80-0084-00-RevB SunTech Vet30E User Manual | 46
2019-12-04
WARNING:
This equipment/system is intended for use by healthcare professionals only. This equipment/ system
may cause radio interference or may disrupt the operation of nearby equipment. It may be necessary to take
mitigation measures, such as re-orienting or relocating the Vet30E or shielding the location.
Guidance and Manufacturer’s Declaration –
Electromagnetic Emissions
The Vet30E Monitor is intended for use in a Professional Healthcare Facility within the electromagnetic
environment specified below. The customer or the user of the Vet30E 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 Vet30E 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 Vet30E 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 Vet30E 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.
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 floor are covered
with synthetic material, the relative
humidity should be at least 30%.
Users must eliminate static in their
hands before use it.