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166 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System

your alarm to sound 98% of the time and not to sound approximately 2%

of time within the 15 minute period before or after your blood sugar goes

above 200 mg/dL.

Calibration Stability

The System must be calibrated every 12 hours. To demonstrate

performance of the System over a 12-hour calibration period, Systems

were evaluated to verify that performance remains consistent over

the 12-hour calibration period. Systems were evaluated in 2-hour

increments after calibration. Performance was estimated at each 2-hour

intervalandstratiedbyglucosevaluesbycalculatingthepercentageof

System readings within 15 mg/dL or 15%, 20 mg/dL or 20%, 30 mg/dL

or 30%, 40 mg/dL or 40% and greater than 40 mg/dL or 40% of the YSI

values in Table 7.

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Dexcom G4 Guía de usuario Pagina 168