Manufacturer's Electromagnetic Compatibility (Emc) Declaration - Fresenius Medical Care 2008K Operator's Manual

Machine Specifications

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
RF Emissions Group 1
CISPR 11
RF Emissions Class A
CISPR 11
Harmonic Not
emissions applicable
IEC 61000-3-2
Voltage Not
fluctuations/ applicable
flicker emissions
IEC 61000-3-3
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
Electrostatic ±8 kV contact
discharge (ESD) ±15 kV air
(Level 4)
IEC 61000-4-2
Electrical fast ±2 kV for power supply lines
transient/burst ±1 kV for input/output lines
IEC 61000-4-4
Surge ±1 kV line(s) to line(s)
±2 kV line(s) to earth
IEC 61000-4-5
Voltage Dips, <5 % U
T
short (>95 % dip in U
interruptions, and for 0.5 cycles
voltage variation
on power supply 40 % U
T
input lines (60 % dip in U
IEC 61000-4-11 for 5 cycles
70 % U
T
(30 % dip in U
for 25 cycles
<5 % U
T
(>95 % dip in U
for 5 seconds
Power-Frequency 3 A/m
(50/60 Hz)
magnetic field
IEC 61000-4-8
NOTE is the a.c. mains voltage prior to application of the test level.
U
T
224
Electromagnetic environment – guidance
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.
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.
Compliance level
±8 kV contact
±15 kV air
(Level 4)
±2 kV for power supply lines
±1 kV for input/output lines
±1 kV line(s) to line(s)
±2 kV line(s) to earth
<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
3 A/m
2008K Hemodialysis Machine Operator's Manual Rev P
Electromagnetic environment – guidance
Can be used in a dry location
(minimum 10% relative humidity)
Mains power quality should be that of a typical
commercial and/or hospital environment.
Mains power quality should be that of a typical
commercial or hospital environment.
Mains power quality should be that of a typical
)
commercial or hospital environment. If the
T
user of the 2008K hemodialysis machine
requires continued operation during power
mains interruptions, it is recommended that
)
the 2008K hemodialysis machine be powered
T
from an uninterruptible power supply or a
battery.
)
T
)
T
Power frequency magnetic fields should be at
levels characteristic of a typical location in a
typical commercial or hospital environment.