Otto Bock Empower 1A1-1 Instructions For Use Manual page 40

Technical data
Directive and manufacturer's declaration – electromagnetic emissions
HR emissions CISPR
11
Harmonic wave emis­
sions IEC 61000-3-2
Voltage fluctuations and
flicker IEC 61000-3-3
Directive and manufacturer's declaration – electromagnetic interference immunity
The prosthetic foot is intended for use in the electromagnetic environment described below. The customer or user must ensure
that it is operated in such an environment.
Interference immunity
test
Electrostatic discharge
(ESD) IEC 61000-4-2
Electrical fast transi­
ents/bursts IEC
61000-4-4
Over voltage IEC
61000-4-5
Voltage drops, brief
interruptions and
voltage fluctuations in
power supply lines
Mains frequency –
(50/60 Hz) – magnetic
field IEC 61000-4-8
Line-conducted HR IEC
61000-4-6
Radiated HR IEC
61000-4-3
NOTICE 1: The higher frequency range applies at 80 MHz and 800 MHz. NOTICE 2: These directives may not apply in all
situations. Electromagnetic propagation is influenced by absorption and reflection on buildings, objects and persons.
a
Field strengths of fixed transmitters, such as base stations for radio telephones (mobile radio/wireless) and land mobile
radio, amateur radio, AM and FM radio, and television transmitters cannot be exactly determined theoretically. An electromag­
netic site survey should be considered to evaluate the electromagnetic environment due to fixed HR transmitters. If the meas­
ured field strength at the location where the prosthetic foot is used exceeds the aforementioned applicable HR compliance
level, the prosthetic foot must be observed during normal use. Should deviating performance be noted, additional measures
b
Within the frequency range of 150 kHz to 80 MHz, the field strength must be less than 10V/m.
40
Class B
Not applicable
Not applicable
IEC 60601 test level
± 8 kV contact ± 15 kV
air±
± 2 kV for power lines ±
1 kV for input and out­
put lines
± 1 kV line against line
± 2 kV line against earth
<5 % U (>95 % drop
T
in U ) for 0.5 cycles 40
T
% U (60 % drop in U )
T T
for 5 cycles 70 % U
T
(30 % drop in U ) for
T
25 cycles <5 % U (>95
T
% drop in U ) for 5 s
T
30 A/m
NOTICE: U is the AC mains voltage before applying the test level.
T
Not applicable
3 V/m 80 MHz to 2.5
GHz
may be required, for example realigning or repositioning the prosthetic foot.
The prosthetic foot is suitable for use in all buildings, including resid­
Compliance level
± 8 kV contact ± 15 kV Floors should be wood, concrete or ceramic tile.
air± If the floor covering is made of synthetic material,
Not applicable Not applicable. The prosthetic foot is powered by
Not applicable Not applicable. The prosthetic foot is powered by
Not applicable Not applicable. The prosthetic foot is powered by
30 A/m
pond to the values that are characteristic for com­
Not applicable
devices should not be operated closer to a com­
10 V/m
than the recommended separating distance cal­
culated using the equation applicable for the fre­
Not applicable. The prosthetic foot is powered by
transmitter in watts (W) according to the transmit­
ter manufacturer, and d is the recommended sep­
according to an electromagnetic site survey
ential buildings.
Electromagnetic environment – directive
the relative humidity must be at least 30%.
a rechargeable battery.
a rechargeable battery.
a rechargeable battery.
Mains frequency magnetic fields must corres­
mercial or hospital environments.
Wearable and portable HR communication
ponent of the battery charger, including cables,
quency of the transmitter.
Recommended separating distance:
a rechargeable battery.
d=1.2√P 80 MHz to 800 MHz
d=2.3√P 800 MHz to 2.5 GHz
P stands for the maximum output power of the
arating distance in metres (m).
Field strengths of HR transmitters determined
be lower than the compliance level in every fre­
quency range
Interference may occur in the vicinity of devices
that are marked with the following symbol:
a must
b
.
Empower 1A1-1