8
There are no risks to the use of EmoLED according to
the present indications.
Possible side effects: scientific literature reports that
blue light use could results in a temporary and
transient iperpigmetation of the perilesional skin. In
described cases, iperpigmentation disappear in a few
tens of seconds. Such event has not been directly
observed.
NOTE.
L
ight emitted by EmoLED could be dangerous
for eyes.
4
PRODUCT DESCRIPTION
4.1
Description of the Device and accessories
EmoLED is a portable medical device powered with
rechargeable batteries, made of two distinguished
parts (see Fig. 1 and 2):
-
the Optical Head containing the LED sources
and the distance sensor;
-
the Body containing a touch screen, a Button
with the ON/OFF function, a power
connector and a micro USB port.
Supplied Accessories are:
-
the charger (shown in Fig. 20);
-
the screen for visual comfort to be placed on
the Optical Head before starting application
(see Fig. 6);
-
UV filtering glasses.
4.2
General
The Device emits a uniform electromagnetic radiation
in the visible range (blue light) over all the irradiated
area.
Recommended distance of application is 4 cm from
wound bed; but it is acceptable to keep a range of
distance between 3 and 5 cm during application. An
indicator on the screen help the user to keep the proper
distance (see par. 4.3). If the distance is outside the
given
parameters
the
application
is
paused
automatically (see par. 4.4). The application time has
been defined according to results of preliminary studies
and clinical trials.
If the wound is larger than 5 cm follow the procedure:
insert the wound dimensions as described in section
FIGURA 2 – Rear view
FIGURA 1 – Front view with the Optical Head in
resting mode
FIGURA 3 - Suggested distance for treatment