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Guidance and Manufacturer's Declaration
Guidance and Manufacturer's Declaration – Electromagnetic Emissions
This Device is intended for use in the electromagnetic environment specified below. The user of the Device
should assure that it is used in such an environment.
Emissions Test
Compliance
Electromagnetic Environment - Guidance
RF Radiated
This Device uses RF energy only for its internal function.
Emissions
Group 1
Therefore, its RF radiated emissions are very low and are not
CISPR 11
likely to cause any interference in nearby electronic equipment.
This Device is suitable for use in all establishments other than
RF Conducted
domestic and those directly connected to a low-voltage power
Emissions
Class A
supply network which supplies buildings used for domestic
CISPR 11
purposes.
Harmonic Emissions
Class A
IEC 61000-3-2
Voltage
Fluctuations/Flicker
Complies
Emissions
IEC 61000-3-3
Guidance and Manufacturer's Declaration – Electromagnetic Immunity
This Device is intended for use in the electromagnetic environment specified below. The user of the Device
should assure that it is used in such an environment.
Immunity Test
IEC 60601 Test Level
Electrostatic
±6 kV Contact
Discharge (ESD)
±8 kV Air
IEC 61000-4-2
±2 kV for power supply
Electrical Fast
lines
Transient/Burst
±1 kV for input/output
IEC 61000-4-4
lines
Surge
±1 kV differential mode
IEC 61000-4-5
±2 kV common mode
<5 % UT
(>95 % dip in UT)
for 0.5 cycle
Voltage Dips, Short
40 % UT
Interruptions
and
(60 % dip in UT)
Voltage Variations
for 5 cycles
on Power Supply
70 % UT
Input Lines
(30 % dip in UT)
IEC 61000-4-11
for 25 cycles
<5 % UT
(>95 % dip in UT
for 5 sec
Power
Frequency
(50/60
Hz)
3 A/m
Magnetic Field
IEC 61000-4-8
1-11 Regulatory Statements
Electromagnetic Environment -
Compliance Level
Guidance
Floors should be wood, concrete
or ceramic tile. If floors are
±6 kV Contact
covered with synthetic material,
±8 kV Air
the relative humidity should be at
least 30%.
±2
kV
for
power
Mains power quality should be
supply lines
that of a typical commercial or
±1 kV for input/output
hospital environment.
lines
±1
kV
differential
Mains power quality should be
mode
that of a typical commercial or
±2 kV common mode
hospital environment.
<5 % UT
(>95 % dip in UT)
Mains power quality should be
for 0.5 cycle
that of a typical commercial or
40 % UT
hospital environment.
(60 % dip in UT)
If the user of the device requires
for 5 cycles
continued operation during power
70 % UT
mains
interruptions,
(30 % dip in UT)
recommended that the device be
for 25 cycles
powered from an uninterruptible
<5 % UT
power source.
(>95 % dip in UT
for 5 sec
Power frequency magnetic fields
should be at levels characteristic
3 A/m
of a typical location in a typical
home or hospital environment.
Guidance and Manufacturer's Declaration
Guidance and Manufacturer's Declaration – Electromagnetic Immunity
This Device is intended for use in the electromagnetic environment specified below. The user of the
Device should assure that it is used in such an environment.
Immunity Test
Conducted RF
IEC 61000-4- 6
Radiated RF
IEC 61000-4-3
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 strength 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
it
is
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 re-
orienting or relocating the Device.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
1-12 Regulatory Statements
IEC 60601 Test Level
Compliance Level
3 Vrms
3 V
150 kHz to 80 MHz
3 V/m
3 V/m
80 MHz to 2.5 GHz
Electromagnetic Environment
- Guidance
Portable and mobile RF commu
nications equipment should be
used no closer to any part of th
e Device, including cables, than
the recommended separation di
stance calculated from the equa
tion applicable to the frequency
of the transmitter.
Recommended Separation
Distance
d = 1.2√P
d = 1.2√P (80 MHz to 800 MHz)
d = 2.3√P (800 MHz to 2.5
GHz)
Where P is the maximum output
power rating of the transmitter i
n watts (W) according to the tra
nsmitter manufacturer and d is t
he recommended separation di
stance in meters (m).
Field strengths from fixed RF tr
ansmitters, as determined by an
electromagnetic site survey, sh
ould be less than the complianc
e level in each frequency range.
Interference may occur in the vi
cinity of equipment marked with
the following symbol:
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