Electromagnetic Compatibility - Acelity PREVENA INCISION Manual De Uso

ELECTROMAGNETIC COMPATIBILITY

All electrical equipment may produce interference. If interference is suspected, move
equipment away from sensitive devices or contact the manufacturer.
The PREVENA™ 125 Therapy Unit needs special precautions regarding EMC and needs to be
installed and put into service according to the EMC information in the following tables.
Guidance and manufacturer's declaration - electromagnetic emissions
The PREVENA™ 125 Therapy Unit is intended for use in the electromagnetic environment specified
below. The customer or user of the PREVENA™ 125 Therapy Unit should assure that it is used in such an
environment.
Emission Test
RF emissions
CISPR 11
RF emissions
CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations /
flicker emissions
IEC 61000-3-3
WARNING: Use of this equipment adjacent to or stacked with other equipment should be avoided because
it could result in improper operation. If such use is necessary, this equipment and the other equipment
should be observed to verify that they are operating normally.
Portable and mobile RF communications equipment (including peripherals such as antenna cables and
external antennas) should be used no closer than 30 cm (12 inches) to any part of the PREVENA™ 125
Therapy Unit. Otherwise, degradation of the performance of this equipment could result. More precisely,
the minimum recommended separation distance should be calculated from the equation applicable to the
frequency of the transmitter, as noted in the guidance below.
NOTE: This equipment has been tested and found to comply with the limits for medical devices to IEC
60601-1-2: 2014 4th edition. These limits and test levels are intended to provide reasonable safety with
regard to electromagnetic disturbances when the device is used in a typical medical installation.
Compliance
The PREVENA™ 125 Therapy Unit uses RF energy only for internal
Group 1 function. Therefore, its RF emissions are very low and are not
likely to cause any interference in nearby electronic equipment.
The PREVENA™ 125 Therapy Unit is suitable for use in all
establishments, including domestic establishments and those
Class B
directly connected to the public low-voltage power supply
network that supplies buildings used for domestic purposes.
Not applicable
Not applicable
Electromagnetic environment
Battery operated device
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