DE102007016447A1 - Living thing`s bio data determining and analyzing device, has analysis device extracting continuous wave parameters, where continuous wave fluctuation is determined from continuous wave parameters and/or measuring signal - Google Patents

Abstract

The device has a base module with a power supply and a storage unit, and a sensor device (16) for non invasive measurement of a measuring signal representing heart and/or breathing activities such as pulse frequency and oxygen saturation. An analysis device extracting continuous wave parameters (CWP) from the signal is attached to the sensor device. Continuous wave fluctuation (CWF) is determined from the CWP and/or the measuring signal. An independent claim is also included for a method for determining and analyzing bio data of living things.

Description

The inventive device and the method relate to a module system for the determination of biodata of a living being, comprising at least one sensor device for non-invasive measurement of at least two signals.

hereby For example, sleep related diseases and / or cardiovascular diseases and / or metabolic diseases determined and supported a diagnosis. The determination of sleep-related disorders or illnesses is currently always by a specialist and mostly during the night in a sleep laboratory. Usually For this purpose a polysomnography device is used. Due to the low Number of trained medical specialists and the small number of sleep laboratories many patients often have long wait for a diagnosis or a diagnosis will not first asked.

task Therefore, the present invention is an apparatus ready to provide a simple, fast and inexpensive diagnosis allows. About that In addition, by evaluating parameters of the pulse wave an extended Statement, opposite the previous polysomnography, be made available. These extended statement is intended in particular the activity and assessment of the autonomous Affecting the nervous system.

Especially There are no devices with fewer input channels than polysomnographs, which allow a diagnosis comparable to that of a polysomnography device or superior to specific questions.

A Another object of the invention is to provide a modular device to provide that makes it possible depending on demand supplementary Modules quick and easy to adapt.

As well There are no devices that can be adapted as needed are, rather, are present ones polysomnographs always with all channels stocked, even if for the current investigation only a few channels sufficient and useful would.

task It is therefore also an object of the present invention to provide a device of the initially mentioned type to construct such that an individual Applicability for allows a patient will, in the sense that for the patient only uses the specific modules for analysis, actually necessary. For Further analyzes are quick and easy to add additional modules the basic module adaptable. A particular advantage of the device according to the invention is that even medical laymen, at least but medical Personnel or non-specialist doctors are readily capable of the patient device of the invention create quickly and correctly.

These Task is inventively characterized solved, that a basic module interfaces to the adaptation of complementary individual modules for a determination of 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 102005020022 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 respiration-correlated portion of the plethysmogram, the rise 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 the PTT (Pulse Transit Time). According to the invention, any parameter describing a property of a portion of the plethysmogram should be representable as CWP be.

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 is thought one of the following sizes as CWF signal: the pulse wave amplitudes, with the integral over a Section of the plethysmogram related parameters, Verhältnises different integrals over different sections of the plethysmogram, correlating with respiration Proportions of the plethysmogram, angle of rise of the pulse waves, angle of departure the pulse waves, relationships from rise to fall angle, duration of pulse wave rises, durations pulse wave waste, conditions from rise to fall times, the envelope of the pulse wave maxima or Pulswellenminima, with the PTT (Pulse Transit Time) in connection standing sizes that Centerline of the plethysmogram, the pulse rate.

It However, it is also thought of the PTT or other signals, the fluctuations are subject to use to determine a CWF. According to the invention, any Fluctuation of the plethysmogram, every CWP and any combination of different CWP be represented as CWF signal.

It It is envisaged that at least one sensor for non-invasive measurement of at least two signals selected from the group: CWF (continous wave fluctuation), SpO2, ECG, heart rate, respiration to an evaluation device is connected, that the evaluation device at least one Analyzer has and that the analyzer through signal analysis definable signal ranges determined and that a comparison device the signal ranges under consideration analyzed further parameters and the result of the analysis as an index value is transmitted to a connected output device.

According to the invention, various Signals are combined to produce relevant fluctuations in the pulse wave to detect and for to use the evaluation.

aim The invention is therefore not the diagnosis of a disease and also not the pure determination of the frequency and strength the occurrence of certain pathophysiological events. much more is determined based on the detected signals, how high the individual Risk of the examined person is to suffer secondary diseases, which the quality of life or life expectancy. Likewise, it can be deduced from the determined risk which Therapy form and therapy dosage is optimal for the person. In addition, can the success of an existing therapy can be measured.

By an evaluation of at least two of the following signals selected from group: CWF (continous wave fluctuation), SpO2, ECG, heart rate, Breathing it is possible the interactions of a variety of physiological and pathophysiological Determine processes. additionally is it possible that using one opposite the prior art considerably reduced number of measuring sensors, namely only one measuring sensor, for example in the form of a pulse oximetry sensor, made comparable statements to already known methods be used, for example with regard to respiratory disorders, Sleep disorders, Diabetes, inflammatory reactions, disorders autonomic regulation and cardiovascular disease.

For example is meant to be a distinction of obstructive and central respiratory disorders Using patterns made in one of the plethysmogram derived CWF signal are detected. Here are the characteristic Pattern frequency shares that are related to the respiratory rate stand.

A Signal evaluation via a predetermined period of time is supported by the fact that the sensor with a first memory unit for storing a detected measurement signal connected is.

to execution a history analysis of the detected signal is proposed that the evaluation device is a history analyzer for analysis the time course of the signal has.

to Further improvement of the evaluation options is proposed. that the comparison device with a second memory unit is provided for storing the calculated index value.

One typical evaluation process takes place in that a CWF waveform the measurement signal is evaluated.

According to one another embodiment is provided that a specific frequency of the measurement signal is evaluated becomes.

Regarding Sensitivity proves to be particularly advantageous that is a change intensity of the measurement signal is evaluated.

A Comprehensive signal evaluation can be done by using pattern recognition is carried out.

A Further signal evaluation can be done by signal analysis Patterns are detected, the occurrence of which or more periodic and / or transient nature.

A supplementary Signal analysis can be done by having a frequency analysis is carried out.

A Alternative signal analysis can be done by doing an analysis carried out the slope becomes.

A Signal evaluation can be done by histograms and / or Distributions and / or derivatives are formed.

A alternative signal evaluation can be done by using thresholds be compared and / or correlated.

A Creation of a hierarchy of signals and / or a decision tree can continue to support the signal evaluation.

A possibility for signal acquisition is that a CWF (continous wave fluctuation) signal is evaluated becomes.

A different possibility for signal acquisition is that a SpO2 signal evaluated becomes.

A another possibility for signal acquisition is that a pulse rate and / or Heart rate signal is evaluated.

A different possibility for signal detection is that a PTT (pulse transit time), or a value associated with the PTT becomes.

A supplementary possibility for signal acquisition is that an EEG signal is evaluated.

Also It is thought that an ECG signal will be evaluated.

Also It is thought that an EMG signal will be evaluated.

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

to Capture of respiratory parameters is intended to be a Respiratory history is evaluated.

to Recording further parameters is provided that in addition also Snoring, arousals, blood pressure, CO2, sleep stages, skin conductance, Sleep depth, sleep fragmentation, parasympathetic activity absolute or in proportion to the sympathetic, vascular compliance can be evaluated.

One easy to implement measuring principle is that an optical Density of at least one body area is evaluated.

According to one typical evaluation method is provided that a signal evaluation is performed with respect to present periodic signal components.

A Evaluation particularly meaningful waveforms This is done by doing an analysis for a maximum signal change carried out becomes.

Especially proves to be advantageous that the index of a cumulative autonomous calm intensity the regulation of the cardiovascular Systems is assigned.

The Capturing particularly meaningful Events are achieved by a signal analysis regarding a period of activation of the autonomous system is performed.

A a further increase in the quality of the statement can be achieved by that in the evaluation of periods of activation of the autonomous System is evaluated at least one other parameter. The Increase the quality of the statement can be achieved by detecting the change of various or parameters derived from the acquired parameters at the time an activation of the autonomous system in strength, type and time sequence is compared.

to Elimination of disturbances or singular Events are suggested that in determining the index the cumulative number and the intensity of the activation periods of the autonomous system becomes.

One Simple measurement setup is supported by the sensor's heart rate is detected.

Especially It is thought that by the sensor variability of heart rate is detected.

Furthermore it is also possible that the PTT is detected by the sensor.

to Suppression of interference contributes, that before the evaluation of the detected parameters an artifact detection or elimination carried out becomes.

A Recognition of short-term signal changes is supported by that an occurring within a predetermined time interval maximum value of the detected by the sensor measurement signal is evaluated.

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

A Increasing system sensitivity can be achieved by that the signal evaluation within at least one pre-eminently Frequency band performed becomes.

to consideration of interactions is provided by the evaluation unit at least one other body parameter is evaluated.

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

Also Is it possible, that as another body parameter the gender of the living being is evaluated.

alternative or in addition it is also possible that as another body parameter the weight of the living being is evaluated. Alternatively or in addition it also possible that as another body parameter one or more known risk factors, for example for one cardiovascular Disease are evaluated.

alternative or in addition it is also possible that as another body parameter one or more already known factors affecting autonomic regulation be evaluated, in particular the medication.

alternative or in addition it is also possible that as another body parameter one or more additional detected parameters are evaluated, e.g. the arterial oxygen saturation.

A consideration from past Events can be done by having as another body parameter the medical history of the living being is evaluated.

A further increase in the quality of the statement can be achieved by that as another body parameter the medication of the living being is evaluated.

A a further increase in the quality of the statement can be achieved by that evaluated as a further parameter comparative values of other persons become.

According to the invention, for example, with a pulse oximeter sensor, at least the following Signals detected: plethysmogram, SpO2, pulse rate.

In addition, by adding suitable sensors, respiratory signals such as Heart rate, PTT (Pulse Transit Time), Flow, pressure or snoring are registered and analyzed. Also is thought to have ECG signals, EEG signals, EMG signals for evaluation to use. Furthermore you can Blood pressure and CO2 are recorded and used for the evaluation become.

• • Mustererkennung
• • Signalanalyse (harmonisch/transient)
• • Frequenz-Analyse
• • Analyse der Steigung
• • Histogramme, Verteilungen, Ableitungen, Integrationen
• • Kombination (statistisch) verschiedener Faktoren, Messwerte, ermittelte werte,
• • Ereignis Daten, langfristiger Trend
• • Schwellwert-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, integrations
• • 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

in the Result determines the device according to the invention one for the patient specific risk index. This can be, for example, percentage be specified. Preference is given to the medical history of the patient together with the current measurement data for identification of the risk index. When Database is at least one in the range of the device according to the invention readable memory arranged.

in the Following the invention is explained in application examples. It demonstrate:

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 connected computer and display 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 inventive device allows in a preferred embodiment, a quick determination of the risk index by using that with help a pulse oximetry sensor at least three signals, namely Plethysmogram, oxygen saturation the blood and pulse rate determined substantially simultaneously become. It can for the further analysis important CWF signals are calculated.

By a pattern recognition, the signals are analyzed and stored with Values compared. The result of the comparison yields one for the patient specific index value that is appropriate to make a statement about that Risk of e.g. Cardiovascular disease, a disease of the Gefäßsytems, a sleep-disordered breathing disorder, a neurological disorder, a respiratory disease or to enable a metabolic disease. The device according to the invention is small and portable. The energy supply takes place alternatively via accumulators / batteries and / or over a power cord.

The measured data are stored in the device, eg on a CompactFlash ^® Card, as well as optionally 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 eg a USB interface or read into the software by reading the storage medium, eg CompactFlash ^® Card via a reader.

The inventive device for the identification and analysis of biodata of a living being from 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 that the heart activity and / or the breathing activity represents. The sensor device may for example be selected from the group: ECG, Blood pressure cuff, pulse oximeter, impedance sensor, Doppler sensor.

The measuring signal, which the heart activity and / or the respiratory activity represents 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) the CWF (conti-nous wave fluctuation) preferably from the CWP and / or the measurement signal is determined.

One Classifier compares at least one CWF information and / or derived variables with deposited Data from this physiological / pathophysiological events too identify. Such events are for example an apnea, according to the invention between central and obstructive apneas can be distinguished.

In another embodiment compares a classifier at least one CWF information and / or derived variables with other measuring signals and / or CWP compares to it physiological / pathophysiological Identify events.

At least a part of the results of the analysis device and / or at least Part of the results of the classifier are essentially directly acoustically and / or graphically, preferably via a Display, output.

According to the invention at least two signals for the identification of physiological events, which are in temporal relation, evaluated.

The inventive device can be extended by additional modules to measure further signals. For this purpose, the modules are preferably adapted in the sense of a "plug and play". Preference is given to complementary sensor devices adapted.

To is at least one interface in the area of the basic module and / or in the area of supplementary modules arranged.

About the Interface is also the reading out of data and / or the controlling from other devices, in particular therapy devices possible.

When Adaptable sensor devices are alternatively or additionally at least the following: ECG, EMG, EOG, EEG, pulse oximetry, blood pressure, Impedance Measurement, Ultrasonic, Doppler, CO2, Respiratory, Snore, Oral, Thoracic, Abdomen, Location Sensor.

The Sensor devices can supplemented in the form of a module which can be used, for example, to determine respiratory Parameters such as respiratory flow, PTT, motion signals, respiratory effort is trained.

The Sensor devices can also supplemented in the form of a module which is used to determine cardiac parameters such as ECG, Heart rate, is formed.

to Input of patient data such as age, gender, Health status, a device for data entry is provided.

One 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 with fastening means, such as straps, solvable on the body fixed by a patient.

In another embodiment is the device for the determination and analysis of biodata of a Living beings, from at least one sensor device for non-invasive Measurement of at least two signals, such as plethysmogram and from it derived contra-nous wave fluctuation (CWF) signals, SpO2, pulse rate and an analysis device connected to the sensor device for the analysis of transient and / or periodically recurring patterns the measured signals. additional is a module for the evaluation of such information with the frequency or amplitude of the signals or the signals derived from them Parameters are provided, provided.

In a supplementary embodiment is the device for the determination and analysis of biodata a living being from a basic module with a power supply and a storage unit and at least one sensor device for the non-invasive measurement of at least one measurement signal, that the breathing activity represents for example, oxygen saturation, Respiratory signal, pressure signal, flow signal and at least one other Sensor device for non-invasive measurement of at least one Measuring signal, the the heart activity represents for example, oxygen saturation, Blood pressure, pulse rate, ECG, plethysmogram and one to the sensor device connected analysis device for the extraction of at least a CWP (continous wave parameter) from at least one of the measurement signals.

For example Thus, by analyzing the measured signals conclusions can be drawn on apneas, hypopneas and other respiratory disorders win. Using at least one sensor device for the non-invasive measurement of at least one measurement signal, that the breathing activity represents and at least one further sensor device for non-invasive Measurement of at least one measurement signal, that the heart activity represents For example, conclusions can be drawn by pattern recognition Diseases of the cardiovascular system and / or the respiratory system win.

• – 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, Windows Vista 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.

• - Applied part consisting of: - Basic module - Cardiology module - Pneumology module - Application parts - Battery / rechargeable battery, eg LiIon rechargeable battery - medically approved power supply (secondary side) with combi cable for charging the battery and data transmission of the stored data via a galvanic separate 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, Windows Vista.
• - Non-medical electrical equipment: - Power supply unit (primary side) - USB / TCP / IP converter - Bluetooth ^® USB adapter - CompactFlash ^® Card reader - PC system (third-party accessory).

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 inventive device has less input channels as usual polysomnographs and is thus much cheaper, smaller, lighter and more energy efficient.

• – Pulsoximetriesensor zur Erfassung von Plethysmogramm, Sauerstoffsättigung, Pulsfrequenz.

sensors:

• - Pulse oximetry sensor for the detection of plethysmogram, oxygen saturation, pulse rate.

• • 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

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

Pneumology Module

For further Analyzes can adapt this module to the data bus of the basic module become. According to the invention is thought the connection between basic and pneumology module as To carry out plug connection which is easy and fast to use. The pneumology module can also be used alone, without basic module. The pneumology module has at least about an 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 (Differenz-Drucksensor).

Possible sensors:

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

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 effort, Work of Breathing

Cardiology module

The Cardiology module allows an ECG recording. additional a position sensor can be adapted. For further analysis this may be Module to the data bus of the basic module and / or the pneumology module be adapted. According to the invention is thought the connection between basic and / or pneumology module and perform cardiology module as a plug-in, which is simple and fast is operable. The cardiology module can also be 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 is intended to adapt further modules according to demand.

converter box and power supply

The optional converter box is used for wired data transmission the one in the device stored data. The data transmission possibly happens galvanically isolated a USB interface. At the same time, the erfindungsge Permitted device on the power Supply be charged, or permanently powered.

PC software

The PC software is used for acquisition, 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 serves the 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 via a secured data transmission protocol with the PC software.

No Medical electronical devices

• - reader for reading the used storage medium, eg for reading the data stored on the CompactFlash ^® Card;
• - Online module for wireless data transmission (e.g., Bluetooth USB adapter);
• - USB-TCP / IP converter;
• - PC system (External accessories).

The inventive device generates information signals (e.g., battery state of charge) that are received both from the Display as well as graphically visualized by the PC system and the PC system or from the device yourself can be saved. 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 otherwise necessary repetition of the night measurement is omitted.

The automatic analyzes (e.g., CWF, PTT, SpO2, Pulse Rate, PLM, Snore, Sleep stage, arousal and cardiorespiratory analysis) online in the device and / or offline from the signals stored in the PC and support the Evaluator in the diagnosis of sleep disorders, autonomic dysfunctions, cardiovascular diseases as well as the therapy initiation and therapy control.

in the Case of online analysis in the device it is possible, to respond immediately to the analysis results, for example another device to remote control. It is thought, for example, in the case of anesthesia Control drug dispensers and / or respirators Pilots of various means of transport (for example, cars, trucks, trains, planes, etc.) due to analysis results (e.g., lack of concentration, high fatigue, high sleep pressure) alarms, autopilot systems or the like or, in the case of sleep medicine, a therapy device (e.g. CPAP device) to remote control.

Basically exists the possibility, the device according to the invention both in prevention for different Use diseases (risk assessment for secondary diseases), as well in real-time scenarios, in which directly on currently detected Pattern is responding.

The PC software is used for visualization, evaluation, documentation and patient - related archiving of long - term studies Diagnosis of, for example, sleep disorders, cardiovascular diseases, Diabetes. Therefore the system is configured and the data transferred automatically analyzed offline. The software allows the input of comments by the user. A manual reclassification of the analysis results through the evaluator is possible.

Of the Patient is after instruction by qualified personnel and according to the instructions for use for the patient able to put on the sensors and the device itself.

The inventive apparatus processes and stores all of the measured signals on the integrated storage medium such as 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, this data can be supplemented 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. The device can also be supplied and operated permanently with the data transmission cable.

The inventive device has an optional position sensor. The sensor registers whether and when the patient lies on his stomach, his back or his side. Likewise owns the device optionally one in the housing integrated effort sensor. The integration reduces the cleaning and increased the life of the sensor.

With Help of a pushbutton can trigger a sensor test / impedance check.

With Help of the display or corresponding LEDs can at a Sensor test / Impedanzcheck be determined, whether or which electrode good or poorly applied.

moreover shows the device according to the invention by a corresponding symbol on the integrated display current state of charge and / or by a light emitting diode in the battery pack next to the battery icon, if the battery is currently charging. The state of charge can also be over the software can be queried because a capacity monitoring integrated in the battery is.

About one Connecting cable between device and PC system, e.g. a USB cable, can store the stored data transferred to the PC Alternatively, this can be over a converter box in which a galvanic isolation is integrated, respectively. about The converter box can also charge the battery with the supplied power adapter become. A battery module can also be charged if it is not in the Device used is.

Function of software

• – CWF-Analyse
• – Schnarch-Analyse
• – Kardiorespiratorische Analyse
• – Arousal Analyse
• – Schlafanalyse

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 analysis

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

Function of the sensors

Respiratory flow nasal cannula

The Respiratory flow snoring nasal cannula detected in conjunction with the in the device according to the invention integrated pressure sensor the respiratory flow as well as snoring. The Inspiration is over registers the generated negative pressure, the expiration over the generated overpressure. Snoring creates pressure fluctuations in the nostrils, which are also registered. The pressure measurement reacts at closed mouth sensitive to low flow limitations than the thermal measurement. It is independent of the ambient temperature and allows additionally the visual assessment of the temporal flow contour. With mouth breathing can attenuated the signals be. 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 measures the pulse oximetry signals, blood oxygen saturation, pulse rate and CWF.

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

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

With Help of photoplethysmography will change the pulse wave, in particular the amplitude of the pulse wave, determined.

The inventive device calculates a quality index for each detected oxygen saturation value, which the goodness or the accuracy of the measured SpO2 value.

Becomes the signal disturbed by movements, the number of values is low. With trouble-free signals is a high number of values. Accordingly, a disturbed measurement signal is generated a low quality value, an undisturbed one Measuring signal has a high quality value. The quality signal is increasing Values between 0 and 100%. In the evaluation of SpO2 long-term measurements can the quality signal be helpful, because it lets close to artifacts, the while the measurement occurred.

1 shows a handset with a pressure port ( 1 ) for connection to a pressure measuring tube, electrode connections ( 2 ), a RIB ( 3 ) and 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 ) and 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 mouth sensor ( 27 ). The connection ( 1 ) is for connection to a respiratory snoring nasal cannula ( 22 ) or a pressure measuring hose ( 28 ) intended. The connections ( 1 . 10 ) are used together to connect to a Pneumo-T adapter ( 33 ).

2 shows, in addition to the sensors already mentioned above for connection to the mobile part, 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 ) measures the pulse oximetry signals, blood oxygen saturation, and your patient's pulse rate. 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 heart rate changes, which were triggered by a sleep-related apnea syndrome sufficiently accurate.

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 to any detected oxygen saturation value a quality index, which the goodness or the accuracy of the measured SpO2 value. Becomes the signal disturbed by movements, the number of values is low. With trouble-free signals is a high number of values. Accordingly, a disturbed measurement signal is generated a low quality value, an undisturbed one Measuring signal has a high quality value. The quality signal takes values between 0 and 100%. In the evaluation of SpO2 long-term measurements can the quality signal be helpful, because it lets close to artifacts, the while the measurement occurred.

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 For example, the fluctuation can represent the pulse wave amplitude It is also conceivable to represent the integral of the plethysmogram as CWF According to the invention, any variability of the plethysmogram is to be represented 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 ).

It However, it is also thought of the PTT or other signals, the fluctuations are subject to the use of a CWF.

According to the invention, various Signals are combined to produce relevant fluctuations in the pulse wave to detect and for to use the evaluation.

thorax sensor and abdomen sensor

Thorax- and abdominal sensor are used to detect the thoracic and abdominal Breathing movements.

breathing movements cause alternating tensile stresses on the sensor in the fastening straps. The sensors change as a result of the piezoelectric effect the movements in electrical signals around.

Of the Abdominal sensor detects, along with the abdominal strains, the abdominal Breathing 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 )

With the respiratory flow snore sensor becomes nasal and oral respiratory flow and the snoring sounds detected. The sensor beads are made of thermistors. They capture the respiratory flow over the temperature of the exhaled and inhaled air. The microphone registered 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 diagnosed along with the respiratory flow snore nasal cannula or at Therapy control or therapy setting for the detection of mouth breathing together with the Pneumo-T adapter ( 28 ) used.

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. Via the pressure measuring tubes, in- and expiratory pressure fluctuations are conducted from the mask to the device. 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 Size detected with the electrodes is the Tension. It measures a voltage difference between two Points of the body. Because the measurement on the skin surface non-invasive, the measurable voltage differences are very small. They are in the range μV for the EEG, EOG and EMG, in the ECG in the Range mV.

The Function of non-medical devices

Bluetooth USB Adapter

With the Bluetooth USB adapter from the device according to the invention receive or transmit data wirelessly online, the device configures and an application control are performed.

Network USB server

With the USB server, the inventive device via a Network operated. about the USB server, the inventive device in conjunction receive data wirelessly with the Bluetooth USB adapter can the device be configured, as well as an application control to be performed. Likewise, the inven tion proper device on the Converter box wired to be connected.

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. Also can use the CompactFlash ^® card reader, the device of the invention were not configured and / or multiple CompactFlash ^® cards are applied with different configurations.

optional modules

A supplementary PC software allows the reading and presentation of the therapy control data and the remote adjustment all mentioned therapy devices over the Software, as well as the PC-based Evaluation of titration data from a ventilation titration device.

combination with therapy systems

When Control system can the device according to the invention with common CPAP, BiLevel and APAP titration home ventilation therapy systems combined become. The coupling of the systems is done quickly and easily via the Pneumo-T-adapter which is inserted between hose and mask. Alternative can the device with therapy systems via an analog or digital Interface can be connected.

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
• - Graphic card: supported by Microsoft Windows, at least resolution 1024 × 768, Color depth 16 bits
• - Monitor: 17 "CRT monitor or bigger, or 15 "TFT monitor or larger
• - 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 Doctor. With each new programming of the device according to the invention the time is in the basic device with the system time of the PC adjusted. If the data transfer to the PC is interrupted, the Measurement data in the device still saved. In the software, the signals are as zero line shown. All data is readable.

As The EMGs will also derive the ECG bipolar. The polysomnographic Derivation of the device according to the invention leans on the Einthoven derivation. The reference electrode is in the device according to the invention the earth electrode at any body location.

With Help of straps, which are guided in lateral eyelets (a, b, c) of the device, can the device of the invention to be created in a patient. Velcro straps allow the straps to fit around the body be adapted to the patient.

Of the Belt consists of a skin-friendly elastic band.

Perform sensor test

To check that all sensors are well connected, a test can be performed after the sensors and devices are connected. For this purpose, for example, the key ( 6 ).

To successful application of all configured electrodes / sensors lights up at the device according to the invention no LED or this is shown on the display accordingly. At the device according to the invention there is then no change of state the LED more, if in the next Step the sensor test by closing the impedance window in the software is terminated.

At the Sensor test are all channels, So also Effort- and pulse oximetry sensors, and thermistor and Nasal cannula tested for the presence of a signal. When the LED is off, means this: "Sensor is connected and transmitted a (physiological) signal ".

Lage-Sensor Lage-Sensor im Gerät integrierter Sensor Wertebereich re. Seite, li. Seite, Bauch, Rücken, stehend Genauigkeit ca. 45° ± 15° Lage CPAP-/BiPAP-/SmartPAP-Druck Messbereich 0 bis 40 hPa Genauigkeit ± 0,6 hPa Pulsoximeter-Clipsensor SpO2- 50 bis 100% Messbereich SpO2- 70% < SpO2 < 100% besser als 2% Genauigkeit Genauigkeit SpO2 Pulsfrequenz Messbereich 30 bis 250 bpm Puls Genauigkeit ± 1 bpm bis 2% vom Anzeigewert Signalqualität > 90% Atemfluss Atemfluss-Schnarch-Sensor 3 Thermistoren als Summensignal, keine Messfunktion bei Umgebungstemperaturen zwischen 33-38°C Atemfluss-Schnarch-Nasenbrille inspiratorische/exspiratorische Druckschwankungen Atemfluss-Mund-Sensor Ein Thermistor, keine Messfunktion bei Umgebungstemperaturen zwischen 33-38°C Elektrophysiologische Signale

Technische Daten nichtmedizinischer Komponenten Flow Differenzdruck Pneumo-T-Adapter Konus nach Norm ISO 22 Sensor Differenzdruck: inspiratorische/exspiratorische Druckschwankungen Effort Sensoren (Thorax, Abdomen) Thorax Sensor Im Gerät integrierter Sensor Methode Piezoelektrische Messung Schnarchen Atemfluss-Schnarch-Sensor Integriertes Mikrofon Atemfluss-Schnarch-Nasenbrille Drucksensor Pneumo-T-Adapter Drucksensor Methode Log. Mittelwert des Schalldrucksignals (Mikrofon) bzw. der Druckschwankungen (Drucksensor) Elektroden Berührungssichere Steckverbinder, nach DIN 42802 1,5 mm 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.

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 pressure measuring range 0 to 40 hPa accuracy ± 0.6 hPa Pulse oximeter clip sensor SpO2 50 to 100% measuring range SpO2 70% <SpO2 <100% better than 2% accuracy Accuracy SpO2 pulse rate 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 a 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

Technical data of non-medical components Flow differential pressure Pneumo-T-adapter Cone according to standard ISO 22 sensor Differential pressure: inspiratory / expiratory pressure fluctuations Effort sensors (thorax, abdomen) Thorax sensor Integrated sensor in the device method 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 (17)

Device for determining and analyzing biodata of a living being, comprising 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 measuring signal representing the cardiac activity and / or the respiratory activity selected from the group: pulse rate, Plethysmogram, oxygen saturation, respiration 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 (continous wave fluctuation) is determined from the CWP and / or the measurement signal. Device according to one of the preceding claims, characterized characterized in that a classifier at least one CWF information and / or derived variables with deposited data compares to physiological / pathophysiological Identify events. Device according to one of the preceding claims, characterized characterized in that a classifier at least one CWF information and / or derived variables with other measuring signals and / or CWP compares to it physiological / pathophysiological Identify events. Device according to one of the preceding claims, characterized characterized in that at least part of the results of the analysis device and / or at least part of the results of the classifier substantially be output directly acoustically and / or graphically. Device according to one of the preceding claims, characterized characterized in that for the identification of physiological events at least two signals are in temporal context, are evaluated. Device according to one of the preceding claims, characterized characterized in that for measuring further signals complementary modules are adaptable. Device according to one of the preceding claims, characterized characterized in that at least one interface in the range of Basic module and / or is arranged in the area of supplementary modules, the reading of data and / or the control of other devices, in particular Therapy devices, serves. Device according to one of the preceding claims, characterized characterized in that for measuring further signals complementary sensor devices are adaptable. Device according to one of the preceding claims, characterized in that sensor devices are selected from the group: ECG, EMG, EOG, EEG, pulse oximetry, blood pressure, impedance measurement, ultrasound, Doppler, CO2, respiratory, snoring, oral, thorax, abdomen, Position sensor are adaptable. Device according to one of the preceding claims, characterized characterized in that a module can be added to which Determination of further biodata is formed. Device according to one of the preceding claims, characterized characterized in that a module can be added to which Determination of respiratory parameters, such as respiratory flow, PTT, motion signals, Respiratory effort, is formed. Device according to one of the preceding claims, characterized characterized in that a module can be added to which Determination of cardiac parameters, such as ECG, heart rate, trained. Device according to one of the preceding claims, characterized in that a device for data input, such as Age, sex, state of health, is provided. Device according to one of the preceding claims, characterized in that a display means and / or an output means for analysis results is provided. Device according to one of the preceding claims, characterized characterized in that means for the attachment of the device to the body of a living being provided are. Device for the determination and analysis of biodata of a living being, consisting of at least one sensor device for the non-invasive measurement of at least two signals, such as plethysmogram and derived from it continous wave fluctuation (CWF) signals, SpO2, Pulse rate and one connected to the sensor device Analysis device for analyzing transient and / or periodically recurring Pattern of the measured signals, which at least one module for evaluation contains such information with the frequency or amplitude of the signals or from them derived parameters are related. Method for the determination and analysis of biodata of a living being in which at least one sensor device non-invasive, at least two signals are measured, in particular two signals selected from the group Pletysmogram with derived CWF signals (Continues Wave Fluctuation) SPO2 signals or pulse rate and at the from an analysis device connected to the sensor device Transient and / or periodic recurring patterns of measured Signals are determined and where in terms of the evaluation results Those information will be further processed with the frequency and / or amplitude of the signals or derived therefrom parameters in association with.