TRANSPORT CONDITIONS:
•
Temperature:
-25°C to +70°C
•
Humidity:
Up to 93%R.H. non condensing
•
Pressures:
500hPa to 1060hPa
If the device has been stored at temperatures outside of the stated operating range, then please allow
at least 30 minutes before use to allow the device to acclimatise.
SmoothSkin Pure Fit has unlimited flashes and is intended for a single user.
Minimum expected service life is 10 years when following the recommended regimen.
CE marking certifies that this appliance conforms to the following EU Directives:
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Low Voltage Directive 2014/35/EU
•
Electromagnetic Compatibility Directive 2014/30/EU
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Energy related Product Directive 2009 / 125 / EC.
SmoothSkin Pure Fit complies with the latest EMC Standards and Amendments applicable to Household
and Medical Devices. These are: EN 55014-1:2017, EN 55014-2:2015, EN 61000-3-2:2014, EN 61000-3-
3:2013, IEC 60601-1-2:2014 (Ed 4.0), FCC CFR 47 Part 15.107 & 15.109, ICES-003 Issue 6.0
SmoothSkin Pure Fit complies with the latest Safety Standards and Amendments applicable to
Household and Medical Devices.
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These are: IEC 60335-1:2010 + Ams, IEC 60335-2-23:2003 + Ams, EN 62233, IEC 60601-1:2005 (Ed
3.1) +A2:2012, IEC 60601-2-57:2011, IEC 60601-1-6:2010 + Ams, IEC 62366-1:2015, IEC 60601-1-9, IEC
62304:2006 + Ams, CAN/CSA - C22.2 No 60601-1:2008 and 2014, ANSI/AAMI ES 60601-1:2005 + Ams
For further details contact CyDen Ltd
DISPOSAL (end of life)
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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