Xavant STIMPOD MMS460 Manual page 6

Neuromodulation device
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Guidance and manufacturer's declaration – electromagnetic immunity
The STIMPOD NMS460 is intended for use in the electromagnetic environment specified below. The customer or the user of the STIMPOD NMS460 should assure that it is used in such an
environment.
Immunity test
IEC 60601 test level
Conducted RF
3V at 0.15 - 80MHz and 6V at ISM
IEC 61000-4-6
Frequency.
Home Healthcare: 3V at 0.15 - 80MHz, and
6V at ISM and Radio Amateur Frequency.
Radiated RF
3 V/m (10V/m Home Healthcare) at
IEC 61000-4-3
80 - 2,700MHz, AM Modulation. And
9-28V/m at 385-6000MHz, Pulse Mode and
other Modulation (upon Risk Analysis).
NOTE 1
At 80 MHz and 800 MHz, 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.
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
a
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 STIMPOD NMS460 is used exceeds the applicable RF compliance level above, the STIMPOD NMS460 should
be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the STIMPOD NMS460.
Compliance level
3V at 0.15 - 80MHz and 6V at ISM
Frequency.
Home Healthcare: 3V at 0.15 - 80MHz, and
6V at ISM and Radio Amateur Frequency.
3 V/m (10V/m Home Healthcare) at
80 - 2,700MHz, AM Modulation. And
9-28V/m at 385-6000MHz, Pulse Mode and
other Modulation (upon Risk Analysis).
v
Electromagnetic environment – guidance
Portable and mobile RF communications equipment should be used no
closer to any part of the STIMPOD NMS460, including cables, than the
recommended separation distance calculated from the equation applicable
to the frequency of the transmitter.
Recommended separation distance
d = 1,2
80 MHz to 800 MHz
d = 2,3
800 MHz to 2,5 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 metres (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.
Interference may occur in the vicinity of equipment marked with the
following symbol:

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