The generated individual recommendations are sent to the control unit and, together with the final conclusion, are sent to the information output units (display 16, and / or printer 15) through the visual information generation unit 17.

These estimates, obtained in real time, allow the dynamic response of the cardiovascular system to functional tests to determine:

Type and types of heart rhythm disturbance;

The state of autonomic regulation of heart rhythm;

The state of the circulatory system regulation mechanisms;

Functional reserves of the cardiovascular system;

Resistance of the cardiovascular system to deep breathing;

Resistance of the cardiovascular system to physical exertion;

Psychophysiological stability of the body;

The rate of aging of the body;

Reserve features of the cardiovascular system;

The operation of the device at any stage of the examination ends upon receipt from the operator 29 by giving them a command containing a sign of the end code or a sign of its interruption from the UVK remote control 13.

The block diagram of the Complex block I of the peripheral pulse sensor contains a block of the measuring element 34, created on the basis of an optocoupler with a matching stage, connected to the galvanic isolation block 35 through a low-pass filter 36 connected in series with each other, a low-frequency amplifier 37 with an automatic gain control element (AGC ), block 38 of an analog-to-digital converter (ADC), parallel-to-serial converter 39, block 40 of the complete code transmitter, multi / demultiplexer 41 power amplifier 42 output signal.

In addition, the multi / demultiplexer 41 is connected by direct and feedback connections to the bioinformation removal control and monitoring unit 43, which, in turn, has an output to the indicator 44 and the calibration signal generator unit 45, the output of the latter being connected to the input of the low-frequency amplifier unit 37 . The clock generator 46 is connected to the ADC block 38 directly and to the parallel-to-serial code converter 39 via a frequency divider 47. The galvanic isolation block 35 has an output to the BR connector block. The indicator 44 is placed inside the housing 48 so that its LG 49, 50, 51 and 52, corresponding to the signals (Lack of operating voltage, Ready, Pulseogram input, Poor input), come to the surface in a convenient place for viewing.

The upper surface of the housing 48 is made in the form of a hemispherical section 53, which serves as a support for the palm of the patient, moving into three inclined paths 54, 55 and 56 for separate placement of fingers on them. The middle track 55 is working, the angle 0 of its inclination to the base of the body (approximately 10-I 2 °) is greater (2n-3 °) than the angle of inclination of the extreme tracks for the convenience of placing fingers. Track 55 is made concave with the formation of a bed 57, on which holes 58 and 59 are made for outputting to the surface of the housing of the elements (lenses) of the optocoupler located inside the housing.

Bottom of the housing 48 is closed by a bottom cover 60 with a platform 61 protruding beyond the bottom outline of the housing. A vertical strut 62 is placed on this platform, on which a spring-loaded rocker arm is hinged 63. A spring-loaded clamp 64 is hingedly suspended at one end of the beam, and the second end of the rocker arm is made in the form of a pressure member 65. The clamp 64 is made concave and is located above the working bed 57 in the placement zone holes 58 and 59.

All working elements of the sensor are located on the boards 66 and 67, mounted inside the housing 48. On the board 66 is mounted a measuring element based on an optocoupler, and on the board 67 - means for converting the parameters of the primary electrical signal received at the output of the optocoupler into an electrical signal with parameters, consistent with the input parameters of the means of its subsequent processing.

Holes are made in housing 48 and rack 62 to provide output of power 68 and data cable 69 to the BR connector block for switching with the corresponding interface elements (voltage stabilizer 32 and multi / demultiplexer 1).

The proposed constructive implementation of the layout of the Complex unit of the peripheral pulse sensor ensures not only its compactness, but also the reliability of the correct fixed position of the hand due to the complete elimination of the possibility of registration artifacts associated with the involuntary movement of the hand or finger from which the sphygmogram is taken.

One of the key points of the device for active diagnostics is the question of the quality of the source information, in this case R-R intervals. First of all, this quality is characterized by the accuracy of determining the values of R-R intervals, while the accuracy itself depends on how accurately the leading edge of the R-peak of the pulse wave and the peak of the R-peak are reproduced.

The accuracy of the reproduction of the latter, in turn, depends on the geometry of the arrangement of the elements of the optocoupler, which is structurally made in the form of a collimated infrared radiation source 70, built into the housing 71 and a photodetector, in the housing 72 of which a recording crystal 73 is placed. A flat lens 74 of the infrared emitter and a convex lens 75 of the photodetector through holes 58 and 59 are brought to the surface of the bed 57.

. In addition, in the optocoupler unit, the relative positions of the measuring elements and their optical axes are made with the following relations: .7ЈLЈl0.5, (L) (1)

16 ° p 45 °, (Ф 2arctg (0.5d / h)) (2)

I. the distance between the centers of the flat and convex lenses of the emitter and the photodetector,

t is the average distance (according to data relating to different parts of the skin) from the surface layer of the skin of the finger to the plane that passes through the region of the location of the maximum density distribution of micro vessels,

a is the angle between the optical axes of the emitter and the photodetector (in gr.),

F is the angle of the cone, in grams (solid angle of registration of the photodetector),

d is the diameter of the convex lens of the photodetector,

h is the distance between the lower plane of the convex lens and the upper plane of the recording crystal of the photodetector.

The specific values of the design parameters d and h are chosen so that a two-sided inequality remains valid, linking them together 8 ° arctg (0.5d / h), Ј 22.5 °.

Relations (1.2) connecting the geometric parameters of the arrangement of the measuring elements of the optocoupler block are obtained on the basis of experimental data and the following considerations.

It is known that in the general case, the amplitude of the signal at the output of the photodetector depends on the following main factors:

emitter power

the geometry of the location of the emitter and receiver (the distance between them, their relative orientation),

 aperture of the photodetector and its sensitivity.

the signal A (t) received by the photodetector is essentially the sum of the components of the signals from the OL regions (ОЈ SOL),

A (t) 2 P (0L, t),

where: P (OL) is the amplitude of the optical signal from the pulse wave coming from the OL region, while in each of them (OL) the pulse wave has, generally speaking, a different phase of ss (2 mc) during its passage through the network of blood vessels. This is precisely what makes it impossible to register the leading edge of the RR peak of the pulse wave and the very top of the RR peak with high accuracy, since this requires recording the wave amplitude P (OL) in a relatively narrow range of phase values.

However, it is quite achievable to increase the amplitude-time resolution of the signal due to the selectivity of registration (selectivity of the signal collection area, from where the radiation comes to the photodetector). Enough for this:

provide the photodetector with a narrow radiation pattern of the received infrared radiation, for example, within the cone of the solid angle of registration Pk «2k, which, accordingly, will ensure that at every current point in time the pulse wave is recorded in a narrow phase range of the Aso juice-PC wave. Technically, a decrease in the solid angle of QR registration is achieved by placing the photodetector crystal at a certain distance from the housing surface and by reducing the diameter (d) of the photodetector lens. Such a cone covers a small region of OR tissue, which is much smaller than the entire OE region. (the area of tissue lying outside the cone is indicated by OS-R);

to reduce the contribution to the detected signal A (t) of the scattered component of the radiation, the source of which is those areas of the tissue from where the radiation after multiple scattering can fall into the registration cone. In order to reduce the contribution of the marked scattered radiation component from the OS-R regions, it is necessary at least to reduce the influx of primary radiation to these regions from the infrared emitter. The technical solution here is associated with the collimation of the output beam of the infrared radiation source, for example, due to the set of diaphragms placed in the tube and the orientation of the optical axis of such directed radiation to the tissue region lying above the photodetector (see Fig. 4). From the conditions of this task, the values of the following interrelated geometric parameters: 1. the angle of the solution (f) of the solid angle of registration QR, which relates the ratio of two design parameters (d / h), which are ultimately to be determined, 2. distance (L) between the centers of the flat and convex lenses of the emitter and the photodetector, 3. angle (a) between the optical axis of the collimated emitter and the optical axis of the infrared receiver. The initial data for solving this problem was primary experimental information related to the dependence of the quantity Al (lmax-Un) / lo on the varied geometric parameters L, φ, and a. Here lmax, tm is the maximum and minimum values of the signal amplitude related to the series of measurements in each of which only one of the three parameters was varied, for example, a - var, a L-constj and ф const;,; I0 is the amplitude of the signal at a solid angle of 2 tf. In FIG. Figure 8 shows, as an example, the influence of the angle a on the value of the experimentally recorded signal A (t). Here, the dependences A (t) f (t, a; 1, f) are represented by two graphs, where t is the current time, A is the signal amplitude in relative units, and the variable value assuming a value of 73 ° a, 2 65 °, the values of L and φ are fixed (constant). It can be seen from the above example that a decrease in the angle a provides a steeper leading edge of the pulse wave and a smaller radius of curvature of its peak, which, in turn, provides a higher accuracy in determining the R-R intervals. The experimentally found relationships (1) - (2) provide a solution to the problem of achieving high accuracy of recording the signal amplitude and amplitude-time resolution. It turns out that the relationship of geometric parameters resulting from (1) (2) (the placement parameters of the optocoupler elements and their mutual orientation) unambiguously determines such structural and technical features of the inventive Integrated sensor unit that have significant features that are absent from known analogues and prototype. These include:

the angle between the optical axes of the emitter and the photodetector,

solid angle of registration (solid angle within which infrared radiation penetrates the photodetector).

Thus, the technical side of the problem of increasing the reliability of the diagnostic Conclusion, which ultimately boils down to obtaining a high-quality signal recorded by the KB unit in the form of a peripheral pulse sphygmogram, is solved by the proposed design.

As noted above, in the work of the Complex units there are two stages: preparatory operations and the actual operation of the device in automatic mode.

Preparatory operations related to KB1 include: preparing the patient for a pulse wave and operations performed by the operator: initial start-up and operability check.

Preparing the patient for a pulse wave is as follows. The patient’s hand is placed on the surface of the case 48 so that its palm rests on the hemispherical section 53, the middle finger lies on the bed 57 of the profiled track 55, and the ring and index fingers are located on the tracks 56 and 54. Then, with the clamp 64, the middle finger is pressed to the surface of the track, while the pillow of the first phalanx of the finger is pressed against the lenses 74 and 75, thereby creating conditions for the penetration of infrared radiation into the area of the blood vessels in the finger and the conditions for the exit of the diffused radiation components. The hand in this position is firmly fixed, as:, - the palm rests on a hemispherical shaped protrusion,

one of the fingers (the worker) is pressed to the surface of the bed (optocoupler lenses),

1 - two others (calmly, without tension) lie on the side tracks in a convenient and comfortable position, while uneven paths naturally prevent lateral shift of the brush in any of the lateral directions.

On this, the preparatory operation associated with the placement of the hand and fingers on the surface of the KB1 block ends, the patient is ready to conduct a pulse wave survey. . data signals (in format) from the KB1 unit, since the latter was developed for primary use with the claimed device for active diagnostics, the following describes the verification procedure with the participation of the KBI block of this device. The health check of the KB1 block begins, as described above, with the inclusion of the power source 31 by the operator and the receipt of the command in the URR block 2, the beginning of work, the health check of the Complex blocks. Upon receipt of this command in block 2 of the RRC, it generates (for block 3 of the RRC) a control signal for establishing (opening) a two-way communication channel with the block 43 for controlling and monitoring the removal of the KBN block and through block 3 of the RRC, multi / demultiplexer 1 and the BR connector block transmits him the command code is a health check. Upon receipt of this code, the control unit 43 verifies the magnitude of the operating voltage (Crab) and determines whether its value is within the established tolerance. If the value of 11rab is within the specified tolerance, then the control unit 43 transmits a signal code via the feedback circuit, then the operating voltage is supplied to the unit 2, then the control unit 2 first sends the calibration command code to the control unit 43, and then generates a control signal (for the unit 3) to establish (opening) the data channel of the data block KBN, after which block 3 KRC opens it. Upon receipt of the Calibration command code for control unit 43, this unit generates a command for indicator block 44 to display this event - There is a voltage, as a result of which LG 50 lights up, then control unit 43 transmits to generator unit 45 a generation command for 15 s of calibration a signal simulating a regulated level signal from an optocoupler unit 34, which is input to an amplifier unit 37. Further, this calibration signal along a chain of blocks: from block 37 to block 2 of the OCR through blocks 38, 39, 40, 41, 42, 35, the connector block of the BR, multi / demultiplexer 1 and block 3 of the RRC enters the block 2 of the OCR. If the parameters of the calibration signal satisfy the criteria, then the OAU block 2 generates a ready signal for the KB unit and transmits it via the feedback circuit (between the OAU blocks 2 and the block 43) to block 43, after which the Ready signal comes from the last to the indicator block 44. This event is displayed by ignition of LG 51, which indicates the readiness of the design bureau to

work. At the same time, information about this event is transmitted to the information output blocks 16 and / or 18, and a message is also sent about the readiness of the peripheral pulse sensor.

If the parameters of the calibration signal do not satisfy the criteria, then the OCR unit 2 generates a signal Unavailability of the KB1 block and, similarly to the above described, a display of this event is formed, as a result of which the LG 52 lights up and a corresponding message is displayed on the display and sound speakers. After that, the operator, monitoring the results of the automatic health check, must identify the corresponding cause of the malfunction, eliminate it, and then repeat the check procedure again.

In the event that the value of the irab is outside the limits of the established tolerance, a signal code is received from the control unit 43 in the OCR unit 2: No operating voltage. In accordance with this, unit 2 of the OAF does not generate and does not transmit the Calibration а command code, since the control unit 43 does not receive this code, the Ready signal is also not received in the indicator unit 44. The display of this event (ie voltage event) is the absence of indication (ignition) of LG 49. After the signal code is received in block 2 of the OAI, the operating voltage is absent or if it is absent for 10 seconds, the URR unit 2 transmits a message through blocks 17 and / or 19 the lack of operating voltage on the KB block and recommendations for eliminating possible causes. For the operator, this is a signal to de-energize the KB1 block, identify and eliminate the corresponding cause, and then repeat the voltage supply procedure again.

On this, the sequence of preparatory operations for Complex block I of the peripheral pulse sensor ends, then it works in automatic mode.

The procedure for taking a pulse wave and the stages of its subsequent processing begins with the formation of a control signal in block 2 of the OAI to establish (open) information channels of communication with control units 43 of KB1. Upon receipt of this control signal in block 3 of the RRC modes of operation, the corresponding communication line is switched. After that, the KBN block is ready to receive and process the pulse wave signal.

During the inspection, the electrical signal from the infrared radiation photodetector of the optocoupler unit 34 through the matching stage, the low-pass filter 36 is fed to the input of the low-frequency amplifier unit 37, the feedback circuit of which has an automatic gain control (AGC) of the output signal.

From the output of the amplifier unit 37, the signal is fed to the input of the ADC (analog-to-digital converter) unit 38, which is necessary to convert the current voltage value equivalent to the flowing current to a digital binary code for its subsequent input into sub-unit 4a of the OPB unit 4 and quality analysis unit 7 pulse wave. Upon completion of the conversion of the analog signal into a parallel digital code, block 38 issues a permit for operation of the code converter block 39, which transforms the parallel code into a serial one.

The operation of block 38 of the ADC and block 39 of the parallel-binary-to-serial converter is controlled by block 46 of the clock generator through block 47 of the frequency divider, which reduces the frequency of the generator to 9.6 kHz.

Block 39 of the code converter includes two 8 (16) input multiprocessors, a binary counter and a trigger. The counter is started after the end of each ADC conversion cycle and is blocked by a trigger after 16 pulses with a frequency of 9.6 kHz pass until the next (new) result appears at the ADC output.

Then this code is fed to the input of the block 40 of the shaper of the complete code message, in which the start and stop bits are added to its composition. Conversion of the parallel code received from the ADC output to serial, the addition of start and stop bits (total signal) occurs during the operation of the pulse counter.

This total signal is fed to the multi / demultiplexer 41 and then to the output signal power amplifier unit 42, which provides for the normal functioning of the galvanic isolation unit 35, made for example on the basis of an optocoupler. The galvanic isolation unit is necessary to fulfill the electrical safety requirements of the patient in the event of a malfunction in the power circuit, for example, block 31.

the sequence An (t) does not contain the necessary minimum of characteristic features that coincide with the characteristics of one of the pulse wave classes; the pulse wave quality analysis unit 7 generates a poor-quality input signal code and transmits it to the URR unit 2, which in turn sends a poor-quality input signal to control unit 43 and, finally, the latter generates a signal code for indicator block 44 to show a sign of poor-quality input, which is reflected by the indication (on) of LG 52. of unit KB1.

For the operator, this means the need to establish and eliminate the causes of poor-quality input and repeat the pulse wave measurement procedure. At the same time, he can be guided by the list of necessary actions displayed on display 16 to establish the possible cause of poor-quality input and eliminate it. The list, among other things, includes recommendations for adjusting the position of the finger on the sensor and a suggestion to repeat removal or disconnect the device for offline testing.

At the end of all measurement cycles, the unit 2 of the OCR of the KBP unit generates a power off signal, which is transmitted to the control and monitoring unit 43. In turn, the control unit 43 supplies a shutdown signal to the voltage stabilizer unit 32 through the BR connector unit and at the same time, the control unit 43 generates a signal. The end of operation, the indicator 44 - transmitted to LG 49, signals the disconnection of the operating voltage.

This completes the work of the Complex block I of the peripheral pulse sensor.

Claims (13)

1. A device for active diagnostics, comprising interconnected by a connector block and enclosed in independent housings. A complex block of a peripheral pulse sensor, including an optocoupler block with a matching cascade, and a Complex software and hardware block, which includes a pulse wave recording block, a high-pass bandpass filter, determination blocks R - R intervals in real time, accumulation of rows of R - R intervals, analysis of the quality of a pulse wave, control of operating modes, memory of classification signs of class ss of a pulse wave, memory of normative data, determination of private and generalized indicators and output of visual information, as well as a control panel for entering anthropometric data of the patient and commands, while the control unit for operating modes is looped with a unit for determining R - R intervals through a filter and a pulse recording unit wave, has a direct and feedback connection with the pulse wave quality analysis unit, which, in turn, has an input from the classification unit of the classification features of the pulse wave classes, and in addition, the control unit Niya has direct and feedback connection with the unit for determining private and generalized indicators, output to the visual information output unit and input from the control panel, characterized in that the device contains the Integrated block of the blood pressure sensor and the Integrated block of actuators associated with the integrated hardware and software block through the block of the connector, as well as a multi / demultiplexer, block of switches of operating modes, block of classification analysis and formation of Conclusions, memory block of regulatory recommendations, block blood pressure data memory, patient anthropometric data memory unit, multi / demultiplexer has a direct and feedback connection with the operating mode control unit through the operating mode switch unit, the classification analysis and formation unit The conclusions have inputs from the private and generalized indicators unit and from the regulatory memory unit data and recommendations, as well as direct and feedback with the control unit of the operating modes, while in the optocoupler unit the mutual placement of the measuring elements of the radiation the body and the photodetector and their optical axes is made with the following ratios:

where L is the distance between the centers of the flat and convex lenses of the emitter and the photodetector;
m is the average distance (according to data relating to different parts of the skin) from the surface layer of the skin of the finger to the plane that passes through the region where the maximum distribution of microvascular density is located;
α is the angle between the optical axes of the emitter and the photodetector, deg .;
Φ - the angle of the cone (solid angle of registration of the photodetector), deg .;
d is the diameter of the convex lens of the photodetector;
n is the distance between the lower plane of the convex lens and the upper plane of the recording crystal of the photodetector.  2. The device according to claim 1, characterized in that the blocks of accumulation of rows of R - R intervals, the blood pressure data memory and the patient anthropometric data memory are arranged together with the pulse wave recording unit in the integrated bioinformation memory unit, while its components are indirectly interconnected through the operating mode control unit.  3. The device according to claim 1, characterized in that the device is equipped with a unit for isolating and analyzing types of cardiac arrhythmias, having inputs from real-time R - R interval determination units and a combined bioinformation memory, as well as access to control operation modes.  4. The device according to claim 1, characterized in that the device is equipped with a unit for generating individual recommendations having inputs from memory blocks of normative data and recommendations, determining private and generalized indicators, and also outputting to the operating mode control unit.  5. The device according to claim 1, characterized in that the device is equipped with a unit for determining the parameters of the test effects, having direct and feedback with the control unit operating modes.  6. The device according to claim 1, characterized in that the device is equipped with an audio information generating unit having an input from the operating mode control unit and output to the speakers.  7. The device according to claim 1, characterized in that the Integrated block of the blood pressure sensor contains a pressure measurement unit, a control and signal conversion unit and an indicator, while the pressure measurement unit through the control unit, connector block, multi / demultiplexer and operating mode switch block connected to the control unit of the operating modes of the Integrated software and hardware unit.  8. The device according to claim 1, characterized in that the Comprehensive block of actuators contains a set of actuators with control units, each of which has two-way communication with the control unit of the operating modes of the Integrated software and hardware unit through the connector block, multi / demultiplexer and switch block operating modes.  9. A complex unit of a peripheral pulse sensor, comprising optocoupler units integrated in the housing with a matching stage, connected to the galvanic isolation unit through a series-connected low-pass filter, a low-frequency amplifier with automatic gain control, a parallel-to-serial converter, an analog-to-digital converter, the complete code transmitter unit and the output power amplifier, while the clock generator has one connection with the converter unit allele code in serial through a frequency divider and a second connection with it through an analog-to-digital converter unit, and the housing has holes for accommodating the lenses of the optical emitter and the photodetector of the optocoupler on the area of its upper surface, which is made in the form of a concave bed for contact with the working finger and equipped with a latch, characterized in that it is equipped with a connector block for providing two-way information communication with a device for recording and processing a signal and communicating with a stabilizer on tension of the power source, while the entire upper surface of the housing of the complex sensor unit is made with the possibility of support and simultaneous fixation of the hand and has the appearance of a convex hemispherical section for supporting the palm, turning mainly into three inclined tracks located at different heights for separate placement of fingers, and above the bed one of the tracks in the exit zone of the optocoupler elements has a latch fixed in the form of a concave spring-loaded finger clip.  10. The block according to claim 9, characterized in that a control and monitoring unit for removal control and a multi-diplexer are connected thereto, connected by direct and feedback, while the first input of the multi-duplexer is connected to the output of the complete code message generator unit, its second input is connected with the output of the galvanic isolation unit, one of the outputs of the multi-deflector is connected to the power amplifier of the output signal, and the control and monitoring unit is connected by direct and feedback to the voltage regulator through the connector block. 11. The block according to claim 9, characterized in that in the optocoupler block, the relative positions of the measuring elements of the emitter and the photodetector and their optical axes are made with the following ratios:

where L is the distance between the centers of the flat and convex lenses of the emitter and the photodetector;
m is the average distance (according to data relating to different parts of the skin) from the surface layer of the skin of the finger to the plane that passes through the region of the maximum distribution of microvessel density;
α is the angle between the optical axes of the emitter and the photodetector, deg .;
Φ - the angle of the cone (solid angle of registration of the photodetector), deg .;
d is the diameter of the convex lens of the photodetector;
n is the distance between the lower plane of the convex lens and the upper plane of the recording crystal of the photodetector.  12. The block according to claim 9, characterized in that a calibration signal generator block is inserted into it, the input of which is connected to the output of the control and removal control unit, and its output is connected to the input of the low-frequency amplifier unit. 13. The unit according to claim 9, characterized in that it is equipped with an indicator having an input from the control unit and the removal control, and the indicator eyes are brought to the surface of the housing.