Safety Precautions
Versana Essential
–
User Guide
4-27
5759238-100 English
Rev. 2
Declaration of Immunity
This system is suitable for use in the following environment. The
user must assure that the system is used according to the
specified guidance and only in the electromagnetic environment
listed.
Table 4-4: Declaration of Immunity
Immunity
Type
Equipment
Capability
Regulatory
Acceptable Level
EMC Environment and
Guidance
IEC 61000-4-2
Static discharge
(ESD)
±
6 kV contact
±
8 kV air
±
6 kV contact
±
8 kV air
Floors should be wood, concrete, or
ceramic tile. If floors are covered with
synthetic material, the relative
humidity should be at least 30%.
Mains power quality should be that of
a typical commercial and/or hospital
environment. If the user requires
continued operation during power
mains interruptions, it is
recommended that the system be
powered from a UPS or a battery.
NOTE: UT is the a.c. mains voltage
prior to application of the test level.
Power frequency magnetic fields
should be at levels characteristic of a
typical location in a typical commercial
and/or hospital environment.
Separation distance to radio
communication equipment must be
maintained according to the method
below. Interference may occur in the
vicinity of equipment marked with the
symbol:
Image degradation or interference
may occur due to conducted RF noise
on the equipment mains power supply
or other signal cable. Such
interference is easily recognized and
distinguishable from patient anatomy
and physiological waveforms.
Interference of this type may delay the
examination without affecting
diagnostic accuracy. Additional mains/
signal RF isolation or filtering may be
needed if this type interference occurs
frequently.
IEC 61000-4-4
Electrical fast
transient/burst
±
2 kV for mains
±
1 kV for SIP/SOP
±
2 kV for mains
±
1 kV for SIP/SOP
IEC 61000-4-5
Surge Immunity
±
1 kV differential
±
2 kV common
±
1 kV differential
±
2 kV common
IEC 61000-4-11
Voltage dips,
short
interruptions and
voltage
variations on
mains supply
< 5% U
T
(> 95% dip
in U
T
) for 0.5 cycle;
40% U
T
(60% dip in
U
T
) for 5 cycles;
70% U
T
(30% dip in
U
T
) for 25 cycles;
< 5% U
T
(>95% dip in
U
T
) for 5 sec
< 5% U
T
(> 95% dip
in U
T
) for 0.5 cycle;
40% U
T
(60% dip in
U
T
) for 5 cycles;
70% U
T
(30% dip in
U
T
) for 25 cycles;
< 5% U
T
(>95% dip in
U
T
) for 5 sec
IEC 61000-4-8
Power
frequency (50/
60 Hz) magnetic
field
3 A/m
3 A/m
IEC 61000-4-6
Conducted RF
3 V
RMS
150 kHz - 80 MHz
3 V
RMS
150 kHz - 80 MHz
IEC 61000-4-3
Radiated RF
3 V/m
80 MHz - 2.5 GHz
3 V/m
80 MHz - 2.5 GHz
NOTE: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption
and reflection from structures, objects, and people. If noise generated from other electronic equipment is near
the probe’s center frequency, noise may appear on the image. Good power line isolation is required.
