Disclaimer
biosignalsplux products are intended for use in life science education and research applications; they are not medical devices nor are they intended for medical diagnosis, cure, mitigation, treatment or prevention of disease.
We expressly disclaim any liability whatsoever for any direct, indirect, consequential, incidental or special damages, including, without limitation, lost revenues, lost profits, losses resulting from business interruption or loss of data, regardless of the form of action or legal theory under which the liability may be asserted, even if advised of the possibility of such damages.
Safety & Standards
biosignalsplux is not a medical device. biosignalsplux is certified as an electronic device with intended use for life science research and educational purposes.
It is in compliance with the essential requirements of the following directives, if applied in accordance with the manufacturer’s specifications and instructions:
- Radio Equipment Directive 2014/53/EU Article 3.1(a) Safety and Health Standards
- Radio Equipment Directive 2014/53/EU Article 3.1(b) Electromagnetic Compatibility
- Radio Equipment Directive 2014/53/EU Article 3.2. Efficient Use of Spectrum Standards
- RoHS Directive 2011/65/EU
- Human Exposure EMF EN 62311 (2008)
- EMC EN 60601-1-2 (2015)
You can find the Declarations of Conformity for biosignalsplux devices below for regulatory purposes.
CE Mark / Certificate: 4-Channel & 8-Channel Hubs
CE Mark / Certificate
4-Channel biosignalsplux hubs are included in the following kits:
- biosignalsplux Explorer
- biosignalsplux ergoExplorer (Discontinued)
- biosignalsplux Force
- biosignalsplux Force+EMG (Discontinued)
- cardioBAN v.1.0 (Discontinued)
- respiBAN Researcher / Professional (Discontinued)
- FNIRS Pioneer
8-Channel biosignalsplux hubs are included in the following kits:
- biosignalsplux Researcher
- biosignalsplux Professional
- biosignalsplux ergoResearcher (Discontinued)
CE Mark / Certificate: openBAN (biosignalsplux Solo)
The CE Mark / CE Certificate, presented in the “Declaration of Conformity” document below, lists the safety and functional standards that are met by the biosignalsplux system.
The certification covers the entirety of the biosignalsplux system including the acquisition unit and connected biosignalsplux sensor.
Individual documentation for individual sensors is not provided, as sensors cannot be used as a standalone device, requiring to be connected to a biosignalsplux acquisition unit to fulfill their designed use, and therefore are covered by the presented overall system certification.
The openBAN is included in the biosignalsplux Solo kit.
CE Mark / Certificate: Wearables (muscleBAN & cardioBAN)
The CE Mark / CE Certificate, presented in the “Declaration of Conformity” document below, lists the safety and functional standards that are met by the biosignalsplux wearables.
