Directives And Manufacturer's Declaration; Electromagnetic Environment - Otto Bock Genium X3 3B5-3 Instructions For Use Manual

Beep sig­ Vibration
nal signal
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 LEDs lit on the side of the char­
ger.
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)
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 20).
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 4 - casing
Phenomenon
Electrostatic discharge
High frequency electro­
magnetic fields
Genium X3 3B5-3/3B5-3=ST
Event
Maintenance note:
e.g. service interval has been exceeded,
temporary disruption of a sensor signal
AXON tube adapter not connected while
removing inductive charger
1 2
11%-30% 31%-50%
EMC basic standard or
test procedure
IEC 61000-4-2
IEC 61000-4-3
Resolution
• Use the Cockpit app to check the next
maintenance date for the prosthesis
(see Page 40). If the date has been
reached or exceeded, the prosthesis
with tube adapter, battery charger
and power supply have to be sent to
an authorised Ottobock Service Cen­
ter.
• Conduct the self-test again by con­
necting/disconnecting
charger.
• If the beep signal sounds again and
the maintenance date has not yet
been reached or exceeded, the pros­
thesis 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 is emitted
again, the product must be inspected
by an authorised Ottobock Service
Center.
3
51%-70%
Interference immunity test level
Professional healthcare
facility
± 8 kV contact
± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV air,
3 V/m
80 MHz to 2.7 GHz
80 % AM at 1 kHz
Appendices
the
4 5
71%-90% >90%
Environments in areas of
home healthcare
10 V/m
80 MHz to 2.7 GHz
80 % AM at 1 kHz
battery
55