Manufacturer's Emc Declaration - Fresenius Medical Care Liberty Select User Manual

Peritoneal dialysis cycler
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Manufacturer's EMC Declaration

The Liberty Cycler has been certified to the requirements of
ANSI/AAMI/IEC 60601-1-2:2007 within the scope of equipment
intended to be used in the home and institutional environments, such as
hospitals.
Emissions testing of the machine was performed using the limits for
CISPR 11 Group 1, Class B which are specified for equipment intended
to be used in homes. However, use of the Liberty Cycler in residential
environments may result in interference with some types of broadcast
receivers such as televisions and radios. Should such interference occur,
it will not permanently affect those receivers and can be reduced or
eliminated by repositioning of the receiver or the Liberty Cycler.
In order to assure the safety of the Liberty Cycler as well as other
medical devices when used with the Liberty Cycler in the home
environment, a detailed technical analysis was performed. This analysis
has shown that the emissions levels of the Liberty Cycler are
significantly below the immunity requirements of ANSI/AAMI/IEC
60601-1-2 and therefore are not likely to impact the safe operation of
other medical devices used within the proximity.
The Liberty Cycler is intended for use in the electromagnetic environment specified below.
The customer or user of the Liberty Cycler should ensure it is used in such an
environment.
Emissions
RF
Emissions
CISPR 11
RF
Emissions
CISPR 11
Harmonic
emissions
IEC 61000-
3-2
Voltage
fluctuations/
flicker
emissions
IEC 61000-
3-3
254
Guidance and manufacturer's declaration – electromagnetic emissions
Compliance Electromagnetic environment – guidance
test
Group 1
The Liberty Cycler uses RF energy only for its internal
functions. Therefore, its RF emissions are very low and are
not likely to cause any interference in nearby electronic
equipment.
Class B
The Liberty Cycler is suitable for use in all establishments
including domestic, and those directly connected to the public
low-voltage power supply network that supplies buildings
used for domestic purposes.
Class A
Complies
P/N 480145 Rev A
Liberty Select Cycler User's Guide

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