8
ELECTROMAGNETIC COMPATIBILITY
Medical Electrical Equipment requires special precautions regarding electromagnetic
compatibility. elements IC needs to be installed and put into service according to the
electromagnetic compatibility information provided in these instructions. Portable
and mobile RF communications equipment can aect Medical Electrical Equipment.
WARNING:
The use of accessories and options other than those specified by the manufacturer
may result in increased emissions or decreased immunity of elements IC. In the
event of intermittent function of the device due to exposure to electromagnetic
interference, power cycle the unit as per IFU instructions provided above.
In the event of permanent damage or display blackouts of the device due to electro-
magnetic interference, stop use of the unit. Contact Kerr Customer Care.
Portable RF communications equipment (including peripherals such as antenna
cables and external antennas) should be used no closer than 30 cm (12 inches) to any
part of elements IC. Otherwise, degradation of the performance of this equipment
could result.
Guidance and manufacturer’s declaration - electromagnetic immunity
elements IC is intended for use in the electromagnetic environment specified below.
The customer or the user of elements IC should assure that it is used in
such an en-
vironment.
Immunity test
IEC 60601
test level
Compliance
level
Electromagnetic
environment -
guidance
Conducted
disturbances
induced by RF
fields IEC
61000-4-6
Radiated RF E
M F i e l d s IEC
61000-4-3
Proximity Fields
from RF Wireless
communications
equipment IEC
61000-4-3
3* Vrms 0.15 MHz
– 80 MHz 80% AM
at 1 kHz
10 V/m 80 MHz –
2.7 GHz, 80% AM
at 1 kHz
Table 9 of IEC
60601-1-2 ed. 4.0
3* Vrms 0.15 MHz
– 80 MHz 80% AM
at 1 kHz
10 V/m
80 MHz –
2.7 GHz, 80% AM
at 1 kHz
Table 9 of IEC
60601-1-2
ed. 4.0
The distance between
transmitting antenna
and EUT was at least 3
meters for proximity
field RF wireless com-
munication equipment
testing.
The testing was
performed with 1.85 m
AC/DC adapter cable
bundled to 1 meter
Interference may occur
in the vicinity of equip-
ment marked with the
following symbol:
NOTE 1: *6 Vrms in the ISM Bands and Amateur Radio Bands
The ISM band is 6.765 MHz to 6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and
40.66 MHz to 40.70 MHz
NOTE 2: elements IC unit was tested at 120 VAC/60 Hz, 230 VAC/50 Hz and 100 V 50/60 Hz.
NOTE 3: These guidelines may not apply in all situations. Electromagnetic propagation is aected
by absorption and reflection from structures, objects and people
Guidance and manufacturer’s declaration - electromagnetic emissions
elements IC is intended for use in the electromagnetic environment specified be-
low. The customer or the user of elements IC should assure that it is used in such
an environment.
Emissions Test Compliance
Electromagnetic environment
- guidance
RF emissions
CISPR 11
Group 1
elements IC uses RF energy only
for its internal function. elements
IC deliver energy to the patient in
a form other than RF electromag-
netic.
RF Emissions
CISPR 11
Class B
elements IC is suitable for use
install establishments with public
low-voltage network that supplies
buildings used for domestic pur-
poses and professional healthcare
facility environment (e.g. hospital)
with dedicated power supply
system.
Harmonic emissions IEC
61000-3-2
Class A
Voltage fluctuations/flicker
emissions IEC61000-3-3
Complies
Guidance and manufacturer’s declaration - electromagnetic immunity
elements IC is intended for use in the electromagnetic environment specified below.
The customer or the user of elements IC should assure that it is used in such an
environment.
Immunity test
IEC 60601-1-2
test level
Compliance
level
Electromagnetic
environment -
guidance
Electrostatic discharge
(ESD)
IEC 61000-4-2
± 8 kV contact
±2 kV, ±4 kV,
±8 kV, ± 15kV air
±8 kV contact
±2 kV, ±4 kV,
±8 kV, ±15 kV air
elements IC complies
antistatic material and
synthetic material with
relative humidity level
as low as 10%.
Electrical fast transient/
burst (Power Lines) IEC
61000-4-4
±2 kV, 100 kHz
repetition
frequency
±2 kV, 100 kHz
repetition
frequency
elements IC is suitable
for use in all estab-
lishments with public
low-voltage network
that supplies buildings
used for domestic pur-
poses and professional
healthcare facility
environment (e.g. hos-
pital) with dedicated
power supply system.
Surge
IEC 61000-4-5
±0.5 kV, ±1 kV
line(s) to line(s)
±0.5 kV, ±1 kV,
±2 kV line(s) to
ground
±0.5 kV, ±1
kV line(s) to
line(s)
±0.5 kV, ±1 kV,
±2 kV line(s) to
ground
elements IC is suitable
for use in all estab-
lishments with public
low-voltage network
that supplies buildings
used for domestic pur-
poses and professional
healthcare facility
environment (e.g. hos-
pital) with dedicated
power supply system.
Voltage dips and Volt-
age interruptions on
power supply input
lines IEC 61000-4-11
Voltage dips: 0%
UT for 0.5 cycle
at 0°, 45°, 90°,
135°, 180°, 225°,
270° and 315°
0% UT for 1 cycle
and 70% UT for
25/30 cycles at
single phase
(0°)
Voltage inter-
ruptions: 0% UT,
250/300 cycle
Voltage dips:
0% UT for 0.5
cycle at 0°, 45°,
90°, 135°, 180°,
225°, 270° and
315°
0% UT for 1
cycle and 70%
UT for 25/30
cycles at single
phase (0°)
Voltage
interruptions:
0% UT, 250/300
cycle
elements IC is suitable
for use in all estab-
lishments with public
low-voltage network
that supplies buildings
used for domestic pur-
poses and professional
healthcare facility
environment (e.g. hos-
pital) with dedicated
power supply system.
Rated power frequen-
cy magnetic fields IEC
61000-4-8
30 A/m; 50 Hz or
60 Hz
30 A/m; 50 Hz
and 60 Hz
elements IC is suitable
for use in all estab-
lishments with public
low-voltage network
that supplies buildings
used for domestic pur-
poses and professional
healthcare facility
environment (e.g. hos-
pital) with dedicated
power supply system.
NOTE: UT is the a.c. mains voltage prior to application of the test level.
077-0900_REVA_ELEMENTS_IC_ROW_IFU_BOOK_P6.indb 8 6/13/19 5:28 PM
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