8
ENGLISH
PRODUCT
DESCRIPTION
Classification
of
medical
devices
pursuant
to
Directive
93/42/EEC
(Annex
IX)
‐
Duration:
Temporary
‐
Invasive
devices:
Non
‐
invasive
‐
Active
medical
device:
Active
Due
to
the
above
characteristics
the
device
falls
under
class
I
(in
accordance
with
Rule
1)
Classification
in
accordance
with
general
regulations
(standard
CEI
EN
60601)
‐
According
to
the
type
of
protection
against
electrical
hazards:
Class
I
equipment
‐
According
to
the
type
of
protection
against
ingress
of
water:
Ordinary
equipment
‐
According
to
the
degree
of
safety
in
use
in
the
presence
of
a
flammable
anaesthetic
mixture
with
air
or
oxygen
or
nitrous
oxide:
Device
not
suitable
for
use
with
what
is
described
above.
The
dental
whitening
lamp
is
for
use
in
the
beauty
and
dental
sector.
Dental
whitening
is
the
only
and
sole
purpose
of
the
whitening
lamp.
The
lamp
emits
an
intense
light
radiation.
The
operator
who
uses
the
whitening
lamp
device
must
have
the
necessary
qualifications
and
experience.
The
operator
must
have
received
the
necessary
training
in
its
correct
use
and
must
know
the
position
of
all
the
controls:
•
for
positioning
the
lamp
•
for
switching
the
lamp
on
and
off
and
the
time
setting
functions.
