DE102007063934B3 - Device for detecting biosignals - Google Patents

Abstract

Device for determining and analyzing biodata of a living being, consisting of a basic module with a power supply and a storage unit and at least one sensor device for non-invasive measurement of at least one measurement signal representing cardiac activity and / or respiratory activity selected from the group: pulse rate, Plethysmogram, oxygen saturation, respiratory signal, heart signal and an analysis device connected to the sensor device for extracting at least one CWP (continous wave parameter) from the measurement signal, and / or means for determining at least one CWF (continuous wave fluctuation), characterized in that the CWF is determined from the CWP and / or the measurement signal, wherein additional modules can be adapted to measure further signals, wherein a module (pneumology module) can be added, which is designed to determine respiratory parameters and this module for wide re analyzes can be adapted to a data bus of the basic module, wherein the connection between basic and pneumology module is designed as a plug-in connection that is easy and quick to use, with a further module (cardiology module) can be added, which is used to determine cardiological Parameter is formed, wherein the cardiology module allows ECG recording and wherein this module can be adapted for further analysis of the data bus of the basic module and / or the pneumology module and wherein the connection between the basic and / or pneumology module and Cardiology module is designed as a plug-in connection, which is easy and quick to use, wherein at least one interface in the range of the basic module and / or in the area of additional modules is arranged, which serves for the reading of data and / or the control of other devices a display means and / or an output means is provided for analysis results, wherein means for d The attachment of the device are provided on the body of a living being, wherein for the identification of physiological events at least two signals that are related in time, are evaluated, wherein a supplementary signal evaluation is performed in that a frequency analysis is performed and that the signal evaluation within at least one the measured data are stored in the device, and optional online via cable or optional wirelessly transmitted to a PC.

Description

The device according to the invention relates to a modular system for determining biodata of a living being, comprising at least one sensor device for the non-invasive measurement of at least two signals.

This is to identify sleep-related illnesses and support a diagnosis. The determination of sleep-related disorders or illnesses is currently always carried out by a specialist and usually during the night in a sleep laboratory. Usually, a polysomnography device is used for this purpose. Due to the small number of trained medical specialists and the small number of sleep laboratories, many patients often have to wait a long time for a diagnosis or a diagnosis is not even made.

Object of the present invention is therefore to provide a device that allows a simple, fast and inexpensive diagnosis. In addition, by evaluating parameters of the pulse wave an extended statement, compared to the previous polysomnography, be made available. This extended statement should particularly concern the activity and assessment of the autonomic nervous system.

In particular, there are no devices with fewer input channels than polysomnography devices that allow for a diagnosis comparable to that of a polysomnography device.

Another object of the invention is to provide a modular device which makes it possible to quickly and easily adapt complementary modules as needed.

Likewise, there are no devices that can be adapted as needed, but rather present polysomnography devices are always equipped with all channels, even if only a few channels would be sufficient and useful for the current investigation.

It is therefore also an object of the present invention to construct a device of the type mentioned in the introduction in such a way that an individual applicability for a patient is made possible, in the sense that only the specific modules which are actually necessary for the patient are used for the analysis , For further analysis further modules can be quickly and easily adapted to the basic module. A particular advantage of the device according to the invention is that even medical laypersons or at least medical staff or non-specialist doctors are readily able to apply the device according to the invention to the patient quickly and correctly.

This object is achieved according to the invention in that a basic module has interfaces for adapting supplementary individual modules for determining further biodata, such as ECG, heart rate, respiratory flow, PTT (pulse transit time).

A plethysmogram ( 49 ), for example with a pulse oximeter and / or a multi-wavelength pulse spectrometer (according to DE 10 2005 020 022 A1 . DE 102 13 692 A1 . DE 103 21 338 A1 ) recorded. The terms pulse oximeter and / or a pulse spectrometer are used here synonymously. The pulse oximeter and / or the pulse spectrometer, using at least two wavelengths selected from the range 400 to 2500 nm, at least determine the following parameters: pulse rate, plethysmogram and oxygen saturation (SpO2 and / or SaO2). In the following, the terms SpO2 and SaO2 are therefore used synonymously.

At least one CWP (continuous wave parameter) is extracted from the plethysmogram, preferably at least two or more CWPs are extracted. CWP are various fluctuating parameters, each describing a property of the plethysmogram. For example, the following quantities can be calculated as CWP: the pulse wave amplitude, the integral over certain sections of the plethysmogram, the ratio of different integrals over different sections of the plethysmogram, a respiratory correlated portion of the plethysmogram, the slope angle of each pulse wave, the fall angle of each pulse wave, the Ratio of rise to fall angle, the duration of a pulse wave rise, the duration of a pulse wave drop, the rise to fall duration ratio, the pulse wave maximum, the pulse wave minimum, a magnitude related to PTT (Pulse Transit Time). According to the invention, any parameter which describes a property of a section of the plethysmogram should be representable as CWP.

Looking at CWP over time, it can produce a CWF signal ( 50 ) (continous wave fluctuation), which is subject to fluctuations (= fluctuations), which are relevant for signal evaluation. The CWF signal ( 50 ) contains information about the fluctuations (= fluctuations) of the plethysmogram or the derived CWP. According to the invention, one of the following quantities is to be represented as a CWF signal: the pulse wave amplitudes, parameters related to the integral over a section of the plethysmogram, ratio of different integrals over different sections of the plethysmogram, parts of the plethysmogram correlating with the respiration, angle of rise of the pulse waves Pulse wave falloff angles, rise to fall angle ratios, pulse wave rise durations, pulse wave fall durations, rise to fall duration ratios, the envelope of the pulse wave maxima or pulse wave minima, values associated with the PTT (pulse transit time), the centerline of the pulse transit time Plethysmogram, the pulse rate.

However, it is also contemplated to use the PTT or other signals subject to variations to determine a CWF. According to the invention, any variation of the plethysmogram, each CWP and any combination of different CWP should be representable as a CWF signal.

It is provided that at least one sensor for non-invasive measurement of at least two signals selected from the group: CWF (continuous wave fluctuation), SpO2, pulse rate, heart rate, PTT (pulse transit time) is connected to an evaluation device that the evaluation device at least has an analyzer and that the analyzer determined by signal analysis definable signal ranges and that a comparison means the signal ranges analyzed taking into account further parameters and the result of the analysis is transmitted as an index value to a connected output device.

According to the invention, different signals can be combined in order to detect relevant fluctuations of the pulse wave and to use them for the evaluation.

The aim of the invention is therefore not the diagnosis of a disease and not the mere determination of the frequency and severity of the occurrence of certain pathophysiological events. On the contrary, it is determined on the basis of the recorded signals how high the individual risk of the examined person is to suffer secondary diseases which impair the quality of life or life expectancy. Likewise, based on the determined risk, it can be deduced which therapy form and therapy dosage is optimal for the person. In addition, the success of existing therapy can be measured. By evaluating at least two of the following signals selected from the group: continuous wave fluctuation: CWF (PWA), SpO2, pulse rate, heart rate, PTT (pulse transit time), for example by application of photoplethysmography, it is possible to study the interactions of a Variety of physiological and pathophysiological processes. In addition, it is possible to make comparable statements to already known methods using, for example, respiratory disorders, sleep disorders, diabetes, using a considerably reduced number of measuring sensors, namely only one measuring sensor, for example in the form of a pulse oximetry sensor. Inflammatory reactions, disorders of autonomic regulation and cardiovascular diseases.

For example, it is contemplated to discriminate obstructive and central respiratory disorders from patterns detected in a plethysmogram-derived CWF signal. The characteristic patterns have frequency components which are associated with the respiratory frequency.

A signal evaluation over a predefinable period of time is supported by the fact that the sensor is connected to a first memory unit for storing a detected measurement signal.

To carry out a course analysis of the detected signal, it is proposed that the evaluation device has a course analyzer for analyzing the time profile of the signal.

To further improve the evaluation options, it is proposed that the comparison device is provided with a second memory unit for storing the calculated index value.

A typical evaluation procedure takes place in that a CWF signal waveform of the measurement signal is evaluated.

According to a further embodiment, it is provided that a specific frequency of the measuring signal is evaluated. With regard to the statement sensitivity, it proves to be particularly advantageous that a change intensity of the measurement signal is evaluated.

A comprehensive signal evaluation can be done by performing a pattern recognition.

A further signal evaluation can take place in that by signal analysis, patterns are detected which are recurrent and / or transient in nature.

A supplementary signal evaluation can be carried out by performing a frequency analysis.

An alternative signal evaluation can take place in that an analysis of the slope is performed.

Signal evaluation can be carried out by forming histograms and / or distributions and / or derivatives. An alternative signal evaluation can take place in that threshold values are compared and / or correlated.

A creation of a hierarchy of the signals and / or a decision tree can further support the signal evaluation.

One way to capture signals is to evaluate a continuous wave fluctuation (CWF) signal.

Another possibility for signal detection is that an SpO2 signal is evaluated.

Another possibility for signal detection is that a pulse rate and / or heart rate signal is evaluated.

Another possibility for signal detection is that a PTT (pulse transit time) is evaluated.

An additional option for signal acquisition is that an EEG signal is evaluated.

It is also thought that an ECG signal is evaluated.

It is also thought that an EMG signal is evaluated.

Another measurement variant is that an oxygen saturation of the blood is evaluated.

Another measurement variant is that a hemoglobin concentration of the blood is evaluated.

To record respiratory parameters, it is provided that a respiratory course is evaluated.

In order to record additional parameters, snoring, arousals, blood pressure, CO2, sleep stages, skin conductance, sleep depth, sleep fragmentation, parasympathetic activity can be evaluated in addition or in relation to the sympathetic, vascular compliance.

An easy to implement measuring principle is that an optical density of at least one body region is evaluated.

According to a typical evaluation method it is provided that a signal evaluation is carried out with regard to present periodic signal components.

An evaluation of particularly meaningful waveforms takes place in that an analysis is carried out with regard to a maximum signal change.

In particular, it proves to be advantageous that the index of a cumulative autonomous resting intensity is associated with the regulation of the cardiovascular system.

The detection of particularly meaningful events is achieved by performing a signal analysis regarding a period of activation of the autonomous system.

A further increase in the quality of the statement can be achieved by evaluating at least one further parameter when evaluating periods of activation of the autonomous system. The increase in the quality of the statement can be achieved by comparing the change in various parameters acquired or derived from the detected parameters at the time of activation of the autonomous system in terms of strength, type and time sequence.

To eliminate interference or singular events, it is proposed that the cumulative number and intensity of the activation periods of the autonomous system be taken into account when determining the index.

A simple measurement setup is supported by the fact that the heart rate is detected by the sensor.

In particular, it is thought that the sensor detects the variability of the heart rate.

In addition, it is also possible that the PTT is detected by the sensor.

To suppress interference, it contributes to the artifact detection or elimination is carried out before the evaluation of the detected parameters.

A recognition of short-term signal changes is supported by the fact that a maximum value of the measured signal detected by the sensor is evaluated within a predefinable time interval.

An easily applicable measurement method is that the signal acquisition is performed using photoplethysmography.

An increase in system sensitivity can be achieved by carrying out the signal evaluation within at least one predeterminable frequency band.

To take account of interactions, it is provided that at least one further body parameter is evaluated by the evaluation unit.

For example, it is thought that as a further body parameter, the age of the living being is evaluated.

It is also possible that the sex of the living being is evaluated as a further body parameter.

Alternatively or additionally, it is also possible for the weight of the living being to be evaluated as a further body parameter. Alternatively or additionally, it is also possible for one or more already known risk factors, for example for a cardiovascular disease, to be evaluated as a further body parameter.

Alternatively or additionally, it is also possible for one or more factors already known which influence the autonomous regulation to be evaluated as further body parameter, in particular the medication.

Alternatively or additionally, it is also possible that one or more additionally detected parameters are evaluated as a further body parameter, eg. B. the arterial oxygen saturation.

A consideration of events past in time can take place in that the patient's health history is evaluated as a further body parameter.

A further increase in the quality of the statement can be achieved by evaluating the medication of the living being as a further body parameter.

A further increase in the statement quality can be achieved by evaluating comparison values of other persons as further parameters.

According to the invention, for example, with a pulse oximeter sensor, at least the following signals are determined: Plethysmogrammcontinous, SpO2, pulse rate.

In addition, respiratory signals such as heart rate, PTT (pulse transit time), flow, pressure or snoring are registered and analyzed by adding suitable sensors. It is also thought to use ECG signals, EEG signals, EMG signals for the evaluation. Furthermore, blood pressure and CO2 can be recorded and used for the evaluation.

• • Mustererkennung
• • Signalanalyse (harmonisch/ transient)
• • Frequenz-Analyse
• • Analyse der Steigung
• • Histogramme, Verteilungen, Ableitungen
• • Kombination (statistisch) verschiedener Faktoren, Messwerte, ermittelte Werte,
• • Ereignis Daten, langfristiger Trend
• • Schwellenwert Vergleich,
• • Korrelation
• • Hierarchie der Signale
• • Entscheidungsbaum
• • Digitale Filterung
• • Wavelet-Analyse
• • Zwischenspeicherung von Signal-, CWP- oder CWF-Abschnitten
• • Entropie, Standardabweichung
• • Verfahren der Chaos-Theorie

The evaluation of the signals is carried out according to at least one of the following methods:

• • Pattern recognition
• • Signal analysis (harmonic / transient)
• • Frequency analysis
• • Analysis of the slope
• • histograms, distributions, derivatives
• • Combination (statistical) of various factors, measured values, determined values,
• • Event data, long-term trend
• • Threshold comparison,
• • correlation
• • Hierarchy of signals
• • decision tree
• • Digital filtering
• • wavelet analysis
• • Caching of signal, CWP or CWF sections
• • entropy, standard deviation
• • Method of Chaos Theory

As a result, the device according to the invention determines a risk index specific for the patient. This can be specified as a percentage, for example. The medical history of the patient is preferably taken into account together with the current measurement data for determining the risk index. As a database, at least one readable memory is arranged in the region of the device according to the invention.

• 1 eine Vorrichtung zur Ermittlung von Werten in mehreren Ansichten,
• 2 adaptierbare Sensoren der Vorrichtung,
• 3 Peripheriegeräte der Vorrichtung,
• 4 Gurte zur Befestigung der Vorrichtung,
• 5 Anwendung mit adaptierten Sensoren,
• 6 eine Vorrichtung mit angeschlossenem Rechner und
• Sichtgerät,
• 7 ein Diagramm einer Sensorregistrierung mit einem Sensorrohsignal und ein extrahiertes Signal (CWF-Signal),
• 8 ein Plethysmogramm und ein extrahiertes Signal (CWF-Signal) zur Amplitudenhöhendarstellung,
• 9 eine Armmanschette mit aufgenommenen Grundmodul und zwei ergänzenden Modulen und
• 10 eine Prinzipdarstellung mit einem Grundmodul und zwei ergänzenden zugeordneten Modulen.

The invention is explained below in application examples. Show it:

• 1 a device for determining values in several views,
• 2 adaptable sensors of the device,
• 3 Peripherals of the device,
• 4 Straps for fastening the device,
• 5 Application with adapted sensors,
• 6 a device with a connected computer and
• Vision device,
• 7 a diagram of a sensor registration with a sensor raw signal and an extracted signal (CWF signal),
• 8th a plethysmogram and an extracted signal (CWF signal) for the amplitude height representation,
• 9 an arm cuff with incorporated basic module and two complementary modules and
• 10 a schematic diagram with a basic module and two complementary assigned modules.

The device according to the invention makes it possible, in a preferred exemplary embodiment, to rapidly determine the risk index in that at least three signals, namely plethysmogram, blood oxygen saturation and pulse rate, are determined substantially simultaneously with the aid of a pulse oximetry sensor. From this, important CWF signals can be calculated for further analysis.

Pattern recognition analyzes the signals and compares them with stored values. The result of the comparison yields a patient-specific index value suitable for providing information about the risk of e.g. Cardiovascular disease, a disease of the vascular system, a sleep-disordered breathing, a neurological disease, a respiratory disease or a metabolic disease to enable. The device according to the invention is small and portable. The energy supply takes place alternatively via accumulators / batteries and / or via a mains cable.

The measured data are stored in the device on a Compact-Flash ^® Card, as well as transmitted online via cable or optionally wirelessly to the PC. For ambulatory use, the data stored in the device can either be transferred to the PC via a USB interface or read into the software by reading the CompactFlash ^® Card via a reading device.

The device according to the invention for determining and analyzing biodata of a living being consists of a basic module with a power supply and a memory unit and at least one sensor device for the non-invasive measurement of at least one measurement signal representing the heart activity and / or the respiratory activity. The sensor device may for example be selected from the group: ECG, blood pressure cuff, pulse oximeter, impedance sensor, Doppler sensor.

The measurement signal, which represents the heart activity and / or the respiratory activity is selected from the group pulse rate, plethysmogram, oxygen saturation, respiratory signal, heart signal. Connected to the sensor device is an analysis device for extracting at least one CWP (continous wave parameter) from the measurement signal, and / or a device for determining at least one CWF (continuous wave fluctuation) wherein the CWF (conti-nous wave fluctuation) is preferred the CWP and / or the measurement signal is determined.

A classifier compares at least one CWF information and / or derived variables with stored data in order to identify physiological / pathophysiological events. Such events are, for example, an apnea, it being possible according to the invention to distinguish between central and obstructive apneas.

In another embodiment, a classifier compares at least one CWF information and / or quantities derived therefrom with other measurement signals and / or CWP in order to identify physiological / pathophysiological events therefrom.

At least part of the results of the analysis device and / or at least a part of the results of the classifier are output substantially directly acoustically and / or graphically, preferably via a display. According to the invention, at least two signals that are temporally related are evaluated for the purpose of identifying physiological events.

The device according to the invention can be expanded to include additional modules for measuring further signals. For this purpose, the modules are preferably adapted in the sense of a "plug and play". Preferably, complementary sensor devices are adapted for this purpose.

For this purpose, at least one interface is arranged in the region of the basic module and / or in the region of supplementary modules.

The interface also makes it possible to read data and / or control other devices, in particular therapy devices.

At least as an alternative or supplemental, at least the following are provided as adaptable sensor devices: ECG, EMG, EOG, EEG, pulse oximetry, blood pressure, impedance measurement, ultrasound, Doppler, CO2, respiratory flow, snore, mouth, Thoracic, abdominal, position sensor.

The sensor devices can be supplemented in the form of a module which is designed, for example, to determine respiratory parameters, such as respiratory flow, PTT, motion signals, respiratory effort.

The sensor devices can also be supplemented in the form of a module, which is designed to determine cardiac parameters, such as ECG, cardiac frequency.

To enter patient data such as age, gender, health, a device for data entry is provided.

A display is provided as a display means for analysis results. In addition, acoustic alarms are provided. According to the invention, at least the basic module is releasably fixed to the body of a patient with fastening means, such as straps, for example.

In another embodiment, the device for detecting and analyzing biodata of a living organism, at least one sensor device for non-invasive measurement of at least two signals, such as plethysmogram and derived from it CWF signals (continous wave fluctuation), SpO2, pulse rate and one of the Sensor device connected to the analysis device for analyzing transient and / or periodically recurring pattern of the measured signals. In addition, a module is provided for evaluating such information related to the frequency or amplitude of the signals or the parameters derived therefrom.

In a supplementary embodiment, the device for determining and analyzing biodata of an animal consists of a basic module with a power supply and a storage unit and at least one sensor device for non-invasive measurement of at least one measurement signal representing the respiratory activity, for example oxygen saturation, respiration signal, pressure signal, flow signal and at least one further sensor device for the non-invasive measurement of at least one measurement signal representing cardiac activity, for example oxygen saturation, blood pressure, pulse rate, ECG, plethysmogram and an analysis device connected to the sensor device for extracting at least one CWP (continous wave parameter) from at least one the measuring signals.

For example, conclusions about apneas, hypopneas and other respiratory disorders can be obtained by analyzing the measurement signals. Using at least one sensor device for the non-invasive measurement of at least one measurement signal representing respiratory activity and at least one further sensor device for non-invasive measurement of at least one measurement signal representing cardiac activity, it is possible to draw conclusions about diseases of the cardiovascular system, for example by pattern recognition System and / or the respiratory system.

• • Anwendungsteil bestehend aus:
  • - Grund-Modul
  • - Kardiologie-Modul
  • - Pneumologie-Modul
  • - Applikationsteile
  • - Batterie/Akku, z.B. LiIon-Akku
  • - medizinisch zugelassenes Netzgerät (Sekundärseite) mit Kombikabel zur Ladung des Akkus und zur Datenübertragung der gespeicherten Daten über eine galvanisch getrennte USB-Schnittstelle (Konverterbox) an einen PC
  • - PC-Software: Die Software kann unter den Betriebssystemen Windows 2000 ab SP 2, Windows XP Professional und Home-Edition betrieben werden.
  • - Nichtmedizinische elektrische Geräte:
  • - Netzgerät (Primärseite)
  • - USB/TCP/IP Konverter
  • - Bluetooth^®-USB-Adapter
  • - CompactFlash^® Card-Lesegerät
  • - PC-System (Fremdzubehör).

In the following, further embodiments will be described.

• • application part consisting of:
  • - Basic module
  • - Cardiology module
  • - Pulmonology module
  • - Application parts
  • - Battery / battery, eg Li-ion battery
  • - Medically approved power supply (secondary side) with combi cable for charging the battery and for data transfer of the stored data via a galvanically isolated USB interface (converter box) to a PC
  • - PC software: The software can be operated under the operating systems Windows 2000 SP 2, Windows XP Professional and Home Edition.
  • - non-medical electrical equipment:
  • - Power supply (primary side)
  • - USB / TCP / IP converter
  • - Bluetooth ^® USB adapter
  • - CompactFlash ^® card reader
  • - PC system (third-party accessories).

Basic module

The basic module consists of a pulse oximeter, a possible interface for the control of other devices, eg therapy devices, possible further interfaces for further, optional sensors, eg connection of a respiratory flow / snore sensor, a communication interface such as USB, or a wireless protocol, a readable memory, a power supply via battery / accumulator and a data bus controller, as a connection for further modules and a display for display of calculated indices, current measurements, current battery charge statuses. The basic module allows bidirectional data exchange with other devices, for example with APAP therapy devices, in order to pass on the determined data. The 9 shows how the basic module ( 53 ) with adapted pneumology module ( 54 ) and adapted cardiology module ( 55 ) on a common ground support ( 58 ) on the arm ( 57 ) of a user are positioned. Bidirectional data transmission is via the connected cable ( 56 ) possible. Alternative application sites for the device according to the invention are: finger, toe, nose, ear, forehead.

The device according to the invention has fewer input channels than conventional polysomnography devices and is thus much cheaper, smaller, lighter and more energy-efficient.

• • Pulsoximetriesensor zur Erfassung von Sauerstoffsättigung, Pulsfrequenz, Pulswelle, CWF, PTT

sensors:

• • Pulse oximetry sensor for detection of oxygen saturation, pulse rate, pulse wave, CWF, PTT

• • Pulsfrequenz
• • Sauerstoffsättigung (SpO2)
• • RDI und AHI (jeweils differenziert nach obstruktiv/ zentral)
• • Risikowert für obstruktive Atemwegserkrankung
• • Risikowert für zentrale Atmungsstörung
• • Risikowert für PLM (Periodic Leg Movement)
• • Kennwert für Erholungsfunktion des Schlafes
• • Autonomer (Micro-)Arousal Index
• • Schlafqualitäts-Index
• • Index für Respiratorische Ereignisse
• • Autonomer Status
• • Kennwert für aktuelle Konzentrationsfähigkeit
• • Kennwert für hohe Müdigkeit
• • Kennwert für hoher Schlafdruck
• • Autonome Ruhe
• • Index für Herz-Kreislauf-Risiko (Gefäßerkrankung, Rhythmologische Erkrankung, Herzinsuffizienz)
• • Leckage, Therapieerfolg
• • Index für den Fortschritt einer Erkrankung Pneumologie-Modul

The basic module can determine the following values:

• • Pulse rate
• • oxygen saturation (SpO2)
• • RDI and AHI (each differentiated according to obstructive / central)
• • Risk value for obstructive pulmonary disease
• • Risk value for central respiratory disorder
• • Risk value for PLM (Periodic Leg Movement)
• • Characteristic value for the recovery function of sleep
• • Autonomous (micro) arousal index
• • Sleep quality index
• • Index for respiratory events
• • Autonomous status
• • Characteristic value for current concentration ability
• • Characteristic for high fatigue
• • characteristic value for high sleep pressure
• • Autonomous tranquility
• • Cardiovascular risk index (vascular disease, rhythmic disease, heart failure)
• • Leakage, therapy success
• • Index for the progress of a disease pulmonology module

For further analysis, this module can be adapted to the data bus of the basic module. According to the invention, it is thought the connection between the basic and pneumology module as Plug-in connection, which is easy and quick to use. The pneumology module can also be used alone, without basic module. The pneumology module has at least one effort sensor system and a sensor device for determining a respiratory flow signal.

• • Effort Sensoren (Thorax- und Abdomenbewegungen);
• • Atemfluss-Schnarch-Sensor (Thermistoren und Mikrofon);
• • Atemfluss-Schnarch-Nasenbrille (Drucksensor);
• • Mundthermistor zur Erfassung von Mundatmung bei Therapiekontrolle;
• • Pneumo-T-Adapter zur Erfassung des Atemflows, Schnarchen und xPAP-Druckes (Drucksensor).

Possible sensors:

• • Effort sensors (thoracic and abdominal movements);
• • Respiratory flow snore sensor (thermistors and microphone);
• • Respiratory flow snoring nasal cannula (pressure sensor);
• • mouth thermistor for recording mouth breathing during therapy control;
• • Pneumo-T adapter for breath flow, snore and xPAP pressure (pressure sensor).

• • RDI/AHI (Apnoe / Hypopnoe Unterscheidung)
• • Arousals die mit einem respiratorischen Ereignis zusammenhängen
• • Unterscheidung zwischen RERAS und Arousals die mit Apnoe / Hypopnoe Ereignissen zusammenhängen
• • Unterscheidung obstruktiver und zentraler Ereignisse
• • Flattening
• • Schnarchen
• • Upper Airway Resistance Syndrom
• • Atemanstrengung, Work of Breathing Kardiologie-Modul

The pneumology module can determine the following values together with the basic module:

• • RDI / AHI (apnea / hypopnea distinction)
• Arousals related to a respiratory event
• • Distinction between RERAS and arousals associated with apnea / hypopnea events
• • Differentiation of obstructive and central events
• • Flattening
• • snoring
• • Upper Airway Resistance Syndrome
• • Breathing Exercise, Work of Breathing Cardiology Module

The cardiology module allows ECG recording. In addition, a position sensor can be adapted. For further analysis, this module can be adapted to the data bus of the basic module and / or the pneumology module. According to the invention, the connection between the basic and / or the pneumology module and the cardiology module is designed as a plug connection which can be operated simply and quickly. The cardiology module can also be used alone, without basic module and / or pneumology module.

• • EKG
• • Herzfrequenz-Variabilität
• • Pulstransit Zeit (PTT)
• • Lage abhängige Ereignisse

The cardiology module can determine the following values:

• • ECG
• • Heart rate variability
• Pulse transit time (PTT)
• • Location dependent events

According to the invention, it is intended to adapt additional modules as needed.

Converter box and power supply

The optional converter box is used for wired data transmission of the data stored in the device. The data transmission is galvanically separated via a USB interface. At the same time the device according to the invention is charged via the power supply unit, or permanently supplied with power.

PC software

The PC software is used for recording, storage, processing, visualization, evaluation, documentation and archiving of patient-related biosignals. This serves to support the diagnosis, therapy adjustment and therapy control of sleep disorders.

Device Software

The device software is used for acquisition, storage, processing and evaluation of biosignals. This serves to support the diagnosis, therapy adjustment and therapy control of sleep disorders. The device software communicates with the PC software via a secure data transfer protocol.

Non-medical electrical equipment

• • reader for reading out the storage medium used, eg for reading out the data stored on the CompactFlash ^® card;
• • Online module for wireless data transmission (Bluetooth USB adapter);
• • USB - TCP / IP converter;
• • PC system (third-party accessory).

The apparatus of the present invention generates information signals (e.g., battery state of charge) that are graphically visualized and stored by the personal computer system. These information signals serve to check the presence of the signals to be recorded, as well as the function check of the device. This avoids faulty recordings and eliminates the need for repetition of the night measurement.

The automated analyzes (CWF, PTT, SpO2, pulse rate, PLM, snore, sleep stage, arousal and cardiorespiratory analysis) take place offline from the signals stored in the PC and support the evaluator in the diagnosis of sleep disorders, as well as the therapy initiation and therapy control ,

In the case of online analysis in the device, it is possible to react directly to the analysis results, for example, remotely controlling another device. It is intended in the case of anesthesia, for example, to control drug dispensers and / or respirators in pilots of various means of transport (eg car, truck, train, plane, etc.) due to analysis results (eg lack of concentration, high fatigue, high sleep pressure ) To activate alarms, autopilot systems or the like or remotely control a therapy device (eg CPAP device) in the case of sleep medicine.

In principle, it is possible to use the device according to the invention both in the prevention of various diseases (risk determination for secondary diseases), as well as in real-time scenarios in which it reacts directly to currently detected patterns.

The PC software is used for visualization, evaluation, documentation and patient-related archiving of long-term examinations for the diagnosis of, for example, sleep disorders, cardiovascular diseases, diabetes. The system is configured and the transferred data is automatically analyzed offline. The software allows the user to enter comments. A manual reclassification of the analysis results by the evaluator is possible.

The patient is able to set up the sensors and the device himself after being instructed by qualified personnel and following the patient's instructions for use.

The inventive apparatus processes and stores all of the measured signals on the integrated CompactFlash ^® card. The data is read either via a USB cable or by reading the CompactFlash ^® Card with a reader. In stationary operation, the device according to the invention can transmit the recorded data online either wirelessly or by cable to the software, where the data is additionally stored.

In online monitoring with the device according to the invention existing networks can be used in clinics. If data is lost, eg when leaving the examination room, you can supplement this data with the data stored on the CompactFlash ^® Card. The inventive device is powered by a removable battery pack, so that it is independent of the network. Battery replacement does not result in loss of stored readings. You can also supply and operate the device permanently with the data transmission cable.

The device according to the invention has an optional position sensor. The sensor registers if and when the patient lies on his stomach, back or side. The device also has an optional Integrated effort sensor in the housing. The integration reduces cleaning and increases the life of the sensor.

With the help of a pushbutton a sensor test / impedance check can be triggered.

With the help of the display or corresponding light-emitting diodes can be determined in a sensor test / impedance check, whether or which electrode is well or poorly applied.

In addition, the device according to the invention by a yellow LED in the battery pack next to the battery icon indicates whether the battery is currently being charged. The state of charge can also be requested via the software, since a capacity monitoring is integrated in the battery.

Via a connection cable between the device and the PC system, e.g. a USB cable, the stored data can be transferred to the PC, alternatively, this can be done via a converter box, in which a galvanic isolation is integrated. The converter box can also be used to charge the battery with the included power supply unit. A battery module can also be charged if it is not inserted in the device.

Function of the software

• • CWF-Analyse
• • Schnarch-Analyse
• • Kardiorespiratorische Analyse
• • Arousal Analyse
• • Schlafstadienanalyse

The data transmitted during the measurement is stored and visualized. The data read in after the measurement are automatically analyzed according to time and value criteria. The software can perform the following automatic analyzes, for example:

• • CWF analysis
• • Snore analysis
• • Cardiorespiratory analysis
• • Arousal analysis
• • Sleep stage analysis

On the basis of the analysis results and the signals presented, the present results can be evaluated according to definable criteria.

Function of the sensors

Respiratory flow nasal cannula

The respiratory flow snore nasal cannula, in conjunction with the pressure sensor integrated in the device according to the invention, detects the respiratory flow and the snoring. The inspiration is registered by the generated negative pressure, the expiration by the generated overpressure. Snoring causes pressure fluctuations in the nostrils, which are also registered. When the mouth is closed, the pressure measurement reacts more sensitively to small flow limitations than the thermal measurement. It is independent of the ambient temperature and additionally enables the visual assessment of the temporal flow contour. In mouth breathing, the signals may be attenuated. Alternatively, therefore, the simultaneous use of the respiratory flow mouth sensor.

Pulse oximetry sensor

• • Die Hauptbestandteile des Sensors sind zumindest zwei Leuchtdioden und eine Empfängerdiode.
• • Für jede Pulswelle werden mehrere SpO2-Werte bestimmt (Split-Pulswave-Algorithmus).

The pulse oximetry sensor is used to measure pulse oximetry, blood oxygen saturation, pulse rate, and CWF.

• • The main components of the sensor are at least two LEDs and a receiver diode.
• • Multiple SpO2 values are determined for each pulse wave (split-pulse-wave algorithm).

The measured pulse rate changes correspond to the heart rate changes that were triggered by a sleep-related apnea syndrome, sufficiently accurate.

With the aid of photoplethysmography, the change in the pulse wave, in particular the amplitude of the pulse wave, is determined.

The device according to the invention calculates a quality index for each detected oxygen saturation value, which characterizes the quality or the accuracy of the measured SpO2 value.

If the signal is disturbed by movements, the number of values is low. Noise-free signals have a high number of values. Accordingly, a disturbed measurement signal produces a low quality value, an undisturbed measurement signal results in a high quality value. The quality signal assumes values between 0 and 100%. When assessing long-term SpO2 measurements, the quality signal can be helpful because it suggests artifacts that occurred during the measurement.

1 shows a handset with a pressure port ( 1 ) for connection to a pressure measuring tube, electrode connections ( 2 ), a RIB ( 3 ) as well as a connection ( 4 ) for an abdomen sensor (not shown) ( 35 ). There are also explained in more detail below LEDs ( 5 ), a button ( 6 ) and a battery lock ( 7 ) to recognize. Furthermore, a connection ( 8th ) for a charge / data transfer cable and a battery ( 9 ) to recognize. Preferably, a second pressure port ( 10 ) intended. The functionality is controlled by a thorax sensor ( 11 ) as well as a connection ( 12 ) for a pulse oximetry sensor further increased.

In the area of a back of the handset is an insert card ( 13 ) provided with application locations. In addition, a Z-electrode ( 14 ) as well as a connection ( 15 ) to recognize. The connection ( 15 ) is used to connect to a in 2 illustrated respiratory flow snore sensor ( 16 ) or a respiratory flow mouth sensor ( 27 ). The connection ( 1 ) is for connection to a respiratory flow snore nasal cannula ( 22 ) or a pressure measuring hose ( 28 intended. The connections ( 1 . 10 ) together serve for connection to a Pneumo-T adapter (33).

2 shows in addition to the above-mentioned sensors for connection to the handset sensor beads ( 17 ), a sleeve ( 18 ), a microphone ( 19 ), a carrier plate ( 20 ) as well as a sensor plug ( 21 ). Also, a sleeve ( 23 ), Cannulas ( 24 ), a tab ( 25 ) as well as a connection ( 26 ) of the respiratory flow snoring nasal cannula ( 22 ).

The pressure measuring hose ( 28 ) comprises a connecting piece ( 29 ), a connecting hose ( 30 ), a plastic tube ( 32 ) as well as a thread ( 31 ) for a CPAP connection. Further sensors are a pulse oximetry sensor ( 34 ) as well as an abdomen sensor ( 35 ).

3 shows components for the data transfer: The handset is typically connected to an evaluation device, which may be designed as a personal computer. The evaluation device in this case comprises a CD-ROM drive with CD ( 36 ), a charger ( 37 ) with power supply ( 38 ) and plugs ( 39 ), a charging data transfer cable ( 40 ) and a USB cable ( 41 ). A converter box ( 42 ) is with a socket ( 43 ) for the charge-data transfer cable ( 40 ), a USB socket ( 44 ) and a charger socket ( 45 ) fitted. A data transfer from the handset to the evaluation device can also directly by changing a memory card ( 46 ) respectively.

4 shows a device strap to support a mobile application ( 47 ) and an abdominal belt ( 48 ). With these, the device according to the invention is attached to the user. The strap is closed with the buckle. By adjusting the Velcro straps, the belt can be adjusted to the body circumference. The strap consists of a skin-friendly elastic loop tape.

5 shows in the left drawing part an application with a respiratory flow snore sensor ( 16 ) and in the right drawing part an application for measuring pressure in the area of a respiratory mask. The device is attached to the user with a pulse oximetry sensor and a respiratory flow snore sensor or connected to a respiratory tube with a Pneumo-T adapter.

6 shows a connected device to an evaluation device, which is designed here as a personal computer. Data are transmitted to a PC via a medically approved power supply unit with a combination cable for charging the battery and for data transfer of the stored data via a galvanically isolated USB interface of the converter box. The converter box is used for the wired data transmission of the data stored in the device. The data transmission is galvanically separated via a USB interface. At the same time the device according to the invention is charged via the power supply unit, or permanently supplied with power. The PC software is running on the PC. The PC software is used for recording, storage, processing, visualization, evaluation, documentation and archiving of patient-related biosignals. This serves to support the diagnosis, therapy adjustment and therapy control of sleep disorders. About the pulse oximetry sensor ( 34 ) are the pulse oximetric signals, the Oxygen saturation of the blood and the pulse rate of your patient measured. The main components of the sensor are at least two light emitting diodes and a receiver diode. For example, several SpO2 values are determined for each pulse wave (split-pulse-wave algorithm).

The measured pulse rate changes correspond to the heart rate changes that were triggered by a sleep-related apnea syndrome, sufficiently accurate.

• 150 nm ± 15%, 400 nm ± 15%, 460 nm ± 15%, 480 nm ± 15%, 520 nm ± 15%, 550 nm ± 15%, 560 nm ± 15%, 606 nm ± 15%, 617 nm ± 15%, 620 nm ± 15%, 630 nm ± 15%, 650 nm ± 15%, 660 nm ±, 705 nm ± 15%, 710 nm ± 15%, 720 nm ± 10%, 805 nm ± 15%, 810 nm ± 15%, 880 nm ± 15%, 890 nm, 905 nm ± 15%, 910 nm ± 15%, 950 nm ± 15%, 980 nm ± 15%, 980 nm ± 15%, 1000 nm ± 15%, 1030 nm ± 15%, 1050 nm ± 15%, 1100 nm ± 15%, 1200 nm ± 15%, 1310 nm ± 15%, 1380 nm ± 15%, 1450 nm ± 15%, 1600 nm ± 15%, 1650 nm ± 15%, 1670 nm ± 15%, 1730 nm ± 15%, 1800 nm ± 15%, 2100 nm ± 15%, 2250 nm ± 15%, 2500 nm ± 15%, 2800 nm ± 15%.

Optionally, sensors are used which alternatively and / or additionally determine the concentration of hemoglobin (cHb), oxyhemoglobin (HbO2), deoxygenated hemoglobin (HbDe), carboxyhemoglobin (HbCO), methemoglobin (MetHb), sulfhemoglobin (HbSulf), bilirubin, glucose enable. For this purpose, the sensors emit at least one light source to which alternatively and / or additionally the following wavelengths are selected, selected from the group:

• 150 nm ± 15%, 400 nm ± 15%, 460 nm ± 15%, 480 nm ± 15%, 520 nm ± 15%, 550 nm ± 15%, 560 nm ± 15%, 606 nm ± 15%, 617 nm ± 15%, 620 nm ± 15%, 630 nm ± 15%, 650 nm ± 15%, 660 nm ±, 705 nm ± 15%, 710 nm ± 15%, 720 nm ± 10%, 805 nm ± 15%, 810 nm ± 15%, 880 nm ± 15%, 890 nm, 905 nm ± 15%, 910 nm ± 15%, 950 nm ± 15%, 980 nm ± 15%, 980 nm ± 15%, 1000 nm ± 15% , 1030 nm ± 15%, 1050 nm ± 15%, 1100 nm ± 15%, 1200 nm ± 15%, 1310 nm ± 15%, 1380 nm ± 15%, 1450 nm ± 15%, 1600 nm ± 15%, 1650 nm ± 15%, 1670 nm ± 15%, 1730 nm ± 15%, 1800 nm ± 15%, 2100 nm ± 15%, 2250 nm ± 15%, 2500 nm ± 15%, 2800 nm ± 15%.

The device calculates a quality index for each detected oxygen saturation value, which characterizes the quality or the accuracy of the measured SpO2 value. If the signal is disturbed by movements, the number of values is low. For interference-free signals there is a high number of values. Accordingly, a disturbed measurement signal produces a low quality value, an undisturbed measurement signal results in a high quality value. The quality signal assumes values between 0 and 100%. When assessing long-term SpO2 measurements, the quality signal can be helpful because it suggests artifacts that occurred during the measurement.

7 shows above the measured signal ( 49 ) as a crude plethysmogram. The plethysmogram ( 49 ) is subject to fluctuations (= fluctuations). From the plethysmogram ( 49 ), a CWF signal ( 50 ) extracted. The CWF signal ( 50 ) contains information about the fluctuations (= fluctuations) "of the plethysmogram. For example, the fluctuation may represent the pulse wave amplitude. It is also conceivable to represent the integral of the plethysmogram as CWF. According to the invention, any fluctuation of the plethysmogram should be representable as CWF.

8th shows a possible embodiment of the CWF signal. Here, the amplitudes ( 51 ) of the plethysmogram ( 49 ) is used to determine the CWF signal. The CWF ( 50 ) in this case represents the amplitude height of the plethysmogram ( 49 ).

However, it is also contemplated to use the PTT or other signals that are subject to variations to determine a CWF.

According to the invention, different signals can be combined in order to detect relevant fluctuations of the pulse wave and to use them for the evaluation.

Thorax sensor and abdomen sensor

Thoracic and abdominal sensors are used to record the thoracic and abdominal respiratory movements.

Breathing movements cause alternating tensile stresses on the sensors in the fastening straps. The sensors convert the movements into electrical signals due to the piezoelectric effect.

The abdominal sensor, along with the abdominal straps, detects the abdominal respiratory movements. The sensor consists of a skin-friendly plastic.

Electrophysiological signals

• • Elektroenzephalogramm (EEG)
• • Elektrookulogramm (EOG)
• • Elektromyogramm (EMG)
• • Elektrokardiogramm (EKG)

The electrophysiological signals are measured by means of electrodes. For this gold or adhesive electrodes can be used.

• • electroencephalogram (EEG)
• • electrooculogram (EOG)
• • electromyogram (EMG)
• Electrocardiogram (ECG)

Respiratory flow snore sensor (16)

The respiratory flow snore sensor detects nasal and oral respiratory flow and snoring sounds. The sensor beads are made of thermistors. They record the respiratory flow via the temperature of the exhaled and inhaled air. The microphone registers the snoring sounds of the patient.

Respiratory flow mouth sensor (27)

With the respiratory flow mouth sensor, oral respiratory flow is detected during diagnosis with the respiratory flow snoring nasal cannula, therapy control or therapy setting. The sensor beads are made of thermistors. They record the respiratory flow via the temperature of the exhaled and inhaled air. The respiratory flow mouth sensor ( 27 ) is used together with the Pneumo-T adapter (28) in the diagnosis together with the respiratory flow snore nasal cannula or in the therapy control or therapy setting for the detection of mouth breathing.

Pneumo-T adapter (28)

The Pneumo-T adapter is used for therapy control together with a nasal mask. Through it the respiratory flow and the snoring of the patient are registered during the therapy and the applied therapy pressure in the mask is measured. In-and expiratory pressure fluctuations are conducted from the mask to the device via the pressure measuring hoses. The exhalation of air generates a slight overpressure, the inhalation corresponding to a negative pressure. From the pressure differences, the breaths can be derived. Snoring sounds are measured by rapid pressure changes. The therapy pressure is derived from the static component of the pressure signal. The Pneumo-T adapter ( 28 ) is used in therapy setting and therapy control with xPAP devices. The Pneumo-T adapter can be used together with the Breathing Flow Mouth Sensor ( 27 ) are used to detect mouth breathing and mouth leakage. The Pneumo-T adapter has a standard cone (ISO 22) for connection to therapy masks.

EXG electrodes

The quantity detected with the electrodes is the voltage. A voltage difference between two points of the body is measured. Since the measurement on the skin surface is noninvasive, the measurable voltage differences are very small. They are in the range μV for EEG, EOG and EMG, and in the range mV for ECG.

The function of non-medical devices

Bluetooth USB Adapter

The Bluetooth-USB adapter can be used to receive or transmit data wirelessly from the device according to the invention, to configure the device, and to carry out an application check.

Network USB server

With the USB server, the device according to the invention can be operated via a network. Via the USB server, the device according to the invention can receive data wirelessly in connection with the Bluetooth USB adapter, furthermore the device can be configured as well as an application control be performed. Likewise, the device according to the invention can be connected via the converter box wired.

CompactFlash ^® Card Reader

With the CompactFlash ^® card reader, the data stored on the CompactFlash ^® Card can be read out by the device according to the invention. ^® via the Compact Flash card reader can also be configured, the inventive apparatus and / or more CompactFlash ^® cards are applied with different configurations.

Optional modules

A supplementary PC software allows the readout and presentation of the therapy control data and the remote adjustment of all mentioned therapy devices via the software, as well as the PC-aided evaluation of titration data from a ventilation titration device.

Combination with therapy systems

As a control system, the device according to the invention can be combined with conventional CPAP, BiLevel and APAP titration home ventilation therapy systems. The coupling of the systems is quick and easy via the Pneumo-T adapter, which is inserted between the hose and the mask.

peripherals

• • USB port: supported by Windows,
• • Connections: at least three free USB interfaces for the connection of card reader, USB connection cable to the datalogger and Bluetooth ^® USB adapter
• • Graphics card: supported by Microsoft Windows, min. Resolution 1024x768, color depth 16 bit
• • Monitor: 17 "CRT monitor or 15" TFT monitor
• • Mouse: Windows compatible mouse
• • Printer: supported by Microsoft Windows
• • Network: Network card, 10/100 MBit (only when using the network USB server)

software

The software is used for analysis and offers alternative evaluation suggestions. The evaluation of automatically generated analysis results is the responsibility of the physician. With each new programming of the device according to the invention, the time in the basic unit is compared with the system time of the PC. If the data transfer to the PC is interrupted, the measurement data is still stored in the device. The software displays the signals as a zero line. All data is readable.

Like the EMGs, the ECG is derived bipolar. The polysomnographic derivative of the device according to the invention is based on the Einthoven derivative. The reference electrode in the device according to the invention is the earth electrode at an arbitrary body location.

With the help of straps, which are guided in lateral eyelets (a, b, c) of the device, the device according to the invention can be applied to a patient. With Velcro straps, the straps can be adjusted to the body circumference of the patient. The strap consists of a skin-friendly elastic loop tape.

Perform sensor test

To verify that all sensors are well connected, a test can be performed after the sensors and devices have been installed. For this purpose, the key ( 6 ). process device Sensor test is running During the sensor test, the LED of the currently tested sensor flashes quickly (4x per second). Sensor test ok The LED of the corresponding signal stops flashing after the end of the impedance test: Impedance of the electrode <5 kΩ OK or sensor signal present. Sensor test medium The LED of the corresponding signal flashes slowly after the end of the impedance test: electrode impedance <10 kΩ not optimal, but acceptable quality. Green LEDs flash slowly at 0.5Hz. Sensor test not ok The LED of the corresponding signal flashes quickly after the impedance test has ended: Impedance of the electrode> 10 kΩ or no sensor signal (check electrode or sensor, unacceptable signal quality). Green LEDs flash rapidly at 1Hz.

After successful application of all configured electrodes / sensors no LED lights on the device according to the invention. At the device according to the invention there is then no change of state of the LED more, if in the next step the sensor test is terminated by closing the impedance window in the software.

The sensor test checks all channels, including the effort and pulsoximetry sensors, as well as the thermistor and nasal cannula for the presence of a signal. When the LED is off, it means: "Sensor is connected and transmits a (physiological) signal".

An impedance test always cycles through all configured channels and then displays its result until the window is closed or a new test is started. Product class according to 93/42 / EEC IIa relative humidity during operation and storage 25 to 95%, non-condensing Dimensions (W × H × D) 80 × 150 × 34 mm Air pressure during operation and storage 700 to 1060 hPa Weight (device without sensors) about 300 g storage medium Compact Flash Card, max. 512 MB Temperature range: - Operation +5 ° C to +40 ° C * Data transmission online - Wireless via radio signals at 2.4 GHz. - Storage - 10 ° C to + 60 ° C - From USB 1.1 (galvanically isolated) Supply voltage for basic unit 3.7V DC Reading the stored data From USB 1.1 Removing the CompactFlash ^® card, reading in via CompactFlash ^Ⓡ Card reader Supply voltage battery 7.5V DC Average power consumption about 340 mW radio module Battery life: - wireless online about 10 hours Carrier frequency 2400 MHz up - outpatient about 20 hours 2483.5 MHz Max. Recording time for one measurement 12 hours transmission power 0 dBm avg. (2nd grade) Electrical connection power supply unit Input: 100-240 V, 50-60 Hz, 400 mA Hopping frequency 2400 to 2483.5 MHz, F = 2402 + k MHz, k = 0 ... 78 Output: 7.5V DC Guard band 2 MHz <F <3.5 MHz, in the USA, Japan, Europe Classification according to EN 60601-1 - Protection against. elec. blow Protection class II battery pack battery type Li Ion - degree of protection against electr. blow Type BF tension 3.7V capacity 2,15 Ah Electromagnetic compatibility (EMC) according to EN 60601-1-2 (the test parameters and limit values can be requested from the manufacturer if required) Overload 4.35 V Max. Charge current 1 A - Radio interference suppression EN 55011 Discharge current normal <1 A - Radio interference immunity EN 61000-4 part 2 to 6, part 11 temperature range -20 to +85 charging cycles 500 Degree of protection against ingress of water IPX 0 Charging time when the device is switched off about 3 hours at 25 ° C and empty battery Position sensor Position sensor integrated sensor in the device value range re. Side, left Side, stomach, back, standing accuracy about 45 ° ± 15 ° Location CPAP / BiPAP / SmartPAP printing measuring range 0 to 40 hPa accuracy ± 0.6 hPa Pulse oximeter cl ipsensor SpO2 measurement range 50 to 100% SpO2 accuracy 70% <SpO2 <100% better than 2% accuracy SpO2 Pulse frequency measuring range 30 to 250 bpm Pulse accuracy ± 1 bpm to 2% of the displayed value signal quality > 90% airflow Respiratory flow snore sensor 3 thermistors as sum signal, no measuring function at ambient temperatures between 33 - 38 ° C Respiratory flow nasal cannula inspiratory / expiratory pressure fluctuations Respiratory flow oral sensor A thermistor, no measuring function at ambient temperatures between 33 - 38 ° C Electrophysiological signals channel ECG EEG EMG EOG Dynamic range (physical value range) ± 5mV ± 500 μV ± 250μV ± 500μV resolution 12 bits 12 bits 12 bits 12 bits Lower limit frequency 0.16 Hz 0.5 Hz 2.7 Hz 0.5 Hz Upper limit frequency 100 Hz 100 Hz 500 Hz 100 Hz accuracy ± 3% ± 3% ± 3% ± 3% Are adjustable EMG, EOG, EEG, ECG specification like EMG, EOG, EEG, ECG Input impedance about 40 MΩ Technical data of non-medical components Flow differential pressure Pneumo-T adapter sensor Cone according to standard ISO 22 Differential pressure: inspiratory / expiratory pressure fluctuations Effort sensors (thorax, abdomen) Thorax sensor method Integrated sensor in the device Piezoelectric measurement snoring Respiratory flow snore sensor Integrated microphone Respiratory flow nasal cannula pressure sensor Pneumo-T-adapter pressure sensor method Log. Mean value of the sound pressure signal (microphone) or pressure fluctuations (pressure sensor) electrodes Touch-proof connector, according to DIN 42802 1.5 mm

Claims (11)

Device for determining and analyzing biodata of a living being, consisting of a basic module with a power supply and a storage unit and at least one sensor device for non-invasive measurement of at least one measurement signal representing cardiac activity and / or respiratory activity selected from the group: pulse rate, Plethysmogram, oxygen saturation, respiratory signal, heart signal and an analysis device connected to the sensor device for extracting at least one CWP (continous wave parameter) from the measurement signal, and / or means for determining at least one CWF (continuous wave fluctuation), characterized in that the CWF is determined from the CWP and / or the measurement signal, wherein additional modules can be adapted to measure further signals, wherein a module (pneumology module) can be added, which is designed to determine respiratory parameters and this module for far Analyzes can be adapted to a data bus of the basic module, wherein the connection between basic and pneumology module is designed as a plug-in connection that is simple and quick to use, with a further module (cardiology module) can be added, which is used to determine cardiological Parameter is formed, wherein the cardiology module allows ECG recording and wherein this module can be adapted for further analysis of the data bus of the basic module and / or the pneumology module and wherein the connection between the basic and / or pneumology module and Cardiology module is designed as a plug-in connection, which is easy and quick to use, wherein at least one interface in the range of the basic module and / or in the area of additional modules is arranged, which serves for the reading of data and / or the control of other devices a display means and / or an output means for analysis results is provided, wherein means for the attachment of the device are provided on the body of a living being, are evaluated for the identification of physiological events at least two signals that are in temporal relationship, with a supplementary signal evaluation is performed by a frequency analysis is performed and that the signal evaluation within at least one the measured data are stored in the device, and optional online via cable or optional wirelessly transmitted to a PC. Device after Claim 1 characterized in that a signal evaluation takes place in that threshold values are compared and / or correlated. Device after Claim 1 or 2 characterized in that for the suppression of interference before the evaluation of the detected parameters an artifact detection or - elimination is performed. Device according to one of the preceding claims, characterized in that for performing a course analysis of the detected signals, an evaluation device has a history analyzer for analyzing the time course of the signals. Device according to one of the preceding claims, characterized in that a converter box for wired data transmission of the data stored in the device is used and at the same time the device according to the invention are charged via the power supply unit, or can be permanently supplied with power. Device according to one of the preceding claims, characterized in that the device generates information signals which can be graphically visualized both by, designed as a display, display means of the device and the PC system and stored by the PC system or the device itself. Device according to one of the preceding claims, characterized in that a device for data input, such as age, sex, health, is provided. Device according to one of the preceding claims, characterized in that the device comprises a position sensor. Device according to one of the preceding claims, characterized in that the device can be combined as a control system with conventional CPAP, BiLevel and APAP titration home ventilation therapy systems, wherein the coupling of the systems takes place quickly and easily via the Pneumo-T adapter, which is inserted between hose and mask. Device according to one of the preceding claims, characterized in that the device can be connected to therapy systems via an analog or digital interface. Device according to one of the preceding claims, characterized in that the device has a software which serves the detection, storage, processing and evaluation of biosignals, wherein the software communicates via a secure data transmission protocol with the PC software.

Images