Iec601-1-2 Electromagnetic Standard Compliance & Documentation; General Scope; Electromagnetic Emission - GE Innova 2000 Preinstallation Manual

GE Medical Systems
REV 5
1-3 IEC601–1–2 Electromagnetic Standard Compliance & Documentation

GENERAL SCOPE

1-3-1
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:
D Emission Compliance level & limits (Table 16).
D Immunity Compliance level & recommendations to maintain equipment clinical utility (see
Table 17, Table 18 and Table 19).
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.

ELECTROMAGNETIC EMISSION

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Table 16 – Electromagnetic Emission
The Innova 2000 system is suitable for use in the specified electromagnetic environment. The
purchaser or user of the Innova 2000 system should assure that it is used in an electromagnetic
environment as described below:
Emissions Test
Radio–Frequency
Emissions
CISPR11
Harmonic emissions
IEC 61000–3–2
Voltage fluctuations/
flicker emissions
IEC 61000–3–3
Innova 2000 Cardiovascular Imaging System
Compliance
The Innova 2000 system is suitable for use in all
establishments other than domestic and those directly
Group1 Class A
connected to the low voltage power supply network that
supplies buildings used for domestic purposes.
limits
The Innova 2000 system uses RF energy only for its internal
function. Therefore, the RF emission is very low and not likely
Group1 Class A
to cause any interference in nearby electronic equipment.
limits
Not applicable The Innova 2000 system is suitable for use only in
establishments not directly connected to a public low voltage
power supply network.
Not applicable
The Innova 2000 system is suitable for use only in
establishments not directly connected to a public low voltage
power supply network.
Electromagnetic Environment
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Pre–Installation Manual
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