REF 2100202-0001/ENG
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Precautions regarding Electromagnetic Compatibility (EMC)
Medical electrical equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in the user's manual and in the present document.
The DMX2 Plus/DMX2 Pro complies with the EMC requirements according to IEC 60601-1-2. Radio transmitting equipment, cellular phones, etc. shall not be used in the close proximity of the device since this could
influence the performance of the device. Particular precaution must be considered during use of strong emission sources such as High Frequency surgical equipment and similar so that e.g. the HF cables are not routed
on or near the device. If in doubt, please contact a qualified technician or Bien-Air Dental.
The DMX2 Plus/DMX2 Pro should not be used adjacent or stacked with other equipment. If adjacent or stacked use is necessary, the DMX2 Plus/DMX2 Pro should be observed to verify normal operation in the
configuration in which it will be used.
WARNING!
The use of accessories, transducers and cables other than those specified, with the exception of transducers and cables sold by Bien-Air as replacements parts for internal components,
may result in increased emissions or decreased immunity of the DMX2 Plus/DMX2 Pro.
Guidance and manufacturer’s declaration – electromagnetic immunity
The DMX2 Plus/DMX2 Pro is intended for use in the electromagnetic environment specified below. The customer or the user of the DMX2 Plus/DMX2 Pro should assure that it is used in such an environment.
Guidance and manufacturer’s declaration – electromagnetic immunity
The DMX2 Plus/DMX2 Pro is intended for use in the electromagnetic environment specified below. The customer or the user of the DMX2 Plus/DMX2 Pro should assure that it is used in such an environment.
NOTE 1
At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2
These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
a
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and lan mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted
theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in
which the DMX2 Plus/DMX2 Pro is used exceeds the applicable RF compliance level above, the DMX2 Plus/DMX2 Pro should be observed to verify normal operation. If abnormal performance is observed,
additional measures may be necessary, such as reorienting or relocating the DMX2 Plus/DMX2 Pro.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Emissions test
RF emissions
CISPR 11
RF emissions
CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Compliance
Group 1
Class B
Not applicable
Not applicable
Electromagnetic environment - guidance
The DMX2 Plus/DMX2 Pro uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any
interference in nearby electronic equipment.
The DMX2 Plus/DMX2 Pro is suitable for use in all establishments, including domestic establishments and those directly connected to the public
low-voltage power supply network that supplies buildings used for domestic purposes.
Guidance and manufacturer’s declaration – electromagnetic emissions
The DMX2 Plus/DMX2 Pro is intended for use in the electromagnetic environment specified below. The customer or the user of the DMX2 Plus/DMX2 Pro should assure that it is used in such an environment.
Immunity test
Electrostatic discharge (ESD)
IEC 61000-4-2
Electrical fast transient/burst
IEC 61000-4-4
Surge
IEC 61000-4-5
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
Power frequency (50/60 Hz)
magnetic field
IEC 61000-4-8
IEC 60601 test level
±2 kV contact
±4 kV contact
±6 kV contact
±2 kV air
±4 kV air
±8 kV air
±2 kV for power supply lines
±1 kV for input/output lines
±0.5 kV line to line
±1 kV line to line
±0.5 kV line to earth
±1 kV line to earth
±2 kV line to earth
<5 %
U
T (>95 % dip in
U
T)
for 0,5 cycle
40 %
U
T (60 % dip in
U
T)
for 5 cycles
70 %
U
T (30 % dip in
U
T)
for 25 cycles
<5 %
U
T (>95 % dip in
U
T)
for 5 sec
3 A/m
Compliance level
±2 kV contact
±4 kV contact
±6 kV contact
N.A.
N.A.
N.A.
±2 kV for power supply lines
N.A.
±0.5 kV differential mode
±1 kV differential mode
N.A.
N.A.
N.A.
<5 %
U
T (>95 % dip in
U
T)
for 0,5 cycle
40 %
U
T (60 % dip in
U
T)
for 5 cycles
70 %
U
T (30 % dip in
U
T)
for 25 cycles
<5 %
U
T (>95 % dip in
U
T)
for 5 sec
3 A/m
Electromagnetic environment - guidance
Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity
should be at least 30 %.
Mains power quality should be that of a typical commercial or hospital environment.
Mains power quality should be that of a typical commercial or hospital environment.
Mains power quality should be that of a typical commercial or hospital environment.
If the user of the DMX2 Plus/DMX2 Pro requires continued operation during power mains interruptions, it is recommended
that the DMX2 Plus/DMX2 Pro be powered from an uninterruptible power supply or a battery.
Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial
or hospital environment.
NOTE
U
T is the a.c. mains voltage prior to application of the test level.
Essential performance
: The essential performance is the maintaining of the visual lighting intensity of the LED and the maintaining of motor speed. Maximum allowed speed deviation is ± 5%.
Immunity test
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
IEC 60601 test level
3 Vrms
150 kHz to 80 MHz
3 V/m
80 MHz to 2.5 GHz
Compliance level
3 V
3 V/m
Electromagnetic environment - guidance
Portable and mobile RF communications equipment should be used no closer to any part of the DMX2 Plus/DMX2 Pro, including
cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
Recommended separation distance
80 MHz to 800 MHz
800 MHz to 2,5 GHz
where
P
is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and
d
is the
recommended separation distance in metres (m).
Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,
a
should be less than the compliance level
in each frequency range.
b
Interference may occur in the vicinity of equipment marked with the following symbol:
