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18 Appendix B: Specifications
(con’t)
Accuracy
Table 1
below shows the distribution of all the data from the In-Clinic study on the Clarke Error Grid. Accuracy
was assessed by comparing the differences between the FreeStyle Navigator system and the YSI laboratory reference.
The Clarke Error Grid Analysis evaluates the clinical relevance of the differences by dividing a correlation plot
(Figure 1) into five zones as described in Table 1. The YSI results and the corresponding glucose results from the
FreeStyle Navigator system together (called a ‘data pair’ or ‘matched data points’) determine what zone of the error
grid the results fall into. Table 1 also shows that glucose data measured by FreeStyle Navigator system on the arm
and on the abdomen have similar distribution on the error grid. This demonstrates that there is no difference in the
performance of the system when worn on the abdomen or on the back of the upper arm.
Table 1.
Clarke Error Grid Analysis. Continuous glucose results from FreeStyle Navigator System (mg/dL)
vs. the YSI (mg/dL)
Zone in the Clarke
Error Grid
N (pairs of data)
Percentage in the
different zones (%)
Sensor Insertion Site
Abdomen %
Arm %
A
16627
81.7
81.5
81.8
B
3398
16.7
16.8
16.6
C
19
0.1
0.1
0.1
D
316
1.6
1.6
1.5
E
2
0.0
0.0
0.0
Total
20362
There is no difference between the performance of the
system on the arm and the performance of the system on
the abdomen.
Error Grid Explanation
A
– Clinically accurate; would lead to correct and safe treatment
B
– Benign; would lead to benign decisions or no treatment decisions
C
– Overcorrection; would lead to over-correction of normal glucose levels
D
– Failure to detect; would lead to failure to detect and treat high or low glucose levels
E
– Erroneous readings; would lead to erroneous treatment decisions
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154
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: ......