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18 Appendix B: Specifications
(con’t)
Stability of Sensor Calibration
FreeStyle Navigator system typically requires a calibration at 10, 12, 24 and 72 hours after insertion of
the sensor. This section presents information about the performance of the system by the 4 calibration
periods. The table (Table 6d) breaks each calibration period into smaller slots and summarizes the
difference from YSI in each slot. The data below demonstrates that there is little change in the system
performance within each period.
Table 6d.
Distribution of the difference from the YSI in the different calibration windows
Calibration Period
Percent Readings
Within 20%* of
the YSI
Percent Readings
Within 30%* of
the YSI
Percent Readings
Within 40%* of
the YSI
Cal 1
(typically occurs 10 hrs
after sensor insertion)
First Calibration Period
80
88
94
Cal 2
(typically occurs 12 hours
after sensor insertion)
First Third of Second
Calibration Period
83
94
98
Second Third of Second
Calibration Period
83
94
98
Final Third of Second
Calibration Period
84
95
98
Cal 3
(typically occurs 24 hours
after sensor insertion)
First Third of Third
Calibration Period
84
94
98
Second Third of Third
Calibration Period
80
92
97
Final Third of Third
Calibration Period
80
91
95
Cal 4
(typically occurs 72 hours
after sensor insertion)
First Quarter of Final
Calibration Period
86
93
96
Second Quarter of Final
Calibration Period
84
92
96
Third Quarter of Final
Calibration Period
80
93
98
Final Quarter of Final
Calibration Period
82
93
97
* The absolute difference from the YSI reading is measured in mg/dL if the YSI reading is at or below
75 mg/dL.
Sample Glucose Traces
The following figures show examples of glucose traces from the In-Clinic study. These traces are
representative examples of excellent, average and poor performance of the system. These traces show
an overlay of the continuous glucose readings from the FreeStyle Navigator system and the blood
glucose measurements made using the laboratory YSI reference. The blood glucose measurements that
were used to calibrate the system are marked with ‘x’ in the traces. Glucose results from the FreeStyle
Navigator system are shown using circles and the glucose results from the laboratory reference (YSI)
are shown using triangles. Time (hours since sensor insertion) is on the horizontal axis, and glucose
value in mg/dL is on the vertical axis.
Customer Care: 1-866-597-5520
158
Section 18
Appendix B: Specifications
Содержание FreeStyle Navigator
Страница 1: ...User s Guide CAUTION Federal law restricts this device to sale by or on the order of a physician ...
Страница 2: ......
Страница 4: ......
Страница 8: ......
Страница 9: ...1 Getting Acquainted ...
Страница 23: ...2 Install or Replace Transmitter and Receiver Batteries ...
Страница 29: ...3 Set the Time and Date ...
Страница 34: ...Customer Care 1 866 597 5520 ...
Страница 35: ...4 Perform a Control Solution Test ...
Страница 42: ...Customer Care 1 866 597 5520 ...
Страница 43: ...5 Insert or Remove Your Sensor ...
Страница 54: ...Customer Care 1 866 597 5520 ...
Страница 55: ...6 Attach Your Transmitter ...
Страница 61: ...7 Calibrate Your System Test Blood Glucose Manually ...
Страница 74: ...Customer Care 1 866 597 5520 ...
Страница 75: ...8 Set Review or Change the Alarm Settings ...
Страница 89: ...9 Daily Use ...
Страница 96: ...Customer Care 1 866 597 5520 ...
Страница 97: ...10 Respond to Alarms Errors and Problems ...
Страница 119: ...11 Add Events ...
Страница 125: ...12 Review Reports and Edit Events ...
Страница 135: ...13 Clean Your System ...
Страница 136: ...Section 13 Key Terms n Receiver n Transmitter n Contact Points Customer Care 1 866 597 5520 ...
Страница 139: ...14 Link and Unlink Your Transmitter and Receiver ...
Страница 140: ...Section 14 Key Terms n BG Mode n CM Mode n Link Unlink n Receiver n Transmitter Customer Care 1 866 597 5520 ...
Страница 144: ...Customer Care 1 866 597 5520 ...
Страница 145: ...15 Reset User Settings ...
Страница 146: ...Customer Care 1 866 597 5520 ...
Страница 149: ...16 Change Country Settings ...
Страница 155: ...17 Appendix A Site Maintenance ...
Страница 158: ...Customer Care 1 866 597 5520 ...
Страница 159: ...18 Appendix B Specifications ...
Страница 173: ...19 Appendix C FCC Compliance Information ...
Страница 174: ...Customer Care 1 866 597 5520 164 Section 18 Appendix B Specifications ...
Страница 182: ...Customer Care 1 866 597 5520 ...
Страница 183: ...20 Glossary ...
Страница 184: ...Customer Care 1 866 597 5520 174 Section 19 Appendix C Classification Compliance Declaration ...
Страница 191: ...21 Index ...
Страница 192: ...Customer Care 1 866 597 5520 ...
Страница 195: ......