Mallinckrodt INOmax DSIR Plus MRI Operation Manual page 140

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Guidance and Manufacturer's Declaration – Electromagnetic Immunity
The INOmax DS
Plus MRI system (with GaussAlert™ alarms) is intended for use in the electromagnetic
IR
environment specified below. The user of the INOmax DS
in such an environment.
Immunity Test
Electrostatic discharge
(ESD)
IEC 61000-4-2
Electrical fast transient/
burst
IEC 61000-4-4
Surge
IEC 61000-4-5
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
NOTE U
is the AC mains voltage prior to application of the test level.
T
7-6
IEC 60601 test level
± 6 kV contact
± 8 kV air
± 0.5kV, ± 1.0kV and
± 2.0kV for power supply
lines
Line-to-line: ± 0.5 kV,
± 1 kV
Line-to-earth: ± 0.5 kV,
± 1 kV, ± 2 kV
<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 s
3 A/m
Plus MRI system should assure that it is used
IR
Compliance Level
± 6 kV Contact
± 8 kV Air
± 0.5kV, ± 1.0kV and
± 2.0kV for power supply
lines
Line-to-line: ± 0.5 kV,
± 1 kV
Line-to-earth: ± 0.5 kV,
± 1 kV, ± 2 kV
< 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.
3 A/m
Electromagnetic
Environment Guidance
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 or
hospital environment.
Mains power quality
should be that of a
typical commercial and/
or hospital environment.
Mains power quality
should be that of a
typical commercial and/
or hospital environment.
If the user of the system
requires continued
operation during power
mains interruptions, it is
recommended that the
system be powered from
an uninterruptible power
supply or a battery.
Power frequency
magnetic fields
should be at levels
characteristic of a typical
location in a typical
commercial or hospital
environment
Part No. 20568 Rev-02
2015-08

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