Electromagnetic Immunity / Portable Radiofrequency Equipment; Recommended Separation Distancesclearances - Ultradent Products Genius Manual Del Usuario

Test Level as per
Immunity Test
Electrical Fast
± 2 kV for electricity
transients
supply lines
IEC61000-4-4
± 1 kV in differential
Surge mode
IEC61000-4-5 ± 2 kV in common
mode
<5% UT (>95% dip in
UT) for 0.5 cycles
40% UT (60% dip in
Voltage dips, brief
UT) for 5 cycles
interruptions, and
voltage variation
70% UT (30% dip in
IEC61000-4-11
UT) for 25 cycles
<5% UT (>95% dip in
UT) for 250 cycles

10.3 ELECTROMAGNETIC IMMUNITY / PORTABLE RADIOFREQUENCY EQUIPMENT

The medical device is designed for use in the magnetic and electromagnetic environment described in the table below. The user
and/or installer must ensure conformity of the electromagnetic environment.
Immunity Test
Handheld and mobile radiofrequency communication devices must not be used near the device (including cables) at medical
device a distance below that recommended and calculated according to the frequency and power of the transmitter.
Radiofrequency conducted
disturbance.
IEC61000-4-6
Radiated radiofrequency
electromagnetic field.
IEC61000-4-3
The electromagnetic field intensity of fixed radiofrequency transmitters, as determined by an electromagnetic environment
measurement (a), must be less than the conformity level for each frequency range (b).
Interferences may occur near the equipment identified by the following symbol:
Note 1: At 80 MHz and 800 MHz, the highest frequency range applies.
Note 2: These specifications cannot be applied to all situations. The electromagnetic propagation is affected by the absorption
and reflection of structures, objects and people.
(a) The electromagnetic field intensity of fixed radiofrequency transmitters, such as base stations for portable phones (mobiles
/ wireless), mobile radios, radio amateurs, AM/FM radio transmissions and TV transmissions cannot be determined accurately by
the theory.
To assess the electromagnetic environment caused by fixed radiofrequency transmitters, an electromagnetic environment
measurement must be taken. If the measured intensity of the radiofrequency field in the immediate product use environment
exceeds the radiofrequency conformity level specified above, it is necessary to test product performance to check this complies
with specifications. If abnormal performance is observed, additional measures may be necessary, such as changing the direction
of or moving the product.
(b) In the 150 kHz to 80 Mhz frequency range, the electromagnetic fields must be less than 3 V/m.

10.4 RECOMMENDED SEPARATION DISTANCESCLEARANCES

The medical device is designed to be used in an electromagnetic environment in which interferences caused by RF radiation
are controlled. The user or installer of the medical device may help to prevent electromagnetic interference by maintaining
a minimum distance, depending on the maximum power of the handheld and mobile radiofrequency transmission equipment
(transmitters), between the medical device and the equipment as recommended in the table below.
Max. nominal power of
the transmitter in Watts
0.01
0.1
1
10
100
Operating Manual ● Genius
®
Compliance Level
IEC60601
± 2 kV for power lines
± 1 kV in differential
mode
± 2 kV in common
mode
<5% UT (>95% dip in
UT) for 0.5 cycles
40% UT (60% dip in
UT) for 5 cycles
70% UT (30% dip in
UT) for 25 cycles
<5% UT (>95% dip in
UT) for 250 cycles
Test Level
3 V/m
150 KHz to 80 MHz
3 V/m
80 MHz to 2.5 GHz
Separation distance in metres (m) determined by transmitter frequency
150 KHz to 80 MHz
d = 1.2
0.12 m
0.38 m
1.2 m
3.8 m
12 m
Endodontic Motor ● J28629 ● V4 ● (16) ● 10/2016 ● NO69US010F
Electromagnetic Environment - Comments
The quality of the electricity supply must be equivalent
to that of a typical commercial environment or hospital
establishment (hospital, clinic).
The quality of the electricity supply must be equivalent
to that of a typical commercial environment or a
hospital.
The quality of the network supply must be equal to
that of a typical commercial or hospital environment.
If the use of the system requires continuous operation
during mains power outages, it is advisable to supply the
medical device using an separate current source (UPS,
etc.).
Compliance Level Electromagnetic Environment - Comments
Recommended separation distances
3 V/m
d = 1.2
d = 1.2
d = 2.3
3 V/m
Where (P) is the maximum nominal power of
the transmitter in Watts (W) according to the
manufacturer specifications and (d) is the
minimum recommended separation distance
in metres (m).
80 MHz to 800 MHz
d = 1.2
0.12 m
0.38 m
1.2 m
3.8 m
12 m
80MHz to 800MHz.
800MHz to 2.5GHz.
800 MHz to 2.5 GHz
d = 2.3
0.23 m
0.73 m
2.3 m
7.3 m
23 m
13