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Electromagnetic Compatibility (Emc) - Interacoustics AA222 Gebruiksaanwijzing

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5.4 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 AA222. Install and operate the AA222
according to the EMC information presented in this chapter. The AA222 has been tested for EMC emissions
and immunity as a standalone AA222. Do not use the AA222 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.
Guidance and manufacturer's declaration - electromagnetic emissions
The AA222 is intended for use in the electromagnetic environment specified below. The customer or the user
of the AA222 should assure that it is used in such an environment.
Emissions Test
RF emissions
CISPR 11
RF emissions
CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations /
flicker emissions
IEC 61000-3-3
Recommended separation distances between portable and mobile RF communications equipment and the
AA222.
D-0119998-D – 2022/12
AA222 – Gebruikshandleidung - NL
Compliance
Group 1
Class B
Complies
Class A Category
Complies
Electromagnetic environment - guidance
The AA222 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.
The AA222 is suitable for use in all commercial,
industrial, business, and residential environments.
Pagina 82

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