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.
- 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
This paper presents a newly-designed and realized Invasive Blood Pressure (IBP) device for the simulation on patient's monitors. This device shows improvements and presents extended features with respect to a first prototype presented by the authors and similar systems available in the state-of-the-art. A peculiarity of the presented device is that all implemented features can be customized from the developer and from the point of view of the end user. The realized device has been tested, and its performances in terms of accuracy and of the back-loop measurement of the output for the blood pressure regulation utilization have been described. In particular, an accuracy of ±1 mmHg at 25 °C, on a range from -30 to 300 mmHg, was evaluated under different test conditions. The designed device is an ideal tool for testing IBP modules, for zero setting, and for calibrations. The implemented extended features, like the generation of custom waveforms and the Universal Serial Bus (USB) connectivity, allow use of this device in a wide range of applications, from research to equipment maintenance in clinical environments to educational purposes. Moreover, the presented device represents an innovation, both in terms of technology and methodologies: It allows quick and efficient tests to verify the proper functioning of IBP module of patients' monitors. With this innovative device, tests can be performed directly in the field and faster procedures can be implemented by the clinical maintenance personnel. This device is an open source project and all materials, hardware, and software are fully available for interested developers or researchers.
- MeSH
- design vybavení MeSH
- kalibrace MeSH
- krevní tlak fyziologie MeSH
- lidé MeSH
- měření krevního tlaku přístrojové vybavení metody MeSH
- monitorování fyziologických funkcí přístrojové vybavení metody MeSH
- monitory krevního tlaku * MeSH
- software MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
