Bilag A: Electromagnetic Compatibility (Emc) - Interacoustics Equinox2.0 Gebrauchsanweisung

Affinity Instruction for Use - EN

Bilag A: Electromagnetic compatibility (EMC)

CAUTION
•
This instrument is suitable in hospital environments except for near active HF surgical equipment
and RF shielded rooms of systems for magnetic resonance imaging, where the intensity of
electromagnetic disturbance is high
•
Use of this instrument adjacent to or stacked with other equipment should be avoided because it
could result in improper operation. If such use is necessary, this instrument and the other equipment
should be observed to verify that they are operating normally
•
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 list of accessories,
transducers and cables can be found in this appendix
•
Portable RF communications equipment (including peripherals such as antenna cables and external
antennas) should be used no closer than 30 cm (12 inches) to any part of this instrument, including
cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment
could result
NOTICE
•
ESSENTIAL PERFORMANCE for this instrument is defined by the manufacturer as:
This instrument does not have an ESSENTIAL PERFORMANCE Absence or loss of ESSENTIAL
PERFORMANCE cannot lead to any unacceptable immediate risk
•
Final diagnosis shall always be based on clinical knowledge There are no deviations from the
collateral standard and allowances uses
•
This instrument is in compliance with IEC60601-1-2:2014, emission class B group 1
NOTICE: There are no deviations from the collateral standard and allowances uses
NOTICE: All necessary instruction for maintaining compliance with regard to EMC can be found in
the general maintenance section in this instruction. No further steps required.
Portable and mobile RF communications equipment can affect the AFFINITY. Install and operate the
AFFINITY according to the EMC information presented in this chapter. The AFFINITY has been tested for
EMC emissions and immunity as a standalone AFFINITY. Do not use the AFFINITY adjacent to or stacked
with other electronic equipment. If adjacent or stacked use is necessary, the user should verify normal
operation in the configuration.
The use of accessories, transducers and cables other than those specified, with the exception of servicing
parts sold by Interacoustics as replacement parts for internal components, may result in increased
EMISSIONS or decreased IMMUNITY of the device.
Anyone connecting additional equipment is responsible for making sure the system complies with the IEC
60601-1-2 standard.
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