M.D. Resource K Pump - Electromagnetic Immunity; Electrostatic Discharge (ESD) Immunity; Electrical Fast Transient;Burst Immunity; Surge Immunity

198-003 K Pump IFU Rev D 19
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
The K Pump is intended for use in the electromagnetic environment specified below. The
customer or the user of the K Pump should assure that it is used in such an environment. Use of
accessories, transducers, power cords, and cables other than those sold by Medical Device
Resource Company may result in system failure, increased EMC emissions, and/or decreased
EMC immunity of the K Pump. If used adjacent to, or stacked with other equipment; all such
equipment should be closely monitored to ensure normal operation.
Immunity test
IEC 60601
test level
Compliance
level
Electromagnetic Immunity
Guidance
Electrostatic
Discharge
(ESD)
IEC61000-4-2
+ 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
+ 1 kV for
input/output lines
Mains power quality should be that of
a typical commercial or hospital
environment.
Surge
IEC 61000-4-5
+ 1 kV
differential mode
+ 2 kV common
mode
+ 1 kV
differential mode
+ 2 kV common
mode
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
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
cycle
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
KPump requires continued operation
during power mains interruptions, it is
recommended that the KPump be
powered from an uninterruptible
power supply (UPS).
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.
Not applicable – KPumps are not Life-Supporting / KPumps not affected by EMI in range from
150 kHz to 80 MHz or 80 MHz to 2.8 GHz
Note: U
T
is the a.c. mains voltage prior to application of the test level