Chapter 2: Safety and Regulatory
5495975-1EN Rev.9 2-11
© 2013-2017 General Electric Company. All rights reserved.
All of the above are required to achieve the Electromagnetic Compatibility for a typical
installation of the system. Further detailed data & requirements are described in the Use
Recommendations and Installation Recommendations sections.
Compatibility Tables
This equipment complies with IEC 60601-1-2 Edition 2.1 (2004-11) EMC standards for medical
devices.
The Optima XR646 systems are suitable to be used in an electromagnetic environment, as per
the limits & recommendations described in the tables hereafter:
• Emission Compliance level & limits (Table 2-5).
• Immunity Compliance level & recommendations to maintain equipment clinical utility (see
Table 2-6 and Table 2-8).
NOTE: This system complies with above mentioned EMC standard when used with supplied
cables.If different cable lengths are required, contact a qualified service representative
for advice.
1. Electromagnetic Emission
Table 2-3 Guidance and manufacturer’s declaration – electromagnetic emissions
Guidance and manufacturer’s declaration – electromagnetic emissions
The Optima XR646 is intended for use in the electromagnetic environment specified below. The customer or the user
of The Optima XR646 should assure that it is used in such an environment.
Emissions Test Compliance Electromagnetic environment – guidance
RF emissions, CISPR 11
Group 1
The Optima XR646 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
The Optima XR646 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.
Harmonic emissions,
IEC 61000-3-2
Class A
Voltage fluctuations/
flicker emissions,
IEC 61000-3-3
Complies
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