58 DePuy Synthes User Manual Small Battery Drive II
Table 3: Immunity (not life-supporting devices)
Guidance and manufacturer’s declaration – electromagnetic immunity
The Depuy Synthes Small Battery Drive II system is intended for use in the electromagnetic environment specified
below. The customer or user of the DePuy Synthes Small Battery Drive II system should ensure that it is used in
such an environment.
Warning:
Use of this equipment adjacent to or stacked with other equipment should be avoided because it
could result in improper operation. If such use is necessary, this equipment and the other equipment
should be observed to verify that they are operating normally.
Electromagnetic environment – guidance
Portable and mobile RF communications equipment should be used no closer to any part of the Depuy Synthes
Small Battery Drive II system, including cables, than the recommended separation distance calculated from the
equation applicable to the frequency of the transmitter.
Immunity test standard
IEC 60601 test level
Compliance level
Recommended
separation distance
a
Conducted RF
IEC 61000-4-6
3 Vrms
150 kHz to 80 MHz
Not applicable
d
= 0.35
P
150 kHz to 80 MHz
Radiated RF
IEC 61000-4-3
3 V/m
80 MHz to 800 MHz
E1 = 10 V/m
(measured 20 V/m)
80 MHz to 800 MHz
d
= 0.35
P
80 MHz to 800 MHz
Radiated RF
IEC 61000-4-3
3 V/m
800 MHz to 2.5 GHz
E2 = 10 V/m
(measured 20 V/m)
800 MHz to 2.7 GHz
d
= 0.7
P
800 MHz to 6.2 GHz
Where
P
is the maximum output power 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,
b
should be less than the compliance level in each frequency range.
c
Interference may occur in the vicinity of equipment marked with the following symbol:
Notes:
•
At 80 MHz and 800 MHz, the higher frequency range applies.
•
These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption
and reflection from structures, objects and people.
a Possible shorter distances of outside ISM bands are not considered to have a better applicability of this table.
b 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 Depuy Synthes Small Battery Drive II system is used
exceeds the applicable RF compliance level above, the Depuy Synthes Small Battery Drive II system should be observed to verify normal operation. If abnormal
performance is observed, additional measures may be necessary, such as reorienting or relocating the Depuy Synthes Small Battery Drive II system.
c Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 10 V/m.
Electromagnetic Compatibility
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