ROOM REQUIREMENTS
GE Healthcare SENOGRAPHE DMR+
REV 1 pim 5128706–1–100
2–7
SECTION 4
IEC60601-1-2 ELECTROMAGNETIC STANDARDS COMPLIANCE
4–1 General
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).
Note: 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.
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
below:
TABLE 2–1
ELECTROMAGNETIC EMISSION
Emissions Test Compliance Electromagnetic Environment
Radio-Frequency
Emissions
CISPR11
Group1 Class
A limits
The Senographe is primarily intended for use in non-domes-
tic environments, and not connected directly to the public
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.
Group1 Class
A limits
The Senographe uses RF energy only for its internal func-
tion. The RF emission is therefore very low, and not likely to
cause any interference in nearby electronic equipment.
Harmonic emissions
IEC 61000-3-2
Not applicable The Senographe is primarily intended for use in non-domes-
tic environments, and not connected directly to the public
mains supply network.
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Not applicable The Senographe is primarily intended for use in non-domes-
tic environments, and not connected directly to the public
mains supply network.