A Study on the Performance and Safety Test of Infant Incubator Devices

Abstract

Nowadays, most neonatal or newborn babies are put in infant incubators to overcome distress during the postnatal care. These incubators can be defined as an optimal cabin environment with electronic equipment that enables premature babies with health problems to be able to continue their vital functions and grow. Despite the support of incubators, many newborn deaths are reported within the neonatal period. Similar to any other electromedical equipment, an infant incubator must be calibrated periodically because its malfunction may cause serious damage to the newborn's health or even lead to the newborn's death. So, the reliability of infant incubator is a matter of importance, and the performance and safety of these devices must be regularly verified, at least annually, using adequate analyzer via expert persons.

Why Should We Have a Periodic Safety and Performance Program for Medical Devices

“…In some cases the amount of leakage currents were over the standard limitations. As a technical investigation, it is shown that the earth system quality of hospital has a role key in electrical safety test and it is necessary to evaluate the quality of hospital earth system [4].…”

“…Due to design and manufacturing technology development of the pumps, it is required to consider supplementary professional training courses for the users to enable them to use all available pump options and reduce the human errors [5].…”

“…General electrical safety evaluations for measuring the patient leakage currents and patient auxiliary currents were carried out for all of the under test devices. In some cases the amount of patient leakage currents was over the standard limitations, especially in two under test devices with recoiling of motor’s fan, the patient leakage current and the noise level of fan were more than limited amounts [6].…”