Manufacturer's Emc Declaration - Fresenius Medical Care 2008K Operator's Manual

Appendix B

Manufacturer's EMC Declaration

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
transient/burst supply lines
±1 kV for
IEC 61000-4-4 input/output lines
Surge ±1 kV line(s) to
line(s)
IEC 61000-4-5 ±2 kV line(s) to earth
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 U is the a.c. mains voltage prior to application of the test level.
T
198
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.
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 T
for 0.5 cycles
40 % U
T
) (60 % dip in U )
T T
for 5 cycles
70 % U
T
) (30 % dip in U )
T T
for 25 cycles
<5 % U
T
) (>95 % dip in U )
T T
for 5 seconds
3 A/m
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 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 magnetic fields should be at levels
characteristic of a typical location in a typical commercial or
hospital environment.
2008K Operator's Manual rev. K