Dr. Langer Medical TWISTER, Инструкция по эксплуатации

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TWISTER
®
Softwareversion 1.19 Page 39 of 46 Version 1.19-4 / 2010-05-31
Guidance and manufacturer's declaration - electromagnetic immunity
The nerve stimulator TWISTER
®
is intended for use in the electromagnetic environment specified
below. The customer or the user of the nerve stimulator TWISTER
®
should assure that it is used in such an
environment.
Immunity-
test
IEC 60601 –
test level
Compliance-
level
electromagnetic environment - Guidance
Portable and mobile RF Communications
equipment should be used no closer to any
part of the nerve stimulator TWISTER
®
,
including cables, than the recommended
separation distance calculated from the
equation applicable to the frequency of the
transmitter.
Recommended separation distance
Conducted RF
IEC 61000-4-6 3 Vrms
150 kHz to 80
MHz 3 Vrms
d=1,2
√
P
Radiated RF
IEC 61000-4-3 3 V/m
80 MHz to 2,5
GHz 3 V/m
d=1,2
√
P 80 MHz to 800 MHz
d=1,2
√
P 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 then the
compliance level in each frequency range.
b
Interference may occur in the vicinity of
equipment marked with the following
symbol:
NOTE 1 At 80 MHz and 800 MHz, tha 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.
a
Field strength from fixed transmitter, 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 m which the nerve stimulator
TWISTER
®
is used exceeds the applicable RF compliance level above, the nerve stimulator TWISTER
®
should
be observed to verify normal operation. If abnormal performance is observed, additional measures may be
necessary, such as reorienting or relocating the nerve stimulator TWISTER
®
.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.