sorin 75220, Operator'S Manual, Page: 277 / 304

X
TRA
Operator’s Manual
20077/021 US
A-1
Appendix A: Safety Standards EN 60601-1-2
Information on electromagnetic compatibility (EMC)
Guidance and manufacturer’s declaration
Warnings
• Note: Medical electrical equipment needs precautions regarding electromagnetic compatibility and
has to be installed and put into service according to the EMC information provided in the following
guidance and the manufacturer's declaration.
• Portable and mobile RF-communications equipment can affect medical electrical equipment.
• The X
TRA
System can have a performance degradation, but the basic safety and essential
performance will not be influenced. If the X
TRA
system is operated outside the EMC environment
specified here, basic safety as well as essential features may fail. In this case the operator should
be aware of a possible risk to the patient.
Guidance and manufacturer's declaration – electromagnetic emission
The X
TRA
is intended for use in the professional healthcare facility environment specified below. In order to prevent
adverse advents to the patient and operator due to electromagnetic disturbances, the X
TRA
System must not be operated
outside its intended EMC environment. Furthermore, the X
TRA
must not be operated if the enclosure, cables or measures
for electromagnetic shielding are damaged.
Phenomenon
Professional healthcare
facility environment
Electromagnetic environment - guidance
Conducted EMISSIONS CISPR 11 Note: The emissions characteristics of this
equipment make it suitable for use in industrial
areas and hospitals (CISPR 11 class A). If it is used
in a residential environment (for which CISPR 11
class B is normally required) this equipment might
not offer adequate protection to radio-frequency
communication services. The user might need to
take mitigation measures, such as relocating or
reorienting the equipment.
Radiated emissions CISPR 11
Harmonic distorsion IEC 61000-3-2 See IEC 61000-3-2
Voltage fluctuations and flicker See IEC 61000-3-2
Table A-1 Emission limits