130 | SEVEN
™
CONTINUOUS GLUCOSE MONITORING SYSTEM
Guidance and Manufacturer’s Declaration- Electromagnetic Immunity
e Transmitter is intended for use in the electromagnetic environment specified below.
e customer or the user of the Transmitter should assure that it is used in such an
environment.
Immunity Test
IEC 60601
Test Level
Seven Transmitter
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
Not Applicable-
Battery Operated
Surge
IEC 61000-4-5
± 1 kV differential mode
± 2 kV common mode
Not Applicable-
Battery Operated
Voltage Dips, Short
Interruptions and Voltage
Variations on Power
Supply Input Lines
IEC 61000-4-11
< 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
Not Applicable-
Battery Operated
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: U
T
is the a.c. mains voltage prior to application of the test level
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