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.

• Keywords
• cardiotocograph, doppler effect, fetal heart rate, fetal heart rate monitor device, heart movement simulator, tests of medical device,
• MeSH
• Humans MeSH
• Monitoring, Physiologic MeSH
• Fetus * MeSH
• Heart Rate, Fetal * MeSH
• Heart Rate MeSH
• Pregnancy MeSH
• Ultrasonography MeSH
• Check Tag
• Humans MeSH
• Pregnancy MeSH
• Female MeSH
• Publication type
• Journal Article MeSH

The second Signal Processing and Monitoring in Labor workshop gathered researchers who utilize promising new research strategies and initiatives to tackle the challenges of intrapartum fetal monitoring. The workshop included a series of lectures and discussions focusing on: new algorithms and techniques for cardiotocogoraphy (CTG) and electrocardiogram acquisition and analyses; the results of a CTG evaluation challenge comparing state-of-the-art computerized methods and visual interpretation for the detection of arterial cord pH <7.05 at birth; the lack of consensus about the role of intrapartum acidemia in the etiology of fetal brain injury; the differences between methods for CTG analysis "mimicking" expert clinicians and those derived from "data-driven" analyses; a critical review of the results from two randomized controlled trials testing the former in clinical practice; and relevant insights from modern physiology-based studies. We concluded that the automated algorithms performed comparably to each other and to clinical assessment of the CTG. However, the sensitivity and specificity urgently need to be improved (both computerized and visual assessment). Data-driven CTG evaluation requires further work with large multicenter datasets based on well-defined labor outcomes. And before first tests in the clinic, there are important lessons to be learnt from clinical trials that tested automated algorithms mimicking expert CTG interpretation. In addition, transabdominal fetal electrocardiogram monitoring provides reliable CTG traces and variability estimates; and fetal electrocardiogram waveform analysis is subject to promising new research. There is a clear need for close collaboration between computing and clinical experts. We believe that progress will be possible with multidisciplinary collaborative research.

• Keywords
• artificial intelligence, cardiotocography, electronic fetal monitoring, health data, hypoxic-ischemic encephalopathy, intrapartum care, sensitivity, specificity,
• MeSH
• Acidosis diagnosis   MeSH
• Algorithms * MeSH
• Electrocardiography methods   MeSH
• Cardiotocography methods   MeSH
• Humans MeSH
• Fetal Monitoring methods   MeSH
• Signal Processing, Computer-Assisted MeSH
• Prenatal Diagnosis MeSH
• Pregnancy MeSH
• Check Tag
• Humans MeSH
• Pregnancy MeSH
• Female MeSH
• Publication type
• Congress MeSH
• Research Support, Non-U.S. Gov't MeSH
• Research Support, N.I.H., Extramural MeSH
• Geographicals
• United Kingdom MeSH