35
Manufacture’s Declaration
Refer to the following table for specific information regarding compliance to IEC
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 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
