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.

Department of Biomedical Technology Faculty of Biomedical Engineering Czech Technical University Prague nam Sitna 3105 272 01 Kladno Czech Republic

Department of Cybernetics and Biomedical Engineering Faculty of Electrical Engineering and Computer Science VSB Technical University of Ostrava 17 listopadu 2172 15 708 00 Ostrava Poruba Czech Republic

Department of Engineering University of Roma Tre Via Vito Volterra 62 00146 Rome Italy

Malaysia Japan International Institute of Technology Universiti Teknologi Malaysia Jalan Sultan Yahya Petra 54100 Kuala Lumpur Malaysia

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