Smoothskin Bare FIT, Руководство пользователя

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16. TECHNICAL SPECIFICATIONS
The SmoothSkin Bare Fit is a filtered broadband Intense Pulsed Light system with the following technical specifications:
•
Repetition Rate: Manually pulsed every 0.6 seconds. Continuous operation
• Max Optical Output: 4J/cm2
•
Pulse Length: 0.8 – 1.0msec FWHM
•
Wavelength: 510-1100nm
•
Power Line Input: 100–240V~, 50/60Hz,1.7-0.91A
•
Operating temperature: Between 5°C and 40°C
•
Operating humidity: Up to 93%R.H. non condensing
• Operating Pressures: 700hPa to 1060hPa
•
Treatment area (spot size): 3 cm2 (30mm x 10mm)
The area directly around the treatment window is classified as the Applied Part, and can reach a maximum temperature of 52°C.
Ensure SmoothSkin Bare Fit is used as directed in Section 8.
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 Bare Fit has unlimited flashes and is intended for a single user.
Minimum expected service life is 10 years when following the recommended regimen.
EMC
SmoothSkin Bare Fit complies with the latest EMC Standards and Amendments applicable to Household and Medical Devices.
These are: EN 60601-1-2:2014 Ed 4.0, EN 55014-1:2017 and EN 55014-2-2015, EN 61000-3-2:2014 & EN 61000-3-3:2013, FCC
CRF 47 Part 15B 15.107 & 15.109
Safety
SmoothSkin Bare Fit complies with the latest Safety Standards and Amendments applicable to Household and Medical Devices.
These are: IEC 60335-1:2010, IEC 60335-2-23 :2003, IEC 60601-11:2015 , IEC 60601-1-1:2005, IEC 60601-2-57:2011, IEC 60601-
1-6:2010, IEC 62366-1:2015, IEC 62366-1:2015, IEC 62304:2006, CAN/CSA -C22.2 No 60601-1:2008 and 2014, ANSI/AAMI ES
60601-1:2005 + AMS
CE marking certifies that this appliance conforms to the following EU Directives:
•
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.