Quality control strategy of remote heart rate monitoring devices in a health center in Peru

Cardiovascular disease (CVD) is a broad term used to refer to heart diseases and blood vessels. According to the World Health Organization (WHO), the number of deaths from heart diseases between the years 2000-2019 has ranged between 2 million and almost 9 million people. After analyzing the need to implement and validate a monitoring system for the PUCP health center, we chose the FL10 device. This device has passed the design specifications under the following standards: IEC 60601-1:2005, IEC 60601-1-2:2014 and ISO 60601-2-47:2012, therefore it meets the safety, sensitivity and efficacy parameters but its design does not favor maintenance and periodic quality evaluations with commercial measurement equipment. An adapter was made by implementing digital manufacturing by 3D design using Inventor professional 2021 software with the educational license granted by the university. The electrical safety test showed that the leakage current value of all the electrodes was 0.3 uA which is less than the standard (0.1 mA) and the efficacy test showed that all measurements were acceptable. In the case of reproducibility and repeatability tests, the measurements were acceptable as well; in the value of 180 bpm, we observe an attenuation (179 bpm), however it is within the margin of error of 1 bpm. In summary, the FL 10 device is electrical safety and efficient in a health center in Peru.