Orthofix AccelStim Manual De Instrucciones página 30

Recommended Separation Distances between Portable and Mobile RF Communications
Equipment and the AccelStim device
The AccelStim device is intended for use in an electromagnetic environment in which
radiated RF disturbances are controlled. The customer or the user of the AccelStim
device can help prevent electromagnetic interference by maintaining a minimum
distance between portable and mobile RF communications equipment (transmitters)
and the AccelStim device as recommended below, according to the maximum output
power of the communications equipment.
Rated Maximum
Output Power of
Transmitter
W
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 80 MHz and 800 MHz, 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.
CLINICAL STUDIES
The Orthofix AccelStim device has been designed to have technical features/device
output, patient populations, intended use and indications for use which are similar to
a previously approved product.
with regards to safety and performance. The following clinical data collected in support
of the US FDA approval
of the Orthofix AccelStim. Please note that the clinical studies leveraged to support the
safety and effectiveness of the AccelStim device may not necessarily be applicable to
patients of all races and ethnicities. Such demographic details were not provided in the
referenced clinical studies.
Treatment of Nonunion Fractures
Study Design
Three prospectively designed studies, undertaken in the USA, Germany, and the
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Separation Distance According to Frequency of Transmitter
m
150 kHz to 80 MHz
0,12
0,38
1,2
3,8
12
Therefore, the device is expected to perform similarly
21
for the prior product is therefore being presented in support
21
80 MHz to 800 MHz
0,12
0,38
1,2
3,8
12
800 MHz to 2,5 GHz
0,23
0,73
2,3
7,3
23