Safety
SmoothSkin Pure Mini Lite complies with the latest Safety Standards and Amendments
applicable to Household and Medical Devices.
These are: IEC 60335-1:2010, IEC 60601-1-11:2015, IEC 60601-1:2005, IEC 60601-2-57:2011, IEC
60601-1-6:2010, IEC 62366-1:2015, IEC 62304:2006, C22.2 No 60601-1:2008 and 2014, IEC
60601-2-83:2019, IEC 60335-2-113:2016, ANSI/AAMI ES 60601-1:2015 + AMS
IEC 60601-2-83 Additions
SmoothSkin Pure Mini Lite is classified as Risk Group Exempt for all hazards.
CE marking certifies that this appliance conforms to the following EU Directives and Regulations:2
•
EU MDR Regulations 2017/745
•
Low Voltage Directive 2014/35/EU
•
Electromagnetic Compatibility Directive 2014/30/EU
•
Energy-Related Product Directive 2009/125/EC
For further details contact CyDen Ltd.
DISPOSAL (END OF LIFE)
This product is a medical device.
In order to minimize hazards to health and the environment and ensure
that materials can be recycled, this product should be disposed of
at a separate collection facility for waste electrical and electronic
equipment.
The WEEE symbol marked on the product is there to remind you.
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