Guidance and manufacturer's declaration
EMC compliance
Special precautions concerning electromagnetic compatibility (EMC) must be taken for all
medical electrical equipment. This device complies with IEC EN 60601-1-2:2007.
• All medical electrical equipment must be installed and put into service in accordance
with the EMC information provided in this Directions for use.
• Portable and mobile RF communications equipment can affect the behavior of
medical electrical equipment.
The monitor complies with all applicable and required standards for electromagnetic
interference.
•
It does not normally affect nearby equipment and devices.
• It is not normally affected by nearby equipment and devices.
• It is not safe to operate the monitor in the presence of high-frequency surgical
equipment.
• However, it is good practice to avoid using the monitor in extremely close proximity
to other equipment.
Emissions and immunity information
Electromagnetic emissions
The monitor is intended for use in the electromagnetic environment specified below. The customer or user of the monitor
should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment - guidance
RF emissions
CISPR 11
Group 1 The monitor 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 B
The CSM is suitable for use in all establishments, including domestic
establishments 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
147
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