Declaration of Conformity
When emitting its red light the Omnilux new-U
has been classified as a CLASS 1 LED PRODUCT
in accordance with the requirements of the
International standard IEC 60825-1:2001 – Safety
of LED Products.
When emitting its IR light output, the Omnilux
new-U has been classified as a CLASS 1 LED
PRODUCT in accordance with the requirements
of the International standard IEC 60825-1:2001 –
Safety of LED Products.
IR light cannot be seen with the eye, therefore the
IR output of the Omnilux new-U is classified as
‘Invisible LED Radiation’.
This standard also recommends Maximum
Permissible Exposures (MPEs) to light sources in
order that the risk of damage to eyes is eliminated.
When used correctly for the recommended
treatments the outputs of the Omnilux new-U are
less than the maximum recommended MPEs.
CLASS 1 products are safe for unprotected
exposure of the eyes.
References
1.
Takezaki S, Omi T, Sato S, Kawana S
;
‘
Light-emitting diode phototherapy at 630 +/- 3
nm increases local levels of skin-homing T-cells
in human subjects’
. - J Nippon Med Sch, 2006;
73: 75-81.
2.
Takezaki I et al
;
‘Ultrastructural Observations Of
Human Skin Following Irradiation With Visible
Red Light-Emitting Diodes (LEDs): A Preliminary
In Vivo
Report’
. - Laser Therapy 14.4: 153-160.
3.
Lee SY et al
;
‘A prospective, randomized,
placebo-controlled, double-blinded, and split-
face clinical study on LED phototherapy for skin
rejuvenation: Clinical, profilometric, histologic,
ultrastructural, and biochemical evaluations and
comparison of three different treatment settings’.
-
Journal of Photochemistry and Photobiology
B: Biology 88; (2007): 51-67.
4.
Russell B et al
;
‘A study to determine the efficacy
of combination LED light therapy (830 nm and
633 nm) in facial skin rejuvenation’.
- Journal of
Cosmetic and Laser Therapy volume 7 issue 3/4.
5.
Calderhead RG
; ‘
The Photobiological Basics
Behind Light-Emitting Diode (LED) Phototherapy’.
- Laser Therapy 16.2: 97-108 2007.
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