User`s guide

180 | Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System
14
The Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring
System is safe for use on U.S. commercial airlines. The Dexcom G4
PLATINUM Transmitter is an M-PED with emission levels that meet
RTCA/DO160, Section 21, Category M. Per FAA Advisory, Circular
#91-21, 1B, dated 8/25/06, any M-PED that meets this standard in all
modes may be used onboard the aircraft without any further testing
by the operator. This device can withstand exposure to common
electrostatic (ESD) and electromagnetic interference (EMI).
Guidance and Manufacturer’s Declaration –
Electromagnetic Immunity
The transmitter (P/N 9438-01 and P/N 9438-05) is intended for use
intheelectromagneticenvironmentspeciedinthenexttable.The
customer or the user of the transmitter should ensure that it is used in
such an environment.
Transmitter Electromagnetic Immunity Specications
Immunity Test IEC 60601 Test
Level
Transmitter
Compliance Level
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 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
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