BIOMET EBI Bone Healing System, Physician Manual And Package Insert

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Portable and mobile RF communications
equipment should be used no closer
to any part of the Biomet
®
EBI Bone
Healing System, including cables, than
the recommended separation distance
calculated from the equation applicable
to the frequency of the transmitter.
Recommended Separation Distance
d = 3.5 √ P
d = 3.5 √ P 80 MHz to 800 MHz
d = 7 √ P 800 MHz to 2.5 GHz
Where P is the maximum power
output rating of the transmitter in
watts (W) according to the transmitter
manufacturer and d is the recommended
separation distance in meters (m).
Field strengths from fixed RF
transmitters, as determined by an
electromagnetic site survey,
a
should be
less than the compliance level in each
frequency range.
b
Interference may occur
in the vicinity of equipment marked with
the following symbol:
3 Vrms
3 V/m
80 MHz to 2.5 GHz
Conducted RF
IEC 61000-4-6
Radiated-4-6
IEC 61000-4-3 1 Vrms
1 V/m
Immunity Test IEC 60601 Test Level Compliance
Level
The Biomet
®
EBI Bone Healing System is intended for use in the electromagnetic environment
specified below. The customer or the user of the Biomet
®
EBI Bone Healing System should assure
that it is used in such an environment.
NOTE 1. At 80 MHz and 800 MHz, the higher frequency applies.
NOTE 2. These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects, and people.
a. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast
cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due
to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured
field strength in the location in which the Biomet
®
EBI Bone Healing System is used exceeds the
applicable RF compliance level, the Biomet
®
EBI Bone Healing System should be observed to verify
normal operation. If abnormal performance is observed, additional measures may be necessary,
such as reorienting or relocating the Biomet
®
EBI Bone Healing System.
b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 1 V/m.
Guidance and Manufactures Declaration – Electromagnetic Immunity
Table 3
Electromagnetic
Environment - Guidance
27