In this paper, a new approach for the periodical testing and the functionality evaluation of a fetal heart rate monitor device based on ultrasound principle is proposed. The design and realization of the device are presented, together with the description of its features and functioning tests. In the designed device, a relay element, driven by an electric signal that allows switching at two specific frequencies, is used to simulate the fetus and the mother's heartbeat. The simulator was designed to be compliant with the standard requirements for accurate assessment and measurement of medical devices. The accuracy of the simulated signals was evaluated, and it resulted to be stable and reliable. The generated frequencies show an error of about 0.5% with respect to the nominal one while the accuracy of the test equipment was within ±3% of the test signal set frequency. This value complies with the technical standard for the accuracy of fetal heart rate monitor devices. Moreover, the performed tests and measurements show the correct functionality of the developed simulator. The proposed equipment and testing respect the technical requirements for medical devices. The features of the proposed device make it simple and quick in testing a fetal heart rate monitor, thus providing an efficient way to evaluate and test the correlation capabilities of commercial apparatuses.

• Klíčová slova
• cardiotocograph, doppler effect, fetal heart rate, fetal heart rate monitor device, heart movement simulator, tests of medical device,
• MeSH
• lidé MeSH
• monitorování fyziologických funkcí MeSH
• plod * MeSH
• srdeční frekvence plodu * MeSH
• srdeční frekvence MeSH
• těhotenství MeSH
• ultrasonografie MeSH
• Check Tag
• lidé MeSH
• těhotenství MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH

Non-adaptive signal processing methods have been successfully applied to extract fetal electrocardiograms (fECGs) from maternal abdominal electrocardiograms (aECGs); and initial tests to evaluate the efficacy of these methods have been carried out by using synthetic data. Nevertheless, performance evaluation of such methods using real data is a much more challenging task and has neither been fully undertaken nor reported in the literature. Therefore, in this investigation, we aimed to compare the effectiveness of two popular non-adaptive methods (the ICA and PCA) to explore the non-invasive (NI) extraction (separation) of fECGs, also known as NI-fECGs from aECGs. The performance of these well-known methods was enhanced by an adaptive algorithm, compensating amplitude difference and time shift between the estimated components. We used real signals compiled in 12 recordings (real01-real12). Five of the recordings were from the publicly available database (PhysioNet-Abdominal and Direct Fetal Electrocardiogram Database), which included data recorded by multiple abdominal electrodes. Seven more recordings were acquired by measurements performed at the Institute of Medical Technology and Equipment, Zabrze, Poland. Therefore, in total we used 60 min of data (i.e., around 88,000 R waves) for our experiments. This dataset covers different gestational ages, fetal positions, fetal positions, maternal body mass indices (BMI), etc. Such a unique heterogeneous dataset of sufficient length combining continuous Fetal Scalp Electrode (FSE) acquired and abdominal ECG recordings allows for robust testing of the applied ICA and PCA methods. The performance of these signal separation methods was then comprehensively evaluated by comparing the fetal Heart Rate (fHR) values determined from the extracted fECGs with those calculated from the fECG signals recorded directly by means of a reference FSE. Additionally, we tested the possibility of non-invasive ST analysis (NI-STAN) by determining the T/QRS ratio. Our results demonstrated that even though these advanced signal processing methods are suitable for the non-invasive estimation and monitoring of the fHR information from maternal aECG signals, their utility for further morphological analysis of the extracted fECG signals remains questionable and warrants further work.

• Klíčová slova
• electronic fetal monitoring (EFM), fetal electrocardiogram (fECG), independent component analysis (ICA), non-invasive ST analysis (NI-STAN), non-invasive fetal ECG (NI-fECG), non-invasive fetal heart rate (NI-fHR) estimation, nonadaptive methods, principal component analysis (PCA),
• Publikační typ
• časopisecké články MeSH