User Manual

108
EU / CE Statement
Hereby, Smartbox Assistive Technology Ltd. declares that
this radio equipment complies with Directive 2014/53/EU. The
frequencies used by the wireless networking feature of this
product are the 2.4 GHz range.
The full text of the EU declaration of conformity is available here:
thinksmartbox.com/GP15-DOC
Applicable Directives
This equipment complies with the requirements of the EU
harmonised legislation; Medical Devices Directive 2007/47/EC
(including EMC Directive 2014/30/EU and LVD Directive 2014/35/
EU), Medical Devices Directive 93/42/EEC as amended by 2007/47/
EC, RoHS Directive 2011/65/EU. WEEE Directives 2012/19/EU.
Directives and Standards
EN 60601-1:2006/A1:2013
Medical electrical equipment - Part 1: General requirements for
basic safety and essential performance
EN 60601-1-2:2015
Medical electrical equipment - Part 1-2: General requirements for
basic safety and essential performance - Collateral Standard:
Electromagnetic disturbances - Requirements and tests
8.6 Statement of compliance
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