Electromagnetic Compatibility - KERR ENDODONTICS elements IC Manual Del Usuario

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 affect 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
vironment.
IEC 60601
Immunity test
test level
Conducted 3* Vrms 0.15 MHz
disturbances – 80 MHz 80% AM
induced by RF at 1 kHz
fields IEC
61000-4-6
10 V/m 80 MHz –
Radiated RF E
2.7 GHz, 80% AM
M F i e l d s IEC
at 1 kHz
61000-4-3
Proximity Fields Table 9 of IEC
from RF Wireless 60601-1-2 ed. 4.0
communications
equipment IEC
61000-4-3
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 affected
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
RF emissions
Group 1
CISPR 11
RF Emissions
Class B
CISPR 11
Harmonic emissions IEC
Class A
61000-3-2
Voltage fluctuations/flicker
Complies
emissions IEC 61000-3-3
8
077-0900_REVA_ELEMENTS_IC_ROW_IFU_BOOK_P6.indb 8
such an en-
Electromagnetic
Compliance
environment -
level
guidance
3* Vrms 0.15 MHz The distance between
– 80 MHz 80% AM transmitting antenna
at 1 kHz 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
10 V/m
Interference may occur
80 MHz –
in the vicinity of equip-
2.7 GHz, 80% AM
ment marked with the
at 1 kHz
following symbol:
Table 9 of IEC
60601-1-2
ed. 4.0
Electromagnetic environment
- guidance
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.
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.
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.
IEC 60601-1-2
Immunity test
test level
± 8 kV contact
Electrostatic discharge
(ESD)
±2 kV, ±4 kV,
IEC 61000-4-2
±8 kV, ± 15kV air
Electrical fast transient/ ±2 kV, 100 kHz
burst (Power Lines) IEC
repetition
61000-4-4 frequency
Surge ±0.5 kV, ±1 kV
IEC 61000-4-5 line(s) to line(s)
±0.5 kV, ±1 kV,
±2 kV line(s) to
ground
Voltage dips and Volt- Voltage dips: 0%
age interruptions on UT for 0.5 cycle
power supply input at 0°, 45°, 90°,
lines IEC 61000-4-11 135°, 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
Rated power frequen- 30 A/m; 50 Hz or
cy magnetic fields IEC 60 Hz
61000-4-8
NOTE: UT is the a.c. mains voltage prior to application of the test level.
Electromagnetic
Compliance
environment -
level
guidance
elements IC complies
±8 kV contact
antistatic material and
±2 kV, ±4 kV, synthetic material with
relative humidity level
±8 kV, ±15 kV air
as low as 10%.
±2 kV, 100 kHz elements IC is suitable
for use in all estab-
repetition
lishments with public
frequency
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.
±0.5 kV, ±1 elements IC is suitable
kV line(s) to for use in all estab-
line(s) lishments with public
low-voltage network
±0.5 kV, ±1 kV,
that supplies buildings
±2 kV line(s) to
used for domestic pur-
ground
poses and professional
healthcare facility
environment (e.g. hos-
pital) with dedicated
power supply system.
elements IC is suitable
Voltage dips:
0% UT for 0.5 for use in all estab-
cycle at 0°, 45°, lishments with public
90°, 135°, 180°, low-voltage network
225°, 270° and that supplies buildings
315° used for domestic pur-
poses and professional
0% UT for 1
healthcare facility
cycle and 70%
environment (e.g. hos-
UT for 25/30
pital) with dedicated
cycles at single
power supply system.
phase (0°)
Voltage
interruptions:
0% UT, 250/300
cycle
30 A/m; 50 Hz elements IC is suitable
and 60 Hz 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.
6/13/19 5:28 PM