Otto Bock Empower 1A1-1 Instructions For Use Manual page 41

Recommended separating distances between wearable and portable HR communication devices and the prosthetic
The prosthetic foot is intended for use in an electromagnetic environment in which radiated HR interference can be controlled.
The customer or user of the prosthetic foot can help avoid electromagnetic interference by maintaining a minimum distance
between wearable and portable HR communication devices (transmitters) and the prosthetic foot, as recommended in the fol­
lowing, according to the maximum output power of the communication device.
Maximum nominal output
power of the transmitter
(W)
0.01
0.1
1
10
100
For transmitters with a maximum nominal output power that is not listed above, the recommended separating distance (d) in
metres can be calculated using the equation applicable for the frequency of the transmitter, where (P) is the maximum nominal
output power of the transmitter in watts (W) according to the transmitter manufacturer.
NOTICE 2: These directives may not apply in all situations. Electromagnetic propagation is influenced by absorption and
The prosthetic foot uses a Bluetooth® wireless connection for the configuration of settings. Other devices can interfere with the
wireless connection, including devices that meet the CISPR emission requirements. If a poor adjustment range or limited
responsiveness is observed, the prosthetic foot may have to be adjusted in a location that is further away from the HR power
sources. The Bluetooth® module receives and transmits the following electromagnetic HR power: frequency band: 2402 - 2480
MHz, modulation: FHSS/GFSK, effective radiant power: 12 dBm
Directive and manufacturer's declaration – electromagnetic emissions
The battery charger is intended for use in the electromagnetic environment described below. The customer or user of the bat­
tery charger must ensure that it is used in such an environment.
Emission test
HF emissions CISPR
11
HF 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 battery charger is intended for use in the electromagnetic environment described below. The customer or user of the bat­
tery charger must ensure that it is used 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 IEC
61000-4-11
Mains frequency –
(50/60 Hz) – magnetic
field IEC 61000-4-8
Empower 1A1-1
Separating distance according to transmitter frequency (m)
150 kHz to 80 MHz d=1.2√P 80 MHz to 800 MHz d=1.2√P
0.12
0.38
1.2
3.8
12
NOTICE 1: The higher frequency range applies at 80 MHz and 800 MHz.
reflection on buildings, objects and persons.
Compliance
Group 1
Class B
Class B
Complies
IEC 60601 test level
± 8 kV contact ± 15 kV
air±
± 2 kV for power lines ± ± 2 kV for power lines ±
1 kV for input and out­
put lines
± 1 kV line against line
± 2 kV line against earth ± 2 kV line against earth
<5 % U (>95 % drop
T
in U ) for 0.5 cycles 40
T
% U (60 % drop in U ) % U
T T
for 5 cycles 70 % U
T
(30 % drop in U ) for
T
25 cycles <5 % U (>95 25 cycles <5 % U
T
% drop in U ) for 5 s
T
30 A/m
foot
0.12
0.38
1.2
3.8
Electromagnetic environment – directive
The battery charger uses HF power only for its internal function.
Therefore its HF emissions are very low, and it is unlikely to cause
interference with electronic devices in the vicinity.
The battery charger is suitable for use in all buildings, including res­
idential buildings and buildings connected directly to the public low-
voltage network that supplies residential buildings with electricity.
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,
1 kV for input and out­
put lines
± 1 kV line against line
<5 % U (>95 % drop
T
in U ) for 0.5 cycles 40 typical commercial or hospital environment. If the
T
(60 % drop in U )
T T
for 5 cycles 70 % U
T
(30 % drop in U ) for tery charger with an uninterruptible power supply
T
(>95
T
% drop in U ) for 5 s
T
30 A/m
pond to the values that are characteristic for com­
800 MHz to 2.5 GHz
12
Electromagnetic environment – directive
the relative humidity must be at least 30%.
The mains current quality must correspond to a
typical commercial or hospital environment.
The mains current quality must correspond to a
typical commercial or hospital environment.
The mains current quality must correspond to a
user wants to use the battery charger continu­
ously during a power failure, operating the bat­
or rechargeable battery is recommended.
Mains frequency magnetic fields must corres­
mercial or hospital environments.
Technical data
d=2.3√P
0.23
0.73
2.3
7.3
23
41