Electromagnetic Compatibility - SybronEndo elements obturation Manual De Instrucciones

ELECTROMAGNETIC COMPATIBILITY

Medical Electrical Equipment requires special precautions regarding electromagnetic compatibility.
The elements obturation unit needs to be installed and put into service according to the
TM
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
• 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
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
that it is used in such an environment.
Emissions Test Compliance
RF emissions CISPR 11 Group 1
RF Emissions CISPR 11 Class B
Harmonic emissions Class A
IEC 61000-3-2
Voltage fluctuations/ Complies
flicker emissions
IEC 61000-3-3
Guidance and manufacturer's declaration - electromagnetic immunity
The elements obturation unit is intended for use in the electromagnetic environment
TM
specified below. The customer or the user of the elements
it is used in such an environment.
Immunity test IEC 60601
test level
Conducted 3* Vrms
disturbances 0.15 MHz –
induced by 80 MHz
RF fields IEC 80% AM at
61000-4-6 1 kHz
Radiated RF 3 V/m
EM Fields IEC 80 MHz –
61000-4-3 2.7 GHz, 80%
Proximity Fields Table 9 of
from RF Wireless IEC 60601-1-2
communications ed. 4.0
equipment IEC
61000-4-3
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 obturation unit was tested at 120 VAC/60 Hz and 230 VAC/50 Hz
TM
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.
obturation unit.
TM
obturation unit should assure
TM
Electromagnetic environment - guidance
The elements obturation unit uses RF
TM
energy only for its internal function. The
Element Obturation Unit delivers energy
to the patient in a form other than RF
electromagnetic.
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
obturation unit should assure that
TM
Compliance level Electromagnetic environment
guidance
3* Vrms The distance between
0.15 MHz – transmitting antenna and EUT
80 MHz was at least 1 meter for proximity
80% AM at field RF wireless communication
1 kHz equipment testing.
The testing was performed with
3 V/m
1.7 m System B handpiece cable,
80 MHz –
1.7 m extruder cable and 1.85 m
2.7 GHz, 80% AM
AC/DC adapter cable bundled
at 1 kHz
to 1 meter.
Interference may occur in the
vicinity of equipment marked
Table 9 of
with the following symbol:
IEC 60601-1-2
ed. 4.0
Guidance and manufacturer's declaration - electromagnetic immunity
The elements obturation unit is intended for use in the electromagnetic environment
TM
specified below. The customer or the user of the elements
it is used in such an environment.
Immunity test IEC 60601-1-2
test level
Electrostatic ± 8 kV contact
discharge (ESD)
IEC 61000-4-2 ±2 kV, ±4 kV,
±8 kV, ± 15 kV air
TM
Electrical fast ±2 kV, 100 kHz
transient/burst repetition frequency
(Power Lines)
IEC 61000-4-4
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 Voltage dips:
and Voltage 0% UT for 0.5 cycle
interruptions at 0°, 45°, 90°, 135°,
on power supply 180°, 225°, 270°
input lines and 315°
IEC 61000-4-11 0% UT for 1 cycle
and 70% UT for
25/30 cycles at
single phase (0°)
Voltage
interruptions:
0% UT, 250/300
cycle
Rated power 30 A/m; 50 Hz or
frequency 60 Hz
magnetic fields
IEC 61000-4-8
NOTE: UT is the a.c. mains voltage prior to application of the test level.
9
obturation unit should assure that
TM
Compliance level Electromagnetic
environment guidance
±8 kV contact The elements
TM
obturation unit
±2 kV, ±4 kV, complies antistatic
±8 kV, ±15 kV air material and synthetic
material with relative
humidity level as low
as 10%.
±2 kV, 100 kHz The elements
TM
repetition frequency 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.
±0.5 kV, ±1 kV The elements
TM
line(s) to line(s) obturation unit is
suitable for use in all
±0.5 kV, ±1 kV, establishments with
±2 kV line(s) to public low-voltage
ground network that supplies
buildings used for
domestic purposes and
professional healthcare
facility environment
(e.g. hospital) with
dedicated power supply
system.
Voltage dips: The elements
TM
>95% UT for 0.5 cycle obturation unit is
at 0°, 45°, 90°, 135°, suitable for use in all
180°, 225°, 270° and establishments with
315°. public low-voltage
>95% UT for 1 cycle network that supplies
and 70% UT for 25/30 buildings used for
cycles at single domestic purposes and
phase (0°) professional healthcare
facility environment
Voltage (e.g. hospital) with
Interruptions: dedicated power supply
100% UT for 250 system.
cycles
30 A/m; 50 Hz and The elements TM
60 Hz 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.