Dexcom G4 Professional User's Guide download pdf (Page 162)

162 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System

or less than the SMBG values and the Median Absolute Percent

DifferenceshowsthathalfofthetimetheSystemreadsabout11.0%or

less different than SMBG values (Table 12).

Adverse Events

No serious adverse events or device-related serious adverse events

occurred during the study. Mild skin irritation, such as erythema or

edema, occurred in low frequency around adhesive area. No infection,

bruising, or bleeding occurred at the sensor needle insertion area or the

adhesive area.

14.2 Product Specications

Sensor Product Specications

Glucose Range 40 - 400 mg/dL

Sensor Life Up to 7 days

Calibration Commercially available blood glucose meter

Calibration Range 40 - 400 mg/dL

Storage

Condition

Temperature: 36° F - 77° F

Humidity:15%-85%RH

Sterilization Sterile by radiation

Transmitter Product Specications

Part Number P/N 9438-01

Dimensions

(including

sensor pod)

Length: 1.5 inches

Width: 0.9 inches

Thickness: 0.5 inches

Weight (including

sensor pod)

0.4 ounces

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Dexcom G4 Professional User's Guide Page 162