Electromagnetic Compatibility - MTR+ Biolito Bedienungsanleitung

If the device is used according to the instructions given in this manual, it corresponds to the
safety requirements for medical electrical systems IEC 60601-1. Biolito was checked and is in
accordance with the limits set for medical products in the standard IEC 60601-1-2:2014. These
limits serve to the safety of the user regarding electromagnetic disturbances.
The Biolito is a Class B device and is suitable for home healthcare environments as well as
typical clinical environments.
Guidance and manufacturer's declaration - electromagnetic emissions
The Biolito unit is intended for use in the electromagnetic environment specified below. The
customer or the user of the Biolito should ensure that it is used in such an
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
Please adhere to these warnings when using the device:
Don't use Biolito near active HF surgical equipment or RF shielded rooms used for magnetic
resonance imaging, where the intensity of EM disturbances is high.
Use of this equipment adjacent to, or placement on top of other equipment should be avoided
in case the output of the Biolito is effected. If this is necessary, Both the Biolito and the other
equipment should be monitored to verify that they are both operating normally.
Use of accessories and lead wires other than those specified or provided by the manufacturer of
this equipment could result in increased electromagnetic emissions or decreased electromagnetic
immunity of this equipment and result in improper operation.
Portable RF communications equipment (including peripherals such as antenna cables and
external antennas) should be used not closer than 30 cm (12 inches) to any part of the Biolito,
including lead wires specified by the manufacturer. Otherwise, degradation of the performance
of this equipment could result.

Electromagnetic Compatibility

Compliance
Group 1
Class B
Not Applicable
Not Applicable
Biolito Bedienungsanleitung / Operators Manual
Electromagnetic environment –
The Biolito 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.
The Biolito is suitable for use in all
establishments, including domestic and
medical establishments and those directly
connected to the public low-voltage power
supply network that supplies buildings
used for domestic purposes.
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guidance