Labels And Symbols; Technical Specifications - Smoothskin BARE+ Guia Del Usuario

13. LABELS AND SYMBOLS

SmoothSkin Bare+ is marked with the following symbols:
Type BF Applied Part
Class II Equipment
Follow Instructions for use
WEEE waste disposal mark
of the European Union
European
Conformity Marking
Keep Dry
NRTL Certification marking
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FCC Statement:
NOTE: This equipment has been tested and found
to comply with the limits for a Class B digital
device, pursuant to part 15 of the FCC Rules.
These limits are designed to provide reasonable
FCC EMC compliance
protection against harmful interference in a
for North America
residential installation. This equipment generates,
uses and can radiate radio frequency energy
Australia Regulatory
and, if not installed and used in accordance with
Compliance Mark
the instructions, may cause harmful interference
to radio communications. However, there is no
guarantee that interference will not occur in a
EAC Conformity Marking
particular installation. If this equipment does
for Custom Union
cause harmful interference to radio or television
reception, which can be determined by turning
Trefoil compliance mark the equipment off and on, the user is encouraged
for Ukraine to try to correct the interference by one or more
of the following measures:
China RoHS environmental
—Reorient or relocate the receiving antenna.
protection use period
— Increase the separation between the equipment
Warning Optical
and receiver.
Radiation from device
may cause eye injury
— Connect the equipment into an outlet on a
circuit different from that to which the receiver
is connected.
— Consult the dealer or an experienced radio/TV
technician for help.

14. TECHNICAL SPECIFICATIONS

The SmoothSkin Bare+ 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/cm 2
• Pulse Length: 1msec 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 cm (30mm x 10mm)
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The area directly around the treatment window is classified as the
Applied Part, and can reach a maximum temperature of 52degC.
Ensure SmoothSkin Bare+ 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+ 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+ 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+ 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
EEC directives:
• Low Voltage Directive 2014/35/EU
• Electromagnetic Compatibility Directive 2014/30/EU
• Energy related Product Directive 2009 / 125 / EC
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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