Iec 60601-1-2:2007 And Iec 60601-1-11:2010; Guidance And Manufacturer's Declaration - Electromagnetic Emissions - DJO Global ARTROMOT-K1 Modo De Empleo

9. IEC 60601-1-2:2007 and IEC 60601-1-11:2010

The ARTROMOT®-K1 device is subject to
particular precautions regarding elec-
tromagnetic compatibility (EMC). The
device must be installed and put into
service strictly in compliance with the EMC
directives set forth in the accompanying
documents.
Portable and mobile RF communication
systems may affect the ARTROMOT®-K1.
The ARTROMOT®-K1 should not be
used adjacent to or stacked with other
equipment. If adjacent or stacked use is
necessary, ARTROMOT®-K1 should be
observed to verify normal operation in the
configuration in which it will be used.
9.1 Electromagnetic emissions
Guidance and Manufacturer's Declaration – Electromagnetic Emissions
ARTROMOT®-K1 is intended for use in the electromagnetic environment specified below.
It is the responsibility of the customer or user to ensure that the ARTROMOT®-K1 unit is
used in such an environment.
Emissions test
RF emissions to CISPR 11
RF emissions to CISPR 11
Harmonic emissions to
IEC 61000-3-2
Voltage fluctuations/flicker
emissions to IEC 61 000-3-3
ORMBS-12006_Artromot_K1_Comfort_2012_rz.indb 64
If you detect damage or malfunctions that
may impair the safety of the patient or
of the operator, have the device repaired
before using it.
If it is necessary to replace assemblies or
cables, only the manufacturer's original
parts must be used to ensure contin-
ued compliance with EMC requirements
after repair. This requirement applies to
the power supply unit, cables and cable
lengths, drive unit consisting of the motor
and the control system, the program-
ming unit incl. the coiled cable and the
connector.
The product designation ARTROMOT®-K1
used in the text below includes all product
variants.
Compliance Electromagnetic environment
– guidance
Group 1 ARTROMOT®-K1 uses RF ener-
gy 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 ARTROMOT®-K1 is suitable for use
in all establishments, including do-
complies with class
mestic and those directly connected
A requirements
to the public low-voltage power
supply network that supplies buil-
complies
dings used for domestic purposes.
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