Information On Electromagnetic Compatibility - SciCan E-STATIS Prep 40-P Manuel De L'opérateur

6 Information on Electromagnetic Compatibility

6 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
Radio-Frequency Emissions CISPR 11
Radio-Frequency Emissions CISPR 11
Harmonic emissions IEC 61000-3-2
Voltage fluctuations / flicker emissions
IEC 61000-3-3
Immunity tests
Electrostatic discharge
(ESD)
IEC 61000-4-2
Fast transient electrical
disturbances/ Bursts
IEC 61000-4-4
Surges
IEC 61000-4-5
Voltage interruptions,
short-term interruptions
and fluctuations of the
supply voltage
IEC 61000-4-11
Magnetic field with a supply
frequency (50/60 Hz) per
IEC 61000-4-8
Conducted HF disturbances
IEC 61000-4-6
Radiated HF disturbances
IEC 61000-4-3
Page 17
Compliance
Group 1
Class B
Class A
Complies
IEC 60601-test level Conformance level
± 6 kV contact ± 6 kV contact discharge
discharge ± 8 kV atmospheric
± 8 kV atmospheric discharge
discharge
± 2 kV for power lines ± 2 kV for power lines
± 1 kV for signal lines ± 1 kV for signal lines
± 1 kV Push-pull ± 1 kV Push-pull voltage
voltage ± 2 kV common mode
± 2 kV common mode voltage
voltage
<5% U for 0.5 periods <5% U
T
40% U for 5 periods 40% U
T
70% U for 25 periods 70% U
T
<5% U for 250 periods <5% U
T
3 A/m 3 A/m
3 V 10 V
eff
150 kHz to 80 MHz
outside of the ISM
a
bands
3 V/m 10 V/m
80 MHz to 2.5 GHz
Electromagnetic Environment
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.
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.
Electromagnetic environment -
guidelines
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%.
The quality of the supply voltage should
correspond to that of a typical business or
hospital environment .
The quality of the supply voltage should
correspond to that of a typical business or
hospital environment .
for 0.5 periods The quality of the supply voltage should
T
for 5 periods correspond to that of a typical business or
T
for 25 periods hospital environment. When the user of the
T
for 250 periods medical device needs continued operation
T
even when the power supply is interrupted,
it is recommended to supply the medical
device from an uninterrupted power supply
or a battery.
Power frequency magnetic fields should be
at levels characteristic of a typical location
in a typical commercial hospital.
Portable and mobile radio devices should not be used
eff
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 = 0.5 √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
devices that have the following symbol.
c d
. Disturbances are possible close to
E-STATIS Prep 40-P