Instructions for Use RAUMEDIC
MPR2 logO
Manufacturer:
RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany
Page 91 of 99
10.2 Manufacturer's declaration on the EMC requirements according to IEC 60601-1-2:2007
The MPR2 devices fulfil the requirements of IEC 60601-1-2:2007.
10.2.1 General information
Special precautions in respect of electromagnetic compatibility (EMC) must be taken for medical electrical
devices and the devices must be installed and operated in conformance with the EMC details contained in
this instruction manual.
Portable and mobile high-frequency (HF) communication devices can impair medical electrical devices.
The transducers and cabling listed in section 9 Accessories fulfil the requirements of IEC 60601-1-2:2007
in respect of use of the MPR2.
Use of accessory parts, cables and sensors other than those listed in 9 Accessories can lead to increased
emissions and/or reduced immunity of the device against such emissions.
Avoid use of the device in the direct vicinity of other devices, such as directly under, above or adjoining
other devices. If such use is unavoidable, you must check, prior to the monitoring of patients, whether
trouble-free operation is possible with the necessary configuration.
Interference effects may arise from other devices, even if the other devices conform to the CISPR emission
requirements.
If the amplitude of the physiological signal from the patient lies below the minimum amplitude and/or the
values given in section 11.1 Technical data, device use could lead to inaccurate results.
The MPR2 is intended for use in an electromagnetic environment as specified below. The operator or the
user of the MPR2 should ensure that it is operated in such an environment.
10.2.2 Electromagnetic emissions
The MPR2
is intended for use in an electromagnetic environment as specified below. The customer or user
of the MPR2 should ensure that it is used in such an environment.
Transient emission
measurements
Conformity
Electromagnetic environment -
guidelines
RF emissions as per CISPR 11
Group 1
The MPR2 uses RF energy solely for its
internal operation. Therefore, its RF
emissions are very low and it is unlikely that
any adjoining electronic equipment will
suffer interference.
RF emissions as per CISPR 11
Class B
The MPR2 is suitable for use in all facilities
including those in living areas, which are
directly connected to a public mains
network, which also supplies buildings that
are used for living purposes.
Emissions of harmonics as per
IEC 61000-3-2
Class A
Emission of voltage
fluctuations/flicker as per IEC
61000-3-3
Matches all
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