DJO 80.00.040, Руководство по эксплуатации

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Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
ARTROMOT®-K1 is intended for use in the electromagnetic environment specified below. It
is the responsibility of the customer or user to ensure that the ARTROMOT®-K1 unit is used
in such an environment.
Immunity test IEC 60601
test level
Home healthcare
Compliance
level
Home healthcare
Electromagnetic
environment - guidance
Conducted RF to
IEC 61000-4-6
6 V
0,15 MHz-80 MHz
80% AM at 1 kHz
6 V
0,15 MHz-80 MHz
80% AM at 1 kHz
Radiated RF to
IEC 61000-4-3
10 V/m
80 MHz-2,7 GHz
80% AM at 1 kHz
10 V/m
80 MHz-2,7 GHz
80% AM at 1 kHz
Proximity fields
from RF wireless
communications
equipment to
IEC 61000-4-3
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 GHz-2,57 GHz
at PM 217 Hz
9 V/m
5,1 GHz-5,8 GHz
at PM 217 Hz
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 GHz-2,57 GHz
at PM 217 Hz
9 V/m
5,1 GHz-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 measured
field strength in the location in which the ARTROMOT®-K1 exceeds the applicable
ARTROMOT®-K1 unit should be observed to verify normal operation. If abnormal
performance is observed, additional measures may be necessary, such as reorienting or
relocating the ARTROMOT®-K1 unit.