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Guidance and manufacturer declaration - Electromagnetic immunity
The device is intended for use in the electromagnetic environment specified below.
The customer or the user of the device 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 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 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
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
< 5% U
T
, (>95% dip in U
T
)
for 1/2 period
40% U
T
, (60% dip in U
T
)
for 5 periods
70% U
T
, (30% dip in U
T
)
for 25 periods
<5% U
T
, (>95% dip in U
T
)
for 5 seconds
< 5% U
T
, (>95% dip in U
T
)
for 1/2 period
40% U
T
, (60% dip in U
T
)
for 5 periods
70% U
T
, (30% dip in U
T
)
for 25 periods
<5% U
T
, (>95% dip in U
T
)
for 5 seconds
Mains power quality should be that of a typical
commercial or hospital environment. If the user
of the device requires continued operation
during power mains interruptions, it is recom-
mended that the device be powered by a UPS
(uninterruptible power supply) or a battery.
Power frequency (50/60 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.
Comment: U
T
is the a.c. supply voltage prior to application of the test level.
Guidance and manufacturer’s declaration – electromagnetic emissions
The device is intended for use in the electromagnetic environment specified below.
The customer or the user of the device should assure that it is used in such environment.
Emission test
Compliance
Electromagnetic environment – Guidelines
RF emissions
CISPR11
Group 1
The device 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 B
The device is suitable for use in all establishments, including domestic establishments and those directly connec-
ted to the public low-voltage power supply network that supplies buildings used for domestic purposes.
Harmonic Emissions
IEC 61000-3-2
Class A
Symmetrical three-phase devices and other devices.
Voltage Fluctuations/
Flicker Emissions
IEC 61000-3-3
Passed
Guidance and manufacturer’s declaration – electromagnetic immunity
The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device
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
3 Veff
150 kHz to 80 MHz
3 V eff
Portable and mobile RF communication equipment should be used no
closer to any part of the device, including cables, than the recommen-
ded separation distance calculated from the equation applicable to the
frequency of the transmitter.
Radiated HF
IEC 61000-4-3
3 V/m
80MHz to 2,5GHz
3 V/m
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 separation distance in metres (m).
Field strengths from fixed RF transmitters, as determined by an
electromagnetic site surveya
a
, 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 80Hz and 800MHz, 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 device is used exceeds the applicable RF compliance level above, the device should be observed to verify normal
operation.
If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the device.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V / m.
Appendix
