Operation Manual

MEDRAD
®
Salient Operation Manual 89
8.11. IEC60601-1-2:2014 (4
th
Ed) Compliance
8.11.1. Electromagnetic Emissions
Guidance and manufacturer’s declaration – electromagnetic emissions
The injector is suitable for use in the electromagnetic environment specified below. The customer or the user of the injector must
ensure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment – guidance
RF emissions
CISPR 11
Group 1 The injector uses RF energy only for its internal function. Therefore,
its RF emissions are very low and are not likely to cause any
interference in nearby electronic equipment.
RF emissions
CISPR 11
Class B
The injector is suitable for use in all establishments, including
domestic establishments and those directly connected to the public
low-voltage power supply network that supplies buildings used for
domestic purposes.
Harmonic emissions
IEC 61000-3-2
Class A
Voltage fluctuations
IEC 61000-3-3
Complies
8.11.2. Electromagnetic Immunity
Guidance and manufacturer’s declaration – electromagnetic immunity
The injector is suitable for use in the electromagnetic environment specified below. The customer or the user of the injector must
ensure that it is used in such an environment.
Immunity test IEC 60601-1-2 test compliance level Electromagnetic environment –
guidance
Electrostatic discharge
(ESD)
IEC61000-4-2
± 8 kV contact Floors should be wood, concrete or
ceramic tile. If floors are covered
with synthetic material, the relative
humidity should be at least 30%.
± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV air
Electrical fast
transient/burst
IEC 61000-4-4
± 2 kV for power supply lines Mains power quality should be that
of a typical commercial or hospital
environment.
± 1 kV for input/output lines
Surge
IEC 61000-4-5
± 0.5 kV, ± 1 kV Line-to-line Mains power quality should be that
of a typical commercial or hospital
environment.
± 0.5 kV, ± 1 kV, ± 2 kV Line-to-ground
Voltage dips
IEC 61000-4-11
Voltage test
level % UT
Phase Duration
cycles
Mains power quality should be that
of a typical commercial or hospital
environment. If the user of the
injector requires continued
operation during power mains
interruptions, it is recommended
that the injector be powered from
an uninterruptible power supply or
a battery.
0 0°, 45°, 90°, 135°, 180°,
225°, 270°, 315°
0.5
0 0° 1
70 0° 25
Voltage interruptions
IEC 61000-4-11
Voltage test
level % UT
Phase Duration
cycles
0 0° 250
Power frequency
(50/60 Hz) magnetic
field
IEC 61000-4-8
30 A/m at 50Hz
Power frequency magnetic fields
should be at levels characteristic of
a typical location in a typical
commercial or hospital
environment.
Note: U
T
is the AC mains voltage prior to application of the test level.
Guidance and manufacturer’s declaration – electromagnetic immunity
The injector is suitable for use in the electromagnetic environment specified below. The customer or the user of the MEDRAD
®
Salient contrast injector must ensure that it is used in such an environment.