Electromagnetic Compatibility (Emc) - Interacoustics AA222 Instructions For Use Manual

AA222 Instructions for Use – US

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.
The AA222 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the
user of the AA222 can help prevent electromagnetic interferences by maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and the AA222 as recommended below, according to the maximum output power of the
communications equipment.
Rated Maximum output
power of transmitter
[W]
0.01
0.1
1
10
100
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be
estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter manufacturer.
Note 1 At 80 MHz and 800 MHZ, the higher frequency range applies.
Note 2 These guidelines may not apply to all situations. Electromagnetic propagation is affected by absorption and reflection from
structures, objects and people.
Guidance and Manufacturer's Declaration - Electromagnetic Immunity
Compliance
Group 1
Class B
Complies
Class A Category
Complies
Separation distance according to frequency of transmitter
[m]
d = 1.17 √ ����
150 kHz to 80 MHz
0.12
0.37
1.17
3.70
11.70
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.
d = 1.17 √ ����
80 MHz to 800 MHz
0.12
0.37
1.17
3.70
11.70
Page 84
d = 2.23 √ ����
800 MHz to 2.5 GHz
0.23
0.74
2.33
7.37
23.30