Electromagnetic Immunity; Guidance And Manufacturer's Declaration - Electromagnetic Emissions - DJO Global ARTROMOT-E2 Mode D'emploi

9. IEC 60601-1-2:2007 and IEC 60601-1-11:2010
The ARTROMOT®-E2/-E2 compact is
subject to particular precautions regard-
ing electromagnetic compatibility (EMC).
The device must be installed and put into
service strictly in compliance with the EMC
directives put forth in the accompanying
documents.
Portable and mobile RF communication
systems may affect the ARTROMOT®-E2/
-E2 compact.
The ARTROMOT®-E2/-E2 compact should
not be used adjacent to or stacked with
other equipment. if adjacent or stacked
use is necessary, the ARTROMOT®-E2/-E2
compact should be observed to verify
normal operation in the configuration in
which it will be used.
9.1 Electromagnetic emissions
Guidance and Manufacturer's Declaration – Electromagnetic Emissions
The ARTROMOT®-E2/-E2 compact is intended for use in the electromagnetic environ-
ment specified below. it is the responsibility of the customer or user to ensure that the
ARTROMOT®-E2/-E2 compact is used in such an environment.
Emissions test Compliance
RF emissions Group 1
to CisPR 11
RF emissions Class b
to CisPR 11
harmonic emissions complies with class
to iEC 61000-3-2 A requirements
Voltage fluctuations/flicker complies
emissions to iEC 61000-3-3
88
if you detect damage or malfunctions that
may impair the safety of the patient or
of the operator, have the device repaired
before using it.
if it is necessary to replace assemblies or
cables, only the manufacturer's original
parts must be used to ensure contin-
ued compliance with EMC requirements
after repair. This requirement applies to
the power supply unit, cables and cable
lengths, drive unit consisting of the motor
and the control system, the program-
ming unit incl. the coiled cable and the
connector.
Electromagnetic environment
– guidance
The ARTROMOT®-E2/-E2 compact
uses RF energy only for its internal
function. Therefore, its RF emissi-
ons are very low and are not likely
to cause any interference in nearby
electronic equipment.
The ARTROMOT®-E2/-E2 compact
is suitable for use in all establish-
ments, including domestic and those
directly connected to the public
low-voltage power supply network
that supplies buildings used for
domestic purposes.
9.2 Electromagnetic immunity
Guidance and Manufacturer's Declaration – Electromagnetic Immunity
The ARTROMOT®-E2/-E2 compact is intended for use in the electromagnetic environ-
ment specified below. it is the responsibility of the customer or user to ensure that the
ARTROMOT®-E2/-E2 compact is used in such an environment.
Immunity IEC 60601- Compliance
test test level level
Electrostatic ± 6 kV contact ± 6 kV contact
discharge (Esd) to
± 8 kV air ± 8 kV air
iEC 61000-4-2
Electrical fast ± 2 kV for power ± 2 kV for power
transient/burst to supply lines supply lines
iEC 61000-4-4
± 1 kV for input/ ± 1 kV for input/
output lines output lines
surges to ± 1 kV differential ± 1 kV differential
iEC 61000-4-5 mode mode
± 2 kV common ± 2 kV common
mode mode
Voltage dips, short < 5 % U < 5 % U
T
interruptions and (> 95 % dip in U ) (> 95 % dip in U
T
voltage variations for ) cycle for ) cycle
on power supply
40 % U 40 % U
T
input lines to
(60 % dip in U ) (60 % dip in U
T
iEC 61000-4-11
for 5 cycle for 5 cycle
70 % U 70 % U
T T
(30 % dip in U ) (30 % dip in U
T
for 25 cycles for 25 cycles
< 5 % U < 5 % U
T
(> 95 % dip in U ) (> 95 % dip in U
T
for 5 s for 5 s
Power frequency 3 A/m 3 A/m
(50/60 hz)
magnetic field to
iEC 61000-4-8
Note :
U is the a.c. mains voltage prior to application of the test level.
T
89
Electromagnetic
environment – guidance
Floors should be wood, con-
crete or ceramic tile. if floors
are covered with synthetic
material, the relative humidity
should be at least 30 %.
Mains power should be that
of a typical commercial or
hospital environment.
Mains power should be that
of a typical commercial or
hospital environment.
Mains power should be that of
T
) a typical commercial or hos-
T
pital environment. if the user
of the ARTROMOT®-E2/-E2
T
compact device requires
)
T
continued operation during
power mains interruptions,
it is recommended that the
)
ARTROMOT®-E2/-E2 com-
T
pact device be powered from
an uninterruptible power
T
supply or a battery.
)
T
Power frequency magnetic
fields should be at levels cha-
racteristics of a typical location
in a typical commercial or
hospital environment. Portable
and mobile RF communica-
tions equipment are used
no closer to any part of the
ARTROMOT®-E2/-E2 compact
device, including cables, than
the recommended separation
distance calculated from the
equation applicable to the
frequency of the transmitter.