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• Materiales sensores biocompatibles (elemento en contacto con el paciente). Sin Látex.
• Conforme a la directiva europea CEE 93/ 42. Dispositivo de Clase 2A (CE 0459 LNE/G-MED)
• Conforme con la norma IEC 60601-1 equipamiento de clase II.
• Conforme con la norma IEC 60601-2-10
• CEM: IEC 60601-1-2
Las siguientes informaciones acerca de las emisiones electromagnéticas han sido redactadas
intencionadamente en inglés.
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
Electrical
fast
transients /
61000-4-4
bursts
Manual del Usuario ToFscan
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)
± 2 kV
IEC
100 kHz
repetition
frequency
EMC Instructions/cautions
The ToFscan uses RF energy only for internal
functions. Therefore RF emissions are very low and
should not disturb other nearby devices.
The ToFscan must be use in professional healthcare
facility environment
The ToFscan 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,
80 % AM at
the
1 kHz
observed to verify that they are operating
normally
Complies to
In order to prevent electromagne-
table 9 of IEC
tic
60601-1-2
separation from RF communication
(2014)
equipment of 30cm
The ToFscan may temporarily not
± 2 kV
display
100 kHz
electromagnetic disturbances such
repetition
as the use of electrosurgery device.
frequency
In that case, the ToFscan will maintain
the safety of the patient and the user.
EMC
Instructions/precautions
this
equipment
other
equipment
should
disturbance,
keep
result
during
and
be
minimum
transient
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