Electromagnetic Compatibility - Ossur POWER KNEE PKA01 Gebrauchsanweisung

ELECTROMAGNETIC COMPATIBILITY

Warning: Use of this device adjacent to or stacked with other equipment should be avoided because it could result
in improper operation. If such use is necessary, this device and the other equipment should be observed to verify
that they are operating normally.
Warning: Use of accessories and cables other than those specified or provided by the manufacturer of this device
could result in increased electromagnetic emissions or decreased electromagnetic immunity of this device and
result in improper operation.
Warning: Portable RF communications equipment (including peripherals such as antenna cables and external
antennas) should be used no closer than 30 cm (12 inches) to any part of the device, including cables specified by
the manufacturer. Otherwise, degradation of the performance of this equipment could result.
The device is suitable for use in any environment except where immersion in water or any other fluid is possible, or in
flammable / explosive atmospheres, or where exposure to highly electrical and/or magnetic fields can occur (e. g.,
electrical transformers, high-power radio/TV transmitters, RF surgical equipment, CT and MRI scanners).
The device may be susceptible to electromagnetic interference from portable and mobile RF communications
equipment such as mobile (cellular) telephones or other equipment, even if that other equipment complies with
CISPR EMISSION requirements.
Table 5 - Electromagnetic Emissions Compliance Information
Emissions test
Conducted and radiated RF emissions
Harmonics emissions
Voltage fluctuations / Flicker emissions
Table 6 - Electromagnetic Immunity Compliance Information
Immunity Test
Electrostatic discharge
Electrical fast transient/burst
Surge
Voltage dips
Voltage interruptions
Power frequency (50/60 Hz)
magnetic field
Conducted disturbances
induced by RF fields
Radiated RF EM fields
Standard
CISPR 11
IEC 61000-3-2
IEC61000-3-3
Standard Compliance Level
± 8 kV contact
IEC 61000-4-2
± 15 kV air
± 2 kV for power supply lines
IEC 61000-4-4
± 1 kV for input/output lines
± 1 kV line(s) to line(s)
IEC 61000-4-5
± 2 kV line(s) to earth
0 % UT; 0.5 cycle
At 0°, 45°, 90°, 135°, 180°, 225°,
270° and 315°
IEC 61000-4-11
0 % UT; 1 cycle and
70 % UT; 25/30 cycles
Single phase: at 0°
IEC 61000-4-11 0 % UT; 250/300 cycle
IEC 61000-4-8 30 A/m
3 V
0,15 MHz – 80 MHz
IEC 61000-4-6 6 V in ISM and amateur bands
between 0,15 MHz and 80 MHz
80 % AM at 1 kHz
10 V/m
IEC 61000-4-3 80 MHz – 2,7 GHz
80 % AM at 1 kHz
12 V/m
EN IEC22523
26 MHz – 1 GHz
Compliance level
Group 1 – Class B
Class A
Complies
11