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18 Appendix B: Specifications
(con’t)
END OF Section 18
Measuring Glucose in Interstitial Fluid
FreeStyle Navigator system measures glucose in the interstitial fluid (ISF) by means of a sensor that is
inserted about 5 mm under the skin. Interstitial fluid is the fluid between the body’s cells. Physiologic
differences between the interstitial fluid and capillary blood may result in differences in glucose
measurements. Differences in glucose measurement between interstitial fluid and your finger may be
observed during times of rapid change in blood glucose, e.g. after eating, dosing insulin, or exercising.
Movement of nutrients, oxygen and glucose from the blood into the cells happen across the ISF.
Therefore, if the glucose in the bloodstream rises (e.g. during meals), that rise is not seen in the ISF
until later. Similarly, if glucose levels in the ISF drop (for example during exercise, the cells consume
glucose rapidly) that drop is not seen in the bloodstream until later.
On average, glucose levels in the ISF lag the glucose levels in capillary blood by 14 minutes. This is a
physiological phenomenon that can vary from one person to another.
Precision
Data from two sensors inserted at different insertion sites was used to calculate the between sensor
reproducibility. Based on 312953 pairs of data sets, the average between sensor reproducibility was 10%.
Sensor Insertion, Calibration and Sensor Wear
Home Use Study
: Sensor insertion, calibration and sensor wear were evaluated in a Home Use Study
where 137 participants used the product on their own in a home environment. The participants wore
8 sensors during the study period of 40 days. They wore the sensors either on the arm or abdomen.
During the first 20 days of the study, continuous glucose results were not visible to the participants.
During the following 20 days, participants had access to the glucose measurements. In addition to
required calibration tests, the participants performed 4 finger stick measurements a day using the
built-in FreeStyle meter. The following information is based on the findings from this study.
When used as directed, 96.8% of the total sensor insertions were successful. 92.6% of the sensors were
calibrated successfully and began producing glucose results within 12 hours after sensor insertion. The
median time for a successful first calibration was 10.1 hours. The median duration of wear of
calibrated sensors was 120 hours. 83% of sensor wears lasted at least 108.3 hours. The median wear
time for sensors inserted on the arm was 0.4 hours longer than for sensors inserted on the abdomen.
Skin Interaction
Based on the examination of 124 study participants at a 21-day follow up, the following incidence of
skin issues were observed in 304 site exams.
Moderate to severe itching – 1.6% of the time
Moderate bruising – 0.3% of the time
Moderate erythema – 1.0% of the time
Moderate pain – 0.3% of the time
Rate of mild incidences for any individual category of skin issues above including edema, rash,
induration, bleeding and others was less than 5%.
Customer Care: 1-866-597-5520
162
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 ...
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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 ...
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