The medical devices should not be used adjacent to or stacked with other equipment. In case
adjacent or stacked use is necessary, the medical device should be observed to verify normal
operation in the configuration in which it will be used.
PORTABLE RF communications equipment (including peripherals as such as antenna cables
and external antennas) should be used no closer than 30cm (12 inches) to any part of [ME
QUIPMENT or ME SYSTEM], including cables specified by the MANUFACTURER. Otherwise,
degradation of the performance this equipment could result.
Do not use mobile (cellular) telephones and other devices, which generate strong electrical or
electromagnetic fields, near the medical device. This may result in incorrect operation of the unit
and create a potentially unsafe situation. Recommendation is to keep a minimum distance of 7
m. Verify correct operation of the device in case the distance is shorter.
Guidance and Manufacturer's declaration – electromagnetic emissions
This device is intended for use in the electromagnetic environment specified below. The customer or
the user of the device should assure that it is used in such environment.
Emissions test
RF emissions
CISPR 11
RF emissions
CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Electromagnetic emission IEC 60601-1-2
Compliance
Electromagnetic environment – guidance
Group 1
This device 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.
Class B
Class A
This device is suitable for use in all establish ments, including
domestic establishments and those directly connected to the
public low-voltage power supply network that supplies
Complies
buildings used for domestic purposes.
23