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Arkon PRT03831-xxx Warnings, Cautions And Important Notes, Important Things to Remember About System Calibration

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Warnings, Cautions And Important Notes

Important Notes About System Performance

e following items describe situations that could lead to inaccurate or unreliable continuous glucose

results.

Cautions:

Movement of the sensor support mount or excessive perspiration at the sensor insertion site due to •

activities like vigorous exercise or bumping against objects may lead to poor adhesion of the support

mount to the skin and cause the sensor to dislodge. If the sensor dislodges due to the sensor support

adhesive failing to adhere to the skin, you may get unreliable results or no results. e system may not

provide a warning in such circumstances. Choose the proper sensor insertion site when inserting the

sensor and prepare the site by following the instructions for site preparation.

If your results from the Continuous Monitoring mode seem erroneous, check and make sure that the •

sensor has not dislodged. If you notice the sensor is dislodged from the skin, or if you see that the adhesive

on your overbandage or the sensor support mount is coming loose, discard the old sensor and insert a

new sensor.

e FreeStyle Navigator system includes built-in self-checks to detect conditions that may cause •

the sensor to not function properly. On rare occasions the system may not be able to detect all such

conditions (for example if the adhesive peels up from your skin), and you may get inaccurate results in

the Continuous Monitoring mode. If you believe your results are not reliable, or are inconsistent with how

you feel, perform a Blood Glucose mode test to measure your glucose. If the problem continues, discard

the old sensor and insert a new sensor.

You should never reset your user settings when you are wearing a sensor. is will reset parameters that •

may aect your system performance.

If you accept an incorrect transmitter ID when linking your Transmitter and Receiver, your glucose •

readings will be incorrect.

Do • NOT use the sensor delivery unit if the sterile package is open or damaged.

Important:

Once the code has been entered and you have hit the Set button, you will not be able to change the sensor •

code number. If you have entered the code incorrectly, you will have to replace the sensor and enter the

right sensor code. If you choose the wrong sensor code, you may get erroneous results from the sensor. e

code numbers MUST match to ensure accurate test results.

Do • NOT remove or replace the transmitter from the sensor support mount while wearing a sensor. If

you notice that the transmitter is not properly attached, replace the sensor with a new sensor and then

reattach the transmitter.

Important Things to Remember About System Calibration

Caution: Always calibrate the system using only a nger-stick blood sample. Do NOT use alternate site

blood glucose measurements to calibrate the system. e receiver contains a built-in FreeStyle® Blood

Glucose Meter for performing calibration tests.

Important: Your blood glucose level must be between 60 and 300 mg/dL (3.3 and 16.7 mmol/L) to be able

to perform calibration tests. If your blood glucose level is changing rapidly, you may not be able to calibrate

the system. For example, during a meal or exercise, your glucose levels may vary rapidly. Try to time your

sensor insertion so that your calibration times do not coincide with your regular meal or exercise activities.

Section 1 7

Getting Acquainted

Contents

Main Users Guide Page Indications for Use Contraindications Page How to Use this Guide? Table of Contents nSection 3: Set the Time and Date ................................................21 23 Page Page Page Section 1 Key Terms 1 Getting Acquainted Introduction Getting Acquainted How are the parts packaged? 2 Section 1 OVER What are the key parts of my system? Your FreeStyle Navigator system includes the following major parts: Sensor Delivery Unit Transmitter Receiver Getting Acquainted Key features of the System Statistics Alarms event Log Line Graph 4 Section 1 Using your system Getting Acquainted How do I prepare my system for the rst time? Warnings, Cautions And Important Notes Important Things to Remember About System Calibration Getting Acquainted Important Things to Remember About System Calibration Before You Get Started 8 Section 1 Before Y ou Get Started Getting Acquainted Helpful health related information: Before Y ou Get Started Customer Care: 1-866-597-5520 10 Section 1 What is Hypoglycemia Unawareness? Symptoms of Hypoglycemia Unawareness: Getting Acquainted What are the Continuous Monitoring mode and Blood Glucose mode? Continuous Monitoring Mode (Glucose CM) Blood Glucose Mode (Glucose BG) 12 Section 1 Page Section 2 Key Terms 2 Install or Replace Transmitter and Receiver Batteries Purpose Materials Section 2 15 Install or Replace Transmitter and Receiver Batteries Install or Replace the Transmitter Battery Install or Replace the Receiver Batteries Match what you see on your Receiver with ONE of the screen shots shown below. If the display is en Section 2 17 Install or Replace Transmitter and Receiver Batteries Reconnect the Receiver to the Transmitter. o o o Page Section 3 Key Terms 3 Set the Time and Date Purpose Start Do this procedure: Materials 1. Section 3 21 Set the Time and Date 2. 3. the System Menu screen. 4. 22 Section 3 5. 6. o o Section 3 23 Set the Time and Date Page Page Section 4 Key Terms 4 Perform a Control Solution Test Purpose Start Section 4 27 Perform a Control Solution Test 1. 2. 3. 4. Section 4 29 Perform a Control Solution Test 5. 6. control solution. 30 Section 4 7. 8. o o o If the result And en Section 4 31 Perform a Control Solution Test Page Page Section 5 Key Terms 5 Insert or Remove Your Sensor Purpose Section 5 35 Insert or Remove Your Sensor 1. If you want to en 36 Section 5 Insert or Remove Your Sensor 2. Section 5 37 Insert or Remove Your Sensor 3. 4. the transmitter. 5. 38 Section 5 Insert or Remove Your Sensor 6. 7. unit from package. 8. the sensor support mount. 9. 10. 13. 11. 12. Section 5 41 Insert or Remove Your Sensor Steps Do This 14. mount. Customer Care: 1-866-597-5520 42 Section 5 Insert or Remove Your Sensor 15. 16. Page Page Section 6 Key Terms 6 Attach Your Transmitter Purpose Start Materials Section 6 47 Attach Your Transmitter 1. 2. If en 3. (Optional). 4. your receiver. Section 6 49 Attach Your Transmitter 5. Page Section 7 Key Terms 7 Calibrate Your System/Test Blood Glucose Manually Purpose Materials Section 7 53 Calibrate Your System/Test Blood Glucose Manually Helpful Information (cont) 54 Section 7 Helpful Information (cont) Section 7 55 Calibrate Your System/Test Blood Glucose Manually 1. the receivers test strip port. If en 2. on the screen matches the code number on the test strip vial. 3. n Section 7 57 Calibrate Your System/Test Blood Glucose Manually 4. If your test site is en 58 Section 7 4. If you are lancing en If you are using en to stimulate blood ow Section 7 59 Calibrate Your System/Test Blood Glucose Manually 5. 60 Section 7 6. Section 7 61 Calibrate Your System/Test Blood Glucose Manually 7. results. 8. 62 Section 7 9. 10. 11. Page Page Section 8 Key Terms 8 Set, Review, or Change the Alarm Settings Purpose Start Materials Section 8 67 Set, Review, or Change the Alarm Settings About Glucose Alarms 68 Section 8 High Threshold (180 mg/dL) Low Threshold (80 mg/dL) About Glucose Alarms (cont) 1. 2. If you want to en 70 Section 8 3. Low Glucose alarm. Section 8 71 Set, Review, or Change the Alarm Settings Steps Do This 4. High Glucose alarm. 72 Section 8 5. Projected Low glucose alarm. Section 8 73 Set, Review, or Change the Alarm Settings Steps Do This 6. Projected High glucose alarm. 74 Section 8 7. Data Loss alarms. Section 8 75 Set, Review, or Change the Alarm Settings 8. If en Customer Care: 1-866-597-5520 76 Section 8 9. Section 8 77 Set, Review, or Change the Alarm Settings 10. 1 hour. 11. 12. 78 Section 8 Page Section 9 Key Terms 9 Daily Use Purpose Start Materials Section 9 81 Daily Use 1. 2. transmitter. If you want to en go to this Step If the receiver has en lost connection 3. Location Description Section 9 83 Daily Use 4. is Icon Means 84 Section 9 5. 6. o o o o Page Page Section 10 Key Terms 10 Respond to Alarms, Errors, and Problems Purpose Start Materials If the level of en the alarm urgency is Section 10 89 Respond to Alarms, Errors, and Problems Status Information Status Information Description 90 Section 10 Alarms and Errors 85 Status Information (cont) Status Information Description Display Description Respond to alarm message: 92 Section 10 Section 10 93 Respond to Alarms, Errors, and Problems 94 Section 10 Section 10 95 Respond to Alarms, Errors, and Problems 96 Section 10 Section 10 97 Respond to Alarms, Errors, and Problems 98 Section 10 Section 10 99 Respond to Alarms, Errors, and Problems Respond to Blood Glucose Mode error codes. 100 Section 10 Troubleshoot problems Section 10 101 Respond to Alarms, Errors, and Problems The receiver will not turn on. The Blood Glucose test wont start after you apply a sample. 102 Section 10 Section 10 103 Respond to Alarms, Errors, and Problems There is no glucose value on the screen. 104 Section 10 Skin irritation at sensor insertion site. If the irritation is en The sensor support mount is not sticking to your skin. Section 10 105 Respond to Alarms, Errors, and Problems Discomfort when inserting the sensor. 106 Section 10 You are not sure whether your receiver and transmitter are connected. Section 10 107 Respond to Alarms, Errors, and Problems The system does not prompt you with a message to do BG test for calibration. Check your work. 108 Section 10 Page Section 11 Key Terms 11 Add Events Purpose Start Materials 1. Section 11 111 Add Events 2. want to record. 3. If the event deals with en 112 Section 11 5 . 6 . Section 11 113 Add Events 7. 8. Check your work. 114 Section 11 Page Section 12 Key Terms 12 Re view Reports and Edit Events Purpose Start 1. the Main menu. 2. 3. 118 Section 12 4. glucose level history. Section 12 119 Review Reports and Edit Events 5. of your glucose levels. 120 Section 12 6. reading. If you want to know en highlight Section 12 121 Review Reports and Edit Events 7. event history. If you want to en If you want to At en highlight review/edit your 122 Section 12 8. Event Note s Section 12 123 Review Reports and Edit Events 9. 10. o o o 124 Section 12 Page Page 13 C lean Your System Purpose Materials Section 13 127 Clean Your System 1. 2. 3. o 128 Section 13 Page Section 14 Key Terms 14 L ink and Unlink Your Transmitter and Receiver Purpose Materials Section 14 131 Link and Unlink Your Transmitter and Receiver 1. 2. your transmitter. If you want to en go to Step 132 Section 14 3. transmitter. o o o o If the And this en ID numbers is your Page Page Page 15 Rese t User Settings Purpose Start Materials 1. Section 15 137 Reset User Settings 2. Settings screen. 3. o o If you want to en Page Section 16 Key Terms 16 C hange Country Settings Purpose Start Materials 1. from the Main menu 2. Access the Country Settings menu. 3. If you want to change how en go this is displayed to Step 142 Section 16 4. 5. Section 16 143 Change Country Settings 6. 7. 144 Section 16 Page Section 17 Appendix A 17 Appendix A: Site Maintenance Introduction Site Selection Helpful products Section 17 147 Appendix A: Site Maintenance Page Page Section 18 Appendix B 18 Appendix B: Specications System Specications Section 18 151 Appendix B: Specications 152 Section 18 Performance Characteristics Section 18 153 Appendix B: Specications Accuracy 154 Section 18 Section 18 155 Appendix B: Specications 156 Section 18 Section 18 157 Appendix B: Specications 158 Section 18 Figure 2. Sample of a Representative Excellent Glucose Trace Figure 3. Sample of a Representative Average Glucose Trace Figure 4. Sample of a Representative Poor Glucose Trace Section 18 159 Appendix B: Specications Determination of Alarm Performance 160 Section 18 OVER Detection of Low Glucose Detection of High Glucose * T rue Alarms are the Section 18 161 Appendix B: Specications Measuring Glucose in Interstitial Fluid Precision Sensor Insertion, Calibration and Sensor Wear Skin Interaction 162 Section 18 Page Page 19 Appendix C: FCC Compliance Information Electromagnetic Interference and Your FreeStyle Navigator Continuous Glucose Monitoring System Section 19 165 Appendix C: Classication/Compliance/Declaration Guidance and Manufacturers Declaration Electromagnetic Emissions Compliance Level 166 Section 19 Guidance and Manufacturers Declaration - Electromagnetic Immunity. (cont) Section 19 167 Appendix C: Classication/Compliance/Declaration 168 Section 19 Section 19 169 Appendix C: Classication/Compliance/Declaration Classication FCC Compliance Information 170 Section 19 Section 19 171 Appendix C: Classication/Compliance/Declaration Page Page Page 20 Glossary Section 20 175 Glossary 176 Section 20 Section 20 177 Glossary 178 Section 20 Section 20 179 Glossary 180 Section 20 Page Page 21 Index Section 21 183 Index 21 Index 184 Section 21