Continuous Glucose Monitoring System User’s Guide
The FreeStyle Navigator™ Continuous Glucose Monitoring System (the “System”) continually reads, displays, and records interstitial fluid glucose levels in people with diabetes as an alternative to traditional blood glucose monitoring. It provides readings directly to the user in real time. It also provides alarms for the detection and assessment of episodes of hypoglycemia or hyperglycemia.
IMPORTANT INFORMATION System-Related Information • The FreeStyle Navigator Continuous Glucose Monitoring System is designed as a complete System. Use only the FreeStyle Navigator Sensor, FreeStyle Navigator Transmitter, and FreeStyle Navigator Receiver. • The System is intended for your own personal use; do NOT share your System. • If you are unsure about the meaning of any Receiver messages or results, consult your healthcare team or call the Clinical Trial Support Line at 1-888-9714766.
• The Sensor should be removed if redness, pain, tenderness, or swelling develops at the insertion site. • The Sensor Support Mount and Transmitter are water resistant and may be worn while bathing, showering, or swimming. While swimming, make sure you do not go deeper than 1 meter (roughly 3 feet) or the Sensor gasket might leak, causing the Transmitter to stop working properly.
• The System is not intended to be used for diagnosing diabetes, testing newborns, or testing arterial blood. • Test results below 60 mg/dL (3.3 mmol/L) mean your glucose levels are too low. • Test results above 300 mg/dL (16.7 mmol/L) mean your glucose levels are too high. • Severe dehydration and excessive water loss may cause false low results. If you believe you are suffering from severe dehydration, consult your healthcare team immediately.
• It is recommended that you test your finger or palm at the base of your thumb if you are testing for hypoglycemia or if you suffer from hypoglycemia unawareness (see Table below). Changes in glucose levels may be observed in finger or palm blood samples sooner than in samples from alternate sites (forearm, upper arm, hand, thigh, calf). Vigorous rubbing of alternate sites before lancing can help minimize this difference. How Would I Know if I Have Hypoglycemia Unawareness? Yes No 1.
Health-Related Cautions • The Low and High Glucose Alarms are not intended to indicate severe hypoglycemia or hyperglycemia because the Low Glucose Alarm can not be set below 60 mg/dL (3.3 mmol/L) and the High Glucose Alarm can not be set above 300 mg/dL (16.7 mmol/L). • Therapy adjustment should be done only with guidance of a healthcare professional.
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TABLE OF CONTENTS IMPORTANT INFORMATION ....................................................................3 System-Related Information ............................................................3 System-Related Warnings and Cautions .........................................3 Health-Related Information ..............................................................4 Health-Related Cautions..................................................................7 INTRODUCTION……....................................
Preparing the Insertion Site.................................................45 Inserting the Sensor ............................................................45 When to Change the Sensor ...............................................49 Site Rotation .......................................................................49 Site Maintenance ................................................................50 Removing the Sensor..........................................................51 The Transmitter.....
Unlinking the Transmitter and Receiver ........................................92 Relinking After Unlinking................................................................93 SECTION 5: ADVANCED FEATURES Alarms… .....................................................................................101 Accessing the Alarms Menu..............................................102 Setting Low and High Glucose Alarms..............................103 Setting Projected Low and Projected High Glucose Alarms......
State of Health Event ........................................................138 Generic Event ...................................................................138 SECTION 6: MAINTENANCE ................................................................141 Cleaning the Transmitter..............................................................141 Cleaning the Receiver..................................................................141 Changing the Transmitter Battery ........................................
INTRODUCTION The FreeStyle Navigator™ Continuous Glucose Monitoring System (the “System”) is designed to give people with diabetes an accurate continual reading of their glucose levels in real time. It does this by measuring glucose levels in the interstitial fluid— the fluid in the tiny spaces between your tissues—via a small, thin, plastic Sensor inserted just under the skin. The System is designed to be used instead of traditional meters that use blood to measure glucose levels.
above the skin. The Transmitter processes the very low current signals it receives from the Sensor and sends the glucose values to the Receiver once every minute. • A wireless FreeStyle Navigator Receiver that captures and displays glucose measurements. With the press of a button, the Receiver displays the glucose measurements taken from the Sensor. The Receiver also has a built-in FreeStyle Blood Glucose Meter that can be used for blood glucose testing.
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THE SYSTEM This section introduces you to the different parts (components) of your FreeStyle NavigatorTM Continuous Glucose Monitoring System, and explains the difference between the Continuous Monitoring Mode and the Blood Glucose Mode. Tips on sleeping, bathing, swimming, and traveling by plane with your System are also included. Components Your System comes in two kits: a System Kit and a Sensor Kit.
This User’s Guide contains detailed information on the use of these components. Please see “Getting Started” (Section 2) for the basic information you’ll need to start using your System. Continuous Monitoring Mode vs Blood Glucose Mode The System operates in two separate modes: Continuous Monitoring Mode and Blood Glucose Mode. The Continuous Monitoring Mode is the mode you will use most of the time.
Table 1.1. Continuous Monitoring Mode vs Blood Glucose Mode Continuous Monitoring Mode Blood Glucose Mode “Glucose CM” is seen at the top left of “Glucose BG” is seen at the top left of the Display Screen. the Display Screen. Most frequently used mode. Built-in FreeStyle Blood Glucose Meter. Used mainly to calibrate the System. Measures glucose from interstitial fluid Measures glucose from a blood sample detected by a Sensor in your skin. that you supply.
Daily Living When using the System, you will be wearing a Sensor and Transmitter at all times (day and night). Only wear the Sensor/Transmitter on your abdomen or on the back of your upper arm. Keep these things in mind as you go about your normal routine. • Sleeping—The Sensor and Transmitter should not interfere with your normal sleeping patterns.
After your flight: 1. Insert a new battery into the Transmitter (see page 28). If you reinsert the old battery, the battery life timer will not be accurate, and the battery may stop working without warning. 2. Relink the Transmitter to the Receiver (see page 93). 3. Insert a new Sensor (see page 45) and attach the Transmitter (see page 57).
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2. GETTING STARTED This section contains everything you need to know to begin using your FreeStyle Navigator Continuous Glucose Monitoring System. You may also want to use the separate “Getting Started Guide” while going through these steps.
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The Receiver: Initial Set-up Clinical Trial Support Line: 1-888-971-4766 ART05005-REV-4 - 25 -
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The Receiver: Initial Set-up This section contains information on installing the Receiver’s batteries, using the Receiver’s buttons, and setting the date and time. Step-by-step instructions for performing a Control Solution test (to ensure that the Receiver is working properly) are also included. The FreeStyle NavigatorTM Receiver (see below) looks and feels much like a traditional blood glucose meter.
The Receiver (Back) Battery Door Installing the Batteries The receiver is designed to operate for 90 days with 2 AAA alkaline batteries. To install the batteries: 1. Press down on the ridged part of the Battery Door on the back of the Receiver and slide the Battery Door out. 2. Insert 2 new AAA alkaline batteries into the compartment. Line up the batteries with the +/- inside the compartment. 3. Close the Battery Door by sliding it into place. Push the Battery Door until it clicks.
Battery life may be shorter than 90 days if your Receiver’s alarms are set to vibrate (see page 112), if you use backlighting frequently, or if the Transmitter/Receiver connection is broken often. If you will not be using your Receiver for an extended period of time, you can unlink it from the Transmitter (see page 92) or remove the batteries from the Receiver to preserve their life. IMPORTANT: An alarm will sound and a Battery Icon will appear on the screen when your Receiver batteries are running low.
To turn the Receiver display screen on with backlighting: 1. Press the Down Arrow Button (see below). 2. Then press the Right Option Button (see below). The Receiver will turn on with the backlight illuminated. Setting the Date and Time You must set the correct date and time when you first install new batteries, and to adjust for Daylight Savings Time. When changing your batteries, be sure to finish within 10 minutes to preserve your date/time settings. To set the date and time: 1.
4. Use the Up/Down Arrow Buttons to highlight Set Date/Time. Press the Right Option Button to Select (see below). 4. Press the Left Option Button to move from one field to the next. 5. Use the Up/Down Arrow Buttons to increase or decrease the numbers (see below). 6. When you are done, press the Right Option Button to Set the date and time. Press the Left Option Button to return to the Main Menu (or wait 12 seconds and the display screen will automatically turn off).
NOTE: If you make a mistake or want to exit from the Set Date/Time screen, simply leave the Receiver alone for 12 seconds. It will automatically turn off, and any changes you made will be cancelled or cleared. IMPORTANT: Be sure to set the date and time correctly. The accuracy of Line Graph and Statistical Reports depends on accurate date/time settings.
• When your Receiver is dropped, damaged, or exposed to liquids. • When your healthcare team advises you to do so. CAUTION: Do NOT use FreeStyle Control Solution for calibration. FreeStyle Control Solution is good for 3 months after opening the bottle, or until the expiration date printed on the label, whichever comes first. Count forward 3 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.
• Error in performing test. • Watered-down Control Solution. • Code on Test Strip vial does not match code set in Receiver. • Receiver malfunction. • Control Solution test done outside 59° to 104°F (15° to 40°C). IMPORTANT: The Control Solution range is a target range for Control Solution only. It is NOT a target range for your blood glucose levels. If your Control Solution test results continue to fall outside the range printed on the Test Strip vial, the Receiver may not be working properly.
To perform a Control Solution test: 1. Insert only the top end of the Test Strip into the Receiver (with the dark-colored rectangle going into the Receiver; see below). Grasp the bottom of the Test Strip with the name “FreeStyle” on the Test Strip facing up. Insert the top of the Test Strip into your Receiver until it stops. This will turn on the Receiver. (See above Table for important Test Strip information.) 2.
NOTE: If you do not change or set the Test Strip code number within 3 seconds, the Receiver automatically moves on to the next step and will accept a Control Solution using the existing Test Strip code number. If you need to change the Test Strip code number, press the Left Option Button to go Back to the previous screen, or simply remove the Test Strip and reinsert it. Then carefully select the correct Test Strip code number as described in Step 2. 3.
5. A stopwatch will appear on the Display Screen while the Receiver is measuring the Control Solution glucose level (see below). The Receiver will beep twice when the Control Solution test result appears. 6. The Receiver will ask you if the result is from a Control Solution test. Select Yes by pressing the Left Option Button (see below). If you do not select Yes, the System will record the result not as a Control Solution result but as a blood glucose result.
7. Compare your Control Solution test result to the range printed on your Test Strip vial label (see below). Your Control Solution result should fall within the range printed on the side of your Test Strip vial. If your test result does not fall within the range, repeat the Control Solution test with a new Test Strip. 8. Remove and discard the Test Strip. (Test Strips may be used only once.) 9. Clean the Receiver after any Control Solution test (see page 141). You are now ready to insert the Sensor.
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The Sensor To measure glucose levels, you must insert the tip of a small thin plastic FreeStyle Navigator Sensor (see below) under your skin. The Sensor Delivery Unit (see below) is designed and packaged to enable safe insertion of the sterile electrochemical glucose Sensor into your skin. Each inserted Sensor is intended to remain in place and provide a continuous glucose reading for up to 3 days.
The Sensor Support Mount Top of sensor support mount Sensor The Sensor Inserter is a plastic-cased device that is cylindrical-shaped. A precocked, coiled spring is connected to a needle, used to guide the Sensor for insertion. With a single push of the Insertion Button, the needle guides the Sensor into the skin and is quickly withdrawn from the skin. The Locking Pin is designed to avoid accidental discharge of the Sensor Inserter.
When to Insert the Sensor It’s best to insert the Sensor when your glucose levels are stable, because you will not have continuous monitoring data during the hour after insertion and you will not be able to calibrate the System if your glucose levels are changing rapidly. If you eat before you are due to calibrate, you may not be able to perform the calibration until your glucose levels stabilize.
Selecting the Insertion Site Wear the Sensor and Transmitter only on your abdomen or the back of your upper arm (see below). NOTE: Avoid areas where the edges of clothing may catch or rub against the Sensor. Do NOT insert the Sensor in the same place it was just inserted. Avoid areas with scars, stretch marks, or lumps. Select an area of skin that stays flat during your normal daily activities (no bending or creasing). Avoid areas with excess hair, or consider shaving the area.
CAUTION: You cannot rely on obtaining glucose results if the Sensor Support adhesive Mount fails to adhere to the skin because of improper site selection. Preparing the Insertion Site 1. Wash your hands thoroughly with soap and water. 2. Clean the selected area with soap and water. Be sure to rinse and pat the area dry. 3. After the area is dry, you may also wipe the area with an IV Prep wipe to promote adhesion. NOTE: The insertion area must be clean and dry.
2. Remove the adhesive protective liner from the bottom of the Sensor Support Mount. The adhesive protective liner has two sections. Bend it slightly so you can see the seam. Peel away the smaller section first. Then remove the larger section (see below). 3. Place the Sensor Support Mount, adhesive side down, on the cleaned area of skin at the insertion site (see below).
4. Smooth the adhesive pad against your skin with your fingers. Hold it firmly in place to make sure it sticks to the skin. NOTE: Do NOT place a bandage under the Sensor. If you use a bandage, the Sensor may not penetrate the skin and the System will not work. 5. Remove the Locking Pin by using your thumb and index finger to twist it a quarter turn (see below). Pull it away to remove. The Sensor Support Mount adhesive will help to keep the Sensor Support Mount in place. 6.
CAUTION: Once the Locking Pin has been removed and the button is pressed, a needle will quickly go just under your skin to place the Sensor. Do NOT press the button until you are ready to insert the Sensor. 7. Hold the Sensor Inserter and firmly squeeze the two blue Release Tabs at its base (see below). Lift the Sensor Inserter straight up and away from the Sensor Support Mount. Make sure the Sensor Support Mount remains on your skin. 8. Check that the Sensor has been properly placed (see below).
readings. If the drop of blood is larger than the example shown below, remove the Sensor, clean the site, and cover with a bandage. Select a new Sensor insertion site and insert a fresh Sensor. Example: 9. Discard the Sensor Inserter in a sharps container or other puncture-proof container with a lid. When to Change the Sensor The Sensor MUST be changed at least every 3 days.
Site Maintenance Careful site preparation and maintenance can help to lower the risk of infection and improve Sensor adhesion. A number of helpful products are available: • Antiseptics—If you tend to develop infections at the Sensor insertion site, consider prepping the skin with an antiseptic. Ask your healthcare team which antiseptic is best for you. • Dressings and Skins—If you are having trouble with the Sensor Support Mount sticking to your skin, consider applying a bandage over the Transmitter.
Removing the Sensor 1. If needed, use an adhesive remover application pad to wipe a small amount of adhesive remover around the edges of the Sensor Support Mount. Or, moisten a cotton ball with adhesive remover and dab it around the edges of the Sensor Support Mount. 2. With the Transmitter still attached to the Sensor Support Mount, grasp the top end of the adhesive and slowly peel it off your skin in one continuous motion (see below).
3. Unhook the latch on the bottom of the Transmitter and slide the Transmitter off the Sensor Support Mount (see below). Discard the Sensor Support Mount (with the Sensor attached). The Sensor Support Mount and Sensor cannot be reused. Do NOT discard the Transmitter. 4. Gently wash the Transmitter with soap and water (see page 141). Rinse thoroughly. Dry thoroughly with a clean, soft, lint-free cloth. 5.
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The Transmitter The FreeStyle Navigator Transmitter is a small electronic device that makes an electrical connection to the portion of the Sensor that extends above the skin (see below). The Transmitter processes the very low current signals it receives from the Sensor and sends the glucose values to the Receiver once every minute. The Transmitter contains a replaceable battery (silver oxide 357) that is designed to provide one month of service.
Installing the Transmitter Battery The Transmitter is designed to operate for 30 days with a single silver oxide 357 battery (small coin cell battery). To insert the Transmitter battery: 1. Using a coin or fingernail, rotate the small circular Battery Door on the Battery Door back of the Transmitter counterclockwise. Remove the Battery Door carefully. 2. Insert a new silver oxide 357 battery. 3. Replace the Battery Door and rotate clockwise (see below).
IMPORTANT: The Receiver will sound an alarm and display a ”Replace TX Battery with New Sensor” message 4 days before the Transmitter battery needs to be changed. Replace the Transmitter battery just before you insert a new Sensor. Attaching the Transmitter to the Sensor 1. After the Sensor has been inserted, place the Transmitter partway over the Sensor Support Mount with the front facing away from the Sensor Support Mount. 2. Slide the Transmitter until it clicks into place (see below).
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The Receiver: Calibration and the Blood Glucose Mode Clinical Trial Support Line: 1-888-971-4766 ART05005-REV-4 - 59 -
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The Receiver: Calibration and the Blood Glucose Mode Once you insert the Sensor and attach the Transmitter, you need to complete just 2 more steps before beginning to receive continuous glucose readings: 1) enter the Sensor code into the Receiver and 2) calibrate the Receiver. Entering the Sensor Code Into the Receiver 1. Within 2 minutes of attaching the Transmitter to the Sensor, the Receiver will beep once to let you know that it recognizes a new Sensor.
2. The Receiver will ask you to select the Sensor code number (see below). 3. Use the Up/Down Arrow Buttons to change the number on the Receiver Screen to match the number on the packaging (see below). Press the Right Option Button to Set.
Calibrating the Receiver and Using the Blood Glucose Mode Your last step in setting up the System is to calibrate the Receiver. You do this by measuring the glucose level in a drop of capillary blood using the Blood Glucose Mode. The Receiver compares the reading it gets from the capillary blood to the reading the Sensor takes from the interstitial fluid (where glucose levels are measured in the Continuous Monitoring Mode). The Receiver can then calculate accurate, real-time glucose readings.
Table 2.1: Calibration Test Details Calibration First Calibration Second Calibration Third Calibration When to Perform What Happens if Calibration is Missed Approximately 1 Continuous hour after Sensor glucose levels will insertion. not be displayed until this An alarm will sound calibration is and the Receiver performed. The display screen will Receiver display show “Do BG Test”. screen will show A blood drop icon “– – –“. will also appear.
NOTE: During the first hour after the Sensor is inserted, or until you successfully complete your first calibration, the Receiver does NOT calculate glucose levels. During this time, you can perform glucose tests in the Blood Glucose Mode if needed. The Blood Glucose Mode testing can be done at any time. Here is a sample calibration schedule: Day 1 8:00 AM: Insert new Sensor. 9:00 AM: Perform First Calibration (1 hour after insertion).
Switching to the Blood Glucose Mode To switch to the Blood Glucose Mode for blood glucose testing for calibration or other purposes, simply insert a FreeStyle Test Strip into the Test Strip Port. You will know you are in the Blood Glucose Mode because the Display Screen will show Glucose BG in the upper left corner (not Glucose CM). To switch back to the Continuous Monitoring Mode, remove the Test Strip.
CAUTION: It is recommended that you test on your fingers or palm at the base of your thumb if you are testing for hypoglycemia or if you suffer from hypoglycemia unawareness (see page 6). Calibrating Follow these steps to calibrate the System: 1. Approximately 1, 3, and 24 hours after you insert a Sensor, the Receiver will alarm and prompt you to Do BG Test (see below). 2. Insert a FreeStyle Test Strip into the Receiver’s Test Strip Port (see below). Insert the end with the dark rectangle.
3. Once the Test Strip is inserted, the Receiver will automatically display the most recently used Test Strip code number. Compare the code number on the Screen to the code number on the Test Strip vial. If the code numbers match, press the Right Option Button to select Set. If the code numbers do not match, use the Up/Down Arrow Buttons to change the code, and, once the code on the screen matches the code on the Test Strip vial, press the Right Option Button to select Set.
4. The Receiver will prompt you to Apply Sample (see below). 5. Lance the test site to get a blood sample. The lancing device, which is included as part of the System kit, is pictured below.
To use the lancing device I. Wash your hands and the selected test site with soap and water. Make sure there is no lotion on the test site. Thoroughly dry your hands and the test site. II. Snap the clear cap off the lancing device. III. Insert a new FreeStyle lancet firmly into the white lancet cup holder. Pushing the lancet into the cup may cock the device; this is OK. IMPORTANT: Use a new sterile lancet for every test. Never use a lancet for more than one person. IV.
VI. The lancing device offers 4 different depth settings. Move the dial to the desired setting as shown in the depth indicator window. Level 1 is the shallowest depth; level 4 is the deepest. To lance parts of the body other than the finger, start at level 2 and use the clear cap. To lance your finger, set the depth setting to its shallowest depth (1) and use the grey cap. VII. Pull the dark grey Cocking Handle out until it clicks. You may have already cocked the device in Step III; this is OK. VIII.
To lance your finger: a. Stimulate blood flow by keeping your hand warm or by lowering your hand to waist level and by gently massaging your finger. b. Lightly touch the lancing device (with the grey cap) against the side of your fingertip. c. Press the release button, and then place the lancing device on to the table or desk near you. Gently squeeze your finger, if needed, until a blood drop the size of a pinhead forms (example: ). IX.
6. With the Test Strip in the Receiver, apply blood to the Test Strip by bringing the edge of the Test Strip to the blood sample at a slight angle and by gently touching the Test Strip—at the half-circle, and at a slight angle—to the blood sample (see below). Blood will be absorbed into the Test Strip. When Using FreeStyle Test Strips: • Do NOT press the Test Strip down hard against the test site. • Do NOT scrape the blood. • Do NOT apply blood to the flat side of the Test Strip.
NOTE: If after 5 seconds you don’t see the Stopwatch Icon on the Receiver display screen, the blood sample may be too small. You can continue to add blood to the Test Strip for up to 60 seconds as long as you apply blood to the same edge of the Test Strip. Low and High Glucose Results The Receiver displays results from 20 to 500 mg/dL (1.1 to 27.8 mmol/L). CAUTION: Low or high glucose measurements can indicate a potentially serious medical condition. LO Readings If your test result is below 20 mg/dL (1.
HI Readings If your test result is above 500 mg/dL (27.8 mmol/L), “HI” appears on the Receiver display screen. This reading indicates severe hyperglycemia (high blood glucose levels). • If you get a “HI” reading and have symptoms such as fatigue, thirst, excess urination, or blurry vision, follow your healthcare team’s recommendations for treating hyperglycemia. • If you get a “HI” reading but have no high blood glucose level symptoms, retest with a new Test Strip.
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USING THE RECEIVER Once you’ve inserted the Sensor, attached the Transmitter, and calibrated the Receiver (see Section 2), you are ready to start using your FreeStyle NavigatorTM Continuous Glucose Monitoring System. This section introduces you to the Receiver’s basic functions. The Glucose (Initial) Display Screen The first screen you see when you turn your Receiver on displays your current glucose level (updated every minute) and a Glucose Trend Arrow (see below).
Table 3.1. Glucose Trend Arrows Glucose Trend Description Arrow Relatively Stable A horizontal Glucose Trend Arrow means your glucose is relatively stable (changing at a rate of less than 60 mg/dL/hr [3.3 mmol/L/hr]). Moderate Rise A Glucose Trend Arrow angled upward means your glucose is increasing moderately (at a rate of greater than 60 mg/dL/hr [3.3 mmol/L/hr] but less than 120 mg/dL/hr [6.7 mmol/L/hr]).
The current time of day can be seen in the display screen’s upper right corner. See page 30 for instructions on how to change the date and time. NOTE: To save on battery power, the Receiver display screen goes blank after 12 seconds of no activity. To turn the Receiver display screen back on, simply press the Right Option Button. Main Menu The Receiver’s Main Menu displays a list of options that allow you to perform many functions and view specific information (see below). To use the Main Menu: 1.
Table 3.2. Main Menu Options Main Menu Options Description Glucose Allows you to see your current continuous glucose level and Glucose Trend Arrow. Alarms Allows you to set and activate different types of alarms. Reports Allows you to view past and current glucose readings and other information in order to evaluate glucose trends and recent therapy decisions (insulin doses, carbohydrate ratio calculations, etc.) System Allows you to view the System Menu.
Icons Icons (graphic symbols) may appear on the Receiver’s Glucose (initial) screen or Main Menu screen. These icons alert you to non-urgent system conditions or required actions. Icons are listed in the Table 3.3. Table 3.3. Icons Icons Description A stopwatch icon appears when the System is processing a Control Solution or blood glucose sample in the Blood Glucose Mode. This icon goes away when the test result appears. A blood drop icon means it is time to do a calibration.
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MAINTAINING THE TRANSMITTER/RECEIVER CONNECTION The Transmitter sends glucose measurements to the Receiver once every minute using radio frequency transmission. The Transmitter and Receiver must be within 10 feet of each other to maintain a consistent connection. If the Transmitter is more than 10 feet from the Receiver, the connection may be broken and you will not receive continuous glucose readings.
Refer to Table 7.2 on page 152 for more information about connection-specific alarms. To temporarily silence the alarms without reconnecting, press the Left Option Button to Acknowledge the alarms. In addition to distance, there are other factors that can affect the Transmitter/Receiver connection: • Receiver Location—In some cases, where the Receiver is located relative to the Transmitter can affect the connection.
Reconnecting Automatically If the Transmitter/Receiver connection is broken, the Receiver will continually try to reconnect with the Transmitter. To reconnect, move the Receiver to within 10 feet of the Transmitter. Wait for the connection icon to disappear from the display to confirm reconnection. Reconnecting Manually If the Receiver has not been connected to the Transmitter for 30 minutes or more, you will need to follow these steps to manually reconnect: 1.
review the information at the beginning of this section, or refer to “Troubleshooting” (Section 7). Linking the Receiver to a New Transmitter When you first receive your System, the Transmitter and Receiver will already be linked. If you replace the Transmitter, you must unlink the old Transmitter from the Receiver, and then link the new Transmitter. You should do this just before inserting a new Sensor.
5. The Display Screen will show the current Transmitter ID. Press the Left Option Button to select Unlink (see below). This will unlink/disconnect the old Transmitter. 6. The display screen will next ask if you want to perform a blood glucose test (BG) or to relink to a Transmitter (see below). Press the Right Option Button to select Relink (see below). 7. Wait for the Receiver to detect the Transmitter and display the Transmitter serial number (ID). This may take up to 70 seconds.
8. Once the Receiver has detected the new Transmitter, the display screen will show the following: 9. Check the ID on the bottom of your Transmitter. If it matches the ID that appears on the display screen, press the Right Option Button to select Yes. CAUTION: If you accept an incorrect Transmitter ID, your glucose readings will be incorrect. Your Transmitter and Receiver are now linked. Unless you unlink the Transmitter and Receiver, you will not have to relink again until you replace the Transmitter.
3. Use the Up/Down Arrow Buttons to highlight Link. Press the Right Option Button to Select. 4. Press the Left Option Button to select Unlink. 5. Press the Left Option Button to select BG. NOTE: You can still perform blood glucose measurements in Blood Glucose Mode while the Transmitter and Receiver are unlinked. Relinking after Unlinking 1. Place the Transmitter within 10 feet of the Receiver. 2. Press the Receiver’s Right Option Button once to turn the Receiver on. Press it again to see the Main Menu. 3.
6. Once the Receiver has detected the new Transmitter, the display screen will show the following: 7. Check the ID at the bottom of your Transmitter. If it matches the ID that appears on the screen, press the Right Option Button to select Yes.
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ADVANCED FEATURES This section explains the use of the FreeStyle NavigatorTM Continuous Glucose Monitoring System’s more advanced features—Alarms, Reports, System, and Add Events—which can be accessed through the Main Menu. NOTE: The Main Menu also includes a Glucose option; for more information about this option, see page 79.
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Alarms The Receiver has seven different alarms—four to alert you to glucose conditions, two for System features, and one for Progress Tones. Alarms are listed in Table 5.1. Table 5.1. Alarms Alarm Low Glucose Description Notifies you when you are at your low glucose threshold (a number you and your healthcare team will set). High Glucose Notifies you when you are at your high glucose threshold (a number you and your healthcare team will set).
Accessing the Alarms Menu 1. Select Alarms from the Main Menu (see below). 2. The Alarms Menu will appear (see below). 3. Use the Up/Down Arrow Buttons to select the alarm you want to view or modify. Press the Right Option Button and the specified alarm screen will appear. NOTE: You can cancel out of any alarm screen by waiting 12 seconds without making a selection. If you don’t press any buttons for 12 seconds, the Receiver screen will go blank.
Setting Low and High Glucose Alarms Low and High Glucose Alarms can be set to notify you when your glucose levels reach a certain low or high threshold. Your healthcare team should help you determine appropriate thresholds. Low Glucose Alarms can be set to anywhere between 60 and 139 mg/dL (3.3 and 7.7 mmol/L). High Glucose Alarms can be set anywhere between 140 and 300 mg/dL (7.8 and 16.7 mmol/L).
2. The first setting on the Low/High Glucose alarm screen is on/off. To move to another option (low or high glucose threshold, type of alarm), press the Left Option Button to select Next. 3. To change the settings, use the Up/Down Arrow Buttons to increase/decrease numbers or move between selections in a field (see below). 4. Press Next (Left Option Button) to move from one field to the next. 5. Press Set (Right Option Button) to accept the settings and return to the Alarms Menu.
warning alarms (which determines how far in advance you are alerted) from the Projected Alarm screens. NOTE: The System uses your low and high glucose thresholds as a basis for triggering Projected Alarms, regardless of whether or not the Low or High Glucose Alarms are turned on. From the Projected Low and Projected High Alarm screens you can: • Turn the Projected Alarms on or off. • Set or change alarm sensitivities (see Table 5.
Table 5.2. Alarm Sensitivity (Projected High/Low Glucose Alarms) Sensitivity High Estimated Time Before Glucose Level Reaches High or Low Threshold 30 minutes When to Use If you want to be warned far in advance if your glucose level approaches your high or low glucose threshold, set the sensitivity to High and you will be warned approximately 30 minutes ahead of when the System thinks you will reach the threshold.
To set or change Projected Alarms: 1. Select Projected Low or Projected High from the Alarms Menu (see below). 2. The first setting option on the Projected Low or Projected High Alarm Screen is on/off. To move to another option (sensitivity, alarm type), press the Left Option Button to select Next. 3. To change the settings use the Up/Down Arrow Buttons to move between selections in a field (see below). 4. Press Next (Left Option Button) to move from one field to the next. 5.
After making an adjustment or reviewing settings, the Receiver will play back a brief example of the alarm you selected. If the alarm is turned off, you will not receive an audible playback of the setting but a message will display on the screen. Setting Data Loss Alarms Data Loss Alarms notify you when: • The Sensor is expired. • The Transmitter/Receiver connection is broken. From the Data Loss Alarm Screen you can: • Turn Data Loss Alarms on or off.
2. The first setting option on the Data Loss alarm screen is on/off. To move to alarm type, press the Left Option Button to select Next (see below). 3. To change the settings use the Up/Down Arrow Buttons to move between selections within a field. 4. Press Next (Left Option Button) to move from one field to the next. 5. Press Set (Right Option Button) to accept the settings and return to the Alarms Menu.
From the System Alarm screen you can: • Turn System Alarms on or off. • Select alarm type (low, medium, or high beep or short, medium, or long vibration). IMPORTANT: If you turn off System Alarms, you will not get the calibration prompts after you insert a new Sensor. To set or change System Alarms: 1. Select System from the Alarms Menu (see below). 2. The first setting option on the System Alarm screen is on/off. To move to alarm type, press the Left Option Button to select Next.
3. Change the desired settings (on/off, alarm type) by using the Up/Down Arrow Buttons to move between selections within a field (see above). 4. Press Next (Left Option Button) to move from one field to the next. 5. Press Set (Right Option Button) to accept the settings and return to the Alarms Menu. After making an adjustment or reviewing settings, the Receiver will play back a brief example of the alarm you selected.
2. The first setting option in the Progress Tones screen is on/off. To move to tone option, press the Left Option Button to select Next. 3. To change the settings use the Up/Down Arrow Buttons to move between selections in a field. 4. Press Next (Left Option Button) to move from one field to the next. 5. Press Set (Right Option Button) to accept the settings and return to the Alarms Menu.
To Mute Alarms: 1. Select Mute Alarms from the Alarms Menu (see below). 2. Press Select (Right Option Button) to mute alarms (see below). Press Select to turn off alarms for 1 hour.
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Reports Clinical Trial Support Line: 1-888-971-4766 ART05005-REV-4 - 115 -
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Reports Your Receiver can provide you with a number of reports, including Line Graphs, Statistical Reports, and Event Histories. IMPORTANT: Be sure to set the date and time correctly (see page 30). The accuracy of Line Graph and Statistical Reports depends on accurate date and time settings. Setting Glucose Targets Your reports will be more meaningful if you set Glucose Targets. Glucose Targets give you something to compare your actual glucose levels with.
3. Press Next (Left Option Button) to move to the next field. Repeat Step 2. 4. Press Set (Right Option Button) to save the settings. Line Graphs Line Graph Reports show continuous glucose lines (plotted at 10-minute intervals) for several different time periods (2, 4, 6, 12, or 24 hours; see below). Line Graph Reports let you see how your glucose levels change over time. Your Glucose Target range is represented by a shaded horizontal band. The selected time period is plotted on the horizontal axis.
To set a time period for a Line Graph Report: 1. Select Reports from the Receiver’s Main Menu. 2. Select Line Graphs from the list of Reports (see below). 3. Select the time period you want using the Up/Down Arrow Buttons. 4. Press the Right Option Button to Select and return to the previous screen. Statistics The System’s statistics screen shows a comprehensive summary of glucose results relative to your Glucose Targets (see below).
To select the time periods for your Statistical Reports: 1. Select Report from the Receiver’s Main Menu. 2. Select Statistics from the list of Reports. 3. Use the Up/Down Arrow Buttons to highlight the statistic you want. 4. Press Next (Left Option Button) to advance to the next time period. Press Back to return to the Reports Menu. NOTE: Statistics include ONLY continuous glucose results. Glucose readings that were taken in the Blood Glucose Mode are not included in the calculations.
Table 5.3. Statistical Reports Statistic Highest CM Description The highest continuous glucose reading over the selected time period. Lowest CM The lowest continuous glucose reading over the selected time period. Ave. CM The average continuous glucose reading over the selected time period. Std. Dev. This number is related to the average glucose level.
Event Histories Event Histories are another type of report that you can select. These reports detail the Events that you have recorded in your Receiver (see page 135 for information about Adding Events). To access Event Histories: 1. Select Reports from the Receiver’s Main Menu. 2. Select Event History (see below). 3. In the Event History menu you will see a list of choices, or filters, through which you can view the events (see below). Types of Event History Reports are listed in Table 5.4.
Table 5.4. Event History Reports Event History Report CM 60 Description Recorded glucose readings (60-minute intervals). Not averaged values. Each CM 60 reading is displayed on a single screen with its date/time. CM 120 Recorded glucose readings (120-minute intervals). Not averaged values. Each CM 120 reading is displayed on a single screen with its date/time. CM 10 Recorded glucose readings (10-minute intervals). Not averaged values.
Event History Report State of Health Description Recorded State of Health. Each State of Health Event entered is displayed with its description (normal, cold, sore throat, infection, for example) and date/time. Generic Recorded Generic Events. Each Generic Event entered is displayed with its description and date/time. Alarm History Recorded Glucose Alarm Events. Each Glucose Alarm Event is displayed with its description (Low Glucose, High Glucose, Projected Low, and Projected High) and date/time.
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System The Main Menu’s System option gives you access to features needed for proper System functioning. System Menu options are listed in Table 5.5. Table 5.5. System Menu Options Menu Option Reconnect Where to Go for More Information See page 89. Data Upload See page 124. Status See below. Link See page 90. Set Date/Time See page 30. Status Information The Receiver can provide you with a number of different types of Status Information. Available Status Information is listed in the Table 5.6.
Table 5.6. Status Information Status Information Removed Description Sensor Alarms will not be set off. System Status Shows information about the System, including Sensor life remaining Allows you to indicate you are removing a Sensor so Data Loss and time since valid data was transmitted. Receiver Status Shows information about the Receiver, including serial number and software version (may be useful when calling Clinical Trial Support), as well as battery life remaining.
System Status System Status allows you to view information about the Sensor. Sensor Life Left will tell you how much Sensor time remains (total Sensor lifespan is 3 days displayed in hours). If the Transmitter/Receiver connection has been broken or if there is a problem with the System, Time Since Sensor Data will tell you how long it has been since the Receiver has received valid data. To view System Status (see below): 1. Select System from the Main Menu. 2. Select Status from the System Menu. 3.
Receiver Status Receiver Status provides you with information regarding the Receiver, including serial number, software version, and battery life remaining (Table 5.7). To view Receiver Status (see below): 1. Select System from the Main Menu. 2. Select Status from the System Menu. 3. Select Receiver Status from the Status Menu. Table 5.7. Receiver Status Field Serial # SW Version Battery Life Description Shows the Receiver’s serial number. Shows the Receiver’s software version.
Transmitter Status Transmitter Status allows you to view the Transmitter serial ID number and battery life remaining (Table 5.8). To view Transmitter Status (see below): 1. Select System from the Main Menu. 2. Select Status from the System Menu. 3. Select Transmitter Status from the Status Menu. Table 5.8. Transmitter Status Field Transmitter ID Description Shows the Transmitter’s serial number. You may need to verify the serial number after linking to a new Transmitter.
Continuous Monitoring (CM) Status Continuous Monitoring (CM) Status lets you view recent error codes related to the Continuous Monitoring Mode (Table 5.9). These codes appear only when the System is not functioning properly. Use this option only under the direction of a Clinical Trial Support representative. Table 5.9. Continuous Monitoring (CM) Status Field Last Reset Can’t Cal Cal Failed Sensor Err Description Stores the reason for the last System reset.
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Add Event The Add Event option allows you to electronically record a variety of activities and observations that may affect your glucose levels. This information may help you evaluate patterns in your glucose control and diabetes management. Once entered, events may be viewed in several ways: • As part of Event History reports (see page122). • As part of Line Graph reports (indicated by small letters stacked on the horizontal time axis; see page 118).
Table 5.10. Events Event Meal Event Description Records details of a meal or snack. A Meal Event may be recorded as carbohydrate grams. This information may help you in carbohydrate counting or determining insulin/carbohydrate ratios. It can also help you recognize glucose patterns. Insulin Event Logs details of an insulin dose (injection or pump) to aid in evaluating dosing decisions.
Insulin Event 1. Use the Left Option Button to select each item (Date, Time, Type of Insulin, Units) and to move from one item to the next. 2. Use the Up/Down Arrow Buttons to select each item. 3. When you are done, press the Right Option Button to Save the Insulin Event. NOTE: Your Insulin Type choices are Rapid, Intermediate, Long Acting, or Pre-mix. Exercise Event 1. Use the Left Option Button to select each item (Date, Time, Type of Exercise, Intensity, Duration) and to move from one item to the next.
State of Health Event 1. Use the Left Option Button to choose each item (Date, Time, State of Health) and to move from one item to the next. 2. Use the Up/Down Arrow Buttons to select each item. 3. When you are done, press the Right Option Button to Save the State of Health Event. NOTE: Your State of Health choices are Normal, Cold, Sore Throat, Infection, Tired, Stress, Fever, Flu, Allergy, Period, Dizzy, Alcohol, Low Symptoms, or High Symptoms. Generic Event 1.
6.
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MAINTENANCE The FreeStyle NavigatorTM Continuous Glucose Monitoring System requires minimal maintenance aside from cleaning and battery replacement. You should, however, avoid getting dirt, dust, blood, control solution, water, or any other substance in the Receiver’s Test Strip Port. The Receiver should be stored in its protective carrying case when not in use. NOTE: The Transmitter and Receiver CANNOT be repaired when broken. There are no replacement parts for these devices except for batteries.
Changing the Transmitter Battery The Transmitter is designed to operate for approximately 30 days with 1 silver oxide 357 battery (small coin cell battery). The Receiver will sound an alarm and display the ”Replace TX Battery with new Sensor” message 4 days before the Transmitter battery needs to be changed. You should wait to change the Transmitter battery until just before you insert a new Sensor. For instructions on changing the Transmitter battery, see page 56.
Disposal of Components • Used Sensor Inserters and lancets should be disposed of in a sharps container or other puncture-proof container with a lid. • Used Transmitter and Receiver batteries should be disposed of according to local regulations. • Should your Transmitter or Receiver need to be replaced, first contact the Clinical Trial Support Line. If they advise you to dispose of either or both of these items, follow your local regulations for disposal of electronic equipment.
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7.
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Alarms, Error Codes, and Troubleshooting Use this section to identify Alarms and Error Codes associated with the Continuous Glucose Monitoring and Blood Glucose Modes. Solutions to problems that may occur are also provided. If you can’t find the information you need, call the Clinical Trial Support Line at 1-888-971-4766.
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Alarms Clinical Trial Support Line: 1-888-971-4766 ART05005-REV-4 - 149 -
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Alarms Continuous Monitoring Alarms alert you to issues related to the Continuous Monitoring Mode. These Alarms are given an Urgency rating based on how soon you need to address the alarm (for example, Low Urgency alarms do not need to be addressed right away, while High Urgency alarms should be addressed immediately; see Table 7.1) Table 7.1: Levels of Alarm Urgency Urgency Level Type of Alarm Low Urgency A single beep.
To acknowledge alarms: • Press the Right Option Button to turn off a vibration or audio alarm. • Press the Left Option Button to turn off a text display message. Table 7.2 provides a complete listing of Continuous Monitoring Mode alarm messages. Table 7.2: Continuous Monitoring Mode Alarm Messages Alarm Urgency* What It Means What To Do Message Calibration Alarms Do BG Test M A Blood Glucose Mode Perform a Blood Glucose test is needed for Mode test (see page 63). calibration.
Alarm Message Do BG Test Alarms Inactive Urgency* What It Means What To Do I Perform a Blood Glucose Mode test. If the alarm persists, remove the Sensor and insert a new one (see page 43). Cal Failed: High BG Redo BG Later I Cal Failed: Low BG Redo BG Later I Cal Failed: Redo BG in 1 HR I Cal Failed: Redo BG Later I Calibration was not performed within the required time; therefore, readings will not be displayed and the alarms are not working.
Alarm Message Cool Down Skin Urgency* What It Means What To Do L Warm Up Skin L Unable to calibrate the System because the skin temperature is too high. Unable to calibrate the System because the skin temperature is too low. Cool the skin at the insertion site. Wait for the “Do BG Test” prompt. Warm the skin at the insertion site. Wait for the “Do BG Test” prompt. The Receiver has not been receiving signals sent by the Transmitter for 8 minutes. Five minutes of data have been lost.
Alarm Message Glucose Level Alarms ——— Urgency* What It Means N/A • Low Glucose H High Glucose M * Urgency is defined as: What To Do • Continuous monitor is not producing glucose results. This is normal for new Sensors before the first calibration (Blood Glucose Mode test) is performed. Low and High Glucose Alarms cannot function while this appears on the display. Connection between • the Transmitter and Receiver is bad. Sensor failure (or Sensor no longer in your skin). Transmitter failure.
Alarm Message Projected High Glucose Urgency* What It Means What To Do M This is an early warning that your glucose level and the rate at which it is changing indicate that you may soon reach your high glucose threshold. Follow the recommendations of your healthcare team for treating or stopping the rise in glucose that you are experiencing. When set to High sensitivity, you probably have about 30 minutes before reaching your high glucose threshold.
Alarm Message Projected Low Glucose Urgency* What It Means What To Do M This is an early warning that your glucose level and the rate at which it is changing indicate that you may soon reach your Low Glucose Threshold. Follow the recommendations of your healthcare team for treating or stopping the drop in glucose that you are experiencing. When set to High sensitivity, you probably have about 30 minutes before reaching your Low Glucose Threshold.
Alarm Message Log Corrupted Some Data Lost Urgency* What It Means What To Do L History log is corrupt. Preferences Lost Reconfigure L The Receiver detected a corrupt sector in the log and erased it. The data in this sector is lost. Your reports will not contain this lost data. If the error occurs again, call Clinical Trial Support. Review your alarm settings. An error occurred with the Receiver configuration. The Receiver has reset. Your stored preferences may be lost.
Alarm Message Alarms Inactive Replace Sensor Urgency* What It Means What To Do I The Sensor is not functioning properly. The alarms are not working. Remove the Sensor and insert a new one (see page 43). Alarms Inactive Skin Temp Range I Remove Any Sensor Alarms Inactive I Did You Remove the Sensor? L Skin temperature at the Remove the Sensor and insertion site is either too insert a new one (see page low or too high for the 43). System to produce correct readings.
Alarm Message Replace Sensor Soon Transmitterrelated Alarms Transmitter Error Alarms Inactive Urgency* What It Means What To Do L The Sensor will reach the end of its life within 2 hours. Replace the Sensor within the next 2 hours (see page 43). I Transmitter problem. Alarms are not working. Alarms I Inactive Replace Transmitter * Urgency is defined as: Wait for the problem to go away. If problem persists for 50 more minutes, you will get the alarm “Alarms Inactive Replace Transmitter.
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Error Codes A complete listing of the Blood Glucose Mode Error Codes can be found in Table 7.3. Table 7.3: Blood Glucose Mode Error Codes Error Code Er1 Er2 What It Means • Not enough blood was applied to Test Strip. • Problem with Test Strip. • Problem with Receiver. • Very low blood glucose (less than 20 mg/dL [1.1 mmol/L]). • Problem with the Test Strip. • Problem with Receiver. • Very high blood glucose (greater than 500 mg/dL [27.8 mmol/L]).
Error Code Er3 Er4 What It Means • Incorrect procedure (for example, blood was applied to Test Strip before Test Strip was inserted into Receiver). What To Do • Be sure you see Apply Sample on the Receiver screen before you apply blood or Control Solution. • Perform a Control Solution test using a new Test Strip. If results are within the range printed on Test Strip vial, retest your blood using a new Test Strip. If Control Solution Test does not work or error code persists, call Clinical Trial Support.
Troubleshooting Clinical Trial Support Line: 1-888-971-4766 ART05005-REV-4 - 165 -
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Troubleshooting A list of problems that may occur as you use your System—along with suggested solutions—is presented in Table 7.4. Table 7.4: Troubleshooting Problem Receiver does not turn on when you press the Right Option Button or insert a Test Strip. Possible Cause • Batteries are dead. • • Batteries were installed incorrectly. Test Strip was inserted incorrectly or incompletely. What To Do • Change batteries, then reset time and date (see page 30).
Problem Blood glucose test does not start after you apply the sample. Unexpected characters on the Receiver screen, unusual screen appearance, or unexpected screen appearance. Discomfort during Sensor insertion. Possible Cause • Sample was too small. • Sample was applied after Receiver automatically shut off. • • Defective Test Strip. Defective Receiver. • Batteries failing. What To Do • Repeat the test with a new Test Strip and larger sample. • Repeat the test with a new Test Strip.
Problem Sensor Support Mount is not sticking to your skin. Possible Cause • Dirty or wet skin at insertion site. • Lotion at insertion site. Skin irritation at Sensor insertion site. What To Do • Clean the Sensor insertion site by washing with soap and water. Make sure your skin is clean and thoroughly dry before placing Sensor Support Mount on skin. • Wipe the skin with an IV Prep wipe before inserting the Sensor.
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APPENDICES Clinical Trial Support Line: 1-888-971-4766 ART05005-REV-4 - 171 -
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Appendix A: Clinical Study for Palm and Finger Test A clinical study was conducted to compare glucose readings using blood from the finger and blood from the palm at the base of the thumb. Forty-one subjects with type 1 diabetes were given a glucose challenge to raise glucose to a hyperglycemic state and then given subcutaneous insulin to reduce glucose to a normal or hypoglycemic state.
Appendix B: Performance Characteristics Description The FreeStyle NavigatorTM System is designed to continuously monitor glucose levels in subcutaneous tissue fluid in the range 20 to 500 mg/dL (1.1 to 27.8 mmol/L). Clinical studies have shown that subcutaneous tissue fluid glucose measurements by the System generally agree with fingerstick or alternate site blood glucose values and with venous laboratory values.
Mean Absolute Difference (MAD) and Mean Absolute Relative Error (ARE) The MAD between the Continuous Monitoring Mode and the Blood Glucose Mode glucose measurements was 17.4 mg/dL (0.4 mmol/L) (for measurements <100 mg/dL (5.6 mmol/L). The ARE was 13.7% for glucose measurements = 100 mg/dL (5.6 mmol/L). Linear Regression Analysis Linear regression analysis of the Continuous Monitoring Mode compared to the Blood Glucose Mode yielded the following results over a glucose range of 20 to 464 mg/dL (1.1 to 25.
Clarke Error Grid Analysis Table 1 shows the distribution of the System/YSI data pairs within the zones of the Clarke Error Grid. Overall, 98.2% of the pairs were within the clinically accurate A Zone or the clinically acceptable B Zone of the error grid. Table B.1: Clarke Error Grid Analysis of Data from FreeStyle NavigatorTM System Accuracy Study Clarke Error Grid Number of Pairs Zone Percent Cumulative Percent A 7865 70.7 70.7 B 3056 27.5 98.2 C 36 0.3 98.5 D 165 1.5 100.0 E 0 0.
Appendix C: Specifications Table C.1: FreeStyle Navigator™ System Specifications Operating and storage 40° to 104°F (4° to 40°C) temperature Operating and storage 5% to 90% relative humidity Operating and storage Sea level to 10,000 feet (3,048 meters) altitude Operating pressure 14.1 psia (sea level) to 10.1 psia (10,000 feet) Sensor life Up to 3 days Glucose result range 20 to 500 mg/dL (1.1 to 27.
Receiver: 12 seconds after last user action • Receiver memory 60 days of normal use including continuous glucose readings (stored every 10 minutes) and daily blood glucose readings • Date/time will be remembered for 10 minutes after Receiver battery removal Calibration • Plasma equivalent Calibration time • First Calibration: This should be done approximately one hour after a new Sensor has been inserted. There is no maximum time allowed for this.
• Internally-powered equipment • Type B equipment • Mode of operation for the Receiver is “continuous operation” • Mode of operation for the Transmitter is “continuous operation with intermittent loading” FCC Compliance Information Transmitter Model Number: PRT01809-001 FCC Rules: Tested to comply with FCC Part 15, Class B, Security/Remote Control Transmitter This device complies with Part 15 of the FCC Rules.
• Increase the separation between the equipment and Transmitter. • Consult the dealer or an experienced radio/TV technician for help. CAUTION: Changes or modification to the device not expressly approved by Abbott Diabetes Care could void the user’s authority to operate the equipment. Receiver Model Number: PRT01845-001 Operating Environment: For Home or Office Use This device complies with Part 15 of the FCC Rules.
CAUTION: Changes or modification to the device not expressly approved by Abbott Diabetes Care could void the user’s authority to operate the equipment.
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GLOSSARY Clinical Trial Support Line: 1-888-971-4766 ART05005-REV-4 - 183 -
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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 the Receiver uses 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. Alarm Sensitivity—Can be adjusted to trigger the Projected Low/High Glucose Alarms (early warning alarms) sooner or later.
Calibration—The System must be calibrated approximately 1, 3, and 24 hours after inserting a new Sensor. The System is calibrated using a blood glucose measurement (performed in the Blood Glucose Mode using the built-in FreeStyle Blood Glucose Meter). The Receiver compares the reading it gets from the blood to the reading the Sensor takes from the interstitial fluid. Based on the calibration, the Receiver calculates the most accurate real-time glucose readings.
Data Loss Alarm—An alarm that tells you when you are about to lose data, or when your alarms are about to stop working. Data Loss Alarms sound when the Transmitter/Receiver connection is broken or when the Sensor has expired. Data Upload—The act of transferring data from the System to a computer. Dressings and Skins—Products that can be used as over-bandages to cover the Transmitter. These can help the Sensor Support Mount adhesive stick to your skin.
FreeStyle Test Strips—A small strip into which you place a drop of blood to perform Blood Glucose Mode tests. You must use ONLY FreeStyle Test Strips with the System. Generic Event—A record of any event that you or your healthcare team think is useful in evaluating glucose patterns. You may assign up to eight Generic Events to observations of your choosing. Glucose Targets—The high and low levels that you would like your glucose to stay between. Used to make reports more meaningful.
Insulin Event—A record of insulin doses (injection or pump) that you enter in the System to help you evaluate current therapy. The time and date of an Insulin Event are always recorded, and you may also enter the type of insulin and dose amount (units). Interstitial Fluid—The fluid in the tiny spaces between your tissues. This is what the System uses to continually measure your glucose levels. In vivo—The measuring of something in the body.
Left/Right Option Buttons—Buttons on the bottom of the Receiver face that allow you to select options shown on the display screen. The Right Option Button also turns the Receiver display screen on. Line Graph Reports—Show continuous glucose lines (plotted at 10-minute intervals) for several different time periods (2, 4, 6, 12, or 24 hours). Low Glucose Alarm—An alarm that tells you when you are at your low glucose threshold (a number you and your healthcare team will set).
your low glucose threshold. Progress Tones—Communicate progress, errors, and successful completion of System activities such as Blood Glucose Mode testing. Receiver—A wireless component of the System that looks and feels much like a traditional blood glucose meter. However, unlike traditional blood glucose meters, the Receiver can provide you with continuous glucose readings from the Sensor.
Sensor Code Number—A number between 106 and 113 that you will find on the Sensor Delivery Unit packaging. This code number must be entered into the Receiver after you insert a new Sensor and before you complete the System calibration. Sensor Delivery Unit—The Sensor Delivery Unit is designed and packaged to enable safe insertion of the electrochemical glucose Sensor into your skin.
Sensor Release Tabs—Parts of the Sensor Delivery Unit that release the Sensor Inserter from the Sensor Support Mount. Sensor Support Mount—The Sensor Support Mount is designed to stay on your skin to hold the Sensor in place and attach the Sensor to the Transmitter. The blue Release Tabs release the Sensor Inserter from the Sensor Support Mount after the Sensor is inserted into the skin.
Status Information—Information about the System and how it is working, such as Sensor time or battery life remaining. System—A short name for the FreeStyle NavigatorTM Continuous Glucose Monitoring System. System Alarms—Non-urgent System messages (for example, low battery life, time for calibration). System Menu—A menu available from the Main Menu that is used to access Status information and other functions.
Transmitter Tabs—Connectors that helps secure the Transmitter to the Sensor Support Mount. Up/Down Arrow Buttons—Buttons on the right face of the Receiver that allow you to move through lists to highlight options. Also used to change numbers.
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INDEX Page numbers for primary entries are in bold.
157, 158, 159, 163, 164, 167, 168, 174, 176, 177, 178, 179, 180, 181, 185, 186, 187, 188, 190, 191, 192, 194, 195 Receiver Arrow Buttons: 30, 31, 35, 62, 68, 79, 80, 81, 82, 89, 90, 92, 93,102, 104, 107, 109, 111, 112, 117, 119, 120, 136, 137, 138, 188, 195 Receiver battery: 142, 158, 177, 178 Receiver Option Buttons: 29, 30, 31, 35, 36, 37, 61, 62, 68, 75, 81, 88, 89, 90, 91, 92, 93, 94, 102, 104, 107, 109, 110, 111, 112, 118, 119, 128, 135, 136, 137, 138, 152, 164, 167, 190 Receiver Status: 128, 130, 191
