Medisafe SI PCF - 6-4 Electromagnetic Immunity

Appendices SI PCF User Manual
Ref: DOC03148 Issue 1 Friday, 06 January 2017 Page 74 of 81
Electromagnetic Immunity
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
The SI PCF is intended for use in the electromagnetic environment specified below. The customer or the
user of the SI PCF 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
Input / output line tests
are not applicable.
Mains power quality should be
that of a typical commercial or
hospital environment.
Surge
IEC 61000-4-5
± 1 kV line(s) to line(s)
± 2 kV line(s) to earth
± 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% 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 s
Not Applicable
(Rated input current
>16A per phase)
Not Applicable
(Rated input current
>16A per phase)
Not Applicable
(Rated input current
>16A per phase)
<5% U
T
(>95 % dip in U
T
) For 5 s
Mains power quality should be
that of a typical commercial or
hospital environment. If the
user of the SI PCF requires
continued operation during
power mains interruptions; it is
recommended that the SI PCF
be powered from an
uninterruptable power supply or
a battery.
Power frequency
(50/60Hz) Magnetic
field
IEC 61000-4-8
3 A/m 3 A/m (50Hz only)
If incorrect operation occurs, it
may be necessary to position
the SI PCF further from sources
of power frequency magnetic
fields or to install magnetic
shielding. The power frequency
magnetic field should be
measured in the intended
installation location to assure
that it is sufficiently low.
Note: UT is the A.C. mains voltage prior to application of the test level.