Directives And Manufacturer's Declaration; Electromagnetic Environment - Otto Bock Genium X3 Instructions For Use Manual

17.3 Directives and manufacturer's declaration

17.3.1 Electromagnetic environment

This product is designed for operation in the following electromagnetic environments:
• Operation in a professional healthcare facility (e.g. hospital, etc.)
• Operation in areas of home healthcare (e.g. use at home, use outdoors)
Observe the safety notices in the section "Information on proximity to certain areas" (see page 21).
Table 1 – Electromagnetic emissions for all devices and systems
Directives and manufacturer's declaration – electromagnetic interference
The product 'Genium X3 - Bionic Prosthetic System 3B5-X3 / Genium X3 3B5-2' is designed for operation in an
electromagnetic environment as specified below. The customer or user of the product 'Genium X3 - Bionic Pros­
thetic System 3B5-X3 / Genium X3 3B5-2' must ensure that the device is operated in such an environment.
Interference measurements
HF emissions according to CIS­
PR 11
HF emissions according to CIS­
PR 11
Harmonics according
IEC 61000-3-2
Voltage fluctuations/flicker accord­
ing to IEC 61000-3-3
Table 2 – Electromagnetic interference immunity for all devices and systems
Directives and manufacturer's declaration – electromagnetic interference immunity
The product 'Genium X3 - Bionic Prosthetic System 3B5-X3 / Genium X3 3B5-2' is designed for operation in an
electromagnetic environment as specified below. The customer or user of the product 'Genium X3 - Bionic Pros­
thetic System 3B5-X3 / Genium X3 3B5-2' must ensure that the device is operated in such an environment.
Interference immunity
test
Electrostatic discharge
(ESD) according
IEC 61000-4-2
Electrical fast transi­
ent/bursts according
IEC 61000-4-4
Surges according
IEC 61000-4-5
Genium X3 - Bionic Prosthetic System 3B5-X3/3B5-X3=ST,Ge­
nium X3 3B5-2/3B5-2=ST
Compliance
Group 1
Class B
to N/A
N/A
IEC 60601 test level
± 6 kV discharge on con­
to tact
± 8 kV discharge through
air
± 2 kV for power lines
to ±1 kV for input and output
lines
to ±1 kV phase-to-phase
voltage
± 2 kV even voltage
Electromagnetic environment dir­
ective
The product 'Genium X3 - Bionic
Prosthetic System 3B5-X3 / Genium
X3 3B5-2' uses HF energy exclus­
ively for its internal functioning.
Therefore its HF emissions are very
low and interference with neighbour­
ing electronic devices is unlikely.
The product 'Genium X3 - Bionic
Prosthetic System 3B5-X3 / Genium
X3 3B5-2' is intended for use in oth­
er than residential facilities and in
facilities connected directly to a pub­
lic low-voltage network that also sup­
plies residential buildings.
Compliance level
± 6 kV discharge on con­
tact
± 8 kV discharge through
air
N/A
N/A
Appendices
Electromagnetic environ­
ment directive
Floors should be wood,
concrete or ceramic tile. If
the floor covering is made
of synthetic material, the
relative humidity must be at
least 30 %.
The quality of the supply
voltage should be equival­
ent to a typical commercial
or hospital supply.
The quality of the supply
voltage should be equival­
ent to a typical commercial
or hospital supply.
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