Disclaimer
BITalino is not a medical device nor is it intended for medical diagnosis and provided to you “as is,” and we make no express or implied warranties whatsoever with respect to its functionality, operability, or use, including, without limitation, any implied warranties, fitness for a particular purpose, or infringement. 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
BITalino is not a medical device. BITalino 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:
- Restriction of Hazardous Substances (RoHS) Directive 2011/65/EU
- Human Exposure Restrictions for Electromagnetic Fields EN 62311 (2008)
- Safety Standards EN 60601-1:2006 + A11:2011 + A1:2013 + A12:2014 + AC:2014
You can find the Declarations of Conformity for BITalino devices below for regulatory purposes.
CE Mark / Certificate: BITalino
The CE Mark / CE Certificate, presented in the “Declaration of Conformity” document below, lists the safety and functional standards that are met by the BITalino system.
The certification covers the entirety of the BITalino system including the acquisition unit and connected and/or onboard BITalino sensors.
Individual documentation for individual sensors is not provided, as sensors cannot be used as a standalone device, requiring sensors to be connected to a BITalino acquisition unit to fulfill their designed use, and are therefore covered by the presented overall system certification.
