User's Manual

Guidance and Manufacturer's Declaration - Electromagnetic Immunity
The MiniMed 640G insulin pump is intended for use in the electromagnetic
environment specified below. The customer or the user of the MiniMed insulin
pump 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
±8 kV contact
±15 kV air
±30 kV air
(<5% relative
humidity)
For use in a typical
domestic, commercial,
or hospital
environment.
Electrical fast transient/
burst
±2 kV for power
supply lines
Not applicable Requirement does not
apply to this battery
powered device.
IEC 61000-4-4 ±1 kV for input/
output lines
Surge
IEC 61000-4-5
±1 kV line(s) to
line(s)
±2 kV line(s) to
earth
Not applicable Requirement does not
apply to this battery
powered device.
Voltage dips, short
interruptions and
voltage variations on
power supply lines
IEC 61000-4-11
<5% U
T
(>95% dip in U
T
) for 0.5 cycle
Not applicable Requirement does not
apply to this battery
powered device.
Power frequency
(50/60 Hz) magnetic
field
IEC 61000-4-8
400 A/m
(continuous
field at 60
seconds)
4000 A/m (short
duration at 3
seconds)
400 A/m
4000 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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product specifications and safety information
Product specifications and safety information 263
MP6025958-022 / A
RELEASED