Directives And Manufacturer's Declaration; Electromagnetic Environment - Otto Bock Genium 3B1-3 Instructions For Use Manual

Appendices
Battery charger disconnected
Beep sig­ Vibration
nal signal
1x short 1x short
3x short 3x short
5x long 5x long
(every
minute)
Battery charge level
During the charging process, the current battery charge level is indicated by the number of LEDs lit on the side of
the charger.
LEDs 0
Battery charge 0%-10%
level

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 20).
Electromagnetic emissions
Interference measure­
ments
HF emissions according to
CISPR 11
Harmonics according to
IEC 61000-3-2
Voltage fluctuations/flicker
according
IEC 61000-3-3
56
Event
Self-test completed successfully. Product
is operational.
Maintenance note:
E.g.: Maintenance
exceeded, temporary
sensor signal
AXON tube adapter not connected while
removing inductive charger
1
10%-30%
Compliance
Group 1/class B
Not applicable – power
below 75 W
Product meets the require­
to ments of the standard.
Resolution
•
interval has been
disruption of a
•
•
•
•
•
2 3
30%-50% 50%-70%
Electromagnetic environment directive
The product uses HF energy exclusively for its internal
functioning. Its HF emissions are therefore very low,
and interference with neighbouring electronic devices is
unlikely.
Use the Cockpit app to check the next
maintenance date for the prosthesis
(see Page 41). If the date has been
reached or exceeded, the prosthesis
and tube adapter, battery charger and
power supply have to be sent to an
authorised Ottobock Service Center.
Conduct the self-test again by con­
necting/disconnecting
charger.
If the beep is emitted again and the
maintenance date has
reached or exceeded, the prosthesis
should be inspected by an authorised
Ottobock Service Center.
The product can be used without
restrictions. However, vibration sig­
nals may not be generated.
Connect the AXON tube adapter and
then restart the knee joint by connect­
ing/disconnecting the battery charger
If the beep/vibration signal recurs, the
product must be inspected by an
authorised Ottobock Service Center.
4 5
70%-90% >90%
–
–
Genium 3B1-3/3B1-3=ST
the battery
not been