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18 Appendix B: Specifications
(con’t)
Performance Relative to the Reference (YSI)
Error grid analysis (like the Clarke Error Grid Analysis and Continuous Glucose-Error Grid Analysis)
is one way to evaluate the accuracy of the FreeStyle Navigator system. The accuracy can also be
assessed by analyzing the difference in the glucose results from the FreeStyle Navigator system when
compared to the results from the YSI. Table 4a shows an analysis of the measure of closeness of the
FreeStyle Navigator system to the YSI. It breaks the data into smaller groups based on the glucose
value reported by the YSI. The table reports the mean absolute difference for the data pairs in each
of the smaller groups. Table 4b shows the same data at different levels of glucose and further groups
them by the amount of difference from the YSI. Table 5 breaks out the overall performance relative to
the YSI for the two sites of sensor insertion.
The overall median absolute relative difference for all the data pairs is
9.3%
.
Table 4a.
Performance relative to YSI at different glucose levels
Glucose (mg/dL)
Performance
20-40
Mean Absolute Difference = 32.3 mg/dL
41-80
Mean Absolute Difference = 18.1 mg/dL
81-120
Mean Absolute Difference = 16.3 mg/dL
121-240
Mean Absolute Relative Difference = 11.0%
>240
Mean Absolute Relative Difference = 9.5%
Table 4b.
Performance relative to YSI at different levels of glucose – grouped by amount of difference
from the YSI
Glucose Range
(mg/dL)
Number of
Paired Readings
Percent Within
20% of the YSI
Percent Within
30% of the YSI
Percent Within
40% of the YSI
20-40*
22
31.8
54.5
72.7
41-80*
1295
65.9
82.0
90.7
81-120
3820
69.5
85.2
92.7
121-240
11430
85.4
95.1
98.3
>241
3795
91.7
98.8
99.9
Overall
20362
82.3
93.1
97.0
*The absolute difference from the YSI reading is measured in mg/dL if the YSI reading is 20-80 mg/dL.
Table 5.
Performance relative to YSI at different insertion sites
Overall MeanAbsolute
RelativeDifference
MARD by Insertion Site
Abdomen
Arm
12.8% (Std. Dev. = 13.6%)
13.1%
12.6%
Customer Care: 1-866-597-5520
156
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: ......