Guidance And Manufacturer's Declaration - Electromagnetic Immunity - DJO Global ARTROMOT-S4 Mode D'emploi

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Guidance and Manufacturer's Declaration – Electromagnetic Immunity
ARTROMOT®-S4 is intended for use in the electromagnetic environment specified below. It is
the responsibility of the customer or user to ensure that the ARTROMOT®-S4 unit is used in
such an environment.
Immunity test
IEC 60601 test
level
Home healthcare
Conducted RF
6V
to IEC 61000-4-6
0,15–80 MHz
80% AM at 1kHz
Radiated RF
10 V/m
to IEC 61000-4-3
80 MHz–2,7 GHz
80% AM at 1 kHz
Proximity fields
27 V/m
from RF wireless
380–390 MHz
communications
PM 18 Hz
equipment
28 V/m
to IEC 61000-4-3
430–470 MHz
FM +/− 5 kHz
1 kHz sine
9 V/m
704–787 MHz
PM 217 Hz
28 V/m
800–960 MHz
PM 18 Hz
28 V/m
1,7–1,99 GHz
PM 217 Hz
28 V/m
2,4–2,57 GHz
at PM 217 Hz
9 V/m
5,1–5,8 GHz
at PM 217 Hz
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radio, AM and FM radio broadcast and TV broadcast cannot be
predicted theoretically with accuracy. To assess the electromagnetic environment due to
fixed RF transmitters, an electromagnetic site survey should be considered. If the mea-
sured field strength in the location in which the ARTROMOT®-S4 exceeds the applicable
ARTROMOT®-S4 unit should be observed to verify normal operation. If abnormal perfor-
mance is observed, additional measures may be necessary, such as reorienting or relocating
the ARTROMOT®-S4 unit.
Compliance level
Electromagnetic
Home healthcare
environment – guidance
6V
0,15–80 MHz
80% AM at 1 kHz
10 V/m
80 MHz–2,7 GHz
80% AM at 1 kHz
27 V/m
380–390 MHz
PM 18 Hz
28 V/m
430–470 MHz
FM +/− 5 kHz
1 kHz sine
9 V/m
704–787 MHz
PM 217 Hz
28 V/m
800–960 MHz
PM 18 Hz
28 V/m
1,7–1,99 GHz
PM 217 Hz
28 V/m
2,4–2,57 GHz
at PM 217 Hz
9 V/m
5,1–5,8 GHz
at PM 217 Hz
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