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EN-58
EN-59
Technical information
Technical information
E
E
Bio-compatibility
ISO 10993-1:2009 Biological evaluation of medical devices
- Part 1: Evaluation and testing within a risk management
process
ISO 10993-5:2009 Biological evaluation of medical devices -
Part 5: Tests for in vitro cytotoxicity
ISO 10993-10:2010 Biological evaluation of medical devices
- Part 10: Tests for irritation and skin sensitization
10. Electromagnetic compatibility (EMC)
The unit is an electrical medical product and is subject to special precau-
tionary measures with regard to EMC which must be published in the in-
structions for use.
Portable and mobile HF communications equipment can affect the unit.
Use of the unit in conjunction with non-approved accessories can affect
the unit negatively and alter the electromagnetic compatibility. The unit
should not be used directly adjacent to or between other electrical equip-
ment.
The unit satisfies the EMC requirements of the international standard
IEC60601-1-2. The requirements are satisfied under the conditions de-
scribed in the tables below.
The device is intended for use in the electromagnetic environment specified below. The
customer or the user of the device should ensure that it is used in such an environment.
Emissions test
Compli-
ance
Electromagnetic environment - guidance
RF emissions CIS-
PR 11
Group 1
The device uses RF energy only for its internal func-
tion. Therefore, its RF emissions are very low and are
not likely to cause any interference in nearby elec-
tronic equipment.
RF emissions CIS-
PR 11
Class B
The device is suitable for use in all establishments,
including domestic establishments and those direct-
ly 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 fluctuations/
Flicker emissions IEC
61000-3-3
Complies
Table 1 Guidance and manufacturer’s declaration - electromagnetic emissions
Table 2 Guidance and manufacturer’s declaration - electromagnetic immunity
The device is intended for use in the electromagnetic environment specified below. The
customer or the user of the device should assure that it is used in such an environment.
Immunity
test
IEC 60601 test level Compliance level
Electromagnetic environ-
ment - guidance
Electrostat-
ic discharge
(ESD) IEC
61000-4-2
±8 kV contact
±15 kV air
±8 kV contact
±15 kV air
Floors should be wood, con-
crete or ceramic tile. If floors
are covered with synthetic
material, the relative humid-
ity should be at least 30 %.
Electrical fast
transient/
burst IEC
61000-4-4
±2 kV for power sup-
ply lines
±1 kV for input/out-
put lines
±2 kV for power sup-
ply lines
Mains power quality should
be that of a typical commer-
cial or hospital environment.
Surge IEC
61000-4-5
line(s) to line(s):
±1 kV
line(s) to earth: ±2 kV
100 kHz repetition
frequency
line(s) to line(s):
±1 kV
100 kHz repetition
frequency
Mains power quality should
be that of a typical commer-
cial or hospital environment.
Voltage dips,
short inter-
ruptions and
voltage var-
iations on
power supply
input lines
IEC 61000-
4-11
0 % U
T
for 0.5 cycle
at 0°, 45°, 90°, 135°,
180°, 225°, 270° and
315°
0 % U
T
for 1 cycle and
70 % U
T
for 25/30
cycles.
Single phase at 0°
0 % U
T
for 300 cycles
0 % U
T
for 0.5 cycle
at 0°, 45°, 90°, 135°,
180°, 225°, 270° and
315°
0 % U
T
for 1 cycle and
70 % U
T
for 25/30
cycles.
Single phase at 0°
0 % U
T
for 300 cycles
Mains power quality should
be that of a typical commer-
cial or hospital environment.
Power fre-
quency
(50/60 Hz)
magnet-
ic field IEC
61000-4-8
30 A/m
50 Hz/60 Hz
30 A/m
50 Hz/60 Hz
Power frequency magnet-
ic fields should be at levels
characteristic of a typical lo-
cation in a typical commer-
cial or hospital environment.
NOTE: U
T
is the a.c. mains voltage prior to application of the test level.
The device is intended for use in the electromagnetic environment specified below. The
customer or the user of the device should assure that it is used in such an environment.
Immunity
test
IEC 60601
test level
Compliance
level
Electromagnetic environment - guidance
Conduct-
ed RF IEC
61000-
4-6
3 V
m
150 kHz
to 80 MHz
6 V
m
(in ISM
and amateur
radio bands)
80 % AM at
1 kHz
3 V
m
150 kHz
to 80 MHz
6 V
m
(in ISM
and amateur
radio bands)
80 % AM at
1 kHz
Portable and mobile RF radio equipment should
be used no closer to any part of the device, in-
cluding cables, than the recommended separa-
tion distance calculated from the equation appli-
cable to the frequency of the transmitter.
Recommended separation distance:
d = 0.35√P
d = 1.2√P
Table 3 Guidance and manufacturer’s declaration - electromagnetic immunity
