1. Electromagnetic compatibility tests and informed consent, in the development of research on biomedical equipment design
- Author
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Carlos Venturo Orbegozo, Denis Morales Saavedra, Alfonso Fuentes, Wilver Auccahuasi Aiquipa, Madelaine Bernardo Santiago, Sergio Arroyo Rivera, Grisi Bernardo Santiago, and Edward Flores Masias
- Subjects
Protocol (science) ,Risk analysis (engineering) ,Computer science ,Informed consent ,visual_art ,Electronic component ,Electromagnetic compatibility ,visual_art.visual_art_medium ,Software design ,Communications protocol ,Original equipment manufacturer ,Task (project management) - Abstract
They are very frequently presented in the realization of research projects in engineering, the designs of biomedical equipment dedicated to solve health problems with the help of engineering techniques, this is achieved thanks to the evolution of information and communications technologies which make it possible to increase electronic components that are an important part of medical devices, in most cases these designs are based on being able to couple pre-designed circuits that are commonly called "OEM" circuits, these circuits fulfill certain functional tasks well defined as for example signal amplifier circuits of ECG, EEG, EMG among others, being the task of being able to complete the design with the feeding stages, communication protocols, software design, security mechanisms among others, these designs must pass by functional tests or clinical tests in "real patients". In most designs, it is not considered to inform patients about safety considerations or the protocol of tests to be performed, which increases the probability of the risk of suffering some kind of damage to the patient, the equipment and the same. designers, in this work we intend to raise awareness among researchers in considering the safety mechanisms in their design, as well as submit to the ethics committees the testing protocols of their designs in order to mitigate the risks that may arise in the At the time of the tests, some electromagnetic compatibility tests of the IEC-606001 family, which can be carried out in pursuit of integral safety, are presented as an example.
- Published
- 2019
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