Accu-Chek D-TRONplus insulin pump Reference Manual
167
Accu-Chek D-TRONplus insulin pump Reference Manual
166
The Accu-Chek D-TRONplus is intended for use in the electromagnetic environment spe-
cified below. The customer or the user of the Accu-Chek D-TRONplus should assure that
it is used in such an environment.
Immunity
test
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
IEC 60601
test level
3 Vrms
150 kHz to
80 MHz
3 V/m
80 MHz to
2.5 GHz
Compliance
level
Not
applicable
10 V/m
80 MHz to
2.5 GHz
(IEC
60601-2-24)
Electromagnetic
environment – guidance
no galvanic coupled ports
Portable and mobile RF communications
equipment should be used no closer to any
part of the Accu-Chek D-TRONplus, including
cables, than the recommended separation
distance calculated from the equation appli-
cable to the frequency of the transmitter.
Recommended separation distance:
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
a
, should be less than the compliance
level in each frequency range
b
.
Interface may occur in the vicinity of equip-
ment marked with the following symbol:
Guidance and manufacturer’s declaration – electromagnetic immunity
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.
d =
P
3.5
E1
d =
P
7
E1
80 MHz to 800 MHz
800 MHz to 2.5 GHz
a Field strengths from fixed transmitters, such as base stations for radio (cellular/cord-
less) telephones and land mobile radios, amateur radio, AM an FM radio broadcast and
TV broadcast cannot be predicted theoretically with accuracy. To asses the electromag-
netic environment due to fixed RF transmitters, an electromagnetic site survey should
be considered. If the measured field strength in the location in which the Accu-Chek
D-TRONplus is used exceeds the applicable RF compliance level above, the Accu-Chek
D-TRONplus should be observed to verify normal operation. If abnormal performance
is observed, additional measures may be necessary, such as reorienting or relocating
the Accu-Chek D-TRONplus.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than
10 V/m.
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