DJO 80.00.040, Operating Instructions Manual

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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.
m WARNING!
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.
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.
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!
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 Compliance Electromagnetic environment
– guidance
RF emissions to CISPR 11 Group 1 ARTROMOT®-K1 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 to CISPR 11 Class B ARTROMOT®-K1 is suitable for use
in all establishments, including do-
mestic and those directly connected
to the public low-voltage power
supply network that supplies buil-
dings used for domestic purposes.
Harmonic emissions to
IEC 61000-3-2
complies with class
A requirements
Voltage fluctuations/flicker
emissions to IEC 61 000-3-3
complies