The REVIAN RED system was tested to IEC 60601-1 and 60601-1-2 to confirm the device’s electrical safety
and electromagnetic compatibility and conformance with ANSI/AAMI HA60601-1-11:2015, IEC 60601-2-57 (Edition 1.0), and IEC 62471 (Edition 1.0).
Biocompatibility testing of the Cap per ISO 10993-1 confirmed no effects of the applied parts were noted for cytotoxicity, skin irritation or skin sensitization.
Performance verification and validation testing demonstrates REVIAN RED meets user needs and design inputs and met requirements for its intended use.
Human factors evaluation of REVIAN RED was tested following ANSI/AAMI/IEC 62366-1 and 60601-1-6 standards. The study protocol was designed to evaluate representative users of the device under expected use conditions during simulated and actual use of the device. The
Human Factors Engineering and Usability Engineering process involved several methodologies, including observational user research, formative and summative user testing.