DJO Global ARTROMOT-E2 COMPACT, Operating Instructions Manual

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Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
The ARTROMOT®-E2/-E2 compact is intended for use in the electromagnetic environ-
ment speciied 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
test IEC 60601-
test level Compliance
level Electromagnetic
environment – guidance
Electrostatic
discharge (Esd) to
iEC 61000-4-2 ± 6 kV contact
± 8 kV air
± 6 kV contact
± 8 kV air
Floors should be wood, con-
crete or ceramic tile. if loors
are covered with synthetic
material, the relative humidity
should be at least 30 %.
Electrical fast
transient/burst to
iEC 61000-4-4 ± 2 kV for power
supply lines
± 1 kV for input/
output lines
± 2 kV for power
supply lines
± 1 kV for input/
output lines
Mains power should be that
of a typical commercial or
hospital environment.
surges to
iEC 61000-4-5 ± 1 kV diferential
mode
± 2 kV common
mode
± 1 kV diferential
mode
± 2 kV common
mode
Mains power should be that
of a typical commercial or
hospital environment.
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines to
iEC 61000-4-11 < 5 %
U
T
(> 95 % dip in
U
T
)
for
)
cycle
40 %
U
T
(60 % dip in
U
T
)
for 5 cycle
70 %
U
T
(30 % dip in
U
T
)
for 25 cycles
< 5 %
U
T
(> 95 % dip in
U
T
)
for 5 s
< 5 %
U
T
(> 95 % dip in
U
T
)
for
)
cycle
40 %
U
T
(60 % dip in
U
T
)
for 5 cycle
70 %
U
T
(30 % dip in
U
T
)
for 25 cycles
< 5 %
U
T
(> 95 % dip in
U
T
)
for 5 s
Mains power should be that of
a typical commercial or hos-
pital environment. if the user
of the ARTROMOT®-E2/-E2
compact device requires
continued operation during
power mains interruptions,
it is recommended that the
ARTROMOT®-E2/-E2 com-
pact device be powered from
an uninterruptible power
supply or a battery.
Power frequency
(50/60 hz)
magnetic ield to
iEC 61000-4-8 3 A/m 3 A/m Power frequency magnetic
ields 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.
Note
:
U
T
is the a.c. mains voltage prior to application of the test level.
9.2 Electromagnetic immunity
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 afect 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 coniguration in
which it will be used.
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.
Guidance and Manufacturer’s Declaration – Electromagnetic Emissions
The ARTROMOT®-E2/-E2 compact is intended for use in the electromagnetic environ-
ment speciied 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 Electromagnetic environment
– guidance
RF emissions
to CisPR 11 Group 1 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.
RF emissions
to CisPR 11 Class b 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.
harmonic emissions
to iEC 61000-3-2 complies with class
A requirements
Voltage luctuations/licker
emissions to iEC 61000-3-3 complies
9.1 Electromagnetic emissions