MTR+ SineBravo - Electromagnetic Compatibility

SineBravo Operators Manual
29
Electromagnetic Compatibility
Guidance and manufacturer‘s declaration - electromagnetic emissions
The SineBravo unit is intended for use in the electromagnetic environment specied below.
The customer or the user of the SineBravo should ensure that it is used in such an
environment.
Emissions test Compliance
Electromagnetic environment –
guidance
RF emissions
CISPR 11
Group 1
The SineBravo 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 SineBravo 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.
Harmonic emissions
IEC 61000-3-2
Not Applicable
Voltage uctuations/
icker emissions
IEC 61000-3-3
Not Applicable
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. SineBravo was checked and
is in accordance with the limits set for medical products in the standard IEC 60601-1-2:2020.
These limits serve to the safety of the user regarding electromagnetic disturbances.
The SineBravo is a Class B device and is suitable for home healthcare environments as well as
typical clinical environments.
Please adhere to these warnings when using the device:
Don’t use SineBravo 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 EMG reading of the SineBravo is eected. If this is necessary, Both the SineBravo
and the other equipment should be monitored to verify that they are both operating normally.
Use of accessories and lead wires other than those specied 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 4 meters to any part of the SineBravo,
including lead wires specied by the manufacturer. Otherwise, degradation of the performance
of this equipment could result.