18 Appendix B: Specifications
(con’t)
Determination of Alarm Performance
The
threshold alarm is characterized below. The projected alarm performance has not been established.
The performance of low and high glucose alarms was assessed in an in-clinic study using 58 subjects with
type 1 diabetes wearing one FreeStyle Navigator sensor on the arm and one sensor on the abdomen. FreeStyle
Navigator continuous data were masked from the subjects and investigators and the alarms were not turned
on. During 50 hours the subjects’ venous glucose was tested with a YSI 2300 Stat Plus glucose analyzer at 15
minute intervals. Arm and abdomen data were pooled in the alarm analysis. Alarm performance was evaluated
in a retrospective analysis of the study data. As alarm performance was developed retrospectively, your results
may vary from those reported below.
Definitions:
Hypoglycemic event – two or more successive YSI measurements below the alarm threshold or one YSI
measurement 6 mg/dL below the alarm threshold.
Hyperglycemic event – two or more successive YSI measurements above the alarm threshold or one YSI
measurement 6% above the alarm threshold.
True Threshold Alarm – a threshold alarm that occurred ± 30 minutes from the start of a hypoglycemic or
hyperglycemic event
True Alarm Rate – the percentage of time the glucose level was beyond the threshold and an alarm was
activated
Events Detected by True Threshold Alarms
Total Events
X 100
Missed Alarm Rate – the percentage of time the glucose level was beyond the threshold and an alarm was not
activated
Events Not Detected by True Threshold Alarms
Total Events
X 100
False Threshold Alarm – a threshold alarm that occurred when a YSI measurement within ± 30 minutes was
not beyond the threshold setting
False Alarm Rate – the percentage of time an alarm occurred when glucose level was not beyond the threshold
setting
False Threshold Alarms
Total Threshold Alarms X 100
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160
Section 18
Appendix B: Specifications
Summary of Contents for FreeStyle Navigator
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Page 8: ......
Page 9: ...1 Getting Acquainted ...
Page 23: ...2 Install or Replace Transmitter and Receiver Batteries ...
Page 29: ...3 Set the Time and Date ...
Page 34: ...Customer Care 1 866 597 5520 ...
Page 35: ...4 Perform a Control Solution Test ...
Page 42: ...Customer Care 1 866 597 5520 ...
Page 43: ...5 Insert or Remove Your Sensor ...
Page 54: ...Customer Care 1 866 597 5520 ...
Page 55: ...6 Attach Your Transmitter ...
Page 61: ...7 Calibrate Your System Test Blood Glucose Manually ...
Page 74: ...Customer Care 1 866 597 5520 ...
Page 75: ...8 Set Review or Change the Alarm Settings ...
Page 89: ...9 Daily Use ...
Page 96: ...Customer Care 1 866 597 5520 ...
Page 97: ...10 Respond to Alarms Errors and Problems ...
Page 119: ...11 Add Events ...
Page 125: ...12 Review Reports and Edit Events ...
Page 135: ...13 Clean Your System ...
Page 136: ...Section 13 Key Terms n Receiver n Transmitter n Contact Points Customer Care 1 866 597 5520 ...
Page 139: ...14 Link and Unlink Your Transmitter and Receiver ...
Page 144: ...Customer Care 1 866 597 5520 ...
Page 145: ...15 Reset User Settings ...
Page 146: ...Customer Care 1 866 597 5520 ...
Page 149: ...16 Change Country Settings ...
Page 155: ...17 Appendix A Site Maintenance ...
Page 158: ...Customer Care 1 866 597 5520 ...
Page 159: ...18 Appendix B Specifications ...
Page 173: ...19 Appendix C FCC Compliance Information ...
Page 174: ...Customer Care 1 866 597 5520 164 Section 18 Appendix B Specifications ...
Page 182: ...Customer Care 1 866 597 5520 ...
Page 183: ...20 Glossary ...
Page 184: ...Customer Care 1 866 597 5520 174 Section 19 Appendix C Classification Compliance Declaration ...
Page 191: ...21 Index ...
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