Owandy Radiology i-max touch 3D, Руководство пользователя

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User Manual
– Safety information
NIMXEN020I
Owandy Radiology SAS
14
3.3.2 Electromagnetic immunity
In accordance with the IEC 60601-1-2 Ed4 standard, I-MAX 3D is suitable for use in the
electromagnetic environment specified below.
The customer or user of the system must ensure that it is used in the said environment.
Immunity
test
IEC 60601-1-2
test level
Compliance
level
Electromagnetic environment
Electrostatic
discharge (ESD)
IEC 61000-4-2
8 kV contact
2/4/8/15 kV air IEC 60601-1-2
Test level
Floors should be wood, concrete
or ceramic tile. If floors are
covered with synthetic material,
the relative humidity should be at
least 30%
Radiated
electromagnetic
field
IEC 61000-4-3
3 V/m
80 MHz to 2.7 GHz IEC 60601-1-2
Test level
Portable and mobile RF
communications equipment
should be used no closer to any
part of I-MAX 3D including cables.
Minimum distance 30 cm
Electrical fast
transient/burst
IEC 61000-4-4
2 kV for power
supply lines
1 kV for input/output
lines > 3 m
IEC 60601-1-2
Test level
Mains power quality should be
that of a typical commercial or
hospital environment
Surge
IEC 61000-4-5
0.5/1 kV differential
mode
0.5/1/2 kV common
mode
IEC 60601-1-2
Test level
Mains power quality should be
that of a typical commercial or
hospital environment
Conducted
disturbances
induced by RF
fields
IEC 61000-4-6
3 V
150 kHz to 80 MHz
6 V
ISM frequencies
IEC 60601-1-2
Test level
Portable and mobile RF
communications equipment
should be used no closer to any
part of I-MAX 3D, including
cables.
Minimum distance 30 cm
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11 10 ms
– 0 % a 0°,
45°, 90°, 135°, 180°,
225°, 270°, 315°
20 ms
– 0% a 0°
500 ms
– 70% a 0°
5 s
– 0%
IEC 60601-1-2
Test level
Mains power quality should be
that of a typical commercial or
hospital environment. If the user
of
the I-MAX 3D requires
continued operation during power
mains
interruptions, it is
recommended that the I-MAX 3D
be
powered from an
uninterruptible power supply or a
battery
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
30 A/m
IEC 60601-1-2
Test level
Power frequency magnetic fields
should be at levels characteristics
of a typical location in a typical
commercial
or hospital
environment