Dexcom G4 Platinum User Manual page 123

Guidance and Manufacturer's Declaration – Electromagnetic Immunity
The receiver is intended for use in the electromagnetic environment specified
below. The customer or the user of the receiver should ensure that it is used in
such an environment.
Immunity Test IEC 60601 Test
Level
Electrostatic ± 6 kV Contact
Discharge (ESD)
± 8 kV Air
IEC 61000-4-2
Electrical Fast
± 2 kV for power
Transient/burst supply lines
IEC 61000-4-4 ± 1 kV for
input/output lines
Surge ± 1 kV line(s) to
line(s)
IEC 61000-4-5
± 2 kV line(s) to
earth
Voltage < 5% U
Dips, Short
(>95% dip in U
Interruptions and 0.5 cycle
Voltage Variations
40% U
on Power Supply
(60% dip in U
Input Lines
for 5 cycles
IEC 61000-4-11
70% U
IEC 60601-1-11 (30% dip in U
for 25 cycles
85% U
(15% dip in U
for 5 sec
< 5% U
(>95% dip in U
5 sec
Power Frequency 3 A/m
(50/60 Hz)
Magnetic Field
IEC 61000-4-8
Note: U is the a.c. mains voltage prior to application of the test level.
T
Receiver
Compliance
Level
± 6 kV Contact
± 8 kV Air
± 2 kV for power
supply lines
Not applicable
± 1 kV line(s) to
line(s)
Not applicable
< 5% U
T T
) for (>95% dip in U
T
for 0.5 cycle
40% U
T T
) (60% dip in U
T
5 cycles
70% U
T T
) (30% dip in U
T
25 cycles
85% U
T T
) (15% dip in U
T
for 5 sec
< 5% U
T T
) for (>95% dip in U
T
for 5 sec
3 A/m
Dexcom G4 PLATINUM User's Guide
Electromagnetic
Environment Guidance
Floors should be wood, concrete
or ceramic tile. If floors are
covered with synthetic material,
the relative humidity should be
at least 30%.
Mains power quality should be
that of a typical commercial or
hospital environment.
Mains power quality should be
that of a typical commercial or
hospital environment.
Mains power quality should be
) that of a typical commercial or
T
hospital environment.
) for
T
) for
T
)
T
)
T
Power frequency magnetic fields
should be at levels characteristic
of a typical location in a
typical commercial or hospital
environment.
| 123