3Shape L1P-1F Инструкции по безопасности и настройке - Страница 6
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Печатать страницу4.16 Declaration – Electromagnetic Emissions
The TRIOS system complies with the requirements EN/(IEC) 60601-1-2 (Edition 4.0)
clause 7 Emissions.
The TRIOS system is intended for use in the electromagnetic environment specified below.
The user or users of the TRIOS system should assure that it is used in such an environment.
Emission
Conformity
measurement
RF emission
Group 1
CISPR11
RF emission
Class B
CISPR11
Harmonic
emission
Class A
IEC 61000-3-2
Voltage
fluctuation and
Complies
flicker
IEC 61000-3-3
4.17 Electromagnetic Immunity
The TRIOS system complies with the requirements EN/(IEC) 60601-1-2 (ed. 4.0)
clause 8 Immunity. The test levels for immunity to RF electromagnetic fields are selected
according to general test conditions for medical equipment.
The TRIOS system is intended for use in a Professional Healthcare Facility Environment with
the electromagnetic environment specified below. The user of The TRIOS system should
assure that it is used in such an environment.
Immunity test
IEC 60601 test
level
Electrostatic
Contact +/-
discharge ESD
8kV.
IEC 61000-4-2
Air:
+/-15kV.
Electrical fast
+/- 2 kV for
transients/burst
power supply
lines
IEC 61000-4-4
+/-1 kV for
input/ output
lines
Surge
+/-1 kV Line(s)
to earth:
IEC 61000-4-5
+/-2 kV. Line
to line.
Voltage
0 % UT for 0.5
dips, short
cycle (1 phase)
interruption
0 % UT
and voltage
for 1 cycle
variations
70 % UT for
IEC 61000-4-11
25/30 cycles
(50/60 Hz)
Power frequency
30 A/m.
(50/60Hz)
Magnet field IEC
61000-4-8
Note: U
is the ac mains voltage prior to application of the test level
T
Immunity test
IEC 60601 test level
Conducted RF
3 Vrms
IEC 61000-4-6
150 kHz to 80 MHz.
6 Vrms in ISM bands
between 0,15 MHz and
80 MHz (Note b)
Radiated RF
3 V/m
IEC 61000-4-3
80 MHz to 2.7 GHz.
6
E lectromagnetic
environment – guidelines
The TRIOS system uses RF energy only for its
internal functions. Therefore, Its RF emissions
are very low and are not likely to cause any
interference in nearby electronic equipment.
The TRIOS system is intended for use
in dental clinical settings, including domestic
establishments and those directly connected
to the public low-voltage power supply
network that supplies buildings used
for domestic purposes
Compliance
Electromagnetic
level
environment – guidelines
Contact
Floors should be wood,
+/-8kV.
concrete or ceramic tile. If floors
are covered with synthetic
Air:
materials, the relative humidity
+/-15kV.
should be at least 30 %.
The TRIOS system is allowed
to have a temporary loss
of function, which requires
operator intervention or
system reset.
+/- 2 kV for
Mains power quality should be
power supply
that of a typical commercial
lines
or hospital environment.
+/-1 kV for
During electrical fast
input/ output
transient/burst the TRIOS
lines
system is allowed to have a
temporary loss of function,
which requires operator
intervention or system reset.
+/-1 kV Line(s)
Mains power quality should be
to earth:
that of a typical commercial or
hospital environment.
+/-2 kV. Line
to line.
0 % UT for 0.5
During the testing the TRIOS
cycle (1 phase)
system is allowed to have a
temporary loss of function
0 % UT for
which requires operator
1 cycle
intervention or reset.
70 % UT for
25/30 cycles
(50/60 Hz)
30 A/m.
Power frequency magnetic
fields should be at levels
characteristic of a typical
location in a typical domestic
or hospital environment.
Compliance level
[V1] 3 Vrms
[V2] 6 Vrms (Note b)
[E1] 3 V/m
80 MHz to 2.7 GHz.
Electromagnetic environment – guidelines
Portable and mobile RF communications equipment should be used no closer to any
part of the TRIOS system, including cables, than the recommended separation distance
calculated from the equation applicable to the frequency of transmitter.
Recommended separation distance
d = 1,2 √P
d = 1,2 √P 80 MHz to 800 MHz
d = 2,3 √P 800 MHz to 2,7 GHz
where P is the maximum output power rating of the transmitter in watts (W) according
to the transmitter manufacture and d is the recommended separation distance in meter
(m), V1 is the conducted RF compliance level, and E1 is the RF radiated compliance level.
Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,
(note a, b and c) should be less than the compliance level in each frequency range.
Interference may occur in the vicinity of equipment
marked with the following symbol:
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, object and people.
Note a: Field strengths from fixed transmitters, such as base stations for radio (cellular/
cordless) telephones and land 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 transmitter, an electromagnetic site survey
should be considered. If abnormal performance of the TRIOS system is observed, additional
measures may be necessary, such as re-orienting or relocating the TRIOS system.
Note b: Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Note c: The ISM (industrial, scientific and medical) bands between 0,15 MHz and 80 MHz
are 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. The amateur radio bands between 0,15 MHz and 80 MHz are
1,8 MHz to 2,0 MHz, 3,5 MHz to 4,0 MHz, 5,3 MHz to 5,4 MHz, 7 MHz to 7,3 MHz, 10,1 MHz
to 10,15 MHz, 14 MHz to 14,2 MHz, 18,07 MHz to 18,17 MHz, 21,0 MHz to 21,4 MHz,
24,89 MHz to 24,99 MHz, 28,0 MHz to 29,7 MHz and 50,0 MHz to 54,0 MHz.
Enclosure port immunity to RF wireless communications equipment
Band (MHz)
Service
380-390
TETRA 400
GMRS460,
430-470
FRS 460
704-787
LTE Band 13, 17
GSM 800/900,
TETRA 800,
800-960
iDEN 820,
CDMA 850,
LTE Band 5
GSM 1800;
CDMA 1900;
1700-1990
GSM 1900;
LTE Band 1,3,4, 25;
UMTS
Bluetooth,
WLAN,
2400-2570
802.11 b/g/n,
RFID 2450
LTE Band 7
5100-5800
WLAN 802.11 a/n
4.18 Distances Between System and Other Equipment
The TRIOS system is intended for use in an electromagnetic environment in which
radiated RF disturbances are controlled. The customer or the user of the TRIOS system
can help prevent electromagnetic interference by maintaining a minimum distance
between portable or mobile RF communications equipment (transmitters) and the
TRIOS system as recommended below, according to the maximum output power of the
communication equipment.
Rated maximum output
Separation distance according to frequency
power of transmitter, W
of transmitter, m
150 kHz
to 80 MHz
d = 1,2 P
0,01
0,12
0,1
0,38
1
1,2
10
3,8
100
12
Immunity test level (V/m)
27
28
9
28
28
28
9
80 MHz
800 MHz to 2,5
to 800 MHz
GHz
d = 1,2 P
d = 2,3 P
0,12
0,23
0,38
0,73
1,2
2,3
3,8
7,3
12
23