Synthes Battery Power Line II Instructions For Use Manual page 83

Table 4: Immunity (not life-supporting devices)
Guidance and manufacturer's declaration –
electromagnetic immunity
The BPL II System is intended for use in the electromag-
netic environment specified below. The customer or the
user of the BPL II System should assure that it is used in
such an environment.
Precaution: Use of this equipment adjacent to or
stacked with other equipment should be avoided be-
cause it could result in improper operation.
Electromagnetic environment – guidance
Portable and mobile RF communications equipment
should be used no closer to any part of the BPL II Sys-
tem, including cables, than the recommended separation
distance calculated from the equation applicable to the
frequency of the transmitter.
Immunity test standard
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
Radiated RF
IEC 61000-4-3
IEC 60601 test level
3 Vrms
150 kHz to 80 MHz
3 V/m
80 MHz to 800 MHz
3 V/m
800 MHz to 2.5 GHz
Compliance level
Not applicable
E110 V/m
80 MHz to 800 MHz
E210 V/m
800 MHz to 2.7 GHz
Battery Power Line II Surgical Technique DePuy Synthes
Recommended
separation distance
c
√P
d0.35
150 kHz to 80 MHz
√P
d0.35
80 MHz to 800 MHz
√P
d0.7
800 MHz to 6.2 GHz
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