Dexcom SEVEN User Manual page 136

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 assure that it is used in such an environment.
Immunity Test
Electromagnetic
Environment
Guidance ± 6 kV Contact
Electrostatic ± 8 kV Air
Discharge (ESD)
IEC 61000-4-2
Electrical Fast
± 2 kV for power supply lines
Transient /burst
± 1 kV for input/output lines
IEC 61000-4-4
Surge ± 1 kV differential mode
IEC 61000-4-5 ± 2 kV common mode
< 5% U
Voltage
Dips, Short 40% UT (60% dip in UT) for
Interruptions and
Voltage Variations 70% UT (30% dip in UT) for
on Power Supply
< 5% UT (>95% dip in UT)
Input Lines
IEC 61000-4-11
Power Frequency
(50/60 Hz)
3 A/m
Magnetic Field
IEC 61000-4-8
Note: UT is the a.c. mains voltage prior to application of the test level
132 | SEVEN CONTINUOUS GLUCOSE MONITORING SYSTEM
™
IEC 60601
Test Level
(>95% dip in U ) for
T T
0.5 cycle
5 cycles
25 cycles
for 5 sec
Seven Receiver Compliance
Level
± 6 kV Contact
± 8 kV Air
± 2 kV for power supply lines
± 1 kV for input/output lines
± 1 kV differential mode
± 2 kV common mode
< 5% UT (>95% dip in UT) for
0.5 cycle
40% UT (60% dip in UT) for
5 cycles
70% UT (30% dip in UT) for
25 cycles
< 5% UT (>95% dip in UT)
for 5 sec
3 A/m
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.
Main power quality should be
that of a typical commercial or
hospital environmental.
Power Frequency magnetic fields
should be at levels characteristic
of a typical location in a
typical commercial of hospital
environment