User's Manual

148 | Continuous Glucose Monitoring System
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
The Transmitter is intended for use in the electromagnetic environment specifi ed
below. The customer or the user of the Transmitter should assure that it is used
in such an environment
Immunity Test IEC 60601 Test Level 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 fl oors 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 fi elds
should be at levels
characteristic of a
typical location in a
typical commercial or
hospital environment
11