12. MANUFACTURER'S DATA REGARDING EMC
Electromagnetic compatibility
Medical electrical equipment is subject to special precautionary measures with regard to electromagnetic compatibility
(EMC). Portable and mobile highfrequency communication equipment can influence medical electrical equipment. This ME
device is intended for operation in an electromagnetic environment as specified below. The user of the device should ensure
that it is operated in such an environment.
The ME device must not be used directly next to or arranged in a stack with other devices. If the device has to be operated
near to or in a stacked arrangement with other devices, then the ME device should be monitored in order to verify that it ope-
rates as intended in this arrangement. This ME device is intended exclusively for use by professional medical staff. This device
can cause radio interference and can disrupt the operation of equipment nearby. Suitable remedial measures, such as for
instance re-alignment, re-arrangement of theME device or shielding, can become necessary.
Guidelines and manufacturer's declaration - electromagnetic emissions
The Blood Pressure Device ri-medic is intended for operation in an electromagnetic environment as
specified below. The customer or the user of the Blood Pressure Device ri-medic should ensure that it
is used in such an environment.
Emission measurements
HF emissions according
toCISPR 11
HF emissions according to
CISPR 11
Harmonics emissions
according to EC61000-3-2
Voltage fluctuation / flicker
emissions according to
IEC61000-3-3
[1] If the more stringent class B limits are passed, also the class A limits can be
considered as fulfilled
Compliance
Electromagnetic environment - guidelines
The Blood Pressure Device ri-medic employs HF energy
solely for an internal function. Its HF emission is
Group 1
therefore very low and it is unlikely that neighboring
electronic devices will be affected by interference.
Class A [1]
The Blood Pressure Device ri-medic is intended for use in
all facilities, including living quarters and such as are
Class B
directly connected to a public power supply that also
supplies buildings that are used for residential purposes.
Not applicable
Not applicable
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