Arkon PRT03831-xxx 19 Appendix C: FCC Compliance Information

19

OVER

19 Appendix C: FCC Compliance Information

Electromagnetic Interference and Your FreeStyle Navigator®

Continuous Glucose Monitoring System

Important Information about Electromagnetic Interference

e FreeStyle Navigator® Transmitter and Receiver communicate using radio frequency waves. e

FreeStyle Navigator system has been designed to be reliable and immune to common electromagnetic

interference so that it is not inuenced by such interference. However, under rare circumstances, if you

happen to be in an environment of strong electromagnetic radiation, there may be some interference.

Examples of possible sources of interference are: store doorways, store checkout counters, metal

detectors like those used in airport security systems or electronic surveillance devices, and radio

transmitting devices such as cellular phones, 2-way radio and cordless phones.

Interference may occur in the vicinity of equipment marked with symbol.

If such interference happens, it tends to be temporary. is makes it unlikely that you will experience

any noticeable dierence in the performance of the system. In the event of electromagnetic

interference, you may experience loss of communication between the receiver and transmitter, you

may see unrecognizable characters on the receiver display screen, or you may not see continuous

glucose results. e system is designed to alert you of these conditions through audio (beep or vibrate)

or visual (icons, unrecognizable characters on the screen or lack of glucose results) means.

If you observe a signicant 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. Always maintain a minimum separation distance from potential sources of

electromagnetic interference (see Tables 3 and 4 in this section for guidance).

Depending on your distance from the source of interference, the strength of the interfering signal,

and the relative orientation between you and the source of interference, you may or may not see or

experience these conditions. When in doubt, move away from any likely source of electromagnetic

interference. If you experience consistent interference from any source, contact the manufacturer or

dealer for that source and have a trained technician assess the situation. In addition, please report any

consistent interference issues to Abbott Diabetes Care Customer Care.

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 aer the radiation session. e eect of these types of radiation on the performance of the

system has not been evaluated.

Section 19 165

Appendix C: Classiﬁcation/Compliance/Declaration

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