Fresenius Medical Care 5008, Руководство по эксплуатации

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Chapter 11: System Description
Fresenius Medical Care 5008 OP 5/09.06 11-3
11.1.6 Guidance and Manufacturer's Declaration on EMC (IEC 60601-1-2:2001)
O
Electromagnetic emissions
O
Electromagnetic immunity
Guidance and manufacturer’s declaration – electromagnetic emissions
The 5008 hemodialysis system is intended for use in the electromagnetic environment specified below. The
customer or the user of the 5008 hemodialysis system should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment – guidance
RF emissions CISPR 11 Group 1 The 5008 hemodialysis system uses RF energy only for its
internal function. Therefore, its RF emissions are very low and
are not likely to cause any interference in nearby electronic
equipment.
RF emissions CISPR 11 Class B The 5008 hemodialysis system is suitable for use in all
establishments, including domestic establishments 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 Class A
Voltage fluctuations/ flicker
emissions IEC 61000-3-3 Complies
Guidance and manufacturer’s declaration – electromagnetic immunity
The 5008 hemodialysis system is intended for use in the electromagnetic environment specified below. The
customer or the user of the 5008 hemodialysis system 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 ±6 kV contact
±8 kV air 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
Not applicable Mains power quality should be that of a
typical commercial and/or hospital
environment.
Surge IEC 61000-4-5 ±1 kV differential
mode
±2 kV common mode
±1 kV differential
mode
±2 kV common mode Mains power quality should be that of a
typical commercial and/or hospital
environment.
Voltage dips, short
interruptions and
voltage variations on
power supply input
lines IEC 61000-4-11 <5 % U
T
(>95 % dip
in
U
T
) for 0.5 cycle
<5 % U
T
(>95 % dip
in
U
T
) for 0.5 cycle
After power supply interruptions, the 5008
hemodialysis system battery takes over
the supply without delay.
40 % U
T
(60 % dip in
U
T
) for 5 cycles
40 % U
T
(60 % dip in
U
T
) for 5 cycles
70 % U
T
(30 % dip in
U
T
) for 25 cycles
70 % U
T
(30 % dip in
U
T
) for 25 cycles
<5 % U
T
(>95 % dip
in
U
T
) for 5 sec
<5 % U
T
(>95 % dip
in
U
T
) for 5 sec