Elitech NANODUCT 1030 User Manual page 66

Appendix J: Electromagnetic Compatibility (EMC)
Medical Electrical Equipment, in general, needs special precautions regarding EMC and needs to be used
according to the EMC information provided in the accompanying documents. Portable and mobile RF
communications equipment can affect Medical Electrical Equipment.
The Nanoduct instrument is not susceptible to some types of electrical interference, because it is battery-
powered and doesn't connect to power lines that might conduct high frequency noise along with the power.
However, it could be affected by radio emissions from other devices. Like all digital electronic equipment,
it also emits some radio frequency energy when it operates. Use of accessories or cables other than those
supplied with the Nanoduct or supplied by the manufacturer as replacement parts could result in increased
emissions or decreased immunity of the Nanoduct.
The tables below show the test results for both EMC emissions and immunity.
Guidance and Manufacturer's Declaration – Electromagnetic Emissions
The Nanoduct system is intended for use in the electromagnetic environment specified below. The customer or the
user of the Nanoduct system should assure that it is used in such an environment.
Emissions Test
RF Emissions
CISPR 11
RF Emissions
CISPR 11
The Nanoduct system should not be used adjacent to or stacked with other equipment. If adjacent or
stacked use is necessary, the Nanoduct system should be observed to verify normal operation in the
configuration in which it will be used.
Guidance and Manufacturer's Declaration – Electromagnetic Immunity
The Nanoduct system is intended for use in the electromagnetic environment specified below. The customer or the
user of the Nanoduct system should assure that it is used in such an environment.
Immunity Test IEC 60601-1-2 Test Level
Electrostatic +/- 2, 4, 8 kV contact
discharge (ESD)
+/- 2, 4, 8, 15 kV air
IEC 61000-4-2
Compliance
Group 1 The Nanoduct system 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 Nanoduct system is suitable for use in all establishments
including domestic. It is battery-powered and does not connect
to the public power supply network.
Electromagnetic Environment - Guidance
Compliance Level
+/- 8 kV contact The Nanoduct system is isolated
from ground. Any typical flooring may
+/- 15 kV air
be used.
Electromagnetic Environment -
Guidance
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