Ossur Rheo Knee Bedienungsanleitung Seite 13

Bluetooth 4.1 Module:
N550M8CC
REPORT OF SERIOUS INCIDENT
Any serious incident in relation to the device must be reported to the manufacturer and relevant authorities.
DISPOSAL
The device and packaging must be disposed of in accordance with respective local or national environmental regulations.
Note: The primary packaging is made from recyclable materials.
LIABILITY
Össur prosthetic devices are designed and verified to be safe and compatible in combination with each other and custom-made prosthetic sockets with
Össur adapters, and when used in accordance with their intended use.
Össur does not assume liability for the following:
• Device not maintained as instructed by the instructions for use.
• Device assembled with components from other manufacturers.
• Device used outside of recommended use condition, application, or environment.
Compliance
The device has been designed and tested according to the applicable international standards or in-house defined standards when no international
standard exists or applies.
The device has been tested by an independent accredited laboratory and found to comply to:
• EN60601-1
• EN60601-1-2
This device has been tested according to ISO 10328 standard to three million load cycles.
The load level specification is ISO10328 - P6 - 136 kg
ISO - P -
*) Body mass limit not to be exceeded!
For speci c conditions and limitations of use
see manufacturer's written instructions on
intended use!
SYMBOLS
Symbol Description
Medical Device
Caution Symbol
Consult instructions for use
FCC
Contains FCC ID: O6R2398
Canada
Contains IC: 3797A-2398
Japan
Contains transmitter with
certificate number R203-JN6049
Australia & New Zealand
ACMA supplier code number is N20233
kg *)
F1D 2402-2480 MHz (1 MHz Interval, 79 Channels) 0.42 mW/MHz
13