Omnilux CONTOUR - Contraindications, Warnings, and Precautions; Contraindications

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7.3. Troubleshooting
Problem Possible Cause Action
No red or near-
infrared light
coming from
Omnilux
Contour
Face
Not charged
Plug the charger into the
controller making sure that the
connectors are attached and
leave charging until the three
indicator LEDs on the controller
remain lit and do NOT flash
No red or
near-inrared
light from
Omnilux
Contour
Face
Device is
connected to
electical outlet
Unplug micro USB connector
from controller
LEDs do not
turn off after
10 minutes
Device is faulty Return to your supplier
LEDs flicker
during
treatment
Omnilux Contour
Face is
not fully inserted
into controller
Ensure the controller and
Omnilux Contour Face are
connected correctly
If the actions suggested fail to fix the problem, or the problem
reoccurs, and your device is within the warranty period please return to
your provider.
• DO NOT attempt to investigate any further.
• DO NOT attempt to modify the device in any way. The
Omnilux Contour Face device has no parts you can
repair yourself.
8.0. Labeling
The labeling supplied with the device contains the following
information:
• Date of manufacture
• Catalogue number and batch code
• Operating environment
Recycling
This symbol indicates: This product shall not be disposed of with
normal household waste (2012/19/EU).
This symbol indicates: This product contains a built-in
rechargeable battery which shall not be disposed of with normal
household waste (2006/66/EC).
We advise you to take your product to an official collection point to
have a professional remove the rechargeable battery. Follow your
country’s rules for the separate collection of electrical and electronic
products and rechargeable batteries. Correct disposal helps prevent
damage to the environment and human health.
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LEDs: Red: 633nm+/-10nm. NIR: 830nm+/-17.5nm
Controller: 102.8mm max (L) x 46.3mm (W) x 34.9mm max (H)
Program time: 10 minutes fixed
Operating temperature: 0°C to 40°C
Storage and transport temperature: -5°C to 55°C
Operating humidity: 30% to 95% without condensation
Storage and transport humidity: 20% to 85%
without condensation
Mains electrical input from power adapt
er: 100-240Vac,
50/60Hz. 0.25A
Electrical output: 5V
Compliance
The Omnilux Contour Face device complies with the standard of
basic safety for medical devices EN60601-1:2006/A12:2014 and with
the relevant collateral and particular standards for non-laser light
source medical equipment for home use EN 60601-1-11:2015, EN
60601-2-57:2011,
and EN 60601-1-2:2015 and IEC 62471:2006 Photobiological Safety
of Lamps and Lamp Systems. EN 55014-1.2006+A1: 2009+A2 2011
Electro Magnetic Compatibility – requirements for household
appliances, electric tools and similar apparatus – Part 1 emissions.
EN 55014-2:2015 Electromagnetic compatibility- requirements for
household appliances electric tools ad similar apparatus – part 2:
immunity – product family standard.
Regarding electromagnetic compatibility (EMC) and electromagnetic
fields (EMF), the device should be kept away from radio frequency (RF)
equipment to avoid interference.