Fresenius Kabi Agilia SP, Техническое руководство

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23.4.5
EMC test deviations and suplementary tests
To ensure compatibility with the new EMC standard IEC / EN 60601-1-2 Ed4 and special
environments, specific, additional or deviating tests are listed below with respect to the
basic tests, in accordance to manufacturer risk analysis.
Immunity test
IEC 60601-1-2
IEC 60601-2-24
Test level
Compliance level
obtained
by the device
Electromagnetic
environment – guidance
Discharge (ESD)
IEC 61000-4-2
± 8 kV contact
± 15 kV air
± 8 kV contact
± 15 kV air
Wooden, tiled or concrete flooring, with a
relative humidity level at least 30%, makes it
possible to guarantee the level of necessary
conformity. If it is not possible to guarantee this
environment, the additional precautions must
be taken, such as: use of anti-static material,
preliminary user discharge and wearing anti-
static clothing.
Radiated RF - IEC
61000-4-3
10 V/m, 80 MHz à 2,7 GHz 10 V/m, 80 MHz à 2,7 GHz
Portable and mobile RF
communications equipment should be
used no closer to any part of the
Agilia pump
, including cables, than the
recommended separation distance
calculated from the equation
applicable to the frequency and power
of transmitter
For standard communication services
and equipment, the specific
frequencies were tested for a minimum
approach distance of 30 cm and 10 cm
(see below)
Near field radiated
RF
IEC 61000-4-3
test method
385 MHz, PM 18Hz, 27 V/m
450 Mhz, 1 KHz, 28 V/m
710 MHz, PM 217 Hz, 9 V/m
745 MHz, PM 217 Hz, 9 V/m
780 MHz, PM 217 Hz, 9 V/m
810 MHz, PM 18 Hz, 28 V/m
870 MHz, PM 18 Hz, 28 V/m
930 MHz, PM217 18 Hz, 28V/m
1720 MHz, PM 217 Hz, 28 V/m
1845 MHz, PM 217 Hz, 28 V/m
1970 MHz, PM 217 Hz, 28 V/m
2450 MHz, PM 217 Hz, 28 V/m
5240 MHz, PM 217 Hz, 9 V/m
5500 MHz, PM 217 Hz, 9 V/m
5785 MHz, PM 217 Hz, 9 V/m
Not tested
Not tested
Not tested
Not tested
Not tested
Not tested
Not tested
Not tested
Not tested
Not tested
Not tested
2450 MHz, PM 217 Hz, 28 V/m
5240 MHz, PM 217 Hz, 9 V/m
5500 MHz, PM 217 Hz, 9 V/m
5785 MHz, PM 217 Hz, 9 V/m
For minimal distance approach 30 cm
(12 inches)
"Not tested" frequencies are replaced
by IEC 61000-4-39 test method and
reduced minimal distance approach
(see below)
Portable and mobile RF
communications equipment should be
used no closer to any part of the
Agilia pump
, including cables, than the
recommended minimal separation
distance (30 cm) for these frequencies
Near field radiated
RF - special test
IEC 61000-4-39
test method
450 MHz, PM 217 Hz, 28 V/m
710 MHz, PM 217 Hz, 28 V/m
787 MHz, PM 217 Hz, 28 V/m
810 MHz, PM 217 Hz, 44 V/m
830 MHz, PM 217 Hz, 44 V/m
870 MHz, PM 217 Hz, 44 V/m
1750 MHz, PM 217 Hz, 28 V/m
1875 MHz, PM 217 Hz, 28 V/m
1970 MHz, PM 217 Hz, 28 V/m
2560 MHz, PM 217 Hz, 28 V/m
2655 MHz, PM 217 Hz, 28 V/m
450 MHz, PM 217 Hz, 28 V/m
710 MHz, PM 217 Hz, 28 V/m
787 MHz, PM 217 Hz, 28 V/m
810 MHz, PM 217 Hz, 44 V/m
830 MHz, PM 217 Hz, 44 V/m
870 MHz, PM 217 Hz, 44 V/m
1750 MHz, PM 217 Hz, 28 V/m
1875 MHz, PM 217 Hz, 28 V/m
1970 MHz, PM 217 Hz, 28 V/m
2560 MHz, PM 217 Hz, 28 V/m
2655 MHz, PM 217 Hz, 28 V/m
For minimal distance approach 10 cm
250 mW average power for 28 V/m
test level
600 mW average power for 44 V/m
test level
Portable and mobile RF
communications equipment should be
used no closer to any part of the
Agilia pump, including cables, than the
recommended minimal separation
distance (10 cm) for these frequencies