Emc Compliance Table - VQ OrthoCare BioniCare Manual De Instrucciones

EMC Compliance Table

Medical electrical equipment needs special precautions regarding EMC and needs to
be installed and put into service according to the EMC information provided below.
Portable and mobile RF communications equipment can affect medical electrical
equipment.
Use of lead wires and other accessories other than those supplied by VQ OrthoCare
may result in increased emissions or decreased immunity of the BioniCare Knee
System.
Guidance and manufacturer's declaration - electromagnetic emissions
The BioniCare Knee System is intended for use in the electromagnetic environment specified
below. The customer or user of the BioniCare Knee System should assure that it is used in such
an environment.
Emissions test
RF Emissions
RF Emissions
Harmonic emissions IEC
61000-3-2
Voltage fluctuations / flicker
emissions IEC 61000-3-3
Guidance and manufacturer's declaration - electromagnetic immunity
The BioniCare Knee System is intended for use in the electromagnetic environment
specified below. The customer or user of the BioniCare Knee System should assure that it is
used in such an environment.
Immunity test
Electrostatic
discharge (ESD)
IEC 61000-4-2
Electrical fast
transient / burst
IEC 61000-4-4
Compliance Electromagnetic Enviornment - Guidance
The BioniCare Knee System uses RF energy only for
its internal function. Therefore it RF emissions are
Group1
very low and are not likely to cause any interference
Class B
The BioniCare Knee System is suitable for use in all
Complies establishments, including domestic establishments
and those directly connected to the public low-
voltage power supply network that supplies
Complies
IEC 60601
Test Level
± 6 kV contact
± 8 kV air
± 2 kV for power
supply lines
± 1 kV for input /
output lines
BioniCare
®
in nearby electronic equipment.
buildings used for domestic purposes.
Compliance level
± 6 kV contact
± 8 kV air
Not Applicable
Knee System
Electromagnetic
environment -
guidance
Floors should be
wood, concrete or
ceramic tile. If floors
are covered with
synthetic material,
the relative humidity
should be at least
30%.
Not Applicable
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