telemetric cardio- vascular and stress analyzer … · telemetric cardio-vascular and stress...

TELEMETRIC CARDIO-VASCULAR AND STRESS ANALYZER SYSTEMS FOR EXERCISE TESTS

3/6/12 channel ECG with complete analysis (measured during exercise)

Available both with bicycle ergometer and treadmill

Automatic measurements based on standard or user-configured protocols

Programmable, non-invasive blood pressure measuring during exercise

Wide range of analysis options: by cycle, averaged, QT, QTv, QTd, HRV

Analysis sheets generated automatically by the software (averaged ECG, trends, summarizing sheet, etc.)

Immediate report printing using pre-defined printing templates

Stress measuring option based on the myoelectric activity of the gastrointestinal tract

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HUMAN DIAGNOSTICS�

Telemetric cardiovascular and stress analyzer systems for exercise tests

Telemetric cardiovascular analyzing systems for exercise tests provide stable and reliable follow-up of physiological changes proportional to the exercise done on bicycle ergometer or treadmill.

The systems are working with the high quality devices produced by Ergo-Fit GmbH, system packages including the measuring and exercise devices, and all accessories required for the examination.

Thanks to the professional technology of the measuring system and the high quality of the attached exercise devices, artifacts occur-ring upon movements will influence neither ECG curves nor NIBP values. Furthermore, automatic signal level detection allows stable online monitoring of the heart rate (HR). These conditions contribute to the high accuracy of the evaluation results.

Based on the requirements and possibili-ties of the user and the examination facility, the measuring devices can be operated either with bicycle or treadmill. The systems are de-livered in dual-monitor build-up, together with a custom-made trolley. Due to the telemetric design these systems require no uncomfort-able cables, so the measuring setup can be placed anywhere within the examination facil-ity, and need not be placed directly next to the exercise device.

The system provides wide range of ap-plication possibilities among others in the everyday practice of cardiologic diagnostics, in sports medicine, and in rehabilitation fol-low-up.

PrODUCT FUNCTIONS SySTEMSMeasuring device Exercise device

TSE-01

Telemetric systemWith cardiac (ECG) module With treadmill

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BSE-01

Telemetric systemWith cardiac (ECG) moduleWith bicycle ergometer

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TSE-02

Telemetric systemWith cardiac (ECG) and gastrointestinal stress (EGIG) modulesWith treadmill

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BSE-02

Telemetric systemWith cardiac (ECG) and gastrointestinal stress (EGIG) modulesWith bicycle ergometer

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The patient manager panel is quickly available via the shortcut icon. Here, data of a new patient can be registered, or previously registered patients can be chosen. The identi-fication code is generated automatically by the software for each patient.

Besides recording of personal data, fur-ther documentation (recording weight and height, creating patient groups, export/import of data, recording all information about the patient), and reloading of the previously saved primary curves can be carried out here. At ar-chiving personal data of the patients, protec-tion of personal data was considered.

Besides recording patient data, important details of individual measurements can be re-corded and stored into a separate data table.

PATIENT MANAGEMENT AND MEASUREMENT NOTES

MEASUREMENT PROTOCOLSThe software contains

the standard protocols used in exercise tests (e. g. Cooper, Bruce) which can be immedi-ately loaded and used.

Furthermore, we pro-vide opportunity for the user to create new protocols by modifying the existing ones or by programming and ap-plying independent proto-cols, used and approved before at the examination facility. In the panel, the user can set the resting phase be-fore measurement (setting the time), exercise phase (setting the speed and angle of inclination, or load wattage) and cool down after exercise (setting exercise load and time) can be set in the panel.

Moreover, frequency of automatic meas-urements (based on time or load level) by the included blood pressure measuring device can be set, but the user can start a measurement at any time during the examination, which is

equivalent to the programmed ones and the result of which will be also stored.

Protocols created by the user can be saved into the data base of the system and re-loaded at any time, for an unlimited number of measurements.



ECG curves of the pa-tient in up to 12 channels, temperature measured con-tinuously, blood pressure values (measured according to a pre-defined schedule or manually), trend(s) chosen by the user, and the continu-ously updated superimposed curve, compared to the rest-ing phase, are displayed dur-ing the measurement on one or two monitors.

Trends can be displayed one-by-one or in pairs de-fined by the user:

ONLINE ECG MONITORING AND RECORDING

ST Slope (mV/s)P (mV)Q (mV)R (mV)T (mV)ST (mV)

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RR (ms)HR (bpm)P range (ms)PP (ms)ST segment (ms)ST interval (ms)

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PR (ms)QRS (ms)QT (ms)QTcb (ms)T-Te (ms)

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OFFLINE AUTOMATIC ECG ANALYSISAfter the test, offline analysis sheets included in the software can be completed quickly. For

this, previous recording has to be reloaded, then basic conditions (e. g. speed, amplification, trig-ger level, filters) required for the analysis and optional parameters of the analysis sheets (e. g. which leads should the software use for ECG averaging or which trends should the software calculate and show.) have to be defined.

After the setup, the software evaluates the record and creates the following analysis sheets:

Summarizing analysis sheet, including the personal data of the patient, all information in relation to the test (e. g. protocol steps, exercise levels, time), and the most important evaluated parameters in tables and graphical representation. The summarizing sheet can be completed with further notes based on the evaluation.

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Averaged ECG analysis sheet, which is a graphical representation of the ECG cycles lead-by-lead, according to exercise levels, averaged from the ECG recorded during a given exercise level.

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Trend analysis sheet, which shows the trend(s) of one (or two) parameters for the whole test, lead-by-lead, chosen from the cycles available online (but independently from the displayed ones).

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After the automatic offline analysis, data sheets can be printed out separately or together as pre-defined, clear medical records. For a given examination, offline automatic analyses are freely repeatable, thus can be run again and printed out even with altered parameters (e. g. choosing other trends).

Value analysis sheet, which is in close relation with the trend analysis sheet and includes the averaged values of the trends lead-by-lead, according to exercise levels.

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OFFLINE MANUAL ECG ANALYSISThe primary curves saved

immediately after examina-tion, or any of the previously archived ones, can be reload-ed and re-evaluated. For the evaluation, the program gives six ways which are accessible via the Analysis drop-down menu. During analysis, the system automatically calcu-lates the characteristic param-eters from a certain part of the ECG chosen by the user. The calculated parameters are recorded in a table auto-matically and can be printed out or exported.




Cycle-based ECG analy-sis with automatic evaluation of the parameters.

Averaged ECG analysis from cycles selected by the user with automatic evalua-tion of the parameters.

QTd (dispersion) deter-mination from 12 leads and one cycle.

EKG QT evaluation:

QT or QTc, depending on RR or HR (user-selected),QT variability (QTv) evaluation from at least 32 cycles.

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HRV (heart rate variabili-ty) determination by time and frequency range analysis.



GASTROINTESTINAL STRESS MEASUREMENT OPTION

Besides the cardiac (ECG) module, some of the exercise systems (TSE-02 and BSE-02) are available with gastrointestinal stress (EGIG) module as well. Using this supplemen-tary measuring device of the system, myoelec-tric activity of the gastrointestinal tract can be, besides ECG recording and blood pressure measurement, measured and recorded simul-taneously during the exercise test.

Following the examination, records can be evaluated by manual and/or automatic analyses included in the software. This way, the effects evoked by exercise can be further evaluated, using also other aspects besides cardiovascular analyses.




Our exercise test systems are outstand-ing examples of product development based on Hungarian innovation and reliable German production technology. Compared to other systems used routinely in this field, the ad-vantage of systems is that they preserved the proven and widely used cardiac examination modes (e.g. ST analysis, continuous monitoring and trend indication of HR, RR and NIBP), fur-ther during exercise and after exercise analysis of cardiovascular changes occurring upon ex-ercise can be done more profoundly. A further remarkable benefit is that, based on gastroin-testinal motility changes (EGIG), stress effects can be examined independently from the car-diovascular system during the whole examina-tion period. The Holter module, which records the myoelectric signals continuously, can be freely connected to any of the systems.

The abilities of the analysis surface of the system shall be demonstrated here with the preventive diagnosis of risk factors of “sudden cardiac death”. In its background, risks from hardly recognizable silent ischemias and myo-cardial infarctions are often present. In young-er individuals, “sudden cardiac death” is often caused by hereditary diseases resulting in ar-rhythmias, such as the congenital long QT syn-drome (LQTS) leading to disorders in the repo-larization of heart muscle. Phenotype is highly variable in patients with LQTS, and the individual susceptibility to arrhythmias can be completely different also in patients having the same LQT mutation. In patients carrying subclinical LQT mutation and having normal length of QT inter-val measured by conventional ECG technique, life-threatening arrhythmias or “sudden cardiac death” can occur due to drugs or dietary factors which prolong cardiac repolarization. Currently it is a major problem in the clinical practice to estimate the risk of and predict the incidence of life-threatening arrhythmias.

The concept of the repolarization reserve was formed in relation to the above mentioned problems and its predictive value has been proven experimentally. According to this con-cept, if the repolarizing function of one ionic current in the heart muscle decreases due to congenital or acquired causes, it will not nec-essarily result in clinically observable prolonga-tion of repolarization and in arrhythmia (merely in decreased repolarization reserve), since the other ionic currents are able to compensate for the missing function. However, if repolari-zation is further is inhibited (even mildly, e.g. by non-cardiovascular drugs or by dietary fac-tors), significant prolongation of the QT interval

and severe ventricular arrhythmias can occur, which can cause “sudden cardiac death”.

In the recent years, the use of a new ECG parameter has been proposed as a more re-liable predictor of proarrhythmic risk and for the investigation of repolarization reserve. This is the beat-to-beat measurement of QT inter-val variability, characterizing the instability of cardiac repolarization, which can numerically define short-term variability of the QT interval. The increment of short-term variability was better correlated with the incidence of serious ventricular arrhythmias occurring later than the conventional ECG parameters, both under preclinical and clinical circumstances.

The above mentioned changes can show increased occurrence upon exercise, so these analysis functions became included as well. At the end of the examination, the system pro-vides automatic evaluation of all parameters (time, amplitude) of the ECG, which can be printed out together with the screenshot. Fur-thermore, the saved primary curves can be re-loaded, and analyzed in details depending on exercise, at any time.

The exercise test systems used for cardi-ac diagnostic examinations (in general cardiol-ogy, sports medicine, military training, etc.) do typically focus first of all on the electrophysi-ological examination of the heart. In case of athletes, this is complemented also with a limited CO2 measurement. In professional cir-cles, the demand on a non-invasive method, where the examined person is not limited in movements, and where simultaneously with the measured parameters of heart function stress effects can be also detected, has been raised several times. It is a well-known physi-ological paradigm that effects of stress can be observed through the motility disorders of the gastrointestinal tract (stomach and bow-els). The enteric nervous system constitutes a separate unit, to be considered as a “visceral brain”, the functioning of which is, however, not really autonomous. Sympathetic and to a lesser extent parasympathetic, vegetative ef-ferents interlace the enteric nervous system and work as primary signalling system in the rapid sensing of external stress effects.

The objectivity of the examinations could be significantly increased by the exact regis-tration of those facts that in what extent can cardiovascular disturbances occurring upon exercise be traced back to the pathological changes of this region or to the indirect effect caused by exercise induced stress.

HOW OUR SYSTEM HELPS WITH YOUR WORK


MDE Gesellschaft für medizin-technische und medizin-biologische Produkte mbH Altrottstrasse 31, 69190 Walldorf, Deutschland

www.mdegmbh.eu, [email protected]

TECHNICAL DATATelemetry module for ECG 12-channel ECG50 Hz analogue noise filter, 120 dBFiltering for motion artifacts (both on treadmill and bicycle)Bluetooth technologyTransmission distance inside buildings: 10 mTransmission distance in open areas: 50 mBattery life (continuous operation without switching off and recharging): 14 hoursCharging time (depending on battery status): max. 4 hours

Telemetry module for NIBPMeasurement controlled by softwareMeasurement frequency defined in protocol: on he basis of time or exercise levelFiltering for motion artifacts (both on treadmill and bicycle)Systolic pressure measurement range: 25 – 280 mm HgDiastolic pressure measurement range: 10 – 220 mm HgBluetooth technologyTransmission distance inside buildings: 10 mTransmission distance in open areas: 50 mBattery life (continuous operation without switching off and recharging): 14 hoursCharging time (depending on battery status): max. 4 hours

EGIG stress holter moduleFour-channel recordingBattery life (continuous operation without recharging): 24 hoursConfiguration controlled from computer softwareMemory capacity: 4 GB (approx. 1,450 hours of measurement data)Manual starting with automatic shut-down protection

TreadmillControlled by computer softwareGradient adjustable between -5° and +15°, or 0° and 20° (depending on type), in increments of 0,5°Speed adjustable between 0 km/h and 25 km/h, in increments of 0,1 km/h

Bicycle ergometerControlled by computer softwareLoad adjustable between 15 W and 600 W, in increments of 5 W

telemetric cardio- vascular and stress analyzer … · telemetric cardio-vascular and stress...

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