11 Information on Electromagnetic Compatibility
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11
Information on Electromagnetic Compatibility
The medical device is suitable for use in the specified electromagnetic environment. The purchaser or user of the medical device should ensure
that it is used in an electromagnetic environment as described below:
Emission Test
Compliance
Electromagnetic Environment
Radio-Frequency Emissions CISPR 11
Group 1
The medical device uses RF energy only for its internal function.
Therefore, the RF emission is very low and not likely to cause any
interference in nearby electronic equipment.
Radio-Frequency Emissions CISPR 11
Class B
The medical device is for use in all facilities including residential facilities
and facilities that are directly connected to a public power supply that also
supplies residential buildings.
Harmonic emissions IEC 61000-3-2
Class A
Voltage fluctuations / flicker emissions IEC
61000-3-3
Complies
Immunity tests
IEC 60601-test level
Conformance level
Electromagnetic environment - guidelines
Electrostatic discharge (ESD)
IEC 61000-4-2
± 6 kV contact discharge
± 8 kV atmospheric
discharge
± 6 kV contact discharge
± 8 kV atmospheric
discharge
Floors should be made of wood or concrete or
have ceramic tiles. When the floor is covered with
synthetic material, the relative humidity must be at
least 30%.
Fast transient electrical
disturbances/ Bursts
IEC 61000-4-4
± 2 kV for power lines
± 1 kV for signal lines
± 2 kV for power lines
± 1 kV for signal lines
The quality of the supply voltage should
correspond to that of a typical business or hospital
environment.
Surges
IEC 61000-4-5
± 1 kV push-pull voltage
± 2 kV common mode
voltage
± 1 kV push-pull voltage
± 2 kV common mode
voltage
The quality of the supply voltage should
correspond to that of a typical business or hospital
environment.
Voltage interruptions,
short-term interruptions
and fluctuations of the
supply voltage
IEC 61000-4-11
<5% U
T
for 0.5 periods
40% U
T
for 5 periods
70% U
T
for 25 periods
<5% U
T
for 250 periods
<5% U
T
for 0.5 periods
40% U
T
for 5 periods
70% U
T
for 25 periods
<5% U
T
for 250 periods
The quality of the supply voltage should
correspond to that of a typical business or hospital
environment. When the user of the medical device
needs continued operation even when the power
supply is interrupted, it is recommended to supply
the medical device from an uninterrupted power
supply or a battery.
Magnetic field with a supply
frequency (50/60 Hz) per
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 hospital.
Conducted HF disturbances
IEC 61000-4-6
3 V
eff
150 kHz to 80 MHz
outside of the ISM
bands
a
10 V
eff
Portable and mobile radio devices should not be used
closer to the medical device (including the electrical lines)
than the recommenced safe distance calculated using the
equation for the transmission frequency. Recommended
safe distance:
d = 0.50
P
d = 0.35
P for 80 MHz to 800 MHz
d = 0.70
P for 800 MHz to 2.5 GHz
with P as the maximum rated power of the transmitter in
Watts (W) according to the transmitter manufacturer, and d
as the recommended safe distance in meters (m).
b
The field strength of stationary radio transmitters should be
less than the conformance level at all frequencies in an on-
site check
c
.
d
Disturbances are possible close to devices that
have the following symbol.
Radiated HF disturbances
IEC 61000-4-3
3 V/m
80 MHz to 2.5 GHz
10 V/m