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APPENDIX E
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 Macroduct Advanced system is not susceptible to some types of electrical interference,
because it is battery-powered. 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 Macroduct Advanced
system or supplied by the manufacturer as replacement parts could result in increased emissions
or decreased immunity of the Macroduct Advanced Model 3710 and result in improper operation.
The tables below show the test results for both EMC emissions and immunity.
Guidance and Manufacturer’s Declaration – Electromagnetic Emissions
The Macroduct Advanced Sweat Collection System (specifically Model 3710) is intended for use in the
electromagnetic environment specified below. The customer or the operator of the Macroduct Advanced Sweat
Collection System should assure that it is used in such an environment.
Emissions Test Compliance Electromagnetic Environment - guidance
RF Emissions
CISPR 11
Group 1
The Macroduct Advanced 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.
RF Emissions
CISPR 11
Class A
The Macroduct Advanced system is suitable for use in all establishments
other than domestic. It is battery-powered and does not connect to the
public power supply network except for the charging of the battery.
The Macroduct Advanced system should not be used adjacent to or stacked with other
equipment. If adjacent or stacked use is necessary, the Macroduct Advanced 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 Macroduct Advanced system is intended for use in the electromagnetic environment specified below. The
customer or the operator of the Macroduct Advanced system should assure that it is used in such an environment.
Immunity Test
IEC 60601 Test
Level
Compliance
Level
Electromagnetic Environment -
Guidance
Electrostatic discharge
(ESD) IEC 61000-4-2
± 8 kV contact
± 2, 4, 8, 15 kV air
± 8 kV contact
± 2, 4, 8, 15 kV air
The Macroduct Advanced system is isolated
from ground. Any typical flooring may be
used.
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