8
Manufacturer’s Declaration
Refer to the following tables for specific information regarding this device’s compliance to IEC 60601-1-2.
Table 1: Electromagnetic Emissions
Emissions Test
Compliance
Electromagnetic Environment—Guidance
This device is intended for use in the electromagnetic environment specified below. The customer and/or user of this device
should ensure that it is used in such an environment.
RF Emissions
CISPR 11
Group 2
This device must emit electromagnetic energy in order to perform its
intended function. Nearby electronic equipment may be affected.
RF Emissions
CISPR 11
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.
Harmonic Emissions
IEC 61000-3-2
N/A
Voltage Fluctuations/Flicker
Emissions
IEC 61000-3-3
N/A
Table 2: Electromagnetic Immunity
Immunity Test
IEC 60601 Test Level
Compliance
Level
Electromagnetic Environment—Guidance
This device is intended for use in the electromagnetic environment specified below. The customer and/or user of this device should ensure that it is
used in such an environment.
Electrostatic Discharge (ESD)
IEC 61000-4-2
±6 kV contact
±8 kV air
±6 kV contact
±8 kV air
Floors should be wood, concrete, or ceramic tile. If
floors are covered with synthetic material, 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
N/A
Mains power quality should be that of a typical
commercial or hospital environment.
Surge
IEC 61000-4-5
±1 kV differential mode
±2 kV common mode
N/A
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 0.5 cycle
±40% U
T
(60% dip in U
T
) for 5 cycles
±70% U
T
(30% dip in U
T
) for 25 cycles
<5% U
T
(>95% dip in U
T
) for 5 sec.
N/A
Mains power quality should be that of a typical
commercial or hospital environment.
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.
NOTE
: U
T
is the AC mains voltage before application of the test level.
