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Innova 2100-IQ, 3100/3100-IQ, 4100/4100-IQ Cardiovascular Imaging System Pre-Installation Manual
GE Healthcare
2.4 IEC60601–1–2 Electromagnetic Standard Compliance & Documentation
The information contained in this section is also found in the Innova system Operator Manual.
2.4.1 General Scope
This equipment complies with IEC60601–1–2 Edition 2 EMC standard for medical devices
The Innova system is suitable to be used in the electromagnetic environment, as per the limits &
recommendations described in the tables here after:
•
Emission Compliance level & limits
•
Immunity Compliance level & recommendations to maintain equipment clinical utility (see
Table 3-10,Table 3-11
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.
2.4.2 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 3-9:
Emissions
Radio–Frequency
Emissions
CISPR11
Harmonic emissions
IEC 61000–3–2
Voltage fluctuations/
flicker emissions
IEC 61000–3–3
60
and
Table
3-12).
Test Compliance
The Innova system is suitable for use in all establishments other than domestic and
Group1 Class A
those directly connected to the low voltage power supply network that supplies
buildings used for domestic purposes.
limits
The Innova system uses RF energy only for its internal function. Therefore, the RF
Group1 Class A
emission is very low and not likely to cause any interference in nearby electronic
equipment.
limits
Not applicable
The Innova system is suitable for use only in establishments not directly connected
to a public low voltage power supply network.
Not applicable
The Innova system is suitable for use only in establishments not directly connected
to a public low voltage power supply network.
(Table
3-9).
Electromagnetic Environment
2 Environmental Requirements/Limitations
Direction 5160944-13-1EN, Revision 2
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