A New Approach for Testing Fetal Heart Rate Monitors

Area of Science:

• Biomedical Engineering
• Medical Device Technology

Background:

• Fetal heart rate monitors are crucial for assessing fetal well-being during pregnancy.
• Accurate and reliable testing of these devices is essential to ensure patient safety and diagnostic accuracy.

Purpose of the Study:

• To propose a novel approach for the periodical testing and functionality evaluation of fetal heart rate monitor devices.
• To present the design, realization, and testing of a new simulator for fetal heart rate monitors.

Main Methods:

• Development of a simulator using a relay element to mimic fetal and maternal heartbeats at specific frequencies.
• Ensuring the simulator's compliance with standard requirements for medical device assessment.
• Evaluating the accuracy and reliability of the simulated signals and the test equipment.

Main Results:

• The developed simulator demonstrated stable and reliable performance.
• Generated frequencies exhibited an error of approximately 0.5% compared to nominal values.
• Test equipment accuracy was within ±3% of the set frequency, meeting technical standards for fetal heart rate monitors.

Conclusions:

• The developed simulator correctly functions and meets technical requirements for medical devices.
• The proposed testing method offers a simple, quick, and efficient way to evaluate commercial fetal heart rate monitor apparatuses.
• This approach enhances the reliability of fetal heart rate monitoring through accurate device evaluation.