26
Immunity Test
EN/IEC 60601 Test Level
Compliance Level
Electromagnetic Environment -
Guidance
Electrical fast transient/ burst
EN/IEC 61000-4-4
±2 kV for power supply lines
±1 kV for input/output lines
±2 kV for power
supply lines
Mains power quality should be that of a
typical commercial or hospital environment.
Surge
EN/IEC 61000-4-5
±1 kV line(s) to line(s)
±2 kV line(s) to earth
±1 kV line(s) to line(s)
±2 kV line(s) to earth
Mains power quality should be that of a
typical commercial or hospital environment.
Voltage Dips/ Dropout
EN/IEC 61000-4-11
>95 % dip
for 0.5 cycle
60 % dip
for 5 cycles
30 % dip
for 25 cycles
>95 % dip
for 5 s
>95 % dip
for 0.5 cycle
60 % dip
for 5 cycles
30 % dip
for 25 cycles
>95 % dip
for 5 s
This condition causes
the ATEC Sapphire
Console to shut down
and then return to
Biopsy mode.
Mains power quality should be that of a
typical commercial or hospital environment.
If the user of the ATEC Sapphire Console
requires continued operation during power
mains interruptions, it is recommended that
the ATEC Sapphire Console be powered
from an uninterruptible power supply or
battery.
Power Frequency
50/60Hz
Magnetic Field
EN/IEC 61000-4-8
3A/m
3A/m
Power frequency magnetic fields should
be that of a typical commercial or hospital
environment.
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms
150 kHz to 80MHz
3 V/m
80 MHz to 2.5 GHz
3 Vrms
3 V/m
Portable and mobile RF communications
equipment should be used no closer to
any part of the ATEC Sapphire Console,
including cables, than the recommended
separation distance calculated from the
equation applicable to the frequency of the
transmitter.
Recommended separation distance
d=1.2√P 150 kHz to 80 MHz
d=1.2√P 80 MHz to 800 MHz
d=2.3√P 800 MHz to 2.5 GHz
where P is the maximum output power
rating of the transmitter in watts (W) and d
is the recommended separation distance in
meters (m).
Field strengths from fixed RF transmitters,
as determined by an electromagnetic site
survey,
a
should be less than the compliance
level in each frequency range.
b
Interference may occur in the vicinity
of equipment marked with the following
symbol:
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
Содержание ATEC SAPPHIRE
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