Otto Bock Genium Series Instructions For Use Manual page 111

• Operation in a professional healthcare facility (e.g. hospital, etc.)
• Operation in areas of home healthcare (e.g. use at home, use outdoors)
The customer or user of the product must ensure that it is operated in such an environment.
Observe the safety notices in the section "Information on proximity to certain areas" (see Page 75).
The following tables outline the test levels of the tests to be carried out. The higher value applies if there is a differ­
ence between the operating environments listed in the tables below.
Table 1 – Electromagnetic emissions for all devices and systems
Directives and manufacturer's declaration – electromagnetic interference
The product 'Genium Bionic Prosthetic System 3B1 / Genium 3B1-2' is designed for operation in an electromag­
netic environment as specified below. The customer or user of the product 'Genium Bionic Prosthetic System
3B1 / Genium 3B1-2' 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 Bionic Prosthetic System 3B1 / Genium 3B1-2' is designed for operation in an electromag­
netic environment as specified below. The customer or user of the product 'Genium Bionic Prosthetic System
3B1 / Genium 3B1-2' 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
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 Bionic Pros­
thetic System 3B1 / Genium 3B1-2'
uses HF energy exclusively for its
internal functioning. Therefore its HF
emissions are very low and interfer­
ence with neighbouring electronic
devices is unlikely.
The product 'Genium Bionic Pros­
thetic System 3B1 / Genium 3B1-2'
is intended for use in other than res­
idential facilities and in facilities con­
nected directly to a public low-
voltage network that also supplies
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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