Guidance and manufacturer’s declaration – electromagnetic emissions
The EN50 UNPLUGGED is intended for use in the electromagnetic environment specied below.
The customer or the user of the EN50 UNPLUGGED should assure that it is used in such environment.
Emission test Compliance Electromagnetic environment – Guidelines
RF emissions CISPR 11 Group 1 The EN50 UNPLUGGED uses RF energy only for its internal function. Therefore, RF-emission is very
low and it is unlikely that any interference in nearby electronic equipment.
RF emissions CISPR 11 Class A The EN50 UNPLUGGED 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.
Warning: This EN50 UNPLUGGED is intended only for use by medical professionals. This is a
ME Equipment of class A CISPR 11 in the domestic environment, this ME Equipment may cause radio
interference, so that it may be necessary in this case, to take appropriate remedial measures, as e.g.
orientation, new arrangement or shielding of the EN50 UNPLUGGED or restrict the connection to the
site.
Harmonic Emissions
IEC 61000-3-2
Class A
Voltage Fluctuations/Flicker
Emissions IEC 61000-3-3
Passed
Guidance and manufacturer declaration - Electromagnetic immunity
The EN50 UNPLUGGED is intended for use in the electromagnetic environment specied below.
The customer or the user of the EN50 UNPLUGGED should assure that it is used in such environment.
Immunity test IEC 60601 test level Compliance level Electromagnetic environment – Guideline
Electrostatic discharge (ESD)
acc. to IEC 61000-4-2
± 6 kV contact discharge
± 8 kV air discharge
± 6 kV contact discharge
± 8 kV air discharge
Floors should be wood, concrete or covered with
ceramic tiles. If oors are covered with synthetic
material, the relative humidity should be at least
30 %.
Electrical fast transient/burst
IEC 61000-4-4
± 2 kV for mains cables
± 1 kV for input and output lines
± 2 kV for mains cables
± 1 kV for input and output lines
The supply voltage quality should be that of
a typical commercial or hospital environment.
Surge IEC 61000-4-5 ± 1 kV voltage phase – phase
± 2 kV voltage phase – earth
± 1 kV voltage phase – phase
± 2 kV voltage phase – earth
The supply voltage 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
< 5% UT, (>95% dip in UT)
for 1/2 period
40% UT, (60% dip in UT)
for 5 periods
70% UT, (30% dip in UT)
for 25 periods
<5% UT, (>95% dip in UT)
for 5 seconds
< 5% UT,(>95% dip in UT
)
for 1/2 period
40% UT, (60% dip in UT)
for 5 periods
70% UT, (30% dip in UT)
for 25 periods
<5% UT,(>95% dip in UT)
for 5 seconds
The supply voltage quality should be that of
a typical commercial or hospital environment.
If the user of the EN50 UNPLUGGED requires
continued operation during power mains interruptions, it s recommended that the EN50
UNPLUGGED be powered by a UPS (uninterruptible power supply) or a battery.
Power frequency (50/60 Hz)
magnetic eld IEC 61000-4-8
3 A/m 3 A/m Power frequency magnetic elds should be at
levels characteristic of a typical location in a
typical commercial or hospital environment.
Comment: UT is the a.c. supply voltage prior to application of the test level.
Guidance and manufacturer’s declaration – electromagnetic immunity
The EN50 UNPLUGGED is intended for use in the electromagnetic environment specied below.
The customer or the user of the EN50 UNPLUGGED should assure that it is used in such environment.
Immunity test IEC 60601 test level Compliance level Electromagnetic environment Guidelines
Conducted RF
IEC 61000-4-6
Radiated HF
IEC 61000-4-3
3 Veff
150 kHz to 80 MHz
3 V/m
80 MHz to 2,5 GHz
3 V
3 V/m
Portable and mobile RF communication equipment should be used no closer
to any part of the EN50 UNPLUGGED
, including cables, than the recommended
separation distance calculated from the equation applicable to the frequency of
the transmitter.
Recommended separation distance:
d = 3,5/3 * SQRT (P/W)
d = 3,5/3 * SQRT (P/W) 80 MHz to 800 MHz
d = 7/3 * SQRT (P/W) 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
separati
on distance in metres (m).
Field strengths from xed RF transmitters, as determined by an electromagnetic
site surveyaa, 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:
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 reection from structures,
objects and people.
a
Field strengths from xed 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 xed RF transmitters, an electromagnetic site survey should
be considered. If the measured eld
strength in the location in which the EN50 UNPLUGGED is used exceeds the
applicable RF compliance level above, the EN50 UNPLUGGED should be
observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating
the EN50 UNPLUGGED.
b
Over the frequency range 150 kHz to 80 MHz, eld strengths should be less than 3 V/m.