Ossur i - DIGITS Gebrauchsanweisung Seite 13

Recommended separation distance between portable and mobile RF communications equipment and the Össur
Myoelectric Prosthetic Devices
Össur Myoelectric Prosthetic Devices are intended for use in an electromagnetic environment in which radiated
RF disturbances are controlled. The customers or the user of Össur Myoelectric Prosthetic Devices can help
prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and the Össur Myoelectric Prosthetic Devices as recommended
below, according to the maximum output power of the communications equipment.
Rated maximum
output power of
transmitter in Watt
0.01
0.1
1
10
100
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in
meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the
maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
Note 1: At 80MHz and 800MHz, the separation distance for the higher frequency range applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption
and reflection from structures, objects, and people.
REPORT A SERIOUS INCIDENT
Important notice to users and/or patients established in Europe:
The user and/or patient must report any serious incident that has occurred in relation to the device to the
manufacturer and the competent authority of the Member State in which the user and/or patient is established.
DISPOSAL
The device and packaging must be disposed of in accordance with respective local or national environmental
regulations.
LIABILITY
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.
Separation distance according to frequency of transmitter in
meters
150 kHz to 80 MHz 80 MHz to 800 MHz
d = 1.2 √P d = 1.2 √P
0.12 0.12
0.38 0.38
1.2 1.2
3.8 3.8
12 12
800 MHz to 2.7GHz
d = 2.3 √P
0.23
0.73
2.3
7.3
23
13