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U5002-1, 7.0
36
XIII.
System Compliance Statements (continued)
IEC 60601-1-2:2004(Ed 2.1) Table 202 Requirements
The equipment is intended for use in the electromagnetic environment specified below. The customer or the user of the Equipment should
assure that it is used in such an environment.
Immunity test
IEC 60601 test level Compliance level Electromagnetic environment – guidance
Electrostatic discharge
(ESD) IEC 61000-4-2
±6 kV contact ±8 kV air ±6 kV contact ±8 kV air with
documented necessary
Floors should be wood, concrete or ceramic tile.
If floors are covered with synthetic material, the
relative humidity should be at least 30 %.
Electrical fast transient/
burst IEC 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.
Surge IEC 61000-4-5 ±1 kV line(s) to line(s) ±2 kV
line(s) to earth
±1 kV line(s) to line(s) ±2 kV
line(s) to earth
Mains power quality should be that of a typical
commercial or hospital environment.
Voltage dips, short
interruptions and voltage
variations on power supply
input lines IEC 61000-4-11
UT = 230 Vac
<5 % UT (>95 % dip in UT)
for 0,5 cycle 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 5 sec
<5 % UT (>95 % dip in UT)
for 0,5 cycle 40 % UT (60 %
dip in UT) for 5 cycles 70 %
UT (30 % dip in UT) for 25
cycles No anomalies 95%
dip meets requirements.
Mains power quality should be that of a typical
commercial or hospital environment. If the
user of the equipment requires continued
operation during power mains interruptions, it is
recommended that the equipment be powered
from an uninterruptible power supply or a
battery.
Power frequency (50 Hz)
magnetic field IEC 61000-
4-8
3 A/m 3 A/m Power frequency magnetic fields should be at
levels characteristic of a typical location in a
typical commercial or hospital environment.
IEC 60601-1-2:2004(Ed 2.1) Table 204 Requirements
The equipment is intended for use in the electromagnetic environment specified below. The customer or the user of the Equipment should
assure that it is used in such an environment.
Immunity
test
IEC 60601
test level
Compliance
level
Electromagnetic environment – guidance
Conducted
RF IEC
61000-4-6
Radiated RF
IEC 61000-
4-3
3 Vrms 150
kHz to 80
MHz
3 V/m 80
MHz to 2,5
GHz
3 V
3 V/m
Portable and mobile RF communications equipment should be used no closer to any part of
the equipment including cables, than the recommended separation distance calculated from
the equation applicable to the frequency of the transmitter.
Recommended separation distance
3,5
V
1
3,5
E
1
80 MHz to 800 MHz
7
E
1
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 meters (m). Field
strengths from fixed RF transmitters, as determined by an electromagnetic site surveya should
be less than the compliance level in each frequency rangeb
Interference may occur in the vicinity of known RF transmitting devices and 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, objects and people.
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 transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location
in which the equipment is used exceeds the applicable RF compliance level above, the equipment should be observed to verify normal
operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the equipment
b) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.