6-12
Electromagnetic Compatibility
Portable and mobile RF communications equipment can affect medical electrical equipment.
Medical electrical equipment needs special precautions regarding EMC and needs to be installed and put into
service according to the EMC information in the following tables.
The following tables document compliance levels and guidance from the IEC 60601-1-2 2007 Standard, for
the electromagnetic environment in which the
TriaDyne Proventa
Critical Care Therapy System should be used
in a clinical environment. The
TriaDyne Proventa
Critical Care Therapy System also meets the intent of the
draft guidance for electromagnetic compatibility related to use in the home care environment (IEC 60601-1-
11 2007-11-30 draft).
Guidance and Manufacturer’s Declaration - Electromagnetic Emissions
The
TriaDyne Proventa
Critical Care Therapy System is intended for use in the electromagnetic environment specified
below. The customer or user of the
TriaDyne Proventa
Critical Care Therapy System should assure that it is used in
such an environment.
Emission Test
Compliance
Electromagnetic environment
RF emissions
CISPR 11
Group 1
The
TriaDyne Proventa
Critical Care Therapy System uses RF energy
only for 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 A
The
TriaDyne Proventa
Critical Care Therapy System is suitable for use
in all establishments other than domestic and may be used in domestic
establishments and those directly connected to the public low-voltage
power supply network that supplies buildings used for domestic
purposes, provided the following warning is heeded:
Warning: This equipment 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
TriaDyne Proventa
Critical Care Therapy System or
shielding the location.
Harmonic
emissions
IEC 61000-3-2
Class A
Voltage fluctuations /
flicker emissions
IEC 61000-3-3
Complies
