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™
CONTINUOUS GLUCOSE MONITORING SYSTEM
Guidance and Manufacturer’s Declaration- Electromagnetic Immunity
e Receiver is intended for use in the electromagnetic environment specified below. e
customer or the user of the Receiver should assure that it is used in such an environment.
Immunity Test
IEC 60601
Test Level
Seven Receiver Compliance
Level
Electromagnetic
Environment Guidance
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
± 1 kV for input/output lines
Mains power quality should be
that of a typical 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 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% 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
< 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
Main power quality should be
that of a typical commercial or
hospital environmental.
Power Frequency
(50/60 Hz)
Magnetic Field
IEC 61000-4-8
3 A/m 3 A/m
Power Frequency magnetic fields
should be at levels characteristic
of a typical location in a
typical commercial of hospital
environment
Note: UT is the a.c. mains voltage prior to application of the test level