Smiths Medical Medfusion 3500, Operator'S Manual

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Medfusion® Model 3500 pump V6 Operator’s Manual
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
The Medfusion® Syringe Pump Model 3500 V6 is intended for use in the electromagnetic environment specified below.
The customer or the user of the Medfusion® Syringe Pump Model 3500 V6 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
±8 kV contact
±15 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
Mains power quality should be that
of a typical commercial or hospital
environment.
Voltage dips, short
interruptions and
voltage variations on
power supply input lines
IEC 61000-4-11
<5 % Uт
(>95 % dip in Uт)
for 0.5 cycle
40 % Uт
(60 % dip in Uт)
for 5 cycles
70 % Uт
(30 % dip in Uт)
for 25 cycles
<5 % Uт
(>95 % dip in Uт)
for 5 sec
<5 % Uт
(>95 % dip in Uт)
for 0.5 cycle
40 % Uт
(60 % dip in Uт)
for 5 cycles
70 % Uт
(30 % dip in Uт)
for 25 cycles
<5 % Uт
(>95 % dip in Uт)
for 5 sec
Mains power quality should be that
of a typical commercial or hospital
environment. If the user of the
Medfusion
®
Syringe Pump Model
3500 V6 requires continued operation
during power mains interruptions, it
is recommended that the Medfusion
®
Syringe Pump Model 3500 V6 be
powered from an uninterruptible power
supply or a battery.
Power frequency
(50/60 Hz)
Magnetic field
IEC 61000-4-8
3 A/m 400 A/m and
3 A/m Power frequency magnetic fields should
be at levels characteristic of a typical
location in a typical commercial or
hospital environment.
Note: Ut is the AC mains voltage prior to application of the test level.