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The Bigfoot Unity
™
Diabetes Management System User Guide | Appendix C
Guidance and Manufacturer’s Declaration –
Electromagnetic Immunity
Bigfoot Unity is intended for use in the electromagnetic environment
specified below. The customer or the user should assure that Bigfoot
Unity 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
±
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 input/
output lines
±
2 kV for
power supply
lines
±
1 kV input/
output lines
Mains power quality should be that of a
typical domestic, 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 domestic, 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
cycles
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
cycles
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 domestic, commercial, or hospital
environment. If the user of Bigfoot Unity
requires continued operation during power
mains interruptions, it is recommended
that Bigfoot Unity be powered from an
uninterruptible power supply or battery.
Power frequency
(50/60 Hz) magnetic
field
IEC 61000-4-8
30 A/m
30 A/m
Power frequency magnetic fields should be
at levels characteristic of a typical domestic,
commercial, or hospital environment.
Conducted RF
IEC 61000-4-6
6 Vrms
150 kHz to
80 MHz
6 Vrms
Portable and mobile RF communications
equipment should be used no closer to
any part of Bigfoot Unity, including cables,
than the recommended separation distance
calculated from the equation applicable to
the frequency of the transmitter.
Recommended separation distance
d=1.2
√
P
Radiated RF
IEC 61000-4-3
10 V/m
80 MHz to
2.7 GHz
10 V/m
Recommended separation distance
d=1.2
√
P
80 MHz to 800 MHz
d=2.3
√
P
800 MHz to 2.5 GHz
