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19. Compatibilidad electromagnético - Instructiones de advertencia
Precautionary measures
There are special precautionary measures for medical electric devices as fare as electromagnetic
compatibility is concerned. This device may be used only for the purpose described in the manual, set up
and put into operation according to the notes for electromagnetic compatibility.
Influence of mobile and portable communication equipment
High-frequency energy radiation from mobile communication equipment may influence on the operation of
the medical electric device. It is not allowed to use those devices (for instance mobile phones and GSM
telephones) close to the medical electric device.
Guidelines and manufacturer's declaration – Electromagnetic radiation
The laser device is designed for the operation only with original accessories in ambient conditions
indicated below. Client and user have to make sure that the device is operated in such ambient conditions.
Radiated disturbance measurements
HF-radiation to
CICPR 11
HF-radiation to
CICPR 11
Radiation of harmonic oscillation
according to
EC 61000-3-2
Radiation of voltage variations/ Flicker
effect according to IEC 61000-3-3
Guidelines and manufacturer's declaration - Electromagnetic immunity
Immunity tests
Discharge of static electricity
(ESD )according to IEC 61000-4-
2
Fast transient electric
disturbance variable / Bursts
according to IEC 61000-4-4
Impulse voltage (Surges)
according to IEC 61000-4-5
Voltage dips, short interruptions
and voltage variations according
to IEC 61000-4-11
Magnetic field at supply
frequency (50/60 Hz)
according to IEC 61000-4-8
Note: U
alternating voltage mains before the application of the test level.
T -
V. 1.0, 11.02.2009
Photonic hair
Conformity
Group 1
Class B
Conforms
Not applicable
IEC 60601-Test level
± 6 kV Contact discharge
± 8 kV Air discharge
± 2kV
for network leads
± 1 kV
for input and output leads
± 1 kV
opposed mode voltage
± 2 kV
common mode voltage
< 5% U
T
(> 95% dip of U
) for ½ period
T
40% U
T
(60% dip of U
) for 5 periods
T
70% U
T
(30% dip of U
) for 25 periods
T
< 5% U
T
(> 95% dip of U
) for 5 s
T
3 A/m
Electromagnetic ambient conditions - guideline
The laser device uses HF-energy only for its internal
function. Therefore HF radiation is very low. The influence
on neighbouring electric devices is unlikely...
The laser device may be used in all kinds of buildings,
including residential buildings and those directly
connected to mains for the public supply which are also
servicing buildings used for residential purposes.
Conformity level
Electromagnetic ambient
conditions - guidelines
conforms
The floor should be made from wood
or concrete or covered with ceramic
tiles. If the floor is covered with
synthetic material the relative
humidity should be minimum 30%
conforms
The quality of the supply voltage
should be typical for business or
hospital ambient conditions.
conforms
The quality of the supply voltage
should be typical for business or
hospital ambient conditions.
conforms
The quality of the supply voltage
should be typical for business or
hospital ambient conditions. If the
user wants to continue operation in
case of an interrupted energy supply
it is recommended to feed the laser
device from a system without
interruption or a battery.
conforms
Magnetic fields at mains frequency
should have the typical values for
business and hospital ambient
conditions.
18
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