9
ELECTROMAGNETIC COMPATIBILITY
Medical Electrical Equipment requires special precautions regarding electromagnetic compatibility.
The elements
TM
obturation unit 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.
WARNINGS:
• The use of accessories and options other than those specified by the manufacturer may result in
increased emissions or decreased immunity of the elements
TM
obturation unit.
• 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 electromagnetic
interference, stop use of the unit. Contact Customer Service.
• 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 the elements
TM
obturation unit, including compatible cable. Otherwise, degradation of the performance of this
equipment could result.
Guidance and manufacturer’s declaration - electromagnetic emissions
The elements
TM
obturation unit is intended for use in the electromagnetic environment
specified below. The customer or the user of the elements
TM
obturation unit should assure
that it is used in such an environment.
Emissions Test Compliance Electromagnetic environment - guidance
RF emissions CISPR 11 Group 1 The elements
TM
obturation unit uses RF
energy only for its internal function. The
Element Obturation Unit delivers energy
to the patient in a form other than RF
electromagnetic.
RF Emissions CISPR 11 Class B The elements
TM
obturation unit is suitable
for use install establishments with
public low-voltage network that supplies
buildings used for domestic purposes and
professional healthcare facility environ-
ment (e.g. hospital) with dedicated power
supply system
Harmonic emissions
IEC 61000-3-2
Class A
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Complies
Guidance and manufacturer’s declaration - electromagnetic immunity
The elements
TM
obturation unit is intended for use in the electromagnetic environment
specified below. The customer or the user of the elements
TM
obturation unit 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, ± 15 kV air
±8 kV contact
±2 kV, ±4 kV,
±8 kV, ±15 kV air
The elements
TM
obturation unit
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
The elements
TM
obturation unit is
suitable for use in all
establishments with
public low-voltage
network that supplies
buildings used for
domestic purposes and
professional healthcare
facility environment
(e.g. hospital) 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
The elements
TM
obturation unit is
suitable for use in all
establishments with
public low-voltage
network that supplies
buildings used for
domestic purposes and
professional healthcare
facility environment
(e.g. hospital) with
dedicated power supply
system.
Voltage dips
and Voltage
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
interruptions:
0% UT, 250/300
cycle
Voltage dips:
>95% UT for 0.5 cycle
at 0°, 45°, 90°, 135°,
180°, 225°, 270° and
315°.
>95% UT for 1 cycle
and 70% UT for 25/30
cycles at single
phase (0°)
Voltage
Interruptions:
100% UT for 250
cycles
The elements
TM
obturation unit is
suitable for use in all
establishments with
public low-voltage
network that supplies
buildings used for
domestic purposes and
professional healthcare
facility environment
(e.g. hospital) with
dedicated power supply
system.
Rated power
frequency
magnetic fields
IEC 61000-4-8
30 A/m; 50 Hz or
60 Hz
30 A/m; 50 Hz and
60 Hz
The elements
TM
obturation unit is
suitable for use in all
establishments with
public low-voltage
network that supplies
buildings used for
domestic purposes and
professional healthcare
facility envi-ronment
(e.g. hospital) with
dedicated power supply
system.
NOTE: UT is the a.c. mains voltage prior to application of the test level.
Guidance and manufacturer’s declaration - electromagnetic immunity
The elements
TM
obturation unit is intended for use in the electromagnetic environment
specified below. The customer or the user of the elements
TM
obturation unit should assure that
it is used in such an environment.
Immunity test IEC 60601
test level
Compliance level Electromagnetic environment
guidance
Conducted
disturbances
induced by
RF fields IEC
61000-4-6
3* Vrms
0.15 MHz –
80 MHz
80% AM at
1 kHz
3* Vrms
0.15 MHz –
80 MHz
80% AM at
1 kHz
The distance between
transmitting antenna and EUT
was at least 1 meter for proximity
field RF wireless communication
equipment testing.
The testing was performed with
1.7 m System B handpiece cable,
1.7 m extruder cable and 1.85 m
AC/DC adapter cable bundled
to 1 meter.
Interference may occur in the
vicinity of equipment marked
with the following symbol:
Radiated RF
EM Fields IEC
61000-4-3
3 V/m
80 MHz –
2.7 GHz, 80%
3 V/m
80 MHz –
2.7 GHz, 80% AM
at 1 kHz
Proximity Fields
from RF Wireless
communications
equipment IEC
61000-4-3
Table 9 of
IEC 60601-1-2
ed. 4.0
Table 9 of
IEC 60601-1-2
ed. 4.0
NOTE 1: *6 Vrms in the ISM 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: The elements
TM
obturation unit was tested at 120 VAC/60 Hz and 230 VAC/50 Hz
NOTE 3: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 4: These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.
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