GE Healthcare
Senographe DS
Revision 1
Service Information and Procedures Class A 2385072-16-8EN
Pre-Installation System Requirements
Page no. 327
Chapter 4
Chap-Pre-Requirements.fm
2.
IEC60601-1-2 ELECTROMAGNETIC STANDARDS COMPLIANCE
2-1. 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:
•
Emission Compliance level and limits (Table 1).
•
Immunity Compliance levels and recommendations for ensuring that the equipment retains its clinical
utility (Tables
, and
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.
2-2. Electromagnetic Emission
TABLE 1 - ELECTROMAGNETIC EMISSION
The Senographe system is suitable for use in the specified electromagnetic environment. The purchaser or
Operator of a Senographe system must ensure that it is used in an electromagnetic environment as
described below:
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 hos-
pitals) 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.
