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Ulthera, Inc.
EMC INFORMATION
In accordance with EN 60601-1-2:2007 Medical electrical equipment - Part 1-2: General requirements for basic safety
and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests, the
following Electro-Magnetic Compatibility (EMC) precautions should be observed:
1)
Medical electrical equipment needs special precautions regarding EMC and needs to be installed and put
into service according to the EMC information provided in this document (the following tables);
2)
Portable and mobile RF communications equipment can affect medical electrical equipment;
3)
The CM1 Motor Module is not life-supporting.
4)
The CM1 Motor Module was found to have no essential performance but functions were tested for immunity.
5)
The CM1 Motor Module should not be used adjacent to or stacked with other equipment and if adjacent or
stacked use is necessary, the CM1 Motor Module should be observed to verify normal operation in the
configuration in which it is used.
6)
The use of accessories, transducers and cables other than those specified may result in increased
emissions or decreased immunity.
The following tables provide information regarding the EMC characteristics of the CM1 Motor Module.
Guidance and Manufacturer's Declaration – Electromagnetic Emissions
The CM1 Motor Module is intended for use in the electromagnetic environment specified
below. The customer or the user of the CM1 Motor Module should assure that it is used in
such an environment.
Emissions test
RF emissions
CISPR 11
RF emissions
CISPR 11
Harmonic
emissions
IEC 61000-3-2
Voltage
fluctuations/
flicker emissions
IEC 61000-3-3
1007270IFU Rev D
®
Cellfina
System
Electromagnetic environment – guidance
Compliance
The CM1 Motor Module uses RF energy only for its
internal function. Therefore, its RF emissions are
Group 1
very low and are not likely to cause any interference
in nearby electronic equipment.
The CM1 Motor Module is suitable for use in all
Class B
establishments, including domestic establishments
and those directly connected to the public low
voltage power supply network that supplies buildings
Class B
used for domestic purposes.
Complies
User Manual
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