User's Manual

39
Electromagnetic Immunity
The autoinjector is intended for use in the electromagnetic
environment specified below. The user of this autoinjector
should ensure 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
±15 kV
Contact
±20 kV Air
Floors should be
wood, concrete
or ceramic tile.
If floors are
synthetic, the
relative humidity
should be at
least 30%.
Power
Frequency
50/60 Hz
Magnetic
Fields
IEC 61000-4-8
30 A/m 30 A/m at
60 Hz
Power frequency
magnetic fields
should be
that of typical
commercial
or hospital
environment.
RF
Electro-
magnetic
Field
IEC 61000-4-3
10 V/m
80 MHz –
2.5 GHz
(E1) = 10
V/m
26 MHz –
2.7 GHz
Portable and
mobile RF
communications
equipment
should be
separated from
the device
by no less than
the distances
of 30 cm.