Electromagnetic Compatibility (Emc) - Derungs Dmed Triango 100 Installation And Operating Instructions Manual

16

ELECTROMAGNETIC COMPATIBILITY (EMC)

The medical device is intended for operation in an electromagnetic environment such as described below. The user must ensure that it is
operated in such an environment.
Emissions
RF emissions
(CISPR 11)
RF emissions
(CISPR 11)
Harmonic emissions
(IEC 61000-3-2)
Voltage fluctuations / flicker emissions
(IEC 61000-3-3)
The medical device is intended for operation in an electromagnetic environment such as described below. The user must ensure that it is
operated in such an environment.
Immunity against
Electrostatic discharge (ESD)
(IEC 61000-4-2)
Rapid transient
electrical disturbances:
Bursts (IEC 61000-4-4)
Impulse voltage/surges
(IEC 61000-4-5)
Magnetic field at the supply
frequency
(50/60 Hz)
(IEC 61000-4-8)
Voltage dips and interruptions
in the power supply
(IEC 61000-4-11)
Emitted RF disturbance
(IEC 61000-4-3)
Conducted RF interference
(IEC 61000-4-6)
d = recommended separation distance [m], P = nominal power of transmitter [W]. The field strength of stationary radio transmitters should be for all
frequencies, according to an on-site examination, less than the compliance level. Faults are possible in the area around devices which are marked with
the following pictogram:
Recommended safety distances to portable and mobile RF communications equipment
Power of transmitter [W]
0.01
0.1
1
10
100
Guidelines - Electromagnetic disturbance emissions
Compliance ac-
cording to
Group 1
Class A
Class A
Compliant
Guidelines - Electromagnetic immunity
IEC 60601-1-2 test level
Contact discharge: ± 8 kV
Air discharge: ± 15 kV
Power cables: ± 2 kV
Longer input and
output power cables: ± 1 kV
±1 kV voltage outer conductor -
outer conductor
±2 kV voltage outer conductor -
earth
30 A/m
<5% Vt (>95% dip in Vt) 0.5 cycle
at 0°, 45°, 90°, 135°, 180°, 225°,
270°, and 315°
<5% Vt (>95% dip in Vt) 1 cycle
at 0°
40%Vt (60% dip in Vt) for 5
cycles
70% Vt(30% dip in Vt) for 25/30
cycles (50 Hz/60 Hz) at 0°
<5% Vt (>95% dip in Vt) dropout
250/300 cycles
50 Hz, 60 Hz
80 MHz up to 2.5 GHz: 10 V/m
150 kHz up to 80 MHz: 3 V
150 kHz - 800 MHz
0.12 m (0.39 ft)
0.38 m (1.25 ft)
1.2 m (3.9 ft)
3.8 m (12.5 ft)
12m (39 ft)
Electromagnetic environment
The medical device uses RF energy only for its internal function. Therefore,
its RF emissions are very low and it is unlikely that nearby electronic devices
will be affected.
The health care product is designed for use in non-residential homes and
those that are connected directly to a public low voltage distribution systems
that also supplies the home.
Conformance level of Electromagnetic environment
the medical device
± 8 kV Floors are preferably made of wood, concrete or
± 15 kV ceramic tiles. In the case of synthetic floor covering,
the relative humidity should be at least 30%.
± 2 kV The quality of the supply voltage should correspond
Not applicable to that of a typical business or hospital environment
.
±1 kV The quality of the supply voltage should correspond
to that of a typical business or hospital environment
n/a .
30 A/m Devices with strong line-frequency magnetic fields
(transformer stations, etc.) should not be operated
in the vicinity of the medical device.
The quality of the supply voltage should correspond
to that of a business or hospital environment. If the
user requires continued functioning during interrup-
tions in the power supply, we recommend powering
the medical device from an uninterruptible power
supply or a battery.
10 V/m Recommended separation distance from portable
and mobile RF devices in transmission power
PEIRP of the medical device including its cords: d =
0.35√P
3 V Recommended separation distance from portable
and mobile RF devices in transmission power
PEIRP of the medical device including its cords:
80 MHz – 800 MHz: d = 1.2√P
800 MHz - 2.5 GHz: d = 2.3√P
d = 1.2√p
800 MHz - 2.5 GHz
d = 2.3√p
0.23 m (0.76 ft)
0.73 m (2.4 ft)
2.3 m (7.6 ft)
7.3 m (23.9 ft)
23 m (76 ft)
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