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46.
Electromagnetic compatibility - Warning instructions
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 -
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.
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