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Caractéristiques techniques
Sécurité
• Œilleton (élément en contact avec le patient). Sans latex.
• Conforme au règlement européen 2017/745.
• Eclairage visible et infrarouge selon normes de sécurité IEC 62471
• Marquage CE (organisme 0459 LNE/G-Med) dispositif de Classe 2a.
• Conforme avec la norme IEC 60601-1 équipement de classe II. / Mode de fonctionnement
continu
• CEM : IEC 60601-1-2
Les informations suivantes sur les émissions électromagnétiques ont été rédigées
intentionnellement en anglais.
EMC Emission
Emission test
RF Emissions CISPR 11
RF Emissions CISPR 11
Harmonics IEC 61000-3-2
Voltage fluctuations
and flicker IEC 61000-3-3
EMC Immunity
Basic EMC
Phenomenon
standard
ELECTROSTATIC
DISCHARGE
61000-4-2
(ESD)
Radiated RF EM
Fields
61000-4-3
Proximity fields
from RF
wireless
com-
61000-4-3
munications
equipment
Manuel Utilisateur NeuroLight
Compliance
Group 1
Class B
Class A
Compliant
Professional
healthcare
facility
environment
Immunity Test
Levels
± 8 kV contact
IEC
± 2 kV, ± 4 kV,
± 8 kV,
± 15 kV air
3 V/m
80 MHz – 2,7
IEC
GHz
80 % AM at
1 kHz
Complies to
IEC
table 9 of IEC
60601-1-2
(2014)
EMC Instructions/cautions
The NeuroLight uses RF energy only for internal
functions. Therefore RF emissions are very low and
should not disturb other nearby devices.
The NeuroLight must be used in professional
healthcare facility environment
The NeuroLight can be connected to the public
mains network
Compliance
levels
± 8 kV contact
In order to reduce ESD, the device
must be used in a 35% humidity
± 2 kV, ± 4 kV,
environment or more
± 8 kV air
Use of this equipment adjacent to or
stacked with other equipment should
3 V/m
be avoided because it could result
80 MHz – 2,7
in improper operation. If such use is
GHz
necessary, this equipment and the
80 % AM at
other equipment should be observed
1 kHz
to verify that they are operating
normally
Complies to
In order to prevent electromagnetic
table 9 of IEC
disturbance,
60601-1-2
separation from RF communication
(2014)
equipment of 30cm
EMC
Instructions/precautions
keep
minimum
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