30
TESI
Relax
gbo Medizintechnik AG
Version 2.1
In accordance with the EMC-regulations for medical products we are obliged by law to
provide the following information.
Guidance and manufacturer’s declaration — electromagnetic emissions
The equipment is intended for use in the electromagnetic environment specified below. The customer or
the user of the equipment should assure that it is used in said environment.
Emissions test
Compliance
Electromagnetic environment – guidance
RF emissions,
CISPR 11
Group 1
The equipment uses RF energy only for its internal function.
Therefore, its RF emissions are very low and are not likely to cause
any interference in nearby electronic equipment.
RF emissions,
CISPR 11
Class B
The equipment is suitable for use in all establishments, including
domestic establishments and those directly connected to the public
low-voltage power supply network that supplies buildings used for
domestic purposes.
Harmonic emissions,
IEC 61000-3-2 (*)
Class A
Voltage fluctuation/flicker
emissions, IEC 61000-3-3 (*)
Complies
(*) Note: For devices with a power consumption between 75 W and 1000 W only.
Guidance and manufacturer’s declaration — electromagnetic immunity
The equipment is intended for use in the electromagnetic environment specified below. The customer or
the user of the equipment should assure that it is used in said environment.
Immunity test
IEC 60601- test level
Compliance level
Electromagnetic environment –
guidance
Electrostatic discharge (ESD),
IEC61000-4-2
6 kV contact
8 kV air
6 kV contact
8 kV air
Floors should be wood, concrete or
ceramic tile. If floors are covered with
synthetic material, the relative humidity
should be at least 30 %.
Electrical fast transient/burst,
IEC 61000-4-4
2 kV for power supply
lines
1 kV for input/output
lines
2 kV for power supply
lines
1 kV for input/output
lines
Mains power quality should be that of a
typical commercial or hospital
environment.
Surge,
IEC 61000-4-5
1 kV differential mode
2 kV common mode
1 kV differential mode
2 kV common mode
Mains power quality should be that of a
typical commercial or hospital
environment.
Voltage dips, short
interruptions and voltage
variations on power supply
input lines,
IEC 61000-4-11
<5 % U
for ½ cycle
(>95 % dip)
40 % U
for 5 cycles
60 % dip)
70 % U
for 25 cycles
30 % dip)
<95 % U
for 5 s
(>5 % dip)
<5 % U
for ½ cycle
(>95 % dip)
40 % U
for 5 cycles
60 % dip)
70 % U
for 25 cycles
30 % dip)
<95 % U
for 5 s
(>5 % dip)
Mains power quality should be that of a
typical commercial or hospital
environment.
If the user of the equipment requires
continued operation during power mains
interruptions, it is recommended that the
equipment be powered from an
uninterruptible power supply or a
battery.
Power frequency (50/60 Hz)
magnetic field,
IEC 61000-4-8
3 A/m
3 A/m
Power frequency magnetic fields should
be at levels characteristic of a typical
location in a typical commercial or
hospital environment.
Note: U is the a.c. mains voltage prior to application of the test level.
