TRANSPORT AND STORAGE CONDITIONS:
Temperature:
•
Humidity:
•
Pressures:
•
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 Mini Lite has unlimited flashes and is intended for a single user.
Minimum expected service life is 10 years when following the recommended regimen.
EMC
SmoothSkin Pure Mini Lite 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, EN/IEC 60601-1-2:2014 (Ed 4.0), FCC CRF 47 Part
15B 15.107 and 15.109, IECS-003 Issue 6.0.
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
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-25°C to +70°C
Up to 93%R.H. non condensing
500hPa to 1060hPa