Additional Information; Service Intervals; Damage Event; Technical Information - Ottobock C-Leg Prosthetic System Instrucciones De Uso

3 Additional Information

3.1 Service Intervals

INFORMATION
This component has been tested according to ISO 10328 standard for three million load cycles. Depending on
the amputee's activity this corresponds to a duration of use of three to five years.
The service life can be individually extended in dependence of the intensity of use by making use of regular service
inspections (respectively after 24 months) (see C-Leg Service Pass 646D241=*).
In the interest of patient safety and in order to maintain operating safety and warranty, a service inspection is re-
quired after 24 months (see 646D241=* C-Leg Service Pass). This service inspection includes a verification of the
sensors and the replacement of worn parts. It is essential that the tube adapter is replaced after a service life of 72
months at the latest.
To obtain the service, send in the knee joint with mounted C-Leg tube adapter and remote control as well as the
complete charger unit including the AC adapter.

3.2 Damage Event

To simplify problem resolution, describe damage events in detail and document patient statements.
Unless the cause of a damage is very apparent, send in all accessories.

3.3 Technical Information

Weight of the joint:
Weight of the 2R82 Tube Adapters
Weight of the 2R81 Tube Adapters
Max. flexion angle
Operating voltage of the battery charger:
Operating frequency of the battery charger:
Battery charging temperature:
Relative humidity range:
Operating, storage, and transport temperature:

3.3.1 Symbols on the Joint

Declaration of conformity according to the European Directive for Medical Devices 93/42/EEC and
1999/5/ EU.
These products may not be disposed of with household waste in some jurisdictions. Disposal that is
not in accordance with the regulations of your country may have a detrimental impact on health and
the environment. Please observe the information provided by the responsible authorities in your country
regarding return and collection processes.

3.3.2 Symbols on the Remote Control

Declaration of conformity according to the European Directive for Medical Devices 93/42/EEC and
0681
1999/5/ EC with the number of the specified authority (0681).
These products may not be disposed of with household waste in some jurisdictions. Disposal that is
not in accordance with the regulations of your country may have a detrimental impact on health and
the environment. Please observe the information provided by the responsible authorities in your country
regarding return and collection processes.
52 Ottobock
approx. 1145 g
approx. 178 g to 256 g
approx. 438 g to 482 g
approx. 125°
100 V to 260 V AC
50 Hz to 60 Hz
> 0 °C
up to 80 %, non-condensing
-10 °C to +60 °C
C-Leg Prosthetic System