Measuring Glucose in Interstitial Fluid | Arkon PRT03831-xxx

162Section 18

Appendix B: Specifications

18 Appendix B: Specifications (con’t)

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%.

END OF Section 18

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Arkon PRT03831-xxx manual Measuring Glucose in Interstitial Fluid

PRT03831-xxx specifications

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Contents

User’s Guide Page Indications for Use Page How to Use this Guide? Glossary of Symbols Table of Contents Review Reports and Edit Events 124 Enter Glucose Targets Clean Your System 128 Clean Your TransmitterAppendix C FCC Compliance Information Page Getting Acquainted Key Terms Getting Acquainted Introduction How are the parts packaged? Delivery Key features of the System Using your system How do I prepare my system for the first time? Important Things to Remember About System Calibration Important Things to Remember About System Calibration con’t Before You Get Started con’t Helpful health related information Symptoms of Hypoglycemia Unawareness Hypoglycemia unawareness can develop for several reasons Blood Glucose Mode Glucose BG Continuous Monitoring Mode Glucose CMYour FreeStyle Navigator system operates in two modes Install or Replace Transmitter and Receiver Batteries Key Terms Install or Replace Transmitter and Receiver Batteries Install or Replace the Transmitter Battery If the display is Reconnect the Receiver to the Transmitter Check your work Set the Time and Date Key Terms When you install new batteries Set the Time and DateGo to the Main screen First time you use your FreeStyle Navigator system Select Set Date/Time from the System Menu screen Go to the System screenSet the time Set the date Customer Care Perform a Control Solution Test Key Terms Perform a Control Solution Test Verify that your FreeStyle Control Solution is current Prepare test strip Insert test strip into the receiver Compare code numbersNumbers match Numbers do not match Apply control solution Confirm that you used a control solution Falls Within Evaluate the test resultsFalls Outside Customer Care Insert or Remove Your Sensor Key Terms Insert or Remove Your Sensor Every 5 days after that Decide what to do Insert your sensor Remove the sensor Reconnect the receiver to Transmitter End sensor sessionSelect an insertion site Prepare the insertion site Remove the sensor delivery Unit from packageRemove the protective liner from the sensor support mount An infection could occur Attach the sensor delivery unit to your skin Ensure that the adhesive pad is adhered to your skinInserting the sensor on the back of your arm Inserting the sensor on your abdomen Insert sensor Remove the locking pinRemove inserter IfThen Check the sensor support mount Discard the sensor inserter Safely Customer Care Attach Your Transmitter Key Terms Attach Your Transmitter Attach the transmitter to the sensor support mount Yes Apply an over-bandage Optional Enter the sensor code into your receiver Steps Do This Calibrate Your System/Test Blood Glucose Manually Key Terms Calibrate Your System/Test Blood Glucose Manually Sterile lancets Sharps container Helpful Information con’t Insertion at night Calibrate Your System/Test Blood Glucose Manually IfThen Select a test site You are simply doing a manual Prepare for lancing Important Do not touch the exposed needle on the lancet Prepare for lancing. con’t FingerYour forearm FreeStyle Lancing Device offers four different depth To lance your finger grey cap Lance the siteTo lance your forearm clear cap You get an error message Test the sampleDo Not Use test strips more than once. Discard used test strips Confirm you didnot use Control Solution Interpret the blood glucose results Remove and discard the test strip Discard the lancet Customer Care Set, Review, or Change the Alarm Settings Key Terms Set, Review, or Change the Alarm Settings About Glucose Alarms About Glucose Alarms con’t Access the Alarms menu From the Main menu Alarm on or off Your threshold value Set, review, or change the Low Glucose alarmAlarm type Setting Set, review, or change the High Glucose alarm Alarm on or off Your threshold value Alarm type Setting Set, review, or change your Projected Low glucose alarm Sensitivity toHigh Medium Set, review, or change your Projected High glucose alarm Alarm on or off Alarm type Setting Set, review, or change the Data Loss alarmsUse the UP/DOWN Arrow buttons to highlight Data Set System Alarms You want to mute alarms Set Progress Tones Mute all audible alarms for Hour Return to the main menu Daily Use Key Terms Daily Use Purpose Start If you want to Then go to this Step Reconnect the receiver to the transmitter Description Interpret the CM screen This Icon Means Interpret the icons Turn the Backlight on Second Customer Care Respond to Alarms, Errors, and Problems Key Terms Alarms are alphabetized in the following tables Must never be ignoredCannot be muted Can be muted Status Information Er1 This is normal for new sensors before System is not producing continuousTransmitter failure Sensor is expired Respond to alarm message con’t Cal Required Redo BG Select Link. If the transmitter ID that appears on System has detected a new sensor If this message appears and you did not insert Respond to alarm message con’t Replace the sensor within the next 2 hours see Respond to alarm message con’t Er1 Er2Er3 Er4 Connection Calibration Receiver will not turn on Then There is no glucose value on the screen Skin irritation at sensor insertion site Discomfort when inserting the sensor Then END of Section Add Events Key Terms Access the Add Event screen from the Main menu Add Events Select the type of event you want to record Record meal events Record insulin events Record state of health eventsRecord exercise events Type Aerobics, Walking, Jogging, Running Record generic events Your glucose levels Review Reports and Edit Events Key Terms Review Reports and Edit Events Access the Reports menu from the Main menuTo edit event history Decide what you want to do Set your glucose targets If you want to View a line graph of your glucose level history View a statistical summary of your glucose levels Select the desired statistical reading Your average glucose readingHow well you are maintaining your Percentage of readings that are Review/edit your Review or change your event history Interpret your events All BG measures are displayed Edit the event Clean Your System Receiver Transmitter Contact Points Clean Your System Every time you change your sensor transmitter Clean your receiver skin Clean your transmitterClean your receiver Link and Unlink Your Transmitter and Receiver BG Mode CM Mode Link/Unlink Receiver Transmitter Key Terms When you replace either your transmitter or your receiver Link and Unlink Your Transmitter and Receiver If you want to Unlink your receiver from your transmitter Link your receiver to your transmitter Are not Customer Care Reset User Settings Customer Care Reset User Settings Access the System menu from the Main menu Reset your settings Access the Reset UserSettings screen Change Country Settings Key Terms Change Country Settings Materials Change the Language Access the Country Settings menuNone of the above Change the Date Format Change the Time Format Change the Decimal Format Appendix a Site Maintenance Appendix a Introduction Customer Care Appendix B Specifications Appendix B System Specifications Appendix B Specifications con’t Days of normal use including continuous glucose1st calibration Must be performed at approximately 3rd calibration Must be performed between 12 Performance Characteristics Accuracy 155 Performance Relative to the Reference YSI Glucose mg/dL Performance Performance Over the Duration of Wear Sensor Stability Stability of Sensor Calibration Sample Glucose Traces Sample of a Representative ‘Excellent’ Glucose Trace Determination of Alarm Performance Definitions Detection of Low Glucose Measuring Glucose in Interstitial Fluid Appendix C FCC Compliance Information Customer Care Appendix C Classification/Compliance/Declaration Appendix C FCC Compliance Information con’t Immunity test Test LevelElectromagnetic Environment- Guidance Compliance Level Input lines 40% Ut* for 5 cycles Battery Operated 168 Applicable to the frequency of the transmitter Classification Declaration of Conformity Customer Care Glossary Appendix C Classification/Compliance/Declaration 2020Glossary Glossary Glossary con’t Continuous 177 178 179 180 Index Customer Care 2121Index Index Index con’t