Customer Care available 24 hours a day, 7 days a week at: 1-866-597-5520 www.continuousmonitor.com User’s Guide This product and its use are protected under U.S.
Indications for Use The FreeStyle Navigator® Continuous Glucose Monitoring System is indicated for continually recording interstitial fluid glucose levels in people (ages 18 and older) with diabetes mellitus for the purpose of improving diabetes management. Readings and alarms about glucose levels from FreeStyle Navigator® Continuous Glucose Monitoring System are not intended to replace traditional blood glucose monitoring.
How to Use this Guide? This guide has many Sections arranged in a logical sequence that will be useful for the first time use and every use thereafter. Most Sections begin with a purpose for that Section, when to perform the steps in that Section, materials required to perform the steps in that Section and important cautions, warnings and helpful information. The first page of each Section will be very useful when you are getting familiar with the system.
Table of Contents n Section 1: Getting Acquainted. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 – 12 Parts of the System. Daily Activities and Traveling. Preparing the System for the First Time. Warnings, Cautions and Important Notes. Hypoglycemia Unawareness. Modes of Operation (Continuous Monitoring Mode (CM) and Blood Glucose Mode (BG)). n Section 2: Install or Replace Transmitter and Receiver Batteries . . . . . . . . . . . . . . . . . . . .
n Section 10: Respond to Alarms, Errors, and Problems. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89 – 108 Alarm Messages: What are they, What do they mean, and What you should do. Error Codes: What are they, What do they mean, and What you should do. Problems: How to troubleshoot the problems you may encounter. n Section 11: Add Events . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1 Getting Acquainted
Section 1 – Key Terms n Alarms n Blood Glucose Mode n Continuous Monitoring Mode FreeStyle Navigator Continuous Glucose Monitoring System n n FreeStyle Test Strips n in vitro n Interstitial Fluid n Left/Right Option Buttons n Receiver n Receiver Display Screen n Receiver Test Strip Port n Reports n Sensor n Sensor Delivery Unit n Sensor Inserter n Sensor Insertion Button n Sensor Locking Pin n Sensor Release Tabs n Sensor Support Mount n Transmitter n Transmitter T
1 Section 1 Getting Acquainted 1 1 Getting Acquainted Introduction Important: Read all of the instructions in this User’s Guide and the FreeStyle® Test Strip package insert before using your FreeStyle Navigator® Continuous Glucose Monitoring System. Adjustments to your treatment should be done under the guidance of your healthcare team. Your FreeStyle Navigator system continuously reads, displays, and records the glucose levels in the fluids found between the cells under your skin (interstitial fluids).
2 Section 1 Getting Acquainted How are the parts packaged? Your FreeStyle Navigator system comes with two kits: • A System kit. • A Sensor kit.
Section 1 3 Getting Acquainted What are the key parts of my system? Your FreeStyle Navigator system includes the following major parts: Sensor Measures your glucose level. Sensor Tip Part of sensor inserted into your skin. Locking Pin Prevents accidental discharge; must be removed before insertion. Insertion Button Pushes a tiny needle into the skin to place the sensor tip just under the surface of the skin. Sensor Inserter Inserts the sensor into the skin. Must be disposed after inserting the sensor.
4 Section 1 Getting Acquainted Key features of the System Alarms Stats 21 day Highest CM: Lowest CM: Ave. CM: Std. Dev: Above Target: Next Select Event Insulin Meals Exercise State of Health Generic Main 08:30A 298 mg/dL 61 mg/dL 160 mg/dL 20 mg/dL 19% Back Statistics 08:30A Select Event Log Line Graph Your receiver comes with backlight capability to see the screen in dark environments.
Section 1 5 Getting Acquainted Using your system For Daily Activities You will be wearing a sensor and a transmitter at all times while you are using the system. Keep the following in mind as you go about your normal routine. • Only wear the sensor and transmitter on a flat surface of either your abdomen or the back of your upper arm. • Sleeping – The sensor and transmitter should not interfere with your normal sleeping patterns.
6 Section 1 Getting Acquainted How do I prepare my system for the first time? When you are setting up your receiver for the first time, perform all of the procedures listed below in the order that they are listed. Check each procedure off when you complete it. o Install batteries in the transmitter first and then in the receiver (see Section 2). o Set the time and date (see Section 3). o Perform a control solution test (see Section 4). o Insert your sensor (see Section 5).
Section 1 7 Getting Acquainted Warnings, Cautions And Important Notes Important Notes About System Performance The 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.
8 Section 1 Getting Acquainted Important Things to Remember About System Calibration (con’t) Important: In clinical trials, we observed that the sensor signal sometimes temporarily decreases from the true value. This typically happens at night during sleep, and recovers rapidly when the user moves or is awakened. However, in order to avoid being affected by this phenomenon the system should not be calibrated when the wearer is asleep.
Section 1 9 Getting Acquainted Before You Get Started (con’t) Cautions: • Low or high glucose measurements can indicate a potentially serious medical condition. • If you have hypoglycemia, or hypoglycemia unawareness, then test ONLY on your fingers. • The high and low alarms are intended to assist you in managing your diabetes and should not be exclusively used to detect hypoglycemia or hyperglycemia.
10 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.
Section 1 11 Getting Acquainted What is Hypoglycemia Unawareness? Hypoglycemia unawareness is a condition where you are having hypoglycemia but you do not have any of the usual warning symptoms (such as rapid heartbeat, sweating, shakiness, anxiety, or a tingling sensation in your fingers or toes). Those warning symptoms are either absent or greatly reduced. Instead, the first sign may be confusion or impaired thinking, which makes it even more difficult to know if you are experiencing low blood glucose.
12 Section 1 Getting Acquainted What are the Continuous Monitoring mode and Blood Glucose mode? Your FreeStyle Navigator system operates in two modes: • Continuous Monitoring mode (Glucose CM). • Blood Glucose mode (Glucose BG). Continuous Monitoring Mode (Glucose CM) The Continuous Monitoring mode is the mode you will use most of the time. It continuously displays the glucose level in the fluid in the tiny spaces between your tissues (interstitial fluid).
2 Install or Replace Transmitter and Receiver Batteries
Section 2 – Key Terms n Alarm n Icon n Receiver n Transmitter n Battery Life n Alkaline Batteries n 357 HC Silver Oxide Battery n Reconnect Customer Care: 1-866-597-5520
2 Section 2 15 Install or Replace Transmitter and Receiver Batteries 2 Install or Replace Transmitter and Receiver Batteries Purpose Start To ensure that your FreeStyle Navigator system has power to operate properly. Materials Gather these materials before you begin: • 2 new AAA alkaline batteries for the receiver. We recommend Energizer® Max®, Energizer® e2® Titanium®, and Energizer® Industrial batteries. Other batteries may not provide expected battery life.
16 Section 2 Install or Replace Transmitter and Receiver Batteries Install or Replace the Transmitter Battery a. Turn the circular battery door counterclockwise with either a coin or your fingernail. (Fig. 1) Fig. 1 Fig. 2 b. Carefully remove the battery door. c. Remove the old battery, if any, and discard it properly. d. Insert a NEW silver oxide 357 HC battery with the plus sign (+) facing you. (Fig.
Section 2 17 Install or Replace Transmitter and Receiver Batteries Match what you see on your Receiver with ONE of the screen shots shown below. If the display is Then • Press the RIGHT Option button to see if the screen turns on. • If screen turns on, compare with the screens below and perform the matching steps. • If screen does NOT turn on, then repeat this procedure ensuring that the batteries are: – New. – Oriented properly in the battery compartment.
18 Section 2 Install or Replace Transmitter and Receiver Batteries Reconnect the Receiver to the Transmitter. System Menu Reconnect Data Upload Status Link Set Date/Time Main 08:30A a. Place the receiver within 10 feet of the transmitter. b. Press the RIGHT Option button twice to display the Main Menu screen. c. Use the UP or DOWN Arrow button to highlight System. Select d. Press the RIGHT Option button (Select) to display the System menu with Reconnect highlighted. e.
3 Set the Time and Date
Section 3 – Key Terms n Left/Right Option Buttons n Main Menu n Receiver n System Menu n Transmitter n Up/Down Arrow Buttons Customer Care: 1-866-597-5520
3 Section 3 21 Set the Time and Date 3 Set the Time and Date Purpose To ensure the correct time and date are associated with your data. Start Do this procedure: • The first time you use your FreeStyle Navigator system. • When you install new batteries. Materials Your FreeStyle Navigator Receiver. Helpful Information Important: Be sure to set the date and time correctly. The correctness of the line graph and statistical reports depends upon the date and the time being correct.
22 Section 3 Set the Time and Date Steps 2. Do This Go to the System screen. Main Glucose Alarms Reports System Add Event a. Press the down Arrow button to highlight System. 08:30A b. Press the right Option button (Select) to go to the System Menu screen. Select 3. Select Set Date/Time from the System Menu screen. System Menu Reconnect Data Upload Status Link Set Date/Time Main 4. 08:30A a. Use the UP/DOWN Arrow buttons to highlight Set Date/Time on the System Menu screen. b.
Section 3 23 Set the Time and Date Steps 5. Do This Set the date. a. Press the left Option button (Next) to move to the Month field. b. Use the UP/DOWN Arrow buttons to set the current month. c. Press the LEFT Option button (Next) to move to the Date field. d. Use the UP/DOWN Arrow buttons to set the current date. e. Press the left Option button (Next) to move to the Year field. f. Use the UP/DOWN Arrow buttons to set the current year. g.
Customer Care: 1-866-597-5520
4 Perform a Control Solution Test
Section 4 – Key Terms n Control Solution Test n FreeStyle Control Solution n FreeStyle Test Strips n Left/Right Option Buttons n Receiver n Up/Down Arrow Buttons Customer Care: 1-866-597-5520
4 Section 4 27 Perform a Control Solution Test 4 Perform a Control Solution Test Purpose Start Materials The purpose of the control solution test is to: • Ensure that your receiver and test strips are working properly prior to calibration or blood glucose testing. • Check that you are following the correct testing procedure. • Practice Blood Glucose mode testing without having to use your own blood. A Control Solution test is not the same as a calibration. See Section 7 for calibrating the system.
28 Section 4 Perform a Control Solution Test Steps 1. Do This Verify that your FreeStyle Control Solution is current. Note: FreeStyle Control Solution is good for three months after opening the bottle, or until the expiration date printed on the label, whichever comes first. Count forward three months from the date you open a new bottle of control solution. This is your discard date. Write this date on the side of the control solution bottle. Example: You open the control solution on January 15th.
Section 4 29 Perform a Control Solution Test Steps 3. Do This Insert test strip into the receiver. a. Turn the test strip so “FreeStyle” text faces up. b. Grasp the test strip by the end with the two half circles. c. Insert the end with the dark rectangle into the receiver at the lower left corner of the receiver. Result: The receiver display screen turns on and displays the Strip Code screen. Note: If the screen does not turn on, refer to Section 10 on troubleshooting. 4. Compare code numbers.
30 Section 4 Perform a Control Solution Test Steps 5. Do This Apply control solution. Important: Do NOT apply control solution to both edges of the test strip. Apply Sample Back 08:30A Notes: • Gently touch ONLY ONE EDGE of the test strip to the control solution next to one of the dark half-circles. Cancel • If progress tones are turned on, the receiver will beep to indicate that enough control solution was applied.
Section 4 31 Perform a Control Solution Test Steps 7. Do This Evaluate the test results. Compare the test results displayed on the screen to the range printed on the vial of test strips. If the result Then • Falls WITHIN the range. ➜ • Falls OUTSIDE of the range. You’ve repeated the test. Call Customer Care. You’ve NOT repeated the test. Repeat the test from Step 1 with a NEW test strip. • Is an error message. Glucose BG 106 And ➜ Go to Step 8. Go to Section 10 on troubleshooting.
Customer Care: 1-866-597-5520
5 Insert or Remove Your Sensor
Section 5 – Key Terms n Calibration n Sensor Inserter n Sensor Release Tabs n Reconnect n Sensor Insertion Button n Sensor Support Mount n Sensor n Sensor Insertion Site n Sharps Container n Sensor Delivery Unit n Sensor Locking Pin n Transmitter Receiver Connection Now that you are ready to insert a sensor, here are a few helpful tips. • Reconnect your transmitter and receiver BEFORE inserting a new sensor.
5 Section 5 35 Insert or Remove Your Sensor 5 Insert or Remove Your Sensor Purpose To insert, remove, or replace a small, thin, plastic sensor under your skin so that your FreeStyle Navigator system can continuously monitor your glucose level. Start Do this procedure: • The first time you use your FreeStyle Navigator system. • Every 5 days after that. • Replace your sensor sooner than 5 days when: – There is any redness, pain, tenderness, or swelling at the insertion site.
36 Section 5 Insert or Remove Your Sensor Important Things to Know About Getting Reliable Results Caution: 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 then 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.
Section 5 37 Insert or Remove Your Sensor Steps Do This 2. Remove the sensor. a. Wipe a small amount of isopropyl alcohol around the edges of the sensor support mount. Note: You can use a regular alcohol prep pad from your local drugstore. Fig. 1 Fig. 2 b. Grasp the top end of the adhesive (the end nearest the sensor, see Fig.1) and slowly peel it off your skin in one continuous motion. c. Pull down on the adhesive at the bottom of the support mount (the end farthest from the sensor, see Fig.2).
38 Section 5 Insert or Remove Your Sensor Steps Do This 3. End sensor session. a. Press the RIGHT Option button twice to get to the Main menu. b. Press the UP/DOWN Arrow button to highlight System. c. Press the RIGHT Option button to select System. d. Press the UP/DOWN Arrow button to highlight Status. e. Press the RIGHT Option button to select Status. f. Press the RIGHT Option button to select Removed Sensor. g. Press the RIGHT Option button to select Yes.
Section 5 39 Insert or Remove Your Sensor Steps Do This 6. Prepare the insertion site. a. Wash your hands thoroughly with soap and water. b. Clean the selected insertion site area with soap and water. c. Rinse the area thoroughly and pat dry. d. Wipe the area with an alcohol prep pad. Note 1: The insertion area MUST be clean and dry. Otherwise: • An infection could occur. • The sensor support mount may not stick to the site.
40 Section 5 Insert or Remove Your Sensor Steps Do This 9. Attach the sensor delivery unit to your skin. a. Locate the top of the sensor support mount. b. Follow the instructions below as you place the sensor support mount, adhesive-side down, on the insertion site: Top of the Sensor Support Mount If you are Then • Inserting the sensor on the back of your arm. Place the sensor support mount lengthwise on your arm with the top of the sensor support mount facing your shoulder.
Section 5 41 Insert or Remove Your Sensor Steps 11. Do This Remove the locking pin. a. Grasp the top of the locking pin with your thumb and index finger. b. Twist the locking pin a 1/4 turn in either direction until the locking pin clicks. c. Pull the locking pin away to remove it. Note: The sensor support mount adhesive will help keep the sensor support mount in place. 12. Insert sensor. Caution: Do NOT press the button until you are ready to insert the sensor.
42 Section 5 Insert or Remove Your Sensor Steps Do This 14. Check the sensor support mount. a. Confirm the sensor support mount remains tightly adhered to your skin by sliding your finger along the edges of the adhesive pad and examine for any gaps in adhesion. b. Examine the area for a drop of blood. You may see some blood from the insertion site.
Section 5 43 Insert or Remove Your Sensor Steps Do This 15. Discard the sensor inserter safely. We recommend a sharps container or a puncture-proof container with a tight lid. 16. Check your work. Result: An inserted sensor, a removed sensor, or a replaced sensor. You have done this procedure correctly when: o The system successfully recognized that you removed a sensor (if you removed a sensor). o The site was selected and prepared according to the guidelines given in this procedure.
Customer Care: 1-866-597-5520
6 Attach Your Transmitter
Section 6 – Key Terms n Left/Right Option Buttons n Receiver n Sensor Code n Sensor Support Mount n System n Transmitter n Up/Down Arrow Buttons Customer Care: 1-866-597-5520
6 Section 6 47 Attach Your Transmitter 6 Attach Your Transmitter Purpose To enable the transmitter to send glucose data to the receiver. Start Do this procedure after inserting a new sensor. Materials Your FreeStyle Navigator Transmitter with battery installed. Helpful Information Important: Do NOT remove or replace the transmitter from the sensor support mount while wearing a sensor.
48 Section 6 Attach Your Transmitter Steps 1. Do This Attach the transmitter to the sensor support mount. a. Position the transmitter over the sensor support mount so that the battery side faces the mount. b. Lower the transmitter onto the mount. Note: It helps to position the transmitter’s connector directly over the round part of the “keyhole” (Fig. 1) as you lower the transmitter. Fig. 1 Result: The transmitter fits flush against the mount and slides smoothly back and forth on the guide rails.
Section 6 49 Attach Your Transmitter Steps Do This 3. Apply an over-bandage (Optional). Apply an over-bandage to hold down the transmitter and sensor support mount. Use an over-bandage if you find that the sensor support mount is not adhering well during daily activities. Caution: If your results from the Continuous Monitoring mode seem erroneous, check and make sure that the sensor has not dislodged.
50 Section 6 Attach Your Transmitter Steps Do This 5. Check your work. Result: A transmitter ready to send glucose data. You have done this procedure correctly when: o The transmitter is securely attached to the sensor support mount. o You have applied an over-bandage as necessary to hold down the transmitter and the sensor support mount. o The sensor code has been correctly entered into the receiver. o You see an the screen.
7 Calibrate Your System/Test Blood Glucose Manually
Section 7 – Key Terms n BG Mode n Calibrate n Calibration BG n Control Solution n FreeStyle Test Strips n Icon n Lancet n Lancing Device n Lancing Device Cocking Handle n Lancing Device Depth Indicator Window n Lancing Device Depth Setting n Lancing Device Lancet Cup Holder n Left/Right Option Buttons n Receiver Test Strip Port n Sharps Container n Up/Down Arrow Buttons Customer Care: 1-866-597-5520
7 Section 7 53 Calibrate Your System/Test Blood Glucose Manually 7 Calibrate Your System/Test Blood Glucose Manually Purpose Start Materials To ensure the receiver will calculate your glucose readings accurately. Do this procedure: • Each time the receiver prompts you with the message, “Do BG Test.” You will see a blood drop icon on the screen and you will also hear the system beep (or vibrate). • When you need to measure your blood glucose manually using the built-in FreeStyle Meter.
54 Section 7 Calibrate Your System/Test Blood Glucose Manually Helpful Information (con’t) • You MUST successfully complete 4 calibration tests. You will calibrate at approximately 10, 12, 24 and 72 hours after sensor insertion. If you do not complete calibration tests successfully in the allotted time periods, your glucose readings will NOT be displayed and alarms will be inactive.
Section 7 55 Calibrate Your System/Test Blood Glucose Manually Helpful Information (con’t) Some common reasons for unsuccessful calibrations • Your BG test result is below 60 mg/dL (3.3 mmol/L) or above 300 mg/dL (16.7 mmol/L). Perform the calibration test when your blood glucose is within the above range. • Your blood glucose is changing too rapidly. This can happen during a meal or exercise activities or if you have taken insulin. Give yourself an hour before you try to perform a calibration test again.
56 Section 7 Calibrate Your System/Test Blood Glucose Manually Steps 1. Do This Insert a FreeStyle Test Strip into the receiver’s test strip port. a. Insert the end with the dark rectangle. b. Gently push until the test strip stops. Result: The receiver will display the most recently used test strip code number. 2. Ensure that the code number on the screen matches the code number on the test strip vial. Strip Code Cancel Caution: The code numbers MUST match to ensure accurate test results.
Section 7 57 Calibrate Your System/Test Blood Glucose Manually Steps Do This 3. Select a test site. Caution: If you have hypoglycemia, or hypoglycemia unawareness, then test ONLY on your fingers. Note 1: Vary the sites from test to test to avoid tenderness and to avoid creating calluses. Note 2: Avoid moles, veins, bones, and tendons. Caution: Always calibrate the system using only a finger-stick blood sample. Do NOT use alternate site blood glucose measurements to calibrate the system.
58 Section 7 Calibrate Your System/Test Blood Glucose Manually Steps Do This 4. Prepare for lancing. a. Wash your hands and the selected test site with soap and water. Make sure there is no lotion on the test site. b. Thoroughly dry your hands and the test site. c. Snap the cap off the lancing device. Important: Use a new sterile lancet for every test. NEVER use a lancet for more than one person. d. Insert a new FreeStyle Lancet firmly into the white lancet cup holder.
Section 7 59 Calibrate Your System/Test Blood Glucose Manually Steps Do This 4. Prepare for lancing. (con’t) g. Select the lancing device depth setting. If you are lancing Then • A finger. Set the depth setting to its shallowest depth (1). • Your forearm. Start at Level (2) or higher if your experience with setting 2 does not produce a usable sample. • The FreeStyle® Lancing Device offers four different depth settings. Move the dial to the desired setting as shown in the depth indicator window.
60 Section 7 Calibrate Your System/Test Blood Glucose Manually Steps Do This 5. Lance the site. To lance your finger (grey cap): a. Lightly touch the lancing device against the side of your fingertip. b. Press the release button. c. Put the lancing device down. d. Gently squeeze your finger, if needed, until a drop of blood the size of a pinhead forms. To lance your forearm (clear cap): a. Hold the lancing device against the test site. b. Press the release button. c.
Section 7 61 Calibrate Your System/Test Blood Glucose Manually Steps Do This 6. Test the sample. Do Not: • Use test strips more than once. Discard used test strips. • Scrape the blood. • Apply blood to the flat side of the test strip. • Apply blood to the test strip when the test strip is out of the receiver. • Apply blood to both edges of the test strip. • Put blood or foreign objects into the receiver’s test strip port. a.
62 Section 7 Calibrate Your System/Test Blood Glucose Manually Steps Do This 7. Interpret the blood glucose results. Caution: Low or high glucose measurements can indicate a potentially serious medical condition. If And • Lo appears in You do NOT have low blood the display. Lo glucose symptoms. appears when the measured glucose result is less than 20 mg/dL You have any of these symptoms: (1.1 mmol/L).
Section 7 63 Calibrate Your System/Test Blood Glucose Manually Steps Do This 9. Remove and discard the test strip. Important: Test strips may be used only once. Discard used test strips. 10. Discard the lancet. Note: Use a sealed container such as a sharps container to avoid biohazards. a. Snap off the cap from the lancing device. b. Hold the lancet over a sharps container or other puncture-proof container with a lid. c.
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8 Set, Review, or Change the Alarm Settings
Section 8 – Key Terms n Alarm Menu n Alarm Sensitivity n Alarm Type n Data Loss n High Glucose Alarm n High Glucose Threshold n Left/Right Option Buttons n Low Glucose Alarm n Low Glucose Threshold n Main Menu n Progress Tones n Projected High Alarm n Projected Low Alarm n Receiver n System n System Alarms n Up/Down Arrow Buttons Customer Care: 1-866-597-5520
8 Section 8 67 Set, Review, or Change the Alarm Settings 8 Set, Review, or Change the Alarm Settings Purpose To set the receiver to: • Alert you when your glucose conditions change. • Notify you when the receiver needs attention. • Notify you when the receiver begins or completes certain activities. Start Do this task: • Immediately after you finish the first set up of your FreeStyle Navigator system. • When your healthcare team gives you new glucose threshold numbers.
68 Section 8 Set, Review, or Change the Alarm Settings About Glucose Alarms The FreeStyle Navigator® system is designed to alert you when your glucose levels reach preset low or high values. These values or ‘threshold values’ can be programmed in the receiver for any individual. These high and low glucose alarms or the threshold alarms are designed to alert you when your glucose levels cross these threshold values.
Section 8 69 Set, Review, or Change the Alarm Settings About Glucose Alarms (con’t) Follow the guidelines below when selecting your alarm settings for detection of high and low glucose conditions. When the detection rate is maximum, you will get the greatest number of alarms. When the detection rate is minimum, you will get the fewest number of alarms.
70 Section 8 Set, Review, or Change the Alarm Settings Steps Do This 1. Access the Alarms menu from the Main menu. Main Glucose Alarms Reports System Add Event Note: If you don’t press any buttons within 12 seconds, the receiver screen will go blank and the last change will be lost if you haven’t pressed the Select button. 08:30A a. Press the up Arrow button or the down Arrow button to highlight Alarms. Select b. Press the right Option button (Select) to go to the Alarms Setting screen. 2.
Section 8 71 Set, Review, or Change the Alarm Settings Steps Do This 3. Set, review, or change the Low Glucose alarm. Caution: The Low Glucose alarm cannot be set below 60 mg/dL (3.3 mmol/L). Therefore, it is not intended to notify you of severe hypoglycemia. Alarm Settings 08:30A Mute Alarms Low Glucose (70) High Glucose (275) Projected Low (On) Projected High (Off ) Main a. Select Low Glucose from the Alarms menu. • Use the UP/DOWN Arrow buttons to highlight Low Glucose.
72 Section 8 Set, Review, or Change the Alarm Settings Steps 4. Do This Set, review, or change the High Glucose alarm. Caution: The High Glucose alarm cannot be set above 300 mg/dL (16.7 mmol/L). Therefore, it is not intended to notify you of severe hyperglycemia. Alarm Settings 08:30A Mute Alarms Low Glucose (70) High Glucose (275) Projected Low (On) Projected High (Off ) Main a. Select High Glucose from the Alarms menu. • Use the UP/DOWN Arrow buttons to highlight High Glucose.
Section 8 73 Set, Review, or Change the Alarm Settings Steps 5. Do This Set, review, or change your Projected Low glucose alarm. a. Select Projected Low from the Alarms menu. • Use the UP/DOWN Arrow buttons to highlight Projected Low. • Press the right Option button to select Projected Low.
74 Section 8 Set, Review, or Change the Alarm Settings Steps 6. Do This Set, review, or change your Projected High glucose alarm. a. Select Projected High from the Alarms menu. • Use the UP/DOWN Arrow buttons to highlight Projected High. • Press the right Option button to select Projected High.
Section 8 75 Set, Review, or Change the Alarm Settings Steps 7. Do This Set, review, or change the Data Loss alarms. Important: If you turn off your Data Loss alarms, you must also turn off your Low Glucose, High Glucose, Projected Low and Projected High alarms. Alarm Settings 08:30A Low Glucose (70) High Glucose (275) Projected Low (On) Projected High (Off ) Data Loss Main a. Select Data Loss from the Alarms menu. • Use the UP/DOWN Arrow buttons to highlight Data Loss.
76 Section 8 Set, Review, or Change the Alarm Settings Steps 8. Do This Set System Alarms. Important: If you turn off the System Alarms, the receiver will NOT prompt you to do the calibration tests after you insert a new sensor. Alarm Settings 08:30A High Glucose (275) Projected Low (On) Projected High (Off ) Data Loss System Alarms Main a. Select System Alarms from the Alarms menu. Select Decide what settings you want: • Alarm on or off. • Alarm type (Setting). – Low, medium, or high beep.
Section 8 77 Set, Review, or Change the Alarm Settings Steps 9. Do This Set Progress Tones. a. Select Progress Tones from the Alarms menu. Alarm Settings 08:30A Projected Low (On) Projected High (Off ) Data Loss System Alarms Progress Tones Main Select Decide what settings you want: • Turn progress tones on or off. • Set progress tones volume low or high. b. Review or change your settings. • Press the left Option button (Next) to move from one field to the next.
78 Section 8 Set, Review, or Change the Alarm Settings Steps Do This 10. Mute all audible alarms for 1 hour. Alarm Settings 08:30A Mute Alarms Low Glucose (70) High Glucose (275) Projected Low (On) Projected High (Off ) Main Alarm Settings Select a. Select Mute Alarms from the Alarms menu. 08:30A Mute Alarms For One Hour? Cancel Note 1: You will still get vibration, visual alarms will still be displayed and you will continue to get Low Glucose alarms.
9 Daily Use
Section 9 – Key Terms n BG Mode n CM Mode n Directional Glucose Trend Arrows n Icon n Receiver n Transmitter n Transmitter Receiver Connection Customer Care: 1-866-597-5520
9 Section 9 81 Daily Use 9 Daily Use Purpose To read and understand your display screen. Start Do this procedure: • Anytime you are using your system in the Continuous Monitoring mode. Materials Your receiver. Helpful Information • Your receiver and transmitter must be linked, connected, and calibrated in order to use the system in the Continuous Monitoring mode.
82 Section 9 Daily Use Steps Do This 1. Decide what to do. If you want to Then go to this Step • Connect your receiver and transmitter. 2 • Reconnect your receiver and transmitter. 2 • Interpret the CM screen. 3 • Interpret icons on the CM screen. 4 • Interpret icons on the Main screen. 4 • Turn the receiver backlight on. 5 2. Reconnect the receiver to the transmitter. a. Place the receiver within 10 feet of the transmitter. b. Decide what to do next.
Section 9 83 Daily Use Steps Do This 3. Interpret the CM screen. Press the right Option button to turn the display on. Result: The Glucose CM screen is displayed. Location Glucose CM 120 08:30A mg/dL Description If CM appears here, the receiver is operating in the Continuous Monitoring mode. If BG appears here, the receiver is operating in the Blood Glucose mode. Main Glucose CM 120 08:30A The current time of day.
84 Section 9 Daily Use Steps Do This 4. Interpret the icons. Note: The directional trend arrows are different from the projected glucose alarms (Section 8). For example, you can have a projected low glucose alarm and still have a relatively stable trend arrow. This Icon Means Your glucose is changing gradually, changing at a rate of less than 60 mg/dL/hr (3.3 mmol/L/hr). Your glucose is increasing moderately, at a rate between 60 mg/dL/hr and 120 mg/dL/hr (3.3 mmol/L/hr and 6.7 mmol/L/hr).
Section 9 85 Daily Use Steps Do This 5. Turn the Backlight on. Press First Press Second 6. Check your work. a. In order to turn the backlight on, your receiver has to be turned off. If the receiver is on, wait for 12 seconds to allow the receiver to turn off. b. Press and release the DOWN Arrow button. Then immediately press and release the RIGHT option button. Your receiver will turn on with a backlight. Result: You are aware of your glucose levels and trends.
Customer Care: 1-866-597-5520
10 Respond to Alarms, Errors, and Problems
Section 10 – Key Terms n Alarms Menu n Calibration BG n CM Status n Calibration n High Glucose Alarm n Icon n Low Glucose Alarm n Projected High Alarm n Projected Low Alarm n Receiver Status n Sensor n Sensor Support Mount n Status Information n Transmitter n Transmitter Receiver Connection n Transmitter Status Customer Care: 1-866-597-5520
10 Section 10 89 Respond to Alarms, Errors, and Problems 10 Respond to Alarms, Errors, and Problems Purpose Start To resolve alarm messages, error codes, or problems. Do this any time you: • Receive either an alarm or an error code in the Continuous Monitoring mode or the Blood Glucose mode. • Experience problems with your FreeStyle Navigator system. Materials Your FreeStyle Navigator system.
90 Section 10 Respond to Alarms, Errors, and Problems Status Information The receiver can provide you with a number of different types of Status Information. Available Status Information is listed in the following table. To access the Status information, press the RIGHT option button twice to get to the Main menu and use the UP or DOWN arrow button to highlight System. Select System by pressing the RIGHT option button. Highlight and select Status from the System menu.
Section 10 91 Respond to Alarms, Errors, and Problems Status Information (con’t) Status Information CM Status. CM Status Last Reset: Can’t Cal: Cal Failed: Sensor Err: 08:30A OK 6 BG High 207 Back Main Calibration BG. 08:30A Do You Want To Calibrate? Yes No Description Stores recent error codes related to the Continuous Monitoring mode (may be useful when calling Customer Care). Note: The CM Status screen shows information about calibration and sensor errors.
N/A I I I I Flashing light at the test strip port. Alarms Inactive Insert New Sensor. Alarms Inactive Replace Receiver. Alarms Inactive Replace Sensor. Alarms Inactive Replace Transmitter. What It Means What to Do Replace the transmitter, and insert a new sensor. Remove the sensor and insert a new one (see Section 5). Call Customer Care. Remove the sensor and insert a new one (see Section 5). Call Customer Care.
I I I I I I Cal Failed: High BG Redo BG Later. Cal Failed: Low BG Redo BG Later. Cal Failed: Receiver Temp Redo BG Later. Cal Failed: Redo BG in 1 hr. Cal Failed: Redo BG Later. Cal Failed: Redo BG Test. What It Means Wait 1 hour and perform a Blood Glucose mode test for calibration. Calibration test was very different from the previous calibration. Perform another Blood Glucose mode test for calibration.
I L I L Cal Required: Redo BG in 2 hrs. Cool Down Skin. Cool Down Skin Redo BG Later. Did You Remove The Sensor? What It Means What to Do OVER • If you did not just remove the sensor, select No. • Ensure that the transmitter is attached firmly to the sensor support mount. • Ensure that the sensor support mount is attached firmly to the skin. • If the alarm persists, remove the sensor and insert a new one (see Section 5). Cool the skin at the insertion site.
I M L L L Do BG Test Alarms Inactive. High Glucose. Link. Log Cleared. Log Corrupted Some Data Lost. What to Do History log is corrupt. History log has been successfully cleared. The receiver is not linked to the transmitter. The link is necessary for the system to operate in the Continuous Monitoring mode. Your glucose has reached your preset high glucose threshold.
L L M New Sensor Detected Have You Recently Inserted a New Sensor? Preferences Lost Reconfigure. Projected High Glucose. High – H, Medium – M, Intermediate – I, Low – L Customer Care: 1-866-597-5520 OVER Review your alarm settings and other user-settable items like the country settings. If you just inserted a new sensor, select Yes. If you did not insert a new sensor, select No. Ensure that the transmitter is attached firmly to the sensor support mount.
M I L M I Projected Low Glucose. Receiver Error Alarms Inactive. Reconnect. Reconnect–Alarms Inactive. Remove Any Sensor Alarms Inactive. What to Do Alarms are not operating. The receiver thought the sensor was inserted when the receiver was reset. The receiver has not been receiving signals sent by the transmitter for 8 minutes. The receiver is either too far from the transmitter or there are materials or signals causing interference.
L L L I I I Replace Receiver Battery Within 1 Week. Replace Sensor Soon. Replace TX Batt With Next Sensor. Sensor Error Alarms Inactive. Sensor Error Replace Sensor. Skin Temp Range Alarms Inactive. What It Means Replace the receiver batteries before you insert a new sensor (see Section 2). Replacing the batteries before a sensor has expired will require you to insert a new sensor. What to Do OVER Bring skin temperature within range.
L L I TX Battery Exhausted Replace Battery. Warm Up Skin. Warm Up Skin Redo BG Later. What It Means Calibration failed because your skin temperature is too cold. Unable to calibrate the System because the skin temperature is too cold. Transmitter battery power loss is imminent. Transmitter problem. Alarms are not working. High – H, Medium – M, Intermediate – I, Low – L I Urgency Transmitter Error Alarms Inactive.
Er6 Er4 Er3 Er2 Er1 If error code is • • • • • • • • • Perform a control solution test using a new test strip: • If results are within the range printed on the test strip vial, retest your blood using a new test strip. • If the test does not work or if the error persists, call Customer Care. ➜ ➜ ➜ Customer Care: 1-866-597-5520 OVER Note: Do NOT touch the RIGHT Option button while applying blood or control solution to the test strip. 1. Retest using a new test strip. 2.
Section 10 101 Respond to Alarms, Errors, and Problems Troubleshoot problems The problems you can troubleshoot in this Section are listed below and are arranged in the order of appearance. Receiver • The receiver will not turn on. • The blood glucose test won’t start after you apply a sample. • Unexpected characters on the receiver display screen, unusual or unexpected receiver screen appearance. • There is no glucose value on the screen.
102 Section 10 Respond to Alarms, Errors, and Problems The receiver will not turn on. a. Was the test strip inserted correctly (the “FreeStyle” side was up as you inserted the end with the dark rectangle)? If YES, go to Step c. If NO, repeat the test with a new strip taking care that the “FreeStyle” side is up as you insert the end with the dark rectangle until it stops. b. Did this solve your problem? If YES, stop. If NO, continue with Step c. c.
Section 10 103 Respond to Alarms, Errors, and Problems Unexpected characters on the receiver display screen, unusual or unexpected receiver screen appearance. If Then The batteries are installed correctly. If you are close to a source of electromagnetic interference (see Appendix C for further details), move away from the interfering source and see if the problem goes away. If there is consistent interference from a source, contact the manufacturer of the source or a certified electrician for help.
104 Section 10 Respond to Alarms, Errors, and Problems There is no glucose value on the screen. If And Then You are waiting for the first calibration. It has been less than icon on the You will see an 10 hours after the screen. Wait for the system to insertion of the sensor. prompt you to do a BG test for calibration. It has been more than 10 hours after insertion of the sensor. You see an on the screen. It has been more than 10 hours after insertion of the sensor.
Section 10 105 Respond to Alarms, Errors, and Problems Skin irritation at sensor insertion site. a. Ensure that seams, waistbands, or other constrictive clothing or accessories do not cover the site causing friction. b. Inspect the site. If the irritation is Then Around the edges of the adhesive or tape. Lift the edges slightly all around the dressing. Wherever the adhesive touches skin. You may be sensitive to the adhesive or material, consult your healthcare team to identify the best solution. c.
106 Section 10 Respond to Alarms, Errors, and Problems Discomfort when inserting the sensor. a. Rub the insertion site with ice before inserting the sensor. b. If that doesn’t work, call Customer Care. The system does not recognize a new sensor after attaching the transmitter to the sensor support mount. If Then Your transmitter and receiver are not connected. You will see the icon on the screen. Try establishing connection between the receiver and transmitter.
Section 10 107 Respond to Alarms, Errors, and Problems You are not sure whether your receiver and transmitter are connected. If You do not see the on the screen. You see the Then icon icon. Your system is connected. There is no connection between the receiver and transmitter. Reconnect the transmitter and receiver, see Section 9. icon and You see the the reconnect procedure was unsuccessful. Check and make sure that the transmitter battery is not old or exhausted.
108 Section 10 Respond to Alarms, Errors, and Problems The system does not prompt you with a message to do BG test for calibration. If And Then The system did not prompt you with a message recognizing a new sensor after you attached the transmitter to the sensor support mount. ➜ Follow the troubleshooting guidelines on sensor recognition. It has been less than 10 hours after insertion of the sensor.
11 Add Events
Section 11 – Key Terms n Events n Exercise Event n Generic Event n Insulin Event n Left/Right Option Buttons n Meal Event n State Of Health Event n Up/Down Arrow Buttons Customer Care: 1-866-597-5520
11 Section 11 111 Add Events 11 Add Events Purpose To create a record of events that may affect your glucose levels. Start Do this procedure any time you observe anything that may affect your glucose levels, including your state of health and daily activities such as meals, exercise, and insulin dosages. Materials • Your FreeStyle Navigator Receiver. • Data and details about the event that you want to record.
112 Section 11 Add Events Steps Do This 2. Select the type of event you want to record. Use the up Arrow button or the down Arrow button to highlight the type of event: If the event deals with Then • Meals or snacks. 1. Highlight Meals. 2. Press the right Option button (Select). 3. Go to Step 3. • Details of an insulin dose. (injection or pump) 1. Highlight Insulin. 2. Press the RIGHT Option button (Select). 3. Go to Step 4. • Exercise. 1. Highlight Exercise. 2.
Section 11 113 Add Events Steps 4. Do This Record insulin events. a. Use the left Option button (Next) to select which item to enter or change (Type, Units, SAVE/CANCEL, Date, Time). History 08:30A Insulin 04-09-05 08:30 A Type: Rapid Units: 0.25 SAVE Set Next SAVE CANCEL Rapid Pre-Mix Intermediate Long Acting b. Use the up Arrow button or the down Arrow button to change the selected item. Note: Your insulin choices are Rapid, Intermediate, Long Acting, or Pre-mix. c.
114 Section 11 Add Events Steps Do This 7. Record generic events. History Generic 04-09-05 a. Use the left Option button (Next) to select which item to enter or change (Event, SAVE/CANCEL, Date, Time). 08:30A 08:30 A Event: 2 Next SAVE Set SAVE CANCEL b. Use the up Arrow button or the down Arrow button to change the selected item.
12 Review Reports and Edit Events
Section 12 – Key Terms n Event History Reports n Events n Exercise Event n Generic Event n Glucose Targets n Insulin Event n Left/Right Option Buttons n Line Graph n Main Menu n Meal Event n Multi-Day Statistics n Reports n Single-Day Statistics n State Of Health Event n Statistical Reports n Up/Down Arrow Buttons Customer Care: 1-866-597-5520
12 Section 12 117 Review Reports and Edit Events 12 Review Reports and Edit Events Purpose • To review your glucose levels. • To help you and your healthcare team detect patterns in your glucose levels relative to your targets. • To review a history of events that are important to your treatment plan. • To edit event history. Start • When you or your healthcare team want to know about your glucose levels or about events that may either explain your glucose levels or influence your treatment plan.
118 Section 12 Review Reports and Edit Events Steps Do This 2. Decide what you want to do. Note: Your reports will be more meaningful if you set glucose targets. Glucose targets give you something to compare your actual glucose levels with. Decide what to do: If you want to Then • Set glucose targets. Go to Step 3. • See a line graph showing a history of your glucose levels. Go to Step 4. • See a statistical summary of your glucose levels over time. Go to Step 5.
Section 12 119 Review Reports and Edit Events Steps Do This 4. View a line graph of your glucose level history. Select Time Period 2 Hour 4 Hour 6 Hour 12 Hour 24 Hour back 08:30A Select Note: The line graph display range is between 20 mg/dL (1.1 mmol/L) and 350 mg/dL (19.4 mmol/L). Glucose values exceeding 350 mg/dL (19.4 mmol/L) will be plotted as 350 mg/dL (19.4 mmol/L). Glucose values falling below 20 mg/dL (1.1 mmol/L) will be plotted as 20 mg/dL (1.1 mmol/L). a.
120 Section 12 Review Reports and Edit Events Steps Do This 5. View a statistical summary of your glucose levels. Stats 3 day Highest CM: Lowest CM: Ave. CM: Std. Dev: Above Target: Next 08:30A 298 mg/dL 61 mg/dL 160 mg/dL 80 mg/dL 19% back a. Select Statistics from the Select Reports menu. i) Use the up Arrow button or down Arrow button to highlight Statistics. ii) Press the right Option button (Select) to go to the Statistics screen.
Section 12 121 Review Reports and Edit Events Steps Do This 6. Select the desired statistical reading. Note: Statistics include ONLY continuous glucose results. Glucose readings that were taken in the Blood Glucose mode are NOT included in the statistics. a. Use the up Arrow button or down Arrow button to highlight the statistic you want to review for the selected period. If you want to know Then highlight • Your highest glucose reading. Highest CM. • Your lowest glucose reading. Lowest CM.
122 Section 12 Review Reports and Edit Events Steps Do This 7. Review or change your event history. Select Filter CM 60 CM 120 CM 10 BG Insulin Back a. Select Event History from the Select Reports menu. 08:30A b. Use the up or down Arrow button to highlight the event you want to review or edit. Select If you want to review/edit your • Continuous glucose measurements.* • Blood glucose readings.* • Insulin events. • Meal events. • Exercise events. • State of health. • Miscellaneous events.
Section 12 123 Review Reports and Edit Events Steps Do This 8. Interpret your events. a. Interpret the events using the notes about each type of event in the table below: Event Notes CM • Each recorded measure is displayed on one screen with its (CM 60, CM 120, date and time. and CM 10) • Displays actual measures at the indicated intervals. • Does NOT display averaged measures. • Use the right Option button (Next) to move to the next recorded CM reading.
124 Section 12 Review Reports and Edit Events Steps Do This 9. Edit the event. Note: You CANNOT edit your glucose measurements. a. Press the right Option button (Edit). b. Use the left Option button (Next) to select the item you want to change. c. Use the up or down Arrow button to change the selected item. d. Repeat this process from Step 9b until you’ve changed every item that you wanted to change. Note: If you change your mind about saving your edits, change SAVE to CANCEL. e.
13 Clean Your System
Section 13 – Key Terms n Receiver n Transmitter n Contact Points Customer Care: 1-866-597-5520
13 Section 13 127 Clean Your System 13 Clean Your System Purpose To maintain the appearance of your system. Start Do this procedure: • Every time you change your sensor (transmitter). • Any time the system needs cleaning. Materials Make sure you have access to these materials before you begin: • • • • Mild soap. Running water. A clean, soft, lint-free towel for cleaning and drying. For example, a dish towel. 70% isopropyl alcohol.
128 Section 13 Clean Your System Steps Do This 1. Clean your transmitter. a. Wash the transmitter with mild soap and water. b. Rinse the transmitter thoroughly under running water. c. Dry the transmitter thoroughly with a clean, soft, lintfree towel. Contact Points d. Shake any water out of the transmitter’s contact points and blot on a clean, dry, lint-free towel. e. Make sure that the contact points are clean, dry, and not excessively worn. 2. Clean your receiver skin.
14 Link and Unlink Your Transmitter and Receiver
Section 14 – Key Terms n BG Mode n CM Mode n Link/Unlink n Receiver n Transmitter Customer Care: 1-866-597-5520
14 Section 14 131 Link and Unlink Your Transmitter and Receiver 14 Link and Unlink Your Transmitter and Receiver Purpose To enable secure communication between your transmitter and your receiver. Start Do this procedure: • When you replace either your transmitter or your receiver. Materials Gather these materials before you begin: • Your receiver. • Your transmitter. Note: Your system may need fresh batteries if it cannot establish communication.
132 Section 14 Link and Unlink Your Transmitter and Receiver Steps Do This 1. Decide what you want to do. If you want to Then go to Step • Unlink your receiver from your transmitter. 2 • Link your receiver to your transmitter. 3 • Check your work. 4 2. Unlink your receiver from your transmitter. Link 08:30A Blood Glucose Mode or Relink to Transmitter BG Relink a. Press the right Option button twice to display the Main menu. b. Use the up or down Arrow button to highlight System. c.
Section 14 133 Link and Unlink Your Transmitter and Receiver Steps Do This 3. Link your receiver to your transmitter. Link a. Place the receiver within 10 feet of the transmitter. b. Press the right Option button twice to display the Main menu. c. Use the up or down Arrow button to highlight System. d. Press the right Option button (Select) to display the System menu. e. Use the up or down Arrow button to highlight Link. 08:30A Searching For Transmitter Allow 70 Seconds Cancel Link 08:30A f.
Customer Care: 1-866-597-5520
15 Reset User Settings
Customer Care: 1-866-597-5520
15 Section 15 137 Reset User Settings 15 Reset User Settings Purpose Start To reset the user settings to the default values. Do this procedure anytime you feel a need to return your settings to the factory defaults. Materials Your FreeStyle Navigator Receiver. Helpful Information • If you don’t press any button within 12 seconds, the receiver screen will go blank and the last change will be lost if you haven’t pressed the Select button.
138 Section 15 Reset User Settings Steps Do This 2. Access the Reset User Settings screen. System Menu Status Link Set Date/Time Country Settings Reset User Settings Main a. Press the up or down Arrow button to highlight Reset User Settings. 08:30A b. Press the right Option button (Select) to go to the Reset User Settings Screen. Select 3. Reset your settings. Confirm what you want to do: If you want to Then • Return your system to its default settings. Press the right Option button (Yes).
16 Change Country Settings
Section 16 – Key Terms n Left/Right Option Buttons n Receiver n System Menu n Up/Down Arrow Buttons Customer Care: 1-866-597-5520
16 Section 16 141 Change Country Settings 16 Change Country Settings Purpose To set the date and time formats, the language, and the decimal format. Start Do this procedure when your requirements differ from the country setting currently being used by the system. Materials Gather these materials before you begin: • Your requirements for displaying date, time format and the other items mentioned in the purpose statement. • Your FreeStyle Navigator Receiver.
142 Section 16 Change Country Settings Steps Do This 2. Access the Country Settings menu. System Menu Data Upload Status Link Set Date/Time Country Settings Main a. Press the up or down Arrow button to highlight Country Settings. 08:30A b. Press the right Option button (Select) to go to the Country Settings screen. c. Decide what you want to do: Select If you want to change how this is displayed Then go to Step • Language. 3 • Date. 4 • Time. 5 • Decimals. 6 • None of the above.
Section 16 143 Change Country Settings Steps Do This 4. Change the Date Format. Country Settings Language Date Format Time Format Decimal Format Back 08:30A (English) (mm-dd-yy) (12h) (x. y) Select a. Use the up or down Arrow button to highlight Date Format. b. Press the right Option button (Select) to go to the Select Date Format screen. c. Use the up or down Arrow button to select either the mm-dd-yy or the dd-mm-yy format. d. Press the right Option button (Set) to accept your choice.
144 Section 16 Change Country Settings Steps Do This 6. Change the Decimal Format. Country Settings Language Date Format Time Format Decimal Format Back 08:30A (English) (mm-dd-yy) (12h) (x. y) Select a. Use the up or down Arrow button to highlight Decimal Format. b. Press the right Option button (Select) to go to the Select Decimal Format screen. c. Use the up or down Arrow button to select either the x.y or the x,y format. d. Press the right Option button (Set) to accept your choice.
17 Appendix A: Site Maintenance
Section 17 – Appendix A n Adhesive Enhancers n Antiseptics n Dressings n Site Rotation n Skin Barriers Customer Care: 1-866-597-5520
17 Section 17 147 Appendix A: Site Maintenance 17 Appendix A: Site Maintenance Introduction Careful site selection, preparation, and maintenance can help to lower the risk of infection and improve sensor adhesion. In addition to site selection, a number of helpful products are available. Site Selection Site rotation helps prevent discomfort, irritation, bruising, skin rashes, and sensitivity to adhesives.
Customer Care: 1-866-597-5520
18 Appendix B: Specifications
Section 18 – Appendix B n Calibration n Hematocrit n Interstitial Fluid n Receiver n Transmitter Customer Care: 1-866-597-5520
18 Section 18 151 Appendix B: Specifications 18 Appendix B: Specifications System Specifications Your FreeStyle Navigator system specifications are listed in the following table: Operating Temperature 40º F to 104º F (4º C to 40º C). Storage Temperature Store the transmitter and receiver between 14º F (-10º C) and 113º F (45º C). Store the test strips and sensor delivery units between 37º F (3º C) and 86º F (30º C). Control solution should be stored between 50º F (10º C) and 86º F (30º C).
152 Section 18 Appendix B: Specifications 18 Appendix B: Specifications (con’t) Receiver Size Height: 2.5 in. (6.3 cm). Width: 3.24 in. (8.2 cm). Depth: 0.88 in. (2.2 cm). Receiver Weight 3.5 oz. (99.2 grams) – including batteries. Receiver Battery Life Up to 60 days. Automatic Shutoff Built-in blood glucose meter: 2 minutes after last user action. Receiver: 12 seconds after last user action.
Section 18 153 Appendix B: Specifications 18 Appendix B: Specifications (con’t) Performance Characteristics Note: Please consult your healthcare team on how to use the information in this section. Performance of the FreeStyle Navigator® Continuous Glucose Monitoring System was evaluated in a controlled clinical study. The study was conducted in 3 centers and included a total of 58 subjects with diabetes. Each subject wore two FreeStyle Navigator Sensors over a 5-day period.
154 Section 18 Appendix B: Specifications 18 Appendix B: Specifications (con’t) Accuracy Table 1 below shows the distribution of all the data from the In-Clinic study on the Clarke Error Grid. Accuracy was assessed by comparing the differences between the FreeStyle Navigator system and the YSI laboratory reference. The Clarke Error Grid Analysis evaluates the clinical relevance of the differences by dividing a correlation plot (Figure 1) into five zones as described in Table 1.
Section 18 155 Appendix B: Specifications 18 Appendix B: Specifications (con’t) Table 2 is a summary of the statistics that describe how well data from the FreeStyle Navigator system correlates to the results from the reference method. Glucose results from the FreeStyle Navigator system and the corresponding results from the YSI (a total 20362 pairs of data points) in the InClinic study were used to determine the correlation. Figure 1. Navigator CM (mg/dL) 500 y=x A B C 400 Table 2.
156 Section 18 Appendix B: Specifications 18 Appendix B: Specifications (con’t) Performance Relative to the Reference (YSI) Error grid analysis (like the Clarke Error Grid Analysis and Continuous Glucose-Error Grid Analysis) is one way to evaluate the accuracy of the FreeStyle Navigator system. The accuracy can also be assessed by analyzing the difference in the glucose results from the FreeStyle Navigator system when compared to the results from the YSI.
Section 18 157 Appendix B: Specifications 18 Appendix B: Specifications (con’t) Performance Over the Duration of Wear This section presents the performance data in a variety of ways to demonstrate the performance of the system over time during the entire sensor wear period. The sensor is worn on the body for up to 5 days, during which time the system has to be calibrated 4 times. Typically, the system has to be calibrated at 10, 12, 24 and 72 hours after sensor insertion.
158 Section 18 Appendix B: Specifications 18 Appendix B: Specifications (con’t) Stability of Sensor Calibration FreeStyle Navigator system typically requires a calibration at 10, 12, 24 and 72 hours after insertion of the sensor. This section presents information about the performance of the system by the 4 calibration periods. The table (Table 6d) breaks each calibration period into smaller slots and summarizes the difference from YSI in each slot.
Section 18 159 Appendix B: Specifications 18 Appendix B: Specifications (con’t) Figure 2. Sample of a Representative ‘Excellent’ Glucose Trace 500 Glucose (mg/dL) 400 300 200 x xx x 100 0 10 14 18 22 26 30 34 38 42 46 50 54 58 62 66 70 74 78 82 86 90 94 98 102 106 110 114 118 122 Sensor Time (hours) FreeStyle Navigator x YSI Reference FreeStyle Calibration Night Time (11pm to 6am) Figure 3.
160 Section 18 Appendix B: Specifications 18 Appendix B: Specifications (con’t) Determination of Alarm Performance The threshold alarm is characterized below. The projected alarm performance has not been established. The performance of low and high glucose alarms was assessed in an in-clinic study using 58 subjects with type 1 diabetes wearing one FreeStyle Navigator sensor on the arm and one sensor on the abdomen.
Section 18 161 Appendix B: Specifications 18 Appendix B: Specifications (con’t) Detection of Low Glucose See Table 7 below for detection of low glucose. As an example, when the threshold alarm was set at 70 mg/dL (during the day), 56 % of the low glucose events were detected by FreeStyle Navigator. Table 7.
162 Section 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.
19 Appendix C: FCC Compliance Information
164 Section 18 Appendix B: Specifications Customer Care: 1-866-597-5520
19 Section 19 165 Appendix C: Classification/Compliance/Declaration 19 Appendix C: FCC Compliance Information Electromagnetic Interference and Your FreeStyle Navigator® Continuous Glucose Monitoring System Important Information about Electromagnetic Interference The FreeStyle Navigator® Transmitter and Receiver communicate using radio frequency waves.
Group 1 Class B Not Applicable Not Applicable RF Emissions CISPR 11 RF Emissions CISPR 11 Harmonic emissions IEC 61000-3-2 Voltage fluctuations/ flicker emissions IEC 61000-3-3 The FreeStyle Navigator system is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. The FreeStyle Navigator system uses RF Energy only for its Intended function.
12.6 dBuV/m @ 203.48MHz 80Mhz-3000MHz 10V/m @ 80% 1kHz AM Modulation 108 second dwell time 80Mhz-3000MHz 10V/m @ 80% 1kHz AM Modulation 108 second dwell time 80Mhz-2500MHz 3V/m @ 80% 1kHz AM Modulation 2.874 msec dwell time 80Mhz-2500MHz 3V/m @ 80% 1kHz AM Modulation 2.874 msec dwell time ±2 kV for power supply lines ±1 kV for input / output lines ±1 kV for Differential mode ±2 kV for common mode <5% for 0.
80 – 800MHz d = 1.2 0.12 0.38 1.20 3.79 12.00 800MHz - 3GHz d = 2.3 0.23 0.73 2.30 7.27 23.00 Separation distance according to frequency of transmitter (m) Customer Care: 1-866-597-5520 For Transmitters rated a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
Compliance Level 80MHz -3000MHz 10V/m @ 89% 1kHz AM Modulation 108 second dwell Time Test Level 80MHz -3000MHz 10V/m @ 89% 1kHz AM Modulation 108 second dwell Time (m) @ 800 MHz to 2.5GHz d = 2.3 Interference may occur in the vicinity of equipment marked with the following symbol: Field strengths from RF transmitters, as determined by an electromagnetic site surveya should be less than the compliance level in each frequency rangeb.
170 Section 19 Appendix C: Classification/Compliance/Declaration 19 Appendix C: FCC Compliance Information (con’t) Caution: The radio receiver and transmitter of your FreeStyle Navigator system operate on the frequency of 433.6 MHz. Primary users of this frequency band include amateur “HAM” radio transmitters.
Section 19 171 Appendix C: Classification/Compliance/Declaration 19 Appendix C: FCC Compliance Information (con’t) Receiver Model Number: PRT03410-xxx. Operating Environment: For Home or Office Use. DECLARATION OF CONFORMITY We, Abbott Diabetes Care Inc. 1360 South Loop Road Alameda, California 94502 510-749-5400 Declare under our sole responsibility that the product FreeStyle Navigator Receiver Part Number: PRT03410-xxx Complies with Part 15 of FCC Rules.
Customer Care: 1-866-597-5520
20 Glossary
174 Section 19 Appendix C: Classification/Compliance/Declaration Customer Care: 1-866-597-5520
20 Section 20 175 Glossary 20 Glossary Adhesive Enhancers Products that can help the adhesive pad on the sensor support mount stick better to your skin Alarms Sounds, vibrations, or text that are used by the receiver to notify you of certain conditions. Alarms Menu A menu you can access from the Main menu. From the Alarms menu, you can turn an alarm on or off, set its sensitivity, and select alarm type.
176 Section 20 Glossary 20 Glossary (con’t) One of two modes in which the system functions (the other is Blood Glucose mode). You will use Continuous Monitoring Mode this mode most of the time. It displays the glucose level in your interstitial fluid continuously, as measured by the sensor you place just beneath your skin. Along with the glucose numbers, this mode also displays a directional glucose trend arrow.
Section 20 177 Glossary 20 Glossary (con’t) Glucose Trend Arrows Arrows shown on the receiver that let you know whether your glucose levels are stable, increasing, or decreasing, and how quickly they are changing. Hematocrit A measure of the amount of red blood cells in your body. High Glucose Alarm Notifies you when you go above your high glucose threshold (a number you and your healthcare team will set). High Glucose Threshold The level you do not want your glucose level to rise above.
178 Section 20 Glossary 20 Glossary (con’t) Line Graph Reports Show continuous glucose lines (plotted at 10-minute intervals) for several different periods (2, 4, 6, 12, or 24 hours). Link This procedure is performed so that the receiver can be paired with a transmitter. Once linked, the receiver would know to accept information from that transmitter alone. When shipped out of the factory, the receiver and transmitter are already linked.
Section 20 179 Glossary 20 Glossary (con’t) Reports Information about your glucose levels shown in a way to help you and your healthcare team analyze changes in your glucose levels and your treatment plan (such as changes in insulin doses, carbohydrate intake, etc.) Several types of reports are available. Sensor The part of the system that you insert under your skin. Each inserted sensor is intended to remain in place and provide a continuous glucose reading for up to 5 days.
180 Section 20 Glossary 20 Glossary (con’t) State of Health Event A record of health-related events, symptoms, and other observations that may help you see patterns in your glucose levels. Statistical Reports A comprehensive summary of glucose results relative to your glucose targets. You can view statistical reports for 1, 3, 7, 14, 21, or 28-day periods. Viewing this kind of information can help you see patterns in your glucose levels.
21 Index
Customer Care: 1-866-597-5520
21 Section 21 183 Index 21 Index Add Events 111 Country Settings Adhesive Adhesion To Skin 40, 105 Adhesive Enhancers 147 Adhesive Removers 37 Arrow Directional Glucose Trend Arrow 83, 84 Arrow Buttons 3 121 Average Backlight 4, 85 Battery Replace Transmitter Battery 16 Replace Receiver Batteries 16 Battery Life 15, 151, 152 Blood Glucose Perform Blood Glucose Test Blood Glucose Mode 12 56 Calibrate Calibrate Your System 53 Sites For Calibration 57 Time To Calibrate 54 Carbs 81 Daily Use Alarm
184 Section 21 Index 21 Index (con’t) 84 Icons Site Select An Insertion Site 38 Blood Glucose Test Site 57 Maintain Your Site 147 Site Rotation 147 Prepare Insertion Site 38, 39 Insertion Sensor Insertion 41 Insertion Site 38, 39 Insulin 112, 113 Interstitial Fluid Standard Deviation 1, 10, 162 State Of Health 4, 119 Line Graph Link Specifications 151 165 Interference Statistics 131 Status 121 113, 122 121 90, 91 Meals 112 Symbols Mode Continuous Monitoring Mode 12 Blood Glucose M