gbo Medizintechnik ULTRATHERM 1008 Instructions For Use Manual page 43

ULTRATHERM 1008
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 cus-
tomer or the user of the equipment should assure that it is used in such an environment.
Emissions test
RF emissions,
CISPR 11
RF emissions,
CISPR 11
Harmonic emissions,
IEC 61000-3-2 (*)
Voltage fluctuation/flicker emis-
sions, IEC 61000-3-3 (*)
(*) 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 cus-
tomer or the user of the equipment should assure that it is used in such an environment.
Immunity test
Electrostatic discharge
(ESD), IEC61000-4-2
Electrical fast transi-
ent/burst, IEC 61000-4-4
Surge,
IEC 61000-4-5
Voltage dips, short interrup-
tions and voltage variations
on power supply input lines,
IEC 61000-4-11
Power frequency (50/60 Hz)
magnetic field,
IEC 61000-4-8
Note: U is the a.c. mains voltage prior to application of the test level.

© gbo Medizintechnik AG
Compliance
Group 2 The equipment must emit electromagnetic energy in order to
perform its intended function. Nearby electronic equipment
may be affected.
Class B The equipment is suitable for use in all establishments, includ-
ing domestic establishments and those directly connected to
the public low-voltage power supply network that supplies
Class A
buildings used for domestic purposes.
Complies
IEC 60601- test
level
6 kV contact
8 kV air
2 kV for power supply
lines
1 kV for input/output
lines
1 kV differential mode
2 kV common mode
<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)
3 A/m
Electromagnetic environment – guidance
Compliance level
6 kV contact
Floors should be wood, concrete or
ceramic tile. If floors are covered with
8 kV air
synthetic material, the relative hu-
midity should be at least 30 %.
2 kV for power supply
Mains power quality should be that of
a typical commercial or hospital
lines
environment.
1 kV for input/output
lines
1 kV differential mode
Mains power quality should be that of
a typical commercial or hospital
2 kV common mode
environment.
Mains power quality should be that of
<5% U

a typical commercial or hospital
for ½ cycle
environment.
(>95% dip)
If the user of the equipment requires
40% U

continued operation during power
for 5 cycles
mains interruptions, it is recom-
60% dip)
mended that the equipment be pow-
ered from an uninterruptible power
70% U

supply or a battery.
for 25 cycles
30% dip)
<95% U

for 5 s
(>5% dip)
3 A/m Power frequency magnetic fields
should be at levels characteristic of a
typical location in a typical commer-
cial or hospital environment.
Electromagnetic environ-
ment – guidance
Version 1.7
43