Is EmotiBit compliant with safe and ethical use in human participants research?

Created by Nitin Nair, Modified on Fri, 13 Dec, 2024 at 3:05 PM by David ten Have

Yes! 


Here is the safety information successfully submitted by one of our partners to an IRB application on a study using EmotiBit:


EmotiBit safety and protection information

EmotiBit has been designed and tested for safety of use. The device operates on a low-voltage battery and wirelessly transmits data with zero risk of electrical shock from power mains. Each device is factory tested for functional insulation, and short-circuit prevention. 


During use, continuous temperature sensing provides protection from overheating. 


Materials and methods used in the device are determined to provide irritant-free body contact utilizing ISO 10993-5 and UL certified conformal coating compliant with RoHS directive 2015/863/EU, individually inspected with UV fluorescence. 


The EmotiBit device is used in conjunction with a replaceable PET plastic barrier and replaceable Ag/AgCl electrodes designed for medical applications that are disinfected between participants to provide hygienic, hypoallergenic and irritant free contact with the skin.

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