Regulatory



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.


CE Mark & Decleration of Conformity

biosignalsplux is certified as 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)


Warnings & Indications

The following warnings & indications are valid for all biosignalsplux products if not stated otherwise in the product-specific documentation.
  • Do not use this device in patients with implanted electronic devices of any kind, including pace-makers, electronic infusion pumps, stimulators, defibrillators or similar.
  • Do not use this system in users with allergy to silicon.
  • Discontinue the use of this system immediately if you experience any kind of discomfort, skin irritation, or other pain.
  • Do not use and/or apply this system over damaged skin.
  • Discontinue the use of this system immediately if it reaches uncomfortable temperatures. Turn of the device immediately and contact PLUX’s technical support team via telephone (+351 211 956 542) or via e-mail (support@plux.info).
  • See all the available biosignalsplux documentation that comes with the system and which is available under biosignalsplux Documentation for instructions on safety, precautions, and usage.
  • Always keep the device and its accessories dry. The presence of liquid contact can compromise the safety operating characteristics of the system. Do not immerse the biosignalsplux, nor clean with liquid or abrasives. Read the User Manual and this Quickstart Guide for further cleaning instructions.
  • Exposing the device or accesories to high accelerations and vibrations may influence its functionality, limit of its functionality or even damage the device.
  • Do not use this equipment in an environment with operating magnetic resonance imaging devices (MRI).
  • Do not use the device near fire or in potentially explosive atmospheres with flammable gas.
  • Conduct visual inspections of the system on a regular basis to identify any visible damages.
  • Do not use this system or any of its accessories if damaged, as it may result in changes to the technical characteristics and features of the system which can put the safe use of the system at risk.
  • Do not place the device or any of its accessories in the microwave.
  • Do not open the biosignalsplux system or its accessories. The repair of the same should only be conducted by properly authorized and trained PLUX personnel.
  • Do not use the device if it stops working properly and/or if any of its features and functionalities are limited. Reach out to PLUX’s support team via telephone (+351 211 956 542) or via e-mail (support@plux.info) for further help.
  • The biosignalsplux may suffer or cause interference to other equipment with radio receiver and/or transmitters, even those that comply with international standards. Keep a safe distance between the biosignalsplux and other devices to ensure their proper functioning. The biosignalsplux should not be used in noisy environments in relation to RF radiation which can cause communication failures with the computer.
  • In compliance with the European Directive on Waste of Electrical and Electronic Equipment (WEEE) 2002/96/EC, do not deposit the biosignalsplux in the trash. Instead, contact your reseller or PLUX for properly recycling of the system. You can get information about the contact nearest to you on https://www.plux.info
  • The biosignalsplux device should be used ad temperatures between 10ºC and 40ºC and sotred at temperatures between 5ºC and 50ºC given the limitations of the integrated LiPo battery. Operating or storing the device outside this range may compromise the integrity and security of it.
  • Use the biosignalsplux within the limits of communication with the receiving equipment of the wireless signal: in a radius of approximately 10 meters for the Bluetooth connection. Working with the device outside of this range of communication can lead to data loss and faulty communications. Please refer to the user manual for more details.