•
Immunity Compliance level & recommendations to maintain equipment clinical utility (see
).
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
Test Compliance
Electromagnetic Environment
Radio–Frequency
Emissions
CISPR11
Group1 Class A
limits
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.
Group1 Class A
limits
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.
Harmonic emissions
IEC 61000–3–2
Not applicable
The Innova system is suitable for use only in establishments not directly connected
to a public low voltage power supply network.
Voltage fluctuations/
flicker emissions
IEC 61000–3–3
Not applicable
The Innova system is suitable for use only in establishments not directly connected
to a public low voltage power supply network.
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
IEC 60601–1–2 Test
Level
Compliance Level
Electromagnetic Environment
Electrostatic dis‐
charge (ESD)
IEC 61000–4–2
6 kV contact
8 kV air
6 kV contact
8 kV air
Floors are wood, concrete, or ceramic tile, or floors are covered
with synthetic material and the relative humidity is at least 30
percent.
Electrical fast transi‐
ent/burst
IEC 61000–4–4
2 kV for power sup‐
ply lines
1 kV for input/output
lines
2 kV for power supply
lines
1 kV for input/output
lines
Mains power quality is that of a typical commercial and/or hospital
environment
Innova 2121-IQ/3131-IQ Biplane Cardiovascular Imaging System Pre-Installation Manual
GE Healthcare
Direction 5177951-4-1EN, Revision 1
60
2 Environmental Requirements/Limitations
Summary of Contents for Innova 2121-IQ Biplane
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