Iec60601-1-2 Electromagnetic Standards Compliance - GE Senographe DS Manual

GE Healthcare
Revision 1
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 2, 3, and 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.
2-2. 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
TABLE 1 - ELECTROMAGNETIC EMISSION
Emissions Test
Radio-Frequency
Emissions
CISPR11
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Chap-Pre-Requirements.fm
Service Information and Procedures Class A 2385072-16-8EN
described below:
Compliance
The Senographe is primarily intended for use in non-domes-
Group1 Class A tic environments, and not connected directly to the public
limits 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.
The Senographe uses RF energy only for its internal func-
Group1 Class A tion. The RF emission is therefore very low, and not likely to
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.
Page no. 327
Pre-Installation System Requirements
Electromagnetic Environment
Senographe DS
Chapter 4