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80-0067-00-MO-RevJ 2019-01-30 SunTech CT40 User Manual | 45
Guidance and Manufacturer’s Declaration Electromagnetic Emissions
The CT40 Monitor is intended for use in a Professional Healthcare Facility within the electromagnetic environment
specified below. The customer or the user of the CT40 Monitor should assure that it is used in such an
environment. This equipment has been tested and found to comply with the limits for medical devices to IEC60601-
1-2: 2014.
Emissions test
Compliance
Electromagnetic Environment
Guidance
RF emissions CISPR 11
Group 1
The CT40 Monitor 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
The CT40 Monitor is suitable for use
in all establishments other than
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
Class A
Voltage fluctuations/ flicker
emissions IEC 61000-3-3 Complies
Guidance and Manufacturer’s Declaration Electromagnetic Immunity
The CT40 Monitor is intended for use in a Professional Healthcare Facility within the electromagnetic environment
specified below. It is not intended for helicopter transport, hospital ambulance or home use. It is not intended for
near active HF SURGICAL EQUIPMENT and the RF shielded room of an ME SYSTEM for magnetic resonance
imaging, where the intensity of EM DISTURBANCE is high. The customer or the user of the monitor should assure
that it is used in such an environment. This equipment has been tested and found to comply with the limits for
medical devices to IEC 60601-1-2: 2014.
In the event of an error, the device will auto-recover within 5 seconds.
Immunity Test
Applies to
Compliance
Level
Electromagnetic Environment-
Guidance for Professional
Healthcare Facility Environment
Electrostatic discharge
(ESD) IEC 61000-4-2
All device input and
output connections
and cables.
± 2, 4, 6, 8kV contact
± 2, 4, 8, 15kV air
discharge
Floors should be wood, concrete
or ceramic tile. If floors are
covered with synthetic material,
the relative humidity should be at
least 30%. Users must eliminate
static in their hands before use it.
45


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