Iec 60601-1-2 And Iec 60601-1; Guidance And Manufacturer's Declaration - Electromagnetic Emissions - DJO Global ARTROMOT-S4 Mode D'emploi

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12. IEC 60601-1-2 and IEC 60601-1-11

The product designation ARTROMOT®-S4
used in the text below includes all their
variants.
The ARTROMOT®-S4 device is subject to
particular precautions regarding electroma-
gnetic 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®-S4.
The ARTROMOT®-S4 should not be
used adjacent to or stacked with other
equipment.
If adjacent or stacked use is necessary,
ARTROMOT®-S4 should be observed to
verify normal operation in the configuration
in which it will be used.
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.
12.1 Electromagnetic emissions
Guidance and Manufacturer's Declaration – Electromagnetic Emissions
ARTROMOT®-S4 is intended for use in the electromagnetic environment specified below. It is
the responsibility of the customer or user to ensure that the ARTROMOT®-S4 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
If it is necessary to replace assemblies or
cables, only the manufacturer's original
parts must be used to ensure continued
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 programming unit incl.
the coiled cable and the connector.
With regards to the electromagnetic com-
patibility, there is no maintenance operation
required during the expected product life
time!
Warning!
m
Use of accessories, transducers and
cables other than those specified or
provided by the manufacturer of this
equipment could result in increased elec-
tromagnetic emissions or decreased elec-
tromagnetic immunity of this equipment
and result in improper operation.
Compliance
Electromagnetic environment –
guidance
ARTROMOT®-S4 uses RF energy
Group 1
only for its internal function. There-
fore, its RF emissions are very low and
are not likely to cause any interfe-
rence in nearby electronic equipment.
Class B
ARTROMOT®-S4 is suitable for use in
all establishments, including domestic
complies
and those directly connected to the
with class A
public low-voltage power supply
requirements
network that supplies buildings used
for domestic purposes.
complies
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