Standards Applied; Content Of Accessible And Non-Accessible Demarcations; Electromagnetic Emissions - GNATUS ENDUS Manual Del Propietário

TECHNICAL SPECIFICATIONS
The materials used to produce the equipment are Biocompatible.
Use of different cables, transducers and accessories from those specifi ed may result
in increased emissions or decreased immunity of the equipment.

Standards applied :

IEC 60601-1:2005 - Equipamento Eletromédico - Parte 1: Prescrições gerais para segurança;
EN ISO 980:2008 (Ed. 2) - Graphical symbols for use in the labelling of medical devices;
EN ISO 14971:2012 - Medical devices - application of risk management medical devices;
EN ISO 13485-2012 - Quality systems - medical devices;
IEC 60601-1-2:2007 - Compatibilidade Eletromagnética;
ISO 10993-1:2003 - Biogicol evaluction of medical devices.

Content of accessible and non-accessible demarcations

Electromagnetic emissions

The equipment
client or the user of the
Emission test
RF emissions
ABNT NBR IEC CISPR 11
RF emissions
ABNT NBR IEC CISPR 11
Emissions of harmonics
IEC 61000-3-2
Fluctuation of Voltage /
Emissions of flicker
IEC 61000-3-3
Eletromagnetic emissions
is made to be used in the electromagnetic environments specified below. The
equipment must be sure that it is used in such environment.
Compliance
Group 1
Class B
Class A
As per
C o n s u m o
<0.05W
Eletromagnetic environment - Guide
This equipment uses RF energy only for
internal functions. However, its
emissions are too low and it's unlikely to
cause any interference in the
equipments next to it.
This equipment is proper to be used in
all establishments; including domestic
settings and those directly connect to a
public low voltage distribution which
feeds domestic buildings.
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