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

Bionic prosthetic system
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Battery charge level
During the charging process, the current battery charge level is indicated by the LEDs lit on the
side of the charger.
LEDs
0
Battery
0%-10%
charge level

18.3 Directives and manufacturer's declaration

18.3.1 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)
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 68).
The following tables outline the test levels of the tests to be carried out. The higher value applies if
there is a difference 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 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 Prosthetic System 3B5-X3 / Genium X3 3B5-2' must ensure that
the device is operated in such an environment.
Interference measurements
HF emissions according to
CISPR 11
HF emissions according to
CISPR 11
Harmonics according to
IEC 61000-3-2
Voltage fluctuations/flicker
according to IEC 61000-3-3
1
2
11%-30%
31%-50%
Compliance
Group 1
Class B
N/A
N/A
3
4
51%-70%
71%-90%
Electromagnetic environ­
ment directive
The product 'Genium X3 -
Bionic Prosthetic System
3B5-X3 / Genium X3 3B5-2'
uses HF energy exclusively for
its internal functioning. There­
fore its HF emissions are very
low and interference with
neighbouring electronic
devices is unlikely.
The product 'Genium X3 -
Bionic Prosthetic System
3B5-X3 / Genium X3 3B5-2' is
intended for use in other than
residential facilities and in
facilities connected directly to
a public low-voltage network
that also supplies residential
buildings.
5
>90%
105

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