DJO 80.00.040, Operating Instructions Manual

Page: 151 / 160

147
12.2 Electromagnetic immunity
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
Electrostatic
discharge (ESD) to
IEC 61 000-4-2
± 8 kV contact
± 15 kV air ± 8 kV contact
± 15 kV air Floors should be wood, con-
crete or ceramic tile. If floors
are covered with synthetic
material, the relative humidity
should be at least 30%.
Electrical fast
transient/bursts to
IEC 61 000-4-4
± 2 kV
100 kHz repetition
frequency
± 2 kV
100 kHz repetition
frequency
Mains power should be that
of a typical commercial or
hospital environment.
Surges to
IEC 61 000-4-5
± 1 kV
line-to-line
voltage
± 1 kV
line-to-line
voltage
Mains power should be that
of a typical commercial or
hospital environment.
Voltage dips
To IEC 61000-4-11
0% U
t
; 0,5 cycle
at
0°, 45°, 90°, 135°,
180°, 225°, 270°,
315°
0%
U
t
; 1 cycle
and
70% U
t
; 25/30
cycles
Single phase at 0°
0% U
t
; 0,5 cycle
at
0°, 45°, 90°, 135°,
180°, 225°, 270°,
315°
0%
U
t
; 1 cycle
and
70% U
t
; 25/30
cycles
Single phase at 0°
Mains power should be that
of a typical commercial or
hospital environment. If the
user of the ARTROMOT®-K1
unit requires continued
operation during power
mains interruptions, it is
recommended that the
ARTROMOT®-K1 unit be
powered from an
uninterruptible power supply
or a battery.
Power frequency
(50/60 Hz)
magnetic field to
IEC 61 000-4-8
30 A/m 30 A/m Power frequency magnetic
fields should be at levels
characteristics of a typical
location in a typical commer-
cial or hospital environment.
Voltage
interuptions to
IEC 61000-4-11
0% U
t
; 250/300
cycles
0% U
t
; 250/300
cycles
Note: U
t
is the a.c. mains voltage prior to application of the test level.