3Shape TRIOS 5 - Distances Between System and Other Equipment

6
ENGLISH
WARNING
Medical electrical equipment needs special precautions regarding EMC
and needs to be installed and put into service according tothe EMC
information provided in this document.
IMPORTANT NOTICE
Portable and mobile RF communications equipment can affect medical
electrical equipment.
4.16 Declaration – Electromagnetic Emissions
The TRIOS system complies with the requirements EN 60601-1-2 (Ed. 4.0 and Ed. 4.1)
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
measurement
Conformity
Electromagnetic
environment– guidelines
RF emission
CISPR11
Group 1
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.
RF emission
CISPR11
Class B
Harmonic
emission
EN 61000-3-2
Class A
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.
Voltage fluctuation
and flicker
EN 61000-3-3
Complies
4.17 Electromagnetic Immunity
The TRIOS system complies with the requirements EN 60601-1-2 (Ed. 4.0 and Ed. 4.1) 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
EN 60601 test
level
Compliance
level
Electromagnetic
environment – guidelines
Electrostatic
discharge ESD
EN 61000-4-2
Contact
+/-8kV.
Air:
+/-15kV.
Contact
+/-8kV.
Air:
+/-15kV.
Floors should be wood,
concrete or ceramic tile. If floors
are covered with synthetic
materials, the relative humidity
should be at least 30 %.
The TRIOS system is allowed
to have a temporary loss
of function, which requires
operator intervention or
system reset.
Electrical fast
transients/burst
EN 61000-4-4
+/- 2 kV
for power
supply lines
+/-1 kV
for input/
output lines
+/- 2 kV
for power
supply lines
+/-1 kV
for input/
output lines
Mains power quality should be
that of a typical commercial
or hospital environment.
During electrical fast
transient/burst the TRIOS
system is allowed to have a
temporary loss of function,
which requires operator
intervention or system reset.
Surge
EN 61000-4-5
+/-1 kV
Line(s) to earth:
+/-2 kV.
Line to line.
+/-1 kV
Line(s) to earth:
+/-2 kV.
Line to line.
Mains power quality should be
that of a typical commercial or
hospital environment.
Voltage
dips, short
interruption
and voltage
variations
EN 61000-4-11
0 % UT
for 0.5 cycle
(1 phase)
0 % UT
for 1 cycle
70 % UT
for 25/30 cycles
(50/60 Hz)
0 % UT
for 0.5 cycle
(1 phase)
0 % UT
for 1 cycle
70 % UT
for 25/30 cycles
(50/60 Hz)
During the testing the TRIOS
system is allowed to have a
temporary loss of function
which requires operator
intervention or reset.
Power frequency
(50/60Hz)
Magnet field
EN 61000-4-8
30 A/m. 30 A/m. Power frequency magnetic
fields should be at levels
characteristic of a typical
location in a typical domestic
or hospital environment.
Proximity
magnetic fields
9 kHz – 13.56 MHz
EN IEC
61000-4-39
134.2 kHz:
65 A/m, 2.1
kHz pulse
modulation
13.56 MHz:
7.5 A/m, 50
kHz pulse
modulation
CT for
transmitters CR
for receivers
Portable and mobile
RF communications
equipment should be used
no closer to the device than
a recommended separation
distance of 30 cm
Note: U
T
is the ac mains voltage prior to application of the test level
Immunity test EN 60601 test level Compliance level
Conducted RF
EN 61000-4-6
3 Vrms
150 kHz to 80 MHz.
6 Vrms in ISM bands
between 0,15 MHz and
80 MHz (Note b)
[V1] 3 Vrms
[V2] 6 Vrms (Note b)
Radiated RF
EN 61000-4-3
3 V/m
80 MHz to 2.7 GHz.
[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.
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 Immunity test level (V/m)
380-390 TETRA 400 27
430-470
GMRS460,
FRS 460
28
704-787 LTE Band 13, 17 9
800-960
GSM 800/900,
TETRA 800,
iDEN 820,
CDMA 850,
LTE Band 5
28
1700-1990
GSM 1800;
CDMA 1900;
GSM 1900;
LTE Band 1,3,4, 25;
UMTS
28
2400-2570
Bluetooth,
WLAN,
802.11 b/g/n,
RFID 2450
LTE Band 7
28
5100-5800 WLAN 802.11 a/n 9