Accu-Chek D-TRONplus, Справочное руководство

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Accu-Chek D-TRONplus insulin pump Reference Manual
165
Accu-Chek D-TRONplus insulin pump Reference Manual
164
Guidance and manufacturer’s declaration – electromagnetic emissions
Emissions test
RF emissions
CISPR 11
RF emissions
CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Compliance
Group 1
Class B
Not applicable
Not applicable
Electromagnetic environment – guidance
The Accu-Chek D-TRONplus uses RF energy only
for its internal function. Therefore, its RF emis-
sions are very low and are not likely to cause any
interference in nearby electronic equipment.
The Accu-Chek D-TRONplus is suitable for use in
all establishments, including domestic establish-
ments and those directly connected to the public
low-voltage power supply network that supplies
buildings used for domestic purposes.
–
–
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 enviroment.
Immunity
test
Electrostatic
discharge (ESD)
IEC 61000-4-2
Electrical fast
transient/burst
IEC 61000-4-4
Surges
IEC 61000-4-5
Voltage dips,
short inter-
ruptions and
voltage
variations on
power supply
input lines
IEC 61000-4-11
Power frequency
(50/60Hz)
magnetic field
IEC 61000-4-8
IEC 60601
test level
± 6 kV contact
± 8 kV air
± 2 kV for power
supply lines
± 1 kV for input/
output lines
± 1 kV
differential mode
± 2 kV
common mode
< 5% U
T
(> 95% dip in U
T
)
for 0,5 cycle
40% U
T
(60% dip
in U
T
) for 5 cycles
70% U
T
(30% dip
in U
T
) for 25 cycles
< 5% U
T
(> 95%
dip in U
T
) for 5 sec
3 A/m
Compliance
level
± 8 kV contact
± 15 kV air
(IEC 60601-2-24)
Not applicable
Not applicable
Not applicable
400 A/m
(IEC 60601-2-24)
Electromagnetic
environment – guidance
Avoid any contact with
synthetic materials. A relative
humidity of 10% will allow ESD
to be more likely.
Mains power quality should
be that of typical commercial
or hospital environment.
Mains power quality should
be that of typical commercial
or hospital environment.
Mains power quality should
be that of typical commercial
or hospital environment.
If the user of the Accu-Chek
D-TRONplus requires continued
operation during power mains
interruptions, it is recommen-
ded that the Accu-Chek
D-TRONplus be powered from
an uninterrupted power supply
or a battery.
Power frequency magnetic
fields should be at levels
characteristic of a typical
location in a typical commer-
cial or hospital environment.
Guidance and manufacturer’s declaration – electromagnetic immunity
Note: U
T
is the a.c. mains voltage prior to application of the test level.
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.