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Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System
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event. The Hyperglycemia Detection Rate is the % of time the blood
glucose level was at or above the alert setting and the device alarmed
within 15 minutes before or after the blood glucose was at or above the
alert settings. The Hyperglycemia Missed Detection Rate is the % of
time the blood glucose was at or above the alert setting, but the device
did not alarm within 15 minutes before or after the blood glucose was at
or above the alert setting.
For example, if you set your High Glucose alert to 200 mg/dL (11.1
mmol/L), how often will your alarm alert you if your blood glucose goes
at or above 200 mg/dL (11.1 mmol/L)? If your blood sugar goes above
200 mg/dL (11.1 mmol/L), you can expect your alarm to sound 97% of
the time and not to sound approximately 3% of time within the 15 minute
period before or after your blood sugar goes above 200 mg/dL (11.1
mmol/L).
Calibration Stability
The System must be calibrated every 12 hours. To demonstrate
performance of the System over a 12-hour calibration period, sensors
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 stratified by glucose concentrations by calculating the
percentage of System readings within 15 mg/dL (0.9 mmol/L) or 15%,
20 mg/dL (1.1 mmol/L) or 20%, 30 mg/dL (1.7 mmol/L) or 30%, 40 mg/dL
(2.2 mmol/L) or 40% and greater than 40 mg/dL (2.2 mmol/L) or 40% of
the YSI values in Table 7.
Summary of Contents for G4 Platinum Professional
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Page 36: ...Dexcom G4 PLATINUM Professional System User s Guide 35 3 chapter three RISKS AND BENEFITS...
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Page 104: ...Dexcom G4 PLATINUM Professional System User s Guide 103 9 chapter nine ALERTS ALARM PROFILES...
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Page 164: ...Dexcom G4 PLATINUM Professional System User s Guide 163 13 chapter thirteen TROUBLESHOOTING...
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Page 218: ...Dexcom G4 PLATINUM Professional System User s Guide 217 15 chapter fifteen USER ASSISTANCE...
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Page 222: ...Dexcom G4 PLATINUM Professional System User s Guide 221 16 chapter sixteen WARRANTY...
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Page 236: ...Dexcom G4 PLATINUM Professional System User s Guide 235 18 chapter eighteen APPENDIX...
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