Fresenius Medical Care DIASAFE 2008 K, Руководство оператора

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Machine Specifications
224 2008K Hemodialysis Machine Operator’s Manual Rev P
Manufacturer’s Electromagnetic Compatibility (EMC) Declaration
The 2008K hemodialysis machine complies with standard ANSI/AAMI/IEC 60601-1-2:2007 with the
following exception:

A portion of the radiated emissions limits for CISPR 11 Group 1, Class A were exceeded, therefore, there is
potential for interference with antenna based broadcast receivers such as televisions and radios in the range
of 50MHz – 120MHz. Though the use of such non-medical equipment in an institutional environment is
unlikely, should such interference occur, it will not permanently affect those receivers and can be reduced
or eliminated by repositioning of the receiver or of the 2008K hemodialysis machine.
Guidance and manufacturer’s declaration – electromagnetic emissions
The 2008K hemodialysis machine is intended for use in the electromagnetic environment specified below. The customer or user of
the 2008K hemodialysis machine should ensure it is used in such an environment.
Emissions test Compliance Electromagnetic environment – guidance
RF Emissions
CISPR 11 Group 1
The 2008K hemodialysis machine uses RF energy only for its internal functions. Therefore, its
RF emissions are very low and are not likely to cause any interference in nearby electronic
equipment.
RF Emissions
CISPR 11 Class A The 2008K hemodialysis machine is suitable for use in all establishments other than domestic,
and those directly connected to the public low-voltage power supply network that supplies
buildings used for domestic purposes.
The 2008K may cause interference with some types of broadcast receivers such as antenna
based televisions or radios. Although unlikely to be present in the use environment of the
2008K hemodialysis machine, this interference is not harmful to such equipment and is only
temporary. Should such interference occur, it can sometimes be reduced or eliminated by minor
repositioning of the receiver or of the 2008K hemodialysis machine.
Harmonic
emissions
IEC 61000-3-2 Not
applicable
Voltage
fluctuations/
flicker emissions
IEC 61000-3-3 Not
applicable
Guidance and manufacturer’s declaration – electromagnetic immunity
The 2008K hemodialysis machine is intended for use in the electromagnetic environment specified below. The customer or the user
of the 2008K hemodialysis machine should assure that it is used in such an environment.
Immunity test IEC 60601 test level Compliance level Electromagnetic environment – guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
±8 kV contact
±15 kV air
(Level 4) ±8 kV contact
±15 kV air
(Level 4) Can be used in a dry location
(minimum 10% relative humidity)
Electrical fast
transient/burst
IEC 61000-4-4
±2 kV for power supply lines
±1 kV for input/output lines ±2 kV for power supply lines
±1 kV for input/output lines Mains power quality should be that of a typical
commercial and/or hospital environment.
Surge
IEC 61000-4-5
±1 kV line(s) to line(s)
±2 kV line(s) to earth ±1 kV line(s) to line(s)
±2 kV line(s) to earth Mains power quality should be that of a typical
commercial or hospital environment.
Voltage Dips,
short
interruptions, and
voltage variation
on power supply
input lines
IEC 61000-4-11 <5 %
U
T
(>95 % dip in
U
T
)
for 0.5 cycles
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 seconds
<5 %
U
T
(>95 % dip in
U
T
)
for 0.5 cycles
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 seconds
Mains power quality should be that of a typical
commercial or hospital environment. If the
user of the 2008K hemodialysis machine
requires continued operation during power
mains interruptions, it is recommended that
the 2008K hemodialysis machine be powered
from an uninterruptible power supply or a
battery.
Power-Frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8 3 A/m 3 A/m
Power frequency magnetic fields should be at
levels characteristic of a typical location in a
typical commercial or hospital environment.
NOTE
U
T
is the a.c. mains voltage prior to application of the test level.