User's Manual

101
Overall, the System in the Advanced study reads, on average, 2.6% lower (Mean Percent Difference) than
SMBG values and 11.3% absolute different (Mean Absolute Percent Difference) than the SMBG values.
The Median Percent Difference shows that half of the time the System reads lower in 2.7% or less than the
SMBG values and the Median Absolute Percent Difference shows that half of the time the System reads
about 8.6% or less different than SMBG values.
Adverse Events
No serious adverse events or device-related serious adverse events occurred during either study. Mild or
very slight skin irritation, such as erythema or edema, occurred in low frequency around the adhesive area.
No infection, bruising, or bleeding occurred at the sensor needle insertion area or the adhesive area.
14.2 PRODUCT SPECIFICATIONS
Sensor Product Specifications
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 Specifications
Part Number
9438-01 9438-05
Dimensions (including
sensor pod)
Length: 1.5 inches
Width: 0.9 inches
Thickness: 0.5 inches
Length: 1.5 inches
Width: 0.9 inches
Thickness: 0.4 inches
Weight (including sensor
pod)
0.4 ounces 0.3 ounces
Power Supply
Silver oxide batteries (not replaceable)
Operational Conditions
Temperature: 50° F - 108° F
Humidity: 10% - 95% RH
Storage Conditions
Temperature: 32° F - 113° F
Humidity: 10% - 95% RH
Operating Altitude
-500 to 12000 feet
Limited Warranty
6 months