Directives And Manufacturer's Declaration; Electromagnetic Environment - Ottobock Genium-Bionic Prosthetic System 3B1 Instrucciones De Uso

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

16.3 Directives and manufacturer's declaration

16.3.1 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 Bionic Prosthetic System 3B1 / Genium 3B1-2' is designed for operation
in an electromagnetic 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 oper­
ated 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
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 electromagnetic 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 oper­
ated in such an environment.
104
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 Bionic
Prosthetic System 3B1 / Geni­
um 3B1-2' uses HF energy
exclusively for its internal func­
tioning. Therefore its HF emis­
sions are very low and interfer­
ence with neighbouring elec­
tronic devices is unlikely.
The product 'Genium Bionic
Prosthetic System 3B1 / Geni­
um 3B1-2' is intended for use
in other than residential facilit­
ies and in facilities connected
directly to a public low-voltage
network that also supplies res­
idential buildings.
5
>90%