Interacoustics Affinity 2.0 Manual De Instrucciones página 77

Appendix C: Electromagnetic Compatibility (EMC)
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.
This Affinity is in compliance with IEC60601-1-2:2014+AMD1:2020, 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.
Guidance and manufacturer's declaration - electromagnetic emissions
The Affinity is intended for use in the electromagnetic environment specified below. The customer or the user of the Affinity 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
The Affinity is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the
user of the Affinity can help prevent electromagnetic interferences by maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and the Affinity 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
The Affinity is intended for use in the electromagnetic environment specified below. The customer or the user of the Affinity should assure
that it is used in such an environment.
Immunity Test
Electrostatic Discharge
(ESD)
IEC 61000-4-2
Immunity to proximity fields
from RF wireless
communications equipment
IEC 61000-4-3
Electrical fast
transient/burst
IEC61000-4-4
Compliance
Group 1
Class B
Not Applicable
Not applicable
Recommended separation distances between
portable and mobile RF communications equipment and the Affinity.
d = 1.17 √ ����
150 kHz to 80 MHz
0.12
0.37
1.17
3.70
11.70
IEC 60601 Test level
+8 kV contact
+15 kV air
Spot freq. 385-5.785 MHz
Levels and modulation
defined in table 9
+2 kV for power supply lines
+1 kV for input/output lines
Electromagnetic environment - guidance
The Affinity 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 Affinity is suitable for use in all commercial, industrial, business,
and residential environments.
Separation distance according to frequency of transmitter
[m]
d = 1.17 √ ����
80 MHz to 800 MHz
0.12
0.37
1.17
3.70
11.70
Compliance
+8 kV contact
+15 kV air
As defined in table 9
Not applicable
+1 kV for input/output lines
Page 1
d = 2.23 √ ����
800 MHz to 2.7 GHz
0.23
0.74
2.33
7.37
23.30
Electromagnetic environment - guidance
Floors should be wood, concrete or ceramic
tile. If floors are covered with synthetic
material, the relative humidity should be
greater than 30%.
RF wireless communications equipment
should not be used close to any parts of the
Affinity.
Mains power quality should be that of a
typical commercial or residential environment.