Helpful health related information | Arkon PRT03831-xxx manual

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Section 1

Getting Acquainted

Before You Get Started (con’t)

•If your results from the continuous monitoring mode do not reflect how you feel, test your glucose using the Blood Glucose mode.

•If you observe a significant change in your continuous glucose readings that you think is erroneous, or if you feel the blood glucose measurement in the Blood Glucose mode is erroneous and you are close to an electromagnetic interference source, move away from the source of interference and check to see if the condition fades away.

•If you have a medical appointment that includes X-ray, MRI (Magnetic Resonance Imaging), CT (Computed Tomography) scan, or another type of exposure to radiation, keep your system and sensor away from the area. Before exposure to such radiation, discard any sensor you are wearing and insert a new sensor after the radiation session. The effect of these types of radiation on the performance of the system has not been evaluated.

Helpful health related information:

The following pertain to your health and should always be kept in mind:

•The system is intended to assist you in better managing your diabetes by allowing you to know your glucose levels throughout the day.

•Test results below 60 mg/dL (3.3 mmol/L) mean your glucose levels are low.

•Test results above 240 mg/dL (13.3 mmol/L) mean your glucose levels are high.

•Severe dehydration and excessive water loss may cause false low results. If you believe you are experiencing severe dehydration, consult your healthcare team immediately.

•If you get results below 60 mg/dL (3.3 mmol/L) or above 240 mg/dL (13.3 mmol/L) and do not have symptoms of hypoglycemia or hyperglycemia, test your glucose using the Blood Glucose mode.

•If you have symptoms of hypoglycemia or hyperglycemia, or continue to get results below 60 mg/dL (3.3 mmol/L) or above 240 mg/dL (13.3 mmol/L), consult your healthcare team.

•If you are experiencing symptoms that are not consistent with your glucose test results, consult your healthcare team. 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.

–Interstitial fluid (ISF) is the fluid between cells in the body. 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.

•When testing your glucose levels in the Blood Glucose mode, differences in the blood circulation in your finger or palm (at the base of your thumb) and other test sites (forearm, upper arm, hand, thigh, or calf) may result in different glucose readings. Differences in blood glucose readings between your finger or palm (at the base of your thumb) and other test sites (forearm, upper arm, hand, thigh, or calf) may be observed after eating, taking insulin, diabetes medication, or exercising.

•Test your finger if you are testing for hypoglycemia or if you have hypoglycemia unawareness (see next page for definition of hypoglycemia unawareness). Changes in glucose levels may be observed in finger blood samples sooner than in samples from alternate sites (forearm, upper arm, hand, thigh, or calf). If an alternate site must be used, vigorous rubbing of the alternate site before lancing can help minimize this difference.

•Do not use the FreeStyle Navigator system for diagnosing diabetes, testing newborns, or testing arterial or venous blood.

Customer Care: 1-866-597-5520

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Arkon PRT03831-xxx manual Helpful health related information

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 Appendix C FCC Compliance Information Clean Your System 128 Clean Your TransmitterReview Reports and Edit Events 124 Enter Glucose Targets 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 Your FreeStyle Navigator system operates in two modes Continuous Monitoring Mode Glucose CMBlood Glucose Mode Glucose BG 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 Set the time Go to the System screenSelect Set Date/Time from the System Menu screen 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 Outside Evaluate the test resultsFalls Within 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 Select an insertion site End sensor sessionReconnect the receiver to Transmitter 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 Remove inserter Remove the locking pinInsert sensor 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 forearm clear cap Lance the siteTo lance your finger grey 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 type Setting Set, review, or change the Low Glucose alarmAlarm on or off Your threshold value 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 Use the UP/DOWN Arrow buttons to highlight Data Set, review, or change the Data Loss alarmsAlarm on or off Alarm type Setting 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 Transmitter failure Sensor is expired System is not producing continuousThis is normal for new sensors before 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 To edit event history Access the Reports menu from the Main menuReview Reports and Edit Events 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 Clean your transmitterClean your receiver skin 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 Settings screen Access the Reset UserReset your settings Change Country Settings Key Terms Change Country Settings Materials None of the above Access the Country Settings menuChange the Language 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