Use Instructions

Manufacturer’s Declaration
Refer to the following table for specific information regarding compliance to IEC/ EN 60601-1-2 for this
device.
Guidance and manufacturer’s declaration - electromagnetic emissions - for all EQUIPMENT and SYSTEMS
Guidance and manufacture’s declaration - electromagnetic Emission
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.
Emissions test
Compliance
Electromagnetic environment -guidance
RF emissions CISPR 11
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.
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
Complies
Voltage fluctuations/ flicker
Emissions IEC 61000-3-3
Complies
Guidance and manufacturer’s declaration - electromagnetic immunity - for all EQUIPMENT and SYSTEMS
Guidance and manufacture’s declaration - electromagnetic immunity
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.
Immunity test
IEC/ EN 60601-1-2
test level
Compliance level
Electromagnetic
environment -
guidance
Electrostatic
Discharge (ESD)
IEC 61000-4-2
±8 kV contact
±15 kV air
±8 kV contact
±15 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
±2 kV for power
supply lines
±1 kV for
input/output lines
Mains power quality
should be that of a
typical commercial
or hospital
environment.
Surge
IEC 61000-4-5
±1 kV differential
mode
±1 kV differential
mode
Mains power quality
should be that of a
typical commercial