GE HEALTHCARE
D
IRECTION 5141177-100, REVISION 14 BRIGHTSPEED ELITE, EDGE, EXCEL: PRE-INSTALLATION
Chapter 1 - Introduction Page 37
1 – Intoduction
Section 4.0
Medical Electrical Equipment for EMC
4.1 General Scope
This equipment complies with IEC60601-1-2: 2001+A1: 2004 (ED2.1) and IEC 60601-1-2: 2007
(ED3) (if the system rating plate of the scanner marked with IPX0) EMC standard for medical
electrical equipment.
The BrightSpeed System is suitable to be used in the electromagnetic environment, as per the limits
& recommendations described in the tables hereafter:
• Emission Compliance level & limits (see Table 1-7)
• Immunity Compliance level & recommendations to maintain equipment clinical utility (see
Table 1-8, Table 1-9, and Table 1-10).
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 cable interconnect diagrams.
4.2 Electromagnetic Emission
Table 1-7 Emission Declaration
EMC Emissions Guidance & Declaration for BrightSpeed System
The BrightSpeed System is intended for use in the electromagnetic environment specified
below. The customer or the user of the BrightSpeed System should assure that it is used in such
an environment.
Emissions Test Compliance Electromagnetic Environment Guidance
RF emissions
CISPR 11
Group 1 The BrightSpeed System uses RF energy only
for its internal function. Therefore, its RF
emissions are very low and are not likely to
cause any interference in nearby electronic
equipment.
RF emissions
CISPR 11
Class A
Harmonic emissions
IEC 61000-3-2
Not applicable The BrightSpeed System is suitable for use in
all establishments other than domestic and
those directly connected to the public low-
voltage power supply network that supplies
buildings used for domestic purposes.
Voltage fluctuations/
flicker emissions
IEC 61000-3-2
Not applicable
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