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OVER
18 Appendix B: Specifications
(con’t)
Table 2 is a summary of the statistics that describe how well data from the FreeStyle Navigator system
correlates to the results from the reference method. Glucose results from the FreeStyle Navigator
system and the corresponding results from the YSI (a total 20362 pairs of data points) in the In-
Clinic study were used to determine the correlation.
YSI Reference (mg/dL)
N
av
ig
at
or CM (m
g/dL)
Figure 1.
y = x
Table 3a displays the distribution of all the data from the In-Clinic study on the Clarke Error Grid.
It breaks the data set into smaller groups based on the glucose value reported by the YSI. For each of
these smaller groups, the table shows what percentage of data fall into different zones of the grid.
Table 3a.
Accuracy performance at different glucose levels using the Clarke Error Grid Analysis
Reference
Glucose Level
(mg/dL)
Number of
Paired
Readings
A and B
(%)
A
(%)
B
(%)
C
(%)
D
(%)
E
(%)
20-40
22
54.5
54.5
N/A*
N/A*
45.5
0.0
41-80
1295
77.7
55.2
22.5
0.0
22.3
0.0
81-120
3820
99.9
69.5
30.4
0.1
N/A*
N/A*
121-240
11430
99.9
85.4
14.4
0.1
N/A*
0.0
241+
3795
99.5
91.7
7.8
0.0
0.4
0.1
Overall
20362
98.3
81.7
16.7
0.1
1.6
0.0
*N/A means that the Clarke Error Grid does not consider the possibility of these zones in that
concentration range.
Table 3b displays the same data as in table 3a on the Continuous Glucose-Error Grid. This is
a modified error grid that is designed to evaluate the clinical accuracy of continuous glucose
monitoring systems based on both glucose data points in time and the rate of change of glucose.
Table 3b.
Accuracy performance at different glucose levels using the Continuous Glucose-Error Grid
Analysis
Zone
YSI ≤ 70 mg/dL
70 mg/dL < YSI
≤180 mg/dL
YSI > 180 mg/dL
All
N
%
N
%
N
%
N
%
Accurate
Readings
369
59.5
10407
98.9
8364
98.6
19140
97.5
Benign
Errors
5
0.8
99
0.9
74
0.9
178
0.9
Erroneous
Readings
246
39.7
22
0.2
41
0.5
309
1.6
ALL
620
100.0
10528
100.0
8479
100.0
19627
100.0
Slope
0.92
Intercept
14.3 mg/dL
Correlation Coefficient (r)
0.93
N
20362
Range
25 – 533 mg/dL
Overall mean bias
+0.8 mg/dL
Table 2.
Regression Analysis. FreeStyle
Navigator System (mg/dL) vs the YSI (mg/dL)
Section 18
155
Appendix B: Specifications
B
B
A
A
C
E
D
D
E
C
0
100
200
300
400
500
500
400
300
200
100
0
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: ......