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Technical Information
Manufacturer's Declaration
See the following tables for specific information regarding this device's compliance to IEC 60601-1-2.
Emissions Test
This device is intended for use in the electromagnetic environment specified below. The user of this device should ensure that it is
RF Emissions
CISPR 11
RF Emissions
CISPR 11
Harmonic Emissions
IEC 61000-3-2
Voltage Fluctuations/ Flicker
Emissions
IEC 61000-3-3
Immunity Test
This device is intended for use in the electromagnetic environment specified below. The user of this device should ensure that it is
Electrostatic Discharge
±6 kV contact
(ESD)
±8 kV air
IEC 61000-4-2
Electrical Fast Transient/
± 2 kV for power supply lines
Burst
± 1 kV for input/output lines
IEC 61000-4-4
Surge
± 1 kV differential mode
IEC 61000-4-5
± 2 kV for common mode
Voltage dips, short
± 5% U
interruptions, and voltage
0.5 cycle
variations on power supply
± 40% U
input lines
5 cycles
IEC 61000-4-11
± 70% U
25 cycles
± 5% U
5 cycles
Power Frequency (50/
30 A/m
60 Hz) Magnetic Field
IEC 61000-4-8
is the AC mains voltage before application of the test level.
Note: U
T
Table 11. Electromagnetic Emissions
Compliance
used in such an environment.
Group 1
This device uses RF energy only for its internal function. Therefore,
its RF emissions are very low and are not likely to cause any
interference in nearby electronic equipment.
Class B
This device is suitable for use in all establishments, including
domestic and those directly connected to the public low-voltage
power supply network that supplies buildings used for domestic
purposes.
Pass
Pass
Table 12. Electromagnetic Immunity
IEC 60601 Test Level
used in such an environment.
±6 kV contact
±8 kV air
± 2 kV for power supply lines
± 500V for input/output lines
± 1 kV differential mode
± 2 kV for common mode
(>95% dip in U
) for
± 5% U
T
T
0.5 cycle
(60% dip in U
) for
± 40% U
T
T
5 cycles
(30% dip in U
) for
± 70% U
T
T
25 cycles
(>95% dip in U
) for
± 5% U
T
T
5 cycles
30 A/m
Electromagnetic Environment—Guidance
Electromagnetic Environment—
Compliance Level
Floors should be wood, concrete, or
ceramic tile. If floors are covered with
synthetic material, the relative humidity
should be at least 30%.
Mains power quality should be that of a
typical commercial or hospital
environment.
Mains power quality should be that of a
typical commercial or hospital
environment.
(>95% dip in U
) for
Mains power quality should be that of a
T
T
typical commercial or hospital
environment. If the user of the device
(60% dip in U
) for
T
T
requires continued operation during
power mains interruptions, it is
(30% dip in U
) for
T
T
recommended that the device be
powered from an uninterruptible power
(>95% dip in U
) for
T
T
supply or battery pack.
Power frequency magnetic fields should
be at levels characteristic of a typical
location in a typical commercial or
hospital environment.
Guidance
53
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