Iec 60601-1-2:2014 And Iec 60601-1-11:2010; Electromagnetic Emissions - DJO ARTROMOT-K1 classic Instrucciones De Uso

12. IEC 60601-1-2 and IEC 60601-1-11
For ARTROMOT®-K1 or ARTROMOT®-K1 Classic devices with serial numbers >#35.000.
The product designation ARTROMOT®-K1 used in the text below includes the
ARTROMOT®-K1 and ARTROMOT®-K1 Classic products with all their variants.
The ARTROMOT®-K1 device is subject to
particular precautions regarding electro-
magnetic 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.
WARNING!
m
Use of accessories, transducers and cables 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.

12.1 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
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 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 compat-
ibility, there is no maintenance operation re-
quired during the expected product life time!
Compliance Electromagnetic environment
– guidance
ARTROMOT®-K1 uses RF energy
Group 1
only for its internal function.
Therefore, its RF emissions are very
low and are not likely to cause any
interference in nearby electronic
equipment.
ARTROMOT®-K1 is suitable for use
Class B
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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