Iec60601-1-2 Electromagnetic Standards Compliance; General; Electromagnetic Emission - GE SENOGRAPHE DMR+ Preinstallation Manual

GE Healthcare
REV 1
SECTION 4

IEC60601-1-2 ELECTROMAGNETIC STANDARDS COMPLIANCE

4–1

General

Note:
4–2

Electromagnetic Emission

The Senographe is suitable for use in the specified electromagnetic environment. The purchaser or
user of the Senographe should assure that it is used in an electromagnetic environment as described
TABLE 2–1
ELECTROMAGNETIC EMISSION
Emissions Test
Radio-Frequency
Emissions
CISPR11 CISPR11
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
This equipment complies with the IEC60601-1-2 Edition 2 EMC standard for medical
devices.
The Senographe Equipment or System is suitable for use in electromagnetic environments as
defined in the limits and recommendations given in the following tables:
D
Emission Compliance level and limits (Table 2–1).
D
Immunity Compliance levels and recommendations for ensuring that the equipment
retains its clinical utility (Tables 2–2, 2–3 and 2–4).
This equipment complies with the above EMC standard when used with cables supplied
by the manufacturer up to the maximum lengths permitted by the system design
specifications.
below:
Compliance
The Senographe is primarily intended for use in non-domes-
Group1 Class tic environments, and not connected directly to the public
A limits mains supply network.
It is primarily intended for use in environments (such as
hospitals) with a dedicated supply system, and in an X-ray
shielded room.
The Senographe uses RF energy only for its internal func-
Group1 Class tion. The RF emission is therefore very low, and not likely to
A limits cause any interference in nearby electronic equipment.
Not applicable The Senographe is primarily intended for use in non-domes-
tic environments, and not connected directly to the public
mains supply network.
Not applicable The Senographe is primarily intended for use in non-domes-
tic environments, and not connected directly to the public
mains supply network.
2–7
Electromagnetic Environment
SENOGRAPHE DMR+
pim 5128706–1–100