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Immunity Compliance level & recommendations to maintain equipment clinical utility (see
Table 3-8,Table 3-9
NOTE:
This system complies with above–mentioned EMC standard when used with supplied
cables up to maximum lengths referenced in the MIS MAPS or system cables
interconnect diagrams.
2.3.2 Electromagnetic Emission
The Innova system is suitable for use in the specified electromagnetic environment. The purchaser
or user of the Innova system should assure that it is used in an electromagnetic environment as
described below:
Table 3-7:
Emissions
Radio–Frequency
Emissions
CISPR11
Harmonic emissions
IEC 61000–3–2
Voltage fluctuations/
flicker emissions
IEC 61000–3–3
2.3.3 Electromagnetic Immunity
2.3.3.1 Electromagnetic Immunity
The Innova system is suitable for use in the specified electromagnetic environment. The purchaser
or user of the Innova system should assure that it is used in an electromagnetic environment as
described below:
Table 3-8:
Immunity Test
Electrostatic dis‐
charge (ESD)
IEC 61000–4–2
Electrical fast transi‐
ent/burst
IEC 61000–4–4
60
Innova 2121-IQ/3131-IQ Biplane Cardiovascular Imaging System Pre-Installation Manual
and
Table
3-10).
Test Compliance
Group1 Class A
limits
Group1 Class A
limits
Not applicable
Not applicable
IEC 60601–1–2 Test
Compliance Level
Level
6 kV contact
6 kV contact
8 kV air
8 kV air
2 kV for power sup‐
2 kV for power supply
ply lines
lines
1 kV for input/output
1 kV for input/output
lines
lines
Electromagnetic Environment
The Innova system is suitable for use in all establishments other than domestic and
those directly connected to the low voltage power supply network that supplies
buildings used for domestic purposes.
The Innova system uses RF energy only for its internal function. Therefore, the RF
emission is very low and not likely to cause any interference in nearby electronic
equipment.
The Innova system is suitable for use only in establishments not directly connected
to a public low voltage power supply network.
The Innova system is suitable for use only in establishments not directly connected
to a public low voltage power supply network.
Floors are wood, concrete, or ceramic tile, or floors are covered
with synthetic material and the relative humidity is at least 30
percent.
Mains power quality is that of a typical commercial and/or hospital
environment
Direction 5177951-4-1EN, Revision 1
Electromagnetic Environment
2 Environmental Requirements/Limitations
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