2 EMI Consideration
IEC60601-1-2 Electromagnetic Standard Compliance & Documentation
The information contained in this section is also found in the system Operator Manual.
2.1 General Scope
This equipment complies with IEC-60601-1-2: Edition 2.1 and Edition 3 standard for medical
devices
The 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 (Table 3-1).
•
Immunity Compliance level & recommendations to maintain equipment clinical utility (see
Table 3-2,Table 3-3 and Table 3-4).
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.
2.2 Electromagnetic Emission
The system is intended for use in the electromagnetic environment specified below.
The customer or the user of the system should assure that it is used in such an environment.
Table 3-1:
Emissions Test Compliance Electromagnetic Environment
Radio-Frequency
Emissions
CISPR11
Group1 Class A
limits
The system uses Radio Frequency energy only for its internal function. There‐
fore, its Radio Frequency emissions are very low and are not likely to cause any
interference in nearby electronic equipment.
The system is suitable for use in all establishments other than domestic and
those directly connected to the public low-voltage power supply network that sup‐
plies buildings used for domestic purposes.
Harmonic emissions
IEC 61000-3-2
Not applicable The system is suitable for use in all establishments other than domestic and
those directly connected to the public low-voltage power supply network that sup‐
plies buildings used for domestic purposes.
Voltage fluctuations /
flicker emissions
IEC 61000-3-3
Not applicable The system is suitable for use in all establishments other than domestic and
those directly connected to the public low-voltage power supply network that sup‐
plies buildings used for domestic purposes.
2.3 Electromagnetic Immunity
2.3.1 Electromagnetic Immunity IEC 60601-1-2
The system is intended for use in the electromagnetic environment specified below.
The customer or the user of the system should assure that it is used in such an environment.
Optima IGS 320, Optima IGS 330 Pre-Installation Manual
Direction 5537562-1-1EN, Revision 3
148 2 EMI Consideration
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