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P/N 490206 Rev E
2008T Hemodialysis Machine with CLiC Device User’s Guide
Manufacturer’s Electromagnetic Compatibility (EMC) Declaration
Medical electrical equipment needs special precautions regarding electromagnetic
compatibility (EMC) and needs to be installed and put into service according to the EMC
information provided herein.
Guidance and manufacturer’s declaration – electromagnetic emissions
The 2008T hemodialysis machine is intended for use in the electromagnetic environment specified below. The
customer or user of the 2008T hemodialysis machine should ensure it is used in such an environment.
Emissions test
Compliance Electromagnetic environment – guidance
RF Emissions
CISPR 11
Group 1
The 2008T 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 2008T 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.
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 2008T hemodialysis machine is intended for use in the electromagnetic environment specified below. The
customer or the user of the 2008T 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
±6 kV contact
±8 kV air
(Level 3)
±6 kV contact
±8 kV air
(Level 3)
Floors should be wood, concrete, or
ceramic tile. If floors are covered with
synthetic material, the relative humidity
should be at least 30%.
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 2008T
hemodialysis machine requires
continued operation during power
mains interruptions, it is recommended
that the 2008T 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.
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